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 .
DETAILED ACTION
Claims 15 and 17-24 are pending.
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, or §365(c) is acknowledged. As noted in the Non-Final Office Action mailed on 10 June 2024, Applicant has claimed the benefit of the filing date of the prior application, and designates the instant application as a "CON" of 15/750,484.
Claims 15 and 17-24 have the effective filing date of 12 August 2016.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 17 June 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Claim Objections
Claim 15 is objected to because of the following informalities: ”wherein said isolated cells...are live or dead or in the form of tyndallized, sonicated, lysed cells, and wherein..." should read: “wherein said isolated cells...are live or dead or in the form of tyndallized, sonicated, or lysed cells, and wherein..."
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. §102 and §103 (or as subject to pre-AIA 35 U.S.C. §102 and §103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. §103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 15, 17-20 and 24 are rejected under 35 U.S.C. §103 as being unpatentable over Castiel et al. (Pub. No. US 2011/0182861 A1) in view of Mogna et al. (2013) (Pub. No. WO 2013/114185 A1).
Regarding claims 15 and 24, Castiel et al. discloses the use of a microorganism in accordance with the described invention, for the preparation of a composition, in particular a dermatological composition (pg. 3, para. [0052]). The described invention is also directed towards the cosmetic use of an effective amount of at least one probiotic microorganism, especially of the Lactobacillus and/or Bifidobacterium sp. genus (pg. 3, para. [0053]). Specific examples of probiotic microorganisms suitable for the described invention include, minimally, Lactobacillus salivarius (pg. 4, para. [0073]). Castiel et al. further discloses a cosmetic composition and/or dermatological composition comprising, in a physiologically acceptable carrier, at least one probiotic microorganism especially of the Lactobacillus and/or Bifidobacterium sp. genus (pg. 3, para. [0056]) and topical application of the microorganism which may be formulated in the form of, minimally, creams and gels (pg. 8, para. [0155]). The probiotic microorganism(s) in the composition may be, minimally, live (pg. 8, para. [0163]).
Castiel et al. does not teach Lactobacillus salivarius LS03 [Claims 15 and 24]; and Lactobacillus reuteri LRE04 [Claim 20].
Mogna et al. (2013) discloses lactic bacteria, and bifidobacteria, and the use thereof to prepare, minimally, a pharmaceutical composition (pg. 1, para. 1 [nexus to Castiel et al.- a composition comprising lactobacilli and/or bifidobacteria]). Mogna et al. (2013) Table A lists a group of microorganisms that have valid application in the context of the described invention (pg. 16, para. 2). Table A includes Lactobacillus salivarius LS03 having the deposit designation DSM 22776 (pg. 36, cont. Table A, entry#106), and Lactobacillus reuteri LRE04 having the deposit designation DSM 23880 (pg. 37, cont. Table A, entry#122).
Regarding claims 15, 20 and 24, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the composition comprising cells of isolated strain Lactobacillus salivarius and additionally Lactobacillus reuteri, as disclosed by Castiel et al., with the specific strains of L. salivarius LS03 and L. reuteri LRE04, as disclosed by Mogna et al. (2013), with a reasonable expectation of success, because it would have been obvious to one of ordinary skill in the art of preparing a composition containing (probiotic) bacteria, to have used any specific strain of L. salivarius, and L. reuteri in a composition comprising L. salivarius and L. reuteri bacteria and a pharmaceutically acceptable carrier (MPEP 2143 (I)(G)) and (MPEP 2144 (III)).
One of ordinary skill in the art would have been motivated to have made those modifications, because one of ordinary skill in the art of formulating compositions for topical application would be motivated to experiment with different L. salivarius and L. reuteri strains in order to determine the specific strain(s) that optimize(s) the properties of the composition, whether it be related to mode of delivery or therapeutic efficacy, depending on the purpose for which the composition is being applied.
Regarding claim 17, Castiel et al. discloses oral administration or administration via a patch also has the advantage of a rapid and relatively non-restrictive mode of administration (pg. 3, para. [0062]).
Regarding claims 18 and 19, the probiotic microorganism(s) in the composition may be, minimally, live or dead (pg. 8, para. [0163]).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 21 and 22 are rejected under 35 U.S.C. §103 as being unpatentable over Castiel et al. in view of Mogna et al. (2013), as applied to claims 15, 17-20 and 24 above, and further in view of Mogna et al. (2008) (Pub. No. US 2008/0107634 A1).
Castiel et al. further discloses that specific examples of probiotic microorganisms suitable for use in the described composition also include, minimally, Lactobacillus delbrueckii (subsp bulgaricus or lactis), and Bifidobacterium longum, besides the L. salivarius and L. reuteri cited above (Castiel et al., pg. 4, para. [0073]).
Castiel et al. in view of Mogna et al. (2013) do not teach: L. salivarius and either L. delbrueckii ssp delbrueckii or L. reuteri in a weight ratio of about 1:1, or 2:1, or 3:1, or 4:1, or 5:1, or 1:2.
Mogna et al. (2008) teaches probiotic bacteria based compositions (pg. 1, para. [0001]). The compositions include a mixture of probiotic bacteria, belonging to the genus Lactobacillus and/ or genus Bifidobacterium (pg. 1, para. [0016] [nexus to Castiel et al. and Mogna et al. (2013)- composition comprising specific species of Lactobacillus strains]). The probiotic is selected from a group which includes, minimally, Lactobacillus salivarius and Lactobacillus delbrueckii subsp bulgaricus (pg. 2, para. [0050]).
Mogna et al. (2008) teaches that the bacterial species constituting the mixture of probiotic bacteria are present in a mutual weight ratio between 0.1:10 to 10:1, preferably in a mutual weight ratio between 0.5:1 to 2:1, more preferably in a mutual weight ratio of about 1:1 (pg. 3, para. [0072]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the composition comprising cells of isolated strain(s) Lactobacillus salivarius and additionally Lactobacillus reuteri, as taught by Castiel et al. in view of Mogna et al. (2013), by: 1) formulating the composition so that L. salivarius and either L. delbrueckii ssp delbrueckii or L. reuteri are in a weight ratio of about 1:1, or 2:1, or 3:1, or 4:1, or 5:1, or 1:2 [Claims 21 and 22], as shown by Mogna et al. (2008), with a reasonable expectation of success, because Mogna et al. (2008) shows a bacterial (probiotic) composition comprising strains from the genera Lactobacillus and Bifidobacterium, which is the composition shown by Castiel et al. and Mogna et al. (2013) (MPEP 2143 (I)(G)).
One of ordinary skill in the art would have been motivated to have made that modification, because one of ordinary skill in the art of formulating therapeutic probiotic compositions would have incorporated the bacterial strains into the composition on a specific weight ratio basis in the event that subjects receiving the composition respond more positively therapeutically to (or, alternatively, experience fewer negative side effects from) one particular strain over another.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim 23 is rejected under 35 U.S.C. §103 as being unpatentable over Castiel et al. in view of Mogna et al. (2013), as applied to claims 15, 17-20 and 24 above, and further in view of Chularojanamontri et al. (J. Clin. Aesthet. Dermatol. 2014, 7(5): 36-44).
Castiel et al. further teaches that an antiseborreic active agent suitable for the described invention may in particular be chosen from a list that includes, minimally, zinc lactate (pg. 5, para. [0114]).
Castiel et al. in view of Mogna et al. (2013) do not teach the composition further comprises ammonium lactate.
Chularojanamontri et al. teaches that acne is a chronic inflammatory disease and topical therapies, which such as benzoyl peroxide, retinoids, antibiotics with alcohol-based preparations, and salicylic acid, can cause skin irritation resulting in a lack of patient adherence (pg. 36, Abstract [nexus to Castiel et al.- the composition is for topical application]). Chularojanamontri et al. further teaches that the clinical features of acne include oily skin, noninflammatory lesions, inflammatory lesions, and various degrees of scarring (pg. 36, column 1, para. 1 [nexus to Castiel et al.- composition for treating and/or preventing oily skin (pg. 2, para. [0029])).
Regarding claim 23, Chularojanamontri et al. teaches that many moisturizers claim to be suitable for acne treatment. Most of the products (92%) have anti-inflammatory properties (pg. 36, Abstract). Moisturizers contain three main properties, which are the occlusive, humectant, and emollient effects (pg. 36, column 2, para. 1). The second property of moisturizers is humectant, examples of which include, minimally, glycerin (glycerol) and ammonium lactate (pg. 38, column 1, lines 2-6).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the composition comprising cells of isolated strain(s) Lactobacillus salivarius and additionally Lactobacillus reuteri, as taught by Castiel et al. in view of Mogna et al. (2013), by including ammonium lactate in the composition, as taught by Chularojanamontri et al., with a reasonable expectation of success, because Chularojanamontri et al. teaches that ammonium lactate can be added as a humectant into a composition intended for topical or dermal use, which is the composition taught by Castiel et al. (MPEP 2143 (I)(G)).
In addition, Castiel et al. teaches that zinc lactate can be added to the composition. Therefore, it would have been obvious to have included in the composition taught by Castiel et al., the ammonium lactate, taught by Chularojanamontri, with the reasonably predictable expectation that the addition of another lactate compound would improve or support the antiseborrheic and/or moisturizing or humectant properties of the composition (MPEP 2143 (I)(G)).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 15, 18, 20 and 24 are rejected under 35 U.S.C. §103 as being unpatentable over Beaulieu et al. (Pub. No. WO 2009/043171 A1) in view of Mogna et al. (2013) (Pub. No. WO 2013/114185 A1).
Regarding claim 15, Beaulieu et al. teaches an anti-inflammatory composition comprising an effective amount of MPM (malleable protein matrix) (pg. 6, para. [0022]; and pg. 1, para. [0001]). The malleable protein matrix (MPM) is produced with the help of a fermentation process of whey using lactic acid bacteria (LAB) (pg. 13, para. [0072]). The preferred microorganism used in the fermentation process of whey is a pure strain of lactobacillus. The process can integrate a variety of other microorganisms either alone or in combination selected from a group which includes, minimally, Lactobacillus salivarius (pg. 14, para. [0073] thru pg. 15, cont. para. [0073]). The final product, MPM, is composed principally of fermented whey proteins and LAB. All components may explain the effect individually, in part, but the synergy between proteins, peptides, LAB and minerals could amplify the resulting immunomodulatory effects (pg. 16, para. [0074]). Formulations of therapeutic and diagnostic agents may be prepared by mixing with physiologically acceptable carriers, excipients, or stabilizers (pg. 25, para. [00102]). MPM is also useful as a component of a cosmeceutical supplement. The ingredients of the cosmeceutical supplement of the described invention are contained in acceptable excipients and/or carriers for dermal application. A cosmeceutical supplement exhibiting biological properties for skin care and maintenance, repair, skin regeneration, and anti-aging is included in products like skin care and sunscreens, which include, minimally, baby creams, emollient creams, and cold creams (pg. 28, para. [00111]).
Regarding claim 20, Beaulieu et al. teaches that the preferred microorganism used in the fermentation process of whey is a pure strain of lactobacillus. The process can integrate a variety of other microorganisms either alone or in combination selected from a group which includes, minimally, Bifidobacterium pseudolongum ssp globosum, Lactobacillus reuteri, and Lactobacillus delbrueckii ssp delbrueckii (pg. 14, para. [0073] thru pg. 15, cont. para. [0073]).
Beaulieu et al. does not teach: Lactobacillus salivarius LS03 [Claims 15 and 24]; live bacterial cells, per se [Claims 18 and 24]; and Lactobacillus delbrueckii ssp delbrueckii (DSM 22016) or Lactobacillus reuteri LRE04 or Bifidobacterium pseudolongum ssp globosum BPS01 [Claim 20].
Regarding claim 15, Mogna et al. (2013) teaches lactic bacteria, and bifidobacteria, and the use thereof to prepare, minimally, a pharmaceutical composition (pg. 1, para. 1). Table A includes Lactobacillus salivarius LS03 having the deposit designation DSM 22776 (pg. 36, cont. Table A, entry#106).
Regarding claim 20, Table A also includes: Lactobacillus delbrueckii ssp delbrueckii (DSM 22106) (pg. 36, cont. Table A, entry#103); Lactobacillus reuteri LRE04 (DSM 23880) (pg. 37, cont. Table A, entry#122); and Bifidobacterium pseudolongum ssp globosum BPS01 (DSM 26456) (pg. 40, cont. Table A, entry#180).
Regarding claims 18 and 24, Mogna et al. (2013) teaches that the lactic bacteria and bifidobacteria are preferably probiotic bacteria. Probiotic bacteria are live bacteria (pg. 9, para. 3).
Regarding claims 15, 18, 20 and 24, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the composition comprising cells of isolated strain(s) Lactobacillus salivarius and Lactobacillus delbrueckii ssp delbrueckii, Lactobacillus reuteri or Bifidobacterium pseudolongum ssp globosum, as taught by Beaulieu et al., with the specific strains of L. salivarius LS03 (DSM 22776), L. delbrueckii ssp delbrueckii (DSM 22106), L. reuteri LRE04 (DSM 23880) and B. pseudolongum ssp globosum BPS01 (DSM 26456) [Claims 15, 20 and 24], as taught by Mogna et al. (2013), with a reasonable expectation of success, because it would have been obvious to one of ordinary skill in the art of preparing a composition containing (probiotic) bacteria, to have used any specific strain of L. salivarius, L. delbrueckii ssp delbrueckii, L. reuteri and B. pseudolongum ssp globosum in a composition comprising L. salivarius, L. delbrueckii ssp delbrueckii, L. reuteri and B. pseudolongum ssp globosum bacteria (MPEP 2143 (I)(G)) and (MPEP 2144 (III)).
It would have been further obvious to have incorporated live isolated bacterial cells into the composition [Claims 18 and 24], with a reasonable expectation of success, because Mogna et al. teaches that probiotic bacteria can be incorporated into the composition, which are live bacteria, and the final product or composition shown by Beaulieu et al. comprises whey proteins and the lactic acid bacteria which have just fermented them (MPEP 2143 (I)(G)). Therefore, one of ordinary skill in the art would have understood that the lactic acid bacteria in the composition shown by Beaulieu et al. would have been live bacteria.
One of ordinary skill in the art would have been motivated to have made those modifications, because Beaulieu et al. teaches that the composition comprising at least one of Lactobacillus salivarius, Lactobacillus delbrueckii ssp delbrueckii, Lactobacillus reuteri, and Bifidobacterium pseudolongum ssp globosum, can be used either as a dietary supplement (i.e., formulated for oral consumption as a nutraceutical or medical food) (pg. 27, para. [00110] thru pg. 28, cont. para. [00110]) or as a cosmeceutical composition for dermal application (pg. 28, para. [00111]). Therefore, one of ordinary skill in the art of preparing probiotic compositions would have been motivated to have prepared a composition which has more than one intended use, thereby broadening and optimizing the therapeutic application of the single composition.
In addition, one would have been motivated to have incorporated specific bacterial strains into the composition (e.g., as cited by Mogna et al. (2013)), in the event that subjects receiving the composition respond more positively therapeutically to (or, alternatively, experience fewer negative side effects from) one particular strain over another.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 17 and 19 are rejected under 35 U.S.C. §103 as being unpatentable over Beaulieu et al. in view of Mogna et al. (2013), as applied to claims 15, 18, 20 and 24 above, and further in view of Born et al. (Pub. No. US 2009/0230013 A1).
Beaulieu et al. in view of Mogna et al. (2013) do not teach the composition is a transdermal patch and comprises dead bacterial cells.
Born et al. teaches a dosing system that allows a user to select and customize dosing of one or more actives (pg. 1, para. [0002]). The dosage units and systems of the described invention can comprise a probiotic. Non-limiting examples of bacteria suitable for use include, minimally, Lactobacillus salivarius, Lactobacillus delbrueckii, Lactobacillus reuteri, and Bifidobacterium pseudolongum (pg. 12, para. [0192] and [0195] [nexus to Beaulieu et al. and Mogna et al. (2013)- composition comprising L. salivarius, L. delbrueckii, L. reuteri, and B. pseudolongum]). Dosage units include transdermal administration for topical use as anti-microbial compositions (pg. 5, para. [0067] [nexus to Beaulieu et al.- dermal application of the composition]). Oral compositions are typically swallowed immediately, or slowly dissolved in the mouth (pg. 5, para. [0067] [nexus to Beaulieu et al. and Mogna et al. (2013)- oral formulations of the composition]).
Regarding claim 17, non-limiting examples of dosage forms include, minimally, patches for transdermal administration (pg. 5, para. [0067]).
Regarding claim 19, the dosage units can comprise at least about 103
CFU, alternatively from about 103 to about 1014 CFU of Lactobacillus per dosage unit. The Lactobacillus may be administered in either viable form, or as killed cells (pg. 13, para. [0200] [nexus to Mogna et al. (2013)- the composition comprises live bacteria]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the composition comprising cells of isolated strain(s) Lactobacillus salivarius LS03 (DSM 22776) and Lactobacillus delbrueckii ssp delbrueckii (DSM 22106), Lactobacillus reuteri LRE04 (DSM 23880) or Bifidobacterium pseudolongum ssp globosum BPS01 (DSM 26456), as shown by Beaulieu et al. in view of Mogna et al. (2013), as applied to claims 15, 18, 20 and 24 above, by: formulating the composition as a transdermal patch [Claim 17]; and formulating the composition using dead bacterial cells [Claim 19], as shown by Born et al., with a reasonable expectation of success, because Born et al. shows dosage units as (a) composition(s) comprising L. salivarius, L. delbrueckii, L. reuteri, and/or B. pseudolongum, which is the composition shown by Beaulieu et al. and Mogna et al. (2013) (MPEP 2143 (I)(G)).
One of ordinary skill in the art would have been motivated to have made those modifications, because Born et al. shows that systems or kits of the described invention and components thereof can be provided in convenient, portable sizes and forms, such as would fit conveniently in a purse or pocket (pg. 1, para. [0011]), and the modifications cited above would facilitate said convenient and portable forms. That is, formulating the bacterial composition as a convenient and portable form would increase the level of compliance with regard to the use of said form by the subject or patient, which would, in turn, optimize the therapeutic value of said bacterial dosage unit compositions.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 21 and 22 are rejected under 35 U.S.C. §103 as being unpatentable over Beaulieu et al. in view of Mogna et al. (2013), as applied to claims 15, 18, 20 and 24 above, and further in view of Mogna et al. (2008) (Pub. No. US 2008/0107634 A1).
Beaulieu et al. in view of Mogna et al. (2013) teach a composition comprising the bacterial strains: Lactobacillus salivarius LS03 (DSM 22776), Lactobacillus delbrueckii ssp delbrueckii (DSM 22106), and Lactobacillus reuteri LRE04 (DSM 23880).
Beaulieu et al. in view of Mogna et al. (2013) do not teach L. salivarius and either L. delbrueckii ssp delbrueckii or L. reuteri are in a weight ratio of about 1:1, or 2:1, or 3:1, or 4:1, or 5:1, or 1:2.
Mogna et al. (2008) teaches probiotic bacteria based compositions (pg. 1, para. [0001]). The compositions include a mixture of probiotic bacteria, belonging to the genus Lactobacillus and/ or genus Bifidobacterium (pg. 1, para. [0016] [nexus to Beaulieu et al., Mogna et al. (2013) and Born et al.- composition comprising specific species of Lactobacillus and Bifidobacterium strains]). The probiotic is selected from a group which includes, minimally, Lactobacillus salivarius and Lactobacillus delbrueckii subsp bulgaricus (pg. 2, para. [0050] [nexus to Beaulieu et al., Mogna et al. (2013) and Born et al.- composition comprising L. salivarius and L. delbrueckii]).
Mogna et al. (2008) teaches that the bacterial species constituting the mixture of probiotic bacteria are present in a mutual weight ratio between 0.1:10 to 10:1, preferably in a mutual weight ratio between 0.5:1 to 2:1, more preferably in a mutual weight ratio of about 1:1 (pg. 3, para. [0072]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the composition comprising cells of isolated strains of Lactobacillus salivarius LS03 (DSM 22776) and Lactobacillus delbrueckii ssp delbrueckii (DSM 22106), Lactobacillus reuteri LRE04 (DSM 23880) or Bifidobacterium pseudolongum ssp globosum BPS01 (DSM 26456), as taught by Beaulieu et al. in view of Mogna et al. (2013), by: 1) formulating the composition so that L. salivarius and either L. delbrueckii ssp delbrueckii or L. reuteri are in a weight ratio of about 1:1, or 2:1, or 3:1, or 4:1, or 5:1, or 1:2, as taught by Mogna et al. (2008), with a reasonable expectation of success, because Mogna et al. (2008) teaches a bacterial (probiotic) composition comprising strains from the genera Lactobacillus and Bifidobacterium, which is the composition shown by Beaulieu et al. and Mogna et al. (2013) (MPEP 2143 (I)(G)).
One of ordinary skill in the art would have been motivated to have made that modification, because one of ordinary skill in the art of formulating therapeutic probiotic compositions would have incorporated the bacterial strains into the composition on a specific weight ratio basis in the event that subjects receiving the composition respond more positively therapeutically to (or, alternatively, experience fewer negative side effects from) one particular strain over another.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim 23 is rejected under 35 U.S.C. §103 as being unpatentable over Beaulieu et al. in view of Mogna et al. (2013), as applied to claims 15, 18, 20 and 24 above, and further in view of Chularojanamontri et al. (J. Clin. Aesthet. Dermatol. 2014, 7(5): 36-44).
Beaulieu et al. in view of Mogna et al. (2013) do not teach the composition further comprises ammonium lactate.
Chularojanamontri et al. teaches that acne is a chronic inflammatory disease and topical therapies, which such as benzoyl peroxide, retinoids, antibiotics with alcohol-based preparations, and salicylic acid, can cause skin irritation resulting in a lack of patient adherence (pg. 36, Abstract [nexus to Born et al.- the composition comprises an active which may serve as an anti-inflammatory, and includes antibiotics as such an active (pg. 5, para. [0065]-[0066])]). Chularojanamontri et al. further teaches that clinical features include oily skin, noninflammatory lesions, inflammatory lesions, and various degrees of scarring (pg. 36, column 1, para. 1 [nexus to Beaulieu et al.- LAB strains have anti-inflammatory properties (pg. 5, para. [0017])]).
Regarding claim 23, Chularojanamontri et al. teaches that many moisturizers claim to be suitable for acne treatment. Most of the products (92%) have anti-inflammatory properties (pg. 36, Abstract). Moisturizers contain three main properties, which are the occlusive, humectant, and emollient effects (pg. 36, column 2, para. 1). The second property of moisturizers is humectant, examples of which include, minimally, glycerin (glycerol) and ammonium lactate (pg. 38, column 1, lines 2-6 [nexus to Born et al.- actives include demulcents, including glycerin (pg. 6, para. [0078])]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the composition comprising cells of isolated strain(s) Lactobacillus salivarius LS03 (DSM 22776), Lactobacillus delbrueckii ssp delbrueckii (DSM 22106), Lactobacillus reuteri LRE04 (DSM 23880) and Bifidobacterium pseudolongum ssp globosum BPS01 (DSM 26456), as taught by Beaulieu et al. in view of Mogna et al. (2013), by including ammonium lactate in the composition, as suggested by Chularojanamontri et al., with a reasonable expectation of success, because Chularojanamontri et al. teaches that ammonium lactate can be added as a humectant into a composition intended for topical or dermal use, which is the composition, shown by Beaulieu et al. and Born et al. (MPEP 2143 (I)(G)).
In addition, Beaulieu et al. teaches that the cosmeceutical supplement may also contain optional ingredients including, for example, herbs, vitamins, minerals, enhancers, colorants, sweeteners, flavorants, inert ingredients and the like. Such optional ingredients may be either naturally occurring or concentrated forms. Selection of one or several of these ingredients is a matter of formulation, design, consumer preference and end-user. The amounts of these ingredients added to the cosmeceutical product of the described invention are readily known to the skilled artisan (pg. 29, cont. para. [00111]). In addition, Beaulieu et al. teaches that the cosmeceutical supplement may be added to products such as baby creams, emollient creams, cold creams, conditioning creams, protective creams and sunscreen lotion (pg. 28, para. [00111] thru pg. 29, cont. para. [00111]; and cited above). Born et al. teaches that the described probiotic dosage unit compositions may include other ingredients, such as humectants (pg. 16, para. [0269]).
That is, it would have been obvious (and one of ordinary skill in the art would have been motivated) to have added ingredients into the bacterial compositions described in the abovecited prior art which would have improved the efficacy and/or cosmetic, aesthetic or sensory characteristics of said compositions, such as a humectant including ammonium lactate. In addition, Beaulieu et al. shows that products comprising the described cosmeceutical bacterial supplement include topical creams, and Born et al. shows that topical administration of the described probiotic dosage unit compositions can performed using creams (pg. 17, para. [0274]). Because Born et al. also shows that said compositions can contain the humectant glycerin, it would have been obvious to one of ordinary skill in the art to have substituted the glycerin, taught by Chularojanamontri et al. to be an example of a humectant, with the ammonium lactate, shown by Chularojanamontri et al., with the reasonably predictable expectation that the ammonium lactate would have imparted the same moisturizing effect as the glycerin, shown by Born et al. (MPEP 2143 (I)(B)(3)(G)).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
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.
(1) Claims 15, 18-19 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 7 of Patent No. 11,628,193 B2 in view of Castiel et al. (Pub. No. US 2011/0182861 A1).
The claimed subject matter of instant Application No. 18/115,752 is:
Claim 15- A composition comprising: (a) cells of the isolated strain Lactobacillus salivarius LS03 (ID 1382) (deposited at the DSMZ as DSM 22776); and (b) a physiologically acceptable carrier. The isolated cells are live or dead or in the form of tyndallized, sonicated, or lysed cells. The composition is formulated as a skin cream, ointment or gel.
Claim 18- the composition comprises live bacterial cells.
Claim 19- the composition comprises dead bacterial cells.
Claim 24- said isolated cells of the strain Lactobacillus salivarius LS03 (ID 1382) (deposited at the DSMZ as DSM 22776) are live.
The claimed subject matter of Patent No. 11,628,193 is:
Claim 1- A method for treating inflammation by pathogenic bacteria belonging to the species Propionibacterium acnes. The method comprises administering an effective amount of a composition comprising Lactobacillus salivarius LS03 (ID 1382) (deposited at the DSMZ as DSM 22776) to a patient.
Claim 2- the composition comprises live bacterial cells.
Claim 7- the composition comprises dead bacterial cells.
Claims 1-7 of Patent No. 11,628,193 do not show: 1) a physiologically acceptable carrier; and 2) the composition is formulated as a skin cream, ointment or gel.
Castiel et al. shows a cosmetic composition and/or dermatological composition comprising, in a physiologically acceptable carrier, at least one probiotic microorganism especially of the Lactobacillus and/or Bifidobacterium sp. genus (pg. 3, para. [0056]). The described invention is also directed towards the cosmetic use of an effective amount of at least one probiotic microorganism, especially of the Lactobacillus and/or Bifidobacterium sp. genus (pg. 3, para. [0053]). The described cosmetic method may be carried out by topical application of the microorganism which may be formulated in the form of, minimally, creams and gels (pg. 8, para. [0155]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to have modified the claims of Patent No. 11,628,193 with the physiologically acceptable carrier and the skin cream or gels, as shown by Castiel et al., with a reasonable expectation of success, because Castiel et al. shows a composition comprising a Lactobacillus strain, which is the composition used in the method for treating inflammation recited in the claims of Patent No. 11,628,193.
One of ordinary skill in the art would have been motivated to have made that modification because one could have modified the composition recited in the claims of Patent No. 11,628,193 with the physiologically acceptable carrier, and the skin creams or gels, shown by Castiel et al., with a reasonable expectation of success. Skin treatment modalities, as recited in the claims of Patent No. 11,628,193, typically contain a physiologically acceptable in the forms of skin creams or gels as shown by the skin treatment composition, shown by Castiel et al.
Although the claims are not identical, they are not patentably distinct from each other because, as demonstrated above in the claim sets from each application, the composition cited in the claims of instant Application No. 18/115,752 is obvious over the method for treating inflammation caused by Propionibacterium acnes, which comprises administering a composition comprising a Lactobacillus strain, as cited in the claims of Patent No. 11,628,193 B2 in view of the cited secondary reference.
(2) Claims 15, 18 and 20-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 9 and 11-13 of Patent No. 11,628,193 B2 in view of Castiel et al. (Pub. No. US 2011/0182861 A1).
The claimed subject matter of instant Application No. 18/115,752 is:
Claim 15- A composition comprising: (a) cells of the isolated strain Lactobacillus salivarius LS03 (ID 1382) (deposited at the DSMZ as DSM 22776); and (b) a physiologically acceptable carrier. The isolated cells are live or dead or in the form of tyndallized, sonicated, or lysed cells. The composition is formulated as a skin cream, ointment or gel.
Claim 18- the composition comprises live bacterial cells.
Claim 20- further comprising: cells of the strain Lactobacillus delbrueckii ssp delbrueckii LDD01 (deposited at the DSMZ as DSM 22106), cells of the strain Lactobacillus reuteri LRE04 (deposited at the DSMZ as DSM 23880), and/or cells of the strain Bifidobacterium pseudolongum ssp globosum BPS01 (deposited at the DSMZ as DSM 26456).
Claim 21- the strain of Lactobacillus salivarius LS03 and the strain of Lactobacillus delbrueckii ssp delbrueckii LDD01 are, respectively, in a weight ratio of about 1:1, or 2:1, or 3:1, or 4:1, or 5:1, or 1:2.
Claim 22- the strain of Lactobacillus salivarius LS03 and the strain of Lactobacillus reuteri LRE04 are, respectively, in a weight ratio of about 1:1, or 2:1, or 3:1, or 4:1, or 5:1, or 1:2.
Claim 23- further comprises ammonium lactate.
Claim 24- said isolated cells of the strain Lactobacillus salivarius LS03 (ID 1382) (deposited at the DSMZ as DSM 22776) are live.
The claimed subject matter of Patent No. 11,628,193 is:
Claim 8- A method for treating inflammation caused by pathogenic bacteria belonging to the species Propionibacterium acnes. The method comprises administering to a patient a composition comprising an effective amount of a mixture of bacteria and a physiologically acceptable carrier. The mixture of bacteria comprises: (i) Lactobacillus salivarius LS03 (ID 1382) (deposited at the DSMZ as DSM 22776); and (ii) at least a strain of bacteria selected from the group consisting of the strain Lactobacillus delbrueckii ssp delbrueckii LDD01 (deposited at the DSMZ as DSM 22106), the strain Lactobacillus reuteri LRE04 (deposited at the DSMZ as DSM 23880), and the strain Bifidobacterium pseudolongum ssp globosum BPS01 (deposited at the DSMZ as DSM 26456).
Claim 9- the composition further comprises ammonium lactate.
Claim 11- the composition comprises live bacterial cells.
Claim 12- the strain of Lactobacillus salivarius LS03 and the strain of Lactobacillus delbrueckii ssp delbrueckii LDD01 are, respectively, in a weight ratio of about 1:1, or 2:1, or 3:1, or 4:1, or 5:1, or 1:2.
Claim 13- the strain of Lactobacillus salivarius LS03 and the strain of Lactobacillus reuteri LRE04 are, respectively, in a weight ratio of about 1:1, or 2:1, or 3:1, or 4:1, or 5:1, or 1:2.
Claims 8-13 of Patent No. 11,628,193 does not show that the composition is formulated as a skin cream, ointment or gel.
Castiel et al. shows a cosmetic composition and/or dermatological composition comprising, in a physiologically acceptable carrier, at least one probiotic microorganism especially of the Lactobacillus and/or Bifidobacterium sp. genus (pg. 3, para. [0056]). The described invention is also directed towards the cosmetic use of an effective amount of at least one probiotic microorganism, especially of the Lactobacillus and/or Bifidobacterium sp. genus (pg. 3, para. [0053]). The described cosmetic method may be carried out by topical application of the microorganism which may be formulated in the form of, minimally, creams and gels (pg. 8, para. [0155]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to have modified the claims of Patent No. 11,628,193 with the skin cream or gels, as shown by Castiel et al., with a reasonable expectation of success, because Castiel et al. shows a composition comprising Lactobacillus strains and a pharmaceutically acceptable carrier, which is the composition recited in the claims of Patent No. 11,628,193.
One of ordinary skill in the art would have been motivated to have made that modification because one could have modified the composition recited in the claims of Patent No. 11,628,193 with the skin creams or gels, shown by Castiel et al., with a reasonable expectation of success, because there are other composition ingredients recited in the claims of Patent No. 11,628,193 (e.g., ammonium lactate) which indicate that the composition is intended for topical application.
Although the claims are not identical, they are not patentably distinct from each other because, as demonstrated above in the claim sets from each application, the composition cited in the claims of instant Application No. 18/115,752 is obvious over the method for treating inflammation which comprises administering a composition comprising Lactobacillus strains and a pharmaceutically acceptable carrier, a cited in the claims of Patent No. 11,628,193 B2 in view of the cited secondary reference.
Response to Arguments
Applicant’s arguments, pp. 4-7, filed on 17 June 2025, with respect to the prior art references cited in the 35 U.S.C. §103 rejection(s), have been fully considered but they are either not persuasive or are moot because the arguments do not apply to the references as they are applied in the context of the current rejection, or as new grounds necessitated by Applicant’s amendment, in which claim 15 was amended, and new claim 24 was added.
1. Applicant remarks (pg. 4, last para. thru pg. 6), with regard to the 102/103 rejection, that because the Lactobacillus salivarius LS03 is not explicitly disclosed in Hsieh, this rejection must be based on a theory of inherency. Hsieh's disclosure of a particular Lactobacillus salivarius strain (i.e., the AP-32 strain) does not necessarily teach or disclose any other distinct Lactobacillus salivarius strain. It was well understood at the time of filing of the present application that microbial strains of lactic acid bacteria (e.g., strains of the genus Lactobacillus genus}, even within the same taxonomically defined species, vary considerably in their genotype and phenotype and thus their probiotic properties (see the cited primary reference of Hsieh et al., and the references of Azais-Braesco et al. and Raftis et al. provided here). In other words, different strains of lactic acid bacteria, even within the same taxonomically defined species, cannot simply be substituted with one another with the expectation that one would possess similar, if any, probiotic properties as the other. Therefore, the Hsieh does not teach or suggest the use of the Lactobacillus salivarius LS03 strain of the present composition.
However, in response to Applicant, although it is well known that there are variations among the putative therapeutic properties of different strains of, here, Lactobacillus salivarius based on their individual biochemical/biophysical properties, it would have been obvious to have substituted L. salivarius strain AP-32, as shown by Hsieh et al., with the L. salivarius strain LS03 strain as instantly claimed, or vice versa, barring a showing of novelty or non-obviousness of the claimed strain. See the 103 rejection above. The instantly-claimed subject matter describes a composition or product, and Hsieh et al. shows a composition comprising isolated cells of a(n) L. salivarius strain, and a physiologically acceptable carrier, the isolated cells being live, and the composition being formulated as, minimally, an ointment, per instant claim 15.
2. Applicant remarks (pg. 6, last para. thru pg. 7), with regard to the 103 rejection, that Castiel does not teach or suggest the Lactobacillus salivarius LS03 strain of the presently claimed composition, and Mogna (2013) is directed to microencapsulated probiotics. In addition to demonstrating that all elements were known in the prior art, the Office must also articulate a reason for combining the elements. As discussed above, it was well understood at the time of filing of the present application that different strains of lactic acid bacteria, even within the same taxonomically defined species, cannot simply be substituted with one another with the expectation that one would possess similar, if any, probiotic properties as the other.
However, in response to Applicant, Mogna et al. (2013) provides a table listing various strains of, minimally, Lactobacillus including Lactobacillus salivarius LS03. The L. salivarius LS03 strain is described as being incorporated into a pharmaceutical composition. Because Castiel et al. shows a composition comprising a(n) L. salivarius probiotic strain, and a physiologically acceptable carrier, it would have been obvious to have substituted the L. salivarius strain, shown by Castiel et al., with the L. salivarius LS03 strain, shown by Mogna et al. (2013), with the reasonably predictable expectation that the composition would have some successful application, as one containing a probiotic bacterium, barring a showing of criticality for the LS03 strain in the composition.
3. Applicant remarks (pg. 7 thru pg. 8), with regard to rejection of dependent claims 21, 22 and 23, that claims 15 and 17-20 are not obvious and that these claims ultimately depend from claim 15.
In response to Applicant, the cited references of Mogna et al. (2008) and Chularojanamontri et al. address the limitations of claims 21, 22 and 23 and need not address any deficiencies in the rejection of independent claim 15, of which there aren't any.
4. Applicant remarks (pp. 8-10), with regard to the 103 rejection of, minimally, independent claim 15 over Beaulieu et al., and Moskal et al., that claim 15 has been amended to delete the limitations that were addressed by Beaulieu et al. and Moskal et al.
In response to Applicant, the 103 rejections featuring Beaulieu et al., and Moskal et al. have been withdrawn in view of Applicant's amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/SMP/Examiner, Art Unit 1657