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 .
Priority
This application was filed 04/27/2023 and claims PRO 63/336630 (04/29/2022). Claims 2-7 have been canceled by paper dated 06/02/2026. Claims 1 and 8-26 are before the Examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 8-21 remain rejected and now new claims 22-26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2019046778 in view of WO2019104316. WO2019046778 teaches ENPP1 inhibitors (claim 1) such as 396 on page 113 which is N-[[4-(7-methoxy-4-uinolinyl)phenyl]methyl]sulfamide (claim 8) as claimed in claim 8. The pharmaceutical composition is taught on pages 122 and 123 of ‘778 (claim 15 and 17). Inhibition of ENPP1 is taught on page 123. Page 123 teaches a composition having an effective amount ranging from 0.1µg – 50mg (claims 9-11). Paragraph 337 of WO2019046778 teaches concentration of1-1000mg/kg/day and the instant specification pages 9-10 have a target of 5-10000uM is achieved by 300mg dosage so claim 1 and claims 9-11 are fully taught by WO2019046778. WO2019104316 teaches that ENPP1 inhibitors can treat cancer, periodontal disease autoimmune disorders, inflammatory disorders, metabolic disorders and other conditions. The only compound taught by applicant is the compound #396 taught by the WO’778. The topological polar surface area (claim 12), molecular weight (claim 13) and hydrogen bond donors (claim 14) are inherent in the compound #396 which is the compound named in claim 8. WO’778 teaches the ENPP1 inhibitor treats cancer (claims 18 and 19). WO316 teaches similar ENPP1 inhibitors and more conditions that such inhibitors can treat including dental diseases, autoimmune disorders and others that cover claims 16 and 20-21. Claims 22-26 are taught by WO’778 paragraph [0336] by “suitable doses and dosage regimens are determined by conventional range-finding techniques known to those of ordinary skill in the art.” Further, claims 22-26 are taught by WO’316 pages 19-20 with injectables, liquids/pastes that can change viscosity with body heat and degradable materials. This anticipates the instant claims.
Applicant argues that the claims (as amended) are not fully anticipated. That the ENPP1 inhibitor is present between about 5uM and about 10000 uM. However, as shown above, the WO teaches the amount of an ENPP1 inhibitor being given as a dosage range that is the same as instantly taught (see instant specification pages 9-10). This inherently gives the ENPP1 inhibitor as being present at the required range. The same range of dosage given to the same patient population must give the same treatment, promoting bone mineralization, bone growth or both. The instant claim 1 is not limited to one ENPP1 inhibitor compound but all and any ENPP1 inhibitor. Claim 8 limits the specific ENPP1 inhibitor compound which the WO’778 teaches.
This rejection is maintained for reasons of record.
Conclusion
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 D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
Prosecution Insights