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 on 06/14/2024 claims the benefit of foreign application PCTEP2023066306 filed 06/16/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/14/2024 has been considered by the examiner.
Claim Objections
Claims 43 and 44 are objected to because of the following informalities:
Claim 43, line 2: Change “said said kidney disease” to “said kidney disease”
Claim 44, line 2: Change “said said kidney disease” to “said kidney disease”
Appropriate correction is required.
Claim Status
Claims Examined: 1-50
Claimed rejected: 1-33, 35-50
Claims objected to: 43 and 44
Claims canceled: 34
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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).
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 1-27, 32-33, 35, 36, 38, and 45-50 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-23, and 25-30 of prior U.S. Patent No. 12312335. This is a statutory double patenting rejection.
Claims 4-10 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-7 of copending Application No. 19/202,127 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 28-31, 39-44 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24 and 27 of U.S. Patent No. 12312335, herein ‘335.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 28 in the instant claims, claim 24 in U.S. Patent ‘335 teaches “Incubating the resulting suspension of step iii and/or step iv for a time period sufficient to form a suspension of Varoglutamstat Hydrochloride crystals”.
Regarding Claim 29 in the instant claims, claim 24 in U.S. Patent ‘335 teaches adding 16 vol. acetone to said suspension while keeping temperature of the suspension at 45+5°C
Regarding Claim 30 in the instant claims, claim 24 in U.S. Patent ‘335 teaches “Cooling of the suspension obtained in step vi to 20±5°C”
Regarding Claim 31 in the instant claims, claim 24 in U.S. Patent ‘335 teaches “Stirring the suspension of step vii”.
Claim 24 in U.S. Patent ‘335 does not teach the time period for step v in instant claim 28, the time period for step v or the temperature, the time period for step vii in instant claim 30, or the time period or temperature for step vii in instant Claim 31.
According to the MPEP, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.).
Regarding Claims 28-31 in the instant claims, it would have been prima facie obvious for one of ordinary skill in the art to optimize the time and temperature ranges required to perform the steps disclosed in Claim 24 of U.S. Patent ‘335 to arrive at the claimed limitations disclosed in instant claims 28-31 because determining the optimal time and temperature for each step of a process does not render the process is routine, and because anyone of ordinary skill in the art would routine experimentation, the claims are rendered obvious.
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Regarding Claims 39-44 in the instant claims, claim 27 in U.S. Patent ‘335 states,
Claim 27 in U.S. Patent ‘335 does not teach the specific embodiments for each kind of disease as is disclosed in instant claims 39-44.
The MPEP teaches “In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Regarding claims 39-44, it would have been obvious for one of ordinary skill in the art to use the embodiments disclosed in Claim 27 of U.S. Patent ‘335, to arrive at the embodiments disclosed in claims 39-44 in the instant claims because having the same method of treatment and disclosing the same disease groups, would render it obvious to further narrow and apply the method to more specific diseases in the larger category without undue experimentation.
Claim 37 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 25 of U.S. Patent No. 12312335 in view of Hanes (Jozef Hanes et al., “Antibody-Based Methods of Detecting and Treating Alzheimer’s Disease”, WO 2019186276 A2, Pub. Date: 10/03/2019).
Claim 25 of U.S. Patent ‘335 teaches “A pharmaceutical composition comprising a therapeutically effective dose of the hydrochloride salt of Varoglutamstat as claimed in claim 14, together with a pharmaceutically acceptable carrier, diluent, or excipient therefor”.
Claim 25 of U.S. Patent ‘335 does not teach the pharmaceutical composition including an additional compound listed in claim 37 of the instant claims.
Hanes teaches a method for treating Alzheimer’s disease that comprises a therapeutic formulation containing PQ912(Varoglutamstat) and additional compounds such as histamine H3 antagonists, PDE4 inhibitors, and NMDA receptor antagonists (Pg. 72, [176] and Pg. 81, [201]).
Hanes also teaches formulations and compositions prepared with pharmaceutically acceptable carriers, diluents, excipients, and stabilizers (Pg. 82, [204]).
Regarding Claim 37, it would have been prima facie obvious for one of ordinary skill in the art to take the method disclosed in Claim 25 of U.S. Patent ‘335 to prepare a pharmaceutical composition comprising the polymorph of Varoglutamstat and acceptable carriers, and combine it with the method disclosed in Hanes because both methods are for pharmaceutical compositions comprising Varoglutamstat and it would be obvious to add an additional compound for added therapeutic benefits.
Claim Rejections - 35 USC § 112
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.
Claim 14 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.
Claim 14 describes a hydrochloride salt of Varoglutamstat consisting of the polymorph of claim 1, and claim 1 discloses a polymorph of Varoglutamstat hydrochloride and lists X-ray diffraction peaks. Claim 14 does not further limit claim 1, because it uses open ended claim language such as “comprising” and it restates the limitations of claim 1.
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.
Conclusion
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/C.M.R./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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