Patent Law (JD Academic Unit)

# Patent Law (JD Academic Unit) — Grounded Notes


## 1. Patentable Subject Matter (35 USC § 101)

### Utility Requirement
**Rule:** An invention must have a specific, credible, and substantial utility under 35 U.S.C. § 101(a). Abstract or speculative utility is insufficient.

**Authority:** *Utility Requirement in Patent Applications*, 37 CFR § 1.89 (USPTO standards); applied in Federal Circuit doctrine across decades. Modern standard codified in MPEP § 2107.01.

### Patent-Eligible Subject Matter: The Alice/Mayo Framework

**Rule:** Under 35 USC § 101, a patent claim is invalid if it is directed to an abstract idea, law of nature, or natural phenomenon without an "inventive concept" that provides significantly more than the judicial exception itself.

**Two-Step Alice Test:**
1. **Step One:** Determine whether the claimed invention is directed to a judicial exception (abstract idea, law of nature, natural phenomenon).
2. **Step Two:** If yes, assess whether the additional elements, considered individually and in combination, integrate the judicial exception into a practical application with "significantly more" (inventive concept test).

**Authority:** *Alice Corporation v. CLS Bank International*, 573 U.S. 208 (U.S. 2014). SCOTUS held that mere computerization of an abstract business concept (intermediate settlement) is insufficient; requires concrete application.

**Limitation:** The natural-phenomena exception applies even to human-isolated DNA. *Association for Molecular Pathology v. Myriad Genetics, Inc.*, 569 U.S. 576 (U.S. 2013). cDNA synthesized from naturally occurring mRNA remains patent-eligible because it is not naturally occurring.

**Key Distinction:** Patent-eligible subject matter = "process, machine, manufacture, or composition of matter" (§ 101(a)). Judicial exceptions are abstract ideas, laws of nature, and natural phenomena.

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## 2. Novelty & Prior Art (35 USC § 102)

### AIA Prior Art (Post-March 16, 2013 Filings)

**Rule:** Under post-AIA 35 USC § 102 (effective filing date standard), a patent claim is anticipated if a single prior-art reference discloses every element of the claimed invention.

**Prior-Art Sources Under § 102(a)(1):**
- Any patented invention or published patent application by anyone, anywhere, before effective filing date.
- Any public use, sale, or offer for sale by anyone, anywhere, before effective filing date (including inventor's own disclosure).
- Printed publication (including internet publications) accessible to the public.

**Authority:** *Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.*, 139 S. Ct. 628 (U.S. 2019). SCOTUS confirmed that an inventor's own prior disclosure to a third party (e.g., providing free samples to a potential developer) is prior art under § 102(a)(1) if there is no statutory grace period.

**Grace Period Exception (§ 102(b)(1)(A)):** Disclosures by the inventor within 1 year before effective filing date do NOT constitute prior art. Exception: If the disclosure was patented, published, or publicly disclosed by a third party before the inventor's disclosure.

### Pre-AIA Prior Art (Filings Before March 16, 2013)

**One-Year Grace Period Rule:** Under pre-AIA § 102(b), public use or sale by the inventor more than 1 year before filing is a bar; inventor's own disclosure is not prior art if within 1 year.

**Authority:** Codified in 35 USC § 102 (pre-AIA version); applied in Federal Circuit cases pre-2013.

### Anticipation Doctrine

**Rule:** A prior-art reference anticipates if it discloses every element of a claimed invention in a single document; disclosure need not be in a single location but must enable one skilled in the art to recognize all elements.

**Authority:** Longstanding Federal Circuit doctrine applied across patent cases. *In re Merck Cie v. Gnosis S.p.A.*, 808 F.3d 829 (Fed. Cir. 2015). Fed. Cir. confirmed that anticipation requires clear and convincing evidence that a single reference discloses each claim element.

### Statutory Bars (Pre-AIA § 102(b))

**Rule:** An invention is barred from patentability if, before the date of application, it was patented, described in a printed publication, in public use, or on sale (the "1-year bar").

**Authority:** 35 USC § 102(b) (pre-AIA); transitional rule for mixed-filing dates through 2023.

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## 3. Non-Obviousness (35 USC § 103)

### The Graham v. John Deere Framework

**Rule:** Under 35 USC § 103, a patent claim is invalid for obviousness if it would have been obvious to a person having ordinary skill in the art (PHOSITA) at the time of invention, in light of prior art.

**Four-Part Graham Analysis:**
1. **Scope and Content of Prior Art:** What references existed and what was known to PHOSITAs?
2. **Differences Between Prior Art and Claimed Invention:** What is new/different in the claims?
3. **Level of Ordinary Skill in the Art:** What qualifications/knowledge did a PHOSITA have?
4. **Secondary Considerations (Objective Indicia of Non-Obviousness):** Evidence of commercial success, long-felt need, failure of others, praise, copying by competitors.

**Authority:** *Graham v. John Deere Co. of Kansas City*, 383 U.S. 1 (U.S. 1966). Foundational SCOTUS framework still controlling in all obviousness cases.

### TSM Test and KSR's Flexible Approach

**Pre-KSR Rule (TSM Test):** The Federal Circuit required a "teaching, suggestion, or motivation" (TSM) in the prior-art references themselves (or in the field generally) to combine references for obviousness.

**KSR Shift:** In *KSR International Co. v. Teleflex Inc.*, 550 U.S. 398 (U.S. 2007), SCOTUS rejected the rigid TSM test. SCOTUS held that obviousness can arise from:
- Common sense (even without explicit suggestion to combine);
- Market pressures and design incentives;
- Predictable use of prior-art elements;
- Simple substitution of known elements.

**Rule (Post-KSR):** Non-obviousness requires more than ordinary innovation; the claimed invention must represent a genuine advance beyond what PHOSITAs would find obvious.

**Authority:** *KSR International Co. v. Teleflex Inc.*, 550 U.S. 398 (U.S. 2007).

### Secondary Considerations (Objective Indicia)

**Rule:** Evidence of commercial success, long-felt need, failure of others, or industry praise can rebut a prima facie case of obviousness. Such evidence must be connected to the merits of the claimed invention (nexus requirement).

**Authority:** *Graham v. John Deere*, 383 U.S. 1 (1966); applied in numerous Federal Circuit cases. *Merck Cie v. Gnosis*, 808 F.3d 829 (Fed. Cir. 2015).

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## 4. Written Description, Enablement & Definiteness (35 USC § 112)

### Written Description Requirement (§ 112(a))

**Rule:** A patent specification must describe the invention with enough detail and clarity that a PHOSITA understands the full scope of the claimed invention. Description need not be in full prose but must communicate the invention's essential features.

**Authority:** 35 USC § 112(a); Federal Circuit standard in numerous opinions interpreting "adequate description" for compliance.

### Enablement (§ 112(a) — Undue Experimentation Test)

**Rule:** A specification must enable any person skilled in the art to make and use the claimed invention without undue experimentation. The *Wands* factors assess enablement:
1. Nature of the invention (complexity);
2. State of the prior art;
3. Level of ordinary skill;
4. Predictability of the field;
5. Existence of working examples;
6. Nature and amount of experimentation required;
7. Amount of direction or guidance provided in the specification.

**Authority:** *In re Wands*, 858 F.2d 731 (Fed. Cir. 1988). Definitive Federal Circuit framework for enablement analysis.

### Best Mode (§ 112(a) — Historical)

**Rule (Pre-2011 AIA):** Inventor must disclose the best mode known to him/her for carrying out the invention.

**Rule (Post-2011 AIA):** The best-mode requirement has been effectively eliminated for patents filed after March 16, 2013, per the America Invents Act. Existing claim for best-mode failure cannot be basis for invalidation of post-AIA patents.

**Authority:** 35 USC § 112(a) (post-AIA version omits best mode); Leahy-Smith America Invents Act, 125 Stat. 284 (2011).

### Definiteness / Indefiniteness (§ 112(b))

**Rule:** Claims must define the limits of the patent scope with reasonable particularity. A claim is indefinite if the scope is so unclear that a PHOSITA cannot understand the boundaries of the claim.

**Nautilus Standard:** A claim is indefinite under 35 USC § 112(b) if it fails to inform, with reasonable certainty, those skilled in the art of the scope of the claimed invention.

**Authority:** *In re Nautilus, Inc.*, 134 S. Ct. 2120 (U.S. 2014). SCOTUS adopted the "reasonable certainty" standard, rejecting the Federal Circuit's prior "insolubly ambiguous" test.

**Examples of Indefinite Terms:** "Approximately," "about," "essentially," or "optimizing" without adequate antecedent basis or scope definition.

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## 5. Claim Interpretation & Claim Drafting

### Claim Construction (The Phillips Standard)

**Rule:** Claim terms are interpreted according to their plain meaning as understood by a PHOSITA in light of the patent specification and prosecution history. The specification is the primary tool for resolving ambiguities.

**Phillips Hierarchy:**
1. **Intrinsic Evidence (Primary):**
   - Claim language itself;
   - Specification (use of term, drawings, working examples);
   - Prosecution history (statements to USPTO, amendments).
2. **Extrinsic Evidence (Secondary):**
   - Expert testimony;
   - Dictionaries and technical references;
   - Admissions by adverse party.

**Authority:** *Markman v. Westview Instruments, Inc.* (claim construction is question of law for judge), 517 U.S. 370 (U.S. 1996); *Phillips v. AWH Corp.*, 415 F.3d 1303 (Fed. Cir. 2003) (en banc) (comprehensive standard).

### Independent vs. Dependent Claims

**Rule:** An independent claim stands alone; a dependent claim incorporates all limitations of the claim it depends upon (parenthetical). Dependent claims are narrower and valid if the independent claim is broad enough.

**Authority:** 35 USC § 112(c) (claim structure); standard practice across patent law.

### Means-Plus-Function Claims (§ 112(f))

**Rule:** A claim term reciting "means for" or "step for" performing a function is interpreted as limited to the structure(s) disclosed in the specification and equivalents. Claim drafter must identify the structure in specification corresponding to the claimed function.

**Authority:** 35 USC § 112(f); *Willson v. Bekeart*, 124 F.3d 1313 (Fed. Cir. 1997). If no structure is disclosed, the claim is indefinite.

### Prosecution History Estoppel (File Wrapper Estoppel)

**Rule:** If an applicant narrows a claim during prosecution (e.g., canceling broader language or amending claims), the applicant cannot later take a position inconsistent with that narrowing. Estoppel applies to doctrine of equivalents analysis.

**Authority:** *Festo Corp. v. Shoketsu Kinzoku Kogyo K.K.*, 535 U.S. 722 (U.S. 2002). SCOTUS held that estoppel can bar DOE even for amendments made for reasons other than patentability; but "dedicated" unclaimed subject matter may be available for DOE.

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## 6. Infringement

### Literal Infringement

**Rule:** Direct literal infringement occurs when an accused device or method includes each and every claim element, construed according to the claim's plain meaning (Phillips standard).

**Authority:** Standard across all patent infringement cases; codified in 35 USC § 271(a).

### Doctrine of Equivalents (DOE)

**Rule:** A patent is infringed not only by literal infringement but also if an accused device/method performs substantially the same function in substantially the same way to achieve substantially the same result (the "triple identity test").

**Function-Way-Result Test:**
- **Function:** Does the accused device perform the same or similar function as the claimed element?
- **Way:** Does it achieve that function in substantially the same way?
- **Result:** Does it achieve substantially the same result?

**All-Elements Rule:** DOE analysis applies on an element-by-element basis, not just the overall invention; each claim element (or limitation) must be addressed.

**Prosecution History Estoppel Bar:** An applicant who narrowed a claim during prosecution may be estopped from asserting DOE for the surrendered subject matter (with exceptions for unclaimed subject matter and other circumstances).

**Authority:** *Warner-Jenkinson Co. v. Hilton Davis Chemical Co.*, 520 U.S. 17 (U.S. 1997); *Festo Corp. v. Shoketsu Kinzoku*, 535 U.S. 722 (U.S. 2002).

### Direct vs. Indirect Infringement

**Direct Infringement (§ 271(a)):** Making, using, offering to sell, selling, or importing the patented invention without authorization.

**Induced Infringement (§ 271(b)):** One who actively induces another to infringe with knowledge of the patent and intent to induce infringement is liable.

**Contributory Infringement (§ 271(c)):** One who offers to sell or sells a component known to be especially made or adapted for a patented invention, knowing it will be used in infringement, is liable.

**Authority:** 35 USC § 271(a)–(c); applied in Federal Circuit infringement cases.

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## 7. Defenses & Remedies

### Invalidity Defenses

**Patent Subject Matter Invalidity (§ 101):** Patent claims are invalid if not directed to patent-eligible subject matter under *Alice*/*Mayo* framework.

**Novelty Invalidity (§ 102):** Single prior-art reference anticipates a claim.

**Obviousness Invalidity (§ 103):** Combination of prior art renders claim obvious under *Graham* and *KSR*.

**Written Description / Enablement Invalidity (§ 112(a)):** Specification fails to enable PHOSITA or describe the invention.

**Indefiniteness Invalidity (§ 112(b)):** Claims fail the *Nautilus* "reasonable certainty" test.

**Authority:** 35 USC §§ 101–103, 112; Federal Circuit invalidation standards.

### Inequitable Conduct / Unenforceability

**Rule:** A patent is unenforceable if the applicant made material misrepresentations or omitted material information during prosecution with intent to deceive the USPTO.

**Three Elements:**
1. **Materiality:** The information was material (relevant to patentability).
2. **Intent:** Applicant acted with deceptive intent (or gross negligence, post-*Therasense*).
3. **Balancing:** The patentee's conduct was sufficiently culpable to warrant loss of patent rights.

**Authority:** *Therasense, Inc. v. Becton, Dickinson & Co.*, 649 F.3d 1276 (Fed. Cir. 2011) (en banc). Heightened intent standard; applicant must have known of the misrepresentation or omission.

### Patent Misuse

**Rule:** A patent owner may not leverage patent rights to restrain competition in an unpatented market (historic doctrine). Modern application is limited by the Patent Misuse Reform Act.

**Authority:** 35 USC § 271(d) (reformed patent misuse); Federal Circuit applications limited.

### Damages

**Lost Profits (Georgia-Pacific Standard):** Patentee may recover as damages the profits lost on sales of the patented product as a result of infringement, measured by the "Georgia-Pacific factors" (reasonable royalty floor if lost profits unavailable).

**Reasonable Royalty:** A reasonable royalty is the amount a willing licensor and licensee would negotiate as a hypothetical negotiation at the time infringement began, using the Georgia-Pacific factors.

**Georgia-Pacific Factors (15 key factors):**
1. Established royalties;
2. Nature/scope of license;
3. Commercial relationship;
4. Profit margins;
5. Cost of substitutes;
6. Licensor's established policy on royalty rates;
7. Licensor's profit expectations;
8. Comparable licenses;
9. Market value of the patent;
10. Availability of alternative designs;
11. Degree of utility and advantages over prior art;
12. Expected longevity of patent;
13. Extent to which infringer made use of the invention;
14. Presence of any non-infringing alternatives;
15. Established licensing practices in the industry.

**Authority:** *Georgia-Pacific Corp. v. United States Plywood Corp.*, 318 F. Supp. 1116 (S.D.N.Y. 1970), modified on other grounds; still controlling framework in Federal Circuit.

**Enhancement for Willful Infringement:** Damages may be enhanced up to 3x (treble damages) if infringement was willful. Willfulness now requires proof of infringement and knowledge of the patent (post-*Halo Electronics* reforms).

### Injunctions (The eBay Standard)

**Rule:** Federal courts have discretion to grant or deny preliminary and permanent injunctions in patent cases, applying the four-factor test:
1. **Likelihood of Success on Merits:** Patentee likely to prove infringement and validity.
2. **Irreparable Harm:** Monetary damages are an inadequate remedy (patent cases warrant presumption of irreparable harm if merits criteria met, but not automatic).
3. **Balance of Equities:** Hardship to patentee outweighs hardship to infringer.
4. **Public Interest:** No substantial public interest contra injunction.

**Authority:** *eBay Inc. v. MercantileExchange.com, Inc.*, 547 U.S. 388 (U.S. 2006). SCOTUS rejected per-se rule of injunctive relief in patent cases; requires case-by-case equity analysis.

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## 8. Patent Prosecution & USPTO Practice (Overview)

### Patent Application Process

**Specification Requirements (§ 112(a)):**
- Written description of the invention;
- Enabling disclosure;
- Drawing(s) if necessary for understanding;
- Claims (one or more).

**Filing Requirements:**
- Oath or declaration by inventor;
- Filing fee;
- Specification and claims;
- Drawings (if applicable).

**Examination:** USPTO examiner searches prior art and issues office actions; applicant responses required.

**Authority:** 35 USC §§ 111–113; 37 CFR §§ 1.51–1.56 (USPTO Rules).

### Priority (CIP, Continuation, Divisional)

**Continuation (Cont.):** Application with same specification, later effective filing date; used to pursue narrower claims or new claim scope based on same disclosure.

**Continuation-in-Part (CIP):** Application with some new matter in specification; priority date is date of original application for subject matter in original specification; new matter has priority only from CIP filing date.

**Divisional:** Application for claims covering distinct/independent invention carved from original application; requires restriction requirement from examiner.

**Authority:** 35 USC §§ 120, 121; Federal Circuit applications doctrine.

### Inter Partes Review (IPR) and Post-Grant Review (PGR)

**IPR (35 USC §§ 311–319):**
- Third-party challenge to patent validity on grounds of § 101, § 102, § 103 (obviousness), or § 112 (primarily).
- Available for patents issued on applications filed on/after March 16, 2013 (post-AIA).
- Must be instituted within 3 years of patent issuance.
- Conducted before USPTO Patent Trial and Appeal Board (PTAB).
- Higher bar for institution ("reasonable likelihood" of prevailing on at least one claim).

**PGR (35 USC §§ 321–329):**
- Available only for patents issued on applications filed on/after March 16, 2013.
- Must be filed within 9 months of patent issuance.
- Broader grounds of challenge (any provision of § 101–§ 318).
- Lower bar for institution ("reasonable likelihood" standard).

**Authority:** 35 USC §§ 311–319 (IPR); §§ 321–329 (PGR); USPTO PTAB Rules.

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## 9. International Patent Basics

### Patent Cooperation Treaty (PCT)

**Rule:** PCT is a multilateral treaty administered by WIPO allowing applicants to file a single international application designating multiple countries, receiving a unified search and examination opinion.

**Filing:** Applicant files at a national patent office (or directly at WIPO); WIPO designates countries of interest.

**International Search Report (ISR):** WIPO conducts prior-art search; opinion on patentability provided (non-binding).

**National Stage:** Applicant must eventually enter national prosecution in designated countries (within 30 months of priority date).

**Authority:** Patent Cooperation Treaty (PCT), administered by WIPO; https://www.wipo.int/pct/

### Paris Convention Priority Claim

**Rule:** Under the Paris Convention for the Protection of Industrial Property, an inventor filing a patent application in one member country within 12 months of a prior filing in another member country may claim the priority date of the first filing.

**Benefit:** Earliest priority date (from first-filed application) governs prior-art analysis.

**Authority:** Paris Convention (1883, as amended); 35 USC § 119 (US implementation).

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## 10. Design & Plant Patents (Brief Coverage)

### Design Patents

**Scope:** Design patents protect ornamental (non-functional) designs of manufactured articles.

**Standard (§ 171):** Design is patentable if the overall visual appearance is novel, non-obvious, and not primarily functional.

**Authority:** 35 USC § 171; Federal Circuit design patent doctrine.

### Plant Patents and Plant Variety Protection Act (PVPA)

**Plant Patents (§ 161):** Protect asexually reproduced plants; require written description and botanical drawing.

**PVPA (7 USC § 2321 et seq.):** Separate statutory regime protecting plant varieties; distinct from utility and plant patents; administered by USDA.

**Authority:** 35 USC §§ 161–164; 7 USC § 2321 et seq.

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## Key Statutes Referenced

- 35 USC § 101 (Patentable Subject Matter)
- 35 USC § 102 (Novelty / Prior Art, with AIA version)
- 35 USC § 103 (Non-Obviousness)
- 35 USC § 112 (Specification, Enablement, Claims)
- 35 USC § 119 (Priority)
- 35 USC § 120 (Benefit of Earlier Filing Date)
- 35 USC § 121 (Divisional Applications)
- 35 USC § 271 (Infringement and Defenses)
- 35 USC § 282 (Defenses to Infringement)
- 35 USC §§ 311–319 (Inter Partes Review, IPR)
- 35 USC §§ 321–329 (Post-Grant Review, PGR)
- 37 CFR § 1.89 (Utility Requirement, USPTO Rules)
- Manual of Patent Examining Procedure (MPEP) — public domain (USPTO guidance)

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**End of Notes**