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
Applicant's election with traverse of Group III (claims 36-38) in the reply filed on 07/27/2026 is acknowledged. The traversal is on the following grounds.
Applicant argues that claim 36 (Group III) has been amended to recite at least two of the recited compositions and Groups I and III share a special technical feature because the amended composition of claim 36 “discloses a composition comprising two or more metabolites that, when administered orally, has similar efficacy as a ketogenic diet in reducing seizure sensitivity” (Remarks, p. 8, par. 2).
Applicant’s arguments have been fully considered but are not found to be persuasive for the following reasons.
The consideration of a “special technical feature” is defined as meaning those technical features that define the contribution which each claimed invention, considered as a whole, makes over the prior art (MPEP § 1893.03(d)). Group III is merely a composition comprising at least two of a list of components and with a carrier. There is no requirement that the composition be administered orally or even be administered in any particular amount. Accordingly, for the reasons discussed in the Requirement for Unity of Invention, the linking feature is not a special technical feature and therefore the inventions lack unity a posteriori.
Accordingly, the requirement is still deemed proper and is therefore made FINAL.
Priority
The present application is a § 371 national stage entry of PCT/US22/51629 (filed on 12/02/2022) and claims benefit of U.S. provisional application 63/285,267 (filed on 12/02/2021).
Specification
The disclosure is objected to for the following reasons:
Table 4 is presented before Table 3;
Table 3 appears to be an image which is not of sufficient quality to be accurately reproduced;
Appropriate correction is required.
Drawings
The drawings are objected to for the following reasons.
Figures 2D, 3A, 3B, 3C, 7B, 8E, 9A, 9B, 9C, 9D, 10, 11A, 11D, 13A, 18A, 18B, 18C, 19A, 19B, 19C, 19D, 20A, and 20B are not presented in sufficient size and quality to be readable when reproduced.
Figures 13C and 13B are presented in inverse order.
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.
Claims 37-38 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 37 depends from claim 36 and limits the composition to further comprise bacteria that enrich as least one of the recited endpoints. Additionally, claim 37 recites “and a pharmaceutically acceptable carrier” (lines 5-6).
This claim is considered to be indefinite because claim 36 already requires a “pharmaceutically acceptable carrier” (line 10). As such, it is not clear whether this claim requires an additional carrier or is merely restating the carrier of claim 36.
In the interest of compact prosecution, this claim has been examined as if the composition requires a single carrier (i.e., the carrier first set forth in claim 36) because this claim does not recite “an additional pharmaceutically acceptable carrier”.
Claim 38 is rejected because it depends from claim 37 and does not further clarify the indefinite language identified above.
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 36-38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
The instant claims recites laws of nature and natural phenomena. These judicial exceptions (JEs) are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A): Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
The Markedly Different Characteristics Analysis
The first step in the analysis is to select the appropriate counterpart to the nature-based product. When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. See MPEP § 2106.04(c)(II)(A).
The second step in the analysis is to identify appropriate characteristics to compare. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673. See MPEP § 2106.04(c)(II)(B).
The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. See MPEP § 2106.04(c)(II)(C).
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP § 2106.05(a);
Applying the judicial exception with, or by use of, a particular machine. See MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP § 2106.05(c);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP § 2106.05(d);
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.05(e).
Step (2B). If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step (1)(direction to a process, machine, manufacture, or composition of matter):
Claims 36-38 are directed to a composition of matter, which is a statutory category.
Therefore, the answer to this step for claims 36-38 is yes.
Step (2A) Prong 1 (recitation of a law of nature, natural phenomenon, or an abstract idea):
Claims 36-38 are directed to a combination of at least two of a litany of naturally occurring compositions or pharmaceutically acceptable salts thereof and a pharmaceutically acceptable carrier.
Claim 37 further requires the composition to further comprise bacteria that enrich at least one of the recited endpoints.
Claim 38 limits the bacteria to one of the recited bacteria of various species, genera, and families.
Applicant defines “pharmaceutically acceptable carrier” as being a pharmaceutically-acceptable material, composition or vehicle, such as a liquid or solid filler, diluent, excipient, solvent or encapsulating material (p. 14, lines 1-3). Applicant gives exemplary carriers such as sugars, starches, cellulose, tragacanth, malt, gelatin, talc, excipients, oils, glycols, polyols, esters, agar, buffering agents, alginic acid, pyrogen-free, isotonic saline, Ringer’s solution, ethyl alcohol, phosphate buffer, and other non-toxic compatible substances (p. 14, par. 1). Accordingly, carriers are a broad genus which also encompass naturally occurring compositions.
There is no evidence of record that combining any (let alone every) compound recited in claim 36 in “at least two” and/or with the addition of any (let alone every) bacterium encompassed by claims 37-38 with a pharmaceutically acceptable carrier elicits a markedly different characteristic such as by changing the naturally occurring compositions in structure, property, and/or function.
Therefore, the answer to this prong for claims 36-38 is yes.
Step (2A) Prong 2 (recitation of additional elements that integrate the JE into a practical application):
Claims 36-38 are merely directed to various combinations of naturally occurring compositions. Accordingly, they do not provide additional elements that integrate the judicial exceptions such as by transforming them to another state or thing.
Therefore, the answer to this prong for claims 36-38 is no.
Step (2B)(recitation of additional elements that amount to significantly different than the JE such that they provide an inventive concept):
Claims 36-38 are merely directed to various combinations of naturally occurring compositions. As such, the combination of these compositions does not amount to significantly different from the judicial exception such that it provides an inventive concept.
Therefore, the answer to step (2B) for claims 36-38 is no.
Conclusion
Claims 36-38 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 36 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Elinav et al. (WO 2020/058979 A2).
Elinav et al. (hereinafter Elinav) teaches a method of treating amyotrophic lateral sclerosis (ALS)(abstract). Elinav teaches that the gut microbiome is a microbial ecosystem impacting multiple host physiological functions and is a large potential source of such potentially bioactive central nervous system (CNS) disease-modulating metabolites (p. 1, lines 31-34). Elinav teaches that there is accumulating evidence suggesting that the composition and function of the gut microbiome plays a significant role in the pathogenesis of neurological disorders such as autism, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, and epileptic seizures (p. 1, line 33 through p. 2, line 3).
Regarding claim 36, Elinav teaches a method of treating ALS in a subject in need thereof comprising administering to the subject a therapeutically effective amount of at least two metabolites ([0008]). Among the metabolites taught by Elinav are serotonin, taurocholate, and taurochenodeoxycholate ([0008]). Additionally, Elinav teaches that the bacterial metabolites may be provided per se or as part of a pharmaceutical composition, where it is mixed with suitable carriers (i.e., a pharmaceutically acceptable carrier)([0132]).
Accordingly, Elinav teaches the composition of claim 36.
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.
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 36-38 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Elinav et al. (WO 2020/058979 A2).
The teachings of Elinav are set forth above and applied herein. Elinav is found to render obvious claim 36.
Regarding claims 37-38, in addition to the metabolites for treating ALS, Elinav teaches that at least one of the at least two metabolites is “comprised in a bacterial population” ([0022]) and teaches that metabolites may be provided via a probiotic composition comprising microbes that generate the metabolites ([0163]). Among the bacterial populations taught by Elinav are Lachnospiraceae and Akkermansia muciniphila ([0023]). Additionally, Elinav teaches bacteria falling within the genus of Bacteroides (Id.).
Accordingly, Elinav teaches a composition comprising at least one of the recited bacteria and such bacteria inherently possess the metabolites discussed above. In other words, Elinav teaches a composition inherently comprising at least two of the recited compositions and also comprising at least one of the recited bacteria. The position that the compositions inherently comprise the metabolites is directly supported by Elinav’s statement that the bacteria may provide the metabolites.
Alternatively, even if the recited bacteria do not inherently possess the metabolites discussed above, it would have been obvious to have arrived at a composition comprising (i) the composition comprising the metabolites per se and (2) the composition comprising the bacterial population because Elinav teaches each composition as being separately suitable for treating conditions such as ALS ([0008] and [0165]). As such, arriving at a composition comprising both elements would have been expected to result in a composition which is more effective in treating ALS. This obviousness is based upon the “Some Teachings, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
With respect to claim 36, this claim merely recites general characteristics of the properties of bacteria. For the reasons discussed above, Elinav teaches or renders obvious the inclusion of bacteria having these properties in the claimed composition. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)(MPEP § 2112(I)). As such, Elinav meets the instant claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRANT C CURRENS/Examiner, Art Unit 1651
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