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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Group 1 (method/ and a composition) Claims 1-17, drawn to a method of reducing gas and/or bloating and a composition of a probiotic, comprising Bifidobacterium adolescentis SH01 or Bifidobacterium pseudocatenulatum SH03, and an additive, classified In A61K 35/745.
II. Group 2 (product/composition) Claims 18-20, drawn to a composition comprising a probiotic (at least one probiotic selected from a genus consisting of Lactobacillus, Bifidobacterium, Bacillus, Streptococcus, Aspergillus, Streptomyces Saccharomyces, Enterococcus, Turicibacter, Veillonellla, Anaerostipes, Catenibacterium, Mediterraneibacter, Prevotella, and a combination thereof), and an additive, classified in A61K 47/26.
Inventions Group 1 and Group 2 are directed to related compositions. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the composition of Group 1 is a materially different design, with a probiotic composition that is distinct from the composition in Group 2. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have different classification, require different search strategies and keywords and separate consideration of different prior art references.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
This application contains claims directed to the following patentably distinct species:
Applicant is required to elect an overall election of one said additive group:
Species 1: Claims 1,12, and 18 wherein the composition comprises a selected additive group:
preservatives,
solvents,
dispersion media,
coatings,
stabilizing agents,
antifungal agents,
isotonic agents,
adsorption delaying agents, or
combination thereof
The species are independent or distinct, each is a chemically and/or mechanistically distinct grouping of agents with differing functions. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: The inventions have different classification, require different search strategies, and keywords and separate consideration of different prior art references.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Mr. Sean Solberg on December 19, 2025 a provisional election was made without traverse to prosecute the invention of Group 1 and Species 1, the selected species was stabilizing agent . Affirmation of this election must be made by applicant in replying to this Office action. Claims 18-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Joint Inventorship
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Rejoinder Potential
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10-13, and 16 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. It is apparent that Bifidobacterium pseudocatenulatum, SH03, Bifidobacterium adolescentis SH01, Bifidobacterium longum subsp. infantis SH07, Bifidobacterium pseudocatenulatum SH03, Lactobacillus acidophilus SH21, Lactobacillus gasseri SH91,and/or Lactobacillus reuteri SH17 is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the strains Bifidobacterium pseudocatenulatum, SH03, Bifidobacterium adolescentis SH01, Bifidobacterium longum subsp. infantis SH07, Bifidobacterium pseudocatenulatum SH03, Lactobacillus acidophilus SH21, Lactobacillus gasseri SH91,and/or Lactobacillus reuteri SH17.
The process disclosed in the specification does not appear to be repeatable. It is not clear that the invention will work with commonly available material and it is not apparent if the biological material(s) considered necessary to make and use the invention is both known and readily available to the public. It is noted that there is no indication that Applicants deposited the biological material as disclosed in Claims 10,11,12,13 and 16; there is no indication regarding public availability.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirements made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F. R. §§1.801-1.809, Applicant must provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. §1.807); and
the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. §1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it an to permit examination.” The specification should be amended to include this information; however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
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, 4, 8-11 and 18-19 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.
The claim recites ‘food’, ‘food product’, ‘food ingredient’, or ‘food component’ in Claims 1,4,8-11 and 18-19, however the metes and bounds of each term is unclear since these terms are overlapping. For instance, it is not clear what the distinction between food and food product is. What the distinction between food ingredient and food component is. The specification does not provide a definition or the distinctions between the terms, therefore one would not know if they are infringing based on the scope of the terms.
Claim Rejections - 35 USC § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Von Maltzahn et al., (AU2016253010 A1; published 2017-10-19).
Regarding claim 1, Von Matlzahn et al. teaches a method of reducing gas and bloating with a composition containing: glycan incorporated foods, probiotics, and stabilizing agents (page 28, paragraph 1 and 2; page 31, paragraph 2; page 77, paragraph 1 and 2; page 80, paragraph 2 and 3; page 85, paragraph 1; page 102, paragraph 4; page 107, paragraph 2).
Regarding claim 2 , Van Matlzahn et al, teaches a method where at least one administered probiotic is from the provided genus: Prevotella, Bifidobacterium, Lactobacilli… (pages 13-14, paragraph 4).
Regarding claim 3, Van Matlzahn et al., teaches a method where in at least one probiotic is selected from the provided group: “probiotic bacteria that can be used in the methods and compositions described herein … L. acidophilus, L. crispatus, … as well as Bifidobacterium species, such as B. lactis, B. animalis, B. bifidum, B. longum, B. adolescentis, and B. infantis” (page 80, paragraph 2).
Regarding claim 4, Van Matlzahn et al., teaches a method wherein said food ( product, ingredient or component) is selected from the provided group: the prebiotic is one or more of galactooligosaccharides (GOS), lactulose, raffinose, … inulin, …sorbitol, … or mixtures thereof (page 79, paragraph 5).
Regarding claim 5, Van Matlzahn et al., teaches a reduction in gas and/or bloating after administering said probiotic composition (pages 115-116, paragraph 4) at least one time, where in “a dosage regimen includes …one, two, three, or four of: a unit dose,” (paragraph 1, page 38).
Regarding claim 7, Van Maltzahn et al., teaches suitability of probiotics for administration to the gut, e.g. via oral dosage forms (page 26, paragraph 1; page 80, paragraph 2).
Regarding claim 8, Van Matlzahn et al., teaches gas and/or bloating are reduced with an effective amount of food (product, ingredient, or component), using “a composition comprising a glycan therapeutic and a second dosage element comprising (… a probiotic, a prebiotic, a micronutrient, etc. or a combination thereof)” (page 87, paragraph 1).
Regarding claim 9, Van Matlzahn et al., teaches administration of the composition results in at least a 10% reduction in gas and/or bloating compared to administration of the same foods etc. without said probiotic, in which, “the subject experiences a reduction in at least one symptom of the gastrointestinal disease, disorder or condition following treatment. …a reduction in the severity of a symptom following treatment can be determined (e.g. by measuring a known biomarker) and is in the order of about 3%, 5%, 7%, 10%, 20%, …in some embodiments, the symptoms, measured…decreased by an average of about 10%, 20%...when compared to symptoms prior to the administration of a pharmaceutical glycan therapeutic composition” (page 144, paragraph 1).
Claim Rejections - 35 USC § 102/103
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.
Claim(s) 11, 12 and 15 are rejected under 35 U.S.C. 102(a) (1) as anticipated by or, in the alternative, under 35 U.S.C. 10 3 as obvious over Van Matlzahn et al., (AU2016253010 A1; published 2017-10-19).
The discussion of Van Matlzahn et al is incorporated herein.
With regards to claims 11, 12 and 15, Van Matlzahn et al., teaches food (product, ingredient, or component, page 26, paragraph 1; page 84, paragraph 3; page 85, paragraph 1) comprising raffinose (page 79, paragraph 5) and the probiotic Bifidobacterium adolescentis (page 80, paragraph 2) as a composition for reducing gas production and/or bloating (page 80, paragraph 1) with a stabilizing agent (page 84, paragraph 1) and/or following the administration of raffinose and/or sorbitol (page 39, paragraph 1; page 79, paragraph 5; page 108, paragraph 1; page 109, paragraph 1) .
Van Matlzahn et al., does not specifically state the strain is Bifidobacterium adolescentis SH01.
However, both the instant strain and Van Matlzahn et al. strain are Bifidobacterium adolescentis and share characteristics such as the strains are probiotic organisms with the ability to reduce bloating and/or gas; therefore, since the Patent Office is not equipped to manufacture products and make physical comparisons therewith, it is reasonably concluded due to the shared characterisitics that Bifidobacterium adolescentis SH01 and the prior art’s Bifidobacterium adolescentis are the same if not obvious variants.
Alternatively, if the prior art’s strain is not the same, it would have been obvious to utilize the instant strain or an obvious variant since both the prior art and instant strain share the same characteristic of reducing bloating and gas and are taught to be probiotics. The use of an alternative strain of Bifidobacterium adolescentis amounts to the simple substitution of known strain(s) for another and would have been expected to predictably and successfully provide such a strain to reduce gas and/or bloating.
Claim Rejections - 35 USC § 103
Claim(s) 6, 10, 13, 14, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Van Matlzahn et al., (AU2016253010 A1; published 2017-10-19) in view of Berry et al., (US9610307B2; published 2017-04-04).
The teachings of Van Matlzahn et al. have been disclosed above.
Van Matlzahn et al. does not teach:
an amount of at least 103 CFU for the probiotic as described in claims 6 and 13.
wherein the probiotic is Bifidobacterium pseudocatenulatum SHO3 as described in claims 10 and 16,
Regarding claim 6 , Barry et al., teaches a composition of Bifidobacterium pseudocatenulatum or Bifidobacterium adolescentis at an amount of at least 103 CFU (Column 47, Lines 28-39; Column 31 Lines 28-30; Column 36, Lines 12-14; Column 31, Line 46; Column 36, Lines 27-29) and as a composition and/or method to prevent dysbiosis, including gas and/or bloating (Column 66, Line 64 through Column 67, Line 12).
Regarding claim 10, Van Matlzahn et al., teaches sorbitol and Barry et al., teaches instant strain Bifidobacterium pseudocatenulaturm, although Barry et al., does not specify strain Bifidobacterium pseudocatenulaturm SH03 (Column 47, Lines 28-39; Column 31 Lines 28-30; Column 36, Lines 12-14; Column 31, Line 46; Column 36, Lines 27-29).
Regarding claim 13, Barry et al., teaches an amount of at least 103 CFU although Barry et al., does not specify strain Bifidobacterium adolescentis SH01 (Column 47, Lines 28-39; Column 31 Lines 28-30; Column 36, Lines 12-14; Column 31, Line 46; Column 36, Lines 27-29) .
Regarding claim 14, Van Matlzahn et al., teaches raffinose.
Regarding claim 16, Barry et al., teaches an amount of at least 103 CFU and instant strain Bifidobacterium pseudocatenulaturm, although Barry et al., does not specify strain SH03 (Column 47, Lines 28-39; Column 31 Lines 28-30; Column 36, Lines 12-14; Column 31, Line 46; Column 36, Lines 27-29) .
Regarding claim 17, Van Matlzahn et al., teaches sorbitol.
Therefore, it would be obvious to one of ordinary skill in the art, at the time of the effective filing date, to modify Van Matlzahn et al., in view of Barry et al., to substitute Bifidobacterium pseudocatenulatum SHO3 and/or Bifidobacterium adolescentis SHO1 for the strains described in the prior art, since both sets of strains are taught to be probiotics , to reduce gas and/or bloating. . It would have been obvious to combine the teachings of Van Matlzahn et al., and Barry et al., and add Bifidobacterium adolescentis SHO1 and/or Bifidobacterium pseudocatenulatum SHO3. One would have been motivated to do so since both strains are taught to be probiotics to reduce bloating. Therefore, it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. See MPEP 2144.06.
Further, it would be obvious to one of ordinary skill in the art, at the time of the effective filing date, to modify Van Matlzahn et al., in view of Barry et al., to substitute an amount of at least 103 CFU as a concentration that addresses result effective variables and to meet dosage optimal parameters for a given population. One would have been motivated to adjust the amount, since the strains of the prior art and the instant application are probiotics which reduce gas and/or bloating resulting from dysbiosis, at an amount of at least 103 CFU. Therefore, it would have been obvious to substitute and/or combine Bifidobacterium pseudocatenulatum SHO3, and/or or Bifidobacterium adolescentis SHO1 at, at least 103 CFU based on the teachings of Van Matlzahn et al., and in view of Barry et al to meet the effective dosage.
Furthermore, since the prior art teaches the composition and administering it, the prior art will be capable of performing the intended use.
Regarding SH03, although Berry does not specify Bifidobacterium pseudocatenulatum SH03, however, both the instant strain and Berry et al. teach Bifidobacterium pseudocatenulatum and share characteristics such as the strains are probiotic organisms with the ability to reduce symptoms of gastrointestinal dysbiosis and can be used with prebiotics, food, and/or pharmaceuticals. Since the Patent Office is not equipped to manufacture products and make physical comparisons therewith, it is reasonably concluded due to the shared characteristics that Bifidobacterium pseudocatenulatum SH03 and the prior art’s Bifidobacterium pseudocatenulatum are the same if not obvious variants.
Alternatively, if the prior art’s strain is not the same, it would have been obvious to utilize the instant strain or an obvious variant since both the prior art and instant strain share the same characteristic of reducing bloating and gas and are taught to be probiotics. The use of an alternative strain of Bifidobacterium pseudocatenulatum amounts to the simple substitution of known strain(s) for another and would have been expected to predictably and successfully provide such a strain to reduce gas and/or bloating.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am- 3:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653