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
Status of the Claims
1. Claims 1-31 are the original claims filed on 5/8/2020. In the Preliminary Amendment of 8/20/2020, Claims 1-37 are amended. In the second Preliminary Amendment of 9/22/2020, Claim 30 is amended. In the Response of 4/10/2023, Claims 1-4, 6-9, 11, and 27-31 are amended, claims 12-14 are canceled and new claims 32-37 are added. In the Response of 8/25/2023, Claims 1, 6, 10, 31, 34-35, and 37 are amended. In the Response of 2/8/2024, Claims 1 and 6 are amended. In the Response of 10/8/2024, Claims 1, 3-4, 11, 17-18, 21, 24-26, 28-31, and 36-37 are amended, claims 15, 19-20, and 22-23 are canceled, and new claim 38 is added. In the Response of 2/26/2025, Claims 1, 18, 21, 24 and 25 are amended and new Claim 39 is added. In the Response After Final Action of 7/14/2025, no claims are amended or added. In the RCE of 9/15/2025 and 10/2/2025 no claims no claims are amended, canceled or added. In the Response of 4/6/2026, claims 1, 5, 8, 11, 21, 28-29, 32, 37-39 are amended, claim 4 is canceled and new claims 40-41 are added.
Claims 1-3, 5-11, 17-18, 21 and 24-41 are all the claims.
This Office Action contains new grounds for objection and rejection. The Office Action is final.
Priority
2. USAN 16/869,793, filed 05/08/2020, and having 3 RCE-type filing therein,
claims foreign priority to EP19208417.6, filed 11/11/2019.
Information Disclosure Statement
3. As of 5/5/2026, a total of six (6) IDS are filed for this application: 8/11/2020; 12/1/2021; 9/26/2022; 1/16/2025; 6/9/2025; and 4/6/2026. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Objections
Claim Objections
4. The objections to the Claims 4 and 32 because of informalities is moot for canceled claim 4 and withdrawn for claim 32.
a) Claim 4 is canceled.
b) Claim 32 is amended to recite “12 mg/day” to comport with the claim set.
Rejections Maintained
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.
5. The rejection of Claims
Applicants allege the amendment of the claims in generic claim 1 overcomes the rejection by clarifying the relationship between the penultimate and final “wherein” clauses.
Response to Arguments
Amended claim 1 recites
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It is not reasonably ascertainable what is claimed in generic claim 1. The phrase “each of said administrations” (2nd “wherein” clause) makes no reference to the “at least three individual administrations” much less to the 1st “wherein” clause for the “administered” dose.
It is not ascertainable what is claimed in generic claim 1. The phrase “and wherein each administration takes place on a different day” is unclear how this relates to the phrase “on a single day” in the 2nd “wherein” clause much less to the 1st “wherein” clause for the “administered” dose.
Claim 1 is indefinite, failing to conform with current U.S. practice. It appears to be a literal translation into English from a foreign document and is replete with errors.
The rejection is 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.
6. The rejection of Claims 1-3, 5-11, 17-18, 21 and 24-39 (and 40-41) on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11352433 or claims 1-19 of U.S. Patent No. 10301391 in view of Cong et al (PTO 892 form)) is maintained.
a) Applicants allege on p. 11 of the Response “the present claims are directed to methods of treating a BCMA-positive B cell or plasma cell neoplasm in a human subject with the recited BCMAxCD3 antibody construct, wherein the antibody construct is administered at a dose of 800 ug/day to 12 mg/day at least three times on different days in one cycle of treatment.”
Response to Arguments
AS discussed herein above under section 5 the amended claims are indefinite, confusing and imprecise much less that they do not recite what is alleged in the Response. The claimed invention is not drawn to what Applicants allege.
b) Applicants allege the present application demonstrates for the first time that dosing in the claimed range effects patient responses to a BCMA-positive B cell neoplasm (relapsed/refractory multiple myeloma), with a manageable safety profile.
The Example of the present application describes a first-in-human clinical study of different doses of the BCMAxCD3 antibody construct as claimed. Patients enrolled in the clinical study were heavily pre-treated and were relapsed or refractory to treatment, as noted, e.g., at p. 61, second paragraph of the original application:
Response to Arguments
The claims are silent as to the subject being heavily pre-treated, relapsed or refractory to treatment. The claimed invention is not drawn to what Applicants allege.
c) Applicants allege 47 patients received treatments of the BCMAxCD3 antibody construct as claimed at doses ranging from 5 to 6500 ug/day; administering a dose as low as 800 ug/day in patients with relapsed/refractory multiple myeloma was both safe and effective. Patients showed complete or partial responses (including a stringent complete response) at target doses from 800 ug to 6500 ug. See, e.g., p. 62, second paragraph of the original application: Responses included 1 stringent complete response (sCR) at 800 ug and 4 partial responses (PRs), 2 PRs at 3000 ug, 1 PR at 4500 ug, and 1 PR and a minimal response at 6500 pg. Follow-up results in Table 2 (p. 63 of the original application) show two more partial responses and another sCR at a target dose of 3000 ug, two very good partial responses (VGPR) at a target dose of 4500 ug, and a PR, two VGPRs, and a complete response (CR) at a target dose of 6500 ug.
Response to Arguments
Example 1 at p. 61 and p. 62 do not teach the days on which the AMG 701 is administered within any given cycles, only in 4-week cycles at given dose ranges for three cohorts:
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d) Applicants allege dosing cohorts of 9000 ug and 12000 ug were described as "yet to be enrolled" at p. 62, second paragraph of the original application. Subsequent data for these cohorts are described in Exhibit A (submitted herewith), which follows up with later results of the clinical study of the Example. As evident from the Table at p. 3 of Exhibit A, the dosing cohort of 9000 ug had 5/10 responders (3 PRs and 2 VGPRs), and the dosing cohort of 12000 ug had 2/7 responders (1 PR and 1 VGPR) with the cohort still enrolling at the time of publication. From the data in the original application, and from Exhibit A, it is clear that responses were achieved in human patients over the whole scope of dosages recited in the claims, i.e., from 800 ug/day to 12 mg/day.
Response to Arguments
Exhibit A does not supplement nor cure the deficiencies of the specification for what Applicants allege to meet the instant claimed invention of claim 1. To repeat and re-iterate, the days within any given cycle of at least one cycle are not shown nor defined for the amount of AMG 701 that is administered accordingly.
The rejection is maintained.
New Grounds for Objection
Claim Objections
7. Claims 5 and 40-41 are objected to because of the following informalities:
a) Amend claim 5(b) to recite “or b) two dose steps[,] from a first dose to a second dose, and a second dose to a third dose, during the first cycle.”
b) Amend claim 40 to recite “12 mg/day” to comport with the other claims.
Appropriate correction is required.
Conclusion
8. No claims are allowed.
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Julie can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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