DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 10/28/25 has been entered in full. The specification is amended. Claim 18 is amended. Claims 21-22 are canceled. New claims 23 and 24 are added. Claims 1-12, 15-20 and 23-24 are pending.
Election/Restrictions
New claims 23-24 depend from claim 19 and are therefore part of Group I.
Applicants' election without traverse of Group I, currently claims 1-12, 15-19 and 23-24 in the reply filed on 10/28/25 is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-12, 15-19 and 23-24 are under consideration.
Claim Objections
Claims 1-12, 15-19 and 23-24 are objected to for the following informalities:
In claim 1, each of lines 4 and 14, “antigen binding” should be “antigen-binding” as in line 3 of the same claim.
In claim 1, line 7, in the limitations of the heavy chain variable region, there is an extraneous “(i)” that should be removed. This number is extraneous because there are no other numbers (e.g., (ii), etc) presented subsequently in the limitations directed to either the heavy or light chain variable regions.
In each of claims 8, 9 and 11-13, lines 2 or 3 of each claim, “antigen-binding fragment” should be “antigen-binding portion” as in parent claim 1.
Claim 11 is missing a period at the end of the claim.
In each of claims 16-19 and 23, line 1 or 2 of each claim, the term “antigen binding” should be “antigen-binding” as in parent claim 1.
In claim 17, line 8, there is an extraneous space between “13” and the following semi-colon; i.e., “SEQ ID NO: 13 ;” should be “SEQ ID NO: 13;”
In claim 17, line 51, “No:” should be “NO:”
In claim 18, lines 1-3, the recitation “wherein the antibody, or antigen binding portion thereof, wherein the first polypeptide portion comprises or consists of an amino acid sequence of” is unclear as to the relationship between the two “wherein” clauses (it appears one or more words are missing). The following language is suggested: “wherein in the antibody, or antigen binding portion thereof, the first polypeptide portion comprises or consists of an amino acid sequence of”.
In claim 18, line 3, “an amino acid sequence” should be “the amino acid sequence”; compare with line 13.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
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.
Claims 12 and 15 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 pre-AIA the applicant regards as the invention.
In claim 12, line 3, the term "immunosuppressive/immunomodulatory" is indefinite because it is unclear if it means "immunosuppressive and immunomodulatory" or "immunosuppressive or immunomodulatory". The term is used several times in the specification, but is not defined. In this respect, the claim could be rendered definite by amending it to recite either of the alternatives noted above, or alternately to recite, "immunosuppressive, immunomodulatory and/or anti-inflammatory".
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Double Patenting
The nonstatutory double (NSDP) 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 NSDP 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 (TD) in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on NSDP 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 TD must be signed in compliance with 37 CFR 1.321(b).
The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD 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 TD 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over either (1) claims 20-25 of U.S. Patent No. 11,254,750, issued 2/22/22 (cited on the 7/7/25 IDS), or (2) claims 1-20 of U.S. Patent No. 12,419,953, issued 9/23/25, each of which shares the same applicant and an inventor (Struthers) with the instant application, and each further in view of Espie et al, U.S. Patent Application Publication 20190153111, published 5/23/19.
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Instant claims 1 and 2 each encompass a method of treating an autoimmune disease (claim 1) that is Sjogren’s syndrome (claim 2) in a human patient comprising administering to the patient at least one dose of an isolated antibody that specifically binds to CD40, wherein the antibody comprises a first polypeptide portion comprising a heavy chain variable region (HCVR) comprising CDR1-3 of SEQ ID NO: 1-3 and a second polypeptide portion comprising a light chain variable region (LCVR) comprising CDR1-3 of SEQ ID NO: 7-9, wherein the dose is selected from 0.3 mg to 1000 mg of the antibody.
The ’750 and ‘953 patents are related in that the application from which ‘953 patent claims priority to the application from which the ‘750 patent issued.
(1) Claims 21 and 25 of ‘750 each encompass a method of treating an autoimmune disease (claim 21) that is Sjogren’s syndrome (claim 25) comprising administering to the subject the antibody of claim 1, which is an isolated antibody that specifically binds to human CD40 comprising the same polypeptide portions as recited in instant claim 1, including the same CDR sequences (SEQ ID NO: 1-3 and 7-9).
(2) Claims 1 and 20 of ‘953 each encompass a method of treating an autoimmune disease (claim 1) that is Sjogren’s syndrome (claim 20) comprising administering a pharmaceutical composition comprising the same antibody as ‘750.
The claims of ‘750 and ‘953 do not specify a human subject, but Sjogren’s syndrome is a human disease, and as such the subject is inherently human. The method of claims of ‘750 and ‘953 do not specify a dose for the administered antibody.
‘111 teaches anti-CD40 antibodies for treatment of Sjogren’s (see Title and ¶ 2). ‘111 further teaches that the antibodies may be administered in a dose of about 150 mg to about 600 mg (¶ 22), which is encompassed by the range recited in instant claim 1.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the method of treatment of Sjogren’s syndrome with an anti-CD40 antibody of the claims of the ‘750 patent or the ‘953 patent, and modify either to administer the anti-CD40 antibody using a dose in the range taught by the ‘111 publication, i.e., a dose in the range of about 150 mg to about 600 mg. The person of ordinary skill in the art would have been motivated to make such a change because the ‘750 and ‘953 patents each claim a method of treatment of an autoimmune disease, including Sjogren’s syndrome, that requires administration of a therapeutic antibody, but do not indicate a dosage, and administration requires a dosage to be administered, and ‘111 provides the missing information. The person of ordinary skill in the art would have had a reasonable expectation of success in using the dosages taught by ‘111 with the antibody of ‘750 or ‘953 patent claims because the antibodies taught by ‘111 target the same molecule (CD40) for treatment of the same disease (Sjogren’s). This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Instant claims 3 and 16-19 further limit the structure of the administered anti-CD40 antibody, and the further limitations of these claims correspond to further limitations of the administered anti-CD40 antibody of the dependent claims of ‘750 and ‘953 in the following manner:
Instant Claim
Claim of ‘750
Claim of ‘953
3
6
5
16
4
3
17
8
7
18
12
13
19
12
13
Instant claims 4-11 each depend from claim 1 and further limit the administered dosage, and also the route of administration and, in claims 6-7, the timing of administration. Each of claims 4-11 encompasses a dosage of 150, 300 or 600 mg. ‘111 further teaches each of these specific dosages (¶ 24). Claims 4-7 require subcutaneous administration, and claims 8-11 require intravenous administration. ‘111 further teaches each of these forms of administration (¶ 19). Claims 6, 7, 10 and 11 each requires four iterations of the administering step, with claims 7 and 11 requiring weekly administrations (and thus four weekly administrations). ‘111 further teaches loading regimens for the antibody that include “weekly administration for several weeks”, for example “1 to 4 weeks”. Thus, the ‘111 teaches each of the parameters of claims 4-11. When practicing the modified method obvious over the claims of ‘750 or ‘953 in view of ‘111 that meets the limitations of parent claim 1, it would have further been obvious to include any of these administration parameters taught by ‘111 because the claims of ‘750 and ‘953 are silent with respect to specific dosages, routes of administration and timing of administration to be administered, and ‘111 provides such information for treatment of the same condition with the same type of antibody.
Instant claim 12 encompasses a method of claim 1 wherein the antibody is administered in combination with an immunosuppressive agent, which corresponds to the further limitations of claim 22 of ‘750 and claim 16 of ‘953.
Instant claim 15 encompasses the method of claim 12 wherein the antibody and immunosuppressive agent are formulated in a single composition. The claims of ‘750 and ‘953 do not include this further limitation, but ‘111 teaches that pharmaceutical compositions comprising anti-CD40 antibodies “may also contain additional therapeutic agents for treatment of the particular targeted disorder” (¶ 177). When practicing the modified method obvious over the claims of ‘750 or ‘953 in view of ‘111 that meets the limitations of parent claim 12, it would have further been obvious to include the immunosuppressive agent in a single composition with the antibody, because the claims of ‘750 and ‘953 include administration of an immunostimulatory agent, but are silent as to whether such is administered together or separately from the antibody, and ‘111 provides such information for treatment of the same condition with the same type of antibody.
Claims 23 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 20-25 of U.S. Patent No. 11,254,750, issued 2/22/22 (cited on the 7/7/25 IDS) or (2) claims 1-20 of U.S. Patent No. 12,419,953, issued 9/23/25, each of which shares the same applicant and an inventor (Struthers) with the instant application, and each further in view of Espie et al, U.S. Patent Application Publication 20190153111, published 5/23/19, and further in view of Engelhardt et al, U.S. Patent Application Publication 2018/0289790, published 10/11/18.
Claims 23 and 24 encompass a method of claim 19 wherein the dose of antibody is a formulation comprising 20 mM histidine, 250 mM sucrose, 50 µM pentetic acid and polysorbate 80, pH 6.0.
The claims of ‘750 and ‘953 do not include a formulation as recited in claims 23 and 24, and neither does the teachings of the ‘111 publication.
‘790 teaches “a sterile, non-pyrogenic, single-use, preservative-free, isotonic aqueous solution for intravenous administration” of an antibody that includes histidine, sucrose, pentetic acid and polysorbate 80 (¶ 417). ‘790 further provide an example of such that contains “20 mM histidine (pH 6.0), 250 mM sucrose buffer, 50 μM pentetic acid (DPTA) and 0.05% polysorbate 80” (¶ 753).
When practicing the modified method obvious over the claims of ‘750 or ‘953 in view of ‘111 that meets the limitations of parent claims 1 and 19, it would have further been obvious to include place the antibody in a formulation containing 20 mM histidine, 250 mM sucrose, 50 µM pentetic acid and polysorbate 80, pH 6.0 as taught by ‘790. The person of ordinary skill in the art would have been motivated to make this change because the claims of ‘750 and ‘953 are silent with respect a formulation for the antibody for administration, and ‘790 provides such information for a formulation suitable intravenous administration of an antibody.
Note on Prior Art Rejection(s)
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 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 1-12 and 15-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Yamniuk et al, WO2020/106620, published 5/28/20, and further in view of Espie et al, U.S. Patent Application Publication 20190153111, published 5/23/19. The earliest date to which the instant application claims priority is 8/25/20.
Instant claims 1 and 2 each encompass a method of treating an autoimmune disease (claim 1) that is Sjogren’s syndrome (claim 2) in a human patient comprising administering to the patient at least one dose of an isolated antibody that specifically binds to CD40, wherein the antibody comprises a first polypeptide portion comprising a heavy chain variable region (HCVR) comprising CDR1-3 of SEQ ID NO: 1-3 and a second polypeptide portion comprising a light chain variable region (LCVR) comprising CDR1-3 of SEQ ID NO: 7-9, wherein the dose is selected from 0.3 mg to 1000 mg of the antibody.
The ’620 publication teaches antibodies that bind CD40 (¶ 3) and further than comprise the same CDR sequences (SEQ ID NO: 1-3 and 7-9) as recited in instant claim 1 (¶ 15). ‘620 further teaches method of administering such to treat an autoimmune disease (¶ 27) that is Sjogren’s syndrome (¶ 27). ‘620 further teaches that the patient is human (¶ 94). ‘620 does not teach a dose in the range of 0.3 mg to 1000 mg as required by claim 1.
‘111 teaches anti-CD40 antibodies for treatment of Sjogren’s. ‘111 further teaches that the antibodies may be administered in a dose of about 150 mg to about 600 mg (¶ 22), which is encompassed by the range recited in instant claim 1.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the method of treatment of Sjogren’s syndrome with an anti-CD40 antibody taught by ‘620, and modify it to administer the anti-CD40 antibody using a dose in the range taught by the ‘111 publication, i.e., a dose in the range of about 150 mg to about 600 mg. The person of ordinary skill in the art would have been motivated to make such a change because ‘620 teaches a method of treatment that requires administration of a therapeutic antibody, but does not indicate a dosage, and administration requires a dosage to be administered, and ‘111 provides the missing information. The person of ordinary skill in the art would have had a reasonable expectation of success in using the dosages taught by ‘111 with the antibody of ‘620 because the antibodies taught by ‘111 target the same molecule (CD40) for treatment of the same disease (Sjogren’s). This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Instant claims 3 and 16-19 further limit the structure of the administered anti-CD40 antibody, and the further limitations of these claims are taught by ‘620 as follows:
Instant Claim
Paragraph of ‘620
3
¶ 12
16
¶ 45
17
¶ 14
18
¶ 77
19
¶ 77
Instant claims 4-11 each depend from claim 1 and further limit the administered dosage, and also the route of administration and, in claims 6-7, the timing of administration. Claims 4-7 require subcutaneous administration, and claims 8-11 require intravenous administration. ‘620 further teaches each of these forms of administration (¶ 97). Each of claims 4-11 encompasses a dosage of 150, 300 or 600 mg. ‘111 further teaches each of these specific dosages (¶ 24). Claims 6, 7, 10 and 11 each requires four iterations of the administering step, with claims 7 and 11 requiring weekly administrations (and thus four weekly administrations). ‘111 further teaches loading regimens for the antibody that include “weekly administration for several weeks”, for example “1 to 4 weeks”. Thus, the ‘111 teaches each of the parameters of claims 4-11. When practicing the modified method obvious over the teachings of ‘620 in view of ‘111 that meets the limitations of parent claim 1, it would have further been obvious to include any of these administration parameters taught by ‘111 because the teachings of ‘620 are silent with respect to specific dosages and timing of administration to be administered, and ‘111 provides such information for treatment of the same condition with the same type of antibody.
Instant claim 12 encompasses a method of claim 1 wherein the antibody is administered in combination with an immunosuppressive agent, which is further taught by ‘620 at ¶ 96.
Instant claim 15 encompasses the method of claim 12 wherein the antibody and immunosuppressive agent are formulated in a single composition. The claims of ‘750 and ‘953 do not include this further limitation, but ‘111 teaches that pharmaceutical compositions comprising anti-CD40 antibodies “may also contain additional therapeutic agents for treatment of the particular targeted disorder” (¶ 177). When practicing the modified method obvious over the teachings of ‘620 in view of ‘111 that meets the limitations of parent claim 12, it would have further been obvious to include the immunosuppressive agent in a single composition with the antibody, because the teachings of ‘620 include administration of an immunostimulatory agent, but are silent as to whether such is administered together or separately from the antibody, and ‘111 provides such information for treatment of the same condition with the same type of antibody. This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Claims 23 and 24 are rejected under 35 U.S.C. 103(a) as being unpatentable over Yamniuk et al, WO2020/106620, published 5/28/20, and further in view of Espie et al, U.S. Patent Application Publication 20190153111, published 5/23/19, and Engelhardt et al, U.S. Patent Application Publication 2018/0289790, published 10/11/18.
Claims 23 and 24 encompass a method of claim 19 wherein the dose of antibody is a formulation comprising 20 mM histidine, 250 mM sucrose, 50 µM pentetic acid and polysorbate 80, pH 6.0.
The teachings of ‘620 do not include a formulation as recited in claims 23 and 24, and neither does the teachings of the ‘111 publication.
‘790 teaches “a sterile, non-pyrogenic, single-use, preservative-free, isotonic aqueous solution for intravenous administration” of an antibody that includes histidine, sucrose, pentetic acid and polysorbate 80 (¶ 417). ‘790 further provide an example of such that contains “20 mM histidine (pH 6.0), 250 mM sucrose buffer, 50 μM pentetic acid (DPTA) and 0.05% polysorbate 80” (¶ 753).
When practicing the modified method obvious over the teachings of ‘620 in view of ‘111 that meets the limitations of parent claims 1 and 19, it would have further been obvious to include place the antibody in a formulation containing 20 mM histidine, 250 mM sucrose, 50 µM pentetic acid and polysorbate 80, pH 6.0 as taught by ‘790. The person of ordinary skill in the art would have been motivated to make this change because the teachings of ‘620 are silent with respect to a formulation for the antibody for administration, and ‘790 provides such information for a formulation suitable intravenous administration of an antibody.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674