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 Claims
Claims 1-105 were originally filed 20 September 2021. The amendments filed 20 September 2021 and 28 April 2022 have been entered. Applicant has cancelled claims 40, 44, 45, 59, 61-63, 66-69, 72, 73, 75-80, 89, 91, 98, 106, and 107 in Response to Non-Final received 26 August 2025 and newly added claims 108-129.
Newly submitted claims 116, 117, 124-129 are drawn to groups previously restricted in the Requirement for Restriction mailed 25 October 2024; therefore, claims 116, 117, 124-129 are hereby withdrawn.
Claims 1, 2, 108-115, and 118-123 are currently under consideration.
Withdrawn Objections
In view of Applicant canceling claims 3-107 and changing the font of all the claims, the claim objections over said claims (i.e., claims 1 and 2) are hereby withdrawn.
Withdrawn Claim Rejections
In view of Applicant amending claims 1 and 2 to recite a particular set of 6 CDRs (claim 1), a single pair of VH and VL (claim 2), changing the font of all the claims, and canceling claims 3, 40, 44, 45, 59, 61-63, 66-69, 72, 73, 75-80, 89, 91, 98,106, and 107 the following rejections
the 35 USC § 112(a) rejections (i.e., enablement, written description),
the 35 USC § 112(b) rejection of claims 3, 40, 44, 45, 59, 61-63, 66-69, 72, 73, 75-80, 89, 91, 98, 106, and 107,
the 35 USC § 112(d) rejection of claim 40,
the nonstatutory double patenting rejection of claims 106 and 107 over US Patent 12,065,489 B2,
the nonstatutory double patenting rejection of claims 1-3, 44, 45, 72, 73, 75-89, and 91 drawn to a conjugate comprising the bispecific CLDN6xCD3 over US Patent 12,065,489 B2 and Duell,
the provisional nonstatutory double patenting rejection of claims 106 and 107 over copending Application No. 18/674612, now US Patent 12,403,202 B2,
the provisional nonstatutory double patenting rejection of claims 106 and 107 over copending Application No. 18/674612, now US Patent 12,403,202 B2 (as cited on the IDS received 08/26/2025), and Duell,
the provisional nonstatutory double patenting rejection of claims 106 and 107 over copending Application No. 18/792,232, and
the provisional nonstatutory double patenting rejection of claims 106 and 107 over copending Application No. 18/792,232 and Duell
are hereby withdrawn.
Maintained Claim Rejections
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1, 2, 108-115, and 118-123 are 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 arguments filed 26 August 2025 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues amending claim 1 to recite, “and a second antigen which is CD3 or CD16A” in line 3 is sufficient to overcome the 35 USC § 112(b) rejection of claims 1, 2, 108-115, and 118-123.
The language of claim 1 is drawn to a bispecific antigen-binding protein that binds to a human Claudin 6 protein and a second antigen which is CD3 or CD16A. The scope of the claim remains unclear. For example, is claim 1 drawn to two separate elements comprising a first “bispecific antigen-binding protein that binds to a human CLDN6” (see lines 1-2) wherein the bispecific antigen binding protein comprises a set of 6 CDRs (see lines 4-5) and a second independent structure “a second antigen which is CD3 or CD16A” (see line 3). Alternatively, is claim 1 drawn to a single structure comprising a bispecific antigen binding protein that binds both human CLDN6 and either CD3 or CD16A wherein the CLDN6 antigen binding domain comprises a set of 6 CDRs.
Therefore the 35 USC § 112(b) rejection of claims 1, 2, 108-115, and 118-123 is hereby maintained.
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, 108-115, and 118-123 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 9-11, 15, 16, 19, 20, 23-25 and 38-40 of U.S. Patent No. 12,065,489 B2 (referred to herein as ‘489 patent, as cited on the IDS dated 08/06/2024) in further view of Stadler (see PTO-892 mailed 02/26/2025) and Fournier (see PTO-892 mailed 02/26/2025). Although the claims at issue are not identical, they are not patentably distinct from each other.
Applicant's arguments filed 26 August 2025 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues it is improper “to add a limitation from another, external reference, without grounding in specific language of a specific claim- is not authorized in any Federal Circuit case nor in the MPEP” and points specifically to MPEP § 804(B)(1) (see Remarks pg. 14, 4th and 5th para).
First MPEP § 804(B)(1) is drawn to provisional double patenting rejections whereas the instant rejection is not provisional. However, MPEP § 804 (II)(B) second paragraph states,
“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 determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent”.
The answer is yes. The invention claimed in the ‘489 patent is a pharmaceutical composition comprising a monospecific CLDN6 antigen binding protein with identical CDRs of the instantly claimed bispecific CLDN6 antibody (see ‘489 patent claims 15 and 16). In addition MPEP § 804(II)(B)(3) states,
“Any secondary reference used to support an obviousness analysis for a nonstatutory double patenting rejection must be prior art under 35 U.S.C. 102 or pre-AIA 35 U.S.C. 102. See MPEP § 2120 et seq. for more information on determining if a reference is prior art and MPEP § 2141, subsection II.A, for determining the scope and content of the prior art”.
It is noted, the ‘489 patent does disclose discloses a bispecific antibody among the structures encompasses by the language “antigen binding protein” (see ‘489 patent col. 11 lines 50-61, in particular line 59). The prior art teaches CLDN6xCD3 bispecific antibodies are effective in eradicating OV-90 xenograft NSG mice (i.e., ovarian cancer) (see Stadler pgs. 3-4, 1st col. 1st para, figure 4B, pg. 8, 2nd col. 5th para). The CLDN6xCD3 bispecific antibody increased median survival from 18-31 days in untreated to 85-87 days treated CLDN6+ OV-90 xenograft mice (see Stadler pg. 5, 1st col. 2nd para, figure 4C). In addition, Stadler also teaches, “to our knowledge, 6PHU3 is the bispecific T-cell engager with the highest cancer-cell selectivity in non-hematological malignancies and may tap into patient populations, who thus far cannot profit from bispecific antibody treatment (see Stadler pg. 2, 1st col. 2nd para) and “these data justify further exploration of 6RHU3 to potentially gain a therapeutic that is highly specific and efficient for the treatment of CLDN6+ solid cancers” (see Stadler pg. 8, 2nd col. 2nd para).
Therefore, a person of ordinary skill in the art would have substituted the CLDN6 antigen binding protein in the pharmaceutical composition claimed in the ‘489 patent for a CLDN6xCD3 antigen binding protein. The reason to do so would be to take advantage of the improved properties of the CLDN6xCD3 antigen binding protein disclosed in the prior art. There is a reasonable expectation of success given the CLDN6xCD3 bispecific taught in the prior art was in clinical trials.
Regarding newly added claims 108-111, the ‘489 patent claims wherein the CLDN6 antigen binding protein is an antibody, in particular a monoclonal antibody (see ‘489 patent claims 1, 2, 5, 9 and 10). Therefore, a person of ordinary skill in the art would modify the claimed antibody or monoclonal antibody of the ‘489 patent to a bispecific antibody or bispecific monoclonal antibody for the advantages for the reasons made of record (see above).
Regarding newly added claims 112 and 113, the ‘489 patent claims wherein the CLDN6 antigen binding protein is a human antibody, a humanized antibody, or a chimeric antibody (see ‘489 claim 11). Therefore, a person of ordinary skill in the art would modify the claimed human, humanized, or chimeric antibody of the ‘489 patent to a bispecific human, humanized, or chimeric antibody for the advantages for the reasons made of record (see above).
Regarding newly added claims 114 and 115, drawn to wherein the bispecific antigen binding protein is a bispecific T-cell engager, this is an inherent property of the CD3 antigen binding domain. Therefore, in modifying the antigen binding protein claimed in the ‘489 patent to a bispecific CLDN6xCD3 structure as taught by the prior art it also renders obvious wherein the bispecific antigen binding protein is also a bispecific T-cell engager.
Regarding newly added claims 118-123 draw to compositions comprising the bispecific CLDN6xCD3, the ‘489 patent claims a pharmaceutical composition comprising the antigen binding protein wherein the structure is an antibody (see ‘489 claim 23), a monoclonal antibody (see ‘489 claim 24), a humanized antibody (see ‘489 claim 25). Therefore, a person of ordinary skill in the art would substitute the pharmaceutical composition comprising the instantly claimed CLDN6 antigen binding domain that is an antibody, monoclonal antibody, or humanized antibody claimed in the ‘4898 patent for a bispecific CLDN6xCD3 structure for the advantages for the reasons made of record (see above).
Therefore the above non-statutory double patenting rejection over the ‘489 patent is hereby maintained.
Claims 1-3, 44, 45, 59, 61-63, 67-69, and 98 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,403,202 (referred to herein as ‘202 patent, referred to previously as ‘612 application), Stadler, and Fournier. Although the claims at issue are not identical, they are not patentably distinct from each other.
Applicant's arguments filed 26 August 2025 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues for the reasons set forth in the previous non-statutory double patenting rejection (see above) the instant rejection should also be withdrawn (see Remarks pg. 17, 2nd full para, pg. 14, 4th and 5th para).
Therefore, for the reasons set forth above the instant provisional non-statutory double patenting rejection is hereby maintained for the reasons made of record.
A person of ordinary skill in the art would substitute the CLDN6 ADC claimed in the ‘202 patent to a CLDN6 bispecific wherein the second antigen binding domain is CD3 given this structure will likewise induce cell death of the tumor cell (i.e., art recognized equivalents for targeting tumor cells). There is a reasonable expectation of success given the CLDN6xCD3 structure disclosed in Stadler was in clinical trials.
Regarding newly added claims 108-111, the ‘202 patent claims wherein the conjugate comprising the CLDN6 antigen binding protein is an antibody, (see ‘202 patent claim 1). Therefore, a person of ordinary skill in the art would modify the claimed conjugate comprising the CLDN6 antigen binding protein as an antibody of the ‘202 patent to a bispecific CLDN6 antibody as these are art recognized equivalents for targeting and eliminating tumor cells (see above). In addition, given the composition is administered to a human subject it naturally flows/obvious both the claimed structure (i.e., CLDN6 ADC) and the bispecific taught by the prior art (i.e., CLDN6xCD3) are monoclonal.
Regarding newly added claims 112 and 113, Fournier disclose, “major limitations of mouse antibodies as therapeutic agents—immunogenicity, lack of effector functions, and short half-life—were subsequently identified and largely overcome by the advent of antibody chimerization and, later, humanization technologies” (see Fournier pg. 35, 2nd col. last para). Therefore, a person of ordinary skill in the art would humanize (i.e., modify) the claimed conjugate comprising the CLDN6 antigen binding protein in order to overcome limitations arising from immunogenicity as taught by the prior art.
Regarding newly added claims 114 and 115, drawn to wherein the bispecific antigen binding protein is a bispecific T-cell engager, this is an inherent property of the CD3 antigen binding domain. Therefore, in modifying the conjugate comprising the CLDN6 antigen binding protein claimed in the ‘202 patent to a bispecific CLDN6xCD3 structure as taught by the prior art it also renders obvious wherein the bispecific antigen binding protein is also a bispecific T-cell engager.
Regarding newly added claims 118-123 draw to compositions comprising the bispecific CLDN6xCD3, the ‘612 patent claims administering a composition comprising the conjugate comprising the CLDN6 antigen binding protein (see ‘202 claim 1). Therefore, given the composition is administered to a subject for inhibiting a solid tumor expressing CLDN6 it necessarily follows the composition is a pharmaceutical composition (see ‘202 claim 1). Therefore, a person of ordinary skill in the art would substitute the composition comprising the conjugate comprising the CLDN6 antigen binding protein and MC-VC-MMAE as claimed in the ‘202 patent for the CLDN6xCD3 bispecific structure taught by Stadler as these are art recognized equivalents for eliminating tumor cells (see above).
Claims 1, 2, 108-115, and 118-123 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4-6 of copending Application No. 18/792,232 (referred to herein as ‘232 application), Stadler, and Fournier. Although the claims at issue are not identical, they are not patentably distinct from each other.
Applicant's arguments filed 26 August 2025 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues amending claims 1 and 2 to recite wherein the bispecific antigen binding protein binds both CLDN6 and either CD3 or CD16A the copending ‘232 application now distinct and do not raise an issue of provisional nonstatutory double patenting (see Remarks para spanning pgs. 18-19).
The ‘232 application is drawn to an a CLDN6 ADC comprising identical CDRs as those instantly claimed. Stadler teaches bispecific CLDN6xCD3 structures effectively eliminate cancer cells via strong T-cell activation (see Stadler pg. 2, 2nd col. 4th para, figure 2A and B, pg. 5, 1st col. 2nd para, figure 4C). The function of the claimed ‘232 conjugate (i.e., MC-VC-MMAE) is to kill the tumor cell. Therefore, the bispecific antibodies wherein the second antigen binding domain recruits a T-cell to the tumor cell to initiate elimination of the cancer cell is an art recognized alternative to the internalized conjugate. Therefore, a person of ordinary skill in the art would substitute the CLDN6 ADC claimed in the ‘232 application to a CLDN6 bispecific wherein the second antigen binding domain is CD3 given this structure will likewise induce cell death of the tumor cell (i.e., art recognized equivalents for targeting tumor cells). There is a reasonable expectation of success given the CLDN6xCD3 structure disclosed in Stadler was in clinical trials.
Regarding newly added claims 108-111, the ‘232 claims wherein the conjugate comprising the CLDN6 antigen binding protein is an antigen binding antibody fragment, antibody, in particular a monoclonal antibody (see ‘232 patent claims 1, 2, 4 and 5). Therefore, a person of ordinary skill in the art would modify the claimed conjugate comprising the CLDN6 antigen binding protein as an antibody or monoclonal antibody of the ‘232 patent to a bispecific CLDN6 antibody or bispecific monoclonal antibody as these are art recognized equivalents for targeting and eliminating tumor cells (see above).
Regarding newly added claims 112 and 113, the ‘232 patent claims wherein the conjugate comprising the CLDN6 antigen binding protein is a human antibody, a humanized antibody, or a chimeric antibody (see ‘232 claim 6). Therefore, a person of ordinary skill in the art would modify the claimed conjugate comprising the CLDN6 antigen binding protein as a human, humanized, or chimeric antibody of the ‘232 patent to a bispecific human, humanized, or chimeric antibody as these are art recognized equivalents for targeting and eliminating tumor cells (see above).
Regarding newly added claims 114 and 115, drawn to wherein the bispecific antigen binding protein is a bispecific T-cell engager, this is an inherent property of the CD3 antigen binding domain. Therefore, in modifying the conjugate comprising the CLDN6 antigen binding protein claimed in the ‘232 patent to a bispecific CLDN6xCD3 structure as taught by the prior art it also renders obvious wherein the bispecific antigen binding protein is also a bispecific T-cell engager.
Regarding newly added claims 118-123 draw to compositions comprising the bispecific CLDN6xCD3, the ‘232 patent claims administering a composition comprising the conjugate comprising the CLDN6 antigen binding protein and a pharmaceutically acceptable carrier, diluent, or excipient (see ‘232 claim 1). Therefore, given the composition is administered to a subject for treating a CLDN6 expressing cancer it necessarily follows the composition is a pharmaceutical composition (see ‘232 claim 1). Therefore, a person of ordinary skill in the art would substitute the composition comprising the conjugate comprising the CLDN6 antigen binding protein and MC-VC-MMAE as claimed in the ‘232 patent for the CLDN6xCD3 bispecific structure taught by Stadler as these are art recognized equivalents for eliminating tumor cells (see above).
Therefore the above provisional non-statutory double patenting rejection over the ‘232 applicant is hereby maintained.
The following rejections are necessitated by amendment.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 112 and 113 are 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 112 and 113 are drawn to wherein the bispecific CLDN6 antigen binding protein is human.
It is noted human antibodies are those necessarily made by a human immune system, and while the specification discloses certain mouse antibodies, no human antibodies are disclosed (see specification pg. 6 para [00310034], pg. 116 para [00351]). Knowing the full HC and LC sequences of a mouse antibody is not sufficient to allow a skilled artisan to envision the structure of human antibodies. There is no evidence that applicant is in possession of any human antibodies, much less those encompassed by claims 112 and 113 which require some degree of structural similarity to the sequences in claims 1 and 2.
One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe human antibodies comprising the instantly claimed CDRs (see claim 1), VH, and VL (see claim 2). Thus, the claimed subject matter is not supported by any adequate written description and therefore, applicant was not in possession of the claimed invention.
Conclusion
No claim 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 HILARY ANN PETRASH whose telephone number is (703)756-4630. The examiner can normally be reached Monday-Friday 8:30-4:30 EST.
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/H.A.P./Examiner, Art Unit 1644 /AMY E JUEDES/Primary Examiner, Art Unit 1644
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