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
This is a US national phase of PCT/US2022/034037, filed June 17, 2022, with provisional application 63/211967, filed June 17, 2021. Applicant’s amendment filed March 13, 2026 is acknowledged. Claims 1-38 are canceled and claims 39-58 are pending.
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on March 13, 2026 is acknowledged. Claims 50-57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 13 2026. Claims 39-49 and 58 are under examination.
Drawings
The drawings are objected to because the drawings are labeled “Figure” instead of “FIG.”. See MPEP 608.02 V. DRAWING STANDARDS (u):
(u) Numbering of views.
(1) The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.
(2) Numbers and letters identifying the views must be simple and clear and must not be used in association with brackets, circles, or inverted commas. The view numbers must be larger than the numbers used for reference characters.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 47-48 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.
Claim 47 recites the limitation "the pathogenic fungi" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is further unclear what the pathogenic fungi’s role in the composition is, as the specification indicates the composition is capable of disrupting biofilm comprising pathogenic fungi, thus more clarity in claim language is needed.
Claim 48 recites that the composition is active in the gastrointestinal tract of a subject to reduce the presence of a pathogenic bacteria Delftia. It is unclear what constitutes the composition as ‘active’ and there is no definition in the specification as to what degree of reduction in Delftia is required to categorize the composition as ‘active’. Therefore, one of ordinary skill in the art would not be apprised as to the metes and bounds of the claim, thus is indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 46 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 46 recites “The composition of claim 45, wherein the enzyme is α-galactosidase.”. The enzyme in the composition of claim 45 is an amylase, which is not categorically an α-galactosidase, thus does not further limit the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 39-49 and 58 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring organism without significantly more.
The Supreme Court has required analysis based on a 3-part test for subject matter eligibility.
- Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
- Step 2A (The Judicial Exceptions): Prong 1: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
-Step 2A (The Judicial Exceptions): Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
- Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claims 39-49 and 58 recite a composition comprising a freeze dried or spray dried blend comprising at least two to four isolated and viable various non-pathogenic bacterial strains selected from the group consisting of Lactobacillus casei, Bifidobacterium longum, Lactobacillus paracasei, Lactobacillus salivarius, Lactobacillus delbrueckii, and Bifidobacterium breve. Claims 45-46 recite the composition further comprises an amylase or a-galactosidase enzyme, and claim 58 recites the composition is combined or infused with a dietary composition for human consumption, thus is a statutory category of invention (Step 1: Yes).
Claims 39-49 and 58 are drawn to compositions comprising natural occurring viable bacterial species that are freeze-dried or spray-dried. Although freeze-drying or spray-drying transforms the bacterial species into an altered physical state not found in nature, the claim recites the composition ‘comprises’ the freeze-dried or spray dried blend, thus can include natural hydrating elements, such as water, that when mixed with the freeze-dried or spray-dried bacteria can transform the bacterial blend back to their naturally occurring physical state found in nature, and loses the markedly different characteristics, i.e. spray drying can alter solubility, flowability, and water activity, while freeze drying confers longer shelf life, which is widely known to one of ordinary skill in the art, thus is a product of nature exception. Similarly the recitation of the composition further including an amylase or a-galactosidase are naturally occurring enzymes found in bacteria. Thus the claims recite a judicial exception in the form of being a product of nature (Step 2A, Prong 1: Yes).
Claim 58 is recites the composition is combined or infused with a dietary composition, which is a common and routine practice in the art as evidenced by Robins et al. (WO 2021081362 A1). Thus the claims do not recite additional elements that integrate it into a practical application, nor recite additional elements that amount to significantly more than the judicial exception (Step 2A, Prong 2: No), (Step 2B: No).
To obviate this 101 rejection, the Examiner suggests amending claim 39 to “A freeze-dried or spray-dried composition comprising at least two isolated and viable non-pathogenic bacterial strains...”.
Claim Rejections - 35 USC § 102
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)(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 39-43, and 47-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Santocchi et al. (Frontiers in Psychiatry, (2020-09-25), vol. 11, pages 1-12, cited in IDS filed 12/15/2023, hereinafter “Santocchi”).
Regarding claims 39-43 and 49, Santocchi teaches administering probiotic compositions to patients suffering from autism spectrum disorder (ASD), wherein the probiotic composition is a lyophilized oral product comprising Bifidobacterium longum, Bifidobacterium longum subsp. infantis, Lactobacillus paracasei, Lactobacillus delbrueckii, and Bifidobacterium breve (abstract, pg. 3, “Interventions”), which anticipates the claims.
Regarding claim 47, the Examiner interprets ‘the pathogenic fungi’ to mean the composition is capable of disrupting biofilm comprising pathogenic fungi. Although Santocchi does not teach the composition disrupts biofilm comprising the recited pathogenic fungi, this function is inherent to the composition, since "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 48, Santocchi teaches administration of the probiotics significantly reduced GI symptoms in children with ASD (pg. 5, Table 3), but is silent on whether the composition reduces pathogenic bacteria Delftia. However, the composition taught in Santocchi would function as presently claimed, because "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claims 39-44, 47-49, and 58 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Robins et al. (WO 2021081362 A1, hereinafter “Robins”).
Regarding claims 39-44 and 49, Robbins teaches symbiotic compositions comprising a plurality of preselected probiotic bacteria with a sterilized organic vegetable or fruit juice liquid medium which may be used for colon health and improving overall immune function and intestinal health, wherein the selected bacterial composition is freeze-dried (abstract, [0048]). The symbiotic composition comprise probiotic bacterial strains of the genus Bifidobacterium include the species B. bifidum, B. breve, B. lactis, B. longum, B. infantis and mixtures thereof, wherein the plurality of probiotic bacterial strains of the genus Lactobacillus include the species L· acidophilus, L. brevis, L. bulgaricus, L. casei, L. gasseri, L. paracasei, L. plantarum, L. reuteri, L. rhamnosus, L. salivarius and mixtures thereof (claim 1), which anticipates claims 39-44 and 49.
Regarding claim 47, the Examiner interprets ‘the pathogenic fungi’ to mean the composition is capable of disrupting biofilm comprising pathogenic fungi. Although Robins does not teach the composition disrupts biofilm comprising the recited pathogenic fungi, this function is inherent to the composition, since "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 48, Robins teaches that the chosen blend of
Bifidobacteria and Lactobacilli functioned in a complementary, additive and possibly synergistic way to completely inhibit growth of C. difficile [0085], but is silent on whether the composition reduces pathogenic bacteria Delftia. However, the composition taught in Robins would function as presently claimed, because "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 58, Robins teaches the probiotic composition is combined in a juice-based medium, which anticipates the claim [0002].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Robins as applied to claims 39-44, 47-49, and 58 above, and further in view of Ghannoum (US20190381119A1, cited in IDS filed 11/14/2024).
Regarding claim 45, Robins teaches the chosen blend of
Bifidobacteria and Lactobacilli functioned in a complementary, additive and possibly synergistic way to completely inhibit growth of C. difficile, wherein the chosen probiotics have released some bioactive compounds into the sterilized organic liquid medium or fruit and vegetable juice that has inhibited growth of C. difficile [0085]. Robins does not teach the composition further includes an enzyme, such as those recited in the claim.
However, Ghannoum teaches compositions for promoting healthy microbial flora in a mammal and teach a composition comprising isolated and viable non-pathogenic bacterial strain and an amylase selected from the group consisting of Bacillus stearothermophilus amylase, Bacillus amyloliquefaciens amylase, Bacillus subtilis amylase, Bacillus licheniformi amylase, Aspergillus niger amylase, and Aspergillus oryzae amylase (claims 1-3 and 13-14). Ghannoum teaches the amylase is capable of disrupting a biofilm, which is now believed that pathogenic bacteria and fungi exist in biofilms on the colonic epithelium, which become impenetrable to antimicrobials and host immune cells, and are difficult to treat [0013, 0008].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to combine the probiotic compositions taught by Robins and an amylase enzyme that can degrade or otherwise disrupt carbohydrate components of the biofilm as taught by Ghannoum. One of ordinary skill in the art would be motivated to combine beneficial probiotic bacteria and an amylase that breaks down biofilms harboring pathogenic bacteria and fungi, to promote healthy gut microbial flora and inhibit harmful gut pathogens, as taught by Robins and Ghannoum.
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Robins in view of Ghannoum as applied to claim 45 above, and further in view of Bobzin et al. (US20210060137A1, hereinafter “Bobzin”).
As discussed above Robins teaches probiotic compositions comprising Lactobacillus and Bifidobacterium species, and Ghannoum teaches probiotic compositions further comprising an amylase enzyme.
Neither reference teaches the probiotic composition further comprises an α-galactosidase, which is how the Examiner interprets the composition in claim 46.
However, Bobzin teaches nutrient compositions having enhanced bioavailability comprising vitamins, minerals, enzymes, inter alia, as well as including an absorption-promoting probiotic (abstract). Bobzin teaches the composition may further comprise a digestive support component that aids in the breakdown, conversion, or hydrolysis of ingested food and/or supplements such as amylase, protease, xylanase, maltase, glucoamylase, hemicellulose, beta-glucanase, phytase, cellulase, alpha-galactosidase, inter alia [0049].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to combine the probiotic compositions taught by Robins with an amylase taught by Ghannoum, and further include an alpha-galactosidase as a digestive support component as taught by Bobzin. One of ordinary skill in the art would have been motivated to include alpha-galactosidase, which increases the bioavailability of the ingested food and/or supplements containing probiotics and other enzymes, as taught by Bobzin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
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