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 .
Continued Examination Under 37 CFR 1.114
Claims 16-35 filed 2024 March 6 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2024 March 6 was submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: In the “Cross-Reference to Related Applications” section, the issued status of parent application 17 / 130564 should be noted.
The example of the change is shown below:
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation application of U.S. Patent Application No. 17/130,564 filed on December 22, 2020, which is a divisional application of 16/338,930 filed on April 2, 2019 and issued as U.S. Patent No. 11,008,342 on May 18, 2021, which is a National Stage Application under 35 U.S.C. 371 of International Application No. PCT/EP2017/075373 filed on October 5, 2017, which claims priority to European Patent Application No. EP 16192494.9 filed on October 5, 2016, the entirety of each of which is incorporated herein by reference.
to
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CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation application of U.S. Patent Application No. 17/130,564 filed on December 22, 2020, issued as US 11866449 on January 9, 2024, which is a divisional application of 16/338,930 filed on April 2, 2019 and issued as U.S. Patent No. 11,008,342 on May 18, 2021, which is a National Stage Application under 35 U.S.C. 371 of International Application No. PCT/EP2017/075373 filed on October 5, 2017, which claims priority to European Patent Application No. EP 16192494.9 filed on October 5, 2016, the entirety of each of which is incorporated herein by reference.
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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.
Claim 26, 27, 31, and 32 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 claims 26 and 27, the peaks that are not present have unclear metes and bounds due to the definition (specification, page 11, to page 12, first paragraph. The term “substantially” is defined as ±>10%.
The table below shows the range values for the peaks in claim 27.
Claim 26 2Θ Peak
“Substantially” Range ±>10%
10.8
0-9.72 2Θ and 11.88-21.6 2Θ
11.9
0-10.71 2Θ and 13.09-23.8 2Θ
These ranges exclude each of the required peaks in parent claim 20.
The table below shows the range values for the peaks in claim 27.
Claim 27 2Θ Peak
“Substantially” Range ±>10%
17.9 ± 0.2Θ
0-16.11 ± 0.2Θ and 19.69-35.8 ± 0.2Θ
24.9 ± 0.2Θ
0-22.41 ± 0.2Θ and 27.39-49.8 ± 0.2Θ
29.3 ± 0.2Θ
0-26.37 ± 0.2Θ and 32.23-58.6 ± 0.2Θ
30.8 ± 0.2Θ
0-27.72 ± 0.2Θ and 33.88-61.6 ± 0.2Θ
These ranges exclude the required peaks in claim 20.
Due the broad ranges that are encompassed by the definition of the term “substantially”, the excluded peaks that are not present are unclear.
In claim 31, what is the property of the crystalline polymorph of (S)-2-ethyl-8-methyl-1-thia- 4,8-diazaspiro[4.5]decan-3-one monohydrate when the relative humidity is 7.0%<x<8.0% in which variable x is the relative humidity percentage? Does it dehydrate or does it not substantially adsorb water?
Claim 32 is dependent on claim 1, which is cancelled. Consequently the process of claim 1 has unclear metes and bounds and the product of claim 32 has unclear metes and bounds.
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 26 and 27 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.
In claims 26 and 27, the peaks that are not present have unclear metes and bounds due to the definition (specification, page 11, to page 12, first paragraph. The term “substantially” is defined as ±>10%.
The table below shows the range values for the peaks in claim 27.
Claim 26 2Θ Peak
“Substantially” Range ±>10%
10.8
0-9.72 2Θ and 11.88-21.6 2Θ
11.9
0-10.71 2Θ and 13.09-23.8 2Θ
These ranges exclude each of the required peaks in parent claim 20.
The table below shows the range values for the peaks in claim 27.
Claim 27 2Θ Peak
“Substantially” Range ±>10%
17.9 ± 0.2Θ
0-16.11 ± 0.2Θ and 19.69-35.8 ± 0.2Θ
24.9 ± 0.2Θ
0-22.41 ± 0.2Θ and 27.39-49.8 ± 0.2Θ
29.3 ± 0.2Θ
0-26.37 ± 0.2Θ and 32.23-58.6 ± 0.2Θ
30.8 ± 0.2Θ
0-27.72 ± 0.2Θ and 33.88-61.6 ± 0.2Θ
These ranges exclude the required peaks in claim 20.
Based on this analysis, claims 26 and 27 are not further limiting of parent claim 26 because the definition of the term “substantially” excludes the required peaks in claim 20.
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.
Double Patenting
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).
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 32-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 12 of U.S. Patent No. 11008342. Although the claims at issue are not identical, they are not patentably distinct from each other because the monohydrate of the same compound and a pharmaceutical composition comprising the same are recited in examined claims 32-35. Monohydrate form III and I of US 11800342 share common XRPD 2-theta values 12.3, 17.3 and 17.5 Claims 1-5 do not recite water content limits and the type of hydrate. Therefore monohydrate form I or III can have either property recited in examined claims 33 and 34.
Claims 35 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 11 of U.S. Patent No. 11866449. Although the claims at issue are not identical, they are not patentably distinct from each other because an oral capsule containing a monohydrate of the same compound of examined claim 35. Monohydrate form III of US 11866449 shares common XRPD 2-theta values 12.3, 17.3 and 17.5. Even though claim 10 does not explicitly state that form III is a monohydrate, form III is a monohydrate (column 10, lines 10-35).
Allowable Subject Matter
Claims 16-25 and 28-30 are allowed. Claims 26, 27, 31-35 are not allowable.
The following is a statement of reasons for the indication of allowable subject matter: BURNS (WO 2010/051497, published 2010 May 6) describes compound C0119M (page 45). This compound does not anticipate or render obvious due to at least three differences: NH (prior art) versus N-Me (examined claim 16); N-S(O)2-phenyl-p--[C(O)-Me] versus S; CH(methylene-imidazole) versus CH(ethyl); and compound C0119M is not a hydrate.
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Compound of Prior Art
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132
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Compound of Examined Claim 16
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699