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
Response to Amendment
The amendment filed 11/10/2025 has been entered. Pending Claims 181-182 are pending in the application. Applicant’s remarks regarding the 35 USC 103 rejection over Bannen previously set forth in the Non-Final Office Action mailed 6/09/2025.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Response to Applicant’s Arguments
It is noted that applicant’s remarks filed 11/10/2025 do not address the objection to the hyperlink embedded in the specification. No amendment to the specification is made. Thus, the same objection to applicant’s disclosure is reissued below.
Regarding the prior art rejection over Bannen et al., applicant submits that both Bannen, which was previously found to qualify as prior art under 35 USC 102(a)(2), and the instant application “were commonly owned by…Exelixis, Inc. not later than the effective filing date of the claimed invention”. Therefore, Bannen is disqualified as prior art as being excepted under 35 USC 102(b)(2)(C) and the corresponding rejection thereover is withdrawn.
The NSDP over App No. 19067042 is withdrawn because the application is abandoned as of 10/22/2025.
Applicant traverses the extant provisional (4) and nonprovisional (2) NSDP rejections on the basis that “Berge teaches that selecting an appropriate salt is not an obvious task”. Specifically, applicant cites Berge at Page 1, Para 1; “[c]hoosing the appropriate salt, however, can be a very difficult task, since each salt imparts unique properties to the parent compound”. Further, applicant totals the salt-forming agents of Berge including 77 anions and 40 other agents known to form pharmaceutical salts. Finally, applicant concludes undue experimentation would be required to arrive at a tosylate salt of the compounds disclosed in each referenced patent document. Applicant’s arguments are fully considered but not persuasive. In the same paragraph cited by applicant, Berge starts “The chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form”.Berge details considerations for an ordinary artisan when choosing drug salt forms; “Salt-forming agents are often chosen empirically. Of the many salts synthesized, the preferred form is selected by pharmaceutical chemists primarily on a practical basis: cost of raw materials, ease of crystallization, and percent yield.” See also MPEP 2144.05(II)(B):
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection…In KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421, 82 USPQ2d at 1397 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.").
The MPEP teaches it is obvious to try is a valid rationale when optimizing and there are a finite number of solutions. Berge teaches a finite number of commonly used salt-forming agents and that forming a salt can be done to achieve biological and physical results notwithstanding pragmatic and economic considerations like cost and yield as taught by Berge. Applicant has not explained what about this routine process of selecting salts through empirical means is “undue”. Time and difficulty of experiments are not determinative if they are merely routine. Quantity of examples is only one factor that must be considered before reaching the final conclusion that undue experimentation would be required. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404. Further, In United States v. Telectronics, Inc., 857 F.2d 778, 8 USPQ2d 1217 (Fed. Cir. 1988), cert. denied, 490 U.S. 1046 (1989), the court reversed the findings of the district court for lack of clear and convincing proof that undue experimentation was needed. The court ruled that since one embodiment and the method to determine dose/response was set forth in the specification, the specification was enabling. The question of time and expense of such studies, approximately $50,000 and 6-12 months standing alone, failed to show undue experimentation. See MPEP 2164.06. Lastly, applicant has not provided unexpected results to overcome the finding of prima facie obviousness described in the NSDP rejections below. Therefore, the rejections over each of the pending or alive patent documents are reissued hereinbelow.
Specification
The disclosure remains objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in Para 432. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
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.
PROVISIONAL:
1. Claims 181-182 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-64 of copending Application No. 18018805 (hereinafter referred to as Exelixis) in view of Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a crystalline salt of “Compound 1” formulated with an excipient.
Exelixis does not teach the formulation of a tosylate salt specifically.
Berge teaches common coformers used in the formulation of pharmaceutical salts which include tosylate as claimed (Page 3, Table 2, Anions). “The chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form” (Page 1, Left Col). One of skill in the art seeking to optimize the physical properties of the drug formulations of Compound 1 would find it obvious to select from the coformers and ions listed in Berge and expect the successful formulation of salt crystals with optimized stability, hygroscopicity, solubility, etc. because Berge cites tosylate as well as other ions as commonly used and efficacious for pharmaceutical salt formulation.
Since both applications teach Compound 1 salts formulated with excipients, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Exelixis.
This is a provisional nonstatutory double patenting rejection.
2. Claims 181-182 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-3, 5-18, 24, and 33-38 of copending Application No. 18035355 (hereinafter referred to as Exelixis) in view of Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a crystalline salt of “Compound 1” formulated with an excipient.
Exelixis discloses a hemifumarate salt but does not teach the formulation of a tosylate salt specifically.
Berge teaches common coformers used in the formulation of pharmaceutical salts which include tosylate as claimed (Page 3, Table 2, Anions). “The chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form” (Page 1, Left Col). One of skill in the art seeking to optimize the physical properties of the drug formulations of Compound 1 would find it obvious to select tosylate from the limited coformers and ions listed in Berge and expect the successful formulation of salt crystals with optimized stability, hygroscopicity, solubility, etc. because Berge cites tosylate as well as other ions like fumarate as commonly used and efficacious for pharmaceutical salt formulation.
Since both applications teach Compound 1 salts formulated with excipients, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Exelixis.
This is a provisional nonstatutory double patenting rejection.
3. Claims 181-182 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 142-153 of copending Application No. 18657052 (hereinafter referred to as Exelixis) in view of Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a crystalline salt of “Compound 1” formulated with an excipient.
Exelixis discloses a hemifumarate salt but does not teach the formulation of a tosylate salt specifically.
Berge teaches common coformers used in the formulation of pharmaceutical salts which include tosylate as claimed (Page 3, Table 2, Anions). “The chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form” (Page 1, Left Col). One of skill in the art seeking to optimize the physical properties of the drug formulations of Compound 1 would find it obvious to select tosylate from the limited coformers and ions listed in Berge and expect the successful formulation of salt crystals with optimized stability, hygroscopicity, solubility, etc. because Berge cites tosylate as well as other ions like fumarate as commonly used and efficacious for pharmaceutical salt formulation.
Since both applications teach Compound 1 salts formulated with excipients, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Exelixis.
This is a provisional nonstatutory double patenting rejection.
4. Claims 181-182 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-2, 5-8, 10, 12-15, 18, 20-27 of copending Application No. 18706757 (hereinafter referred to as Exelixis) in view of Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a salt of “Compound 1” formulated with an excipient.
Exelixis discloses a hemifumarate salt but does not teach the formulation of a tosylate salt specifically.
Berge teaches common coformers used in the formulation of pharmaceutical salts which include tosylate as claimed (Page 3, Table 2, Anions). “The chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form” (Page 1, Left Col). One of skill in the art seeking to optimize the physical properties of the drug formulations of Compound 1 would find it obvious to select tosylate from the limited coformers and ions listed in Berge and expect the successful formulation of salt crystals with optimized stability, hygroscopicity, solubility, etc. because Berge cites tosylate as well as other ions like fumarate as commonly used and efficacious for pharmaceutical salt formulation.
Since both applications teach Compound 1 salts formulated with excipients, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Exelixis.
This is a provisional nonstatutory double patenting rejection.
NONPROVISIONAL:
1. Claim 181 is rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-2 of U.S. Patent No. 11542259 (hereinafter referred to as Exelixis) in view of Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a salt of instant Compound 1 or Exelixis Compound 8,
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Exelixis does not teach the formulation of a tosylate salt specifically.
Berge teaches common coformers used in the formulation of pharmaceutical salts which include tosylate as claimed (Page 3, Table 2, Anions). “The chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form” (Page 1, Left Col). One of skill in the art seeking to optimize the physical properties of the drug formulations of Compound 1 would find it obvious to select from the coformers and ions listed in Berge and expect the successful formulation of salt crystals with optimized stability, hygroscopicity, solubility, etc. because Berge cites tosylate as well as other ions as commonly used and efficacious for pharmaceutical salt formulation.
Since both claim sets teach instant Compound 1 salts, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Exelixis.
2. Claims 181-182 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-2 of U.S. Patent No. 12017995 (hereinafter referred to as Exelixis) in view of Berge (J. of Pharmaceutical Sci. Vol. 66, No. 1, January 1977).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a crystalline salt of “Compound 1” formulated with an excipient.
Exelixis discloses a hemifumarate salt but does not teach the formulation of a tosylate salt specifically.
Berge teaches common coformers used in the formulation of pharmaceutical salts which include tosylate as claimed (Page 3, Table 2, Anions). “The chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form” (Page 1, Left Col). One of skill in the art seeking to optimize the physical properties of the drug formulations of Compound 1 would find it obvious to select tosylate from the limited coformers and ions listed in Berge and expect the successful formulation of salt crystals with optimized stability, hygroscopicity, solubility, etc. because Berge cites tosylate as well as other ions like fumarate as commonly used and efficacious for pharmaceutical salt formulation.
Since both claim sets teach crystalline salts of Compound 1 and compositions thereof comprising excipients, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Exelixis.
Conclusion
No claim is allowable.
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 extension fee 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 7:30am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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