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 Amendment filed 01/15/2025 has been entered. Claims 1 and 4 remain pending in the application. Claim 1 is amended to recite subject matter previously recited in claims 2-3 along with other amendments.
Status of Objections and Rejections
The rejection of claims 2-3 is obviated by Applicant's cancellation.
The rejection of claims 1 and 4 under 35 U.S.C. 112(b) is withdrawn in view of Applicant's amendment.
The rejection of claims 1 and 4 under 35 U.S.C. 102 as being anticipated by Verdoliva et. al is
withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Response to Arguments
Applicant' s arguments, see pages 3-4, filed 06/12/2026, with respect to the amendment of claim(s) 1 regarding the limitation of a “peptide molecule alternate sequentially between D-form amino acids and L-form amino acids” have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see pages 2-3, filed 06/12/2026, with respect to the amendment of claim(s) 1 have been fully considered but they are not persuasive.
Applicant argues (p. 3) that amended claim 1 now requires the peptide to be synthesized directly on the affinity chromatography resin and remains on that same resin for antibody purification without separation or transfer to another resin. Applicant distinguishes Verdoliva as using a two-support process where the peptide is synthesized on one resin, cleaved and purified, and subsequently coupled to an Emphaze matrix for chromatography. Applicant therefore contends that Verdoliva does not disclose the claimed same-resin/no-separation arrangement.
The Examiner respectfully disagrees.
Amended claim 1 is directed to an affinity chromatography resin, and the recited synthesis steps are drawn to product-by-process limitations. The patentability of a product does not depend on the process by which it is made where the claimed product is the same as or indistinguishable from the product of the prior art (See MPEP 2113). Although Applicant argues that Verdoliva synthesizes the peptide on a first resin, cleaves and purifies the peptide, and subsequently couples it to an Emphaze matrix, Applicant has not established that synthesizing the peptide directly on the affinity chromatography resin and retaining it there imparts any structural or functional distinction to the resulting Emphaze affinity resin containing the purified peptide. Applicant acknowledges that Verdoliva ultimately produces an affinity resin capable of antibody purification; therefore, the difference in the process by which the peptide becomes attached to the resin does not, without a corresponding difference in the resulting product, distinguish the claimed resin from Verdoliva’s resin. Applicant’s arguments pertaining to the “same-resin/no-separation” manufacturing history are therefore not persuasive.
Abstract
The amended abstract was received on 06/12/2026 and is acceptable.
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.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Verdoliva et. al (“Affinity purification of polyclonal antibodies using a new all-D synthetic peptide ligand: comparison with protein A and protein G”; 2002) in view of Pei et al. (US 20210038737 A1).
Regarding claim 1, Verdoliva teaches an affinity chromatography resin (D-PAM/Emphaze affinity resin; Table 3) comprising a peptide molecule (D-PAM; Abstract) resistant to a protease (“As shown in Table 1A, this all-D peptide, called D-PAM, resulted very stable to treatment with proteolitic enzymes…(no degradation was observed after 180 min of incubation),” wherein the replacement of all amino acids of PAM to create D-PAM was “to avoid protease degradation”; pp. 81-81; Abstract), wherein
the resin is configured to bind an antibody (able to capture IgG directly from the serum; Abstract; See IgG, IgA and IgM; Table 3) in a liquid containing the antibody (serum; Abstract; Table 3) for a separation of the antibody from a molecule in the liquid (See Bound column of Table 3: IgG, IgA and IgM recovery after fractionation process of human serum on D-PAM/Emphaze affinity resin).
Verdoliva fails to that the teach amino acids of the peptide molecule alternate sequentially between D-form amino acids and L-form amino acids, and
wherein the peptide molecule is synthesized directly on the affinity chromatography resin in a peptide synthesizer by solid-phase peptide synthesis and remains on that same affinity chromatography resin for antibody purification without being separated from the affinity chromatography resin and without being attached to a different resin.
However, although Verdoliva synthesizes the D-PAM peptide on one resin, then transfers the peptide to another resin, there is no apparent difference between the apparatus as claimed and the D-PAM/Emphaze affinity resin end-product taught by Verdoliva. Page 79, col. 1, section 2.2 of Verdoliva explains that the peptide was synthesized on one resin, then cleaved, and purified. Section 2.4 states that these peptides were then coupled to an Emphaze affinity resin and tested for the effectiveness of the coupling. The resin is then packed into a column. Section 2.5 states that this column, which contains the resin, is then used to purify antibodies; Table 3 shows the results of this effective separation. The final resin (D-PAM/Emphaze affinity resin) is functionally capable of antibody purification and therefore meets the instant limitations of claim 1 regardless of the resin’s manufacturing history; p. 79, 2.2-2.5)("[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”; See MPEP 2113(I)).
Pei teaches amino acids of a peptide molecule alternate sequentially between D-form amino acids and L-form amino acids (at least two amino acids having the opposite chirality can be adjacent to each other…D-L; L-D;…L-D-L-L-D; [0118]).
Pei is considered to be analogous to the claimed invention because it is in the same field of endeavor for designing and synthesizing protease resistant peptides through amino acid stereochemistry and solid phase peptide synthesis on a resin ([0168]). Verdoliva already teaches D-form amino acids within the peptide molecule (Abstract), and Pei states that “A D-amino acid at the P-4 position would increase the proteolytic stability, whereas D/L-cysteine would provide an alternative site of cyclization” ([0194]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the all D-form amino acid sequence taught by Verdoliva with an alternating D and L-form arrangement as taught by Pei because it would “generate a smaller and more rigid ring, which would improve the metabolic stability and the cell-permeability of the peptide,” (Pei, [0194]) as well as to “improve cytosolic uptake efficiency,” (Pei, [0118]) and this involves the simple substitution of one known element for another to obtain predictable results (See MPEP 2143(I)(B)).
Regarding claim 4, Modified Verdoliva teaches an affinity chromatography column for an antibody purification, comprising the affinity chromatography resin according to claim 1 (“D-PAM affinity columns, prepared by immobilizing the all-D peptide on the commercially available support Emphaze,” wherein “the resin was finally packed into a 100 6.6 mm I.D. glass column”; Abstract; p. 79, ll. 5-6; See “Table 3, IgG, IgA and IgMa recovery after fractionation process of human serum on D-PAM/Emphaze affinity resin”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Menegatti et al., 2016 (instant PTO-892) teaches synthesizing a resin comprising a protease-resistant peptide by the method of claim 2. The resin is then packed into a column ([0053]-[0058]).
Pei et al., 2022-05-26, (instant PTO-892) teaches synthesizing a resin comprising a protease-resistant peptide with an alternating D amino acid and an L amino acid sequence ([0345])
Qiu et. al., 2017, (instant PTO-892) teaches that partial or all substitution of L-amino acid by its D-enantiomer could maintain the bioactivity of peptides and increase its resistance toward trypsin.
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.
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/V.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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