DETAILED ACTION
Claims 1-4, 6-7 and 39-41, submitted 12 May 2026, are pending in the application. Claims 40-41 remain withdrawn. Claims 1-4, 6-7 and 39 are under examination in the instant Office 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 .
Rejections – Withdrawn and Maintained
The status of the rejected claims of the previous Office Action is set out below.
Rejections under 35 U.S.C. §112(d)
The Applicant has amended claim 7 to be dependent of independent claim 1. This amendment is sufficient to overcome the previous rejection.
Rejections under 35 U.S.C. § 102
The Applicant has provided a Statement pursuant to 35 U.S.C. § 102(b)(2)(C) stating common ownership. However, this statement is not sufficient to overcome the previous rejection. Thus, the rejection of claims 1-4, 6-7, and 39 under 35 U.S.C. § 102(a)(1) as being anticipated by Brown et al. (WO 2016/033486) is made.
Response to Arguments
Applicant's arguments filed 12 May 2026 have been fully considered but they are not persuasive.
The Applicant has submitted a Statement of Common Ownership, filed 12 May 2026, to declare common ownership of the instant application and the prior art reference used in the previous 102 rejection, (WO 2016/033486). However, this is insufficient to overcome the previous rejection due to the document having a publication date that is several years earlier than the earliest effective filing date of the instant application. The prior art used in the previous rejection qualifies as art under both 102(a)(2) as well as 102(a)(1) because WIPO publications of a PCT international application that designates the United States is an application for patent deemed published under 35 U.S.C. 122(b). See MPEP 2154.01(a). Also, a U.S. patent document may also be prior art under AIA 35 U.S.C. 102(a)(1) if its issue or publication date is before the effective filing date of the claimed invention. See MPEP 2154.01. On the basis that the international publication date of the WO document is 3 March 2016 and the earliest effective filing date of the instantly claimed invention is 05 April 2022, the WO document serves as prior art and thus the rejection of claims 1-4, 6-7 and 39 is maintained.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-7, and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al. (WO 2016/033486).
Brown teaches a polymorph compound identical to that of the Applicant’s in instant claim 1. Brown teaches the compound,
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132
174
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(Pg. 112-114, Example 4), which is identical to that of the structure of AMG 176,
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163
296
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Additionally, this reference teaches the solid form crystallization of the compound AMG 176 in an identical method of preparation to that of the instantly claimed invention as laid out in the Applicant’s specification in paragraph 125. The method as taught by Brown states that after synthesis of the compound, “After the same scale reaction was repeated four times, all the crude products ( 4 x 49 .1 mmol = 196 mmol) were dissolved in EtOAc, combined, and concentrated under reduced pressure. Then the combined crude product was recrystallized as follows: ethanol (800 mL) was added to the crude product and the resulting slurry solution was shaken while heating the solution for 20 min. H2O (250 mL) was added dropwise for 30 min at rt and the slurry was cooled down to 0°C. After the slurry was kept in an ice bath for 4 h, the solid product was filtered through filter paper. The filter cake was rinsed with ice-cold 30% H2O in EtOH (300 mL) and air dried for 2 days. The product was further dried under high vacuum at 40°C for 4 days to provide the pure target compound (115 g, 188 mmol, 96 % yield) as a white solid.”. The process as defined by the Applicant in the specification recites “AMG 176 (121 g) was dissolved in ethyl acetate. Ethanol (800 mL) was added, and the combination was mixed for 20 min while heating. Water (250 mL) was added dropwise over 30 min. The slurry was allowed to cool to room temperature for 2 h and then further cooled in an ice bath for 4 h prior to filtering. The wet cake was washed with cold 30% ethanol in water (300 mL). The cake was air dried for two days and then further dried under vacuum at 40°C for four days.”. The Examiner acknowledges that Brown does not teach identical 13C NMR peaks, however, as the methods of preparation of the crystalline compound are identical, it would stand to reason that the inherent properties of the product are also identical. "In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990).
Claims 2-4, 6-7 and 39 stand rejected as they are dependent upon the above rejected independent claim.
Conclusion
No claims are allowed.
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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