PATENTABILITY OF INVENTIONS : US and European perspectives

SWAPNA SUNDAR

CEO, IP DOME – IP STRATEGY ADVISORS

Module III

CONTACT SEMINARS ROUND 1

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Agenda • US Patent Regime

1.Patentability of Inventions

2.Utility

3.Anticipation

4.Obviousness

5.Enablement• European Patent regime• Questions

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• US PATENT REGIMEI. Title 35 USC & Title 37 CFR

II. Patentability

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Consists of 37 chapters (376 sections of which 149 of are used).

Title 35 has four parts:

Part I—USPTO Part II—Patentability of Inventions and Grant of Patents Part III—Patents and Protection of Patent Rights Part IV--Patent Cooperation Treaty

Title 35 of the US Code governs Patent law

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Code of Federal Regulations is the codification of the general and permanent rules and regulations.

CFR must have an "enabling statute”.

USC is a codification of legislation; CFR is administrative law.

USC precedes the CFR and contains statutes enacted by Congress.

CFR spells out in further detail how the executive branch will interpret the law.

CFR Title 37 – Patents, TM and ©

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The Applicant must be the inventor.

Patentable subject matter (section 101)

Novel and the application for a patent on the invention must be timely (section 102)

The invention must be non-obvious (section 103)

The invention must be sufficiently documented (section 112)

Patentabililty: Eligibility for grant

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-UTILITY PATENTS- generally permits patentee monopoly over making, using,

or selling the invention for 20 years from the date of patent application filing, subject to the payment of maintenance fees.

-DESIGN PATENTS-PLANT PATENTS

-Reissue patents, defensive publication, statutory invention registration

Patents issued by the USPTO

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Whoever invents or discovers

any new and useful process,

machine,

manufacture, or

composition of matter,

or any new and useful improvement thereof,

may obtain a patent therefor, subject to the conditions and requirements of this title

35 USC 101 Inventions patentable

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An invention must belong to one of these classes:

a. Machine (eg. Mechanism with moving parts)

b. Article of manufacture (eg. Hand tool or diagnostic kit)

c. Composition of matter (eg. Drug)

d. Process (eg. Of making nanotubes)

PROCESS defined in 35 U.S.C. 100:- means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.

What is patentable – (102 & 103)

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e. New use or improvement of existing invention

f. Modified living organism (eg. Transgenic rice)

g. Isolated or purified natural materials (eg. Purified proteins)

- Mathematical formulae, chemical elements, laws of nature are not patentable.

Gene Patents are patent on a specific isolated gene sequence, its chemical composition, the processes for obtaining or using it, or a combination of such claims. Gene patents are a part of the broader category of biological patents.

What is patentable Contd.

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Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948): Kalo got patents on packaged mutually non-inhibitory rhizobia species for inoculation into the roots of leguminous plants and for the process. Held unpatentable as: “qualities of these bacteria…are manifestations of laws of nature”“aggregation of species”

ISOLATES: The first patent for a human product was granted on March 20, 1906 for a purified form of adrenaline. It was challenged and upheld in Parke-Davis v. Mulford [2] Judge Hand argued that natural substances when they are purified are more useful than the original natural substances.

Cases

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• US PATENT REGIMEI. Utility

II. Novelty

III. Non-obviousness

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Invention must demonstrate identifiable benefit and use; must express a specific, credible, and substantial utility.

• Operability whether the invention actually works or accomplishes the utility that the inventor claims

• a beneficial use requires that the patented invention “not be frivolous or injurious to the well-being, good policy, or sound morals of society”. An invention is ‘useful’ under section 101 if it is capable of providing some identifiable benefit.

• practical use: in Brenner V. Manson a novel process for making a known steroid did not satisfy the utility requirement because the patent applicants did not show that the steroid served any practical function.

Utility 35 USC 101

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Utility diluted

Juicy Whip, Inc. v. Orange Bang, Inc. dealing with a juice dispenser that arguably deceived the public into believing that the liquid seen in the attached reservoir was that which was being dispensed

Gambling

Toys to enhance sexual pleasure

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Patent can be granted to an invention unless it (a) was known or used by others in this country, or patented or

described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or

(b) was patented or described in a printed publication in US or another country or in public use/sale in this country, more than 1 year prior to the date of the application for patent in the US

(c) Was abandoned by the applicant(d) patented in another country <12 months before US filing

Novelty

(e) the invention was described in - (1) a published US prior patent application

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(2) A patent granted before the invention or an international application filed under the PCT in English(f) he did not himself invent the subject matter sought to be patented(g)(1) during the course of an interference it is established that the invention was made by another inventor and not abandoned, suppressed, or concealed.

or (2) that the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it.

Considerations:dates of conception and reduction to practice of the inventionreasonable diligence of one who was first to conceive and last to reduce to practice,

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City of Elizabeth V. American Nicholson Paving: Nicholson sought to patent a process for a system of pavement using wooden blocks and sued the City of Elizabeth, NJ for infringement. City claimed that he had publicly used the system for 6 years. Court found that he had been testing it in private conditions.

Nicholson put down a section of his new pavement on a turnpike operated by a private corporation in which Nicholson was a shareholder and officer in 1848 in order to test its durability and the public's response to it. Supreme Court held that while the public use of an invention more than one year prior to the inventor's application for a patent normally causes the inventor to lose his right to a patent, there is an exception to this rule for public uses for experimental purposes.

Nicholson paving case

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• ANTICIPATION"A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference."

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Verdegaal Bros. v. Union Oil Co. of California, "When a claim covers several compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.

" Brown v. 3M (claim to a system for setting a computer clock to an offset time to address the Year 2000 (Y2K) problem, applicable to records with year date data in "at least one of two-digit, three-digit, or four-digit" representations, was held anticipated by a system that offsets year dates in only two-digit formats.

Richardson v. Suzuki Motor Co., The elements must be arranged as required by the claim, but identity of terminology is not required.

Anticipation

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35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:

(A)Prove the primary reference contains an "enabled disclosure;" In re Donohue, claims were rejected over a publication in view of two patents.

• The publication disclosed the claimed compound structure • the patents taught methods of making compounds of that

general class.

The court held that the publication taught all the elements of the claim and thus motivation to combine was not required.

Anticipation contd.

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Anticipation contd. (B) Extrinsic evidence may be used to explain but not expand the meaning of terms used in the anticipating reference. In re Baxter Travenol Labs. Baxter invented a blood bag system incorporating a bag containing DEHP.

The examiner rejected the claims over a technical progress report by Becker which taught the same blood bag system without expressly disclosing DEHP but disclosing the commercial blood bag system as "very similar to Travenol's." Extrinsic evidence (depositions, declarations and patentees admissions) showed that commercial blood bags contained DEHP. PHOSITA would have known that "commercial blood bags" meant bags containing DEHP.

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Anticipation contd. (C) Show that a characteristic not disclosed in the reference is inherent. Continental Can Co. USA v. Monsanto Co., accommodates situations in which the common knowledge of technologists is not recorded in the reference.

Atlas Powder Co. v. IRECO, Inc., Two prior art references disclosed blasting compositions containing water-in-oil emulsions with identical ingredients to those claimed, in overlapping ranges with the claimed composition. The only element of the claims arguably not present in the prior art compositions was "sufficient aeration . . . entrapped to enhance sensitivity to a substantial degree." The Federal Circuit found that the emulsions described in both references would inevitably and inherently have "sufficient aeration“.

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A plant patent is granted by the Government to an inventor who has invented or discovered and asexually reproduced a distinct and new variety of plant, other than a tuber propagated plant or a plant found in an uncultivated state.

The grant, which lasts for 20 years from the date of filing the application, protects the inventor's right to exclude others from asexually reproducing, selling, or using the plant so reproduced. Mutants, hybrids, and transformed plants are comprehended; sports or mutants may be spontaneous or induced.

Plant Patents (161)

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Hybrids may be natural, from a planned breeding program, or somatic in source. While natural plant mutants might have naturally occurred, they must have been discovered in a cultivated area. Algae and macro fungi are regarded as plants, but bacteria are not.

In Pioneer Hi-bred Intl V. J.E.M. Ag Supply : Supreme Court upheld the validity of sexually reproduced plants as subject matter for patent protection.Rejecting the argument that the 1930 Plant Patent Act2 (“PPA”) and the 1970 Plant Variety Protection Act3 (“PVPA”) precluded the patenting of plants under section101

Plant Patents Contd.

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INFRINGEMENT A patent provides its proprietor with the right to exclude others from utilizing the invention claimed in that patent. Should a person utilize that invention, without the permission of the patent proprietor, they may infringe that patent.

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Direct infringement

A person directly infringes a patent by making, using, offering to sell, selling, or importing into the US any patented invention, without authority, during the term of the patent.

Unlike direct infringement, which does not require knowledge of the patent or any intent to infringe.

While the United States Patent Act does not directly distinguish "direct" and "indirect" infringement, it has become customary to refer to describe infringement under 35 U.S.C. § 271(a) as direct infringement, while grouping 35 U.S.C. § 271(b) and 35 U.S.C. § 271(c) together as "indirect" ways of infringing a patent.,

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Indirect Infringement

Accused has some knowledge and intent

35 U.S.C. § 271(b) "active inducement of infringement “by encouraging, aiding, or otherwise causing another person to infringe. Inducer must be aware of the patent and intend. 35 U.S.C. § 271(c) "contributory infringement," is triggered when a seller provides a part or component that, while not itself infringing of any patent, has a particular use as part of some other machine or composition that is covered by a patent.[3] If there are other valid uses for the product.

Only occurs when there has actually been a direct infringement of the patent. There must have been at least one instance where the inducement or contribution resulted in the practice of the patented art.

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Defenses Non-infringement:to prove infringement, patentee must show that each and every limitation of the asserted claim is present in the accused product, either literally or equivalently. If the patentee fails to show the presence of even a single claim limitation, that is enough to negate an allegation of infringement of the claim. This is known in patent law as the “all elements rule”.

Attack the validity of the Patent and claims. Even if patent is determined to be valid, the Plaintiff must prove that every element of at least one claim was infringed.

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Safe Harbour defense: Research for "purely philosophical" inquiry is not an infringement, but research directed to commercial purposes is infringing. 1813 decision in Whittemore v. Cutter, Justice Story wrote that the intent of the legislature could not have been to punish someone who infringes "merely for [scientific] experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects.“

Hatch-Waxman process – Where research is directed toward obtaining approval of the Food and Drug Administration (FDA) for introduction of a generic version of a patented drug

Defenses contd.

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Reasonable royalty determined by the standard practices of the particular industry

Lost profits due to infringement

"willful" infringement could lead to punitive damages assessed up to 3X actual damages. Legal fees can also be assessed.

Injunction and removal of an infringing product from the market.

Until the 2006 Supreme Court case of eBay v. MercExchange, plaintiffs routinely sought, and were granted, injunctions prohibiting infringement of their patents. After 2006, injunctions were much harder to obtain, leaving plaintiffs to pursue remedies only for damages.

Remedies

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• DOCTRINE OF EQUIVALENTS

holds a party liable for patent infringement even though the infringing device or process does not fall within the literal scope of a patent claim, but nevertheless is equivalent to the claimed invention.

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In the US, the doctrine is applied to individual claim limitations, not to the invention as a whole and is limited by prosecution history estoppel.

The difference between the limitation in the accused device and the limitation literally recited in the patent claim may be found to be "insubstantial on the basis of the triple identity test:

It performs substantially the same functionIn substantially the same wayTo yield substantially the same result

Infringement: Doctrine of Equivalents

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If the patentee abandoned through an amendment to the patent application certain literal claim coverage (e.g., by narrowing the literal scope of the patent claim), then the patentee is estopped from later arguing that the surrendered coverage is insubstantially different from the literally claimed limitation.

Prosecution history estoppel

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Hilton Davis Chemical Co. had developed an "ultrafiltration" process to purify dyes. By amendment he specified that a solution used in the process must have a pH level between 6.0 and 9.0, to avoid overlap with prior art which specified lower limit of 9.0; however, the plaintiff was unable to explain why the amendment stated a lower level of 6.0. The defendant had developed a process using a solution with a pH level of 5.0, which was outside the range of the plaintiff's patent. Held estopped.

Warner-Jenkinson Co. v. Hilton Davis Chem. Co. (1997)

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Festo was marketing a patented industrial device . SMC began marketing a device that used one two-way sealing ring and a non-magnetizable sleeve. Festo filed suit claiming infringement under the doctrine of equivalents. Festo's claim had been amended during prosecution for statutory compliance and SMC claimed that prosecution history estoppel should bar Festo .

(a) To enable a patent holder to know what he owns, and the public to know what he does not, the inventor must describe his work in “full, clear, concise, and exact terms.” Thus, a patent's scope is not limited to its literal terms, but embraces all equivalents to the claims described.

Festo Corporation Vs. SMC

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Festo Corpn. Contd. (b) Prosecution history estoppel requires that patent claims be interpreted in light of the proceedings before the Patent and Trademark Office (PTO). When the patentee originally claimed the subject matter alleged to infringe but then narrowed the claim in response to a rejection, he may not argue that the surrendered territory comprised an unforeseen equivalent. Were it otherwise, the inventor might avoid the PTO's gatekeeping role and seek to recapture in an infringement action the very subject matter surrendered as a condition of receiving the patent.

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Gottschalk v. Benson method of programming a general-purpose digital computer using an algorithm to convert binary-coded decimals into pure binary numbers.

Held the discovery was un-patentable since it was no more than abstract mathematics; granting it would preclude others from using the abstract mathematical principles. Court’s decision did not preclude patenting of software, only patentability where the only useful characteristic was an algorithm.

Software/algorithm patentability: trilogy

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Parker v. Flook method of calculating alarm limits by using a "smoothing algorithm" to make the system responsive to trends but not momentary fluctuations in process variables (such as temperature). Held Where a patent was sought on an implementation of a principle (the algorithm), the implementation itself must be inventive for a patent to issue. Since that was not so, the Court held unpatentable.

Diamond v. Diehr A method of operating a rubber-moulding press for precision molded compounds with the aid of a digital computer. In this case the Court backed away from the analytic dissection approach, and insisted that patent-eligibility must be decided on the basis of the claim (or invention) considered as a whole, granting the patent. Court studiously avoided stating that Flook and Benson were overruled or limited.

Trilogy Contd.

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Business Methods The Federal Circuit has not yet defined what it is that specifically characterizes a business method claim and separates it from other process claims. The Court has stated that claims drawn to a method of doing business should not be categorized as a “business method” claim, instead they should be treated like any other process claim. State Street Bank & Trust Co. v. Signature Financial Group, 1998: The claimed invention as a whole must accomplish a practical application. It must produce a "useful, concrete and tangible result."

A business method may be defined as "a method of operating any aspect of an economic enterprise". International Patent Classification (IPC), for business methods: "G06Q" (Data processing systems or methods, specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes).

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Business Method claims

U.S. Class 705: Automated business data processing technologies, applications related to financial data processing.

Class 434 Education and Demonstration: methods of teaching are classified in

Class 273, Amusement Devices & games: Methods of playing games

Class 47, Plant Husbandry: Methods of improving crop

Other process claims which may be labelled a “business method” are classified and examined according to their technology.

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Drafting Business Method claims

- “Jepson-type” claim construction - Limit claims, drawn to a single invention - claims have proper antecedence in the specification - Start with broad claims and then narrow them - Range within a range normally raises 112, 2nd paragraph issuesBe aware of 101 issues:• data streams per se (not patentable per se)• non functional data (not patentable per se)

Be careful with statements of intended use; “able” or “adapted for” clauses & “whereby” and “wherein” clauses - the limiting effect of the language in the claim

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Bilski v. Kappos - method of hedging the seasonal risks of buying energy On June 28, 2010, the Court ruled] that Bernard Bilski's patent application is an abstract idea and is therefore unpatentable.

However, it also said that business methods are not inherently unpatentable, and was silent on the subject of software patents. The majority opinion also said that the Federal Circuit's "machine or transformation" test, while useful, is not an exclusive test for determining the patentability of a process.

Bilsky: patent-eligibility of a process

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Patenting of life

1970s A.M.Chakrabarty of GE developed a geneticallyimproved microorganism that was designed to break down crude oil rapidly; Process granted but not productIn 1980, 8 years after the initial filing, the Supreme Court held that the microorganisms were a new composition of matter, the product of human ingenuity and not of nature’s handiwork, and thus a patentable subject matter. – Human intervention test

Chakrabarty and Kellogg for ‘‘Bacteria capable of dissimilation of environmentally persistent chemical compounds,” in 1985. Kenneth Hibbard, Paul Anderson, and Mellanie Barker for ‘‘Tryptophan overproducer mutants of cereal crops,’’in 1986. Philip Leder and Timothy Stewart ‘‘Transgenic nonhumanmammals’’ in 1988 the ‘‘Harvard Mouse,’’

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Human cells patentingHuman cells, expressed sequence tags (ESTs), single nucleotide polymorphisms (SNPs), and cultivation and isolation of stem cells have also been patented.

David Golde and Shirley Quan for ‘‘Unique T-lymphocyte line and products derived therefrom’’ in 1984 for cell line derived from John Moore’s spleen

Ann Tsukamoto, Charles Baum, Ykoh Aihara, and Irving Weissman for ‘‘Human hematopoetic stem cell,’’ isolated human bone marrow stem cells in 1991

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Test for patenting lifeThe relevant distinction was not between living and inanimate things but between products of nature, whether living or not, and human-made inventions. The tests set forth by the Court :

(A) "The laws of nature, physical phenomena and abstract ideas" are not patentable subject matter(B) A "non-naturally occurring manufacture or composition of matter - a product of human ingenuity -having a distinctive name, character, [and] use" is patentable subject matter.(C) "[A] new mineral or Einstein's E=mc2 are 'manifestations of nature, free to all men and reserved exclusively to none.'"(D) Production of articles prepared by giving to raw materials new forms, qualities, properties, or combinations whether by hand labour or by machinery" [emphasis added] is a "manufacture" under 35 U.S.C. 101.

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Diamond vs. Chakrabarty:Genetic engineer Ananda Mohan Chakrabarty, working for General Electric, had developed a bacterium (derived from the Pseudomonas genus) capable of breaking down crude oil, which he proposed to use in treating oil spills. The application for patent was turned down by the USPTO because the law dictated that living things were not patentable. The Board of Patent Appeals and Interferences agreed with the original decision; however, the United States Court of Customs and Patent Appeals overturned the case in Chakrabarty's favor, writing that "the fact that micro-organisms are alive is without legal significance for purposes of the patent law."

Diamond v. chakrabarty

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Sidney A. Diamond, Commissioner of Patents and Trademarks, appealed to the Supreme Court. The Supreme Court case was argued on March 17, 1980 and decided on June 16, 1980. In a 5–4 ruling, the court ruled in favor of Chakrabarty, and upheld the patent, holding that: A live, human-made micro-organism is patentable subject matter under § 101. Respondent's micro-organism constitutes a "manufacture" or "composition of matter" within that statute.

Diamond Vs. Chakrabarty Contd.

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Class 800: living multicellular organisms (nonhuman animals and plants) and separated or severed parts thereof that have not undergone any modification or treatment subsequent to their separation. Genetic modification processes are included.

Mammals, method of making and using a transgenic nonhuman animal in an in vivo test method (e.g., drug efficacy tests, etc.) & method of using a transgenic nonhuman animal to manufacture a protein which is then to be isolated or extracted are contemplated.

Different types of breeding techniques are also provided for.

Living multicellular organisms

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Inventors: Philip Leder, Timothy A. StewartOriginal Assignee: President and Fellows of Harvard CollegeCurrent U.S. Classification: 800/10; 435/6.14; 435/317.1; 536/23.5; 800/18International Classification: C12N 100; C12Q 168; C12N 1500; C12N 500

Patent number: 4736866Filing date: Jun 22, 1984Issue date: Apr 12, 1988

Two patents were issued to Harvard College covering methods for providing a cell culture from a transgenic non-human animal (expired Feb 11, 2009) and testing methods using transgenic mice expressing an oncogene (expiring 2016)

Harvard Oncomouse

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Other jurisdictions

Canada2002: Supreme Court rejected the patent in Harvard College v. Canada, overturning a Federal Court of Appeal verdict which ruled in favour of the patent. 2003: Canadian patent 1,341,442 CA 1341442 was granted to Harvard College amended to omit the "composition of matter" claims on the transgenic mice. Canadian patent law allowed the amended claims to grant under pre-GATT rules and the patent remains valid until 2020.EPO1989: refused in by an Examining EPO as EPC excludes patentability of animals per se. 1992 granted on the ground that varieties were unpatentable not animals per se. 2001, hearing on objections, the patent was maintained in amended form. 2006 revoked for failure to pay the fees and to file translated claims.

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3. NON-OBVIOUSNESS• If the differences between the subject matter sought to be patented

and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.

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Non-obviousness

(A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution to obtain predictable results; (C) Use of known technique to improve similar devices(D) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (E) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (F) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.

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Structural obviousnessthe motivation of PHOSITA to make a claimed compound, expecting compounds similar in structure will have similar properties

In re Merck & Co., Inc., 1986, claimed and prior art compounds used in a method of treating depression expected to have similar activity because the structural difference between the compounds involved a known bioisosteric replacement.

In re Dillon, 1991, The tri-orthoester fuel compositions of the prior art and the claimed tetra-orthoester fuel compositions would have been expected to have similar properties based on close structural and chemical similarity between the orthoesters and the fact that both the prior art and applicant used the orthoesters as fuel additives.

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Formulation

Unigene Labs. and Upsher-Smith Labs v. Apotex, 2011: Unigene's reissued patent covers its Fortical calcitonin nasal spray developed in response to Novartis's Miacalcin calcitonin nasal spray. Content of citric acid, polysorbate 80, phenylethyl alcohol and benzyl alcohol are claimed in Unigene's patent. Citric acid enhances absorption. Novartis product used BZK for the purpose.

In 2006, Apotex filed an ANDA to import a generic version of Unigene's spray. Unigene sued for infringement. Apotex’s obviousness defense was struck down by Fed.Cir.

The court determined that the citric acid in Unigene serves as a substitute for BZK and that at the time of invention, it was not an obvious substitute for BZK.

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Process

"A process yielding a novel and nonobvious product may nonetheless be obvious; conversely, a process yielding a well-known product may yet be nonobvious." TorPharm, Inc. v. Ranbaxy Pharmaceuticals, Inc., (Fed. Cir. 2003)

Brouwer, "highly fact-specific by design“ to be assessed on a case-by-case basis. Ochai: flexibility

Process of chemically reducing one novel, nonobvious material to obtain another novel, nonobvious material was held obvious because the reduction reaction was old. In re Albertson (CCPA 1964)

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Federal Circuit:[A]n otherwise old process becomes a new process when apreviously unknown starting material is subjected to a conventional manipulation to produce a product which may also be new. But it does not necessarily mean that the whole process has become unobvious. If the "use of an unobvious starting material renders a process unobvious“ - every step, for example, dissolving or heating, when performed on a new compound would result in a patentable process.

Applicant claimed the process of making the novel carbamate products from the novel oxime starting materials

In re Durden

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In re Kuehl, (CCPA 1973) Process of cracking hydrocarbons using novel zeolite catalyst found to be patentable even though catalytic cracking process was old. The obviousness of the process of cracking hydrocarbons with ZK-22 as a catalyst must be determined without reference to knowledge of ZK-22 and its properties.” PHOSITA would not only have to able to predict the outcome of using ZK-22, but also find it obvious to use ZK-22 which was not predictable until the invention.

In re Kuehl

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Method of use

Obviousness-type double patenting applies

Applicants are barred from obtaining multiple patents covering the same invention by the doctrine of double patenting.  There are two types of double patenting: statutory double patenting, which prohibits a later patent from covering the identical invention, and obviousness-type double patenting, which prevents a later patent from covering a slight variation of an earlier patented invention.

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Sun Pharma V. Eli Lilly

Eli Lilly’s Patent No. 4,808,614 related to Gemzar – which claims both gemcitabine itself, a method of using it to treat viral infections, as well as discloses using gemcitabine to treat cancer. Patent No. 5,464,826 claims a method of treating cancer comprising administering a therapeutically effective amount of gemcitabine. 

The applications leading to both the '614 (exp. 2010) and '826 (exp. 2012) patents were filed on the same day, December 4, 1984.  The '614 was a continuation-in-part of application No. 473,883 which did not disclose using gemcitabine to treat cancer. 

Obviousness-type of double patenting

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Proteins which are the product of biotechnological processes are often known and naturally occurring and therefore product claims can be subject to rejection during prosecution.

Thus process claims can protect the biotechnology product as well as the process where the product is not patentable for obviousness. A process will prevent a foreign competitor from importing the product into US. Based on in re Durden, PTO routinely rejected claims to process for cultivating a patented transformed host cell to produce an unpatentable product.

PTO rejected process claims with genetically engineered starting materials.

Process in biotechnology and chemistry

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THE BIOTECHNOLOGY PROCESS PATENT ACT, 1995

Divided section 103 into three subsections.

Section 103(b) now provides that the applicant can elect for patent to proceed under a biotechnologicalprocess using or resulting in a composition of matter that is novel undersection 102 and nonobvious under section 103(a). Claims to the process and the composition of matter should be contained in either the same application for patent or in separate applications having the same filing date; and the compositions of matter, and the process at the time it was invented should be owned by the same person or subject to an obligation for assignment to the same person.

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Contd.

The term “biotechnological process” means -(A) a process to genetically alter or otherwise inducing a single-or multi-celled organism to -(i) express and exogenous nucleotide sequence,(ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotidesequence, or(iii) express a specific physiological characteristic not naturally associated withsaid organism;(B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and(C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B).

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PHOSITA is a legal fiction defined in the Patent Act of the United States, based on

- educational level of the inventor;- type of problems encountered in the art;- prior art solutions to those problems;- rapidity with which innovations are made;- sophistication of the technology; and-educational level of active workers in the field

PHOSITA

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Teleflex, Inc. sued KSR International, claiming that KSR products infringed Teleflex's patent on connecting an adjustable vehicle control pedal to an electronic throttle control. KSR argued that the combination of the two elements was obvious, and the claim was therefore not patentable.

The district court ruled in favour of KSR. Federal Circuit reversed in January 2005.

On April 30, 2007, the Supreme Court reversed the judgment of the Federal Circuit, holding that the disputed claim 4 of the patent was obvious.

Federal Circuit had rigidly applied the "teaching-suggestion-motivation" (TSM) test.

Obviousness: KSR V. Teleflex

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Winner Int'l Royalty Corp. v. Wang, (2000), there must be a suggestion or teaching in the prior art to combine elements shown in the prior art in order to find a patent obvious.

Non-obviousness grant of patent requires more than simple novelty. Thomas Jefferson's 1813 letter: changing material to "chain, rope, or leather" was insufficient for patentability. Patent Act of 1952, in part, to reduce the impact of nonobviousness on patentability and to eliminate the flash of genius test.

Obviousness: TSM Test

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Graham et al. v. John Deere Co. of Kansas City et al., (1966) held that obviousness should be determined by looking at

the scope and content of the prior art;the level of ordinary skill in the art;the differences between the claimed invention and the prior art; andobjective evidence of non-obviousness outlined by:

commercial success;long-felt but unsolved needs; andfailure of others.

Graham Factors

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Environmental Designs, Ltd. v. Union Oil Co. of Cal., (Fed. Cir. 1983) considering scepticism or disbelief before the invention as an indicator of non-obviousness;

Allen Archery, Inc. v. Browning Mfg. Co., (Fed. Cir. 1987) considering copying, praise, unexpected results, and industry acceptance as indicators of non-obviousness

Graham Factors contd

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4. ENABLEMENT• a written description of the invention, and of the

manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.

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PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLINGWhen it expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to provide facts rebutting the presumption of operability. In re Sasse, (CCPA 1980)

WHAT CONSTITUTES AN "ENABLING DISCLOSURE" DOES NOT DEPEND ON THE TYPE OF PRIOR ART THE DISCLOSURE IS CONTAINED IN

The level of disclosure required within a reference to make it an "enabling disclosure" is the same no matter what type of prior art is at issue. It does not matter whether the prior art reference is a U.S. patent, foreign patent, a printed publication or other. In re Moreton, (CCPA 1961).

In general

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EFFICACY IS NOT A REQUIREMENT FOR PRIOR ART ENABLEMENT for anticipation. If it in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention. Impax Labs. Inc. v. Aventis Pharm.Inc., (Fed. Cir. 2006).

REJECTIONS AND USE OF INOPERATIVE PRIOR ART

"Even if a reference discloses an inoperative device, it is prior art for all that it teaches." Beckman Instruments v. LKB Produkter AB, (Fed. Cir. 1989). Therefore, "a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103." Symbol Techs. Inc. v. Opticon Inc (Fed. Cir. 1991).

Contd.

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Best Mode: Patent must disclose the best mode of practising the invention including preferred materials and methods. Failure may result in patent being declared ‘unenfoceable’.

Duty of Candor: good faith and specifically requires that everyone involved with a patent application must disclose all publications that they know of which may adversely affect the patentability of their invention through out the pendency of the application . Within 3 months all material information must be disclosed.

Further requirements (112)

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Oath: The inventor must swear that she understands the patent document, the duty of candour and full disclosure and that the named inventor is the true and first inventor.

Inventorship The requirement that the applicant for a patent be the inventor is a characteristic of U.S. patent law. The threshold question in determining inventorship is who conceived the invention. Unless a person contributes to the conception of the invention, he is not an inventor. Conception of atleast one claim.

Further requirements Contd.

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The Leahy-Smith America Invents Act (AIA) is United States federal legislation that was passed by Congress and was signed into law by President Barack Obama on September 16, 2011.

Changes to be implemented with varying dates between Sept. 2012 -13

America Invents Act

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Substantive Changes

• Changes from "First to Invent" to "First to File" Systemo "Effective Filing Date"o Eliminates One-year Grace Period for 3rd party disclosureso Makes changes to prior art

• Provides Derivation Proceedings • Adds Pre-Grant Submissions• Expands Post-Grant Proceedings

o Expands on Post-Grant Submissionso Retains Ex Parte Reexaminationo Eliminates Inter Partes Reexamination, but…

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Substantive Changes II

Adds Post-Grant Patent ReviewAdds Inter Partes Review

• Adds Post-Grant Supplemental Examination o Provides Patent Owner with an opportunity to "cure" errors in

prosecution

• Eliminates Best Mode Failure as a Defense

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Prior ArtThe Act omits the 102(g) interference and prior art provisions, relating to an invention that was previously made in this country by another inventor who had not abandoned, suppressed, or concealed it

oNo more patent interferences oDerivation proceedings will be available102(a) A person shall be entitled to a patent unless—

(1)the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or

(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.

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• Exceptions from Prior Arto Applicant's own "disclosures" within 1 year before the

"effective filing date" of a U.S. application and the information derived therefrom.

o Includes Applicant's own publicationso Grace period is expanded in cases claiming foreign priorities

and provisional applicationso Subject matter related to a research agreement.

Prior Art Exceptions

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Post-Grant Patent Review Procedures Summary and Timing

Procedure Request Effective Date

Threshold

Ex parte reexam Anyone In effect Substantial new question of patentability

Inter partes reexam

Third party request based on patents and printed publications

Now – 9/2012

Reasonable likelihood that petitioner would prevail (upon enactment)

Inter partes review

Third party request based on patents and printed publications

Beginning 9/2012

Reasonable likelihood that petitioner would prevail (upon enactment)

Post-grant review

Third party request based on any ground of invalidity that could be raised under paragraph (2) or (3) of § 282 (b) or showing a novel or unsettled legal question that is important to other patents

Beginning with patents filed after 3/2013

More likely than not that at least 1 challenged claim is unpatentable

Supplemental examination

Patent owner 9/2012 Substantial new question of patentability

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Overview of Available Procedures

1 2 3 4 5

Relevant Dates1: Filing Date2: Notice of Allowance3: Patent Grant Date4: 9 mo from Patent Grant Date5: Patent Expiration Date

A* BC

Relevant FilingsA: Third Party SubmissionsB: Post-Grant Review C: Inter partes ReviewD: Supplemental Examination (Patent Owner Only)E: Ex parte Reexamination (Patent Owner or 3rd Party)

D/E

*Third Party Submissions may be f iled during prosecution. The date for submission depends on the facts.

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First to File

• "Effective Filing Date" • One year grace period only good for Inventor's own disclosures• Broader scope of patent-defeating prior art• Derivation Proceeding- operate only when inventor alleges that

the other applicant derived invention from the inventor• Priority based on effective filing date

o Effective March 16, 2013 (may be a rush to file for choice of law) and it applies to any patent application that has an "effective filing date" after the 18 month period.

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Will replace patent interference 35 U.S.C. § 291

(a) In General – when a patentee claims the same invention with an earlier effective filing date, an owner of a patent may have relief by civil action against him, if the former patent was derived from the inventor of the latter patent.

(b) Filing Limitation – An action under this section may be filed only before the end of the 1-year period beginning on the date of the issuance of the first patent containing a claim to the allegedly derived invention and naming an individual alleged to have derived such invention as the inventor or joint inventor.

Derivations

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Pre-grant submissions (3rd party observations)Effective date: September 16, 2012; applies to any pending patent application at that time.

• When:o Must be filed "before the earlier of–"

(A) Date of Notice of Allowance or(B) the later of (i) 6 months after publication date or(ii) date of first Office Action (rejection)

• What: Third Party Submissionso Citation to Printed publications (patent, non-patent, or court

decision (can likely introduce an argument under §§ 101 and 112))

o "Concise" Description of Relevance

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Post-grant submissions Expands Post-Grant SubmissionsRetains Ex Parte ReexaminationEliminates Inter Partes Rexamination, but…

Adds Post-Grant Patent ReviewAdds Inter Partes Review

Adds Post-Grant Supplemental Examination

Request for Ex Parte Reexamination (§ 302) Effective date: N/A

Who and When: Any person at any timeScope: §§ 102 and 103

Threshold for Initiation: Substantial New Question of Patentability

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Post-grant submissions – II

Post-Grant Submissions (§ 301)• When (September 16, 2012)

o Any time after patent grant• What

o InformationPrior Art consisting of patents or printed publications

(same as before) orWritten Statements made by the patent owner either

before a Federal court or the USPTO related to claim scope (new)

o Include written explanation that provides reasons why the Prior Art or Written Statements are relevant

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Post-grant proceedingsPost-Grant Review (§ 321) and Inter Partes Review (§ 311)

• Effective Date (September 16, 2012). • Post-grant review: Applies only to patents having an

effective date on or after 18 months from enactment. • Inter partes review: Applies to any patent issuing before, on,

or after that date. • When

o Post-grant review: petition filed within 9 months from patent grant date of patent or from grant date of reissued patent (§ 321(c))

o Inter partes review: petition filed after the later of either 9 months after patent grant or termination of a post-grant review (§ 311(c))

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Post-Grant Review (§ 321) and Inter Partes Review (§ 311)

• Scopeo Post-grant review: Can challenge any aspect of patentability

of any claim including §§ 101 and 112 o Inter partes review: Restricted to patents and printed

publications and to issues of novelty and non-obviousness• Patent Owner's Right

o Post-grant review: Preliminary Responseo Inter partes review: Preliminary Response

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Post-Grant Review (§ 321) and Inter partes review (§ 311)

• Threshold for Initiationo Post-grant Review: USPTO must consider petition

information and patent owner's preliminary response and will initiate post-grant review if it is more likely than not that at least one claim is unpatentable. (§ 324(a), i.e., preponderance of evidence standard). Threshold "may also be satisfied by a showing that the

petition raises a novel or unsettled legal question that is important to other patents or patent applications." (§ 324(b))

o Inter partes review: Same as above except that the required showing is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition. (§ 314(a))

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Post-Grant Review (§ 321) and Inter partes review (§ 311)

• Evidentiary Standardo Post-grant Review: The "petitioner shall have the burden of

proving a proposition of unpatentability by a preponderance of the evidence." (§ 326(e))

o Inter partes review: Same as above. (§ 316(e))

• Patent Owner's Right to Amend• Post-grant Review: Right to file motion to amend the

claims, second motion only possible if both parties agree (§ 326(d))

• Inter partes review: Same as above. (§ 316(d)) ● Confidential Settlements are Allowed ● Intervening Rights (§ 252) Apply

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Post-Grant Review (§ 321) and Inter partes review (§ 311)

• Time Limit for Completiono Post-grant Review: Proceeding should be completed within

1 year with one 6 month extension available on a showing of "good cause." (§ 326(a)(11))

o Inter partes review: Same as above. (§ 316(a)(12))

• Preclusive Effect (Estoppel)• Post-grant Review: Cannot raise issues before the USPTO,

District Court, or the ITC if the issues were previously raised or reasonably could have been raised. (§ 325(e))

• Inter partes review: Same as above. (§ 315(e))

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Post-Grant Review (§ 321) and Inter partes review (§ 311)

• Litigation Limitationso Post-grant Review: Cannot request review if previously filed

declaratory judgment ("DJ") action contesting the validity of the patent (§ 325(a)(1))

o Inter partes review: Same as above. (§ 315(a)(1)) Except that inter partes review cannot occur after 9 months of the filing of the complaint by the patent owner against the petitioner. (§ 315(b))

o Post-grant Review: If petitioner files civil action on or after request for review, then civil action automatically stayed unless (i) the patent owner requests to lift the stay, (ii) the patent owner files its own civil action or files a counterclaim, or (iii) the petition requests to dismiss civil action. (§ 325(a))

o Inter partes review: Same as above. (§ 315(a))

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For both types of proceedings, discovery rules will be promulgated for:• Setting forth standards and procedures for discovery of

relevant evidence, including that such discovery shall be limited to:

• PGR: evidence directly related to factual assertions advanced by either party to the proceeding.

• IPR: the deposition of witnesses submitting affidavits or declarations; and what is otherwise necessary in the interest of justice.

• Prescribing sanctions for abuse of discovery, abuse of process, or any other improper use of the proceeding, such as to harass or to cause unnecessary delay or an unnecessary increase in the cost of the proceeding

• Providing for protective orders governing the exchange and submission of confidential information

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Supplemental Examination

Supplemental Examination (§ 257)Effective Date: September 16, 2012 – applies to any patent issued before, on, or after that date.

• Wheno Post-Grant

• What: Request by Patent Owner Onlyo Consider, reconsider, or correct information believed to

be relevant to the patento Request must raise substantial new question of

patentability• Effect: A mechanism for the patent owner to ward off a

potential inequitable conduct defense

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Supplemental Examination (cont'd)

Supplemental Examination (§ 257)Effective Date: 1 year after enactment date

• Key Provision• "A patent shall not be held unenforceable on the basis of

conduct relating to information that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent if the information was considered, reconsidered, or corrected during a supplemental examination of a patent.

• Exceptions (cannot file request):• Prior allegations (made in a PIV certification letter)• Defense raised in a pending litigation unless Supplemental

Examination proceedings concluded prior to the date of litigation

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• EUROPEAN PATENT REGIMEI. European patent convention

II. Patentable inventions in European Patent systems

III. History of the Broad Definition of Patentability

IV. Final form of European Patent system Development of EPO Practice in Relation to Software Industries

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Novelty Art. 54 of EPC

(1)An invention shall be considered to be new if it does not form part of the state of the art. 

(2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application. 

(3) The content of European patent applications as filed prior to the date referred to, and which were published on or after that date

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(4) shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art.

(5) shall also not exclude the patentability of any substance for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.

Contd.

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Utility (and patentability) Art. 52

European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application.

Art. 57 An invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry, including agriculture. Profitable use.

Art. 83 Sufficiency of disclosure  

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Inventive Step Art. 56

An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art. If the state of the art also includes documents within the meaning of Article 54, paragraph 3, these documents shall not be considered in deciding whether there has been an inventive step.

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European Patent Convention, 5 October 1973

A multilateral treaty instituting the European Patent Organisation and providing an autonomous legal system according to which European patents are granted.

European patent is not a unitary right, but a group of essentially independent nationally-enforceable, nationally-revocable patents subject to central revocation or narrowing as a group pursuant to two types of unified, post-grant procedures: a time-limited opposition procedure, which can be initiated by any person except the patent proprietor, and limitation and revocation procedures, which can be initiated by the patent proprietor only.

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.

Discoveries, scientific theories, mathematical methods, aesthetic creations, schemes, rules and methods for performing mental acts, playing games or doing business, programs for computers and presentations of information – as such

The second set of exclusions, or exceptions, includeinventions contrary to "ordre public" or morality,plant or animal varieties and essentially biological processes for the production of plants and animals, andmethods for treatment of the human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body,which have been excluded for "socio-ethical considerations and considerations of public health”.

EPC and exclusions under Article 53 EPC

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Software

Art. 52(2) The following in particular shall not be regarded as inventions …(c) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers; 52(3) Paragraph 2 shall exclude the patentability of the subject-matter or activities referred to therein only to the extent to which a European patent application or European patent relates to such subject‑matter or activities as such.

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Claim 4 is directed to a computer-readable mediumhaving computer-executable instructions (i.e. a computer program) on it to cause the computer system to perform the claimed method.

The subject-matter of claim 4 has technical character since it relates to a computer-readable medium, i.e. a technical product involving a carrier. Moreover, the computer executableinstructions have the potential of achieving the above-mentioned further technical effect of enhancing the internal operation of the computer, which goes beyond the elementary interaction of any hardware and software of data processing (see T 1173/97 - Computer program product/IBM; OJ EPO 1999, 609). The computer program recorded on the medium is therefore not considered to be a computer program as such,

T469/03

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Differences between US and Eu practicesFirst inventor to file system effective March 16, 2013 v. First to file .

Inventor’s own personal publications and disclosures will not constitute prior art so long as they are published no more than one year prior to the patent application – no such grace period in Eu

Best mode requirement

Non-obvious v. inventive step

10/04/2023

THANK YOU

for your attention

SWAPNA SUNDARCEO, IP Dome – IP Strategy AdvisorsNo. 7/8 Flowers Road III LanePurusaiwalkam, Chennai 600084

swapna@ipdome.in