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
The amendment filed 06/20/2025 has been entered. Claims 1-53, 56-58, 60-65, and 67 are cancelled. Claims 74-81 are newly added. Claims 54, 55, 59, 66, and 68-81 are pending. Claims 69-73 are withdrawn. Claims 54, 55, 59, 66, 68, and 74-81 are under examination.
Response to Arguments
With respect to the rejection of claims 54, 55, 59, 66, and 68 under 35 USC 101, Applicant's arguments filed 06/20/2025 have been fully considered but they are not persuasive. Applicant argues that because each of the claimed bacterial species were isolated from different sources that they would not come into contact with each other in nature, however, this is not a factor for evaluation of nature-based products.
MPEP 2106.04(b)II states: “It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible."). Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g., In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 130-132, 60 USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.”
Applicant argues that the claimed microbial consortium is unexpectedly capable of inducing a pro-inflammatory effect in a subject. However, Applicant has provided no evidence to suggest that any of the claimed bacterial species alone cannot induce a pro-inflammatory response in a human, i.e., Applicant has not demonstrated that the pro-inflammatory effect of the microbial consortium is due to combining the claimed bacterial species. Therefore, Applicant has provided no evidence to demonstrate that the claimed microbial consortium has markedly different structural and/or functional characteristics compared to any of the bacterial species alone.
Applicant’s arguments, with respect to the rejection of claims 54 and 68 under 35 USC 102 and the rejection of claims 59 and 66 under 35 USC 103, 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.
Claim Objections
Claims 59, 66, and 76 are objected to because of the following informalities:
A space is missing in “ones16S” in line 4 of claim 59.
“One bacteria” in line 1 of claim 66 is not in singular form; line 6 of claim 66 recites “Veillonella parvula ATCC 17745 and” and should instead recite “and Veillonella parvula ATCC 17745”.
Claim 76(ii) recites Veillonella parvula ATCC but does not recite a deposit number.
Appropriate correction is required.
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 54, 55, 59, 66, 68 and 74-81 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a microbial consortium comprising naturally occurring bacteria. This judicial exception is not integrated into a practical application because the bacterial species comprising the microbial consortium are naturally occurring, as interpreted in the instant disclosure, and the claims do not include any additional elements other than the naturally occurring bacteria.
Prong 1 - Statutory category: Here, the claimed invention is either a composition of matter or a manufacture. Under 35 USC 101, the claimed invention must be “any new and useful process, machine, manufacture, or composition of matter.” The invention falls under one of the statutory categories (composition of matter) identified in 35 USC 101.
Prong 2A – Judicial exception: Here, the claimed invention is a composition or a manufactured product but is directed to the judicial exception, specifically a law of nature or a natural phenomenon (product of nature). Even a composition of matter or a manufacture may not be patent eligible if it falls under a judicial exception. The three judicial exception categories are: enumerated abstract idea, law of nature, and natural phenomenon (product of nature). Nature based products include both naturally occurring as well as non-naturally occurring products that have characteristics that are not markedly different from a natural occurring counterpart and fall within the judicial exception.
Here, the microbial consortium comprises naturally occurring strains of the following bacterial species: Clostridium tyrobutyricum, Clostridium cellulovorans, Cetobacterium somerae, Veillonella parvula, Corynebacterium glyciniphilum, Oenococcus oeni, Bacteriodes caccae, and Lactobacillus casei, all of which are naturally occurring species. Therefore, the claimed invention is directed to products of nature and falls within the judicial exception category.
Prong 2B: Judicial Exception/Significantly More: The “significantly more” analysis is a determination whether a claim is eligible if the claims recite additional elements that integrate the judicial exception into a practical application. Integration requires an additional element in the claim to apply, rely on, or use the judicial exception in a manner than imposes a meaningful limit on the judicial exception. Claims 54, 55, 59, 66, 68 and 74-81 are drawn to a microbial consortium comprising naturally occurring bacterial species with no additional elements. These limitations do not recite any meaningful additional limitations, modifications or transformations that indicate that the composition comprises anything other than naturally occurring bacteria, and there is no information to suggest that the bacteria have been genetically modified by the applicant (i.e., it is interpreted that they are naturally occurring). Therefore, the claims do not recite any limitations significantly more than the judicial exception and are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or a law of nature without significantly more.
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.
Claims 54, 55, 68, 74, 76, and 81 are rejected under 35 U.S.C. 103 as being unpatentable over Rahman et al., (WO 2016/086205 A2, hereinafter "Rahman").
Regarding claim 54, Rahman teaches a probiotic composition containing bacterial entities (Abstract) and a bacterial composition that includes a consortium of microbes comprising two or more OTUs (para. [0593]). Rahman teaches that the bacterial population may comprise two or more bacterial species set forth in Table 1 and Tables 1A-1F (para. [014]), which list Clostridium tyrobutyricum in Table 1 (p. 396) and Clostridium cellulovorans in Table 1A (p. 455), Cetobacterium somerae (p. 428) and Veillonella parvula (p. 417) in Table 1, and Bacteroides caccae (p. 456) and Lactobacillus casei (p. 458) in Table 1B. It would have been obvious to one of ordinary skill in the art to combine any two bacterial species taught by Rahman to form a probiotic composition containing Clostridium tyrobutyricum or Clostridium cellulovorans, and Cetobacterium somerae, Veillonella parvula, Bacteroides caccae, or Lactobacillus casei.
Although Rahman does not teach that the probiotic composition induces a pro-inflammatory effect in a human subject, inducing said effect is considered an intended use of the claimed probiotic composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, the limitation of inducing a pro-inflammatory effect in a human subject is met when the prior art product teaches and suggests the same bacterial species.
Regarding claim 55, Rahman teaches that the probiotic composition comprises an isolated bacterial population (para. [019]).
Regarding claims 68 and 81, inducing a pro-inflammatory effect in a human subject diagnosed with a cancer selected from breast, lung, pancreatic, bladder, melanoma, kidney, head and neck, or lymphoma is considered an intended use of the probiotic composition and therefore is met when the prior art product teaches and suggests the same bacterial species.
Regarding claim 74, Rahman teaches that the bacterial population may comprise two or more bacterial species set forth in Table 1 and Tables 1A-1F (para. [014]) and Cetobacterium somerae (p. 428) in Table 1.
Regarding claim 76, Rahman teaches that the bacterial population may comprise two or more bacterial species set forth in Table 1 and Tables 1A-1F (para. [014]); specifically, Clostridium tyrobutyricum (p. 396) and Cetobacterium somerae (p. 428) in Table 1, Clostridium cellulovorans (p. 455) in Table 1A, and Bacteroides caccae (p. 456) in Table 1B.
Claims 59, 66, 75, 77, and 79 are rejected under 35 U.S.C. 103 as being unpatentable over Rahman et al., (WO 2016/086205 A2, "Rahman"), as applied to claims 54, 74, and 76 above, and further in view of Henn et al., (US 8,906,668 B2)
Rahman teaches probiotic compositions comprising two or more bacterial species that may include Clostridium tyrobutyricum, Clostridium cellulovorans, Cetobacterium somerae, Veillonella parvula, Bacteroides caccae, or Lactobacillus casei. Rahman does not teach the 16S rDNA sequences or strain names of said species.
Regarding claims 59 and 66, Henn teaches synergistic bacterial compositions that may comprise bacteria that comprise 16S rDNA sequences shown in SEQ ID NOs. 1-1,864 (Column 3, line 30). Henn teaches a sequence (SEQ ID NO:595) with 100% identity to the instant SEQ ID NO:2. According to table 1 of the instant specification (p. 55), SEQ ID NO:2 is the 16S rDNA sequence of Clostridium tyrobutyricum KCTC 5387 (see alignment attached to this Office action). Henn teaches a sequence (SEQ ID NO:1830) with 100% sequence identity to the instant SEQ ID NO:7 (see alignment attached to this Office action), which, according to table 1 of the instant specification, is the 16S rDNA sequence of Veillonella parvula ATCC 17745. Therefore, the strains taught by Henn are Clostridium tyrobutyricum KCTC 5387 and Veillonella parvula ATCC 17745.
Regarding claim 75, Henn teaches synergistic bacterial compositions that may comprise bacteria that comprise 16S rDNA sequences shown in SEQ ID NOs. 1-1,864 (Column 3, line 30). Henn teaches a sequence (SEQ ID NO:449) with 100% sequence identity to instant SEQ ID NO:3 (see alignment attached to this Office action). According to table 1 of the instant specification, SEQ ID NO:3 is the 16S rDNA sequence of Cetobacterium somerae ATCC BAA-474. Therefore, the strain taught by Henn is Cetobacterium somerae ATCC BAA-474.
Regarding claim 77, Henn teaches synergistic bacterial compositions that may comprise bacteria that comprise 16S rDNA sequences shown in SEQ ID NOs. 1-1,864 (Column 3, line 30). Henn teaches a sequence (SEQ ID NO:595) with 100% identity to instant SEQ ID NO:2 (see alignment attached to this Office action). According to table 1 of the instant specification (p. 55), SEQ ID NO:2 is the 16S rDNA sequence of Clostridium tyrobutyricum KCTC 5387. Henn teaches a sequence (SEQ ID NO:449) with 100% sequence identity to instant SEQ ID NO:3 (see alignment attached to this Office action). According to table 1 of the instant specification, SEQ ID NO:3 is the 16S rDNA sequence of Cetobacterium somerae ATCC BAA-474. Therefore, the strains taught by Henn are Clostridium tyrobutyricum KCTC 5387 and Cetobacterium somerae ATCC BAA-474.
Regarding claim 79, as stated, Henn teaches synergistic bacterial compositions that may comprise bacteria comprising the 16S rDNA sequences shown in SEQ ID NOs. 1-1,864 (Column 3, line 30). Henn teaches sequences with 100% sequence identity to instant SEQ ID NOs: 2 and 3, which are the 16S rDNA sequences of Clostridium tyrobutyricum KCTC 5387 and Cetobacterium somerae ATCC BAA-474, respectively. Henn teaches a sequence (SEQ ID NO:1830) with 100% sequence identity to instant SEQ ID NO:7 (see alignment attached to this Office action), which, according to table 1 of the instant specification, is the 16S rDNA sequence of Veillonella parvula ATCC 17745.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to use the strains, Clostridium tyrobutyricum KCTC 5387, Cetobacterium somerae ATCC BAA-474, and Veillonella parvula ATCC 17745, as taught by Henn in a probiotic composition comprising Clostridium tyrobutyricum, Cetobacterium somerae, or Veillonella parvula as taught by Rahman. One of ordinary skill in the art would have been motivated to do so because Henn teaches that the bacterial strains of the compositions of the invention have a plurality of beneficial properties (Column 2, lines 34-35). One of ordinary skill in the art would have had a reasonable expectation of success because Rahman and Henn are in the same field of endeavor of probiotic development.
Claims 78 and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Rahman et al., (WO 2016/086205 A2), as applied to claim 76 above, and further in view of Henn et al., (US 8,906,668 B2) and Tamaru et al., (JOURNAL OF BACTERIOLOGY, Feb. 2010, p. 901-902).
Rahman teaches probiotic compositions comprising two or more bacterial species that may be Clostridium tyrobutyricum, Clostridium cellulovorans, Cetobacterium somerae, Veillonella parvula, Bacteroides caccae, or Lactobacillus casei, but does not teach the 16S rDNA sequences or strain names of said species.
Regarding claims 78 and 80, Henn teaches synergistic bacterial compositions that may comprise bacteria that comprise 16S rDNA sequences shown in SEQ ID NOs. 1-1,864 (Column 3, line 30). Henn teaches a sequence (SEQ ID NO:595) with 100% identity to instant SEQ ID NO:2 (see alignment attached to this Office action). According to table 1 of the instant specification (p. 55), SEQ ID NO:2 is the 16S rDNA sequence of Clostridium tyrobutyricum KCTC 5387. Henn teaches a sequence (SEQ ID NO:1830) with 100% sequence identity to instant SEQ ID NO:7 (see alignment attached to this Office action), which, according to table 1 of the instant specification is the 16S rDNA sequence of Veillonella parvula ATCC 17745. Therefore, the strains taught by Henn are Veillonella parvula ATCC 17745 and Clostridium tyrobutyricum KCTC 5387.
Henn does not teach Clostridium cellulovorans 743B.
However, Tamaru teaches Clostridium cellulovorans 743B (Abstract).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have used Clostridium cellulovorans strain 743B as taught by Tamaru, and Veillonella parvula ATCC 17745 and Clostridium tyrobutyricum KCTC 5387 as taught by Henn, in a probiotic composition comprising Clostridium cellulovorans, Veillonella parvula, or Clostridium tyrobutyricum as taught by Rahman. One of ordinary skill in the art would have been motivated to do so because Rahman teaches that the bacterial population of the probiotic may comprise two or more bacterial species set forth in Table 1 and Tables 1A-1F (para. [014]), and teaches Clostridium cellulovorans in Table 1A (p. 455). One of ordinary skill would be reasonably expected to understand that any known strain of Clostridium cellulovorans may be used in the probiotic composition of Rahman.
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 RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657