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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 25, 2026, has been entered.
Applicant has amendment filed April 16, 2026, is acknowledged and has been entered. Claims 40-68 have been newly added.
Claims 21-68 are pending and under consideration.
Information Disclosure Statement
The information disclosure statements (IDS) have been considered.
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.
Claims 40-51 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a NEW MATTER rejection.
New claim 40 has been a presented and recites “[t]he pharmaceutical composition of claim 35, further comprising from about 5 mM to about 50 mM of a buffer.”
In this case, Applicant submits that support or the new claims can be found “at paragraphs [0044]-[0051], [0053]-[0055], [00135], [00140], [00155], [00162], [00174], [00186], [00228], [00232], and [00233] of the Specification as filed”.
In response, after reviewing these sections and the entire application as filed, support for “from about 5 mM to about 50 mM of a buffer” could not be found.
Notably, the specification at ¶¶ 134-135 discloses that the composition can comprise a generic buffer, but does not set forth generic concentrations for “buffers”. While ¶ 186 sets forth histidine at about 5 mM to about 50 mM, this reference is not to a genus of buffers. Therefore, the disclosure does not appear to support generic buffers at about 5 mM to about 50 mM. Claims 41-51 depend ultimately from claim 40 and require this limitation, so they are rejected for the same reasons.
Accordingly, given the apparent difference in the claims and that of the pertinent disclosures it is submitted that this clearly illustrates that such amendments have in fact introduced new concepts, thereby violating the written description requirement set forth under 35 U.S.C. §112, first paragraph.
Otherwise, these issues might be resolved if Applicant were to point to other disclosures in the specification, including the claims, as originally filed, which are believed to provide the necessary written support for the language of the instant claims.
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 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.
Claims 21-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-60 of U.S. Patent Application 19/563,621.
Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite the same antibody (claimed as daratumumab which comprises the instant sequences claimed) in a composition with rHuPH20 and general formulation details such that the instant claims are anticipated by the copending claims or would be considered patentably indistinct from the instant claims (see claims 31-47 in particular).
Therefore, all of the claims are not patentably distinct from the copending claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner works a flexible schedule.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (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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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
April 17, 2026