Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
RESPONSE TO APPLICANT’S AMENDMENT
1. Applicants amendment filed on 04/02/26 is acknowledged.
2. Claims 18-38 are pending.
Claims 22, 24-38 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 18-21 and 23 read on tumor specific neoantigeneic peptide, wherein said peptide is encoded by a part of ORF sequence from transcript associated with SF3B1 mutation are under consideration in the instant application.
The following new ground of rejections are necessitated by the amendment filed on 04/02/26
3. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain 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, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
5. Claims 18-21 and 23 are rejected under 35 U.S.C. 112(a, b) on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of variant neoantigenic peptide comprising any of SEQ ID NO: 1-1058 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use .
Regarding the “single structural similarity” of a proper Markush grouping, the alternatives must share a substantial structural feature from which the common use flows. In the case of the instant neoantigenic peptide comprising any of SEQ ID NO: 1-1058 With a range of length from 8 to 9 total residues, and the amount of variability in residues from one variant to the next, it is difficult to assign even a basic shared structural similarity to all neoantigenic peptide upon which variants may be generated. That is, a common base sequence structure from which techniques such as affinity maturation may be used to determine specific point mutations in order to generate variant embodiments.
Section 803.04 of the MPEP states that “sequences that encode different proteins are structurally distinct and are deemed to constitute distinct and independent inventions.” The neoantigenic peptide comprising any of SEQ ID NO: 1-1058 described are not all members of the same recognized physical or chemical class or the same art-recognized class, as the disclosed neoantigens are novel. Therefore, neoantigenic peptide comprising any of SEQ ID NO: 1-1058 do no comprise a “proper” Markush grouping.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
6. The following is a quotation of the appropriate paragraphs of AIA U.S.C. §101 that form the basis for the rejections under this section made in this Office action:
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.
7. The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 18-21 and 23 do not recite something significantly different than a judicial exception.
8. Claim 18 as written, do not sufficiently distinguish tumor specific neoantigenic peptide as they exist naturally because the claims do not particularly point out any non-naturally occurring differences between the claimed products and the naturally occurring products. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements Thus, the claimed neoantigenic peptide of any of SEQ ID NO: 1-1058 are not markedly different from what exists in nature.
The claims do not integrate the exception into a practical application, as there are no additional elements which rely on, use, or apply the exception. See MPEP 2106.04(d), in particular second paragraph.
Mayo made clear that transformation into a patenteligible application requires “more than simply stat[ing] the law of nature while adding the words ‘apply it.’” Id. At 1294. A claim that recites an abstract idea, law of nature, or natural phenomenon must include “additional features”
to ensure “that the [claim] is more than a drafting effort designed to monopolize the [abstract idea, law of nature, or natural phenomenon].” Id. at 1297. For process claims that encompass natural phenomenon, the process steps are the additional features that must be
new and useful. See Parker v. Flook, 437 U.S. 584, 591 (1978) (“The process itself, not merely the mathematical algorithm, must be new and useful.”).
See “Supreme Court Decision in Association for Molecular Pathology v. Myriad Genetics, Inc.”
Inc., 569 , 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013) (Myriad) on the Supreme Court’s long-standing “rule against patents on naturally occurring things”, as expressed in its earlier precedent including Diamond Chakrabarty, 447 U.S. 303 (1980) (Chakrabarty), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) (Mayo). See Myriad, 133 S. Ct. at 2116. Myriad relied on Chakrabarty as “central” to the eligibility inquiry, and re-affirmed the Office’s reliance on Chakrabarty’s criterion for eligibility of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products). Id. at 2116-17. Myriad also clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., “isolated”) in the claims does not automatically confer eligibility. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not “depend simply on the draftsman’s art”). Thus, while the holding in Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty.
The Supreme Court instructs that “[g]round breaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Myriad Genetics, Inc., 133 S. Ct. at 2117. The discovery of the BRCA1 and BRCA2 genes was a significant contribution to the medical field, but it was not patentable. Id. at 2117.
The Supreme Court has recently articulated a two part test for distinguishing patents that claim one of the patent-ineligible exceptions from those that claim patenteligible applications of those concepts. Id. (citing Mayo, 132 S. Ct. at 1294, 1296-97). Step one asks whether the claim is “directed to one of [the] patent-ineligible concepts.” Id. If the answer is no, the inquiry is over: the claim falls within the ambit of § 101. If the answer is yes, the inquiry moves to step two, which asks whether, considered both individually and as an ordered combination,
“the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Id. (quoting Mayo, 132 S. Ct. at 1297). Step two is described “as a search for an ‘inventive concept.’” Id. (quoting Mayo, 132 S. Ct. at 1294). At step two, more is required than “wellunderstood, routine, conventional activity already engaged in by the scientific community,” which fails to transform the claim into “significantly more than a patent
upon the” ineligible concept itself. Mayo, 132 S. Ct. at 1298, 1294.
Based on the analysis of factors in the Myriard-Mayo, the Examiner determiners that factors against eligibility are satisfied.
See MPEP § 2106.03. The Manual contains instructions to examiners, as well as other material in the nature of information and interpretation, and outlines the current procedures which the examiners are required or authorized to follow in appropriate cases in the normal examination of a patent application. The Manual does not have the force of law or the force of the rules in Title 37 of the Code of Federal Regulations.
For these reasons the claims are rejected under section 101 as being directed tonon-statutory subject matter.
9. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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