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 I (i.e., claims 1, 3, 5, 6, 9, 13 and 19; drawn to a composition comprising a supernatant from a Clostridia consortium), and Species A (i.e., single and specific composition indicating: single and specific combination of bacterial strains including whether the composition further comprises one or more bacterial strains from Table 1, and if so, a single and specific additional bacterial strain or combination thereof, Applicant’s Election: Clostridia anaerovorax, Clostridium XIVa, Clostridium IV and Lachnospiraceae spp. and Eisenbergiella), in the reply filed on 12/11/2024 is acknowledged. The traversal is on the grounds that the Examiner has not shown that a serious burden would result if all of the claims are examined together (see Remarks, filed on 12/11/2024, pg. 6). This is not found persuasive because the undue search burden is not a criterion for election/restriction purposes under 35 USC §121 and 35 USC § 372.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10, 14, 25-26, 29-34, 36 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/11/2024.
Please note that claims 10 and 14 were inadvertently withdrawn in the action mailed on 04/21/2025. However, claims 10 and 14 were rejoined and fully examined in the action mailed on 12/29/2025.
Status of Claims
Claims 1-44 were originally filed on 01/10/2022.
The amendment filed on 07/11/2022, cancelled claims 2, 4, 7-8, 11-12, 15-16, 18, 20-24, 27-28, 35, 37-40 and 42-44; and amended claims 1, 3, 5, 6, 9-10, 13-14, 17, 19, 25, 29-34, 36, and 41.
The amendment filed on 12/11/2024, amended claim 19.
The amendment filed 07/07/2025, canceled claim 17.
The amendment filed on 11/17/2025, cancelled claim 13 and amended claims 1, 10 and 25.
The claim set filed on 06/29/2026 was not amended.
Claims 1, 3, 5-6, 9-10, 14 and 19 are currently pending and under consideration.
Priority
The present application claims status as a 371 (National Stage) of PCT/US2020/042578 filed July 17th, 2020, and claims the benefit under 35 U.S.C 119 (e) to U.S. Provisional Application No. 62/875,194 filed July 17th, 2019. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C 119 (e) or under 35 U.S.C 120, 121, or 365 (c ) is acknowledged.
Information Disclosure Statement
The IDS filed on 06/29/2026 has been considered by the Examiner.
However, per 37 CFR 1.98, when applicants cite a foreign language ref, whether Non-Patent Literature (NPL) or Foreign Patent (FP); Applicants are required to submit (1) an English language abstract, (2) English translation/equivalent reference, or (3) a statement of relevance in a transmittal letter.
In the instant case, foreign patent documents No. 1 and No. 2 have not been considered because it is not evident that the US Patent Publications included as citation No. 1 and citation No. 2 are the equivalent references in English. Foreign Document No. 1 and Foreign Document No. 2 are in Korean and an English translation/equivalent reference, nor a statement of relevance in a transmittal letter have been submitted.
Claim /Sequence Interpretation
For purposes of applying prior art, the claim scope has been interpreted as set forth below, per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation set forth below, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
For claim 1, regarding the scope of “a Clostridia consortium, consisting of Clostridia anaerovorax, Clostridium XIVa, Clostridium IV and Lachnospiraceae spps.” It is noted that the instant specification does not teach an identification number (i.e., Accession Number or NRRL number) for Clostridia anaerovorax. Pursuant to MPEP 2111.01, under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. The Midas Field Guide describes the genus Anaerovorax as belonging to the family Anaerovoracaceae, class Clostridia, phylum Firmicutes (see Midas Field Guide, Genus: Anaerovorax, pp. 1-3, latest update July 6, 2024, available online at https://www.midasfieldguide.org/guide/fieldguide/genus/anaerovorax, accessed on 04/11/2025) (herein after “Midas”). Additionally, Midas also discloses that the only species described of the Genus Anaerovorax is Anaerovorax odorimutants (see Midas, pg. 1). As such, the Examiner is interpreting the scope of “Clostridia anaerovorax” as any strain belonging to the class Clostridia, phylum Firmicutes, genus Anaerovorax and comprises an amino acid sequence having at least 98% identity to SEQ ID NO: 1.
With respect to SEQ ID NO:1, please note that the Examiner is interpreting the scope of the 16S rDNA sequence of Clostridia anaerovorax as a naturally occurring bacterium isolated from a fecal pellet and luminal content from the lower small intestine of CD4-Cre+ wild type mice, as recited in para[0058] pg. 13 of the instant specification.
Regarding the scope of “Clostridium XIVa” and “Clostridium IV”, it is noted that the instant specification does not specify which genera of Clostridium XIVa and IV clusters are comprised by the Clostridia consortium comprising two or more strains of bacterium. Pursuant to MPEP 2111.01, under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. Chun describes that Clostridium clusters XIVa and IV are groups of bacteria that have been known as major players in the human microbiome and the designation of these clusters was proposed by using 16S rRNA phylogeny (see Chun, Taxonomy of Clostridium Clusters XIVa and IV, 2017, pp. 1-5, retrieved from https://help.ezbiocloud.net/taxonomy-of-clostridium-cluster-xiva-iv/ on 04/11/2025 (herein after “Chun”). Chun also describes the list of genera for both clusters (see pp. 1-3), with Clostridium cluster XIVa encompassing 13 different genera, but not all genera in the family Lachnospiraceae, and Clostridium cluster IV encompasses 12 different genera, but not all genera in the family Ruminococcaceae (see pp. 1-3). As such, the Examiner is interpreting the scope of “Clostridium XIVa” and “Clostridium IV” as any of the genera encompassed by Clostridium cluster XIVa and by Clostridium cluster IV, respectively, where the cluster necessarily comprises an amino acid sequence having at least 98% identity to SEQ ID NOs: 2-3, respectively.
With respect to SEQ ID NO:2 and to SEQ ID NO: 3, please note that the Examiner is interpreting the scope of the 16S rDNA sequence of Clostridium XIVa and the 16S rDNA sequence of Clostridium IV, respectively as naturally occurring bacteria isolated from a fecal pellet and luminal content from the lower small intestine of CD4-Cre+ wild type mice, as recited in para[0059-0060] pg. 13 of the instant specification.
Similarly, regarding the cope of “Lachnospiraceae spps.” it is noted that the instant specification does not specify which genera of the Lachnospiraceae family are comprised by the Clostridia consortium comprising two or more strains of the species Lachnospiraceae. Pursuant to MPEP 2111.01, under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. Stackebrandt describes that the family Lachnospiraceae is a phylogenetically and morphologically heterogeneous taxon of the class Clostridia, phylum Firmicutes (see Stackebrandt, E., Chapter 15-The Family Lachnospiraceae in The Prokaryotes Firmicutes and Tenericutes 4th Edition, 2014, pp. 197-201 at pg. 197)(herein after “Stackebrandt”). Stackebrandt adds that the family encompasses 19 genera and the family has been described on phylogenetic grounds, i.e., the position of authentic members of Lachnospiraceae, branching within the radiation of the order Clostridiales, especially associated to members of Clostridium rRNA cluster XIVa (see pg. 197). As such, the Examiner is interpreting the scope of “Lachnospiraceae spps.” as any of the 19 genera belonging to the Lachnospiraceae family where the Lachnospiraceae spps. necessarily comprises an amino acid sequence having at least 98% identity to SEQ ID NO: 4.
With respect to SEQ ID NO:4, please note that the Examiner is interpreting the scope of the 16S rDNA sequence of Lachnospiraceae spps. as a naturally occurring bacterium isolated from a fecal pellet and luminal content from the lower small intestine of CD4-Cre+ wild type mice, as recited in para[0061] pg. 14 of the instant specification.
It is noted that claim 1 does not recite a function associated with the Clostridia consortium consisting of Clostridia anaerovorax, Clostridium XIVa, Clostridium IV, and Lachnospiraceae spps; As such, given the disclosure of SEQ ID NOs: 1-4, (see instant specification, Table 1, pg. 16), and combined with the pre-existing knowledge in the art regarding the genetic code and its redundancies, an ordinary skilled artisan would have put one in possession of the genus of a Clostridia consortium comprising two or more strains of bacterium encoded by a base DNA sequence set forth in SEQ ID NOs: 1-4 . With the aid of a computer, an ordinary skilled artisan could have identified all of the bacteria strains as claimed. Thus, an ordinary skilled artisan would conclude that the Applicant was in possession of the claimed genus (i.e., Clostridia consortia) at the time the application was filed.
Response to Arguments
1. Applicant's arguments filed 06/29/2026, with respect to the Specification, have been fully considered and are persuasive. The objection to the specification (i.e., pg. 13, para[0058]) has been withdrawn.
2. Applicant's arguments filed 06/29/2026, with respect to the Specification, have been fully considered and are persuasive. The objection to the specification (i.e., pg. 4, para[0019]) has been withdrawn.
3. Applicant's arguments filed 06/29/2026, with respect to the Specification (i.e., new matter), have been fully considered and are persuasive. The objection to the specification (i.e., para[0019], lines 6-7) has been withdrawn.
4. Applicant's arguments filed 06/29/2026, with respect to the Specification (i.e., editing mistakes), have been fully considered and are persuasive. The objection to the specification (i.e., editing mistakes) has been withdrawn.
5. Applicant’s arguments, filed 06/29/2026, with respect to the 35 U.S.C. 101 because the claimed invention is directed to a nature-based product; have been fully considered but are not persuasive. The 35 U.S.C. 101 rejection of claims 1, 3, 5-6, 9-10, 14 and 19 has been maintained.
Maintained/Modified Rejections
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 therefore, subject to the conditions and requirements of this title.
1. Claims 1, 3, 5-6, 9-10, 14 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a nature-based product (i.e., a supernatant from a Clostridia consortium) without significantly more. As discussed in the “Claim/Sequence Interpretation” section above, the Examiner is interpreting the scope of the 16S rDNA sequence of Clostridia anaerovorax, the 16S rDNA sequence of Clostridium XIVa, the 16S rDNA sequence of Clostridium IV, and the 16S rDNA sequence of Lachnospiraceae spps as naturally occurring bacteria isolated from the fecal pellet and luminal content from the lower small intestine of CD4-Cre+ wild type mice (see instant specification, pg. 13, para[0058]). Therefore, the claimed composition comprising a supernatant wherein the Clostridia consortium consists of Clostridia anaerovorax having a 16S rDNA sequence comprising SEQ ID NO: 1, Clostridium XIVa having a 16S rDNA sequence comprising SEQ ID NO: 2, Clostridium IV having a 16S rDNA sequence comprising SEQ ID NO: 3, and Lachnospiraceae spps. having a 16S rDNA sequence comprising SEQ ID NO: 4 is directed to a product, which is one of the statutory categories of invention.
Regarding step 2A, Prong One of the patent eligible subject analysis, the claims recite a judicial exception of a nature-based product. Claims 1, 10 and 14 are drawn to a composition comprising a Clostridium consortium, wherein the consortium consists of Clostridia anaerovorax having a 16S rDNA sequence comprising SEQ ID NO: 1, Clostridium XIVa having a 16S rDNA sequence comprising SEQ ID NO: 2, Clostridium IV having a 16S rDNA sequence comprising SEQ ID NO: 3, and Lachnospiraceae spps. having a 16S rDNA sequence comprising SEQ ID NO: 4. Claims 3, 5, 6, 9 and 19 are directed to properties of the composition comprising the claimed Clostridia consortium. These limitations therefore encompass nature-based products of the Clostridia anaerovorax having a 16S rDNA sequence comprising SEQ ID NO: 1, Clostridium XIVa having a 16S rDNA sequence comprising SEQ ID NO: 2, Clostridium IV having a 16S rDNA sequence comprising SEQ ID NO: 3, and Lachnospiraceae spps. having a 16S rDNA sequence comprising SEQ ID NO: 4. The claims thus encompass bacteria (i.e., a Clostridia consortium) that are identical (i.e., no difference in structural and/or functional characteristics) to naturally occurring Clostridia. Moreover, there is no indication in the specification nor the claims that isolating a Clostridia consortium from the fecal pellet, and luminal content from the lower small intestine of CD4-Cre+ wild type mice; markedly changes the structure and/or function of the claimed bacteria consortium. Similarly, there is no indication that the claimed composition imparts a structural and/or functional characteristic distinct from the naturally occurring Clostridia consortium found in a fecal pellet and luminal content of the lower small intestine of CD4-Cre+ wild type mice.
Since there is no difference between the Clostridia consortium which naturally inhabits the luminal content of the lower small intestine of CD4-Cre+ wild type mice and which is naturally found in a fecal pellet of a CD4-Cre+ wild type mice (i.e., naturally occurring Clostridia consortium); and the claimed supernatant from a Clostridia consortium consisting of Clostridia anaerovorax having a 16S rDNA sequence comprising SEQ ID NO: 1, Clostridium XIVa having a 16S rDNA sequence comprising SEQ ID NO: 2, Clostridium IV having a 16S rDNA sequence comprising SEQ ID NO: 3, and Lachnospiraceae spps. having a 16S rDNA sequence comprising SEQ ID NO: 4. The claimed composition does not have markedly different characteristics and thus is a “product of nature” exception. In re Roslin Institute (Edinburgh), 750 F.3d at 1338-39, 110 USPQ2d at 1672-73 (Fed. Cir. 2014).
The instantly claimed Clostridia consortium (i.e., Clostridia anaerovorax having a 16S rDNA sequence comprising SEQ ID NO: 1, Clostridium XIVa having a 16S rDNA sequence comprising SEQ ID NO: 2, Clostridium IV having a 16S rDNA sequence comprising SEQ ID NO: 3, and Lachnospiraceae spps. having a 16S rDNA sequence comprising SEQ ID NO: 4) does not result in a markedly different structural and/or functional characteristic of the naturally occurring Clostridia consortium, it would then follow that a supernatant that results from the claimed Clostridia consortium is also a natural composition without evidence to the contrary.
As such, there is no difference between the claimed composition comprising a supernatant from a Clostridia consortium wherein the Clostridia consortium consists of:
-Clostridia anaerovorax having a 16S rDNA sequence comprising SEQ ID NO: 1, isolated from the fecal pellet and luminal content from the lower small intestine of CD4-Cre+ wild type mice;
-Clostridium XIVa having a 16S rDNA sequence comprising SEQ ID NO: 2, isolated from the fecal pellet and luminal content from the lower small intestine of CD4-Cre+ wild type mice;
-Clostridium IV having a 16S rDNA sequence comprising SEQ ID NO: 3, isolated from the fecal pellet and luminal content from the lower small intestine of CD4-Cre+ wild type mice; and
-Lachnospiraceae spps. having a 16S rDNA sequence comprising SEQ ID NO: 4, isolated from the fecal pellet and luminal content from the lower small intestine of CD4-Cre+ wild type mice;
and the clostridia Consortium which naturally occurs in the luminal content from the lower small intestine of CD4-Cre+ wild type mice or in a fecal pellet from CD4-Cre+ wild type mice. Therefore, the claimed supernatant does not have markedly different characteristics, and thus it is a “product of nature” exception. In re Roslin Institute (Edinburgh), 750 F.3d at 1338-39, 110 USPQ2d at 1672-73 (Fed. Cir. 2014). Accordingly, the claims are directed to an exception (i.e., nature-based products). Thus, the answer to step 2A, Prong One is YES.
Regarding Step 2A, Prong Two, of the patent eligible subject analysis, the claims do not integrate the judicial exception into a practical application. The judicial exception is not integrated into a practical application because the claims fail to recite a practical application of the nature-based product.
Although claim 14 further encompasses a pharmaceutically acceptable carrier, the incorporation of a carrier is recited at a high level of generality and would be considered a nominal or tangential addition to the claims. In other words, claim 14 recites additional elements beyond the judicial exception (i.e., a pharmaceutically acceptable carrier), however this limitation does not provide any additional information regarding any markedly changes to the structure and/or function of the claimed bacteria consortium. Instead, the claim covers any pharmaceutically acceptable carrier that the relevant audience (i.e., a scientist) decides to employ, without indicating that such carrier imparts a distinct structural and/or functional characteristic to the claimed Clostridium consortium. Furthermore, the closest naturally occurring pharmaceutically acceptable carrier can be a natural product such as water. Therefore, all of the components of the claimed composition appear to be identical to the components as they occur in nature.
Moreover, although the claim is directed to additional/further components (i.e., pharmaceutically acceptable carrier), such recitation of additional components tells the relevant audience about which parameters to modify, and at most adds a suggestion that the scientist take those parameters into account when preparing a composition comprising a supernatant from a Clostridium consortium, wherein the consortium consists of bacteria represented by instants SEQ ID NOs: 1-4. As such, the limitations of the claim recite a high level of generality without any specificity and are nothing more than an attempt to generally link the judicial exception to a particular technological environment. Therefore, the answer to step 2A, Prong Two, is NO.
Regarding step 2B of the patent eligible subject analysis, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the composition comprising a supernatant from a Clostridia consortium of the claimed invention is directed to non-statutory subject matter. Although claim 14 encompasses a pharmaceutically acceptable carrier, this limitation is routine and conventional in the art. Similarly, the limitations recited in claims 3, 5-6, 9-10 and 19 are routine and conventional as they encompass well-known members of the Clostridiaceae and Lachnospiraceae families. Therefore, the claim as a whole adds nothing significantly more to the “products of nature” themselves. Thus, the claims do not amount to significantly more than the judicial exception itself and the answer to Step 2B is NO.
Accordingly, the claimed invention is directed to ineligible patent subject matter.
Response to Arguments
Applicant's arguments filed 06/29/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that the claimed invention is not directed to a law of nature, a natural phenomenon, or an abstract idea because a composition comprising a supernatant from a Clostridia consortium, wherein the Clostridia consortium consists of Clostridia anaerovorax having a 16S rDNA sequence comprising SEQ ID NO: 1, Clostridium XIVa having a 16S rDNA sequence comprising SEQ ID NO: 2, Clostridium IV having a 16S rDNA sequence comprising SEQ ID NO: 3, and Lachnospiraceae spps. having a 16S rDNA sequence comprising SEQ ID NO: 4 that are not found exclusively together in nature (see Remarks, filed 06/29/2026, pg. 10 of 14, first and second paragraphs). These arguments have been fully considered but are not persuasive.
Per MPEP 2106.04(b), [i]t 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.
In the instant case, the claimed composition of matter is ineligible for patentability because the composition comprises unmodified genetic material that naturally occurs in a host. Stated differently, the instantly claimed Clostridia consortium consists of four different bacteria, Clostridia anaerovorax having a 16S rDNA sequence comprising SEQ ID NO: 1, Clostridium XIVa having a 16S rDNA sequence comprising SEQ ID NO: 2, Clostridium IV having a 16S rDNA sequence comprising SEQ ID NO: 3, and Lachnospiraceae spps. having a 16S rDNA sequence comprising SEQ ID NO: 4, which have not been demonstrated to be any different (in structure and/or function) from the Clostridia consortia that is naturally found in the host, i.e., CD4-Cre+ transgenic mice.
Genetic modifications to the host (i.e., mice genetically modified to express Cre recombinase under the control of the CD4 promoter/enhancer) do not change or alter the natural biological identity of the bacterial consortia that naturally occurs in the luminal content from the lower small intestine of the transgenic mice nor in the fecal pellet produced by the transgenic mice. As such, the claimed isolated Clostridia consortia (i.e., Clostridia anaerovorax having a 16S rDNA sequence comprising SEQ ID NO: 1, Clostridium XIVa having a 16S rDNA sequence comprising SEQ ID NO: 2, Clostridium IV having a 16S rDNA sequence comprising SEQ ID NO: 3, and Lachnospiraceae spps. having a 16S rDNA sequence comprising SEQ ID NO: 4), would naturally occur in the genetically modified host. Contrary to Applicant’s argument, the claimed composition is not significantly different from what exists in nature and therefore it is not patent eligible.
In response to Applicant’s argument that the claimed Clostridia consortium is markedly different from the properties of the mixture allegedly found in nature (see Remarks, filed 06/29/2026, pg. 12 of 14, first paragraph), has been fully considered but it is not persuasive.
The instant specification refers to Example 2 and Fig. 18, wherein a refined 4-member community that contains Clostridia anaerovorax, Lachnospiraceae spps, Clostridium XIVa. and Clostridium IV, (also referred to herein as refined Clostridia consortia-rCC-4 ), were used to colonize mice and compare fat accumulation to the more complex clostridia consortia (see instant spec, pg. 55, Example 2, para[0180]). The specification also teaches that Female (F) and male (M) germfree mice were colonized with the 4 strains cultured (rCC) from the more complex Clostridia consortia and analyzed by NMR 4 weeks after colonization; and that rCC-4 reduced adiposity to the same degree as the complex Clostridia consortia in males but not females (see instant spec, pg. 9, para[0035], Fig. 18 description).
The instant specification also teaches that treatment of obesity prone T-MyD88-/- animals with a cocktail of spore-forming bacteria significantly reduced weight gain and fat accumulation (Figs. 19A-B) (see instant spec, pg. 56, para[0181]). However, the specification does not establish whether the results reported in Figs. 19A-B were obtained by administering the refined 4 strain Clostridia consortium. Thus, as best understood, the reduced weight gain and fat accumulation observed in obesity prone T-MyD88-/- animals was achieved with a Clostridia consortium which includes Clostridia anaerovorax, Clostridium XIVa, Clostridium IV, Lachnospiraceae spps., as well as any other unrecited Clostridiaceae member. Additionally, it is noted that the only recitation of the refined 4-member Clostridium consortium is related to the favorable rCC-4 reduced adiposity observed in male mice but not in female mice.
Stated differently, the results depicted in Figs 19A-E cannot be attributed to the claimed consortium (i.e., Clostridia anaerovorax having a 16S rDNA sequence comprising SEQ ID NO: 1, Clostridium XIVa having a 16S rDNA sequence comprising SEQ ID NO: 2, Clostridium IV having a 16S rDNA sequence comprising SEQ ID NO: 3, and Lachnospiraceae spps. having a 16S rDNA sequence comprising SEQ ID NO: 4), because there is no clear evidence in the specification to support that a Clostridia consortium consisting of only four members of the Clostridiaceae family (i.e., Clostridia anaerovorax, Clostridium XIVa, Clostridium IV, and Lachnospiraceae spps) elicits the same results (i.e., lower body fat percentage, reduced VAT mass, decreased blood glucose levels and reduced insulin resistance) as a Clostridia consortium that comprises unspecified clostridia species (see Figs. 19A-19E), additionally that the claimed Clostridia consortium elicits the same results in both male and female mice.
In response to Applicant’s argument that the current pending claims comprise aspects that weight in favor of patent eligibility and are similar to Example 2 of the Guidance (see Remarks, filed 06/29/2026, pp. 11-12), has been fully considered but it is not persuasive.
On a first instance, Example 2 of the Guidance categorized under Nature-Based Products exceptions recites a product claim (i.e., beverage composition) that is not directed to an exception. The example recites that a beverage comprising the nature-based product (i.e., pomelo juice) and an added preservative was determined to have markedly different characteristics from any naturally occurring counterpart in its natural state (i.e., pomelo juice from the pomelo fruit itself).
However, Example 2 of the Guidance, is far from the instantly claimed composition because the claimed composition comprises a supernatant from a Clostridia consortium that has been limited to four bacterial species. However, it has not been demonstrated that the claimed species (i.e., Clostridia anaerovorax having a 16S rDNA sequence comprising SEQ ID NO: 1, Clostridium XIVa having a 16S rDNA sequence comprising SEQ ID NO: 2, Clostridium IV having a 16S rDNA sequence comprising SEQ ID NO: 3, and Lachnospiraceae spps. having a 16S rDNA sequence comprising SEQ ID NO: 4), are markedly different or have markedly different characteristics from their naturally occurring counterparts (i.e., Clostridia consortium) in their natural state (i.e., in the lower small intestine of CD4-Cre+ mice, or in a fecal pellet produced by CD4-Cre+ mice). Additionally, it has not been demonstrated that the preparation of a supernatant of the claimed Clostridia consortium changes the structure and/or function of the members of the consortium; nor that any of the components comprised by the claimed composition such as a pharmaceutically acceptable carrier, which can also be a naturally occurring component such as water, changes the structure and/or function of the claimed Clostridia consortium. As such, Example 2 of the Guidance and the instantly claimed invention constitute two different scenarios that are far from comparison.
Instead, the analysis of the instantly claimed composition is closely related to the Bacterial Mixtures, nature-based product exception described in Example 6 of the Guidance (see Guidance, pp. 8-9). Additionally, MPEP 2106.04(c) states that [w]hen there are multiple counterparts to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature). See MPEP 2106.04(c). Thus, the individual components of the instant composition: Clostridia anaerovorax having a 16S rDNA sequence comprising SEQ ID NO: 1, Clostridium XIVa having a 16S rDNA sequence comprising SEQ ID NO: 2, Clostridium IV having a 16S rDNA sequence comprising SEQ ID NO: 3, and Lachnospiraceae spps. having a 16S rDNA sequence comprising SEQ ID NO: 4, when compared to the naturally occurring counterparts, are not markedly different from each other. Thereby, the claimed composition is ineligible for patentability because the claim is directed to a nature-based product, and the claim does not include any additional features that add significantly more to the nature-based product. Thus, the claimed composition does not have markedly different characteristics from what occurs in nature therefore is a “product of nature” exception.
Accordingly, the 35 U.S.C. 101 rejection of claims 1, 3, 5-6, 9-10, 14 and 19 has been maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 CLAUDIA E ESPINOSA whose telephone number is (703)756-4550. The examiner can normally be reached Monday-Friday 9:30-5:30 EST.
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/CLAUDIA ESPINOSA/Patent Examiner, Art Unit 1654
/JEANETTE M LIEB/Primary Examiner, Art Unit 1654
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