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 .
DETAILED ACTION
Response to Amendment and Arguments
The Amendment filed on 3/6/2026 in response to the previous Non-Final Office Action (9/8/2025) is acknowledged and has been entered.
Claims 96-105 have been added.
Claims 3-4, 6-12, 16-17 and 21-95 have been cancelled.
Claims 1-2, 5, 13-15, 18-20 and 96-105 are pending and under consideration for an IgM, IgA, IgG/IgM or IgG/IgA antibody comprising a modified J-chain that comprises an extraneous binding moiety introduced into native sequence of J-chain.
Rejections Withdrawn:
The rejection of Claims 1-20 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the claim amendment.
The ODP rejections on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of following
US Patent No. 9,951,134, US Patent 10,975,147, US Patent No. 10,400,038, and
US Patent 11,555,075 are withdrawn in view of the terminal disclaimers filed and approved.
The arguments are moot in view of withdrawals of the rejection(s).
Rejection Maintained and Response to Arguments
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Over Patents:
5. Claims 1-2, 5, 13-15, 18-20 remain and newly added claims 96-105 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of 1-12 and 14 of US patent No. 10,570,191 (original application 15/566485). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to binding molecule including an antibody (IgM) comprising a J-chain modified by moieties. The claims would thus anticipate or obvious over each other.
The instant claims are
An IgM, IgA, IgG/IgM and IgG/IgA antibodies or antigen binding fragment thereof comprising modified J-chain, wherein the modified J-chain comprising an extraneous binding moieties introduced into the native sequence J-chain at one or more of the flowing locations:
(a) at or within about 10 amino acid residues from the C-terminus, or
(b) at or within about 10 amino acid residues from the N-terminus,
wherein the native sequence of J-chain is human J-chain of SEQ ID NO: 1 or factional fragment thereof and wherein the binding moiety is introduced into the native human J-chain of SEQ ID NO: 1 through a peptide linker at or around the C-or N-terminus of the J-chain sequence of SEQ ID NO: 1 by direct or indirect fusion.
The claims of Patent ‘191 are drawn to
A multimeric binding molecule comprising IgM comprising least two bivalent binding Units to human HIV viral particles and a modified J-chain, wherein the J-chain is modified with antigen binding scFv binding to effector cell…
wherein binding molecule is pentameric and IgM and comprises a J-chain or modified J-chain fused to polypeptides at C, or N terminus of binding scFv ….
Both sets of the claims are drawn to multimeric binding molecule, the same as polymeric antibody comprising IgM with modified J-chain. The difference is 1) that claims of ‘191 patent recite the binding molecule recognizing HIV molecule, while the instant application is drawn to any polymeric antibody without indicating the antigens and 2) instant claims encompass antigen binding fragment thereof and functional fragment of J-chain. In addition, the instant claims as amended recites the specific location of the extraneous binding moiety in J-chain.
Thus, the difference between the two sets of the claims is the scope of the claimed binding molecule comprising IgM antibody with modified J-chain. Since the claims of ‘191 patent recite specific antigen for multimeric binding molecule comprising IgM with whole J-chain modified, the claims of the patent have smaller and overlapped scope as compared to the instant claimed antigen binding fragment of the IgM and IgA with modified J-chain fragment, the claims of ‘191 patent would anticipate and be obvious over the claimed invention.
6. Claims 1-2, 5, 13-15, 18-20 remain and newly added claims 96-105 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of 1-15 and 17-18 US patent No. 10,604,559 (original application 15/560905). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to binding molecule including an antibody (IgM) comprising a J-chain modified by moieties. The claims would thus anticipate or obvious over each other.
The instant claims are set forth above.
The claims of Patent ‘559 are drawn to
A multimeric antibody comprising IgM or IgA binding to hepatitis B virus (HBV) antigen and are potent than reference IgG antibody, wherein the multimeric antibody having a modified J-chain, wherein the J-chain is modified with heterologous polypeptide directly or indirectly linked to J-chain at C, or N terminus (claim 4+), wherein the modified J-chain is comprising J15V or V15J (claim 15).
Both sets of the claims are drawn to multimeric binding molecule (polymeric antibody) comprising IgM or IgA antibody with modified J-chain or variant thereof. The first difference is that claims of ‘559 patent recite the binding molecule to HBV antigen, while the instant application is drawn to any polymeric antibody without specific antigen for binding. Second difference is instant claims encompass J-chain functional fragment and antigen binding fragment of polymeric antibody comprising IgA and IgM. In addition, the instant claims as amended recites the specific location of the extraneous binding moiety in J-chain.
Thus, the difference between the two sets of the claims is the scope of the claimed binding molecule (antibody) with modified J-chain. Since the claims of ‘559 patent recite specific antigen for the whole antibody modified with J-Chain, which has smaller and overlapped scope as compared to the instant claims, the claims of ‘559 patent anticipate or be obvious over the claimed invention.
7. Claims 1-2, 5, 13-15, 18-20 remain and newly added claims 96-105 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of 1-7 US patent No. 10,618,978 (original application 15/764859). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to binding molecule including an antibody (IgM) comprising a J-chain modified by moieties. The claims would thus anticipate or obvious over each other.
The instant claims are set forth above.
The claims of Patent ‘978 are drawn to
A IgM with a modified J-chain, wherein the J-chain is modified mature peptide of polypeptide having SEQ ID NO: 102, wherein the IgM antibody comprising CDRs from heavy and light chains and binding to CD20.
Both sets of the claims encompass IgM antibody with modified J-chain. The first difference is that claims of ‘978 patent recite the IgM antibody to specific antigen CD20 and specific modified J-chain of SEQ ID NO: 102, while the instant claims encompass any polymeric IgM comprised antibody without specific antigen and a polymeric antigen binding fragment modified with J-chain or functional fragment thereof. In addition, the instant claims as amended recites the specific location of the extraneous binding moiety in J-chain.
Thus, the difference between the two sets of the claims is the scope of the claimed binding molecule (antibody) with modified J-chain. Since the claims of ‘978 patent have specific antigen binding with specific IgM modified with whole J-chain, the Patent has smaller scope as compared to the instant claims, the claims of ‘978 patent would anticipate or be obvious over the claimed invention.
8. Claims 1-2, 5, 13-15, 18-20 remain and newly added claims 96-105 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of 1-31 US patent No. 10,787,520 (original application 15/554301). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to binding molecule including an antibody (IgM) comprising a J-chain modified by moieties comprising heterologous polypeptide fused to J-chain. The claims would thus anticipate or obvious over each other.
The instant claims are set forth above.
The claims of Patent ‘520 are drawn to
A dimeric or pentameric binding molecule comprising two heavy chain constant region binding to CD20 and CD3e and a modified J-chain, wherein the J-chain is modified with heterologous ploypeptide comprising scFv fragment and directly or indirectly fused to the J-chain, wherein the fusion is at C-terminus or N-terminus of J chain.
Both sets of the claims encompass IgM antibody with modified J-chain. The first difference is that claims of ‘520 patent recite the IgM antibody to specific antigen CD20 and specific modified J-chain of SEQ ID NO: 64, while the instant application is drawn to any polymeric antibody and antigen binding fragment thereof modified with J chain or J-chain functional fragment without specific antigen. In addition, the instant claims as amended recites the specific location of the extraneous binding moiety in J-chain.
Thus, the differences between the sets of the claims and instant claims are the scope of the claimed antibody with modified J-chain, the claims of the patent and present application would be anticipated or be obvious over each other.
9-11. Claims 1-2, 5, 13-15, 18-20 remain and newly added claims 96-105 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over:
Claims 1-19 of US Patent 11,535,664 (original application 16/795433, a child application of US Patent 10,604,559),
Claims 1-20 of US patent No 11,192,941 (original application No. 16/736327, a child application of US Patent 10,570,191),
Claims 1-20 of US patent No 11,542,342 (original application No. 16/745059, a child application of US Patent 10,618,978).
Although the conflicting claims are not identical, they are not patentably distinct from the present claims because two sets of claims are drawn to multimeric antibody comprising a J-chain modified by linking to a moiety. The claims would thus be anticipated or obvious over each other.
The instant claims are set forth above.
The claims of ‘664 patent are drawn to
A dimeric or pentameric binding molecule comprising two heavy chain constant region binding to HBV antigen with a modified J-chain, wherein the J-chain is modified with heterologous polypeptide comprising directly or indirectly fused to the J-chain, wherein the fusion is at C-terminus or N-terminus of J chain
The claims are further drawn to specific HBV antibodies with binding domain.
The claims of ‘941 patent are drawn to
A dimeric or pentameric binding molecule comprising two heavy chain constant region, wherein the J-chain is modified with heterologous polypeptide comprising directly or indirectly fused to the J-chain, wherein the fusion is at C-terminus or N-terminus of J chain
The claims are further drawn to specific HIV antibodies with binding domain.
The claims of ‘342 patent are drawn to
A polymeric antibody with a modified J-chain, wherein the J-chain native human polypeptide of SEQ ID NO: 1, wherein the polymeric antibody fused to indirectly through a peptide linker and at C or N terminus of the J chain,
wherein the antibody binding to huma CD3, comprise antigen binding domain scFv.
All sets of the claims are drawn to a J-chain comprised antibody (IgA or IgM) with the J-chain being modified. The differences are that claims of all patents recite specific antigens HBV, HIV or CD3 etc, that the antibody binds to, while the instant application is broadly drawn to antigen binding fragment of the polymeric antibody with modification of J-chain’s functional binding fragment without a specific antigen. In addition, the instant claims as amended recites the specific location of the extraneous binding moiety in J-chain.
Thus, the differences between the sets of the claims and instant claims are the scope of the claimed antibody with modified J-chain, the claims of the patents and present application would be anticipated or be obvious over each other.
Response to applicant’s argument:
On page 6, Applicant argues:
…. the rejections over Cited Patents (a) to (g) are improper at least because all of Cited Patents (a) to (g) are later-filed and later-expiring than any patent that could issue from the present application. Ex parte Baurin, Appeal 2024-002920, Decision on Appeal dated November 8, 2024 in Application No. 17/135,529 ("Baurin").
Applicant cites board decision, reversal of the ODP rejections of the later-filed patents and conclude that the ODP rejection for later-filed and later expiring patent were improper…..
In response, first, there is no final decision made for this application since the board decision is appealed for review and rehearing (applicants answered on 3/27/2026, but the Board has not yest responded). Second, the board decision for this application is not presidential and not cited by MPEP. Therefore, the decision could not be referred and used as a guidance for examination of the present application.
Thus, based on the guidance of MPEP, the ODP rejections for this application will be maintained for the following reasons:
While it’s true that “preventing the unjustified extension of patent exclusivity beyond the term of a patent” is one of the goals for double patenting rejections, it is NOT the only goal. See In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013) (“There are two justifications for obviousness-type double patenting. The first is "to prevent unjustified timewise extension of the right to exclude granted by a patent no matter how the extension is brought about." Van Ornum, 686 F.2d at 943-44 (quotation and citation omitted). The second rationale is to prevent multiple infringement suits by different assignees asserting essentially the same patented invention. Fallaux, 564 F.3d at 1319 (recognizing that "harassment by multiple assignees" provides "a second justification for obviousness-type double patenting"); see also Chisum on Patents § 9.04[2][b][ii] ("The possibility of multiple suits against an infringer by assignees of related patents has long been recognized as one of the concerns behind the doctrine of double patenting.")
It would appear that Applicant has conveniently forgot about the second of the two goals noted above. That is, whether there’s an extension of patent rights or not, you should still make the double patenting rejection (based on the second goal). In addition, the idea that “there is very little likelihood that the instant application will accrue and PTA” would also not be found persuasive.
Therefore, terminal disclaimers should be filed to overcome rejections.
Conclusion
No claims are allowed.
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 extension fee 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 Lei Yao, whose telephone number is (571) 272-3112. The examiner can normally be reached on 8:00am-6:00pm Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEI YAO/Primary Examiner, Art Unit 1642