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 .
Applicant’s Response Dated August 21, 2025
In the Response dated August 21, 2025, claims 2 and 6 were amended, and claims 1 and 3-5 were canceled. Claims 2 and 6 are pending. An action on the merits of claims 2 and 6 is contained herein.
The rejection of claim 2 under 35 U.S.C. 101 has been rendered moot in view of applicant’s amendment dated August 21, 2025.
The rejection of claim 2 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Seals et al. WO 2015/148522 A1 (Seals) is maintained for the reasons of record as set forth in the Office Action dated May 22, 2025.
The rejection of claim 2 under 35 U.S.C. 102(a)(1) as being anticipated by Ummarino et al. Food Chemistry (2017), Vol. 221, pages 161-168 (Ummarino) has been rendered moot in view of applicant’s amendment dated August 21, 2025.
The rejection of claim 6 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Seals et al. WO 2015/148522 A1 (Seals) is maintained for the reasons of record as set forth in the Office Action dated May 22, 2025.
The rejection of claim 6 under 35 U.S.C. 103 as being unpatentable over Ummarino et al. Food Chemistry (2017), Vol. 221, pages 161-168 (Ummarino); Akkerman, Renate, Marijke M. Faas, and Paul de Vos. "Non-digestible carbohydrates in infant formula as substitution for human milk oligosaccharide functions: Effects on microbiota and gut maturation." Critical Reviews in Food Science and Nutrition 59.9 (2019): 1486-1497 (Akkerman); and Mulol, Helen, and Anna Coutsoudis. "Breastmilk output in a disadvantaged community with high HIV prevalence as determined by the deuterium oxide dose-to-mother technique." Breastfeeding Medicine 11.2 (2016): 64-69 (Mulol) in combination has been rendered moot in view of applicant’s amendment dated August 21, 2025.
Rejections Set Forth in the Office Action Dated May 22, 2025
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2 and 6 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Seals et al. WO 2015/148522 A1 (Seals).
Applicant's arguments filed August 21, 2025 have been fully considered but they are not persuasive. Claims 2 and 6 have been amended. Applicant submits that claim 6 is no longer subject to the § 102 rejection.
Applicant’s arguments have been fully considered.
However, applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
As set forth in the last Office Action, Seals teaches a method of treating vascular endothelial dysfunction comprising administering a daily dose of a composition comprising from about 1 mg to about 25 mg per kg body weight per day. A subject having vascular endothelial dysfunction (e.g., cardiovascular disease) is embraced by an instant target as vascular endothelial dysfunction (e.g., cardiovascular disease) is embraced by “lifestyle-related diseases” as it is related to diet and exercise. Thus, the rejection(s) is maintained.
Claim Rejections - 35 USC § 112
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 2 and 6 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.
Regarding claim 6, the term “lifestyle-related diseases” renders the claim(s) indefinite as the term is not defined in the claims or specification. It is unclear what disease(s), and by extension what target(s), applicant intends to be part of the claimed invention. For example, it is unclear whether applicant intends for “lifestyle-related diseases” to include cardiovascular disease. Forman, Daniel, and Bernard E. Bulwer. "Cardiovascular disease: optimal approaches to risk factor modification of diet and lifestyle." Current treatment options in cardiovascular medicine 8.1 (2006): 47-57 (Forman) teaches that as much as 70% of CVD can be prevented or delayed with dietary choices and lifestyle modifications (Opinion Statement). Forman teaches that Western-style diets, sedentary lifestyles, and cigarette smoking are key modifiable CVD risk factors. For the purposes of applying art, the examiner interprets the term to include cardiovascular disease and/or any other disease or condition that is related to lifestyle.
Conclusion
Claims 2 and 6 are pending. Claims 2 and 6 are rejected. 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.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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, Shaojia Jiang can be reached at (571) 272-0627. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/
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