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 the Claims
Claims 21-30 and 34-38 remain pending in the application.
Withdrawn Objections and Rejections and Response to Arguments
Applicant’s arguments filed 5/19/2026 (hereafter, “Remarks”) have been fully considered and are addressed as follows. The claims as amended 5/19/2026 find support in the specification as filed, as Applicant notes. Any rejections of claims now canceled are withdrawn.
The objections to claims 21, 34, 36, and 39-40 are withdrawn in view of the claim amendments filed 5/19/2026.
The rejections of claims 21-38 under 35 U.S.C. 101 is withdrawn in view of the claim amendments filed 5/19/2026.
Regarding the rejections of all pending claims under 35 U.S.C. 112(b), Applicant requests withdrawal and points to the specification as filed for description in process steps. In reply, Applicant’s argument has been fully considered but is not persuasive since limitations are not imported from the specification into the claim. Appropriate clarification is required. The rejections have been modified as necessitated by amendment as detailed below.
The rejection of claim 25 under 35 U.S.C. 112(d) is withdrawn in view of Applicant’s amendments to the claims. It is noted that the amended claims filed 5/19/2026 incorrectly fails to denote the amendment reciting the claim from which claim 25 depends, however it is apparent that Applicant has amended the dependency from claim 4 to claim 24. In the interest of compact prosecution, the amendment is entered and examined.
The rejections of claims 21-28 and 31-38 under 35 U.S.C. 103 are withdrawn in view of Applicant’s amendments to the claims. Applicant’s argument that Smith ‘991 does not teach a magnesium chelate as claimed is persuasive, and, more particularly, Applicant’s argument on page 8 of 9 of Remarks as to the difference between zinc chelate and zinc salt is persuasive. Applicant’s argument and subsequent conclusion that the proposed combination of references does not reasonably teach each and every claimed limitation is persuasive in view of the preponderance of evidence in the record; specifically, rationale for selecting and combining the particular elements claimed is lacking.
The double patenting rejections have not been properly addressed and are maintained except where Applicant has canceled claims in the instant application.
Claim Objections
Claim 21 is objected to because of the following informalities: claim 21 includes a period at the end of line 10 indicating the end of the sentence constituting the claim, however additional text follows said period. Appropriate correction is required.
Maintained Grounds of Rejection, Modified as Necessitated by Amendments of 5/19/2026
Claim Rejections - 35 USC § 112(b)
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 21-30 and 34-38 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 21 is unclear because the sentence ends in a period, and then three additional clauses are recited; it is unclear whether Applicant intends to include the final two steps of “determining” and the step of “recommending” or if Applicant intends to end the claim after the 30 mg of zinc chelate and the period. Appropriate clarification is required.
Claim 21 recites an element of the claim which is “a food index for the individual based on a weight loss composition” wherein the metes and bounds of this term are unclear. What is included and/or required by this language? Is the “food index” a material object and what would be considered to meet the claim? Similarly, what is necessary to meet the “base food allowance based on the gender, age, height, BMI, weight, or life activity of the individual”? What is required to meet “an activity index based on an activity and a time interval for that activity performed by the individual”, and is the activity index a standard used to apply a stepwise method or is it an objective metric? The included “daily food allowance for the individual based on the food index, the activity index, and the base food allowance” has an unclear meaning because what does it mean to be “based on”? What steps are necessary to meet the claim, and what components are included and excluded? Similarly, in claim 22, what does it mean for “the food index” to be “also based on the four categories of food: vegetables; proteins; carbohydrates; and fat”? “The four categories” is interpreted to mean that four categories of vegetables, proteins, carbohydrates, and fat are referenced, but which of these is required to be present and/or absent to meet the claim? In claim 23, how does one “define” and “assign” the stated items within the scope of the claims?
Further, in claim 24, what does “the individual” convey? If exercises “could be performed”, what structural requirement is claimed? Further, what are the metes and bounds of remaining described items “defined”, “performed”, and “assigns” as in claim 24?
Claim 25 recites a daily food allowance being a sum, however what units are referenced? Further, what is the antecedent of “the values obtained from the activity index” and what units correspond to these values or activity index items? Similarly, claim 27 recites “the sum of the food values” and similarly unclear portions and/or a concurrent “predetermined relationship” which is not defined; said portions refer to foods to be chosen, however no clear antecedent is established.
Claim 26 recites “the food value is based on…” additional items, however what is the required component? And what does it mean to be “based on” or what structural or stepwise components are required by this language?
What meat constitutes a “lean-meat” in a protein source as in claims 30 and 39? What constitutes “lean” may be subjective; for instance, one person may consider 90% lean meat to be lean while another may consider 98% lean meat to be lean with 90% being subjectively considered fatty and not lean.
All claims depending from a rejected base claim are also rejected here.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-28, and 34-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11883456. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition for weight loss comprising banaba leaf extract, apple fruit extract, rhodiola root extract, chromium chelate, magnesium chelate, and zinc chelate, in the same ranges and amounts as well as the same additional elements gardenia fruit extract, Salacia extract, inositol, berberine, or a combination thereof.
The instant claims differ from the 11883456 allowed claims in that the instant claims further encompass potential structure for a method as claimed and elements associated with an intended use or process steps (food index, base food allowance, activity index, and daily food allowance elements) which are otherwise addressed above. It is noted that the issued claims further pertain to a kit with instructions for a plan for instance wherein said kit may be defined as a kit comprising a bulk food product comprising a plurality of meal portions each comprising protein, fat, carbohydrates etc. as instantly claimed also. Accordingly, both sets of claims appear directed to the same invention.
Claims 21-30 and 34-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11458182. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition for weight loss comprising banaba leaf extract, apple fruit extract, rhodiola root extract, chromium chelate, magnesium chelate, and zinc chelate, in the same ranges and amounts as well as the same additional elements gardenia fruit extract, Salacia extract, inositol, berberine, or a combination thereof.
The instant claims differ from the 11458182 allowed claim in that the instant claims particularly claim 21 and those depending from claim 21 further encompass potential structure for a method of use and elements associated with an intended use or process steps (food index, base food allowance, activity index, and daily food allowance elements) which are otherwise addressed above. Interpreting the instant claims as noted above, the issued claims appear directed to the same method in instant the claims. As to claims 39 and 40, the instant claims differ from the allowed claim since the instant claims further require a bulk food product in combination with a weight loss composition in a meal kit as recited in claim 39. It is noted that claim 40 encompasses the same amounts as in the issued claim. The specification for the issued claims defines the kit may be an embodiment which comprises a bulk food product comprising protein, fat, carbohydrates, fiber, etc. as instantly recited. Accordingly, both sets of claims are directed to the same invention.
Claims 21-30 and 34-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11141448. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition for weight loss comprising banaba leaf extract, apple fruit extract, rhodiola root extract, chromium chelate, magnesium chelate, and zinc chelate, in the same ranges and amounts as well as the same additional elements gardenia fruit extract, Salacia extract, inositol, berberine, or a combination thereof.
The instant claims differ from the 11141448 allowed claim in that the instant claims particularly claim 21 and those depending from claim 21 further encompass potential structure for a method for managing weight and elements associated with an intended use or process steps (food index, base food allowance, activity index, and daily food allowance elements) which are otherwise addressed above. Interpreting the instant claims as noted above, the issued claims appear directed to the same composition encompassed in the instant method, and the corresponding disclosure for the issued claims discloses a bulk food embodiment and a diet plan wherein food components may be included as part of a food index element wherein all four food groups may be included in meal form with the aforementioned extracts, chelates, and additional components encompassed in the claims. The specification for the issued claims defines the kit may be an embodiment which comprises a bulk food product comprising protein, fat, carbohydrates, fiber, etc. and the method of use thereof, as instantly recited. Accordingly, both sets of claims are directed to the same invention.
Claims 21-30 and 34-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10765718. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition for weight loss comprising banaba leaf extract, apple fruit extract, rhodiola root extract, chromium chelate, magnesium chelate, and zinc chelate, in the same ranges and amounts, the issued claims further require berberine inositol, and Salacia extract in claim 1 whereas in the instant invention these elements are included in dependent claims in the same amounts.
The instant claims differ from the 10765718 allowed claims in that the instant claims further encompass potential structure for a method for managing weight and elements associated with an intended use or process steps (food index, base food allowance, activity index, and daily food allowance elements) which are otherwise addressed above. Interpreting the instant claims as noted above, the instant claims further require bulk food product components and/or kit components which is noted to be defined in the specification for the issued claims as an embodiment of the invention. Accordingly, both sets of claims are directed to the same invention.
Conclusion
No claim is allowed at this time.
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 AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
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