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
The amendment filed on 05/04/2026 amended claims 1-8 and 12-13. Claims 1-14 are pending and will be examined on the merits.
Response to Amendment
The amendment filed 05/04/2026 in response to the office action mailed 02/09/2026 is acknowledged. The rejections set forth under 35 USC 112(a) and 112(b) are withdrawn for the following reasons:
The claim objections for claims 5, 12, and 13 and the rejections under 35 USC 112(b) for claims 6, 7, and 9 are withdrawn in light of the amended claims. The rejections under 35 USC 112(a), enablement provision, have been withdrawn in light of the Declaration under 37 CFR §1.808, signed 4/30/2026, that provided complete information regarding the biological deposit of the recited strains in accordance with the Budapest Treaty.
Applicant’s arguments, see page 8, lines 3-15, filed 05/04/2026, with respect to the 35 USC 102 rejection of claims 8-12 have been fully considered and are persuasive. The rejection of 02/09/2026 has been withdrawn. The Declaration under 37 CFR §1.130 signed 4/30/2026 convincingly attests to the fact that the information disclosed in the Birmingham Business Journal article dated 10/28/2021 was disclosed by the inventor and thus qualifies for the grace period under 35 USC 102(b)(1)(A).
Maintained or modified rejections are set forth below, as necessitated by the amendments. Responses to arguments follow.
New 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 1-14 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.
Claims 1-4, 6, and 8 contain the trademark/trade name RSB11®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the claimed bacterial strains and, accordingly, the identification/description is indefinite. Claims 5, 7, and 9-14 depend from the rejected claims and therefore inherit this rejection.
Maintained Claim Rejections - 35 USC § 101
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 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 naturally occurring form. Additionally, the claims recite herbs, which are naturally occurring plants. 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 elements are naturally occurring products, thus are also judicial exceptions, and the combination of elements does not exhibit an effect that is markedly different than what is expected.
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.
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive.
Applicant argues that the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts, as recited in MPEP 2106.04(c)(I)(A). Applicant emphasizes the Supreme Court finding in Funk, indicating that in order for a mixture of bacteria to be patentable, the mixture must improve the natural functioning of the bacteria. Applicant argues that the instant claims differ from the Funk finding in that the claimed strains act in synergy with the herbal supplements, having markedly different ability to mitigate symptoms of bronchopulmonary disease. Applicant provides, in a Declaration filed under 37 CFR 1.132, additional evidence that the herbs act on the bacteria to increase production of nitric oxide, butyric acid, and hydrogen peroxide, and recites the claimed nature-based product of instant claims 1-14 therefore have markedly different characteristics compared to either the probiotic strains or herbal extracts alone, since the combination of herbs and bacteria does improve the natural function of the bacteria.
In regards to Applicant’s argument that the markedly different characteristics analysis should be applied to the combination of elements rather than component parts, Examiner points to page 10, lines 1-2, to show that the combination of elements was considered, but the specification did not support an effect that is markedly different than what is expected. The figures, which are not discussed in the specification in detail, do not provide sufficient evidence that the combination of bacteria and herbs amounts to significantly more than their individual components. Figure 10 demonstrates the effect of a mix of the three bacteria, resB blend #1, on MMP-9 expression in a dose dependent manner; Figure 12 demonstrates the effect of a mix of all three herbs on MMP-9 expression; Figure 13 demonstrates the effect of resB blend #1 and increasing concentrations of herbs on MMP-9 expression. As the axis is expressed in fold change, there is no direct comparison that can be made between these two measures. Additionally, there is no information about how many CFU of the resB #1 blend was used in the experiments in Figure 13, not in the figure itself, in the brief description of the drawings, or anywhere else in the specification. Therefore, no direct comparison of figure 10, 12, and 13 can be made to determine the synergistic effect of resB blend #1 and the herbal mix. Similar logic is applied to Figures 14 and 15, as there is no disclosure of how much of resB blend #1 is used in the experiments and there is no disclosure of which dose of vitamin D was used in the experiments of Figure 15. All subsequent figures 16-24 use the nutraceutical blend of resB, and therefore only provide data for treatment with all three bacteria and all three herbs in light of the specification, and therefore do not provide any data to support a synergistic effect between the bacteria and the herbs. Therefore, the specification as written at the time of the Office Action issued 02/09/2026 did not support that the combination of elements is markedly different than was is expected. Examiner will reevaluate the markedly different characteristics analysis in light of the Declaration filed under 37 CFR 1.132.
The Declaration under 37 CFR 1.132 filed 05/04/2026 is insufficient to overcome the rejection of claims 1-14 based upon 35 USC 101 as set forth in the last Office action because: the Declaration does not provide sufficient support that the combination of elements amounts to significantly more, as argued in the response filed 05/04/2026.
The Declaration discloses, in Figures D1-D6 (figure numbers are proceeded with a D for Declaration so as to not confused them with the specification figures), the results of in vitro experiments culturing the three strains of bacteria with or without the three herbal extracts and subsequently measuring butyric acid, nitric oxide, and peroxide. Examiner notes that the term “culture” is defined by the Merriam-Webster Dictionary as “to grow in a prepared medium”. However, while the starting CFU of the culture is provided in paragraph 5 of the Declaration, there is no recitation of how much the bacteria grew during the experiment, or terminal CFU. Therefore, there can be no determination that modest increase seen in the “PAR + Herbs” column, as compared to the addition of the values in the “PAR” and “Herbs” columns, is not simply a consequence of increased growth over the course of the experiment. Logically, more bacterial growth would amount to increased secretion of metabolites such as butyric acid, nitric oxide, and peroxide. Similarly, there are no CFU counts provided for the data in Figure D7, where the bacteria were cultured on cells with or without the herbs, and MMP-9 expression was measured. Additionally, Examiner notes that the difference between the PAR, Herbs, and PAR + Herbs groups in the left of Figure D7 are not denoted as significant, and the visual comparison between the Herbs group and the PAR + Herbs group does not indicate a synergistic effect. Therefore, the data in figures D1-D7 do not convincingly support that the herbs provide a synergistic effect to the bacteria.
The Declaration further discloses, in figures D8-D11, clinical data from NCT05523180, comparing biomarkers at baseline and week 12 after treatment with resB Lung Support, which constitutes all three bacteria and all three herbs. There is no in vivo data, in the specification or in the Declaration, that demonstrates synergy between the herbs and the bacteria, as there is no data, either from a mouse model or from a clinical trial, that provides comparison on how well the combination of elements treats the condition and how well each individual element treats the condition. Therefore, there is no in vivo data that supports the claimed synergistic effect.
Taken together, Applicant’s argument that the claimed strains act in synergy with the herbal supplements and have a markedly different ability to mitigate symptoms of bronchopulmonary disease is not found persuasive based on the data provided.
Finally, all data provided, in both the specification and in the Declaration, uses all three bacteria and/or all three herbs or herbal extracts. This is not commensurate with the scope of the claims. Claim 1, as written, is drawn to at least one strain and at least one herbal. Claim 2, as written, is drawn to a mix of two or three strains and at least one herbal. Claims 3 and 4, as written, is drawn to all three strains and at least one herbal. None of the claims require all three herbs. All data provided uses all three herbs. Therefore, the entire scope of the claim is never supported in the specification or the Declaration. MPEP §716.02(d) indicates that unexpected results (in this case, markedly different characteristics) “must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).” As neither the specification nor the Declaration provide support that the “markedly different characteristics” claimed occur over the scope of all the claims (from one bacteria and one herb to all three bacteria and all three herbs), the rejection of claims 1-14 under 35 USC 101 is upheld.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of markedly different characteristics fails to be persuasive.
Double Patenting - Modified as Necessitated by Claim Amendments
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 (DSM Deposit Number 35551), Lactobacillus acidophilus RSB12.RTM (DSM Deposit Number 35552), and Lactobacillus rhamnosus RSB13.RTM (DSM Deposit Number 35553), 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 (DSM Deposit Number 35551), Lactobacillus acidophilus RSB12 (DSM Deposit Number 35552), and Lactobacillus rhamnosus RSB13 (DSM Deposit Number 35553), 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.
In all, the ‘339 claims encompass all limitations of the instant 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. 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 claims 6 and 7 state a range of percentages that the three strains of claim 3 or the three herbals of claim 1, respectively, may be present in; each species is limited to 1-30% weight. This is anticipated by the limitation of ‘339 claim 1, which limits the amount of each Lactobacillus species and each herbal extract to somewhere between 5 % and 15% weight. 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, 3, 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.
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive.
Applicant requests that the rejection be held in abeyance until all other substantive issues are addressed. Applicant provides no argument on the content of the rejection. In light of Applicant’s remarks, the rejection is maintained. The rejection has been updated to include the latest claims from both the instant application and the reference application.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. 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 Amelia 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
/WU CHENG W SHEN/ Supervisory Patent Examiner, Art Unit 1682
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