DETAILED ACTION
Claims 1-7 and 9-11 are currently pending in the instant application.
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 .
Response to Amendment
Applicant’s response filed 12/17/2025 has overcome the prior rejections of record.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to claims 1-7 and 10-11, with election of species of a compound of Formula III
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in the reply filed on 04/25/2025 is acknowledged.
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/25/2025.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Applicant's elected species appears allowable over the prior art of record. Therefore, the search of the Markush-type claim has been extended to the non-elected species of
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,
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or
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and
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.
As prior art has been found which anticipates the above identified nonelected species, the Markush-type claims are rejected as follows and the subject matter of the claims drawn to nonelected species held withdrawn from consideration. Claims 1-7 and 10-11 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since art was found on the nonelected species, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
The remaining subject matter of claims 1-7 and 10-11 that are not drawn to the above elected invention stand withdrawn under 37 CFR 1.142(b) as being non-elected subject matter. The remaining compounds which are not within the elected invention are independent and distinct from the elected invention as they differ in structure and composition. Therefore the compounds, which are withdrawn, have been restricted as the withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference, which anticipates one group, would not render obvious the other. Thus all claims containing compounds falling outside the search strategy of the elected compound and structure shown above are heretofore directed to non-elected subject matter and are withdrawn from consideration under 35 U.S.C. § 121 and 37 C.FR. § 1.142(b).
Claim Objections
Claim 1 is objected to because of the following informalities: Under the proviso, it states that R1 is not
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. However the definition of n has been included in the proviso. Appropriate correction is required.
New 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.
Claims 1, 3, 6-7 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CA Reg No. 1715755-67-1, entered into STN on 05/29/2015. CA Reg No. 1715755-67-1 corresponds to structure
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which is a compound of claim 6. In regards to claim 7, according to MPEP 2111.02, Section II, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”).
In re Tuominen (213 USPQ 89) states the following:
The composition is the same no matter what its intended use is, and consequently, the appealed claims are not seen to distinguish over the art which also discloses a composition of the recited active ingredient. We will not construe the instant claims to be limited to compositions also containing other ingredients usually utilized in sunscreening compositions merely by the fact that the introductory clause of the claims recites a different contemplated utility for the claimed composition not taught by the art. Rather, as done by the Examiner, we interpret the claims to be drawn to a composition of the active ingredients, per se, and, as such, under the rationale of Pearson, they fail to distinguish over the references.
The compound of CA Reg No. 1715755-67-1 corresponds to the same compound described in claim 7, and since the preamble of claim 7 merely recites the intended use of the compound, CA Reg No. 1715755-67-1 anticipates claim 7.
Regarding the composition of claim 10, which comprises the anticipatory compound and an excipient, the Registry entry for Registry no. 1715755-67-1 discloses a mass solubility of 0.065 g/L, in unbuffered water at pH 3.90. This teaching of water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
New 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.
Claims 1, 4-7 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wanaksi (see WIPO Pub No. WO 2010/085352, pub. 01/22/2010). Wanaksi teaches compounds of formula
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(see p. 362) with compounds including
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or
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exemplified for methods of treating conditions such as addictive disorders, Alzheimer’s, etc. Said compounds are taught in compositions (see claim 177( The exemplified compounds correspond to compound of Formula II wherein R2 is C(=O)-OH rather than C(=O)-OCH3. However since R20 is taught to be hydrogen or alkyl, it would be obvious to arrive at compound of Formula II wherein C(=O)-OCH3 especially since such compound is exemplified. Further the compound having R2 as C(=O)-OCH3 also corresponds to a compound of Formula II except that it has a tertiary rather than secondary amine group. The interchange of alkyl and hydrogen is obvious in and of itself. Secondary and tertiary amines are interchangeable. See Ex parte Bluestone, 135 USPQ 199.
Wanaksi also exemplifies compounds such as
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(see p. 363) which corresponds to a compound of Formula I wherein R1 is NH-CH2-phenyl rather than having R1 as
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. However, the compounds of Wanaksi corresponds to the compounds of the instant application except Wanaksi exemplifies a secondary rather than a tertiary amine group. However, the interchange of alkyl and hydrogen is obvious in and of itself. Secondary and tertiary amines are interchangeable. See Ex parte Bluestone, 135 USPQ 199. Further the compound of Wanaksi has a CH2-phenyl rather than CH(CH3)-phenyl and compounds that differ only by the replacement of a methyl for a hydrogen atom would be obvious. As stated in re Wood, 199 USPQ 137, hydrogen and methyl are deemed obvious variants, and substitution of a methyl for the hydrogen (i.e. substitution of CH3 for H) in the compound of Wanaksi would give rise to the compounds of the instant claims.
One would be motivated to synthesize said compounds in order to discover other compounds that function in treatment and/or prophylaxis of conditions that involve the Na+K+Cl- co-transporter or GABAA receptor including but not limited to addictive disorders, Alzheimer's Disease, etc. The motivation to make the claimed compound derives from the expectation that structurally similar compounds are generally expected to have similar properties and similar utilities. Further, there is close structural similarity of the instantly claimed compounds to the prior art compounds and the common utility shared among the compounds. There is an expectation among those of ordinary skill in the art that similar structural compounds will have similar properties and that modification of a known structure is mere experimentation within the means of a skilled artisan. See MPEP 2144.09(I). Additionally, regarding claim 11, tt is obvious to combine two compositions taught by the prior art to be useful for the same purpose to form a third composition that is to be used for the very same purpose, See In re Kerkoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Please note the above rejections made over Wanaksi are for exemplary compounds and there may be further compounds in Wanaksi that read on the claims.
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623