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
Applicant’s amendment filed on 02 July 2025 is entered. Claims 1, 4-6, 9-10, are 13-14 are amended.
Claims 1, 4-6, 8-10, 13-15, 17-20, 39-40, 44, 57, 61, and 68 are pending. Claims 18-20, 39-40, 44, 57, 61, and 68 are withdrawn. Claims 1, 4-6, 8-10, 13-15, and 17 are under examination on the merits.
The previous objections to the claims, and 112b, 102, and 103 rejections are withdrawn in light of Applicant’s amendment.
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.
(Maintained) Claims 1, 4-6, 8-10, 13-15, and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Claim 1 recites a pharmaceutical composition comprising a preparation comprising a species of viable anaerobic gut bacteria comprising a 16s rDNA sequence at least 97% identical to SEQ ID NO: 16, a pharmaceutically acceptable carrier, and an oxygen impermeable capsule. Claim 1 also further limits the dose of viable anaerobic gut bacteria to be at least 5x106 colony forming units per mL (CFU/mL) to 2x107 CFU/mL. Claim 4 further limits the composition of claim 1 to comprise an enteric coating composition that encapsulates the species of viable gut bacteria. Claim 5 limits the composition of claim 4 to be a capsule. Claim 6 limits the amount of capsules per one time dose to be 12 to 30 capsules. Claim 8 recites that the composition of claim 1 is frozen for storage. Claim 9 recites that the viable gut bacteria is encapsulated under anaerobic conditions, and claim 10 recites the composition further comprises reducing agents N-acetylcysteine, cysteine, or methylene blue. Claim 13 limits the viable anaerobic gut bacteria of claim 1 to be lyophilized, formulated as a food or a liquid, gel, fluid-gel, or nanoparticles in liquid. Claim 14 recites the composition of claim 1 further comprises a prebiotic composition. Claims 15 and 17 further limit the dysbiosis disease state that is functionally claimed in claim 1.
The composition of claim 1 recites the judicial exception of a product of nature because the compositional elements of the viable anaerobic gut bacteria, the pharmaceutically acceptable carrier, and the oxygen impermeable capsule, are nature-based materials. The viable gut bacteria is a natural microorganism derived from a gut microbiota, and the broadest reasonable interpretation (BRI) of the phrase pharmaceutically acceptable carrier is sufficiently broad enough to encompass many natural materials, including water. The oxygen impermeable capsule are inclusive of naturally-derived materials that make up the capsule, for example natural compound sodium alginate isolated from brown algae, as evidenced by Figs. 1 and 5 of Urena et al. (Potential of polysaccharides for food packaging applications. Part 1/2: An experimental review of the functional properties of polysaccharide coatings, Food Hydrocolloids 144 (2023) 108955). The enteric coating recited in claim 4 is also not limited to comprising any non-natural components, and enteric coatings can comprise natural components/compounds, such as fatty acids or plant fibers, as evidenced by the instant specification (Instant specification [0020]). Claims 5, 8, and 13 relate to different physical forms of the compositions, but do not recite any non-natural components. The phrase “capsules are prepared under anaerobic conditions” recited in claim 9 limits the conditions with which the capsules are formed, but does not recite any additional, non-natural structures. In claim 10, the addition of reducing agent N-acetylcysteine, cysteine, or methylene blue to the composition also does not limit the compositions to comprise non-natural compounds because both N-acetylcysteine and cysteine are naturally occurring compounds. The BRI of prebiotic as recited in claim 14 also includes many natural compounds, such as natural compounds like oligosaccharides, inulin, plant fibers, and pectin, as evidenced by the instant specification (Instant specification [0149]). Claims 15 and 17 further limit the dysbiosis disease state that is functionally claimed in claim 1, but do not recite any additional structural elements. Therefore, the instant compositions as claimed recite the judicial exception of a product of nature.
The closest natural counterpart of the invention of claims 1, 4-6, 8-10, 13-14, and 15-17 is the claimed viable gut bacteria, the pharmaceutically acceptable carrier, and the oxygen impermeable capsule material as they occur in nature. Since the instant composition recites wholly the same structural components as present in its natural counterpart, and does not recite any modifications or additional components that introduce any markedly different characteristics that amount to significantly more, the compositions of claims 1, 4-6, 8-10, 13-14, and 15-17 do not amount to significantly more than the judicial exception of a product of nature. The limitation of claim 8, which limits the composition to being frozen, does not add any markedly different characteristic to the frozen composition as compared to the closest natural counterpart. The structural and compositional elements remain the same between the composition of claim 8 and the natural counterpart; the only difference is that the composition of claim 8 is now frozen, which Examiner notes is also a natural process. The addition of a prebiotic into the composition of claim 14 does not add any markedly different characteristic of the composition over its natural counterpart because the viable gut bacteria in its natural gut microbiota habitat is routinely exposed to prebiotic compounds traveling through the digestive tract of the microbiota’s host. The encapsulation of the bacteria in an enteric coating also does not offer any markedly different characteristics to the claimed composition over the natural counterpart because the BRI of the claim term “enteric coating” is sufficiently broad that it encompasses many chemical compounds that the natural counterpart either comes into direct contact with (such as plant fibers being digested in the gut) or naturally coats itself with (fatty acids). Accordingly, there is no markedly different characteristic introduced to the claimed composition by the encapsulations of claims 9-10 and the enteric coating of claim 4.
This judicial exception is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims themselves are drawn to compositions of matter, and thus the claims do not recite any limiting integration of the composition into a practical application. Examiner does note that claim 1 recites the functional limitation “…treat or prevent a dysbiosis when administered to an individual in need thereof…”, but this functional limitation amounts to a desired function or effect of the instant composition, and does not recite any additional structural or compositional elements. As such, the claimed composition is not integrated into a practical application because the claims are not limited to any practical application. Therefore, the instant compositions as claimed are directed to the judicial exception of a product of nature.
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.
(New rejection necessitated by amendment) Claims 1, 4-6, 8-10, 13-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Henn et al. (US20140147425A1, published 29 May 2014) in view of Chavarri et al. (Encapsulation Technology to Protect Probiotic Bacteria, Chapter 23 of Probiotics, published 03 October 2012, doi 10.5772/50046), and as evidenced by Urena et al. (Potential of polysaccharides for food packaging applications. Part 1/2 : An experimental review of the functional properties of polysaccharide coatings, Food Hydrocolloids 144 (2023) 108955).
Regarding the functional limitations of claims 1, 15, and 17: claim 1 recites the limitation “…treat or prevent a dysbiosis when administered to an individual in need thereof…”, claim 15 recites the limitation “…wherein the dysbiosis is associated with…”, and claim 17 recites the limitation “…wherein the atopic disease or disorder is…”. The limitation of claim 1 recites a desired use of the instant composition to treat or prevent dysbiosis in a subject when administered, but the limitation of claim 1 does not recite any additional structural or compositional elements. Furthermore, the limitations of claims 15 and 17 are merely further limiting the desired use limitation of claim 1, and also do not recite any additional structural or compositional elements. Therefore, where the art teaches the structure/composition of the instant claims, the desired use limitations recited in claims 1, 15, and 17 are considered obvious.
Regarding claim 1, Henn teaches a composition comprising an effective amount of a bacterial composition, wherein in one embodiment the bacteria comprise a 16s rRNA sequence at least 95% identical to the 16s rRNA sequences from Table 3 (Henn [0008]). One such sequence that is listed in Table 3 of Henn is SEQ ID NO: 1754, which is 100% identical to instant SEQ ID NO: 16 of the instant claims (reference Sequence Search results of 8/20/2024 in the IFW). Henn teaches that the composition may comprise acceptable carriers (Henn [0119]). Henn also teaches that the composition may be administered to the small intestine, and is thus formulated to be delivered to the small intestine (Henn [0143]). Henn teaches the composition comprises at least 104 to 1011 CFU, which encompasses the entire instantly claimed range of viable gut bacteria (Henn [0013]).
Henn does not teach their composition is formulated in oxygen impermeable capsules.
Chavarri teaches the JetCutter bacterial encapsulation technique which microencapsulates probiotic bacteria with polymers such as alginate, kappa-carrageenan, and whey proteins under anaerobic conditions (Chavarri pg. 520-521 bridging para.). Chavarri also teaches that there are reports that probiotics have poor survival rates in products with free probiotic cells, and that providing living probiotic cells with barriers to resist adverse environments during and after administration and storage is an area of interest in art (Chavarri Intro. para. 1). Chavarri continues to teach that encapsulation techniques offer protection of the probiotic bacteria, and can enhance viability in the GI tract of humans, provide a convenient platform for introducing the probiotic to foods, converting the probiotics into powders for convenient use and storage, and for controlled release and optimized delivery of the probiotics to the site of action (Chavarri Intro. para. 2).
Hen and Chavarri do not teach that the capsules made of alginate, kappa-carrageenan, or whey proteins are oxygen impermeable.
However, the alginate and kappa-carrageenan capsules taught by Chavarri have very low oxygen permeance, and thus exhibit excellent oxygen barrier performance, as evidenced by Urena (fig. 5, data points labeled SA and KC, respectively).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to have encapsulated the probiotic bacteria comprising 16s rDNA sequence of SEQ ID NO: 1754 as taught by Henn (which is 100% identical to instant SEQ ID NO: 16) with oxygen impermeable sodium alginate or kappa-carrageenan capsules using the JetCutter encapsulation technique taught by Chavarri. One of ordinary skill in the art would have been motivated to encapsulate the probiotic bacteria with oxygen impermeable sodium alginate or kappa-carrageenan capsules because 1) Chavarri taught that there is considerable interest in providing probiotic bacteria with a physical barrier to resist adverse environmental conditions such as oxygen, and 2) in order to provide the probiotic bacteria taught by Henn with a structural protective coating that can withstand harsh environmental conditions such as the GI tract and oxygen that would be detrimental to the anaerobic bacteria. The encapsulating coating can also provide the probiotic bacteria of Henn with the advantages of having a convenient platform for introducing the probiotic to foods, converting the probiotics into powders for convenient use and storage, and controlling the release and optimizing delivery of the probiotics to a desired site of action. One of ordinary skill in the art would have had reasonable expectations of success in this endeavor because Chavarri taught that certain encapsulation techniques can 1) be performed under anaerobic conditions, and 2) can confer the benefits of protection and enhanced viability of the probiotic bacteria in the GI tract of humans, as well as providing a convenient platform for introducing the probiotic to foods, converting the probiotics into powders for convenient use and storage, and controlling the release and optimizing the delivery of the probiotics to a site of action.
Regarding claim 4, Henn teaches in one embodiment that the composition comprises a pharmaceutically acceptable excipient and an enteric coating (Henn [0013]).
Regarding claim 5, Henn teaches the composition solid dose form can be capsules (Henn [0120]).
Regarding claim 6, the claim recites that the composition comprises 12 to 30 capsules per one time dose, but this limitation only limits the dosage amount of the composition when the composition is administered and does not add any additional structural characteristics to the instant composition. As described above, claim 1 recites the functional limitation “…treat or prevent a dysbiosis when administered to an individual in need thereof…”, which is a desired use of the instant composition to treat or prevent dysbiosis in a subject when administered. Thus the limitation of claim 6 is interpreted to be the effective dose of the composition which results in the desired effect of treating or preventing a dysbiosis to an individual in need thereof when administered, and is obvious over Henn in view of Chavarri because the structural elements of the claimed composition are taught by Henn and Chavarri.
Regarding claim 8, Henn teaches that the composition can be preserved and stored by freezing/cryopreservation (Henn [0099]).
Regarding claims 9 and 10, Henn teaches that anaerobic bacteria, such as the probiotic gut microbiota taught within Henn, should be cultured in anoxic/reducing environments by adding reducing agents such as cysteine to the culture broth (Henn [0098]).
Regarding claim 13, Henn teaches the encapsulation of the composition in an enteric coating (Henn [0013]), that the composition can be lyophilized (Henn [0125]), that the composition may be incorporated into a food (Henn [0122]), and that the composition can be in the form of a liquid or gel (Henn [0143]).
Regarding claim 14, Henn teaches that the composition may comprise a prebiotic (Henn [0153]).
Regarding claims 15 and 17, as described above, claims 15 and 17 recite further limitations to the intended use limitation of claim 1, and thus do not recite any additional structural or compositional elements. Since Henn in view of Chavarri teaches all of the structural elements of the instant composition, claims 15 and 17 are obvious over Henn in view of Chavarri for the reasons described above.
Response to Arguments
Applicant's arguments filed 02 July 2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the 102 and 103 rejections of claims 1, 4-6, 8-10, 13-15, and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding Applicant’s arguments against the 101 rejection that the instant composition exhibits markedly different characteristics from its closest natural counterpart because the arrangement of the viable-gut bacteria within such capsules does not occur in nature and protects the bacteria from oxygen exposure (remarks pg. 8 last para. through pg. 9 last para.), MPEP 2106.04(c)(II)(A) recites "[w]hen the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination." As instantly claimed, the nature-based combination is produced from multiple components, thus the closest natural counterpart is the individual nature-based components of the combination. As described in the rejection, the viable gut bacteria is a natural microorganism derived from a gut microbiota, the broadest reasonable interpretation (BRI) of the phrase pharmaceutically acceptable carrier is sufficiently broad enough to encompass many natural materials, including water, and the oxygen impermeable capsule is inclusive of naturally-derived oxygen impermeable materials that make up the capsule, for example oxygen impermeable sodium alginate isolated from brown algae, as evidenced by Figs. 1 and 5 of Urena. Therefore, the instant composition does not exhibit any markedly different characteristics.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander M Duryee whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached on (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
/Alexander M Duryee/Examiner, Art Unit 1657