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 .
Status of Claims
The preliminary amendment filed on 1 August 2024 has been received and examined.
Claims 1-9 are pending. Claims 3, 4, and 6 have been amended.
Priority
This application claims the benefit of US Provisional Application No. 63/472,994. The claim for benefit is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 29 August 2024 has been received and is acknowledged.
Claim Rejections - 35 USC § 112(b)- Indefinite
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.
Claims 4-7 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.
Claim 4 recites: "The method according to Claim 1, wherein the uterine fibroid…" There is insufficient antecedent basis for this limitation in the claim because claim 1 only introduces the broader limitation “fibroid.” For example, claim 3 is a proper dependent claim as it further limits “fibroid” to “uterine fibroid.” Claim 5 depends on claim 4 and is rejected because of its dependency. Appropriate correction to claim 4 is requested.
Claim 6 recites: “The method according to Claim 1, wherein the subject is a mammal.” There is insufficient antecedent basis for this limitation in the claim because claim 1 does not introduce the term “subject” only the term “patient.” Appropriate correction is requested.
Claim Rejections - 35 USC § 102
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, 3-4, 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malik et al. 2009 (Curcumin, a nutritional supplement with antineoplastic activity, enhances leiomyoma cell apoptosis and decreases fibronectin expression, Fertility and Sterility, 91, 5, 2177-2184. Published May 2009), evidenced by Malik et al. 2007 (Novel method to characterize primary cultures of leiomyoma and myometrium with the use of confirmatory biomarker gene arrays, Fertility and Sterility, 87, 5, 1166-1172. Published May 2007).
Regarding claims 1, 3-4, and 6-8, Malik et al. 2009 teaches curcumin suppresses activation of nuclear factor kappa B (NF-kB) (p. 2177, 2nd column; Figure 3E-F). Curcumin was administered to human immortalized leiomyoma and myometrial cell lines and was found to reduce leiomyoma cell concentrations at curcumin concentrations as low as 5 µM (p. 2178, 2nd column). The human immortalized leiomyoma cells were collected from both submucosal and intramural leiomyomas from patients undergoing medically indicated hysterectomy for symptomatic leiomyomas, evidenced by Malik et al. 2007 (p. 1167, Tissue Collection).
Claim 9 is rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention, namely compound entered into the PubChem Database as PubChem CID:5353431, Deposited 25 March 2005 (431).
Regarding claim 9, 431 is also known as Bay-11 7082 (p. 7, 2.4 Synonyms) and is also known to target NF-kB (p. 21, 10.2 Chemical-Target Interactions).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Malik et al. 2009 (Curcumin, a nutritional supplement with antineoplastic activity, enhances leiomyoma cell apoptosis and decreases fibronectin expression, Fertility and Sterility, 91, 5, 2177-2184. Published May 2009) in view of Thomas (US 9,017,697), evidenced by Malik et al. 2007 (Novel method to characterize primary cultures of leiomyoma and myometrium with the use of confirmatory biomarker gene arrays, Fertility and Sterility, 87, 5, 1166-1172. Published May 2007).
Malik et al. 2009 teaches curcumin suppresses activation of nuclear factor kappa B (NF-kB) (p. 2177, 2nd column; Figure 3E-F). Curcumin was administered to human immortalized leiomyoma and myometrial cell lines and was found to reduce leiomyoma cell concentrations at curcumin concentrations as low as 5 µM (p. 2178, 2nd column). The human immortalized leiomyoma cells were collected from both submucosal and intramural leiomyomas from patients undergoing medically indicated hysterectomy for symptomatic leiomyomas, evidenced by Malik et al. 2007 (p. 1167, Tissue Collection).
Thomas teaches compositions for modulating an immune response, wherein the compositions generally comprise an inhibitor of the NF-kB pathway (col. 16) and an antigen, enclosed in a liposome. The number of inhibitors of the NF-kB pathway are vast and shown in Tables 1-3 (pp. 24-54). Curcumin is shown in table 1 (p. 24) and Bay-11 7082 is shown in Table 2B (p. 33). Out of all the NF-kB inhibitors, Bay-11 7082, curcumin, and quercetin were chosen for further study and also part of the claimed invention (claim 9).
Malik et al. 2009 and Thomas are analogous art to the claimed invention, because both are in the field of applying compositions to inhibit NF-kB. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) to administer an NF-kB inhibitor, like curcumin, to a patient to treat a fibroid. A PHOSITA would have been motivated to administer curcumin to patients to treat a fibroid as taught by Malik et al. 2009 and substitute curcumin for Bay-11 7082 because Thomas implicitly teaches, out of all the NF-kB inhibitors, curcumin, Bay-11 7082, and quercetin showed the best results. Thus, it would have been obvious for a PHOSITA to substitute curcumin as taught by Malik et al. 2009 for Bay-11 7082 as taught by Thomas because both are known NF-kB inhibitors (MPEP §2144.06(II)). The teachings of Thomas, provide a finite number of effective NF-kB inhibitors, which further obviates the substitution of curcumin for Bay 11-7082 (MPEP §2143(I)(E)). Accordingly, claims 1-4 and 6-9 are prima facie obvious.
Regarding claim 5, the administration of a NF-kB inhibitor would necessarily lead to amelioration of symptoms associated with a fibroid. In other words, the amelioration of symptoms is inherent in the administration of an NF-kB inhibitor, like curcumin or Bay-11 7082, to a fibroid, as taught in Malik et al. 2009. There would have been a reasonable expectation of success in the amelioration of symptoms because Malik et al. 2009 further teaches that the cells treated are from patients with symptomatic leiomyomata (p. 2177, Patient(s)).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHIL CHANDER AGGARWAL whose telephone number is (571)272-7755. The examiner can normally be reached 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C 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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/SAHIL CHANDER AGGARWAL/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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