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 76-95 are pending in the instant application.
Claims 1-75 have been canceled.
Withdrawn Objections/Rejections
The replacement drawings received November 19th, 2025 are sufficient to overcome the objections to the drawings as noted in the non-final rejection mailed August 19th, 2025.
Applicant’s amendment is sufficient to overcome the rejection of Claim 95 under 35 U.S.C. 112(a). This rejection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claims 84-85 and 90-94 under 35 U.S.C. 112(b). This rejection is hereby withdrawn.
Applicant’s statement pursuant to 35 U.S.C. 102(b)(2)(C) is sufficient to overcome the rejection of Claims 76-78 and 95 under 35 U.S.C. 102(a)(2). This rejection is hereby withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The rejection of Claim 79 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is maintained.
Applicant has traversed this rejection on the basis that Claim 79 introduces the limitation of being a composition that is an immediate release formulation, and that the pharmaceutical composition of Claim 76 does not concern release characteristics.
The examiner does not find this persuasive. While Claim 76 is silent with respect to the release characteristics of the composition, no additional components are recited at Claim 79 that would differentiate the composition of Claim 79 from that of Claim 76. In other words, the recitation of an immediate release formulation is descriptive of the composition of Claim 76. The MPEP states that if the composition is physically the same, it must have the same properties. Per MPEP 2112.01, II., “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.”
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
The rejection of Claims 76, 78, and 95 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4 of U.S. Patent No. 11,241,418 is maintained.
Applicant traverses this rejection at Page 9 of the remarks filed November 19th, 2025 on the basis that “the specification of a reference patent should not be used as if it were prior art in an obviousness double patenting rejection” and cites MPEP 804, B., 1. in support of this statement.
The examiner does not find this persuasive. For clarity of the record, the examiner notes the paragraph of MPEP 804, B., 1. concludes with the statement, “This does not mean that one is precluded from all use of the reference patent or application disclosure to understand the meaning of the reference claims.”
MPEP 804, B., 1. further 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. For example, assume that the claim in a reference patent is directed to a genus of compounds, and the application being examined is directed to a species within the reference patent genus. If the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim.”
In this case, as noted in the non-final rejection mailed August 19th, 2025, Claim 1 of the reference patent is drawn to a meglumine salt of Compound FA represented by the structure:
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Claim 2 of the reference patent is drawn to a pharmaceutical composition comprising this meglumine salt. This formula is identical to the formula disclosed at instant Claim 76.
At Column 6, Lines 16-18 of U.S. Patent No. ‘418, this meglumine salt of Compound FA is taught to exist in multiple crystalline forms, including Form I, to which the instant claims are drawn. At Column 7, Lines 13-16, U.S. Patent No. ‘418 teaches that Form I can be characterized by an XRPD pattern having four or more of the peaks: 4.7, 9.1, 10.0, 17.6, 18.2, 19.0, 21.5, and 23.7 degrees 2 theta. These are the same peaks instantly recited at Claim 76.
In other words, Claim 1 of the reference patent is drawn to a genus of compounds represented by the formula as noted above. The disclosure of the patent teaches Form I as a species of this genus. Therefore, per the MPEP, as noted above, use of the disclosure to construe the claim of the reference patent as anticipating the instantly claimed species is proper.
Regarding instant Claim 78, as noted in the non-final rejection mailed August 19th, 2025, at Column 21, Lines 15-18 of U.S. Patent No. ‘418 teaches the pharmaceutical composition comprising the meglumine salt of Compound FA and an excipient to be formulated comprising the meglumine salt of Compound FA and an excipient to be administered in a unit dosage form. Construing the claim based on the disclosure here is proper, as per MPEP 804, B., 1., “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999).” Here, the disclosure is used to understand the meaning of “pharmaceutical composition” as recited.
Finally, regarding instant Claim 95, Claim 4 of U.S. Patent ‘418 is drawn to a method of treating breast cancer comprising administration of the meglumine salt of Compound FA. Therefore, administration of the instant composition would read on Claim 4 of U.S. Patent ‘418.
Allowable Subject Matter
Claim 77 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 80-94 are allowed.
Conclusion
Claims 76, 78-79, and 95 are rejected.
Claim 77 is objected to.
Claims 80-94 are allowed.
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 DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624