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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 12/23/2025 has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The certified copy of EP20382019.6 was received on 06/08/2022.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
The instant claims are entitled to an effective filing date of 01/14/2021, which is the filing date of PCT/EP2021/050631.
DETAILED ACTION
Claims 2, and 9-13 are canceled.
Claims 1, 3-8 and 14-17 are pending and under consideration.
In light of the amendment filed 12/23/2025, the §112(a) scope of enablement rejection of claims 14-17 is withdrawn in light of the amendment. However, a new §112(a) rejection necessitated by amendment is addressed below.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “vehicles are high protein milkshake, a high protein smoothie or an energy gel”, which should either be replaced with “vehicle is a high protein milkshake, a high protein smoothie or an energy gel” or “vehicles are high protein milkshakes, high protein smoothies or energy gels”, so that the verb is in agreement with the predicate nominatives.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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, 3-8 and 14-17 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amendment filed on 12/23/2025 has introduced new matter into the claims.
Claim 1, as filed on 12/23/2025, recites a composition that comprises the bacteria Lactobacillus rhamnosus, Lactobacillus casei and Bifidobacterium longum, together with one or more food-based and/or pharmaceutically acceptable vehicles and/or excipients, wherein L. rhamnosus is the strain BPL0015 deposited in the Spanish Type Culture Collection under deposit number CECT8361, L. casei is the strain BPL0004 deposited in the Spanish Type Culture Collection under deposit number CECT9104 and B. longum is the strain IATA-ES 1 deposited in the Spanish Type Culture Collection under deposit number CECT7347, and wherein the food-based acceptable vehicles are high protein milkshake, a high protein smoothie or an energy gel.
Claim 1 and dependent claims 3-8 and 14-17 contain new matter because of the limitation requiring a high protein milkshake, a high protein smoothie or an energy gel, as underlined above. The specification as filed and the original claims do not provide support for this limitation in claim 1. According to the specification, examples of foods that may comprise the composition include but are not limited to dairy products, plant products, beverages, dehydrated powdered foods, food gels, and baby foods. Examples of dairy products include, but are not limited to, products derived from fermented milk or unfermented milk (e.g., whey). Beverages may be unfermented milk or smoothies in liquid form or in powder for reconstitution with water. In a particular embodiment, the food product is selected from the group consisting of: fruit or vegetable juices, ice-cream, infant formula, milk, yogurt, cheese, fermented milk, powdered milk, cereals, pastry products, dairy products, meat products, beverages and confectionery, gum-based products (for example, fruit gums, with or without added sugars). See page 10 lines 14-27. Thus, the specification provides support for dairy products, smoothies and food gels, but the specification is silent regarding a high protein milkshake, high protein smoothie, or energy gel.
Such limitations recited in the instant claim 1 (and dependent claims), which did not appear in the specification or original claims, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in the instant claim. Applicant can remove the new matter limitations from the claims to obviate this rejection.
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 1, 3-8 and 14-17 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.
A broad limitation together with a limitation that falls within the broad 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 1 recites the broad recitation “one or more food-based and/or pharmaceutically acceptable vehicles and/or excipients” (lines 2-3), and the claim also recites “wherein the food-based acceptable vehicles are high protein milkshake, a high protein smoothie, or an energy gel” (last 2 lines) which is the narrower statement of the 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. Furthermore, it is unclear whether the claim encompasses “one or more” food-based acceptable vehicles or whether the claim is limited to a plurality of food-based vehicles, because “vehicles” (line 8) is recited in the plural form.
The terms “high” (line 8) and “energy” (line 9) in claim 1 are relative terms which render the claim indefinite. The terms “high” and “energy” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the instant case, the amount of protein required for a milkshake or smoothie to be considered high in protein is unclear. Furthermore, the way in which an energy gel differs from any other food-based gel is unclear. The specification does not provide any relevant teachings.
Claims 3-8 and 14-17 depend from claim 1 and are rejected for the reasons set forth above.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 does not clearly include all of the limitations of claim 1, because claim 3 does not clearly limit the L. rhamnosus, L. casei and B. longum to the specific CECT8361, CECT9104 and CECT7347 strains of claim 1 respectively. To obviate this rejection, “L. rhamnosus” (line 1), “L. casei”(line 2) and “B. longum”(line 2) can be replaced with “the L. rhamnosus”, “the L. casei” and “the B. longum” respectively, so that each species recitation in claim 3 clearly refers to the specific strains of claim 1.
Claim 5 does not clearly limit claim 1 from which it depends. Claim 1 can reasonably be interpreted as a food composition because the composition of claim 1 comprises a high protein milkshake, a high protein smoothie or an energy gel. However, claim 5 requires the composition to be a “pharmaceutical or food composition”. Therefore, claim 5 broadens the scope of the food composition in claim 1 to a pharmaceutical.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 and 3-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product, which is a judicial exception, without significantly more. Each step described below is in reference to the subject matter eligibility test for products and processes (MPEP 2106).
Claim 1 recites a “composition” in line 1, which is one of the statutory categories (Step 1:Yes).
Claim 1 requires a composition comprising Lactobacillus rhamnosus deposit number CECT8361, L. casei deposit number CECT9104, and B. longum deposit number CECT7347. According to the instant specification, these strains can be isolated from the feces of a Spanish baby under 3 months of age fed exclusively by breastfeeding. See lines 17-18 on page 3, lines 20-21 and 33-34 on page 4, and lines 12-13 page 5. Compared to closest naturally occurring counterpart, there is no structural difference between the natural probiotic strains from feces and the instantly claimed bacteria. Because there is no indication in the record that the instantly disclosed Lactobacillus rhamnosus deposit number CECT8361, L. casei deposit number CECT9104, and B. longum deposit number CECT7347 have a markedly different characteristic in structure, function, or other properties as compared to its natural counterpart (i.e. the strains found together in baby feces), the claims are directed to a natural-product, which is a judicial exception (Step 2A Prong 1: Yes).
The additional claimed elements separately and accumulatively fail to integrate the product of nature into practical application. Besides the natural product judicial exception identified above, claim 1 requires the composition to have one or more food-based and/or pharmaceutically acceptable vehicles and/or excipients; wherein the food-based acceptable vehicles are high protein milkshake[s], high protein smoothie[s] or energy gel[s]. However, these food-based acceptable vehicles are recited with a high level of generality such that the broadest interpretation encompasses any edible gel and any beverage blend that includes protein. Furthermore, the instant specification states that the “excipient and/or vehicle may be natural, i.e., they exist in nature” (page 8 line 11). As such, the additional vehicle element of claim 1 does not add anything of significance to the judicial exception that could integrate it into a practical application. Claims 3 and 4 limit the concentration and total amount of the bacteria in the composition respectively. The limitations of claims 3 and 4 do not substantially limit the structure of the composition and there is no indication of record that the specific amounts impact the properties of the Lactobacillus rhamnosus deposit number CECT8361, L. casei deposit number CECT9104, and B. longum deposit number CECT7347 apart from any inherent properties. See lines 21-32 on page 8 of the instant specification for the instantly claimed amounts. Consequently, claims 3 and 4 do not add any elements to the judicial exception that could integrate it into a practical application. Claims 5 and 6 do not limit the structure of the composition in anyway. Rather, claims 5 and 6 link the judicial exception to an intended use as a probiotic pharmaceutical or food composition for oral administration. As such, claims 5 and 6 do not add any significant elements to the natural product that could integrate it into a practical application. Claim 7 requires the composition to be in a solid form, which merely describes one natural state of the judicial exception. Claim 8 requires the composition to be in a capsule form. The capsule element of claim 8 is insignificant because it is a tangential or nominal addition to the primary composition of the claims. Therefore, the claim as a whole, does not integrate the judicial exception into a practical application (Step 2A Prong 2: No).
The additional elements fail to amount to an inventive concept in view of the well-known and conventional practices in the art of using probiotics for oxidative stress treatment. Asemi (Annals of nutrition and metabolism, 63(1-2), 1-9) teaches a multispecies probiotic capsule that includes L. casei, L. rhamnosus, B. longum, fructo-oligosaccharide and lactose. See the characteristics of supplements section on page 3. Asemi teaches a study in which patients with type 2 diabetes consume the multispecies probiotic capsule. See the participants and study design sections on page 2. Asemi discloses that the majority of diabetic patients have oxidative stress. See the first paragraph of the introduction section on page 2 and the first 3 lines of page 6 in the left column. Thus, solid capsule formulations for oral administration were well known in the art prior to the effective filing date and the additional limitations in claims 1-8 fail to amount to an inventive concept (Step 2B: No).
For all of these reasons, claims 1, and 3-8 are not patent eligible.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
§101 rejection of claims 1, and 3-8
Applicant argues that the evidence provided in figures 2-5 of Affidavit A is commensurate in scope with amended claim 1, because claim 1 now requires a high protein milkshake, high protein smoothie, or energy gel. See the first paragraph on page 7.
This argument is not persuasive for two reasons. First, the evidence in figures 2-5 of Affidavit A, received 05/08/2025, is not commensurate in scope with amended claim 1 because claim 1 recites the broad recitation “one or more food-based and/or pharmaceutically acceptable vehicles and/or excipients”; and because the compositions of the claimed high protein milkshake, high protein smoothie, and energy gel are not particularly limited. Second, the evidence set forth in Affidavit A does not sufficiently establish a markedly different characteristic, as discussed at length in the action mailed 06/27/2025. Figures 2-5 show the % survival of C. elegans N2 when fed with a 45%:45%:10% strain mix (L. casei CECT 9104: L. rhamnosus CECT 8361: B. longum CECT 7347) alone, the strain mix in combination with a food-based vehicle, and the food-based vehicle alone. Although, figures 2-5 indicate that the probiotic and vehicle mixtures increase the % survival as compared to the individual components, the increases appear to be an additive effect. Thus, the affidavit filed 05/08/2025 is insufficient to overcome the §101, as discussed on pages 14-16 of the action mailed 06/27/2025.
Applicant argues that the term “synergistic effect” from the chemical point of view is different from the synergistic effect in a biological system. In this context, synergy refers to interaction, not to an absolute magnitude. See the last full paragraph on page 7 of the remarks. Applicant asserts that the magnitude of the combined effect does not determine the presence of synergy; a synergistic interaction may yield a response smaller than that produced by the most potent individual component, provided that the observed outcome cannot be explained by simple summation or multiplication of individual effects. See the paragraph spanning pages 7-8 of the remarks. Applicant asserts that figures 1-5 [of affidavit A] show a biological interaction between the strains of the invention and the food matrix to enhance the inhibition of radical scavenging activity. See the first full paragraph on page 8 of the remarks. Applicant discloses that the results in figure 1 of Affidavit A are normalized with data from food vehicles alone. See paragraph 2 on page 7 of the remarks.
This argument is not persuasive, because Affidavit A, received 05/08/2025, does not clearly provide factual evidence of a synergistic effect. Figure 1 of Affidavit A teaches that the % of inhibition of the radical scavenging activity of the probiotic blend shows a significant increase with the following vehicles: commercial energy drink, energy juice, apple juice, peach & grape juice, lemonade, soy drink, liquid yogurt drink and in-house red fruits still water matrix. See the last paragraph on page 4 of affidavit A. The percent of inhibited varies depending on the vehicle used. Yet, no common structure is identified amongst the vehicles, so it is unclear which, if any, specific interactions can be considered synergistic rather than additive. Considering the % inhibition of the positive control, i.e. vitamin C alone, one could reasonably infer that the % inhibition for each probiotic + vehicle combination depends on the amount of vitamin C present in the vehicle rather than a specific synergistic interaction.
Applicant argues the antioxidant activity of the claimed bacterial mixture is significantly higher than that exerted by each individual strain. The tested individual strains do not significantly protect against oxidative stress compared to the control (not treated, Nematode Growth Medium or NGM) used in the assay. Applicant references exhibit 1. See the last paragraph on page 8 of the remarks. Applicant asserts that the three-strain combination leads to the surprising and unexpected technical effect of increasing survival in the C. elegans oxidative stress model to a significantly higher degree than the individual strains used separately. See the first paragraph on page 9 of the remarks. Furthermore, Applicant asserts that Exhibit 2 shows that the mix of the three claimed strains significantly protects against oxidative stress, while alternative combinations with strains of the same species do not show any protective effect. See the paragraph spanning pages 9-10 of the remarks. Thus, Applicant asserts that claim 1 shows markedly different characteristics. See the last paragraph on page 10.
The examiner acknowledges receipt of the two affidavits “Exhibit 1” and “Exhibit 2” under 37 CFR 1.132 by Ms. Chenoll Cuadros, a co-inventor, on 12/23/2025.
The affidavits (Exhibit 1 and Exhibit 2) under 37 CFR 1.132 filed 12/23/2025 are insufficient to overcome the rejection of claims 1, and 3-8 based upon §101 as set forth in the last Office action because: the facts presented are not germane to the rejection at issue. The markedly different characteristics analysis (step 2 prong 1) compares the nature-based product limitation to its naturally occurring counterpart in its natural state. In the instant case, the nature-based product limitation is the combination of the three recited strains; and the natural counter-part for comparison is also the combination of the three recited strains because the three strains can be found together in baby feces in their natural state. Therefore, the comparisons provided in Exhibits 1 and 2 are not germane to the markedly different characteristics analysis discussed in the rejection above, because Exhibits 1 and 2 are silent regarding a comparison between the claimed strain combination and the strain combination found in baby feces. MPEP 2106.04(c)(II)(C) states that “[t]he courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart”. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75.
Claim Rejections - 35 USC § 103
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.
Claims 1 and 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lopéz (EP 3 222 282 A1 published 09/27/2017; hereafter Lopéz (2017)) in view of Lopéz (EP 3 272 396 A1 published 01/24/2018; hereafter Lopéz (2018)).
Claim 1 is a product that requires L. rhamnosus CECT 8361, L. casei CECT 9104, B. longum CECT 7347, and a food-based acceptable vehicle that is a milkshake with protein, a smoothie with protein, or a gelatin, and/or pharmaceutically acceptable excipients.
Regarding claim 1, Lopéz (2017) teaches a probiotic composition comprising Bifidobacterium longum CECT7347 and Lactobacillus rhamnosus CECT8361. See claims 1-2 of Lopéz (2017). The composition comprises a pharmaceutically acceptable carrier. See claim 5 of Lopéz (2017). Examples of pharmaceutically acceptable carriers include gelatin. See [0027]. The probiotic composition further comprises a microorganism selected from a group that includes Lactobacillus. See claim 11 of Lopéz (2017). Lopéz (2017) teaches an embodiment in which the Lactobacillus is L. casei. See [0040].
Lopéz (2017) does not teach L. casei CECT9104.
Lopéz (2018) teaches a probiotic composition that comprises L. casei CECT 9104 and B. longum CECT 7347. See claims 1-2, and 15 and paragraphs [0030-0032]. The composition comprises a pharmaceutically acceptable carrier. See claim 4 of Lopéz (2018). Examples of pharmaceutically acceptable carriers include gelatin. See [0042]. Lopéz (2018) teaches a composition that further comprises a microorganism selected from a group that includes Lactobacillus. See claim 10 of Lopéz (2018). Lopéz (2018) teaches an embodiment in which the Lactobacillus is L. rhamnosus. See [0055].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine the L. casei CECT 9104 of Lopéz (2018) with the probiotic composition of Lopéz (2017). One would be motivated to do so because Lopéz (2017) teaches an embodiment in which the probiotic composition further comprises L. casei. There would be a reasonable expectation of success because Lopéz (2018) teaches an L. casei strain (CECT 9104) that can be used in combination with B. longum CECT 7347 (i.e. the same B. longum strain as Lopéz (2017)) and L. rhamnosus.
Regarding claim 3, Lopéz (2017) teaches a L. rhamnosus concentration that is at least 30%. See [0046] and [0057].
Lopéz (2018) teaches a B. longum CECT7347 concentration of 10% and a L. casei CECT 9104 concentration of 45%. See [0060].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to optimize the concentrations of the L. rhamnosus CECT8361, B. longum CECT7347 and L. casei CECT 9104 strains in the composition of Lopéz (2017) and Lopéz (2018). One would be motivated to do so because Lopéz (2017) and Lopéz (2018) suggests that the probiotics should be present in a therapeutically effective amount so that they can exert their effect. See [0042] of Lopéz (2017) and [0057] of Lopéz (2018). There would be a reasonable expectation of success because both references provide starting concentrations from which one could reasonably optimize. MPEP 2144.05(II) indicates that differences in concentration generally amount to “routine optimization” and will not support patentability unless there is evidence indicating the claimed feature is critical. “Where 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).
Regarding claim 4, Lopéz (2017) teaches a microorganism concentration in the composition between 103 and 1012 cfu, preferably 109 cfu. See [0044] and [0059].
Lopéz (2018) teaches a total concentration of microorganisms of microorganisms of L. casei CECT 9104 and/or B. longum CECT7347 in the composition between 103 and 1012 cfu, preferably 109 cfu. See [0059].
Regarding claim 5, Lopéz (2017) teaches a probiotic composition that is a pharmaceutical composition or a nutritional composition. The nutritional composition is a food or a nutritional supplement. See claims 4 and 9-10 of Lopéz (2017).
Lopéz (2018) teaches a probiotic composition that is a pharmaceutical composition or a nutritional composition. The nutritional composition is a food or a nutritional supplement. See claims 3 and 8-9 of Lopéz (2018).
Regarding claim 6, Lopéz (2017) teaches a probiotic composition to be administered to a subject orally. See [0021], [0032] and [0096].
Lopéz (2018) teaches a probiotic composition to be administered to a subject orally. See [0036], [0047] and [0091]-[0093].
Regarding claim 7, Lopéz (2017) teaches a composition formulated in solid form. See claim 6 of Lopéz (2017).
Lopéz (2018) teaches a composition formulated in solid form. See claim 5 of Lopéz (2018).
Regarding claim 8, Lopéz (2017) teaches a solid formulation selected from a group that includes capsules See claim 7 of Lopéz (2017).
Lopéz (2018) teaches a solid formulation selected from a group that includes capsules See claim 6 of Lopéz (2018).
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lopéz (EP 3 222 282 A1 published 09/27/2017; hereafter Lopéz (2017)) and Lopéz (EP 3 272 396 A1 published 01/24/2018; hereafter Lopéz (2018)), as applied to claims 1 and 3-8 above, and further in view of Zhou (Free Radical Biology and Medicine, 2009, 47(7), 891-905), Ji (Oxidative Medicine and Cellular Longevity, 2016, 2721469, 8 pages), and Román (Francisco Clinicaltrials.gov, NIH, 10 Jan. 2019).
The teachings of Lopéz (2017) and Lopéz (2018) with respect to instant claim 1 are discussed above.
Regarding claim 14, Lopéz (2017) teaches administering a single daily tablet of the probiotic composition to plaque psoriasis patients. See example 2 paragraphs [0085]-[0092].
Lopéz (2018) teaches dosing atopic dermatitis patients with one capsule of the probiotic composition per day. See example 2 [0088]-[0096].
Lopéz (2017) and Lopéz (2018) do not teach administering a composition to a subject in need of oxidative stress treatment and/or reduction.
Zhou discloses that reactive oxygen species (ROS) play a role in the pathogenesis of psoriasis; and that skin is a major target of oxidative stress due to ROS. See the abstract and the last paragraph on page 900 of Zhou. Therefore, Zhou suggests that psoriasis (i.e. the same disease taught by Lopéz (2017)) is associated with ROS.
Ji teaches that oxidative stress is a factor in the pathogenesis of atopic dermatitis. See lines 1-2 of the conclusion section on page 6. Therefore, Ji suggests that atopic dermatitis (i.e. the same disease taught by Lopéz (2018)) is associated with oxidative stress.
Román teaches evaluating the antioxidant efficacy of a product probiotic and determining the efficacy of the investigational product versus placebo in reducing oxidative stress during the performance of a physical exercise of a certain intensity and duration. See the title on page 1 and the brief summary section on page 4. Román teaches a dietary supplement consisting of Lactobacillus rhamnosus, Lactobacillus casei, and Bifidobacterium longum. See the intervention/ treatment section on page 2. Román discloses that the dietary supplement is formulated into a capsule. See the left column on page 6.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to substitute the L. rhamnosus CECT 8361 Lopéz (2017), the L. casei CECT 9104 of Lopéz (2018), and the B. longum CECT 7347 taught by Lopéz (2017) and Lopéz (2018) for the L. rhamnosus, L. casei and B. longum used in Román’s method of reducing oxidative stress. One would be motivated to use the specific strains of Lopéz (2017) and Lopéz (2018), because Zhou and Ji suggest using the strains of Lopéz (2017) and Lopéz (2018) for treating diseases associated with oxidative stress. There would be a reasonable expectation of success because Román teaches formulating a composition comprising L. rhamnosus, L. casei and B. longum. Thus, one would reasonably expect the L. rhamnosus CECT 8361, L. casei CECT 9104 and B. longum CECT 7347 to serve the same function in the composition of Román in the same field of reducing oxidative stress.
Regarding claim 15, Román teaches a study for determining the efficacy of the investigational product (i.e. the dietary supplement) in reducing oxidative stress during the performance of a physical exercise. See the brief summary section. The primary purpose of the study plan is for treatment. See page 5. Román teaches a study population comprised of subjects that perform physical exercise (e.g. subjects in need thereof). See the inclusion criteria section.
Regarding claim 16-17, Román teaches a study design that includes the consumption of one dietary supplement capsule at breakfast for six weeks. See the left column on page 6.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered to the extent that they might apply to the new grounds of rejection set forth above, but they are unpersuasive.
Applicant argues that Exhibit 3 shows that the combination of Lopéz (2018) is not useful as the combination of claim 1 for treating oxidative stress, i.e. the antioxidant activity of the probiotic blend of claim 1 is significantly higher than the antioxidant activity of the combination 1 blend. Furthermore, Applicant assert that Exhibit 2 shows that different strain combinations result in a loss of effect. See the last paragraph on page 12.
This argument is not persuasive because one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The probiotic combination of claim 1 is rendered obvious over the combination of Lopéz (2018) and Lopéz (2017), and not Lopéz (2018) alone as argued. Furthermore, claim 1 does not require the composition to be for the purpose of treating oxidative stress. Exhibits 2 and 3 will be addressed separately below.
Applicant asserts that combining the strains of Lopéz (2017) and Lopéz (2018) is not mere substitution of equivalents. It is combining specific strains for obtaining a higher antioxidant activity. See the last paragraph on page 12.
This argument is not persuasive because the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant asserts that knowing that B. longum CECT 7347 and L. rhamnosus CECT 8361 are used for treating atopic dermatitis does not indicate that they can be used for treating oxidative stress. See the first paragraph on page 13.
This argument is not persuasive because instant claims 14-17 are not rejected over the atopic dermatitis treatment method of Lopéz (2018). For clarity of the record, Lopéz (2018) teaches treating atopic dermatitis patients with a probiotic combination that includes B. longum CECT 7347 and L. casei CECT 9104. See example 2 and specifically paragraph [0091] of Lopéz (2018). Lopéz (2017) is relied upon for teaching the L. rhamnosus CECT 8361 element. Ji teaches the association between oxidative stress and atopic dermatitis. Román is relied upon for teaching that L. casei, B. longum and L. rhamnosus can be used for improving oxidative stress. As such, the argument is not persuasive because claims are rejected over the combination of references and not Lopéz (2018) alone.
The examiner acknowledges receipt of the affidavits “Exhibit 2” and “Exhibit 3” under 37 CFR 1.132 by Ms. Chenoll Cuadros, a co-inventor, on 12/23/2025.
The affidavits (Exhibit 2 and Exhibit 3) under 37 CFR 1.132 filed 12/23/2025 are insufficient to overcome the rejections of claims 1, 3-8, and 14-17 based upon §103 as set forth in the last Office action because: showings are not commensurate in scope with the claims. Exhibit 2 shows that the mix of B. longum CECT7347 (IATA ES1), L. rhamnosus CECT8361 (BPL0015) and L. casei CECT9104 (BPL004) in an amount of 1x107 CFU in a ratio of 1:1:1 (i.e. the ES1+BPL15+BPL4 1:1:1 mixture) significantly protects against oxidative stress, while the other combinations do not have a significant effect. Exhibit 3 shows the radical scavenging inhibition for combination 1, ES1+BPL15+BPL4 in a 10%:45%:45% ratio, to combination blend 2 of Lopéz (2018), which includes B. lactis BPL001, B. longum ES1 (i.e. the claimed CECT7347), and L. casei BPL004 (i.e. the claimed CECT9104) in a 3.5 – 3.5 – 3 ratio. However, the composition of instant claim 1 is not limited to the specific mixture of Exhibit 2 or the specific combination of Exhibit 3. Rather, claim 1 encompasses compositions comprising ESI+BPL15+BPL4 at any ratio, and in any amount. Furthermore, claim 1 recites the open-ended term “comprising”, so the claim does not exclude additional elements.
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, 3-8 and 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,434,127 B2 to Rodríguez (hereafter Rodríguez ‘127) in view of Lopéz EP 3 272 396 A1 published 01/24/2018 (hereafter Lopéz (2018)) and Román, Francisco Clinicaltrials.gov, NIH, 10 Jan. 2019.
Claim 1 of Rodríguez ‘127 recites a formulation comprising the strains Lactobacillus rhamnosus CECT 8361 and Bifidobacterium longum CECT 7347, the combination of which is able to improve semen quality, and a carrier and/or an excipient.
Claim 2 of Rodríguez ‘127 recites the formulation according to claim 1, wherein the Lactobacillus rhamnosus CECT 8361: Bifidobacterium longum CECT 7347 ratio is 50:50.
Claim 3 of Rodríguez ‘127 recites the formulation according to claim 1, wherein the formulation is a pharmaceutical formulation or a functional nutritional formulation.
Claim 4 of Rodríguez ‘127 recites the formulation according to claim 3, wherein the pharmaceutical formulation comprises a pharmaceutically acceptable carrier and/or excipient.
Claim 5 of Rodríguez ‘127 recites the formulation according to claim 3, wherein the pharmaceutical formulation is suitable for oral administration.
Claim 6 of Rodríguez ‘127 recites the formulation according to claim 3, wherein the nutritional formulation is a functional food or a nutritional supplement.
Claim 7 of Rodríguez ‘127 recites the formulation according to claim 6, wherein the food is selected from the group consisting of a dairy product, a meat product, a vegetable product, an animal feed and a beverage.
Claim 8 of Rodríguez ‘127 recites the formulation according to claim 1, wherein the total concentration of microorganisms of the strains Lactobacillus rhamnosus CECT 8361 and Bifidobacterium longum CECT 7347 in the formulation is between 106 and 1012 cfu.
Claim 9 of Rodríguez ‘127 recites the formulation according to claim 1, wherein the strains Lactobacillus rhamnosus CECT 8361 shows greater antioxidant activity than other strains of Lactobacillus, wherein greater antioxidant activity means that Lactobacillus rhamnosus CECT 8361 affords cells greater protection against oxidative stress than other strains of Lactobacillus.
Claim 10 of Rodríguez ‘127 recites the formulation of claim 8, wherein the total concentration of microorganisms of the strains Lactobacillus rhamnosus CECT 8361 and Bifidobacterium longum CECT 7347 in the formulation is 109 cfu.
Claim 11 of Rodríguez ‘127 recites the method for improving semen quality in a subject comprising administering to a subject a formulation comprising a Lactobacillus rhamnosus strain CECT 8361 in combination with a Bifidobacterium longum strain CECT 7347 and a carrier and/or excipient.
Claim 12 of Rodríguez ‘127 recites the method according to claim 11, wherein the Lactobacillus rhamnosus: Bifidobacterium longum ratio is 50:50.
Claim 13 of Rodríguez ‘127 recites the method according to claim 11, wherein the formulation is a pharmaceutical formulation or a functional nutritional formulation.
Claim 14 of Rodríguez ‘127 recites the method according to claim 13, wherein the pharmaceutical formulation comprises a pharmaceutically acceptable carrier and/or excipient.
Claim 15 of Rodríguez ‘127 recites the method according to claim 13, wherein the pharmaceutical formulation is developed for oral administration.
Claim 16 of Rodríguez ‘127 recites the method according to claim 13, wherein the functional nutritional formulation is a food or a nutritional supplement.
Claim 17 of Rodríguez ‘127 recites the method according to claim 16, wherein the food is selected from the group consisting of a dairy product, a meat product, a vegetable product, an animal feed and a beverage.
Claim 18 of Rodríguez ‘127 recites the method according to claim 11, wherein the subject is a fish or a mammal.
Claim 19 of Rodríguez ‘127 recites the method according to claim 11, wherein the microorganisms of the strains Lactobacillus rhamnosus and Bifidobacterium longum in the formulation are administered at a dose of between 106 and 1012 cfu/day.
Claim 20 of Rodríguez ‘127 recites the method according to claim 19, wherein the microorganisms of the strains Lactobacillus rhamnosus and Bifidobacterium longum in the formulation are administered at a dose of 109 cfu/day.
Claim 21 of Rodríguez ‘127 recites the method according to claim 11, wherein the dosage of the formulation is at least once a day.
The instant claims 1, and 3-8 differ from the patent claims of Rodríguez ‘127 in that the patent claims of Rodríguez ‘127 lack: Lactobacillus casei deposit number CECT9104, and food-based acceptable vehicle that is high protein milkshake, high protein smoothie or energy gel (relevant to instant claim 1); L. rhamnosus at a concentration of 45%, L. casei at a concentration of 45% and B. longum at a concentration of 10% (relevant to instant claim 3): a solid form (relevant to instant claim 7); and a composition presented in capsule form (relevant to instant claim 8).
However, Lopéz (2018) teaches a probiotic composition comprising L. casei CECT 9104, and further comprising a pharmaceutically acceptable carrier. See claims 1-2 and of Lopéz (2018). Lopéz (2018) teaches examples of carriers including gelatin [0042] (relevant to instant claim 1). Lopéz (2018) teaches a L. casei strain CECT 9104 concentration of 45%, and B. longum CECT 7347 concentration of 10% [0060] (relevant to instant claim 3). Lopéz (2018) teaches solid formulations selected from a group that includes capsules. See claim 6 of Lopéz (2018) (relevant to instant claims 7-8).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the formulation of Rodríguez ‘127 by adding the L. casei CECT 9104 and gelatin of Lopéz (2018), and further optimizing the percentage of each strain in order to arrive at pharmaceutical probiotic composition.
The instant claims 14-17 differ from the patent claims of Rodríguez ‘127 in that the patent claims of Rodríguez ‘127 lack: a subject in need of oxidative stress treatment and/or reduction (relevant to instant claim 14); wherein the oxidative stress is caused by physical activity (relevant to instant claim 15); and a composition that is administered for 6 weeks (relevant to instant claim 17).
However, Román teaches administering a composition comprising B. longum, L. casei, and L. rhamnosus for the purpose of treating oxidative stress during the performance of a physical exercise. See the brief summary section and pages 5-6 (relevant to instant claims 14-15). The study design includes the consumption of one dietary supplement capsule at breakfast for six weeks. See the left column on page 6 (relevant to instant claim 17).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the method of Rodríguez ‘127 by adding the L. casei, and gelatin of Lopéz (2018) to the formulation of Rodríguez ‘127 and by further administering the formulation for 6 weeks, as taught by Román, for the purpose of treating oxidative stress caused by physical activity.
Claims 1, 3-8 and 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,912,802 B2 to Lopéz (hereafter Lopéz ‘802) in view of Lopéz EP 3 272 396 A1 published 01/24/2018 (hereafter Lopéz (2018)) and Román, Francisco Clinicaltrials.gov, NIH, 10 Jan. 2019.
Claim 1 of Lopéz ‘802 recites a probiotic composition comprising microorganisms of Bifidobacterium animalis subs. lactis (B. lactis), Bifidobacterium longum and Lactobacillus rhamnosus, wherein the concentration of B. longum with respect to the total concentration of microorganisms present in the composition is at least 30%, wherein B. lactis is B. lactis CECT 8145, B. longum is B. longum ES1 CECT 7347 and L. rhamnosus is L. rhamnosus CECT 8361.
Claim 2 of Lopéz ‘802 recites a method for the treatment or prevention of psoriasis outbreaks or psoriasis comprising administering to a subject in need thereof an effective amount of a probiotic composition comprising Bifidobacterium animalis subsp. lactis (B. lactis), Bifidobacterium longum and Lactobacillus rhamnosus, wherein B. lactis is B. lactis CECT 8145 is, B. longum is B. longum ES1 CECT 7347 and/or L. rhamnosus is L. rhamnosus CECT 8361.
Claim 4 of Lopéz ‘802 recites the method according to claim 2, wherein the probiotic composition is a pharmaceutical composition or a nutritional composition.
Claim 5 of Lopéz ‘802 recites the method according to claim 4, wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier and/or an excipient.
Claim 6 of Lopéz ‘802 recites the method according to claim 4, wherein the pharmaceutical composition is formulated for administration in liquid form or in solid form.
Claim 7 of Lopéz ‘802 recites the method according to claim 6, wherein the solid formulation is selected from the group consisting of tablets, lozenges, sweets, chewable tablets, chewing gum, capsules, sachets, powders, granules, coated particles or coated tablets, tablets and gastro-resistant tablets and capsules and dispersible strips and films.
Claim 9 of Lopéz ‘802 recites the method according to claim 4, wherein the nutritional composition is a food or a nutritional supplement.
Claim 10 of Lopéz ‘802 recites the method according to claim 9, wherein the food is selected from the group consisting of fruit or vegetable juices, ice cream, infant formula, milk, yogurt, cheese, fermented milk, milk powder, cereals, baked goods, milk-based products, meat products and beverages.
Claim 11 of Lopéz ‘802 recites the method according to claim 2, wherein the composition further comprises a microorganism selected from the group consisting of Lactobacillus sp., Streptococcus sp., Bifidobacterium sp., Saccharomyces sp., Kluyveromyces sp. and combinations thereof.
Claim 12 of Lopéz ‘802 recites the method according to claim 2, wherein the total concentration of microorganisms of the strains B. lactis, L. rhamnosus and B. longum in the composition is between 103 and 1012 cfu.
Claim 13 of Lopéz ‘802 recites the method according to claim 2, wherein the concentration of B. longum with respect to the total concentration of microorganisms present in the composition is at least 30%.
The instant claims 1, and 3-8 differ from the patent claims of Lopéz ‘802 in that Lopéz ‘802 lacks Lactobacillus casei CECT9104 and food-based vehicle that is high protein milkshake, a high protein smoothie or an energy gel (relevant to instant claim 1); L. rhamnosus at a concentration of 45%, L. casei at a concentration of 45% and B. longum at a concentration of 10% (relevant to instant claim 3).
However, Lopéz (2018) teaches a probiotic composition comprising L. casei CECT 9104, and further comprising a pharmaceutically acceptable carrier. See claims 1-2 and of Lopéz (2018). Lopéz (2018) teaches examples of carriers including gelatin [0042] (relevant to instant claim 1). Lopéz (2018) teaches that the concentration of L. casei strain CECT 9104 at a concentration of 45%, and B. longum CECT 7347 at a concentration of 10% [0060] (relevant to instant claim 3).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the formulation of Lopéz ‘802 by adding the L. casei CECT 9104 and gelatin of Lopéz (2018), and by further optimizing the percentage of each strain and total bacterial concentration in order to arrive at a pharmaceutical probiotic composition.
The instant claims 14-17 differ from the patent claims of Lopéz ‘802 because the patent claims of Lopéz ‘802 lack: a subject in need of oxidative stress treatment and/or reduction (relevant to instant claim 14); oxidative stress caused by physical activity (relevant to instant claim 15); a composition administered once a day (relevant to instant claim 16); and administered for 6 weeks (relevant to instant claim 17).
However, Román teaches administering a composition comprising B. longum, L. casei, and L. rhamnosus for the purpose of treating oxidative stress during the performance of a physical exercise. See the brief summary section and pages 5-6 (relevant to instant claims 14-15). The study design includes the consumption of one dietary supplement capsule at breakfast for six weeks. See the left column on page 6 (relevant to instant claims 16-17).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the treatment method of Lopéz ‘802 by adding the L. casei CECT 9104 of Lopéz (2018) to the formulation, and by further administering the formulation for 6 weeks, as taught by Román, for the purpose of treating oxidative stress caused by physical activity.
Claims 1, 3-8 and 14-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-11 and 16 of copending Application No. 16/318,684 (hereafter Lopéz ‘684; effective filing date of 07/18/2016) in view of Lopéz EP 3 222 282 A1 published 09/27/2017 (hereafter Lopéz (2017)) and Román, Francisco Clinicaltrials.gov, NIH, 10 Jan. 2019.
This is a provisional nonstatutory double patenting rejection.
Claim 1 of Lopéz ‘684 recites a probiotic composition comprising Bifidobacterium animalis subsp. lactis (B. lactis), Bifidobacterium longum and Lactobacillus casei, wherein B. lactis is B. lactis CECT 8145, B. longum is B. longum CECT 7347 and L. casei is L. casei CECT 9104, wherein - B. longum concentration is 35% with respect to the total concentration of microorganisms present in the composition; B. lactis concentration is 35% with respect to the total concentration of microorganisms, and L. casei concentration is 30% with respect to the total concentration of microorganisms; -the total concentration of microorganisms of the strains B. lactis, L. casei and B. longum in the composition is from 107 cfu/mL to 109 cfu/mL, and - the probiotic composition is a food selected from the group consisting of fruit or vegetable juices and infant formula.
Claim 10 of Lopéz ‘684 recites the probiotic composition according to claim 1, wherein the composition further comprises a microorganism selected from the group consisting of Lactobacillus sp., Streptococcus sp., Bifidobacterium sp., Saccharomyces sp., Kluyveromyces sp. and combinations thereof.
Instant claims 1, and 3-8 differ from the copending claims of Lopéz ‘684 in that the copending claims of Lopéz ‘684 lack: Lactobacillus rhamnosus CECT 8361 and food-based vehicle that is high protein milkshake, a high protein smoothie or an energy gel (relevant to instant claim 1); L. rhamnosus at a concentration of 45%, L. casei at a concentration of 45% and B. longum at a concentration of 10% (relevant to instant claim 3); total amount of bacteria that is 109 CFU (relevant to instant claim 4); a composition in solid form (relevant to instant claim 7); and in capsule form (relevant to instant claim 8).
However, Lopéz (2017) teaches a probiotic composition comprising L. rhamnosus CECT 8361 and further comprising a pharmaceutically acceptable carrier. See claims 1-2 and 5 of Lopéz (2017). Lopéz (2017) teaches gelatine as an example of a carrier [0027] (relevant to instant claim 1). Lopéz (2017) teaches L. rhamnosus at a concentration of at least 30%. See [0044] (relevant to instant claim 3). Lopéz (2017) teaches a total concentration of 109 cfu. See paragraphs [0044], [0059] (relevant to instant claim 4). Lopéz (2017) teaches solid formulations selected from a group that includes capsules. See claim 7 of Lopéz (2017) (relevant to instant claim 7-8).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the probiotic composition of Lopéz ‘684 by adding the L. rhamnosus CECT 8361 and gelatine of Lopéz (2017), and by further optimizing the percentage of each strain and total bacterial concentration in order to arrive at a pharmaceutical probiotic composition.
Instant claims 14-17 differ from the copending claims of Lopéz ‘684 in that the copending claims of Lopéz ‘684 lack: a subject in need of oxidative stress treatment and/or reduction (relevant to instant claim 14), wherein the oxidative stress is caused by physical activity (relevant to instant claim 15); a composition administered once a day (relevant to instant claim 16); and a composition administered for 6 weeks (relevant to instant claim 17).
However, Román teaches administering a composition comprising B. longum, L. casei, and L. rhamnosus to a study population for the purpose of treating oxidative stress during the performance of a physical exercise. See the brief summary section and pages 5-6 (relevant to instant claims 14-15). The study design includes the consumption of one dietary supplement capsule at breakfast for six weeks. See the left column on page 6 (relevant to instant claims 16-17).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the probiotic composition of Lopéz ‘684 by adding the L. rhamnosus CECT 8361 and gelatine of Lopéz (2017) and to further administer the probiotic composition in accordance with the study design of Román in order to treat oxidative stress caused by physical activity.
Claims 1, 3-8 and 14-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-11 and 16 of copending Application No. 17/888,317 (hereafter Lopéz ‘317; effective filing date of 07/18/2016) in view of Lopéz EP 3 222 282 A1 published 09/27/2017 (hereafter Lopéz (2017)) and Román, Francisco Clinicaltrials.gov, NIH, 10 Jan. 2019.
This is a provisional nonstatutory double patenting rejection.
Claim 1 of Lopéz ‘317 recites a method for the treatment and/or prevention of atopic dermatitis comprising administering to a subject in need thereof an effective amount of a probiotic composition comprising a therapeutically effective amount of Bifidobacterium animalis subsp. lactis (B. lactis), Bifidobacterium longum and Lactobacillus casei, wherein B. lactis is B. lactis CECT 8145, B. longum is B. longum CECT 7347 and L. casei is L. casei CECT 91042 wherein B. longum concentration is 35% with respect to the total concentration of microorganisms present in the composition; B. lactis concentration is 35% with respect to the total concentration of microorganisms; and L. casei concentration is at 30% with respect to the total concentration of microorganisms; and wherein the total concentration of microorganisms of the strains B. lactis, L. casei and B.longum in the composition is from 107 to 109 cfu/mL.
Claim 2 of Lopéz ‘317 recites the method according to claim 1 wherein the probiotic composition is a pharmaceutical composition or a nutritional composition.
Claim 3 of Lopéz ‘317 recites the method according to claim 2 wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier and/or an excipient.
Claim 4 of Lopéz ‘317 recites the method according to claim 2, wherein the pharmaceutical composition is formulated for administration in liquid form or in solid form.
Claim 5 of Lopéz ‘317 recites the method according to claim 4, wherein the solid form is selected from the group consisting of tablets, lozenges, sweets, chewable tablets, chewing gum, capsules, sachets, powders, granules, coated particles or coated tablets, tablets and gastro-resistant tablets and capsules and dispersible strips and/or films.
Claim 6 of Lopéz ‘317 recites the method according to claim 4, wherein the liquid form is selected from the group consisting of oral solutions, suspensions, emulsions and syrups.
Claim 7 of Lopéz ‘317 recites the method according to claim 2, wherein the nutritional composition is a food or a nutritional supplement.
Claim 8 of Lopéz ‘317 recites the method according to claim 7, wherein the food is selected from the group consisting of fruit or vegetable juices, ice cream, infant formula, milk, yogurt, cheese, fermented milk, milk powder, cereals, baked goods, milk-based products, meat products and beverages.
Claim 9 of Lopéz ‘317 recites the method according to claim 1, wherein the composition further comprises a microorganism selected from the group consisting of Lactobacillus sp., Streptococcus sp., Bifidobacterium sp., Saccharomyces sp., Kluyveromyces sp. and combinations thereof.
Instant claims 1, and 3-8 differ from the copending claims of Lopéz ‘317 in that the copending claims of Lopéz ‘317 lack: Lactobacillus rhamnosus CECT 8361 and food-based vehicle that is high protein milkshake, a high protein smoothie or an energy gel (relevant to instant claim 1); L. rhamnosus at a concentration of 45%, L. casei at a concentration of 45% and B. longum at a concentration of 45% (relevant to instant claim 3); and 109 CFU total amount of bacteria (relevant to instant claim 4).
However, Lopéz (2017) teaches a probiotic composition comprising L. rhamnosus CECT 8361 and further comprising a pharmaceutically acceptable carrier. See claims 1-2 and 5 of Lopéz (2017). Lopéz (2017) teaches gelatine as an example of a carrier [0027] (relevant to instant claim 1). Lopéz (2017) teaches L. rhamnosus in a concentration of at least 30%. See [0044] (relevant to instant claim 4). Lopéz (2017) teaches a total concentration of 109 cfu. See paragraphs [0044], [0059] (relevant to instant claim 4).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the pharmaceutical composition or a nutritional composition of Lopéz ‘317 by adding the L. rhamnosus CECT 8361 and gelatine of Lopéz (2017), and by further optimizing the percentage of each strain and total bacterial concentration in order to arrive at a probiotic composition.
Instant claims 14-17 differ from the copending claims of Lopéz ‘317 in that the copending claims of Lopéz ‘317 lack: a subject in need of treatment and/or reduction of oxidative stress (relevant to instant claim 14), wherein the oxidative stress is caused by physical activity (relevant to instant claim 15); a composition that is administration once a day (relevant to instant claim 16); and a composition that is administered for 6 weeks (relevant to instant claim 17).
However, Román teaches administering a composition comprising B. longum, L. casei, and L. rhamnosus to a study population for the purpose of treating oxidative stress during the performance of a physical exercise. See the brief summary section and pages 5-6 (relevant to instant claims 14-15). The study design includes the consumption of one dietary supplement capsule at breakfast for six weeks. See the left column on page 6 (relevant to instant claims 16-17).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the method of Lopéz ‘317 by adding the L. rhamnosus CECT 8361 and gelatine of Lopéz (2017) to the pharmaceutical composition or a nutritional composition and by further administering the composition once a day for six weeks in accordance with the study design of Román in order to treat oxidative stress caused by physical activity.
Response to Arguments
Non-statutory Double Patenting
Applicant asserts that the amendment overcomes the following non-statutory double patenting rejections over the patent claims of U.S. 10434127 (Rodríguez ‘127) and U.S. 10912802 (Lopéz ‘802), and over the co-pending applications 16/318,684 (Lopéz ‘684) and 17/888,317 (Lopéz ‘317). See the paragraph spanning pages 15-16 of the remarks.
This argument is not persuasive because the non-statutory double patenting rejections are obvious-type rejections. As such, the instantly claimed food-based vehicle is taught by the prior art of Lopéz (2017) or Lopéz(2018), as cited above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY C BREEN whose telephone number is (571)272-0980. The examiner can normally be reached M-Th 7:30-4:30, F 8:30-1:30 (EDT/EST).
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657