DETAILED ACTION
Claims 1-4, 6-7, 10, 12, 17, 21-22, 27, 31, 37, and 39-41, submitted 30 June 2023, are pending in the application. Claims 1-4, 6-7, and 39 are under examination in the instant Office Action. Claims 10, 12, 17, 21-22, 27, 31, 37, and 40-41 have been withdrawn.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I and the elected species of the crystalline form of AMG 176, in the reply filed on 10 December 2025 is acknowledged.
Claims 10, 12, 17, 21-22, 27, 31, 37, and 40-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 December 2025.
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.
Claim 7 is rejected 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.
The aforementioned claim expands the temperature range limitation presented in claim 6, of which claim 7 is dependent of. Claim 7 recites wherein the endothermic transition is 236°C ±3°C. However, claim 6 recites the limitation of wherein Form 1 has an endothermic transition at 233°C to 238°C. 35 U.S.C. 112(d) states 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.
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.
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 1-4, 6-7, and 39 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Brown et al. (WO 2016/033486).
The applied reference has a common Assignee (Amgen Inc) and Inventor (Manual Zancanella) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Brown teaches a polymorph compound identical to that of the Applicant’s in instant claim 1. Brown teaches the compound,
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108
143
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(Pg. 112-114, Example 4), which is identical to that of the structure of AMG 176,
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146
274
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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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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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