DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
The response filed July 18, 2025, has been received and entered.
Claims 1, 3, 4, 9-11, 14, 15, and 206-217 are pending.
Election/Restrictions
Applicant’s election of Group II (diseases or conditions caused by or associated with having a low methanogen quantity), claims 1 (in part), 4, 11, 206 (in part), 207-209, 210 (in part), 211, and 214, and the species ‘ulcerative colitis’ for (b), in the reply filed on July 18, 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 3, 9, 10, 14, 15, 212, 213, and 215-217 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claim.
Claims 1, 4, 11, 206-211, and 214 are examined on the merits.
Claim Objections
Claim 214 is objected to because of the following informalities:
Claim 214 is missing the conjunction “and” at various instances. In particular, the conjunction “and” should be inserted between “glucose intolerance,” and “hyperglycemia” in lines 5 and 10, and before the recitation “the first therapy” in lines 6 and 11.
Appropriate correction is required.
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 1, 4, 11, 206-211, and 214 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.
The terms “high methanogen quantity,” “low methanogen quantity,” and “low quantity of methanogens” in claims 1, 4, 11, 206, and 210 are relative terms which render the claims indefinite. The terms “high methanogen quantity,” “low methanogen quantity,” and “low quantity of methanogens” are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what ranges of methanogen quantity are directed to a “high methanogen quantity,” “low methanogen quantity,” and “low quantity of methanogens.” Since these terms are not clear, then it is unclear what constitutes a “disease or condition caused by or associated with having a high methanogen quantity” and a “disease or condition caused by or associated with having a low methanogen quantity” of claims 1 and 206. As such, claims 1, 4, 11, 206-211, and 214 are rejected under 35 U.S.C. 112, second paragraph.
Claim 207 is indefinite because it is unclear to what the selected or directed therapy is administered to. For the purpose of applying prior art, claim 207 is being interpreted as: The method of claim 206, further comprising administering the selected or directed therapy to the subject.
Claim 210 is rendered indefinite by the recitation “fatty liver (NASH).” It is unclear how “NASH” modifies the term “fatty liver.” It is confusing because NASH is known in the art as “non-alcoholic steatohepatitis.” See paragraph [0016] of Schentag (US 2013/0337055). It is unclear whether the disease or condition is fatty liver or NASH.
Claim 211 is rendered indefinite by the recitation “about 1,000 per ml of the biological sample.” Since the reference value is being compared to methanogen quantity, it is unclear how the reference value can be a dimensionless number of “about 1,000” that is per mL of the biological sample. For the purpose of applying prior art, the reference value is being interpreted as “about 1,000 methanogen cells per ml of the biological sample.”
Claim 214 is indefinite because it is unclear which one of the two distinct diseases or conditions of parent claim 206 (a disease or condition caused by or associated with having a high methanogen quantity; a disease or condition caused by or associated with having a low methanogen quantity) is each recitation of “the disease or condition” in claim 214. For instance, it is unclear whether “the disease or condition” in line 2 of claim 214 is (1) the disease or condition caused by or associated with having a high methanogen quantity, or (2) the disease or condition caused by or associated with having a low methanogen quantity.
Claim 214 contains the trademark/trade name “welchol.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe colesevelam and, accordingly, the identification/description is indefinite. See paragraph [00196] of the specification which recites WELCHOL as the trade name of colesevelam.
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 206-211 and 214 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. All claims are directed to a statutory category, i.e. a process (Step 1: YES).
Claims 206, 208-211, and 214: Claim 206 recites subjecting a biological sample from a subject to analysis for methanogen quantity, comparing the methanogen quantity to a reference value, and selecting or directing a first therapy or a second therapy for the subject if the methanogen quantity is higher or lower than the reference value. These steps are drawn to observations and evaluations which could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas. They fall within the ‘Mental Processes’ grouping of abstract ideas. Accordingly, claim 206 recites abstract ideas (Step 2A, Prong One: YES).
These judicial exceptions are not integrated into a practical application. Claim 206 does not recite any additional elements other than the abstract ideas (analyzing, comparing, selecting/directing, each being an abstract idea). Therefore, there is no integration of the abstract ideas into a practical application (Step 2A, Prong Two: NO). Thus, claims 9 and 10 are each directed to a judicial exception, specifically an abstract idea (Step 2A: YES).
The claim does not recite any additional elements other than the abstract ideas, so the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B: NO). As such, claim 206 is not eligible subject matter under 35 U.S.C. 101.
This analysis also applies to claims 208-211 and 214.
Claim 207: Claim 207 recites administering the selected or directed therapy. This is directed to an ‘additional element’ other than the abstract ideas recited in parent claim 206.
The judicial exceptions are not integrated into a practical application. The additional element of administering the selected or directed therapy is recited at such a high level of generality given that the disease or condition is broad (since high and low methanogen quantities are unclear). Accordingly, the limitation of claim 207 does not integrate the judicial exceptions into a practical application (Step 2A, Prong Two: NO). Thus, claim 207 is directed to a judicial exception, specifically an abstract idea (Step 2A: YES).
Claim 207 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Given the high level of generality of the administering step, the administration of the therapy is well-known, routine, and conventional activity. It provides mere instructions to apply the judicial exceptions. See MPEP 2106.05(f). Thus, the additional element is not sufficient to amount to significantly more than the judicial exception (Step 2B: NO). Accordingly, claim 207 is not eligible subject matter.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 4, 11, 206-208, 210, 211, and 214 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pimentel (US 2006/0246045. Listed on IDS filed 10/5/22).
Pimentel discloses treating disorders exhibiting diarrhea, including ulcerative colitis, by increasing the partial pressure of methane in the subject’s intestines by administering to the subject a methanogenic probiotic agent (paragraph [0015]). See also paragraph [0034] which defines the probiotic agent, which includes methanogenic bacterium. Pimentel also teaches increasing the partial pressure of methane in the intestines by administering a prebiotic agent that enhances the growth of methanogenic bacteria (paragraph [0035]). Ulcerative colitis is directed to the elected species for the disease or condition (instant claim 11).
Pimentel differs from the claimed invention in that Pimentel does not expressly disclose that the therapy is administered to a subject who has or is determined to have a methanogen quantity that is lower than a reference value. However, given that there is a tie between methanogenic bacteria in the intestines and the partial pressure of methane (given that methanogenic bacteria addresses the need for increase of methane partial pressure and based on paragraph [0035] for enhancing methanogen growth), it would have been obvious to the person of ordinary skill in the art to measure the methanogen bacteria quantity of a sample from the subject (obvious to use a stool sample since the methanogenic bacteria are in the intestines based on paragraph [0035]) to determine if the quantity is low (i.e. lower than any particular level, directed to a reference level). As such, Pimentel renders obvious the instant claims. R
Conclusion
No claims are allowed.
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/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651