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 25 August 2025 has been entered in full. Claims 1-10 and 13 are canceled. Claims 20 remains withdrawn from consideration as being directed to a non-elected invention. Claims 11, 12, 14-19, 21, and 22 are under examination.
Withdrawn Objections And/Or Rejections
The rejection of claim 17 under 35 U.S.C. 112(b) as set forth at pp. 2-3 of the previous Office action (mailed 23 April 2025) is withdrawn in view of the amended claims (as per the amendment of 25 August 2025).
The rejection of claims 11-19 under 35 U.S.C. 112(a) regarding enablement as set forth at pp. 3-6 of the previous Office action (mailed 23 April 2025) is withdrawn in view of the amended claims (as per the amendment of 25 August 2025).
The rejection of claims 11-19 under 35 U.S.C. 102(a)(1) and (a)(2) as set forth at pp. 12-14 of the previous Office action (mailed 23 April 2025) is withdrawn in view of the amended claims (as per the amendment of 25 August 2025).
Claim Rejections - 35 USC § 112
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.
Written Description:
Claims 11, 12, 14-19, 21, and 22 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.
The issues raised at pp. 6-12 of the previous Office action (mailed 23 April 2025) remain. Furthermore, the amended claims recite anti-BSP antibodies IDK1, AF165R4.2-E2, and AF177.3. These new limitations constitute new matter, since the specification as originally filed does not describe these antibodies.
Applicant argues (pp. 7-8, remarks received 25 August 2025) that the claims have been amended to recite anti-BSP antibodies IDK1, AF165R4.2-E2, and AF177.3, thus resolving the issue regarding the recitation of a genus of antibodies. Applicant points to the specification’s reference to EP 15756875.9, a European application that is incorporated by reference at [0067] of the instant specification, as providing origin, sequence information, and binding data for these antibodies. Applicant concludes that the specification provides adequate written description for the claimed invention.
This has been fully considered but is not found to be persuasive for two reasons. First, the specification as originally filed does not refer to the anti-BSP antibodies IDK1, AF165R4.2-E2, and AF177.3 by name, structure (sequence), origin, or binding data. While it is acknowledged that the specification as originally filed points to EP 15756875.9, a European application, at [0067] of the instant specification, as providing information regarding an anti-BSP antibody used in the examples, there is no indication anywhere in the application as originally filed that the publications and/or patent documents cited in the specification are incorporated by reference.
Second, even if the cited document were incorporated by reference, this is an improper incorporation by reference, because the information about the antibodies is essential subject matter for the instant claims. 37 CFR 1.57 (d) is as follows:
(d) "Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. "Essential material" is material that is necessary to:
(1) Provide a written description of the claimed 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 set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a);
(2) Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or
(3) Describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f).
In the instant case, the names, origins, sequences, and binding data of anti-BSP antibodies IDK1, AF165R4.2-E2, and AF177.3 are essential to the claimed invention. However, this information is incorporated by reference to a European application, not a U.S. patent or U.S. patent application publication.
Accordingly, the claimed subject matter is not supported by an adequate written description, and the claims are properly rejected under 35 U.S.C. 112(a).
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 11, 12, 14-19, 21, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 5 of U.S. Patent No. 10,947,301 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons set forth at pp. 15-16 of the previous Office action (mailed 23 April 2025).
Applicant requests reconsideration of the rejection and further requests that the rejection be held in abeyance until there is allowable subject matter in the application (p. 10,8, remarks received 25 August 2025). This has been fully considered but is not found to be persuasive for reasons of record. Also, Applicant’s attention is respectfully directed to M.P.E.P. § 804(I)(B)(1), which states:
A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.
As filing 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, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03.Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. See MPEP § 804.02, subsection VI, for filing terminal disclaimers required to overcome nonstatutory double patenting rejections in applications filed on or after June 8, 1995. (emphasis added)
Accordingly, the rejection is maintained and is expressly not held in abeyance.
Conclusion
No claims are 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 ELIZABETH C. KEMMERER whose telephone number is (571)272-0874. The examiner can normally be reached M-F 6:30-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at 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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/ELIZABETH C. KEMMERER/Primary Examiner, Art Unit 1674
/ECK/
15 September 2025