DETAILED ACTION
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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/JP2020/041277 filed 11/05/2020, which claims the benefit of the priority of Japanese Patent Application No. 2019-202407 filed 11/07/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 2-10, 12, 15, 17-26 are pending. Claims 2, 4, 7-9, 12, 20-23 are amended. Claims 1, 11, 13-14, 16 are canceled. Claims 2-10, 12, 15, 17-26 are being examined on the merits in this office action.
Claim Rejections - Withdrawn
The rejection of claims 2-10, 12, 15, 17-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the claim amendments.
Claim Rejections - 35 USC § 112 - Maintained
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 2-10, 12, 15, 17-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2137 states that "the written description requirement for a genus must be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
For written description, the analysis (a) considers actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties, functional characteristics when coupled with known or disclosed and (d) representative number of examples.
Actual reduction to practice and (b) disclosure of drawings or structural chemical formulas:
The instant claims recite a cyclic peptide compound of Formula 2 shown below
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545
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597
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566
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548
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576
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582
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Examiner notes that even though Applicant has reduced to practice the compounds that have the general core structure of Formula 2, Applicant has not reduced to practice a representative number of species that are covered by all the variables recited in the instant claims. Examiner notes that given the number of variables, thousands of compounds would be generated and it is unclear if Applicant has possession of all the compounds that could be generated given the vast number of variables on the compound of Formula 2. Examiner notes that the instant claims currently recite the compound of Formula 2 with a laundry list of possible groups or variables and the claims are not a representation of any particular species. Written description issues may also arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not necessarily constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) (See MPEP 2162.1 (A).
sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties
A correlation between structure and function, for the instantly claimed genus of compounds, is not disclosed in the specification. Examiner notes that some species disclosed in the instant application comprise the instant core structure of Formula 2. The instant claims however, list numerous variables or functional groups that could be attached to the compound leading to the numerous compounds. Further, the instant Examples are focused on producing the compounds and the IC50 values of the compounds on Kras inhibition. Examiner notes that it is unclear if the entire genus of the compounds would have the functional property of inhibiting Kras, and it appears that some of the compounds, such as compound 598, 617, appear to be less potent. The instant claims are not limited to a particular compound given the variability of the compounds that could be generated.
Representative number of examples
A “representative number of species” means the species which are adequately described are a representative of the entire genus. Therefore, when there is a substantial variation within a genus, the applicant must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). See MPEP 2163.3 (ii). The elected species and the compounds recited in the application specification are not a representation of the entire genus recited in the claims. The instant Examples are focused on producing the compounds and the IC50 values of the compounds on Kras inhibition. Thus, the specification fails to provide adequate written description for the genus of compounds claimed and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Response to Arguments
Applicant's arguments filed 06/17/2026 have been fully considered but they are not persuasive.
Applicant argues that the claimed invention has sufficient and that Applicant has defined the variables in claim 2 and that the chemical genus is well represented (Page 4-6 of Arguments).
The arguments presented above have been fully considered but are unpersuasive. Examiner insists that claim 2 recites numerous variables leading to thousands of compounds and it is unclear if Applicant has possession of all the compounds that could be generated given the vast number of variables on the compound of Formula 2. Written description issues may also arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not necessarily constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) (See MPEP 2162.1 (A). The arguments are unpersuasive and the rejection is maintained.
Closest Prior art
Examiner notes that the elected species is free of prior art. The search was extended to the genus which is free of prior art.
The closet prior art is Kariyuki et al. (WO2013100132A1 – hereinafter “Kariyuki”).
Kariyuki teaches a cyclic peptide with the structure DP-66 (Page 169) as shown below:
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Kariyuki does not teach the instant compound of Formula 2.
Conclusion
Claims 2-10, 12, 15, 17-21 are rejected.
Claims 22-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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