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 .
Claims 1-18 are currently pending. Claim 1 is independent.
Priority
The instant application claims priority as follows:
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Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 16/525,319, 15/579,705, PCT/IB2016/001181 and Application No. 62/195,486, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Crystal forms “substantially” characterized by an X-ray diffraction pattern as claimed in the claims lack support in said prior-file applications. The effective filing date of this application is the filing date of 17/222,611, which is April 5, 2021.
Election/Restriction
Applicants’ election without traverse of Group I, claims 1-9, drawn to a crystal form of ANAVEX2-73 made by a process, in the reply filed December 16, 2025 is acknowledged.
Accordingly, claims 10-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 16, 2025.
Claims 1-9 are the subject of this Office Action.
Specification Objection
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The claimed subject matter that does not find proper antecedent basis in the specification is “substantially characterized by X-ray diffraction pattern …”. This phrase is absent from the specification as well as a description of what the term “substantially” encompasses.
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 1-9 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.
In the claims, the term “substantially characterized by” is a relative term which renders the claims indefinite because one of ordinary skill would not be able to determine what the critical (characteristic) peaks are. The term “substantially” is not defined in the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill could not ascertain and interpret the metes and bounds of the patent protection desired as to this term. Terms of degree, such as “substantial” or “relatively” are indefinite when the specification contains no “explicit guidelines” to distinguish from things which are not so, Ex parte Oetiker, 23 USPQ2d 1651, 1655 (1990) and Ex parte Oetiker, 23 USPQ2d 1641; Seattle Box Co. v. Industrial Crating & Packaging, Inc. 221 USPQ 568, 574 and York Prods. Inc. v. Central Tractor Farm & Family Ctr., 40 USPQ2d 1619. See Exxon Research and Engineering Co. v. United States, 54 USPQ2d 1519 for “substantially” and “substantial”. Note MPEP 2173.05(b).
Claim 5 claims a crystal form characterized by an X-ray pattern diffraction of Fig. 1, Fig. 4 or Fig. 8, further characterized by the FTIR spectrum of Fig. 5 or Fig. 9. This is ambiguous because the FTIR in Fig. 5 and Fig. 9 are different and belong to different crystal structures, and they cannot belong similarly to any or either crystalline form in Fig. 1, Fig. 4 or Fig 8.
Claim 6 claims a crystal form characterized by an X-ray pattern diffraction of Fig. 1, Fig. 4 or Fig. 8, further characterized by the particle shapes of Fig. 2, Fig. 3, Fig. 7 or Fig 11. This is ambiguous because the particle shapes in Fig. 2, Fig. 3, Fig. 7 and Fig 11 belong to different crystal structures, and they cannot belong similarly to any or either crystalline form of Fig. 1, Fig. 4 or Fig 8.
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.
Claim(s) 1-9 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by U.S. Patent No. 10,413,519 (published on Sept. 17, 2019).
This rejection is proper since the effective filing date of this application is the filing date of 17/222,611, which is April 5, 2021.
The crystalline forms recited in the instant claims are the same exact crystalline forms Form I of PXRD of Fig. 1, Form II of PXRD of Fig. 4 and Form III of PXRD of Fig. 8 in the patent. All the limitations of the instant claims are found in U.S. Patent No. 10,413,519, thus, the claims are anticipated.
MPEP 2113: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)
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 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10, 12-13 and 16 of U.S. Patent No. 10,413,519. Although the claims at issue are not identical, they are not patentably distinct from each other because the crystalline forms recited in the claims of the patent are the same exact crystalline forms claimed in the instant claims.
MPEP 2113: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)
The crystalline forms of the patented claims have the same characteristics (X-ray pattern, FTIR, morphology) as the claimed crystalline forms and were made by the same process as the claimed crystalline forms.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,661,405. Although the claims at issue are not identical, they are not patentably distinct from each other because there is no patentable distinction between the products as claimed in the instant claims, and the method of making the products, as claimed in the patented claims. See Mosler Sage & Lock Co. V. Mosler, Bahmann & Co., 127 U.S. 354, 218 S.Ct. 1148 (1888) [The first patent was of an article; the second patent, held invalid, was for a method of making it]. The claims of the patent disclose the same process of making crystal Form I, II and III and the instant claims claim the same crystal Form I, II and III made by the patented process.
Statutory DP –This rejection is made in anticipation of the removal of “substantially” from “substantially characterized by …”.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-4 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 10,413,519. The rejected claims cover the same exact subject matter already patented, that is, Form I of PXRD of Fig. 1, Form II of PXRD of Fig. 4 and Form III of PXRD of Fig. 8. This is a statutory double patenting rejection.
Conclusion
Claims 1-9 are rejected. No claim is allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621