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 .
Claim Rejections - 35 USC § 112(a)
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 15-34 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. Claims comprise limitations directed to solvates of compound (I). Solvates are crystal forms of the compound that comprise solvent molecules in the crystal matrix. There is no data in the specification identifying solvates of any of the compounds with the scope of the claims. Whether a specific crystal form of a compound can be formed is highly unpredictable (Gavezzotti et al Acc. Chem. Res, 1994, 27, 309-314; first paragraph). Thus, without specific examples of solvates, Examiner concludes that applicants did not have possession of solvates of the claimed compound at the time of filing.
Claim Rejections - 35 USC § 112(b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-34 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15-34 comprise 2 definitions of L. The first one, at the top of page 5/41, L is a carbon chain, which can include any number of heteroatoms. In the second definition, L is a group containing moiety W, where W can be a ring. The definitions are not recited as alternatives. It’s unclear what L is.
Claims 15-34 comprise limitation directed to X: ”Alternatively, X is not the structure represented by formula Ib’, and provided that R2 is methyl, L and X for any group containing carbons; Y is selected from group consisting of…”. Its unclear is L and X can be any group containing carbons or if L has to be one of the recited groups. If L is one of the recited groups, then what’s X? Additionally, the claim limits Y to alkyne. The limitation states that X in not the structure Ib’, but does not state that Y can be changes. Lastly, It is unclear what the structure of X is when R2 is not methyl. The definition addresses the instance where X is not the structure Ib’ and R2 is methyl, but what about when R2 is not methyl?
Claims 15-34 comprise 2 definitions of Y. The first one is in the part of the claim that’s discussed above, where X is not the structure Ib’. The second one is at the end of the claim where Y is alkyne.
Claims 15-34 comprise limitation directed to prodrug of the claimed compound. It is unclear what the structure of the prodrug is. Applicants have not provided any specific examples of prodrugs.
Claims 20-23 recite the limitation "Y and Y’ are CH2" in line 3. There is insufficient antecedent basis for this limitation in the claim. Definition of Y in claim 15 does not include CH2.
Claims 24-26 recite the limitation "L is absent" in definition of L. There is insufficient antecedent basis for this limitation in the claim. Claim 15 does not comprise the limitation “L is absent”.
Claim 33 and 33 comprise limitations directed to preferred embodiments. It’s unclear if the claim is limited to recited embodiments or not.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
Claim(s) 15, 32, 33 and 34 is/are rejected under 35 U.S.C. 102(a)(1) and under 35 U.S.C. 102(a)(2) as being anticipated by over Zhou et al (WO 2020088194; US 12,065,447 is used as an English language equivalent).
Zhou discloses compound ZB-R-68 which anticipates the rejected claims (column 69):
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In the disclosed compound:
X is not the structure represented by Ib’,
R2 is H,
X is H, and
L is a chain containing carbons and includes an O atom.
Regarding claims 32 and 33:
Claims 32 and 33 recite an intended use of the claimed compound. It is well settled that the intended use of a composition or product (e.g. as a cosmetic composition) will not further limit claims drawn to a composition or product, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount as instantly claimed. See, e.g., Ex parte Masham, 2 USPQ2d, 1647.
Regarding claim 34, directed to a medicament comprising the claimed compound and an excipient:
In column 92, lines 37-39, art discloses dissolving the compound in DMSO, which meets the limitation directed to compound + excipient.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15, 25, 26 and 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al (WO 2020088194; US 12,065,447 is used as an English language equivalent).
Scope of prior art
Chen discloses compounds ZB-R-25 (column 85, lines 1-20)
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Ascertaining the difference
In compound ZB-R-25 R2 is H, in rejected claims R2 is Me.
Obviousness
A person of prdinary skill in the art, prior tot eh earliest effective filing date of the current application, would have found it obvious to prepare a methylated derivative of compound ZB-R-25 of Zhou with an expectation that the resulting compound will retain the RIP1 inhibitory activity of the parent. It is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S. P.Q. 477, 51 U.S.P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C.P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963): In re Hoehsema, 399 F.2d 269, 158 US.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.P.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel. 130 U.S.P.Q. 474. (P.O.B.A. 1960).
Regarding claims 32 and 33:
Claims 32 and 33 recite an intended use of the claimed compound. It is well settled that the intended use of a composition or product (e.g. as a cosmetic composition) will not further limit claims drawn to a composition or product, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount as instantly claimed. See, e.g., Ex parte Masham, 2 USPQ2d, 1647.
Regarding claim 34, directed to a medicament comprising the claimed compound and an excipient:
Art teaches RIP1 inhibitory activity of the compounds. Since the methylated derivative is expected to retain the biological properties of the parent compound, one would have found it obvious to formulate it into a composition for administration to subjects who require inhibition of RIP1.
Conclusion
Claims 15-34 are pending
Claims 15-34 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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