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 Objections
Claims 1-15 are objected to because of the following informalities: The claims contain numerous grammatical errors. For example, there are numerous instances where the words are not separated by a space For Example: claim 8 line 3 “unsubstitutedgroup”; claim 1, definition of Ring B “alkyl-S(O)2,and” a space before “and” is missing”. There are too many grammatical errors to list each one. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
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.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to use of a compound for preparation of a medicament. I. THE FOUR CATEGORIES
35 U.S.C. 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of § 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007).
Claim Rejections - 35 USC § 112
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.
Claim 15 is 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 pre-AIA the applicant regards as the invention. Claim 15 appears to be directed to a process without setting forth any method steps.
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112, second paragraph. For example, a claim which read: "A process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon." was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Claims 1-15 are 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.
Claims 1-15 are indefinite because the claims comprise limitations directed to preferred embodiments. For example, in definition of R in claim 1, the claim states “preferably, the carbocycle or heterocycle is a 5-9 membered carbocycle or heterocycle, more preferably a 5-7 membered carbocycle or heterocycle”. Recitation of preferred embodiments renders the claim indefinite because it is unclear if the claim is limited to the recited embodiments. The preferred embodiments are not limited to claim 1 and appear in numerous instances throughout the claims. In every instance the term “preferred” or “preferably” renders the claim indefinite.
Claims 1-15, comprise limitations that are followed by a limitation in parentheses. For example, in claim 1, definition of R6 includes the following limitation” “, sulfonyl (-SO2-OH),”. It is unclear if use of parentheses is intended to provide an example of the recited functional group, or if the group is limited to the contents of parentheses. In the example provided, the term “sulfonyl” encompasses a broader scope than the sulfonic acid functionality presented in the parentheses.
Claim 5 recites specific examples of R3 that are outside of the scope of claim 1. The ring structures depicted in claim 5 comprise polycyclic rings that are outside of the scope of R3 as defined in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 is also rejected because if recites a ring having variables X1, X2, X3 and X4, but fails to define the variables. It appears that the claim limits R3 to the specifically disclosed cyclic systems recited in the claim. In this case the limitation directed to ring comprising the variables is not necessary.
Claim 8 is rejected as indefinite because the claim appears to further limit R3, but does not provide any limitations directed to R3 and instead proceeds to define Ring A. The claim reads:
“R3 is a group selected from the group consisting of: ring A is a substituted or unsubstituted group”. Applicants’ intent is unclear.
Claim 13 is rejected as being indefinite. The claim recites “any one of the compound of Example P1-P448”. A) The word “compound” should be plural. B) Specification recites “compounds P001-P448” (see page 56), but not Example P1-P448.
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) 1-4, 6-8, 10, 14 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tran et al (Bioorganic & Medicinal Chemistry Letter, 2007, 17, 5165-5170; submitted by applicant on 11/20/23).
Compound 24c (page 5168, Table 1) is within the scope of the rejected claims.
Regarding claim 14: the compounds in Table 1 are tested in a binding affinity assay which requires dissolving the compound in a carrier. This meets the limitation directed to pharmaceutical composition.
Regarding claim 15: Tran prepares a solution for testing compound 24c in a binding assay. The solution meets the limitation directed to pharmaceutical composition. Tran therefore uses compound 24c to prepare a pharmaceutical composition. Limitation “for treatment of prevention of diseases…” is treated as an intended use of the product. 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
Claim Rejections - 35 USC § 103
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) 1 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al (Bioorganic & Medicinal Chemistry Letter, 2007, 17, 5165-5170; submitted by applicant on 11/20/23).
Scope of prior art
Tran teaches compound 24c (page 5168, Table 1).
Ascertaining the difference
In compound 24c the moiety W is MeNHCH2CH2NHCH2 while in the claimed compound a nitrogen atom carries a methyl group instead of a hydrogen: MeNHCH2CH2NMeCH2.
Obviousness
A person of ordinary skill in the art, prior to the earliest effective filing date of the current application, would have found it obvious to substitute a methyl group for hydrogen atom in compound 24c of Tran with an expectation that the resulting product would retain the binding affinity of 24c.
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).
Conclusion
Claims 1-15 are pending
Claims 1-15 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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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628