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 .
Status of Claims and Response to Amendments
The amendments filed December 19, 2025 have been acknowledged and entered. Claims 1-3, 6-10, 13-17, 22, 24, 29, 32, 34-42, 45, 47-49, 51-54, 57-61, 66 and 71-72 are pending.
Election/Restriction
The present examination is based on Applicant’s election without traverse of Group I (claims 1-3, 6-9 and 72) in the reply filed on August 11, 2025. Applicant has not overcome all previously set forth art rejections. Claims 10, 13-17, 22, 24, 29, 32, 34-42, 45, 47-49, 51-54, 57-61, 66 and 71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Maintained Rejections
Claim Rejections - 35 USC § 102 / 103
Claim(s) 1-3, 6-9 and 72 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by Eary et al (US 11,098,064 B2) or, in the alternative, claims 1-3, 6-9 and 72 are rejected under 35 U.S.C. 103 as obvious over Eary et al (US 11,098,064 B2) (hereinafter “Eary”).
The applied reference has a common assignee 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 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); 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 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. See generally MPEP § 717.02.
The reasons for this rejection were set forth in the previous Office Action mailed September 25, 2025 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed December 19, 2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the reference fails to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the pending claims are directed to selpercatinib Form B, see page 9 of remarks, rejection based on 35 USC § 102 ) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In the present case, the claims require no particular crystalline form of selpercatinib. The reference does not recite any particular crystalline form of selpercatinib; however, the reference teaches the crystalline form was obtained under similar conditions to those described in the specification (see page 5 of rejection). Applicant seems to be arguing that small differences in the methods of crystallization resulted in different forms prepared (see page 9 of remarks: “Small differences can and often do make a significant change in the final form that is prepared. Such is the case here…”); however, given the similarity in the methods (noted on page 5 of the rejection) one skilled in the art would expect that the reference conditions may result in the claimed crystalline form. There is no evidence in the record to show that the reference does not include the crystalline form of the claims.
As noted in the rejection :
It is well settled that the PTO can require an applicant to establish that a prior art product does not necessarily possess the characteristics of the claimed product when the prior art and claimed products are identical or substantially identical. An applicant's burden under these circumstances was described in In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-434 (CCPA 1977) as follows:
Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product...Whether the rejection is based on 'inherency' under 35 U.S.C. § 102, or 'prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products (footnote omitted).
“[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102. on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)). See MPEP 2112.
Overcoming the rejection is very straightforward. One simply replicates the prior art procedure. If the XRPD data are different at all in that product, compared to the instant invention, then the rejection is overcome (see page 7 of the previous Office Action).
Claim(s) 1-3, 6-9 and 72 is/are rejected under 35 U.S.C. 103 as obvious over Metcalf et al. (US 10,584,124 B2).
The reasons for this rejection were set forth in the previous Office Action mailed September 25, 2025 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed December 19, 2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the reference fails to show certain features of the invention (e.g. page 13 of remarks, nothing in Metcalf suggest the claimed Form B exists), it is noted that the features upon which applicant relies (i.e., Form B) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant’s arguments are not persuasive because they are directed toward subject matter which is not claimed.
As per unexpected results, MPEP 716.01(c) states arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. Applicant is thus encouraged to submit any evidence of unexpected results in the appropriate declaration or affidavit.
Conclusion
No claim is allowed.
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.
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February 9, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624