DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claim 11 is missing from the instant claim set and as such the claims past claim 10 have been re-numbered to wherein claim 12 is now claim 11, claim 13 is now claim 12, and so forth. Claims 1-10 are not affected by the re-numbering. Accounting for the claim re-numbering, claims 1-19 are pending and under examination (claim set as filed on 10/21/2024).
Priority
Acknowledgement is made of the benefit to priority of provisional application no. 63/591,993 filed on 10/20/2023. Thus the effective filing date of this application is 10/20/2023.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “wherein the at least one strain of bacteria” is improper grammar. Appropriate correction is required to change the phrase to “wherein at least one strain of bacteria”.
Claims 2-8 are objected to for depending on claim 1.
Claims 2 and 10 are objected to because of the following informalities: “UF1 is probiotic” is improper grammar. Appropriate correction is required to change to “UF1 is a probiotic”.
Claims 3-4 are objected to for depending on claim 2. Claims 11-16 are objected to for depending on claim 10.
Claim 8 is objected to because of the following informalities: “Propionibacterium acnes;,” is improper grammar. Appropriate correction is required to remove the comma separating the bacterial species names as there is already a semicolon separating them. Claim 8 is also objected to because of the following informalities: “lactobacilli”, “streptococci”, and “bifidobacteria” are all in lowercase which is improper naming convention for a biological genus. Appropriate correction is required to capitalize the bacterial genus names. Claim 8 is also objected to because of the following informalities: “wherein the at least one strain of bacteria comprises” is improper grammar. Appropriate correction is required to remove “the” from the aforementioned phrase.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-16 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 range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “lactic acid bacteria including lactobacilli”, and the claim also recites “ssp. acidophilus, fermentum, plantarum, rhamnosus, casei, reuteri, gasseri” which is the narrower statement of the range/limitation. The claims 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.
Claim 8 recites the phrase “at least one strain of bacteria comprises at least a second strain of bacteria” which renders the claim indefinite as a bacterial strain can only be one individual strain. Thus it is unclear how a bacteria could comprise another strain in addition to its own strain. For examination purposes, the examiner has chosen to interpret the composition as comprising a second strain of bacteria. The examiner suggests amending the claim to state wherein the composition comprises at least a second strain.
Claim 8 recites the phrases "e.g. salivarius, thermophilus" and “e.g. coagulans, subtilis” and “lactic acid bacteria including lactobacilli”, “spore forming bacteria including Bacillus”, and “yeast-derived bacteria including Saccharomyces boulardii” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention or merely exemplary. See MPEP § 2173.05(d).
Claim 9 recites the phrase “administering to a subject a therapeutically effective amount of a composition” which renders the claim indefinite. Although the claim language specifies the therapeutically effective amount is in reference to the composition, the instant specification states the subject is administered a specified dosage of the bacteria within the composition (see specification [0034]), and does not necessarily state the amount of the composition itself. Therefore one could not properly ascertain what the therapeutically effective amount of the composition as a whole, not just the bacteria within it, is being administered to a subject.
Claims 10-16 are rejected for depending on claim 9.
Claim 13 recites the limitation "AFU". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7, 9-12, 14, and 17-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mohamadzadeh (Pre-Grant Publication No. US 2018/0199611 A1 – date of publication 7/19/2018).
Mohamadzadeh’s general disclosure relates to administering food enriched with probiotic Propionibacterium freudenreichii UF1 strain to an infant (see [0088]) and can also be administered to humans with cancer (see [0091]).
Regarding claims 1-2, 7, and 17, Mohamadzadeh teaches the administering of a probiotic infant food enriched with a Propionibacterium freudenreichii UF1 strain to an infant (see [0088]). Since prior art reference Mohamadzadeh teaches the same method steps of administering a Propionibacterium freudenreichii UF1 strain to a subject, the preamble’s recitation in claim 1 of reducing body weight in a subject and in claim 17 of enhancing endurance in a subject would be the implicit outcomes.
Regarding claims 9-10, Mohamadzadeh teaches the administering of food enriched with a probiotic Propionibacterium freudenreichii UF1 strain to a subject in need thereof such as a human with cancer (see Mohamadzadeh [0088]). As defined in instant specification, cancer is defined as a type of body weight disorder in a subject (see specification [0018]). Since prior art reference Mohamadzadeh teaches the same method steps of administering a Propionibacterium freudenreichii UF1 strain to a subject, the preamble’s recitation of managing body weight disorder in a subject in need thereof would be the implicit outcome. Furthermore as noted in the 112b rejection above, the term “therapeutically effective amount” is indefinite as it is unclear if the amount administered is referring to the bacterial strain or the overall composition comprising the bacterial strain. The instant specification defines “therapeutically” as a preparation administered to treat an exisiting disease or condition (see specification [0023]), and as such the prior art Mohamadzadeh teaches administering an effective amount as the bacteria is used treat cancer.
Regarding claims 3-4, 11-12, and 18-19, Mohamadzadeh teaches the probiotic is administered to the subject at a concentration of about 1 x 108 - 1 x 1012 colony forming units (CFU) (see [0082]), which covers the claimed ranges.
Regarding claim 14, Mohamadzadeh teaches the probiotic composition can also be administered to a human having cancer (see Mohamadzadeh [0091]). The instant specification defines cancer as a body weight disorder (see specification [0018]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 7-12, 14, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi (Pre-Grant Publication No. US 2023/0044923 A1 – date of publication 2/9/2023) and as evidenced by ELiE HealthSolutions (ELiE HealthSolutions, “Propionibacterium freudenreichii Optim PropioniBacter”, 2022 Apr 15, https://eliehs.com/en/optim-propionibacter-2/, accessed 2026 Jul 22).
Wakabayashi’s general disclosure relates to the administering of a propionic acid bacterium composition that can suppress weight gain in a subject (see abstract).
Regarding claim 1 and 17, Wakabayashi teaches the administering of a pharmaceutical composition which includes a propionic acid bacterium, and wherein the bacterium can be Propionibacterium freudenreichii (see [0044] and [0050]). Since prior art reference Wakabayashi teaches the same method steps of administering a Propionibacterium freudenreichii strain to a subject, the preamble’s recitation in claim 1 of reducing body weight in a subject and in claim 17 of enhancing endurance in a subject would be the implicit outcomes.
Regarding claim 9, Wakabayashi teaches the administering of a pharmaceutical composition which includes a propionic acid bacterium, and wherein the bacterium can be Propionibacterium freudenreichii (see Wakabayashi [0044] and [0050]), to treat obesity (see Wakabayashi [0021]). As defined in instant specification, obesity is defined as a type of body weight disorder in a subject (see specification [0018]). Since prior art reference Wakabayashi teaches the same method steps of administering a Propionibacterium freudenreichii strain to a subject, the preamble’s recitation of managing body weight disorder in a subject in need thereof would be the implicit outcome. Furthermore as noted in the 112b rejection above, the term “therapeutically effective amount” is indefinite as it is unclear if the amount administered is referring to the bacterial strain or the overall composition comprising the bacterial strain. The instant specification defines “therapeutically” as a preparation administered to treat an exisiting disease or condition (see specification [0023]), and as such the prior art Wakabayashi teaches administering an effective amount as the bacteria is used treat obesity.
However, regarding claims 1, 9, and 17, Wakabayashi does not specify that the bacteria was the UF1 strain.
Regarding claim 1, 9, and 17, it would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the Propionibacterium freudenreichii strain as taught in Wakabayashi for the UF1 strain. One would be motivated to do so because Wakabayashi teaches Propionibacterium freudenreichii strain in the pharmaceutical composition has the same function of preventing an increase in body weight by suppressing weight gain (see Wakabayashi [0009]) as the UF1 strain in the instant application (see specification [0033]). Therefore, it would be prima facie obvious to do a simple substitution of one strain for another as they are functionally the same and one would have had a reasonable expectation of success in doing so.
Regarding claims 2, 7, and 10, Wakabayashi teaches the pharmaceutical composition comprising a Propionibacterium freudenreichii strain, which is naturally a probiotic strain as evidenced by ELiE HealthSolutions (see pg. 1, ¶ 1).
Regarding claims 3-4, 11-12, and 18-19, Wakabayashi teaches the pharmaceutical composition is administered to the subject at a concentration of about 1 x 106 - 1 x 1012 colony forming units (CFU) (see [0045]), which covers the claimed ranges.
Regarding claim 8, Wakabayashi teaches the pharmaceutical composition may contain more than one bacterial strain such as Propionibacterium acnes strain (see [0044]).
Regarding claim 14, Wakabayashi teaches the pharmaceutical composition may be used to treat obesity (see [0018]). The instant specification defines cancer as a body weight disorder (see specification [0018]).
Claims 5-6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi (Pre-Grant Publication No. US 2023/0044923 A1 – date of publication 2/9/2023), further in view of Seed (Seed, “CFU vs. AFU: Precision in Counting Microbes”, 2022 Aug 11, https://web.archive.org/web/20220811002437/https://seed.com/cultured/cfu-vs-afu-whats-the-difference-and-which-is-better/, accessed 2026 Jul 23), and as evidenced by ELiE HealthSolutions (ELiE HealthSolutions, “Propionibacterium freudenreichii Optim PropioniBacter”, 2022 Apr 15, https://eliehs.com/en/optim-propionibacter-2/, accessed 2026 Jul 22).
Wakabayashi’s general disclosure has been set forth above.
Seed’s general disclosure relates to the benefits of using active fluorescent units (AFU) as a unit of measurement over colony forming units (CFU) to more precisely measure live cell counts (see pg. 3, ¶ 3).
Regarding claims 5-6 and 13, Wakabayashi teaches the administering of a pharmaceutical composition which includes a propionic acid bacterium, and wherein the bacterium can be Propionibacterium freudenreichii (see [0044] and [0050]). However, Wakabayashi does not teach the concentration of the probiotic dose in active fluorescent units (AFU).
Regarding claims 5-6 and 13, Seed teaches measuring the concentration of probiotics in active fluorescent units (AFU) (see pg. 3, ¶ 3).
Regarding claims 5-6 and 13, it would have been obvious to one of ordinary skill in the art before the effective filing date to add the measuring the probiotic concentration in AFU as taught in Seed to the to the probiotic administering method as taught in Wakabayashi. One would be motivated to do so because Seed teaches that AFU offers a more precise way of measuring the number of living viable probiotic bacterial cells in a product compared to CFU (see Seed pg. 3, ¶ 3 and pg. 5, ¶ 1). The ordinary artisan would have found it prima facie obvious to add such an addition to Wakabayashi’s disclosure which states a desire for living bacterial cells in their pharmaceutical composition (see Wakabayashi [0044]), and thus using AFU would have offered a more accurate concentration of the live bacteria in the composition.
However, regarding claims 5-6 and 13, Seed does not specify the concentrations of the bacteria in AFU. It would have been obvious though to optimize the concentration (in AFU) of the bacteria as taught in Seed and Wakabayashi to the claimed ranges. One would be motivated to do so because Wakabayashi teaches that the subject can alter the intake of the bacteria composition to their preference (see Wakabayashi [0053]). Thus one of ordinary skill in the art would find it only a matter of routine experimentation to modify the bacterial concentration (in AFU) to suit the need of the subject and would have had a reasonable expectation of success in doing so.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi (Pre-Grant Publication No. US 2023/0044923 A1 – date of publication 2/9/2023), further in view of Darimont-Nicolau (Pre-Grant Publication No. US 2016/0089404 A1 – date of publication 3/31/2016), and as evidenced by ELiE HealthSolutions (ELiE HealthSolutions, “Propionibacterium freudenreichii Optim PropioniBacter”, 2022 Apr 15, https://eliehs.com/en/optim-propionibacter-2/, accessed 2026 Jul 22).
Wakabayashi’s general disclosure has been set forth above.
Darimont-Nicolau’s general disclosure relates to the use of a pharmaceutical probiotic composition comprising Lactobacillus rhamnosus for use in managing weight in obese subjects (see [0019] and [[0028]) and wherein it was used in conjunction with calorie restriction in subjects (see [0034]) to increase the overall weight loss effect.
Regarding claim 15, Wakabayashi teaches the administering of a pharmaceutical composition which includes a propionic acid bacterium, and wherein the bacterium can be Propionibacterium freudenreichii (see [0044] and [0050]). However, Wakabayashi does not teach that the composition was administered with calorie restriction.
Regarding claim 15, Darimont-Nicolau teaches the administering of a probiotic pharmaceutical composition while the subject also underwent a calorie restricted diet (see [0034]).
Regarding claim 15, it would have been obvious to one of ordinary skill in the art before the effective filing date to add the calorie restriction conditions as taught in Darimont-Nicolau to the probiotic administering method as taught in Wakabayashi. One would be motivated to do so because Darimont-Nicolau teaches that the probiotic pharmaceutical composition is most effective at producing weight loss results when combined with a moderately calorically-restricted diet (see Darimont-Nicolau [0115]). Such an addition would improve upon Wakabayashi’s disclosure which uses the pharmaceutical composition to prevent or treat obesity in subjects (see Wakabayashi [0050]), and the addition of calorie restriction would increase the weight loss effect.
Regarding claim 16, Darimont-Nicolau teaches the combination of the probiotic composition and the calorie restriction resulted in greater weight loss in a subject than with just calorie restriction alone (see FIGURE 3 below).
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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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/986,463.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims are directed towards:
A method of administering a Propionibacterium freudenreichii UF (UF1) bacteria strain to a subject (claims 1, 9, and 18)
Composition comprises a probiotic and prebiotic (claim 2, 7, and 10)
Composition comprises a second strain of bacteria (claim 8)
Composition is in conjunction with calorie restriction and wherein the two combined result in more weight loss than calorie restriction alone (claims 15-16)
Copending application no. 18/986,463 claims are directed towards:
A method of administering a Propionibacterium freudenreichii UF (UF1) bacteria strain to a subject (claims 1, 9, and 14)
Composition comprises a probiotic and prebiotic (claim 6-7, 11, and 17)
Composition comprises a second strain of bacteria (claim 8)
Composition is in conjunction with calorie restriction and wherein the two combined result in more weight loss than calorie restriction alone (claims 13)
As such, both the instant application and the copending application no. 18/986,463 are directed to overlapping subject matter.
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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/E.R.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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