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 .
Applicants' arguments, filed August 11, 2025, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 – Indefiniteness
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, 3, 6, 9, 14, 15 and 17 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 1 recites the limitation "the aromatic groups" in lines 9 - 10. There is insufficient antecedent basis for this limitation in the claim. It is not clear if the phrase “the aromatic groups” refers to each side chain aromatic group, each of which must contain one or aromatic amine groups or if “the aromatic groups” refers to the population of three or more side chain aromatic groups and of that group of side chains, one or more of the amino acid monomers is required to have an aromatic amine group and not just an aromatic group. As discussed in greater detail below, a single amino acid monomer having a side chain with two or more aromatic amine groups is not supported by the disclosure as originally filed. However, if the phrase “wherein the aromatic groups comprise one or more aromatic amine groups” is refers to all of the monomers with side chain aromatic groups, that one of more of those monomers can have an aromatic amine group as a side chain. Please clarify. The dependent claims fall therewith.
Claim Rejections - 35 USC § 112 – New Matter
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 1, 3, 6, 9, 14, 15 and 17 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. This is a new matter rejection.
As discussed above, one interpretation of claim 1 as currently amended is that more than 1 amino acid with an aromatic side chain in the H portion of the claimed amphiphilic block copolymer has a side chain comprised of 2 or more aromatic amine groups and such side chains were not disclosed in the application as originally filed. The specific paragraphs cited for support were reviewed and no verbatim support was found in those paragraphs or elsewhere in the specification. Structures of various side chains comprising one aromatic amine were found (e.g., ¶ [00135] of the specification as filed) but no exemplary side chains that contained two or more aromatic alkyl groups were located that would provide support for at least some species within the claimed genus. That amino acid monomers comprising the hydrophobic polymer or oligomer can have a side chain with an aromatic amine group and that at least two of those monomers, due to the use of the plural form in the aromatic groups, is supported by the disclosure as originally filed but the claims are not limited to such embodiments.
The dependent claims fall therewith.
If Applicant is in disagreement with the Examiner regarding support for the amended claim, Applicant is respectfully requested to point to additional locations wherein support may be found for the instant invention and/or explain how implicit or inherent support is present for claim 1 as currently amended.
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.
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, 3, 6, 9, 14, 15 and 17 were rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2011/0150978) in view of Oh et al. (Int J Pharm, 2009), Du et al. (Colloids Surface A Physicochem Eng Aspects, 2010) and Hein et al. (Pharm Res, 2008). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed February 11, 2025 and those set forth herein.
Claim 3 previously required three or more side chain aromatic amine groups, and such polymers will have at least 3 amino acids in the hydrophobic polymer or oligomer segment of the claimed polymer with a side chain comprising one or more aromatic amine groups as required by amended claim 1.
Applicants traverse this rejection on the grounds that Lee provides no teaching, suggestion or motivation to modify its disclosed block copolymers in accordance with the teachings of Oh, Du and/or Hein. Even supposing a person of ordinary skill in the art were to make the modifications to Lee as suggested by the Examiner, which Applicants do not concede, none of the references teach or suggest amphiphilic block copolymers as claimed. Amphiphilic bock copolymers comprised of hydrophobic polymers or oligomers comprising aromatic amines lead to improved manufacturability and solubility in water miscible solvents and lead to the formation of stable particles with low critical micelle concentration (CMC, ¶ [0130] of the specification as filed).
These arguments are unpersuasive. An explicit teaching, suggestion or motivation in the prior art provides the necessary rationale for an obviousness rejection, it is not the only possible rationale for an obviousness rejection. While no single piece of prior art discloses all aspects of the claimed invention, the explicit, implicit and inherent teachings of the applied prior art along with the knowledge of the person of ordinary skill in the art before the effective filing date of the instant invention are sufficient to render obvious the polymers as presently claimed. It appears that Applicants are also arguing that unexpected results are present for the polymers as claimed. Attention is directed to MPEP 716.02 et seq. for a complete discussion of unexpected results, but Applicants bear the burden of explaining the evidence of record in support of unexpected results. The remarks make mention of alleged surprising results but the specification contains little data on the aspects alleged to be unexpected. A determination of unexpected results requires that the expected results be states and that the results actually obtained are different from what is expected. Additionally, any evidence in support of unexpected results must be reasonably commensurate in scope with the claims. Due to the use of “comprising” when defining each section of the amphiphilic block copolymer S-B-H, the claimed amphiphilic block copolymers are not limited the recited elements, and even as claimed, S can be any charged amino acid; three or more side chain aromatic groups and aromatic amine groups must also be present in the H block and the claims are not even limited to natural amino acids. Despite the lack of explanation of evidence in support of the alleged unexpected results, Table 7 does appear to show that SEQ ID NOs 99 and 100 could not be synthesized while SEQ ID NOs 101 – 106 could be synthesized although it appears that only a single synthesis procedure was tried. Only the natural amino acid W (tryptophan, an aromatic amine), E (glutamic acid, an anionic amino acid) and K (lysine; a cationic amino acid) are used and all but SEQ ID NOs. 105 and 106 are not 10 amino acids in length. Even when considering the claimed portions of H, 5 to 50 amino acid monomers with three or more side chain aromatic groups and the aromatic groups comprise one or more aromatic amine groups. Tryptophan is a cyclic aromatic amine but is only a single species within that genus and almost all sequences in Table 7 are predominantly tryptophan. These polypeptides are limited scope given their similarity to each other and are just one of the 3 blocks required to be present in the claimed amphiphilic block copolymer. Such materials are not reasonably commensurate in scope with the instant claims even if the expected results had been established and the observed results were in fact different from the expected results. Therefore the evidence of record in support of the alleged unexpected results do not outweigh the prima facie case of obviousness and the rejection is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 6, 9, 14, 15 and 17 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97 – 116 of copending Application No. 18/027,346 in view of Oh et al. (Int J Pharm, 2009) and Hein et al. (Pharm Res, 2008). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed February 11, 2025 and those set forth herein.
Applicants request that this rejection be held in abeyance until patentable subject matter has been identified.
Therefore this rejection is maintained for the reasons of record set forth in the Office Action mailed February 11, 2025.
This is a provisional nonstatutory double patenting rejection.
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Nissa M Westerberg/Primary Examiner, Art Unit 1618