35 U.S.C. 112, Sixth Paragraph As Applies To Biotechnology & Chemical Practice Ram R. Shukla, Ph.D. SPE AU 1632 & 1634 Technology Center 1600 571-272-0735 Ram.shukla@uspto.gov 9/21/2018 SHUKLA, BCP Presentation 9/13/06

MPEP § 2181-2185 (MPEP (Rev 3, August 2005)) § 2181: Identifying a 35 U.S.C. 112, Sixth Paragraph Limitation § 2182: Scope of Search & Identification of the Prior Art § 2183: Making a Prima Facie Case of Equivalence § 2184: Determining Whether an Applicant Has Met the Burden of Proving Nonequivalence After a Prima Facie Case is Made § 2185: Related Issues Under 35 U.S.C 112, First or Second Paragraphs 9/21/2018 SHUKLA, BCP Presentation 9/13/06

35 U.S.C. 112, Sixth Paragraph An element in a claim for a combination may be expressed as a means or step for performing a specified function without recital of structure, material, or acts in support thereof and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Invoking 35 U.S.C. 112, Sixth Paragraph During examination, a three prong analysis is used to determine if 35 U.S.C. 112, sixth paragraph is being invoked. MPEP 2181 9/21/2018 SHUKLA, BCP Presentation 9/13/06

The First Prong: must use the phrase “means for” or “step for” The words “means” and “for” need not be immediately adjacent to each other, e.g., “means … for”. A claim element not using “means for” or “step for” will not be considered to invoke 35 U.S.C. 112, Sixth Paragraph. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

The First Prong (cont.): If an applicant does not use “means for” or “step for”, yet wishes to have the claim limitation treated under 35 U.S.C. 112, Sixth Paragraph, applicant must either: (A) amend the claim to include the phrase “means for” or “step for”; or (B) show that the claim limitation is written as a function to be performed and does not provide sufficient structure, material, or acts which would preclude application of 35 U.S.C. 112, Sixth Paragraph. MPEP 2181 9/21/2018 SHUKLA, BCP Presentation 9/13/06

The Second Prong: “means for” or “step for” must be modified by functional language For example: -Means for treating -Step for treating 9/21/2018 SHUKLA, BCP Presentation 9/13/06

The Third Prong: the phrase “means for” or “step for” must not be modified by sufficient structure, material or acts for achieving the specified function. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Do the following expressions meet the third prong? “means for hybridization” “means for hybridization, said means comprising high GC content” 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Analysis by Examiner Three prong analysis is applied for each “means for” or “step for” limitation in each claim. A statement will be made in the office action regarding elements in the claims that are being treated under 35 U.S.C. 112, Sixth Paragraph. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

35 U.S.C. 112, First Paragraph (Written Description) Analysis The structure, material or acts corresponding to a means/step plus function limitation must be described so that one skilled in the art will understand what structure, material or acts will perform the recited function. MPEP 2181 (II) 9/21/2018 SHUKLA, BCP Presentation 9/13/06

35 U.S.C. 112, First Paragraph (Written Description) Analysis (cont). The disclosure may be implicit or inherent IF it would have been clear to one of skill what structure, material or acts will perform the recited function. MPEP 2181 (II) 9/21/2018 SHUKLA, BCP Presentation 9/13/06

35 U.S.C. 112, First Paragraph (Written Description) Analysis (cont). If no explicit disclosure of structure, acts or function is present: -The examiner may require applicant to amend the written description to expressly recite the implicit or inherent structure, material or acts; or -The examiner may state on record what structure, materials, or acts perform the function recited in the “means for” or “step for” limitation. MPEP 2181(IV) 9/21/2018 SHUKLA, BCP Presentation 9/13/06

35 U.S.C. 112, First Paragraph (Written Description) Analysis in relation to 35 U.S.C.112, Second Paragraph Analysis “Whether a claim reciting an element in means- (or step-) plus-function language fails to comply with 35 U.S.C. 112, second paragraph, because the specification does not disclose adequate structure (or material or acts) for performing the recited function is closely related to the question of whether the specification meets the description requirement in 35 U.S.C. 112, first paragraph.” (MPEP 2181) Therefore, when a 112 second paragraph issue arises for this reason (lack of adequate structure), then a 112, 1st paragraph rejection should also be made. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

A means-(or step-) plus function claim limitation satisfies 35 U. S. C A means-(or step-) plus function claim limitation satisfies 35 U.S.C. 112, First Paragraph (written description) and 112, Second Paragraph if: (1) written description links or associates particular structure, material, or acts to the function recited in a means-(or step-) plus function claim limitation; or (2) it is clear that one skilled in the art would have known what structure, material, or acts perform the function recited in the means-(or step-) plus function limitation. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

35 U.S.C. 112, Second Paragraph Analysis (cont.) The duty to link or associate structure or function is the quid pro quo for the convenience of using 35 U.S.C. 112, Sixth Paragraph. T* 37 CFR 1.75(d)(1) can (and should) be used to require corresponding terminology. An examiner will use form paragraph 7.44 in the office action for such requirement. ¶ 7.44 Claimed Subject Matter Not in Specification The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP §  608.01(o). Correction of the following is required: [ 1 ] No new matter may be added to the specification. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Scope of the Search and Identification of the Prior Art The “means or step plus function” limitation should be interpreted in a manner consistent with the specification disclosure. -If the specification defines what is meant by the limitation for the purposes of the claimed invention, the examiner should interpret the limitation as having that meaning. -If no definition is provided, some judgment must be exercised in determining the scope of the limitation. (MPEP 2182) 9/21/2018 SHUKLA, BCP Presentation 9/13/06

In re Donaldson Co., 16 F.3d 1189, 29 USPQ2d 1845 (Fed. Cir. 1994) In this decision, the Federal Circuit stated: …… the “broadest reasonable interpretation” that an examiner may give means-plus-function language is that statutorily mandated in paragraph six. Accordingly, the PTO may not disregard the structure disclosed in the specification corresponding to such language when rendering a patentability determination. … 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Prior Art Analysis: Making a Prima Facie Case of Equivalence (MPEP 2183) The examiner should ask the following questions: (1) does the prior art element perform the function specified in the claim? (2) does any explicit definition provided in the specification exclude the prior art element as an equivalent? (3) is the prior art element an equivalent of the means-(or step) plus function limitation? 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Prior Art Analysis: Factors Supporting a Prima Facie Case of Equivalence (MPEP 2183) (A) The prior art element performs (*or is capable of performing) the identical function in substantially the same way and produces substantially same result, or (B) Art Recognized Interchangeability, or (C) Insubstantial Differences between the prior art element and corresponding element shown in the specification, or (D) The prior art element is a structural equivalent Only one of the above noted factors need exist to support a finding of equivalence. Further, these examples are not an exhaustive list, see MPEP 2184 (II). The examiner should ensure that the record is clear why the prior art element, or step, is an equivalent. *see, e.g. RCA Corp. v. Applied Digital Data Systems, Inc. at 221 USPQ 385, 388 (Fed. Cir. 1984) 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Prior Art Analysis: Examiner’s Office Action If the examiner determines that the prior art element is equivalent to the structure, material, or acts described in the applicant’s specification, the examiner should conclude that the prior art anticipates the means-(or step-) plus-function limitation. Examiners should also make a 35 U.S.C. 103 rejection where appropriate. Applicant then has the burden of proving nonequivalence. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Evidence of nonequivalence include: Applicant’s Burden of Proving nonequivalence after a prima facie case is made (MPEP 2184) Evidence of nonequivalence include: Teachings in the specification that show that particular prior art is not equivalent; Teachings in the prior art itself that may tend to show nonequivalence; or - Evidence of facts provided in 37 CFR 1.132 affidavits showing nonequivalence. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Applicant’s Burden of Proving nonequivalence after a prima facie case is made (cont.) Re-consider the factors which are used to establish a prima facie case of equivalence. Mere allegations of non-equivalence in applicant’s response are not sufficient. *MPEP 2184(III): “..However, under no circumstance should an examiner accept as persuasive a bare statement or opinion that the element shown in the prior art is not an equivalent embraced by the claim limitation. Moreover, if an applicant argues that the "means" or "step" plus function language in a claim is limited to certain specific structural or additional functional characteristics (as opposed to "equivalents" thereof) where the specification does not describe the invention as being only those specific characteristics, the claim should not be allowed until the claim is amended to recite those specific structural or additional functional characteristics…” 9/21/2018 SHUKLA, BCP Presentation 9/13/06

New Appeal Brief Criteria: 35 U.S.C. 112, Sixth Paragraph Appeal Brief must contain the following items (see 37 CFR 41.37(c)(1)(v)) (Effective Date: September 13, 2004) V. Summary of claimed subject matter (replacing “summary of invention”) A concise explanation of the subject matter defined in each of the independent claims involved in the appeal, Must refer to the specification by page and line number, and to the drawing, if any, by reference characters. For each independent claim involved in the appeal and for each dependent claim argued separately: Every means plus function and step plus function must be identified, and The structure, material, or acts described in the specification as corresponding to each claimed function must be set forth with reference to the specification by page and line number, and to the drawing, if any, by reference characters. See MPEP 1205, 1205.02 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Examples 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Example 1 Claim 1: A kit for screening a gene-specific drug therapy, the kit comprising: a means for detecting a mutation in a gene. Claim 2: a means for detecting a mutation in a gene, wherein the means for detecting comprises, mutation-specific primers and probes. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Three prong analysis of Example 1 (Claim 1: A kit for screening a gene-specific drug therapy, the kit comprising: a means for detecting a mutation in a gene.) 1- Does the claim recite the required “means for” ? Yes; 2- Is there a link between the “means for” and a “function”? Yes; 3- Is the “means for” NOT modified by sufficient structure, material or acts? Yes. Conclusion: 35 U.S.C. 112, Sixth Paragraph is invoked for claim 1. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Three prong analysis of Example 1 (Claim 2: A kit for screening a gene-specific drug therapy, the kit comprising: a means for detecting a mutation in a gene, wherein the means for detecting comprises, mutation-specific primers and probes.) 1- Does the claim recite the required “means for” ? Yes; 2- Is there a link between the “means for” and a “function”? Yes; 3- Is the “means for” NOT modified by sufficient structure, material or acts? No. Conclusion: 35 U.S.C.112, Sixth Paragraph is not invoked for claim 2. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Description in the Specification (Example 1) The specification provides general description for a kit for screening gene sequences. The specification also provides a general description of primers and probes in screening of gene sequences. A general description of relationship between mutations and diseases is also provided. No specific genes are set forth. No specific gene sequence-specific probes and primers are disclosed. No guidance is provided regarding which mutations would reasonably be correlated to disease. One skilled in the art would not have known what structure or material performs the function recited in the claim. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Do the claims in Example 1 meet 35 U. S. C Do the claims in Example 1 meet 35 U.S.C. 112, First and Second Paragraph requirements? Claim 1: A kit for screening a gene-specific drug therapy, the kit comprising: a means for detecting a mutation in a gene. Claim 2: a means for detecting a mutation in a gene, wherein the means for detecting comprises, mutation-specific primers and probes. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

1- The claims do not meet 35 U.S.C. 112, First Paragraph requirements. Do claims 1 and 2 meet 35 U.S.C. 112, First and Second Paragraph requirements?(cont.) Does the specification define structure corresponding to the claimed “means for detecting”? No Would one skilled in the art have known what structure performs the function recited in the claims? No Note-This is a "single means" claim and would likely also be rejected as nonenabled (See MPEP 2181(V) and 2164.08(a)). Conclusion: 1- The claims do not meet 35 U.S.C. 112, First Paragraph requirements. 2- The claims also do not meet 35 U.S.C. 112, Second Paragraph requirements. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Analysis of Prior Art Claim 1: A kit for screening a gene-specific drug therapy, the kit comprising: a means for detecting a mutation in a gene. Claim 2: a means for detecting a mutation in a gene, wherein the means for detecting comprises, mutation-specific primers and probes. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Analysis of Prior Art (cont.) A reference teaching a relationship between a drug and a mutation in a gene sequence and describing primers that can be used to detect the gene or parts of the gene will anticipate the claim(s). 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Examiner’s Office Action The examiner will acknowledge and explain that 35 U.S.C. 112, Sixth Paragraph has been invoked for claim 1, but not for claim 2. The examiner will also explain why the claims do not meet the requirements under 35 U.S.C. 112, First and Second Paragraphs. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Examiner’s Office Action (cont.) The examiner will explain how the prior art cited anticipates the claimed limitations examined under 35 U.S.C. 112, Sixth Paragraph. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Example 2 Claim 1: An apparatus comprising: - a first means for heating a sample; and - a second means for holding the sample. Claim 2: An apparatus comprising: - a second means for holding the sample, wherein said second means has a conical bottom. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Three Prong Analysis of the Claims in Example 2 1- Do the claims recite “means for”? Yes; 2- Is there a link between the “means for” and a “function”? Yes; 3- Is the “means for” NOT modified by sufficient structure, material or acts – Claim 1-Yes; Claim 2-first “means for”- yes; second “means for”-No. Conclusion: 35 U.S.C. 112, Sixth Paragraph is invoked for Claim 1 and first “means for” of claim 2, but not for second “means for” of Claim 2. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Description in the Specification The specification defines the first “means for” as an electrical heater wire and the second “means for” as a chamber block that holds reaction tubes. The specification describes that reaction tubes can be of different sizes. The specification also describes that the chamber block could have holes/recesses with different shape bottoms, including a conical bottom, to hold tubes with different shape bottoms. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Examiner’s Office Action The examiner will acknowledge that 35 U.S.C. 112, Sixth Paragraph has been invoked for claim 1 and the first “means for” limitation in claim 2. The examiner will also explain how 35 U.S.C. 112, Sixth Paragraph has not been invoked for the second “means for” limitation in claim 2 (since it fails to meet the third prong). 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Examiner’s Office Action (cont.) The examiner will also explain how the cited prior art anticipates the claimed “means”. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Example 3 Claim 1: A method for determining anti-inflammatory response comprising: a system for measuring an anti-inflammatory response in a sample before and after treatment; and, comparing the measurements. (Note: A "system" can be a method or an apparatus, thus this claim may be indefinite.) 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Three Prong Analysis of the Claim in Example 3 1- Does the claim recite “means for” or “step for”? No; 2- Is there a link between the “means for” and a “function”? Yes; 3- Is the “means for” NOT modified by sufficient structure, material or acts? Yes. Conclusion: 35 U.S.C. 112, Sixth Paragraph is not invoked. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Example 3 (cont.) In the first office action on merits, the examiner will not consider the claim under 35 U.S.C. 112, Sixth Paragraph. If applicant wishes to have the claim limitation treated under 35 U.S.C. 112 Sixth Paragraph, applicant must either: (1) amend the claim to include the phrase “means for” or “step for”; or (2) show that the claim limitation is written as a function to be performed and does not provide sufficient structure, material, or acts which would preclude application of 35 U.S.C. 112, Sixth Paragraph. 9/21/2018 SHUKLA, BCP Presentation 9/13/06

Thank you Ram Shukla 571-272-0735 ram.shukla@uspto.gov Acknowledgement: Betty Forman, Ph.D. Primary Examiner, AU 1634 9/21/2018 SHUKLA, BCP Presentation 9/13/06