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
Claims 1-14 are pending and will be examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/211,887, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The contents of Application No. 63/211,887 are drawn to a dietary supplement comprising a combination of Lactobacilli RSB11®, RSB12®, and RSB13® and at least one herb, or an extract thereof, wherein the at least one herb is selected from the group herbal extract consisting of holy basil, turmeric, and vasaka. For the purposes of compact prosecution, the examiner will be interpreting RSB11®, RSB12®, and RSB13® as the same strains of instant claim 1. This means there is support for claims 1-7 and 13-14 of the instant application in '887. However, '887 does not disclose any excipient, carrier, diluent, adjuvant, or nutritionally active ingredient added to the dietary supplement of '887 claim 1, and there is no support for the addition of any of these additives in the specification of '887. Therefore, instant claims 8-12 are not supported by the provisional application 63/211,887.
Thus, for the purposes of applying prior art, claims 8-12 have the effective filing date of 6/16/2022, the date that PCT/US2022/072975 was filed. Claims 1-7 and 13-14 have the effective filing date of 6/17/2021, the date that provisional application 63/211,887 was filed. Should applicant disagree with the examiner’s factual determination above, applicant may point to the particular places in provisional application 63/211,887, for example, page and line numbers or figures, which disclose support for instant claims 8-12.
Information Disclosure Statement
The information disclosure statement filed on 08/19/2025 has been considered. Signed copies are enclosed.
The information disclosure statement filed 12/15/2023 and 10/22/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. See lined through references for those without a legible or translated copy.
Drawings
The drawings are objected to because Figures 19A and 19B are labeled opposite to their description in the specification. Correction is required. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the terms Karallief, Star Hi Herbs, and Naturex, which are trade names or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Correction of the organization names on pages 18-20 with the proper symbols is required.
Claim Objections
Claim 5 is objected to because of the following informalities: the word 'of' is missing before 'claim 2'. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Vitamin E is listed twice. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the word 'of' is missing before 'claim 1'. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is a biological deposit enablement rejection.
It is apparent that the bacterial strains represented by the ATCC Patent Deposit Numbers PTA-127171, PTA-127172, and PTA-127173 are required in order to practice the invention. Specifically, it is noted that claims 1-4, 6 and 8 recite deposited material and that claims 5, 7, and 9-14 depend from claims reciting deposited material. The deposit of biological organisms is considered by the Examiner to be necessary for the enablement of the current invention (see 37 CRF 1.808(a)). The examiner acknowledges the deposit of organisms under the ATCC Patent Deposit Numbers PTA-127171, PTA-127172, and PTA-127173 in partial compliance with this requirement. However, said deposits are not in full compliance with 37 CFR 1.803-1.809.
If the deposit is made under terms of the Budapest Treaty, then an affidavit or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit, or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the following criteria have been met:
1) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
2) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent; and
3) the deposits will be maintained for a term of at least thirty (30) years from the date of the deposit or for the enforceable life of the patent or for a period of at least five (5) years after the most recent request for the furnishing of a sample of the deposited material, whichever is longest; and
4) a viability statement in accordance with the provisions of 37 CFR 1.807; and
5) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CRF 1.809(d) should be added to the specification. See 37 CFR 1.803 – 1.809 for additional explanation of these requirements. To fulfill these requirements, Applicant must provide a statement ensuring all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, and provide the address of the depository.
Applicant’s attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR 1.801-1.809 for further information concerning deposit practice.
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 6 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 6 recites several ranges for each of the claimed strains, as well as several ration ranges of bacteria mix:excipient. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation 1-30%, and the claim also recites 5%-30%; 5%-20%; 5%-15%; 5%-10%; 10%-30%; 10%-20%; 10%- 15%; 15%-30%; 20%-30%, which are the narrower statement of the range/limitation. Additionally, claim 6 recites the broad recitation 10:about 1, and the claim also recites about 7:about 1, about 5:about 1, about 4:about 1, about 3:about 1, about 2:about 1, about 1:about 1, about 1:about 2, about 1:about 3, about 1:about4, about 1:about5, about 1:about7, about 1:about 10, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The percentages and ratios listed in claim 6 are not presented as options; that is, they are not separated by “and” or by “or”. This makes it impossible to determine which ranges are required to meet the metes and bounds of the claim. Therefore, claim 6 is indefinite. Claim 9 is included in this rejection, as it is dependent on claim 6.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation 1%-30%, and the claim also recites 5%-30%; 5%-20%; 5%-15%; 5%-10%; 10%-30%; 10%-20%; 10%- 15%; 15%-30%; 20%-30%, which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The percentages listed in claim 7 are not presented as options; that is, they are not separated by “and” or by “or”. This makes it impossible to determine which ranges are required to meet the metes and bounds of the claim. Therefore, claim 7 is indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite bacterial strains, and the specification does not provide support that the bacterial strains were modified from their natural. This judicial exception is not integrated into a practical application because the claims are drawn to a product, not a method of using. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because all additional .
The following analysis is laid out in accordance with MPEP 2106.
Question 1: Is the claim directed to a process, machine, article of manufacture, or composition of matter?
Yes; the claims are directed to a composition of matter.
Question 2A: Is the claim directed to a law of nature, natural phenomenon, or an abstract idea?
Yes; the claims are directed to a product of nature, which is a form of a natural phenomenon.
Question 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon (natural product)?
Yes; claims 1-4 recite a combination of probiotic bacterial strains, with no source or genetic modifications mentioned in the instant specification, and herbs or herbal extracts, which are plants, or are derived from plants and have no different chemical characteristics than the plants they are derived from. Claim 5 recites that one of the species is heat-killed. Examiner notes that dead bacteria are present in nature, and the method of killing does not produce something markedly different from the naturally occurring dead bacteria. Claims 6 and 7 are drawn to relative amounts of the bacteria and herbs of claims 1-4. The specification does not provide support that indicates the claimed amounts change the judicial exceptions to amount to something significantly more or markedly different from the judicial exceptions themselves. Claim 13 recites a formulation of the judicial exceptions of claims 1-4, but does not recite any limitation that would make the claimed invention markedly different from the recited judicial exceptions.
Question 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No; all claims are drawn to a product, not a method of using or a method of making.
Question 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the additional elements in the claims do not amount to significantly more than the judicial exception.
Question 2B, Prong 1: Are there any additional elements recited in the claim beyond the exception identified above?
Yes; claim 8 recites an excipient of magnesium stearate, silica, and MCC (interpreted as microcrystalline cellulose, the most common term abbreviated as MCC in the art, as the specification does not define MCC). Claim 9 recites a nutritionally acceptable carrier, diluent, excipient, adjuvant, or nutritionally active ingredient. Claim 10 recites one or more nutritionally active ingredients, and claim 11 specifies this ingredient is a vitamin, micronutrient, mineral, prebiotic fiber, fatty acid, amino acid, or combinations thereof. Claim 12 further limits the vitamins and minerals recited in 11. Claim 14 recites the form of the compound.
Question 2B, Prong 2: Do the additional elements, taken individually and as a combination result in significantly more?
No. Claim 8 recites silica and MCC as excipients. These are well known in the art as naturally occurring minerals and polysaccharides, respectively. Claim 8 also recites magnesium stearate, a compound created from a reaction of naturally occurring compounds, also well known in the art. The specification does not indicate that combining these excipients with the strains and plants identified as judicial exceptions above will produce something markedly different than the judicial exceptions themselves. Claim 9 recites the use of a nutritionally acceptable carrier, diluent, excipient, adjuvant, or nutritionally active ingredient. Water reads on a nutritionally acceptable carrier, diluent, or excipient. Therefore, claim 9 encompasses a judicial exception. Claim 10 encompasses vitamins, which are judicial exceptions. Claim 11 recites a vitamin, micronutrient, mineral, prebiotic fiber, fatty acid, or amino acid, all of which are naturally occurring and thus judicial exceptions. The vitamins and minerals recited by claim 12 are naturally occurring; hence, are judicial exceptions. Claim 14 recites the form of the product; however, a capsule that contains a judicial exception does not impart a markedly different characteristic or result in something substantially more than the judicial exception itself. Therefore, claims 1-14 are not eligible subject matter under 35 USC 101.
Claim Rejections - 35 USC § 102
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 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 8-12 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention. Claims 8-12 are rejected under 35 USC 102(a)(1) as anticipated by Birmingham Business Journal, as evidenced by resB® Lung Support Probiotic web page, downloaded 1/21/2026. The Birmingham Business Journal article dated 10/28/2021, authored by Tyler Patchen, titled "ResBiotic creates drug development spinoff, launches its first consumer health product, raises $4.5 million", demonstrates that, as of the publication date of the article, the product called “resB® Lung Support Probiotic”, as evidenced by the photo in the article, was publicly launched and therefore available for public use. As the effective filing date of instant claims 8-12 is 6/16/2022, the product “resB® Lung Support Probiotic” was on sale for public use before the effective filing date of the invention.
Claim 8 is drawn to “A food product, dietary supplement, medical food, or nutraceutical, wherein the food product, dietary supplement, medical food, or nutraceutical…comprising a mix of the bacterial strains Lactobacillus plantarum RSB11.RTM (ATCC Patent Deposit Number PTA-127171), Lactobacillus acidophilus RSB12.RTM (ATCC Patent Deposit Number PTA- 127172), and Lactobacillus rhamnosus RSB13.RTM (ATCC Patent Deposit Number PTA- 127173), and a herbal mix comprising at least one herbal, or an extract thereof, wherein the at least one herbal is selected from the group consisting of holy basil, turmeric, and vasaka…wherein (i) the bacterial mix consists of Lactobacillus plantarum RSB11.RTM, Lactobacillus acidophilus RSB12.RTM, and Lactobacillus rhamnosus RSB13.RTM, and an excipient consisting of magnesium stearate; silica, and MCC and (ii) the herbal mix consists of turmeric extract, holy basil extract, and vasaka extract. Claim 9 is drawn to “A food product, dietary supplement, medical food, or nutraceutical, wherein the food product, dietary supplement, medical food, or nutraceutical…comprising a mix of the bacterial strains Lactobacillus plantarum RSB11.RTM (ATCC Patent Deposit Number PTA-127171), Lactobacillus acidophilus RSB12.RTM (ATCC Patent Deposit Number PTA- 127172), and Lactobacillus rhamnosus RSB13.RTM (ATCC Patent Deposit Number PTA- 127173), and a herbal mix comprising at least one herbal, or an extract thereof, wherein the at least one herbal is selected from the group consisting of holy basil, turmeric, and vasaka…further comprising a nutritionally acceptable carrier, nutritionally acceptable diluent, nutritionally acceptable excipient, nutritionally acceptable adjuvant or nutritionally active ingredient in addition to the bacteria and the at least one herb or herb extract.
Claim 10 is drawn to “A food product, dietary supplement, medical food, or nutraceutical, wherein the food product, dietary supplement, medical food, or nutraceutical…comprising a mix of the bacterial strains Lactobacillus plantarum RSB11.RTM (ATCC Patent Deposit Number PTA-127171), Lactobacillus acidophilus RSB12.RTM (ATCC Patent Deposit Number PTA- 127172), and Lactobacillus rhamnosus RSB13.RTM (ATCC Patent Deposit Number PTA- 127173), and a herbal mix comprising at least one herbal, or an extract thereof, wherein the at least one herbal is selected from the group consisting of holy basil, turmeric, and vasaka…comprises at least one nutritionally active ingredient.” Claim 11 further limits claim 10, disclosing “wherein the at least one nutritionally active ingredient is a vitamin, a micronutrient, a mineral, a prebiotic fiber, a fatty acid, an amino acid, or any combination thereof.” Claim 12 further limits claim 11, disclosing “wherein the at least one vitamin is ascorbic acid (vitamin C), D, E, A, E, K, thiamine (B1), riboflavin (B2), niacin (B3), pantothenic acid (B5), B6, B7, B9, B12, or any combination thereof and the at least one mineral is sulfur, potassium, chlorine, sodium, calcium, phosphorus, magnesium, iron, zinc, manganese, copper, iodine, chromium, molybdenum, selenium, cobalt, or any combination thereof.”
These claims are anticipated by Patchen, Birmingham Business Journal, as evidenced by resB® Lung Support Probiotic web page, downloaded 1/21/2026. As stated above, the Patchen article demonstrates that the resB® Lung Support Probiotic was on sale as of 10/28/2021. In the instant specification, the examples and figures refer to “resB”, the same name of the product for sale from 10/28/2021. Taken together, the examiner interprets the resB of the instant specification to be the same as the resB® Lung Support Probiotic. Additionally, the resB® Lung Support Probiotic webpage, accessed from (https://resbiotic.com/products/resb) on 1/21/2026, shows that the resB® Lung Support Probiotic Supplemental Facts state the product contains 144 mg of the resB® Probiotic Blend, Lactiplantibacillus plantarum RSB11®, Lactobacillus acidophilus RSB12®, and Lacticaseibacillus rhamnosus RSB13®, and 240 mg of the resB® Botanical Blend, made of Vasaka (Adhatoda vasica) leaf extract, Holy Basil (Ocimum sanctum) leaf extract, and Turmeric (Curcuma longa) root extract. As each strain in the resB® Probiotic Blend has identical corresponding strain names to the instant specification, the examiner is interpreting these strains as the same as those deposited with ATCC in the instant claims, thereby meeting the bacterial mix limitations of claims 8-12. The herbs present in the resB® Botanical Blend are those disclosed in the instant claims, meeting the limitations of claims 8-12. As the resB of the instant specification appears to be the same as the resB® Lung Support Probiotic, and as the full contents of the resB® Lung Support Probiotic is not publicly available, the examiner concludes that the remaining limitations of claims 8-12 are met by the resB® Lung Support Probiotic product. Therefore, the sale of the resB® Lung Support Probiotic before the effective filing date of 6/16/2022 anticipates claims 8-12 of the instant application.
Should applicant disagree with the examiner’s factual determination above, applicant may provide support that the resB® Lung Support Probiotic is not the resB of the instant application, or that the resB® Lung Support Probiotic does not meet all limitations of claims 8-12 to overcome this rejection.
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 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-8, and 11-12 of copending Application No. 17/695339 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of 17/695339.
The instant claims are drawn to a food product, dietary supplement, medical food, or nutraceutical, wherein the food product, dietary supplement, medical food, or nutraceutical comprises at least viable one probiotic bacterial strain selected from Lactobacillus plantarum RSB11.RTM (ATCC Patent Deposit Number PTA-127171), Lactobacillus acidophilus RSB12.RTM (ATCC Patent Deposit Number PTA-127172), and Lactobacillus rhamnosus RSB13.RTM (ATCC Patent Deposit Number PTA- 127173), and a herbal mix comprising at least one herbal, or an extract thereof, wherein the at least one herbal is selected from the group consisting of holy basil, turmeric, and vasaka. Claims 1-4 are drawn to variations of this composition, where claim 1 only requires one of each bacterial strain and herb, claim 2 requires a mix of two or more bacterial strains and one or more herb, claim 3 requires all three bacterial strains and one or more herb, and claim 4 requires only a mix of all three bacterial strains and the herbal mix comprising at least one herbal, or an extract thereof. The claims of ‘339 are drawn to a food product, dietary supplement, medical food, or nutraceutical in an orally ingestible form, wherein the food product, dietary supplement, medical food, or nutraceutical consists of (i) a mixture of probiotic bacterial strains consisting of Lactobacillus plantarum, Lactobacillus acidophilus, and Lactobacillus rhamnosus, and (ii) an herbal mix consisting of the herbal extracts holy basil extract, turmeric extract, and vasaka extract, and (iii) a nutritionally acceptable carrier, nutritionally acceptable diluent, nutritionally acceptable excipient, nutritionally acceptable adjuvant, nutritionally active ingredient, or any combination thereof, wherein the orally ingestible form is selected from the group consisting of a capsule, microcapsule, tablet, granule, powder, troche, pill, suspension, and syrup (claim 1). These claims are patentably indistinct as the instant claims, as being drawn to “one or more” Lactobacillus strains and herbs can include all three, as in ‘339 claim 1. Moreover, as defined in the specification, “comprises” does not limit the contents of the composition to only bacterial strains and herbs, and thus can include the other materials mentioned in ‘339 claim 1.
Claim 4 of the instant application is drawn to “a food product….consisting of a mix of the bacterial strains Lactobacillus plantarum RSB11.RTM (ATCC Patent Deposit Number PTA-127171), Lactobacillus acidophilus RSB12.RTM (ATCC Patent Deposit Number PTA-127172), and Lactobacillus rhamnosus RSB13.RTM (ATCC Patent Deposit Number PTA- 127173), and a herbal mix comprising at least one herbal, or an extract thereof, wherein the at least one herbal is selected from the group consisting of holy basil, turmeric, and vasaka.” ‘Consisting of’ is interpreted in line with long-standing patent law convention, meaning that the food product…of claim 4 must only contain the three bacterial species and the herbal mix. However, the herbal mix itself is “comprising at least one herbal, or an extract thereof”. “An extract thereof” is not defined in the specification. An extract is commonly understood to be a processed version of a plant, and thereby often contains excipients, diluents, or carriers. For example, as stated above, water reads on an excipient or diluent; an aqueous extract of an herb is still an herbal extract, and therefore can be included in the herbal mix, and also contains water, a nutritionally accepted carrier or diluent. Thus, claim 4 is properly included in this rejection because a nutritionally acceptable carrier, diluent, or excipient may still be present in the product of claim 4.
The examiner acknowledges that the instant claims require an ATCC deposited strain, whereas the ‘339 application claim 3 requires a DSMZ-deposited strain. Although the USPTO does not have the facilities to determine if they are identical, they both have corresponding strain names (e.g., RSB11), and that the specification of ‘339 discloses (p. 2 lines 7-10, for example) that these strains, identified by name, have actually been deposited with ATCC, under the same accession numbers as the instant application. Thus to the best extent possible, the strains of ‘339 appear to be identical to those of the instant application, and ‘339 claim 3 anticipates the instant claims. Applicant may provide evidence the strains are not identical.
In all, the instant claims encompass all limitations of the ‘339 claims. Claim 9 of the instant application further limits the composition of claim 3 (containing all three bacterial strains and one or more herbs) to have a nutritionally acceptable carrier, nutritionally acceptable diluent, nutritionally acceptable excipient, nutritionally acceptable adjuvant or nutritionally active ingredient, as taught by claim 1 of ‘339. Claim 10 of the instant application specifies the composition of claim 3 has at least one nutritionally active ingredient, as taught in ‘339 claim 1, and claim 11 limits this ingredient to be a vitamin, a micronutrient, a mineral, a prebiotic fiber, a fatty acid, an amino acid, or any combination thereof, identical to ‘339 claim 11. Claim 12 of the instant application and claim 12 of ‘339 both further limit the ingredient with identical lists of vitamins and minerals. Claim 13 of the instant application limits the composition to be formulated for oral consumption, as stated in ‘339 claim 1, and claim 14 provides options of orally ingestible forms for the product, identical to the options in ‘339 claim 1.
Finally, claims 5-8 of the instant application provide further limitations of the composition, and are patentably indistinct from claims 5-8 of ‘339. Instant claim 5 states that in the composition of claim 2 (comprising at least 2 bacterial strains and one or more herbs), at least one Lactobacillus species is heat-killed. ‘339 claim 5 further limits claim 1 with ‘wherein the probiotic bacterial strains are heat-killed’. As more than one strain can be heat-killed in instant claim 5, it is anticipated by ‘339 claim 5. Instant claim 6 states a range of ratios and percentages that the three strains of claim 3 may be present in; each species is limited to 1-30% weight. This matches the limitation of ‘339 claim 6, which limits the amount of each Lactobacillus species to 1-30% weight. Instant claim 6 also provides the limitation that the ratio of bacteria:excipient is between 10:1 and 1:10. If all bacteria in ‘339 claim 6 are present at 30%, as falls within the range provided, the bacteria consist of 90% of the weight, and the excipient is 10%, resulting in a ratio of 9:1, which falls within the range of instant claim 6. Instant claim 7 provides the same percent weight ratios for the herbal mix, with each herb present in 1-30% and adjusted to 100% with at least one excipient. This is identical to ‘339 claim 7, where the percent weight ranges of the three herbal components are all 1-30%, adjusted to 100% with at least one excipient. Instant claim 8 reads on a composition that contains all three bacterial strains, all three herbs, and an excipient consisting of Mg stearate, silica, and MCC. ‘339 claim 8 limits the composition of claim 1, (which contains all three strains and all three herbs), stating the nutritionally acceptable excipient of claim 1 consists of magnesium stearate, silica, and MCC, as in instant claim 8.
Therefore, claims 1-14 are anticipated by claims 1, 5-8, and 11-12 of ‘339.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following pieces of prior art do not contain the claimed Lactobacillus strains; however, as the specification does not disclose the origin of the claimed strains, the art is relevant to the disclosure.
US 7,923,044 B2, 2011, Bias. This art discloses a dietary supplement that contains a blend of L. rhamnosus, L. acidophilus, and L. plantarum, in addition to holy basil leaf and turmeric rhizome. See claims 1, 2, 8, 15, and 17.
WO 2017/093961 A1, 2017, Chadha. This art discloses an herbal pharmaceutical composition that may contain a blend of L. rhamnosus, L. acidophilus, and L. plantarum, as well as turmeric and tulsi, also known as holy basil. See claims 1, 7, 8, 10 and 14.
US 2020/0054698 A1, 2020, Lal et al. This art claims a pharmaceutical composition with a bacterial population consisting of L. rhamnosus, L. acidophilus, and L. plantarum to reduce symptoms of bronchopulmonary disease.
US 2003/0228383 A1, 2003, Doshi et al. This art discloses an herbal composition to treat chronic respiratory disordered that comprises holy basil, turmeric, and vasaka within the 1-30% range of instant claim 7.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amelia C Stephens whose telephone number is (571)272-1006. The examiner can normally be reached M-F 8-5 EST.
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/AMELIA STEPHENS/ Examiner, Art Unit 1645
/DANIEL E KOLKER/ Supervisory Patent Examiner, Art Unit 1645