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 .
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 5/7/26 are acknowledged. Any objection or rejection from the 2/11/26 office action that is not addressed below is withdrawn based on the amendments.
Previously, Group 1 and the species of YC55 were elected. The elected species was found to be free of the prior art. The search was extended in accord with MPEP 803.02.
Claims 3 and 5-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/25.
Claim 11 has been added as a new claim.
Claims 1-2, 4 and 11 are being examined.
Priority
The priority information is found in the filing receipt of 8/16/23.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 does not end in a period. Claim 2 of the 12/10/25 claim set ended in a period but the most recent claim set does not include a period at the end of claim 2.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims were previously rejected under 35 USC 112. Since the claims have been amended and a new claim added, the rejection is updated to correspond to the instant claims.
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 1-2, 4 and 11 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.
In claim 1 the R4 variable recites n-butyle. The meaning of this terms is unclear as no art-recognized definition for such term could be found. It is unclear if this is an alternate spelling of a known term. It is unclear if such term is to be identical with the corresponding structure shown. Dependent claim 4 does not clarify the claim scope.
The 4th option for R4 of claim 1 is
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76
130
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. However, this structure is incomplete as the right hand side appears to have been cut off. It is unclear if a methyl group or hydrogen or something else is attached to the right hand side of the structure. Although unclear, the claim has been interpreted as including no new matter.
Claim 2 recites
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832
258
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However, the structures are incomplete as the right hand side appears to have been cut off. It is unclear what is attached to the right hand side of the structures. It is unclear if claim 2 is a proper dependent claim. Although unclear, the claim has been interpreted as including no new matter.
Claim 11 recites as an option for R1 that is CH(CH3)CH2CH3CH3. Thus, the carbon of the CH2 appears to be bonded to 2 hydrogens and 3 carbons. However, carbon typically only forms 4 bonds. The intended structure is unclear. It is not clear if claim 11 is a proper dependent claim. Although unclear, claim 11 has been interpreted as including no new matter.
In claim 11 the R1 variable recites CH3 (L-Ala), CH(CH3)2 (L-Val), CH(CH3)CH2CH3CH3 (L-Ile). First, such description is confusing because the R1 corresponds to a side chain not a complete amino acid. Second the claim refers to both broad and narrow limitations. For example, the stereochemistry of CH3 is not specified so it can be attached in various orientations while L-Ala is suggesting a specific orientation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation CH3, CH(CH3)2 and CH(CH3)CH2CH3, and the claim also recites (L-Ala), (L-Val) and (L-Ile) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Within claim 1 (Y and Z), various groupings are recited. The last options within the groupings are not separated by the word ‘and’ or the word ‘or’ making the scope of the claims unclear. It is unclear if additional options are possible. It is also unclear if all options are required.
Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification.
Response to Arguments - 112
Applicant's arguments filed 5/7/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Claim Rejections - 35 USC § 103
Claims were previously rejected under 35 USC 103 based on the references cited below. Since the claims have been amended and a new claim added, the rejection is updated to correspond to the instant claims.
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) 1, 4 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (EP 0360258 03-1990; ‘Chu’) in view of Deber (WO 2018/132920 07-2018; ‘Deber’).
Chu teach antibacterial compounds and teach a goal of improved solubility and improved cell permeability (page 2 lines 15-30). Chu teach the use of ‘A’ as a solubilizing group where ‘A’ can be Gly-Gly-Gly-Ala (page 2 lines 36-55 and claims 3-4). Chu teach that the peptide solubilizing groups can be prepared by any of a variety of recognized methods (page 14 lines 52-54). Chu recognizes the reaction of a carboxyl group of an amino acid with a free amino group (page 10 lines 38-40 and page 15 lines 15-17). In claims 11-12, Chu expressly teach modifying a base compound by attaching the ‘A’ group. Chu also recognizes that the compounds can act as prodrugs (pages 46-47).
Chu does not teach examples using N-substituted amino acids.
Deber teach solubility-increasing tags and membrane insertion tags specifically those that contain 2-6 peptoid residues specifically N-isobutylglycine (NLeu) where the tag can be at the N-terminus (page 3 lines 1-9). Deber specifically teach that to achieve a burrowing property that the peptide includes an acetylated N-terminal residue followed by 3 additional residues (page 18 lines 16-22). Deber teach that methods of peptide synthesis were known (pages 18-19 connecting paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Chu because Chu teach antibacterial compounds and teach a goal of improved solubility and improved cell permeability (page 2 lines 15-30). Chu teach the use of ‘A’ as a solubilizing group where ‘A’ can be Gly-Gly-Gly-Ala (page 2 lines 36-55 and claims 3-4). Since Deber teach solubility-increasing tags and membrane insertion tags specifically those that contain 2-6 peptoid residues specifically N-isobutylglycine (NLeu) where the tag can be at the N-terminus (page 3 lines 1-9) and specifically teach that to achieve a burrowing property that the peptide includes an acetylated N-terminal residue followed by 3 additional residues (page 18 lines 16-22) one would have been motivated to modify the Gly-Gly-Gly-Ala peptide of Chu to obtain Ac- N-isobutylglycine - N-isobutylglycine - N-isobutylglycine – Ala. Stated another way, since Chu expressly refers to improved cell permeability one would have been motivated to modify the peptide of Chu (Gly-Gly-Gly-Ala) based on the known modifications that allow for membrane insertion as taught by Deber (N-acetylation and use of N-modified glycine). Such peptide is an intermediate that would then be conjugated to obtain an antibacterial compound (see page 2 lines 36-55 of Chu) for example by creating an amide bond between the C-terminal group of the peptide and the NH2 group (claim 11 of Chu and page 10 lines 38-40 and page 15 lines 15-17 of Chu). One would have had a reasonable expectation of success since methods of synthesizing peptides was known. Chu teach that the peptide solubilizing groups can be prepared by any of a variety of recognized methods (page 14 lines 52-54). Deber teach that methods of peptide synthesis were known (pages 18-19 connecting paragraph).
In relation to claims 1 and 11, Ac- N-isobutylglycine - N-isobutylglycine - N-isobutylglycine – Ala as discussed above is such that R5 is CH3, R4, R3 and R2 are CH2CH(CH3)2 and R1 is CH3 and the third residue is an N-substituted alpha amino acid (n is 1).
In relation to claim 4, in claims 11-12, Chu expressly teach modifying a base compound by attaching the ‘A’ group. Chu teach that the peptide solubilizing groups can be prepared by any of a variety of recognized methods (page 14 lines 52-54) which would include preparing the peptide in a composition with a carrier.
Response to Arguments - 103
Applicant's arguments filed 5/7/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue that the references do not teach treatment of chronic pain, the instant claims are composition claims and no treatment is required. It is noted that the features upon which applicant relies (i.e., treatment of chronic pain) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Although applicants argue that the claimed peptoids are designed to interrupt the interaction between TRIP8b and the C-terminus of HCN channels, the instant claims are composition claims and no treatment or interaction is required. It is noted that the features upon which applicant relies (i.e., interrupt the interaction between TRIP8b and the C-terminus of HCN channels) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Although applicants argue that the A group of Chu is not a standalone compound, the A group must first be made before it is attached. In claims 11-12, Chu expressly teach modifying a base compound by attaching the ‘A’ group.
Although applicants argue that only one compound is mapped onto claim 1, a species reads on a genus (see MPEP 2131.02).
Although applicants argue that there is not adequate motivation to combine the references, since Chu expressly refers to improved cell permeability one would have been motivated to modify the peptide of Chu (Gly-Gly-Gly-Ala) based on the known modifications that allow for membrane insertion as taught by Deber (N-acetylation and use of N-modified glycine).
Although applicants argue about motivation for designing TRIP8b-HCN inhibitors, MPEP 2144 IV recognizes that the reason to modify a references can be different from applicants.
Although applicants argue about 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). In the instant case, the details of the rejection are set forth above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
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