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 18/002,578
Claims 1, 6-7, and 9 are currently pending.
Priority
Instant application 18/002,578, filed 12/20/2022, claims priority as follows:
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The Examiner appreciates the submission of the certified, translated foreign priority documents and acknowledges that the documents contain support for the instant claims. Thus, the instant claims are granted the effective filing date of 6/23/2020.
Information Disclosure Statement
All references from the IDS submitted on 1/28/2025 have been considered unless marked with a strikethrough.
Response to Applicants Arguments/Amendments
The amendment filed 12/12/2025 has been entered. No claims have been amended, cancelled, or added.
In the Non-Final dated 9/12/2025, the drawings were objected to for containing pixelated and illegible images. Though a number of drawings are now able to be interpreted, some drawings remain pixelated and illegible. Thus, the objection is maintained. The objection has been updated to reflect the deficient drawings.
Claims 1 and 6 were rejected in the Non-Final Rejection dated 9/12/2025 under 35 U.S.C. 103. In response, Applicant argues that there is no motivation for a skilled artisan to combine the references because the compounds are structurally different (pyrimidine versus triazine), and that no evidence has been provided by the Office demonstrating that the salt forming property of a compound would not be influenced when an atom of in the central ring is changed. Further, Applicant argues that the experimental data of the mesylate salt of instant formula (I) in a 1:1 ratio has better chemical stability, better physical stability, and better solubility. Applicants arguments have been considered, but are not persuasive because the mesylate salt of instant formula (I) in a 1:1 ratio demonstrates almost equivalent chemical stability to the free base of formula (I), also known as the compound of Hunan in the 35 U.S.C. 103 rejection. The single category where the mesylate salt of instant formula (I) in a 1:1 ratio is superior to the free base, also known as the compound of Hunan, is stability under 60°C temperatures in a closed container for a week. It is unclear how this condition translates to treating non-small cell lung cancer. With respect to Applicant’s argument that there is no motivation for a skilled artisan to generate the mesylate salt in a 1:1 ratio of the compound of Hunan, the Examiner points to the FDA reference provided in the Non-Final dated 9/12/2025. The compounds are for the same purpose and therefore, one can expect similar properties and similar results. Applicant has not provided the data demonstrating superior results over Hunan or over the FDA reference of the Non-Final Rejection of 9/12/2025. Thus, the rejection is maintained.
Claims 1 and 6 were provisionally rejected in the Non-Final Rejection dated 9/12/2025. In response, Applicant argues there is no motivation present for a skilled artisan to combine the teachings of the ‘741 application with FDA because of the difference of an atom in the central ring, and no evidence has been provided by the Office to show that the salt-forming property would not be influenced when the atom in the central ring is changed. Applicant’s arguments have been considered, but are not found persuasive for the same reasons as above. Thus, the rejection is maintained.
Election/Restriction
Applicant’s election of Group I, claims 1-6, drawn to salts of a compound of formula (I) and pharmaceutical composition thereof, in the reply filed 8/20/2025 is acknowledged. The Examiner notes claims 2-5 have been cancelled, therefore leaving claims 1 and 6 as the remaining claims in Group I. Applicant’s election of the methanesulfonic acid salt of the compound of formula (I) in a 1:1 ratio in the reply filed 8/20/2025, is also acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the elections have been treated as elections without traverse (MPEP § 818.01(a)).
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified. See the 103 rejection below. Claims 1 and 6 read on the elected species. Claims 7 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
MAINTAINED OBJECTIONS AND REJECTIONS
Objection to the Drawings
The drawings are objected to because figures 2, 7, 12, 17, 22, 27, 32, 42, 54, 59, 65, 70, 80, and 85 remain pixelated and contain illegible text. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Food and Drug Administration TagrissoTM Label 2015 (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208065s000lbl.pdf, published November 2015, accessed September 8th, 2025, herein after “FDA”) and further in view of Hunan Fuwo Pharmaceutical Co LTD (CN106928200 A, cited in the IDS of 1/28/2025, herein after “Hunan”).
Determining the scope and contents of the prior art
The reference FDA teaches the label for the pharmaceutical Tagrisso™, which is osimertinib mesylate in a 1:1 ratio (Page 9, Description):
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and the methods of treatment for epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (Page 9, Description and Page 1, Indications and Usage) with Tagrisso™. The compound osimertinib differs by the presence of a nitrogen, in the place of a carbon highlighted in with a red circle, from the compound of formula (I) of the instant claims:
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With respect to claim 6, FDA teaches the compound as the mesylate salt with inactive ingredients such as mannitol and microcrystalline cellulose to generate a tablet as a pharmaceutical composition (Page 10, Description), and as a dissolution in water for alternative patient administration methods (page 2, Administration to Patients Who Have Difficulty Swallowing Solids).
The reference Hunan teaches the compound of the instant claims as embodiment 1 (page 9, lines 6 and 7):
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For treatment of non-small cell lung cancer (page 2, technical field and page 2, claim 12), and further teaches the compound may be formed as a pharmaceutically acceptable mesylate salt (page 5). With respect to claim 6, Hunan teaches the compound in 100% DMSO for biological assays (page 9).
Ascertaining the differences between the prior art and the claims at issue
The reference FDA fails to teach the compound of formula (I) of the instant claims, whereas Hunan fails to teach the 1:1 ratio of the compound to methanesulfonic acid.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of pharmaceutically acceptable salts to treat non-small cell lung cancer. An artisan possess the technical knowledge necessary to make adjustments to the pharmaceutically acceptable salts to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said pharmaceutically acceptable salts to treat non-small cell lung cancer and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (B), it would have been prima facie obvious to one having ordinary skill in the art to substitute the compound osimertinib of FDA with embodiment 1 of Hunan because both compounds are known to occur as mesylate salts and are known for the same purpose, to treat non-small cell lung cancer. Thus, the substitution of embodiment 1 for osimertinib to arrive at the compound and pharmaceutically acceptable mesylate salt in a 1:1 ratio of the instant claims would be expected to have similar properties. A skilled artisan would have been motivated before the effective filing date to make such a substitution to identify additional methods of treating non-small cell lung cancer in view of the teachings of FDA and Hunan.
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.
Claims 1 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of copending Application No. 18/011,741 (herein after the ‘741 application) in view of Food and Drug Administration TagrissoTM Label 2015 (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208065s000lbl.pdf, published November 2015, accessed September 8th, 2025, herein after “FDA”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘741 application recite the mesylate salt of the compound of formula I, and a pharmaceutical composition thereof. Though the ‘741 application does not explicitly teach a 1:1 ratio of compound to acid, FDA teaches the 1:1 ratio of osimertinib to methanesulfonic acid to treat non-small cell lung cancer as stated above in the 103 rejection.
Applying KSR prong B, it would have been prima facie obvious to one having ordinary skill in the art to substitute the compound osimertinib of FDA with the compound of formula I of the ‘741 application because both compounds are known to occur as mesylate salts and are known for the same purpose, to treat non-small cell lung cancer. Thus, the substitution of the compound of formula I for osimertinib to arrive at the compound and pharmaceutically acceptable mesylate salt in a 1:1 ratio of the instant claims would be expected to have similar properties. A skilled artisan would have been motivated before the effective filing date to make such a substitution to identify additional methods of treating non-small cell lung cancer in view of the teachings of FDA and the ‘741 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1 and 6 are rejected. Claims 7 and 9 are withdrawn.
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 Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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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.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621