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, filed 16 May, 2024, is a national stage application of PCT/EP2022/082192, filed 17 November, 2022, which claims foreign benefit of application EP21209197.9, filed 19 November, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 May, 2026 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 12 May, 2026, in the matter of Application N° 18/665,776. Said documents have been entered on the record.
Claims 15-17 are new. No new matter was introduced.
Thus, Claims 1-17 represent all claims currently under consideration.
Claim Objections
Claims 2, 4, and 13-14 are objected to because of the following informalities: the claims do not end with a period as required by §608.01(m). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2 and 4 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.
Claim 2 recites that Form A is “…characteristic peaks expressed in values of degrees 2-theta at approximately (±20 degree 2-theta)” and claim 4 recites the same limitation with respect to Form B. This language is indefinite for the following reason:
Claim 2 and 4 recites, the compound of claim 1, the use of parenthesis in the claim renders the claim indefinite because it is unclear whether the recitation within the parenthesis are definitions or preferred embodiments. For example, it is unclear ±20 degree 2-theta is meant to be the tolerance on the peak location or if it is merely a suggestion (e.g., “preferably”) since it shows up in parentheses. As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, given the uncertainty around the terms within the parenthesis claims 2 and 4 is rejected under 35 U.S.C. 112(b).
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.
Claims 3 and 5 are 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.
Claims 2 is directed to crystalline Form A of the compound of formula I and claim 4 is directed to the crystalline Form B of the compound of formula I.
Claim 3 recites crystalline Form A, according to claim 2 characterized by the XRPD shown in figure 1. Claim 5 is similar and recites the crystalline Form B, according to claim 4 as characterized in Figure 4. However, claims 2 and 3 specify the crystal is of Form A or B respectively. Form A is Form A (and Form B is Form B) – further specifying characteristics fails to further limit. As soon as the claim calls for Form X – that is as specific as the claim form can get. The examiner suggests making claims 3 and 5 depend from a more generic claim, like claim 1. Or amending claims 2 and 4 to be a crystalline form characterized by the 2-theta peaks (omit the Form A/B from these claims). The most specific dependent claim should be directed to a crystalline form which is Form A/B.
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 § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Runtz- Schmitt et al. (US 10,479,796 B2, published 19 November, 2019, cited in IDS), hereinafter Runtz, and further in view of Elder et al. (International Journal of Pharmaceutics 2013; 88-100), hereinafter Elder.
Runtz teaches the compound for Formula I, as presently claimed, including the specific compound 2'-(7,7-dimethyl-1'H,7H-spiro[furo[3,4-b]pyridine-5,4'-piperidin]-1'-yl)-1,3-dihydro-4'H-spiro[indene-2,5'-[1,3]oxazol]-4'-one (‘796, Col 10, Lines 10-12, Col 16, Lines 12-16), and processes for preparing the compound (‘796, Col 16-20). Runtz further teaches pharmaceutical compositions and medicaments comprising the compound (‘796, Abstract), and recognizes that crystalline products or crystalline intermediates may be characterized by X-Ray crystallography (Col 17, Lines 52-60). Runtz, however, does not expressly disclose a crystalline form of the compound of Formula I as presently claimed.
Elder teaches the importance of solid-form selection and characterization in pharmaceutical development. Elder explains that traditional pharmaceutical solid-state forms include polymorphs and salts (2013, Pg. 89, Col 1, Para 3) and discuss high throughput crystallization screening of candidate molecules, including polymorphs/solvates, in which crystallization conditions such as solvent composition, temperature, anti-solvent addition, evaporation rate/time, and slurry conversion are varied to generate and evaluate different solid forms. Elder further explains that understanding processing conditions leading to different forms, including polymorphs and solvates, provides useful information for developing scalable processes for later-stage development (2013, Pg. 92, Col 1).
Elder additionally teaches that pharmaceutical compounds may exist in multiple solid forms and that polymorphic form can affect thermodynamic stability and pharmaceutical properties (2013, Pg. 94, Col 1). Elder further summarizes that selection of an appropriate solid form is important to pharmaceutical processing and to obtaining a product having suitable solubility and physicochemical properties, and identify crystallinity, hygroscopicity, physical form, and stability as relevant attributes in solid-form optimization (2013, Pg. 98, Conclusion). Thus, although Elder principally discusses salt and cocrystal selection, Elder expressly places such selection within the broader practice of pharmaceutical solid-form development and recognizes polymorphic crystalline forms and their characterization as relevant to that process.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to prepare and evaluate the known pharmaceutical compound of Formula I taught by Runtz in crystalline form as part of conventional pharmaceutical solid-form development. One of ordinary skill in the art would have been motivated to do so in view of Elder’s teaching that solid-form selection and characterization permit evaluation of forms having properties relevant to pharmaceutical processing and performance, including solubility/dissolution, stability, and other physicochemical properties. Such investigation would have involved conventional crystallization and solid-form characterization techniques, as taught by Elder, to obtain and evaluate a crystalline form of the known compound.
One of ordinary skill in the art would have had a reasonable expectation of success in obtaining a crystalline form because Runtz recognizes crystalline products or crystalline intermediates and its characterization by X-ray crystallography (‘796, Col 17, Lines 56-61), while Elder teaches conventional crystallization techniques for obtaining and evaluating crystalline pharmaceutical solid forms (2013, Pg. 92, Col 1). The claimed invention does not require a particular polymorphic form, XRPD pattern, degree of crystallinity, or improvement in a pharmaceutical property, but merely a crystalline form of the known compound of Formula I. Accordingly, the combined teachings of Runtz and Elder renders obvious the subject matter of Claim 1.
Regarding Claim 15, Runtz further teaches a medicament comprising the compound of Formula I (‘796, Col 17, Lines 12-15). In view of the reasons discussed above, it would have been obvious to employ the crystalline form of the compound in the medicament taught by Runtz, thereby arriving at the medicament comprising a crystalline form according to instant Claim 1.
Double Patenting
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.
Claims 1 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1 and 12-13 of U.S. Patent No. 10,479,796 B2 in view of Elder (International Journal of Pharmaceutics 2013; 88-100).
‘796 recites the identical compound of Formula I presently claimed, both by structure (claim 1) and by chemical name (claim 12). ‘796 further recites a pharmaceutical composition comprising the compound (claim 13), corresponding to the medicament of instant claim 15. ‘796 does not, however, expressly require the compound to be in crystalline form.
Elder teaches that solid-form selection and characterization are important aspects of pharmaceutical development and recognizes polymorphs as conventional pharmaceutical solid-state forms. Elder further teaches crystallization screening of pharmaceutical compounds, including polymorphs/solvates, by varying crystallization conditions to generate and evaluate different solid forms, and explains that selection of an appropriate soli form is important to pharmaceutical processing and to obtaining suitable physicochemical properties, including solubility and stability.
It would have been prima facie obvious to one of ordinary skill in the art to prepare and evaluate the known compound of ‘796 in crystalline form as part of conventional pharmaceutical solid-form development, with motivation to identify a solid form having properties suitable for pharmaceutical processing and performance. Accordingly, the crystalline form of the compound recited in instant claim 1, and the medicament comprising that crystalline form recited in instant claim 15, would have been obvious over the claims of ‘796 in view of Elder.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Claims 2-5 and 16-17 contain allowable subject matter over the prior art of record. Runtz (U.S. 10,479,796 B2) considered the closest prior art, discloses the compound of Formula I presently claimed, but does not teach or suggest the specific crystalline Forms A and B having the respective XRPD characteristics recited in Claims 2-5. Claims 16-17, by virtue of their dependence from Claims 2 and 4, respectively, likewise contain allowable subject matter over the prior art of record. Claims 2-5 and 16-17, however, are not presently in condition for allowance because they ultimately depend from rejected Claim 1 and are subject to the outstanding rejections under 35 U.S.C. 112(b), as applicable. These claims would be allowable if rewritten to overcome the outstanding rejections and to include all of the limitations of the base claim and any intervening claims.
Claims 6-14 are allowable over the prior art of record. Although Runtz discloses the compound of Formula I and processes for its preparation, Runtz employs a different synthetic route, including thermal condensation of a secondary spiropiperidine with a 2-amino-oxazol-4-one. In contrast, Claims 6-14 recite a particular multistep synthetic route to the compound of Formula I through specifically defined intermediates, including the preparation and sequential conversion of the pyridyl and spiropiperidine intermediates recited therein. Runtz does not teach or suggest this claimed sequence of intermediates and transformations.
Accordingly, the prior art of record, considered individually and in combination, does not teach or render obvious the specific XRPD-defined crystalline forms recited in claims 2-5 and relied upon by claims 16-17, or the particular synthetic route to the compound of Formula I recited in claims 6-14.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.N./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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