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
The present Application, filed February 22, 2023, is a national stage entry under 35 U.S.C. § 371 of International Patent Application No. PCT/IB2021/057741, which claims priority to Japanese Patent Application No. JP2020-140877, filed August 8, 2020.
Status of the Claims
In the amendment filed October 14, 2025, claims 14-15 are canceled and claims 1 and 7 are amended. Claims 12-13 were previously canceled. Claims 1-11 and 16-22 are currently pending.
Previous Rejections and/or Objections
Any objections and/or rejections raised in the previous Office Action but not reiterated below are considered to have been withdrawn.
Response to Amendments and Arguments
The amendments to claim 1 obviate the objection to claim 1 and overcome the reasons for rejection under 35 U.S.C. s 112(a).
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on September 5, 2023, April 18, 2024, April 30, 2024, August 15, 2024, august 30, 2024, September 12, 2024, October 17, 2024, January 10, 2025, and February 13, 2025 are acknowledged.
Claim Rejections - 35 USC § 112 – Maintained in Part
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 6-7 are indefinite:
Claims 4 and 6-7 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to the rejections of claims 4 and 6-7 for indefiniteness for improperly reciting drawings from the specification, Applicant asserts that there is no practical way to define the invention of the rejected claims in words and that the USPTO’s own guidance supports the idea that recitation of XRD patterns in claims as suitable for § 112 purposes (paragraph spanning the bottom of pg. 6 to the top of pg. 7 of Applicant’s Remarks of October 14, 2025). These arguments have been fully considered, but are not found persuasive.
Regarding the assertion that there is no practical way to define the invention short of direct reference to the XRD pattern, as noted in the previous Office Action and reiterated below, this can be accomplished by reciting peak locations (and peak widths, if desired). Regarding the assertion that USPTO guidance supports the propriety of reciting figures in the claims for XRD data, Applicant references a presentation that appears to have been delivered at a conference in 2009. It is noted, however, that the presentation in question deals with issues relating to 35 U.S.C. § 112(a), not § 112(b); and furthermore, the cited presentation does not represent official USPTO guidance.
The rejections, as pertaining to claims 4 and 6-7, are maintained.
Reiterated rejections:
Claim 4 is indefinite for reciting “which has an x-ray powder diffraction spectrum substantially as shown in Figure 1,” because this recitation improperly references drawings from the specification. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 Bd. Pat. App. & Inter. (1993). In the instant case, there is no apparent impracticality to defining the invention in words, such as by describing the positions, in degrees, of the desired XRD peaks. As such, the reference to Figure 1 is unnecessary and improper. Claims 6 and 7 are similarly indefinite for referencing Fig. 2 and Fig. 3, respectively. In the case of claim 6, it is feasible to quantitatively recite a temperature location of any calorimetric transition, as is done in claim 5. In the case of claim 7, it is feasible to quantitatively recite the location of as many of the approximate forty DVS data points as desired.
Double Patenting – Rejections Reiterated
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.
The following rejections are reiterated because Applicant did not address them in the response of October 14, 2025.
Claims 1-11 and 16-22 are rejected for nonstatutory double patenting over the ’345 patent and Nichols:
Claims 1-11 and 16-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,037,345 to Shimamura et al. (hereinafter, “the ’345 patent”), in view of International Patent Application Publication No. WO2020/076723 to Nichols et al. (hereinafter, “Nichols”). Although the claims at issue are not identical, they are not patentably distinct from each other because the compositions and methods recited in the 345 overlap with and encompass the compositions and methods of the instant claims.
As noted above, instant claim 1 recites a crystal of 2-((1R,2R,4S)-2-amino-7-azabicyclo[2.2.1]heptan-7-yl)-5-(3,4-dichloro-2-methyl-2H-indazol-5-yl)-3-methyl-3,7-dihydro-4H-pyrrolo[2,3-d]pyrimidin-4-one
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while dependent claims recite various compositions containing the crystal and methods of making or using the crystal.
Claim 1 of the ’345 patent recites a compound of formula (I)
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which encompasses the compound of the crystal of instant claim 1. Claim 10 of the ’345 patent recites several dozen species of this formula, including the exact compound of the crystal of instant claim 1. Instant claim 1 thus recites a crystal of the same compound claimed in the ’345 patent. Instant dependent claims 2-7, reciting characteristic features of this crystal are likewise within the scope of the compounds claimed in the ’345 patent. Claim 11 of the ’345 patent recites a pharmaceutical composition of the compound in combination with a pharmaceutically acceptable carrier, overlapping with the composition of instant claim 10. Claims 12-17 of the ’345 patent recite various methods for treating diseases, involving administering a compound claimed in the ’345 patent. These claims overlap and encompass instant method of treatment claims 16-22
With respect to instant claims 8-9 and 11, which recite, inter alia, a pharmaceutical combination having the crystal of instant claim 1 in combination with one more therapeutic agents, i.e. an anti-cancer agent, this feature is not recited in the claims of the ’345 patent, but it was well-known in the art to combine SHP2 inhibitors with anti-cancer agents. For example, Nichols teaches combining SHP2 inhibitors with other chemotherapeutic anti-cancer agents to treat cancer (paragraph [0010]). Instant claims 8-9 and 11 are thus obvious over the claims of the ’345 patent, in view of Nichols.
Claims 1-11 and 16-22 are provisionally rejected for nonstatutory double patenting over the ’335 application and Nichols:
Claims 1-11 and 16-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49-64 of copending Application No. 17/759,335 to Hoshino et al. (hereinafter, “the ’335 application”), in view of Nichols. The ’335 application corresponds to U.S. Patent Application Publication No. 2023/0146795, which is cited in the form 892 attached to this Action. Although the claims at issue are not identical, they are not patentably distinct from each other because the compositions and methods recited in the ’335 application overlap with and encompass the compositions and methods of the instant claims.
Claim 49 of the ’335 application recites a combination comprising a compound of formula (I)
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,
which encompasses the compound of the crystal of instant claim 1, and at least one additional compound having an antitumor effect. Claim 50 of the ’335 application recites that the compound of formula (I) is one of several species, including the exact compound of the crystal of instant claim 1. Instant claim 1 thus recites a crystal of the same compound claimed in the ’335 application. Instant dependent claims 2-7, reciting characteristic features of this crystal are likewise within the scope of the compounds claimed in the 345. Claim 11 of the ’335 application recites a pharmaceutical composition of the compound in combination with a pharmaceutically acceptable carrier, overlapping with the composition of instant claim 10. Instant claims 8-9 and 11 recite a combination of the same type recited in claims 49-54 of the ’335 application. Claims 57-64 of the ’335 application recite various methods for treating diseases, involving administering a compound claimed in the ’335 application. These claims overlap and encompass instant method of treatment claims 16-22.
Instant claims 10-11 require, inter alia, that the crystal of claim 1 be combined with an excipient to produce a pharmaceutical composition. While this feature is not present in the claims of the ’335 application, such inclusion of an excipient with an SHP2 inhibitor to make a pharmaceutical composition was well-known in the art. For example, Nichols teaches combining an SHP2 inhibitor with a pharmaceutically acceptable excipient (e.g. paragraph [0134]) to produce a pharmaceutical composition. Claims 10-11 are thus obvious over the claims of the ’335 application, in view of Nichols.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 ALEXANDER K SHOWALTER whose telephone number is (571)270-0610. The examiner can normally be reached M-F 9:00 am to 5:00 pm, eastern time.
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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629