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 Application
The claims and remarks of 8 December 2025 are entered.
The election requirement remains in effect.
Claims 1-18 are pending. Claims 9-15 are withdrawn without traverse. Claims 1-8 and 16-18 are being examined on the merits.
The rejection of claims 1-8 under 35 U.S.C. 112(b) is withdrawn in light of the amendment filed 8 December 2025.
The rejection of claims 1-8 under 35 U.S.C. 102(a)(1) or 102(a)(2) is withdrawn in light of the amendment filed 8 December 2025.
The rejection of claims 1-8 under 35 U.S.C. 102(a)(1) as being anticipated by ‘826 is withdrawn in light of the amendment filed 8 December 2025.
New grounds of rejection are presented below in response to Applicants’ amendment.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Nucleotide and/or Amino Acid Sequence Disclosures
The Examiner gratefully acknowledges filing of an amendment incorporating the required SEQ ID NOs into the specification. However, the Examiner apologizes for stating an incorrect filing date for the purposes of sequence compliance, as the instant application has an international filing date of 15 July 2021, such that a sequence listing under ST.25 is required, not ST.26 as filed on 8 December 2025. Applicants’ assistance in filing the corrected sequence listing (same as that on 12 January 2023) and amendment to the specification directing reference to that listing instead of the .XML reference is requested.
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.
Claims 1-8, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Braun et al. (WO 2020/260436 A1, published 30 December 2020, filed 25 June 20220, priority to 27 June 2019, hereafter referred to as ‘436).
The ‘436 art discloses a peptide tag (HR)4 of SEQ ID NO: 6 (see e.g. SEQ ID NO: 6, claims 1-6). This overlaps with claim 1, as it is a peptide between 5 or 6 to 30 amino acids, has at least 1/3 residues having a functional group or side chain that is positively charged at neutral pH in the form of arginine, and has at least two amino acids that are histidines.
The difference between ‘436 and the claimed invention is that ‘436 does not explicitly show the tag being bound to an inorganic surface as found in the amended claims.
The ‘436 does indicate that purification of a tagged protein using tags such as (HR)4 can be accomplished via ion exchange chromatography (see e.g. claims 1 and 33). ‘436 indicates that ion exchange resins can include those containing particles based upon silica or hydroxyapatite, i.e. inorganic surfaces (see e.g. p.16 lines 25-32).
It would have been obvious to one of ordinary skill in the art to utilize the tag of ‘436 in an ion exchange chromatography process by passing the tag and/or tagged protein through a resin based upon silica or hydroxyapatite and expect binding to occur to the resin based upon buffer conditions, and in doing so achieve a peptide consisting of 5 or 6 to 30 amino acids having at least 1/3 positively charged amino acids at neutral pH and at least two histidines bound to an inorganic surface. The rationale comes from ‘436 suggesting the ion exchange process for purification, which by necessity depending on charge of the resin and salt conditions results in either binding to the resin or flowthrough, and in the case of binding achieves the same peptide bound to an inorganic surface in the form of a silica or hydroxyapatite resin particle. The invention could have been reproduced with a reasonable expectation of success since bind and elute type ion exchange chromatography was well-known in the art. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 2, as set forth above ‘436 discloses arginine as the charged amino acid.
With respect to claim 3, the ‘436 peptide is in a (S)(W) repeat.
With respect to claim 4, at least two histidines are present in ‘436 in a stretch of no more than 8 consecutive amino acids.
With respect to claim 5, there are no amino acids present that have no functional group or side chain or having a functional group or side chain with a negative charge at neutral pH, as allowed by the claim.
With respect to claim 6, the ‘436 art claims a fusion between the (HR)4 tag and another protein of interest (see e.g. claims 1, 5, and 6).
With respect to claim 7, as set forth above ‘436 claims fusion to a protein of interest.
With respect to claim 8, ‘436 claims fusion with antigenic or carrier proteins, reasonably reading upon the claims (see e.g. claims 9-11 and 20).
With respect to claims 16 and 17, as set forth above ‘436 discloses silica particles.
2. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Braun et al. (WO 2020/260436 A1, published 30 December 2020, filed 25 June 20220, priority to 27 June 2019) as applied to claims 1 and 16 above, and further in view of Altintoprak et al. (Beilstein J. Nanotechnol. 6:1399-1412, published 25 June 2015, hereafter referred to as Altintoprak).
The relevance of ‘436 is set forth above. The difference between ‘436 and the claimed invention is that ‘436 does not disclose silanol or siloxane.
The Altintoprak art discloses peptides containing high levels of histidine or basic amino acids (see e.g. Table 1). Altintoprak also discloses that basic amino acids like Lys and Arg have electrostatic interactions with siloxane groups.
It would have been obvious to one of ordinary skill in the art given the highly charged nature of the ‘436 peptide tag to utilize the siloxane groups of Altintoprak as a silica particle since ‘436 contains a number of arginine resides in a short sequence indicating it would interact with siloxane. The rationale comes from Altintoprak disclosing that positively charged amino acids create electrostatic interactions with siloxane groups, which would indicate that as a starting point for resin chemistry for the ‘436 peptide bound to silica. There would have been a reasonable expectation of success because ‘436 already provides use of silica resin and the peptide such that the only alteration the skilled artisan needs to make is to the base silicone chemistry provided by Altintoprak. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
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 ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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/Z.J.M/Patent Examiner, Art Unit 1658 /SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658