DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. The restriction requirement dated November 4, 2025 is withdrawn.
Status of Claims
3. Claim 1, 3-20 are pending and elected. Claim 1 is independent.
Information Disclosure Statement
4. The information disclosure statements (dated June 27, 2024 and May 7, 2024 and June 1, 2023) were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The statements were considered. Signed copies of form 1449 are enclosed herewith.
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.
5. Claim 59 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 59 provides the following limitation:
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Claim 57, which claim 59 depends from, provides the same structural boundary to variables R6 and R1. Therefore, claim 59 does not further narrow the claim from which it depends. 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
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.
6. Claim 57 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 18 and 23 of U.S. Patent No. 11,332,438.
The claims are drawn to methods of treating a disease in a patient by administration of a compound of Formula
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. The administration of the compound, which is the same as those in the present claims, inherently results in the increasing of creating concentration in the brain. Claims 17, 18 and 23 of the patent anticipate present claim 57.
7. Claims 58-74 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 18 and 23 of U.S. Patent No. 11,332,438. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons provided below.
Determination of Scope and Contents of the Claims of the Patent
The claims are drawn to methods of treating a disease in a patient by administration of a compound of Formula
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. Various embodiments of the generic formula is claimed in the claims of the patent.
Ascertaining the differences between claims of patent and claims at issue
The present claims are directed to methods of increasing creatine concentration in the brain by administration of compounds of the same formula as shown above. Dependent claims of the present application are directed to the methods using different subgenuses of compounds for administration.
Resolving the level of ordinary skill in the pertinent art - Prima Facie Case of
Obviousness
MPEP 2144.08.11.A.4(c) states "...consider teachings of a preferred species within the
genus. If such a species is structurally similar to that claimed, its disclosure may
motivate on of ordinary skill in the art to choose the claimed species or subgenus from
the genus, based on the reasonable expectation that structurally similar species usually
have similar properties." This is a "Genus-Species Guidelines” for the examination
based on 35 USC 103. An analogous guideline was followed here for the analysis of
obviousness type double patenting. The claims of the patent suggest the administration of the various genuses in present claims 58-74. These subgenuses are within the scope of the broad patent claim. For this reason, the skilled artisan has the teaching, suggestion, and motivation to practice present claims 58-74. The present claims are prima facie obvious over the claims of the patent.
8. Claims 57-74 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,753,369.
The claims are drawn to methods of treating creatine deficiency in a patient by administration of a compound of Formula
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. The administration of the compound, which is the same as in the present claims, inherently results in the increasing of creating concentration in the brain. As such, the claims of the patent anticipate the present claims. Claim 1 of the reference patent anticipates claim 57 of the present application. Claims 2-20 of the reference patent anticipate claims 58-74 of the present application.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621