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 .
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.
DETAILED ACTION
This action is in response to claim amendments filed 8/1/25. Claims 1-12 are pending and under examination. This action is non-final.
Withdrawn Rejections
The drawing objection is withdrawn.
The objection to the specification is withdrawn; the drawings are no longer in color.
The claim objections are withdrawn.
The §112 rejections are withdrawn in light of the amendments.
Current Rejections
Claim Rejections – 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 1-7 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12358944 in view of claims 1-22 of U.S. Patent No. 8673988. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1 of the instant application, claim 1 of the reference document claims “A method for the chromatographic purification and/or separation of protein glycoforms by contacting the sample comprising the protein glycoforms with a separation material comprising of a base matrix to the surfaces of which polymer chains are covalently bonded, characterized in that
the polymer chains comprise end groups —N(Y)—R3 with
Y being independently from each other H or CH3, and
R3 being —CHCOOMR4
with R4 being C1 to C4 alkyl or C1 to C4 perfluoroalkyl
and M being H, Na, K, or NH4.”.
The claims do not claim the base matrix comprises a hydroxyl group.
‘988 is also concerned with a separating material for ion exchange chromatography comprising polymers bonded to the surface of a support (base) material. ‘988 teaches this base material comprises aliphatic hydroxyl groups. It would have been obvious to include these groups in the base material of ‘944 for the same reasons to serve the same purpose in a predictable manner. This combination would have made the instant claims an obvious variation of the reference claims to the person of ordinary skill in the art.
Regarding claim 2, claim 8 of the ‘944 document recites, “Method according to claim 1, characterized in that the polymer chains are built by monomer units and the monomer units of the polymer chains are linked in a linear manner and each monomer unit comprises an end group —N(Y)—R3.”. This teaches the instant claim 2 is an obvious variation of the reference claims. The amended limitations to instant claim 2 are addressed with respect to claim 1.
Regarding claim 3, claim 10 of the ‘944 document recites, “Method according claim 1, characterized in that the sample is applied to the separation material at an ionic density between 10-1200 μeq/g.”. The claimed range of “400-900ueq/g” lies entirely within the range disclosed in the ‘944 document. The instant range is prima facie obvious over the reference range. See MPEP § 2144.05 - Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions - which states that, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Regarding claim 4, claim 9 of the ‘944 document recites, “Method according to claim 1, characterized in that Y is H and R4 is isopropyl and/or isobutyl.”, teaching the limitations of the instant claim and so making such limitations obvious.
Regarding claim 5, claim 1 of the ‘988 document states, “a) the support material contains aliphatic hydroxyl groups”. For the same reasons the combination would have been obvious, it would have been obvious to specifically include aliphatic hydroxyl groups taught by ‘988.
Regarding claim 6, the claim is a product-by-process claim (the material formed by). Since the combination of references renders obvious the same structural limitations as instantly claimed, the presumption is that the reference combination could have been prepared by this claimed process. There is no clear structural change that occurs when preparing the base matrix by this claimed process as opposed to some other process and a composition is patentable based on its structure, not the method by which it was formed. See MPEP §2113. Burden is shifted to Applicant to demonstrate a non-obvious structural difference implied by the process (MPEP §2113(II)).
Additionally, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized ‘that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’’’ MPEP §804(II)(B)(1).
The claims are directed to a composition of matter. Those portions of the specification which describe the methods of producing that claimed composition support the claims under §112(a) (enablement; how to make and use). The same method of making the composition is disclosed at, e.g., paragraphs 40, 85).
Regarding claim 7, first, the claim only describes one method of preparing the composition of claim 1. There is no evidence of record to suggest the composition claimed by ‘944 could not be prepared by such a method and the method itself is not practiced by the instant claim. Since the combination of references renders obvious the same structural limitations as instantly claimed, the presumption is that the reference combination could have been prepared by this claimed process. Second, the ‘988 Patent discloses that the polymer can be prepared in various ways including, “A preferred one-step graft polymerization reaction can be initiated by cerium(IV) on the hydroxyl-containing support” (Column 9, lines 43-46), further supporting the conclusion that the composition discussed above could have been prepared by the method of instant claim 7.
Regarding claim 12, the composition would have been obvious as above. One of ordinary skill in the art would have found it obvious to use known methods of preparing such compositions. The ‘988 Patent discloses that the polymer can be prepared in various ways including, “A preferred one-step graft polymerization reaction can be initiated by cerium(IV) on the hydroxyl-containing support” (Column 9, lines 43-46). With respect to the claimed formula V, this structure is indefinite as above. The ‘988 document discloses the monomer in claim 2 and methods of generating the composition as disclosed. The monomer meets the instant limitations where R1 is H, R2 is H, Y is H, R3 is R4COO where “M” would be H (COO implicitly is COOH to satisfy the bonding requirements) and R4 is a branched alkylene having 2-4 carbon atoms. ‘988 also discloses isopropylenes as preferred arrangements for the alkenes (e.g., C6-8). The disclosure in ‘988 is considered to make obvious a relevant structure and makes the instant claims obvious.
Therefore, claims 1-7 and 12 would have been obvious.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12358944 in view of claims 1-22 of US 8673988 and further in view of Padmanaban (form 892).
Regarding claim 8, claim 1 of the ‘944 document discloses a method for the chromatographic purification and/or separation of protein glycoforms by contacting the sample with the material. The composition used in this method would have been obvious for the reasons above. The ‘944 claims do not specify that the separation matrix is used to separate ADCs.
However, claim 7 of the ‘944 document claims the sample comprising the protein glycoforms are glycosylated antibodies.
Padmanaban teaches that ADCs also have multiple glycans remaining after conjugation (e.g., abstract, p.2 C2, figure 4).
It would have been obvious to a person of ordinary skill that the method of 944/988 could be used to purify ADCs because 988 teaches the method for purifying glycosylated antibodies and Padmanaban teaches glycosylated ADCs exist. Thus, the separation technique relying on glycosylated would be reasonably expected to function to separate ADCs as well.
Regarding claims 9-11, these are results of practicing the method. As the same structure is being used in the same way, the same results must inherently flow from those method steps.
In support of this expectation:
Regarding claim 9, claim 11 of the ‘944 document recites, “Method according to claim 1, characterized in that the protein glycoforms are bound to the separation material at a pH between 2 and 7.”. There is no evidence of record to suggest that the glycosylated ADCs would not bind at these same pH values and so instant claim 9 is obvious.
Regarding claim 10, claim 10 of the ‘944 document states, “Method according to claim 1, characterized in that the ionic density of the separation material is between 10-1200 μeq/g.”. There is no evidence of record to suggest that the glycosylated ADCs would not bind at the same density and so instant claim 10 is obvious.
Regarding claim 11, claim 13 of the ‘944 document states, “Method according to claim 1, characterized in that between 10 mg and 100 mg of the protein glycoforms are bound per ml of the separation material.”. There is no evidence of record to suggest that the glycosylated ADCs would not bind in the same manner and so instant claim 11 is obvious.
Response to Arguments
Applicant's arguments filed 8/1/25 have been fully considered but they are not persuasive.
Regarding the double patenting rejections, Applicant makes no arguments regarding the merits of the rejection. Applicant “defers rebuttal of the rejection of the claims until the claims are deemed to be allowable”. This is not persuasive because a double patenting rejection is a rejection on the merits and so a claim cannot be deemed allowable until the double patenting rejection is withdrawn. Further, deferring rebuttal is not a complete reply nor an option for Applicant. The actual filing of a terminal disclaimer or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims is necessary for further consideration of the rejection of the claims; nonstatutory double patenting rejections, including provisional ODP rejections, are not held in abeyance (MPEP §804(I)(B)(1)). To be considered a bona fide reply to this action, the response must contain a bona fide attempt at a complete reply, including a reply to the double patenting rejection.
Applicant’s request for an interview submitted 5/13/26 has been denied. Applicant proposes that the “particular references” were not applied “correctly”. This proposed interview was submitted after Applicant had already responded by “deferring” any argument against the double patenting rejection. Applicant had an opportunity to elaborate on how these references were not applied correctly in their initial response but elected not to. As such, an interview at this time would not be productive; an interview is not a substitute for a written response (37 CFR 1.2; 37 CFR 1.111).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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/Adam Weidner/ Primary Examiner, Art Unit 1675
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