The examiner of this application in the PTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Peter Johansen, Group Art Unit 1642, Technology Center 1600.
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 .
Applicant's response to the previous Office action, dated October 31, 2025, has been received. By way of this submission, Applicant has amended claims 1, 23, and 27, and cancelled claims 19, 22, and 30.
Claims 1-2, 23, 26-29, 37, 70-71, 94, 138, 183, 233, 279, 284 and 326 are pending in the application. Claims 71, 94, 138, 183, 233, 279, 284 and 326 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed April 2, 2025.
Claims 1-2, 23, 26-29, 37 and 70 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated July 31, 2025.
Claim Objections
Claim 2 is objected to because of the following informalities: clauses (a), (d), and (e) are grammatically awkward, referring to: (a) the VHH domain binds to: i) extracellular domain 1 of pIgR; (d) the pIgR is a human the pIgR; (e) the pIgR is a mouse the pIgR.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 19 was previously rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections.
Applicant's cancellation of claim 19 has rendered this rejection moot, and it is withdrawn.
Claims 19 and 22 were previously 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.
Applicant's cancellation of claims 19 and 22 has rendered this rejection moot, and it is withdrawn.
Claim 23 was previously 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.
Applicant's amendment to the claims have addressed this issue, and this rejection is hereby withdrawn.
Claim 27 was previously 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.
Applicant's amendment to the claims have addressed this issue, and this rejection is hereby withdrawn.
Claim 27 and 30 were previously 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.
Applicant's amendment to the claims have addressed this issue, and this rejection is hereby withdrawn.
Claim 30 was previously rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections.
Applicant's cancellation of claim 30 has rendered this rejection moot, and it is withdrawn.
Claims 1-2, 19, 23, 26, 27, 28, 29, 30, 37 and 70 were previously 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.
Applicant's amendment to the claims have addressed this issue, and this rejection is hereby withdrawn.
Claim Rejections – Improper Markush
Claims 1-2, 23, 26-29, 37 and 70 are rejected on the basis that the claims contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 1 and 27 are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: while all members of the group are antibodies that bind to the same target (an extracellular domain of polymeric immunoglobulin receptor (pIgR), the claimed complimentary determining regions of the antibodies which give them the common function of binding to the pIgR are structurally distinct. Compare, for example, the sequences of SYRMG (SEQ ID NO: 1) and GLTFSSY (SEQ ID NO: 10). While both are listed as being alternatives for the heavy chain complementary determining region 1 of VHH2, they are clearly structurally distinct. Using the above example, the various antibodies of the Markush group are patentably distinct from one another as prior art on one would not anticipate or render obvious any of the others.
There is also no indication in the art that each member of the Markush group will in the same way in the context of the claimed invention. The common use among the members of the Markush is the ability to bind pIgR. It is the specific sequences of each CDR that gives each antibody its ability to bind pIgR, and here, that common use does not flow from a structural feature that is common to all members of the Markush.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Applicant is advised to present a consensus sequence common to all members of the Markush group in order to assist in addressing this rejection.
Claim Rejections - 35 USC § 102
Claims 1-2, 26, 28-29, 30, 37 and 39 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dolk (US20100136018A1, cited in IDS).
Applicant argues that Dolk does not teach every aspect of the claims as amended; specifically, Dolk does not teach the claimed CDRs.
Applicant's amendment to the claims have addressed this issue, and this rejection is hereby withdrawn.
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, 2, 19, 22, 23, and 37 were previously provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16 and 34 of copending Application No. 17/630,718.
As the '718 application is currently abandoned, this rejection has been rendered moot, and it is withdrawn.
Claims 1-2, 23, 26-29, 37 and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 7-9 of U.S. Patent No. 12,134,658.
Applicant argues that the claims of the '658 patent do not anticipate the instant claims, as the '658 patent claims a multispecific molecule comprising: (a) a first binding domain that specifically binds to polymeric immunoglobulin receptor (pIgR), and (b) a second binding domain that specifically binds to SARS-COV-2. Applicant further argues that the claims of the '658 patent are not obvious over the instant claims under a "two-way test".
Applicant's arguments have been considered fully but are not found to be persuasive.
The single-domain antibody (VHH) that specifically binds to polymeric immunoglobulin receptor (pIgR) recited in clause (b) of claim 1 of the '658 patent is identical to the single-domain antibody of clause (a) of the instant application. The entirety of the instant claim is claimed by the '658 patent. The multispecific molecule claimed by the '658 patent is a narrower species of the broader genus of the instantly claimed antibody, and as such, the double patenting rejection is based upon anticipation. The "two-way test" of obviousness does not apply here. MPEP 804(II)(B)(2).
This rejection is therefore maintained.
Allowable Subject Matter
The elected species of complementarity determining regions for the elected species of antibody only are free of the prior art.
Conclusion
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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