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 .
Status of the Claims
Claims 1-20 were originally filed February 3, 2023.
The amendment received August 9, 2023 added status identifiers only.
The amendment received March 27, 2024 amended claim 5 and canceled claim 9.
The amendment received October 17, 2024 amended claims 1 and 8 and canceled claims 2-5 and 18.
The amendment received July 30, 2025 changed the status identifiers only.
Claims 1, 6-8, 10-17, 19, and 20 are currently pending.
Claims 1, 10, and 12 are currently under consideration.
Election/Restrictions
Applicant elected, with traverse, Group I (claims 1-12 and 18-20) in the reply filed on August 9, 2023. The traversal is on the grounds that the claims are related and Groups I and II are linked. This is not found persuasive because while Group I and II are related, the inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process for using the product as claimed can be practiced with another materially different product (e.g. any FDA approved treatments for the myriad of diseases or conditions encompassed by present claims 13 and 15-17).
In addition, restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112.
Furthermore, the claims of Groups I and II are not linking claims – see MPEP § 809.03.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method, there being no allowable generic or linking claim.
Applicant elected, with traverse, SEQ ID NO: 4, angiopep-2, and cyclic in the reply filed on August 9, 2023 is acknowledged. The traversal is on the grounds that the peptide species have a disclosed relationship (i.e. common function of altering angiogenesis), any additional components may be utilized in the pharmaceutical composition, and any form of peptide may be employed in the pharmaceutical compositions. This is not found persuasive because the species are structurally and/or functionally different and a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the species require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(b) the species may have separate status in the art;
(c) the species may raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112;
(d) the species are structurally and/or functionally different.
The requirement is still deemed proper and is therefore made FINAL.
Alternatively, if the particulars of the additional components and form are not germane to the pharmaceutical compositions, applicants are invited to clearly state on the record that all species are obvious variants.
Please note: applicant’s election of species do not actually read on any of the claims of record (e.g. applicants did not elect a liposome, non-antibody scaffold, or nanoparticle – see independent claim 1 or an unnatural amino acid – see independent claim 18). However, in order to advance prosecution, the election has been accepted and independent claims 1 and 18 are being examined.
Claims 6-8, 11, 19, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species, there being no allowable generic or linking claim.
Potential Rejoinder
Applicant elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a CON of 17/157,617 filed January 25, 2021 (now U.S. Patent 11,608,367) which is a DIV of 16/465,808 filed May 31, 2019 (now U.S. Patent 10,934,334) which is a 371 (National Stage) of PCT/US19/15210 filed January 25, 2019 which claims the benefit of 62/622,012 filed January 25, 2018.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Maintained Rejection
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.
Claims 1, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. U.S. Patent Application Publication 2019/0206512 filed January 16, 2018 (effective filing date of July 21, 2017); Seth U.S. Patent Application Publication 2005/0065333 published March 24, 2005; and Zou et al., 2017, Progress in Research and Application of HIV-1 TAT-Derived Cell-Penetrating Peptide, J Membrane Biol, 250: 115-122.
For present claims 1, 10, and 12, Lu et al. teach SEQ ID NO: 4 (present SEQ ID NO: 4), SEQ ID NO: 6 (present SEQ ID NO: 6), SEQ ID NO: 8 (present SEQ ID NO: 8), SEQ ID NO: 19 (present SEQ ID NO: 10), SEQ ID NO: 11 (present SEQ ID NO: 11), SEQ ID NO: 12 (present SEQ ID NO: 12), and SEQ ID NO: 16 (present SEQ ID NO: 16).
However, Lu et al. does not teach liposomes, non-antibody scaffolds, fusion polypeptides, HIV tat, or cyclic peptides.
For present claims 1, 10, and 12, Seth teaches SEQ ID NO: 26 which is a 14mer (i.e. 15 fewer amino acids than SEQ ID NO: 4) and has 100% identity to residues 16-29 of present SEQ ID NO: 4; peptidomimetics; cyclic peptides; pharmaceutically acceptable carriers (e.g. non-antibody scaffold) or liposomes; and fusion proteins including protein transduction domains including HIV tat (please refer to the entire specification particularly paragraphs 32, 42, 87, 106, 125, 152, 154-157, 161, 166, 171, 173, 234, 245, 262, 305, 327, 365, 386, 473, 482, 484, 486, 512, 513).
For present claims 1, 10, and 12, Zou et al. teach HIV tat (47-57) as a protein transduction domain which was first discovered in 1997 (please refer to the entire reference particularly abstract; Table 1; page 116, right column, first full paragraph).
The claims would have been obvious because a particular known technique (e.g. utilizing liposomes or carries in combination with peptides in pharmaceutical compositions to increase stability; utilizing HIV tat 47-57 to transport peptides into cells; making peptides cyclic to increase stability) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Lu et al., Seth, and Zou et al. for claims 1, 10, and 12 were considered but are not persuasive for the following reasons.
Applicants contend that since Lu et al. does not teach any use of the polypeptides that Lu et al. cannot be utilized as prior art. Applicants contend that Lu et al. is non-analogous art. Applicants contend that Lu et al. teach thousands of peptides and one of skill in the art would not would need to do extensive experimentation to determine activity. Applicants contend that there is no motivation to combine the references.
Applicants’ arguments are not convincing since the teachings of Lu et al., Seth, and Zou et al. render the polypeptides of the instant claims prima facie obvious.
The present claims are drawn to products and not a method of utilizing the products.
In response to applicant's argument that Lu et al. is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Lu et al. teach peptides which are in the inventor’s field of endevor.
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). When the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that "the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ in that publication."). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims were directed to polycarbonate containing cadmium laurate as an additive. The court upheld the Board’s finding that a reference specifically naming cadmium laurate as an additive amongst a list of many suitable salts in polycarbonate resin anticipated the claims. The applicant had argued that cadmium laurate was only disclosed as representative of the salts and was expected to have the same properties as the other salts listed while, as shown in the application, cadmium laurate had unexpected properties. The court held that it did not matter that the salt was not disclosed as being preferred, the reference still anticipated the claims and because the claim was anticipated, the unexpected properties were immaterial.).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The claims would have been obvious because a particular known technique (e.g. utilizing liposomes or carries in combination with peptides in pharmaceutical compositions to increase stability; utilizing HIV tat 47-57 to transport peptides into cells; making peptides cyclic to increase stability) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
It is respectfully noted that applicant is far from the first to utilize PTDs/CPPs (protein transduction domains/cell penetrating peptides) to deliver peptides to cells (see prior art above; additional prior art will be provided upon request). It is also respectfully noted that applicant is far from the first to utilize a liposome, non-antibody scaffold, or nanoparticle with a peptide or to make a peptide cyclic to increase stability (see prior art above; additional prior art will be provided upon request). In addition, screening assays are exceedingly common in the prior art to determine binding, activity, etc. Screening assays can be scaled up to quickly screen hundreds, thousands, etc. of peptides at one time. References will be provided upon request.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 02/087507 (SEQ ID NO: 4 – claim 9)
U.S. Patent Application Publication 2004/0152626 – SEQ ID NO: 19 (see residues 13-28 of present SEQ ID NO: 10).
THIS ACTION IS MADE FINAL. 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.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658