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 .
Claim Status
Applicant’s remarks and amendments, filed 24 November 2025 in response to the non-final rejection mailed 25 July 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 24 November 2025 replaces all prior versions and listings of the claims.
Claims 18, 20-26, 28-34, and 38-40 are pending. Claim 19 is canceled by Applicant’s amendment. Claims 18, 20-23, 25, 31-34, and 40 are amended. Claims 18, 20-26, 28-34, and 38-40 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s amendments to the specification have overcome the specification objections in regards to minor informalities. The objection to the specification has thus been withdrawn.
Applicant’s amendments to the claims and cancellation of Claim 19 have overcome the objection in regards to minor informalities. The objection to Claims 18, 19, 21, 22, 31, 32, 34, and 40 has thus been withdrawn.
Applicant’s arguments and amendments, on pages 6-7 of the reply filed 24 November 2025 with respect to the rejection of Claims 25, 26, 34, and 40 under 35 USC § 112(b) have been fully considered. The rejections of Claims 25, 26, 34, and 40 are withdrawn due to amendment of the claims.
Applicant’s arguments and amendments, on pages 7-14 of the reply filed 24 November 2025 with respect to the rejection of Claims 18-21, 23, 25, and 28-30 under 35 USC § 102(a)(1) or in the alternative under 35 USC § 103 have been fully considered. The rejections of Claims 18-21, 23, 25, and 28-30 are withdrawn due to amendment and/or cancellation of the claims.
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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 18, 20, 21, 23, and 28-30 are rejected under 35 U.S.C. 103 as obvious over Capello (US 2013/0115195 A1) in view of Dull et al. (Molecules, 2019, 21 pages), and Arablou & Kolahdouz-Mohammadi (Biomed Pharmacol, 2018, 91-97) as evidenced by Ultrus (Lynside® Pro SCB, 2025, 2 pages).
The instant claims are as of record, drawn to a method for treating a subject suffering from, or susceptible of suffering from, endometriosis, comprising the administration of an effective dose of resveratrol, a curcuma extract, and a Saccharomyces cerevisiae species to said subject.
Capello teaches a composition comprising 150-250 mg or more of Saccharomyces cervisiae ([0045]), 5-150 mg of 98% trans-resveratrol ([0030], [0040]), and 5-150 mg of 95% standardized curcumin extract (at least 15% curcuminoid content by weight; effective dose; [0028], [0040]; as required for instant Claims 18, 22, 31, 32, 34, and 40). The specification (page 17, lines 21-23) indicates that Lynside® Pro SCB may be used as the Saccharomyces cervisiae strain, which according to the product page provided by Ultrus, comprises 20 x 109 CFU/g, which converts to 200,000,000 CFU/mg, and thus the composition of the prior art would contain between 3 x 1010 and 5 x 1010 CFU of Saccharomyces cervisiae (as required for instant Claims 31, 33, and 34). If the maximum amount of each ingredient was used, the total mass of the composition would be 550 mg, comprising 45.5% Saccharomyces cervisiae and 27.3% of each of trans-resveratrol and curcumin extract (as required for instant Claim 28). Additionally, since the curcumin extract comprises 95% curcuminoids, the curcuminoids are therefore present in a range of 4.75-142.5 mg (as required for instant Claims 34 and 40). The composition is a nutritional supplement (nutraceutical; food supplement; [0020]) administered daily to a human ([0018]; as required for instant Claims 18 and 40) as an oral capsule wherein the ingredients can be provided in a single capsule (dosage form; [0058]; as required for instant Claims 23, 25, 28, 31, 32, 38, and 40). The composition additionally comprises vitamin D3 and vitamin C (Claims 12 and 13, page 6; as required for instant Claim 29). The composition comprises a probiotic, Saccharomyces cervisiae, and does not comprise Lactobacillus (as required for instant Claim 30).
Capello does not expressly teach treating a subject suffering from, or predisposed to development of endometriotic lesions or delaying, slowing down, or reducing endometriotic lesions in a subject.
Dull et al. teach that resveratrol is known to have anti-inflammatory properties that can inhibit endometriotic lesions (Dull et al., page 2; as required for instant Claim 18), decrease pain (e.g., pelvic pain) associated with endometriosis (Dull et al., page 10; as required for instant Claim 20), and induce antioxidant enzymes (decrease oxidative stress; Dull et al., page 11; as required for instant Claim 21). Arablou & Kolahdouz-Mohammadi further teach that curcumin inhibits endometrial lesions and reduces inflammation and thus is a useful dietary and pharmaceutical agent for prevention and treatment of endometriosis (Arablou & Kolahdouz-Mohammadi, Conclusion, page 96; as required for instant Claims 18, 20, and 21).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Capello, Dull et al., and Arablou & Kolahdouz-Mohammadi to arrive at the instantly claimed invention. The positive teachings of Dull et al. and Arablou & Kolahdouz-Mohammadi regarding the usefulness of resveratrol and curcumin for reducing inflammation, inhibiting endometriotic lesions, and decreasing pain, thereby treating endometriosis, provide motivation for a skilled artisan to administer the anti-aging composition of Capello to a subject suffering from, or predisposed to development of endometriotic lesions. Additionally, a skilled artisan would be motivated to use the composition of Capello and had a reasonable expectation of success in so providing, due to the added benefits of anti-aging, stimulation of stem cell production, and reduction of inflammation, which would provide additional benefits to the subject (Capello, Claim 1, page 6), and especially in the absence of evidence to the contrary or the criticality of some unrecited features.
Claims 18, 20-23, 28-32, 38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Capello (US 2013/0115195 A1) in view of Dull et al. (Molecules, 2019, 21 pages), and Arablou & Kolahdouz-Mohammadi (Biomed Pharmacol, 2018, 91-97) as evidenced by Ultrus (Lynside® Pro SCB, 2025, 2 pages) as applied to Claims 18, 20, 21, 23, and 28-30 above and further in view of McFarland (World J Gastroenterol, 2010, 2202-2222).
The claims and teachings of Capello in view Dull et al. and Arablou & Kolahdouz-Mohammadi are as of record.
Capello, Dull et al., and Arablou & Kolahdouz-Mohammadi do not teach wherein the Saccharomyces cerevisiae is of the variety boulardii.
McFarland teaches that S. boulardii is a safe and effective probiotic with clinical evidence for various diseases to back up its use, particularly in comparison to other strains of Saccharomyces (McFarland, Conclusion, 2216).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Capello and McFarland to arrive at the instantly claimed invention. Due to its use for various diseases and safety profile, a skilled artisan would have provided S. cerevisiae v. boulardii as the probiotic in the instant method with a reasonable expectation of success.
Capello and McFarland are relied upon for the reasons discussed above. Based upon the overall beneficial teaching provided by this reference with respect to S. boulardii, the selection of a particular variety of yeast from among those well-known in the art would have been a manner of judicial selection and routine optimization well within the purview of the skilled artisan, absent any specific evidence to the contrary regarding the nonobviousness of this variant.
Claims 18, 20, 21, 23, 24, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Capello (US 2013/0115195 A1) in view of Dull et al. (Molecules, 2019, 21 pages), and Arablou & Kolahdouz-Mohammadi (Biomed Pharmacol, 2018, 91-97) as evidenced by Ultrus (Lynside® Pro SCB, 2025, 2 pages) as applied to Claims 18, 20, 21, 23, and 28-30 above, and further in view of Maia et al. (Int J Women Health, 2012, 543-549).
The claims and teachings of Capello in view Dull et al. and Arablou & Kolahdouz-Mohammadi are as of record.
Capello, Dull et al., and Arablou & Kolahdouz-Mohammadi do not teach wherein the subject suffering from endometriosis has undergone or is to undergo a surgical treatment of resection of the endometriotic lesions, medically assisted reproduction, and/or contraceptive treatment.
Maia et al. teach that endometriosis patients taking a combination of oral contraceptives (under contraceptive treatment; as required for instant Claim 24) and resveratrol experience less endometriotic pain (Maia et al., Table 2, page 545). Additionally, patients having undergone laparoscopy or hysteroscopy to treat endometriotic lesions taking resveratrol also experienced less pain (Maia et al., Results, page 545).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide the composition of Capello to the patient population of Maia et al. in order to reduce endometriosis-associated pain in patients undergoing contraceptive treatment and/or surgical intervention. A skilled artisan would do so with a reasonable expectation of success due to the positive teaching of resveratrol as a compound for pain reduction in a subject suffering from endometriosis.
Claims 18, 19-23, 25, 26, 28-34, and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Capello (US 2013/0115195 A1) as evidenced by Dull et al. (Molecules, 2019, 21 pages) and Arablou & Kolahdouz-Mohammadi (Biomed Pharmacol, 2018, 91-97) in view of McFarland (World J Gastroenterol, 2010, 2202-2222) as applied to Claims 18, 20-23, 28-32, 38, and 40 above and in further view of Yadav et al. (AAPS Pharm Sci Tech, 2009, 752-762), Gandia et al. (Int J Vitam Nutr Res, 2007, 243-248), and Staff (US Pharmacist, 2006, 13 pages).
The claims and teachings of Capello as evidenced by Dull et al. and Arablou & Kolahdouz-Mohammadi in view of McFarland are as of record.
Capello, Dull et al., and Arablou & Kolahdouz-Mohammadi, and McFarland do not teach wherein each dosage unit comprises zinc and inulin, that the zinc is in the form of bisglycinate, or wherein the curcuma extract is associated with a cyclodextrin.
Yadav et al. teach that inclusion complexes of cyclodextrin and curcumin (curcuma extract) protect the guest molecule from the environment while increasing solubility and stabilization for pharmaceutical purposes (Yadav et al., Introduction, page 753; as required for instant Claim 34).
Gandia et al. teach that zinc is an essential trace mineral and that zinc bisglycinate is a safe, well-tolerated, and has higher oral availability than zinc gluconate (Gandia et al., Abstract, page 243; as required for instant Claims 26, 33, and 39).
Staff teaches that inulin is a natural food fiber that is highly soluble, act as a prebiotic, and improve immune function (Staff, pages 1-2; as required for instant Claim 33).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Capello, McFarland, Yadav et al., Gandia et al., and Staff to arrive at the instantly claimed invention. Providing zinc in the bisglycinate form provides a more readily available form of an essential trace mineral and inulin to improve immune function as a prebiotic. Additionally, providing the curcuma extract in association with cyclodextrin would increase solubility and stability of the composition, thereby providing motivation for a skilled artisan to include it in the instant invention. A skilled artisan could therefore include zinc in the bisglycinate form, inulin, and curcuma extract associated with cyclodextrin in the composition of the claimed method with a reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within the processes thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 24 November 2025 have been fully considered but they are not persuasive.
First, it is noted that the patient population for the instantly claimed method is broad. The specification defines “a subject predisposed to endometriosis” as a woman having a clinical picture suggesting the presence of endometriosis, which includes strong or severe menstrual pain, hypofertility, infertility, or a family history of the disease (Specification, page 17). There are various additional risk factors (e.g., predispositions) including socio-economic status, family history, weight, peripheral body fat distribution, pigmentary traits, sun habits, diet, physical activity, smoking, alcohol intake, age at menarche, menstrual cycle length, duration of menstrual flow, parity, oral contraceptive use, exposure to polychlorinated biphenyls and dioxins, and comorbidities including gastrointestinal, immunological, and cardiovascular diseases (Parazzini et al., Table 1, page 4). With such broad and varied risk factors predisposing those with a uterus to endometriosis, the patient population of a subject predisposed to development of endometriotic lesions is equally broad.
Applicant argues that Capello does not disclose or suggest a method for treating endometriosis, however Capello does teach administration (e.g., a single step method) of a composition comprising the same ingredients as the instantly claimed invention for the purpose of anti-aging, stimulation of stem cell production, and reduction of inflammation, which would provide additional benefits to the subject (Capello, Claim 1, page 6). The ingredients of the composition, specifically resveratrol and curcuma, have been shown to be effective at reducing inflammation, inhibiting endometriotic lesions, and decreasing pain, thereby treating endometriosis (Dull et al., page 2 and 10; page 10; Arablou & Kolahdouz-Mohammadi, Conclusion, page 96). Since the patient population of a subject predisposed to endometriosis broadly covers women with various risk factors, it is not hard to contemplate that the composition of Capello would be administered to a woman taking oral contraceptives or who has irregular menstrual cycles, potentially with heavy bleeding, thereby providing the additional benefit of delaying the onset of formation of endometriotic lesions. Additionally, a skilled artisan would be motivated to provide this known composition with anti-inflammatory effects specifically to those predisposed or currently suffering from endometriotic lesions because of the beneficial effects of curcuma and resveratrol.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, as discussed above, the beneficial effects of curcuma and resveratrol regarding endometriotic lesions was known in the art prior to the filing of the instant application, in addition to the claimed composition which was administered to a person for anti-aging, anti-inflammatory, and promotion of stem cell growth.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., synergistic effects; reduction of proinflammatory cytokines; cellular oxidative stress; plasma level of zonulin; ratio of M1/M2; normalize inflammatory state at the peritoneal level) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, it is noted that the present disclosure does not provide data regarding synergy and merely states that a combination of only resveratrol and curcuma extract slows down progression of endometriotic lesions relative to the claimed composition. Evidence of a greater than expected result may be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately. However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. See MPEP § 716.02(a).
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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