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 the Claims
Claims 21-40 are pending in the application as presented in the preliminary amendment to the claims filed 10/13/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/10/24 has been considered by the examiner.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 21, 25, 27, 30, and 31 are objected to because of the following informalities: the following items are capitalized, and it is not apparent that these names should be capitalized: “Rhodiola” in claim 21; “Salacia” in claims 25 and 27, “Rhodiola” and “Salacia” in claim 30, “Rhodiola” in claim 31.
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 22-24 and 31-39 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 31 recites an element of the claim which is “a food index 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? These terms are subjective and the metes and bounds of these terms may vary from one artisan to another; appropriate clarification is required.
In claim 33, how does one “define” and “assign” the stated items within the scope of the claims?
Further, in claim 34, is the activity index an indicia or a label in the form of a list for instance? Is it an intended use of a claimed product? 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 34?
Claim 35 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 37 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 40 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 protein source 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.
Claim 22 refers to “the amount of chromium” in line 1. Does this refer to the chromium metal or chromium metal ion or the entire chromium chelate coordination compound? Claims 23 and 24 refer to magnesium and zinc in kind; appropriate clarification is requested.
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 21-30 and 40 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 encompass 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 a method step of administering the composition to an individual which in the allowed claims is presented as an intended use. Moreover and further regarding claim 40, the specification for the issued claims recites a bulk food product as a composition for delivering the weight loss composition further specified in the claims and addressed above. It is the examiner’s position that the issued claims render obvious the claimed method in the instant context since administration would have been a readily apparent and immediately envisaged way to use the weight loss composition and kit or bulk food product thereof as detailed in the issued claims.
Claims 21-40 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 issued claim is a composition whereas the instant claims are methods encompassing said composition. It is the examiner’s position that where the issued claim recites a weight loss intended use and a daily dosage of a composition whereas the instant claims recite the same composition within a method of administering or for managing weight, the issued claims render obvious the claimed method, particularly in view of the indefinite claim language detailed above.
Where 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 such as in a meal kit as recited in claim 39, it is noted that 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. all for the very same intended use or process as instantly recited. Accordingly, both sets of claims are directed to the same invention.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11141448. Although the claims at issue are not identical, they are not patentably distinct from each other where the issued claims are drawn to a composition for weight loss comprising requisite components the same as in the instant claims and where the issued claims further are drawn to a method for promoting weight loss by the stepwise administration of the composition, the instant claims are addressed to the same invention which is a stepwise method of administering or managing weight by administering a daily dosage of the same composition for the same purpose.
As to the difference where the instant claims differ by further requiring a bulk food product in combination with a weight loss composition in a meal kit, 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 21-40 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 encompass 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, and 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 recite a stepwise method of administering the composition in a daily dosage for the intended use of weight loss or management whereas the issued claims are merely drawn to a composition. In view of the aforementioned issues under 35 U.S.C. 112, it is the examiner’s position that the issued claims drawn to a composition for weight loss render obvious the instant method claims for managing weight and/or weight loss by administration of the same composition, with a reasonable expectation of success. One would have been motivated to administer the weight loss composition to achieve the known desired weight loss or management results purported for the composition of the issued claims. Accordingly, both sets of claims are directed to the same invention.
Claims 21-40 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-40 of copending Application No. 18486306(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the method in the instant claims corresponds to the daily dosage for weight management or weight loss [from administering] the very same composition included in the instant claims as recited in the copending claims. The same composition components and amounts (ranges and single values) are encompassed in both sets of claims as is the intended use or stepwise method of administering the composition for the very same purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
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 21-38 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0028991 (“Smith”) in view of US 2013/0028988 (“Smith [b]”) and US 2016/0339058A1 (Michlig Gonzalez et al.; “Michlig Gonzalez”).
The instant claims are drawn to a method of administering a composition comprising
a daily dosage of the composition comprising banaba leaf extrac[t] in an amount of about 20 mg to about 100 mg; apple fruit extract in an amount of about 30 mg to about 100 mg; rhodiola root extract in an amount of about 140 mg to about 400 mg; chromium chelate; magnesium chelate; and zinc chelate, as further specified in the claims. Any recited terms of plan, activities, and indices are considered addressed above in the rejections under 35 U.S.C. 112(b). The claimed structural elements are addressed in detail below.
Smith teaches the administration of a dietary supplement which may be considered a weight loss composition. The composition comprises banaba leaf extract in an amount of 30-490 mg (see [0023]), chromium chelate (see [0021]) in an amount of 75 mg as well as magnesium chelate which is magnesium stearate.
Smith [b] teaches the administration of a weight-loss program composition including magnesium and zinc in combination with rhodiola rosea and inositol (see [0039])(further limitation of claim 28) wherein the compositions further may include apple fruit extracts (see [0064]); Table 3 demonstrates apple polyphenols in a dosage range of 20-550 mg, a range including the instantly claimed range (see [0070]). Smith [b] teaches a chromium component may be included in a dosage range of 5-200 mcg (Table 2 at [0070])(limitation of claim 22). Smith[b] further teaches magnesium in a range of 5-100 mg per daily dosage (see Table 1 at [0070])(limitation of claim 23). Smith[b] teaches inositol in a dosage range of 35-600 mg ([0070])(limitation of claim 28). Smith[b] also teaches Gardenia fructus in a dosage of 25-500 mg (see [0070])(limitation of claim 26) alongside a comparable component known to treat diabetes as a food supplement for suppressing high blood sugar levels, Salacia reticulata (see [0066])(limitation of claim 26), which it would have been obvious to substitute or include in place of or in addition to similar functional agents disclosed in paragraphs [0064]-[0068] and as embodied in paragraph [0070]) in an amount within the range of the disclosed functionally similar components (limitation of claim 27). Smith[b] also teaches berberine in a dosage of 5-500 mg (see [0070])(limitation of claim 38), the hydrochloride salt of which one of ordinary skill would have immediately envisaged as an acceptable form of berberine for oral formulation and administration.
Both Smith references pertain to the administration of weight loss and/or weight management compositions. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to combine formulation components including banaba leaf extract, apple fruit extract polyphenols, rhodiola root extract, and chromium chelate, magnesium chelate, and a source of zinc from two weight loss compositions into a single weight loss methods, with a reasonable expectation of success. One would have been motivated to do so to combine prior art elements according to known methods to yield predictable results particularly in a weight loss formulation.
Smith [b] includes zinc but not in a chelate form; Smith [b] teaches zinc in a dosage range of 2-30 mg (limitation of claim 24). Michlig Gonzalez cures this deficiency. Michlig Gonzalez teaches weight management compositions for oral administration wherein zinc chelate is included in the form of zinc citrate (see [0016], [0021], and [0053]).
Both Smith references as well as Michlig Gonzalez are directed to weight loss formulations. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to add Michlig Gonzalez’s zinc citrate to the formulations of Smith and Smith[b], with a reasonable expectation of success. One would have been motivated to do so to facilitate weight loss as taught by Michlig Gonzalez and as a species of Smith[b]’s generically disclosed zinc component.
Further regarding the allowances and indices further described in claim 31, the Smith, Smith[b], and Michlig Gonzalez references are considered to teach the structural components claimed with allowances and indices unclear terms interpreted as written instructions for instance which are nonfunctional descriptive material per MPEP 2111.05. There is no claimed feature or evidence in the record demonstrating new or nonobvious relationship between a base food allowance, a food index, an activity index, or a daily food allowance as claimed components. Limitations are not imported from the specification into the claims. Similarly, the food index in claims 32 and 33, the activity index in claim 34, food allowance in claim 35, food value in claims 36 and 37, and provision that is allowing the individual to choose portions as in claim 37 are likewise interpreted as elements lacking a functional relationship and capable of being performed and/or administered with the elements claimed. Claim 38 pertains to a method of making or an intended use and not an actual step of the claimed method.
Specifically regarding the amounts of formulation components in claim 30 and as to the ranges of components claimed and otherwise addressed above, the prior art reasonably suggest the claimed amounts and/or ranges as detailed above, however “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0028991 (“Smith”) in view of US 2013/0028988 (“Smith [b]”) and US 2016/0339058A1 (Michlig Gonzalez et al.; “Michlig Gonzalez”) as applied to claims 21-38 above, and further in view of JP2015-528705 (“JP’705”).
The teachings of Smith, Smith[b], and Michlig Gonzalez have been delineated above. None of these specifies a bulk food or portion or kit-type features as detailed in instant claims 39 and 40. It is noted that the weight loss composition items including banaba, apple, rhodiola, chromium, magnesium, and zinc and dosages thereof have been addressed above by Smith, Smith[b], and Michlig Gonzalez.
JP’705 cures this deficiency. JP’705 teaches a feed composition comprising various functional benefit components in a feed product. JP’705 specifies that animal feed may include cereals for instance, proteins including those from beans, fats, minerals and vitamins, and additional functional agent additives (see page 29/62 of translation which begins a definition of feed product). JP’705 further teaches that a suitable premix is a composition which may be blended into commercial feed (top of page 31/62 of translation (“A suitable premix…”) and continues that cereals, proteins such as soybeans, peanuts, lupines, peas, broad beans, etc., and fats may be included further in combination with vitamins and minerals (see page 31/62 of translation paragraph starting “Animal feed within the meaning..includes…”).
Smith, Smith[b], Michlig Gonzalez, and JP ‘705 all pertain to nutritional compositions. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to add the obvious composition for weight loss based on combinations of Smith, Smith[b], and Michlig Gonzalez above into a bulk feed product of JP ‘705, with a reasonable expectation of success. One would have been motivated to do so to provide good nutrition functioning as a carrier formulation alongside dietary benefits from the weight management compositions of Smith, Smith[b], and Michlig Gonzalez.
Conclusion
No claim is allowed at this time.
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