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 .
Response to Amendment
The amendments received 09/02/2026 have been entered. Claims 1-8 and 11-22 are pending. Any objection or rejection previously set forth in the Office Action mailed 03/02/2026 not maintained herein has been overcome and is withdrawn.
New grounds of rejection are set forth herein.
Claim Objections
Claim 5 is objected to because of the following informalities: "is independent an integer" should read "is independently an integer". Appropriate correction is required.
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 7-8, 11-12, 14, and 20-22 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.
Claim 7 recites “Ab represents an… antibody-like molecule”. It is unclear to what degree a compound must be similar to an antibody to be considered antibody-like, or what particular compounds fall within the scope of being antibody-like. In looking to the specification, page 29 states, “Antibody-like molecules may function similar to antibodies but are structurally no antibodies. Such molecules include, for example and without limitation, anticalins, aptamers and the like. They may chemically be peptides or include peptide moieties, but may also be non-peptide compounds, such as nucleic acids and derivatives thereof.” The definition provided in the specification is notably open and provides no particular metes and bounds as to what functions must be similar, and to what degree, to be considered “antibody-like”. As such, the claim lacks clarity. Claims 8, 11-12, 14, and 20-22 incorporate the limitations of claim 7 and are similarly rejected.
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 5-8 and 11-22 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 5-8 and 11-22 have been amended to recite and/or require the variables “n1”, “n2”, “n3”, and/or “n4”. However, these variables were not disclosed or suggested in the instant disclosure at the time of filing, and are therefore considered new matter. Moreover, the parts of the disclosure pointed to by Applicant in the remarks filed 09/02/2026 (see p. 18 of remarks) do not provide support for any of “n1”, “n2”, “n3”, and/or “n4”. Correction is required.
Claims 5-8 and 11-22 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 5-8 and 11-22 have been amended to recite and/or require the limitation “wherein each R13 independently represents hydrogen or…”. Claims 5 and 7 are directed toward formulas (II) and (III), respectively. In looking to the disclosure to find support for the claims as amended, variable R13 is disclosed as being hydrogen in formulas (I) and (I.1) (see p. 3 of originally filed specification), but is only disclosed as being (C1-C6)alkyl in formulas (II) and (III) (see p. 4 and 6 of originally filed specification). As such, there is no teaching or suggestion of the limitation “wherein each R13 independently represents hydrogen or…” for formulas (II) and (III) in the instant disclosure, and the amendment is considered new matter. Correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sammet et al. (J. Org. Chem.; 2010; IDS filed 11/02/2023).
Sammet et al. discloses the following compounds (p. 6954, Figure 1).
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The compounds are within the scope of formulas (I) and (I.1) wherein X is O, R1 is methyl, R2 and R3 are hydrogen, one of R4 and R5 are methyl, R7 is hydrogen, R8 is C1 alkylene-COO-(hydrogen or C3 alkenyl), R9 is alkoxy or halogen, and R10 is hydrogen.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bigot et al. (WO 2017/076998 A1; IDS filed 11/02/2023).
Bigot et al. discloses cryptophycin compounds of formula (I) as below (p. 10).
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The variable “W” is defined as follows (p. 9).
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Bigot et al. does not explicitly disclose a compound wherein R6 is hydrogen, R8 is methylene-N(Me)2 or methylene-COOH, and R10 is hydrogen, -OH, (C1-C4)alkylene-OH, (C1-C4)alkoxy, or (C1-C4)alkyl. However, this limitation is obvious over Bigot et al.
Bigot et al. additionally discloses the following compound (p. 14).
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It would be prima facie obvious for one of ordinary skill in the art to try to substitute the W of the above subgenus, wherein R8 is methylene-N(Me)2 or methylene-COOH, with the methylene-OH group of the above compound disclosed by Bigot et al. One would have been motivated to try, with reasonable expectation of success, as Bigot et al. sets forth a closed list of predictable alternatives including (C1-C4)alkyl-OH that can be present in the W position of formula (I). One would therefore be apprised that methylene-OH would yield predictable results.
Response to Arguments
Applicant's arguments filed 09/02/2026 have been fully considered but they are not persuasive.
Regarding the rejection under 35 U.S.C. 103 as above, Applicant argues that the compounds of Bigot et al. differ from the instant invention in that the group “W” is positioned on the phenyl ring attached to the epoxy group which functions as the linker, while every exemplary compound of Bigot et al. has tert-pentyl or isobutyl in the instant R8 position (remarks, p. 24). Applicant additionally argues that Examiner relies on impermissible hindsight (remarks, p. 25). This is not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Additionally, Applicant argues that there is no teaching, suggestion, or motivation for a person of ordinary skill in the art to relocate the linker “W” of Bigot et al. to the position of instant R6 or R8 in order to arrive at the instant invention. However, such an argument was never made by Examiner. As in the above rejection, Examiner argues that it would be prima facie obvious to substitute “W” of subgenus D7 (and now, additionally, subgenus D8) with the methylene-OH in the “W” position of the compound depicted on page 14 of Bigot et al. Notably, subgenuses D7 and D8 contain methylene-N(Me)2 or methylene-COOH, respectively, in the instant R8 position. Examiner’s argument of prima facie obviousness requires no relocation of “W” to the instant R8 position in order to arrive at the instant invention and merely rests on the substitution of “W” with a disclosed moiety particularly delineated by Bigot et al. which falls within a preferred embodiment of “W”.
Whether the methylene-N(Me)2 or methylene-COOH themselves are intended to function as linkers, as in the later instantly claimed formulas (II) and (III), is not necessarily required to establish prima facie obviousness. Per MPEP 2144(IV), “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)”. In Bigot et al., the motivation stems from the desire to modify the moiety in the “W” position, which functions as a linker in the invention of Bigot et al., rather than the moiety in the instant R8 position, which functions as a linker in the instant invention. Despite solving different problems, the modification of the subgenuses D7 and D8 still suggests compounds which fall within the scope of the instant invention. For these reasons, the rejection is maintained.
Conclusion
No claims are allowed.
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 MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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/MADELINE E BRAUN/Examiner, Art Unit 1624 09/30/2026
