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 .
Election/Restrictions
Applicant's election with traverse of Group III in the reply filed on 5/29/2025 is acknowledged. The traversal is on the ground(s) that because claims of non-elected Group II have been canceled that examination of Group I and elected Group III together would not present on undue burden on the Examiner. This is not found persuasive because as set forth in the Requirement for Restriction, mailed 4/1/2025, the inventions have a separate status in the art, in view of their different classifications, and different fields of search are required. Each of these individually establish the serious burden if restriction had not been required.
The requirement is still deemed proper and is therefore made FINAL.
Applicant's election with traverse of:
(ii-a) 9,12-benzo-LXA4;
(iii-b) topical application to mucosal tissue of the oral cavity;
(iv) mouth rinse;
(v) the elected compound, under (ii-a), not in combination with a second active agent;
(vi-b) reducing unstable atherosclerotic plaque;
claims 26-29, 32 read thereon in the reply filed on 5/29/2025 is acknowledged. The traversal is on the ground(s) that see above. This is not found persuasive because see above.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/29/2025.
Claims 29-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/29/2025.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 26-28, 32 is/are rejected under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by Smith et al. (WO 2008/058274 A2; 2008; cited in the parent application).
Claim(s) 26-28, 32 is/are rejected under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by Smith et al. (WO 2008/058274 A2; 2008), as evidenced by Camare et al. (“Angiogenesis in the atherosclerotic plaque”; 2017 Aug; Redox Biol.; 12:18-34; doi: 10.1016/j.redox.2017.01.007; cited in the parent application).
Smith teaches use of resolvins for the treatment of angiogenesis (title). A method of treatment of angiogenesis in a subject, comprising administering to the subject an effective amount of a pharmaceutical composition comprising a resolvin (claim 1). The angiogenesis being treated is associated with, inter alia, capillary proliferation in atherosclerotic plaques; this embodiment reads on the claim 26 “subject in need”; i.e., a subject having atherosclerotic plaques associated with capillary proliferation satisfies the subject in need of reducing unstable artherosclerotic plaque. Resolvins administered include the claimed resolvin E1 (RvE1; claim 5). Regarding topical administration, relevant to instant claim 26, suitable means of administration include topical [90]. Regarding the requiring topically to oral tissue of the subject, these compounds may be administered by any suitable route of administrations, which include buccally and sublingually (both of which are topically to mucosal tissue of the oral cavity, an oral tissue) [103]. In Example 2, administration of Resolvin E1 resulted in potent protection against retinopathy in an oxygen-induced retinopathy model mouse model; protection was observed from vaso-obliteration, and less neovascularization was observed, relative to saline controls (Example 2). This observed protective effect is construed to be equivalent to the instant “therapeutically effective amount … to… reduce unstable atherosclerotic plaque”, absent evidence to the contrary.
Regarding the “reducing unstable atherosclerotic plaques”, required by claim 26, as evidenced by Camare, neovascularization in atherosclerotic lesions plays a major role in plaque growth and instability (abstract). Accordingly, the presence of capillary proliferation in atherosclerotic plaques taught by Smith is construed to read on the presence of unstable atherosclerotic plaques.
Regarding the “effective amount” of claim 26, the taught amount effective to treat, inter alia, capillary proliferation in atherosclerotic plaques, is construed to be an equivalent amount to the instant effective amount of claim 26, and equivalent to that required to increase plaque stabilization and/or reducing unstable plaques. The Examiner further notes the instant disclosed “typical effective amount” is a wide range, from “about 0.5 to about 10 grams”, i.e., over a 20-fold range (instant disclosure, 23:10-11). Smith discusses suitable daily dosing at [94], which includes a “more preferable range” from about 0.1 to about 40 mg per kg per day. For a typical 70kg adult, this corresponds to the range 7-2800 mg (0.007-2.8 g), substantially overlapping with the disclosed “effective amount” range; thus, the range taught by Smith is construed as sufficient for anticipation of the recited “effective amounts” (MPEP 2131.03(II)).
For the upper amounts of this range (overlapping with the disclosed range), the recitations of claim 1 (a “therapeutically effective amount … to… reduce unstable atherosclerotic plaques”) is characteristic of the same amount taught as that disclosed in the instant application; i.e., the overlapping amount simply corresponds to the recitation of a desired outcome, positively recited.
MPEP 2111.04 (I) indicates: 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.’" The recitation of the amended outcome of claim 1 and claim 5 is similarly construed as simply expressing the intended result of a process step positively recited, which does not render the claim patentable over Smith.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Thus, a subject with capillary proliferation in atherosclerotic plaques; i.e., “afflicted with” atherosclerosis, falls within the scope of the recited subjects, in need of reducing unstable atherosclerosis plaque.
Regarding claim 27, requiring the Resolvin E1 to be formulated in a pharmaceutically acceptable carrier, mouth sprays and mouthwashes are among forms taught [113], and a pharmaceutically acceptable carrier is taught in [114].
Regarding claim 28, the mouth sprays and mouthwashes are construed to be types of Applicant elected mouth rinses; it is noted that chewing gum is also taught [113].
Regarding claim 32, buccally and sublingually (both of which are topically to mucosal tissue of the oral cavity, an oral tissue) are taught [103]
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614