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 Claims
Claims 1-19 are pending.
Priority
Instant application 18/106,893, filed 02/07/2023, claims priority as follows:
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Information Disclosure Statement
All references from IDS(s) received 5/18/2023, 01/31/2024, 12/16/2025 have been considered unless marked with a strikethrough.
Response to Amendment/Arguments
The amendment filed 12/15/2025 has been entered. Applicant has amended claims 1 and 4-19.
Claims 1-11 and 19 were rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement in the Office action dated 09/15/2025. In view of the amendment filed 12/15/2025, applicant has overcome the rejection. Therefore, the rejection under section 112(a) is withdrawn.
Claims 1-19 were rejected under 35 U.S.C. 112(b) as indefinite in the Office action dated 09/15/2025. In view of the amendment filed 12/15/2025, applicant has overcome the rejection. Therefore, the rejection under section 112(b) is withdrawn.
Double Patenting - Maintained
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.
17/723,199
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 17/723,199 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites a method of treating a human with multiple myeloma comprising administering an effective amount of a compound of Formula:
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or a pharmaceutically acceptable salt or composition thereof to the human in need thereof. Dependent claim 20 of the reference application recites the same compound recited in instant claim 1.
The reference application recites administering “an effective amount of a compound…or composition thereof”, but does specifically not recite administering the compound in a dose between about 1 microgram and about 500 micrograms.
However, the portions of the specification in the reference application that provide support and guidance for the meaning of the term “effective amount” in the claims include page 224, lines 5-29, which states that “the disclosure provides pharmaceutical compositions comprising an effective amount of compound or pharmaceutically acceptable salt…for any of the uses described herein”; and describes that in certain embodiments the pharmaceutical composition comprising the active compound can comprise, inter alia, from about 0.001 mg (1 microgram) to about 1 mg (1000 micrograms) of the active compound. The specification of the reference application (page 224, lines 5-29) also describes dosage amounts of, inter alia, 0.01 mg (10 micrograms), 0.02 mg (20 micrograms), 0.05 mg (50 micrograms), 0.1 mg (100 micrograms), 2.5 mg (250 micrograms), and 5 mg (500 micrograms).
A person of ordinary skill in the art would have identified and consulted the above passage in the specification of the reference application as support for the phrase “effective amount” in the claims. The dosage range of about 1 microgram to about 1000 micrograms overlaps with the claimed range of 1 microgram to 500 micrograms. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Note also that differences in result-effective variables will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating the value of the result-effective variable is critical. See MPEP 2144.05. In the instant case, the dose range of the claimed compound is considered a result-effective variable that impacts, for example, the occurrence of a desired or undesired effect in a subject. Absent a showing of criticality, optimizing result-effective variables is deemed routine optimization.
Therefore, the instant claims are prima facie obvious in view of the reference application.
This rejection is proper according to MPEP 804(II)(B)(1):
Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
In the Remarks filed 12/15/2025, applicant traverses the rejection, arguing that none of the claims in the reference application recite a dose of the instant compound in the range between 1 microgram and 500 micrograms (Remarks, page 5). Applicant additional argues that “the double patenting rejection has to be limited to what is in the claims and the specification can generally not be used in double patenting rejections” (Remarks, page 5). Applicant argues that the specification may only be consulted for determining the utility of claimed compounds (Remarks, page 5).
Applicant’s arguments have been fully considered but are not found persuasive. MPEP 804(II)(B)(1), “Construing the Claim Using the Reference Patent or Application Disclosure”, states that “Each nonstatutory double patenting situation must be decided on its own facts”; and states that “To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.”
In the instant case, a portion of the specification that was relied upon to construe the scope of the reference claim is the passage at page 224, lines 5-29, which is used to construe the scope of the phrase “an effective amount of a compound…or pharmaceutically acceptable salt or composition thereof” in the reference claims. MPEP 804(II)(B)(1) additionally states, “In construing the claims of the reference patent or application, a determination is made as to whether a portion of the specification, including the drawings and claims, is directed to subject matter that is within the scope of a reference claim.” The passage at page 224, lines 5-29 is directed to subject matter within the scope of the reference claims, because the reference claims administering an “effective amount” of a compound having the formula:
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or a composition thereof, and the aforementioned passage in the specification provides guidance to the person of ordinary skill about particular amounts of the claimed compounds which are contemplated by the inventor to be “effective”.
MPEP 804(II)(B)(1) further states “The specification can be used as a dictionary to learn the meaning of a term in the claim” and states “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’”
Accordingly, applicant’s conclusion that “[t]he claims of the ‘199 application already disclose the utility of the invention….so there are no grounds for consulting the specification in making a double patenting rejection” (Remarks, page 6) is unpersuasive. Moreover, applicant has not provided any evidence that the dosage range in the instant claims (1 microgram to 500 micrograms) is critical when compared with the dosage ranges disclosed in the reference application. The rejection is therefore maintained.
18/797,261
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/797,261 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites a method of treating a cancer that is mediated by IKZF1 (Ikaros) and/or IKZF3 (Aiolos) comprising administering an effective amount of a crystalline compound of Formula:
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to a human in need thereof. Claims 17-20 in particular recite the particular disorders multiple myeloma, non-Hodgkin’s lymphoma, and B-cell lymphoma.
The reference application recites administering an “effective amount” of the compound, but does not recite administering the compound in a dose between about 1 microgram and about 500 micrograms.
However, the portions of the specification in the reference application that provide support for the reference claims include page 8, lines 9-20, which disclose that pharmaceutical compositions comprising the active compound can comprise at least about 1, 5, 10, …, 450, 475, or 500 ug of the active compound, which may be given once a day. The doses of the active compound taught in the reference application read on the dose range recited in the instant claims. Therefore, the instant claims are prima facie obvious in view of the reference application.
This rejection is proper according to MPEP 804(II)(B)(1); note the relevant sections cited earlier in the rejection over Application No. 17/723,199.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Please note that reference Application No. 18/797,261 is a CON of PCT/US2023/012734, filed 02/09/2023. Therefore, the reference application has a later patent term filing date than the instant application. See MPEP 804(I)(B)(1)(a). Please also note MPEP 804(I)(B)(1)(b)(i), which states:
“If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.”
Response to Arguments
In the Remarks filed 12/15/2025, applicant traverses the rejection, arguing that none of the claims in the reference application recite a dose of the instant compound in the range between 1 microgram and 500 micrograms (Remarks, page 6). Applicant repeats the additional arguments regarding the use of the specification in double patenting rejection which were presented for the rejection over the ‘199 application above.
Applicants arguments have been fully considered but are not found persuasive. The claims of the reference application recite administering an “effective amount” of a compound of claim 1 to a human in need thereof, including humans having multiple myeloma, non-Hodgkin’s lymphoma, and B-cell lymphoma. As noted in the response for the rejection over the ‘199 application above, “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’”
Accordingly, the rejection is maintained for the same reasons articulated above in the response to arguments for the ‘199 application.
Conclusion
Claims 1-19 are rejected.
THIS ACTION IS MADE FINAL. 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 Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 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, Clinton Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621