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 without traverse of Group 1 (a method of prophylaxis, treatment or mitigation of a disease or condition characterized by impaired glucose metabolism) in the reply filed on 12 Nov 2025 is acknowledged.
In response to applicant’s argument that examination of all claims would not present a serious burden (Remarks pg. 5), the examiner respectfully disagrees. The reasons that there is a search burden were presented on pg. 3 of the Restriction requirement mailed 12 Sep 2025.
In response to applicant’s request for rejoinder of claims 8-9 upon indication of allowable subject matter (Remarks pg. 5), claims will be considered for rejoinder consistent with Office policy. See “Notice of Potential Rejoinder” section (pg. 4-5) of the Restriction requirement mailed 12 Sep 2025.
Claim Status
The amended claim set filed 12 Nov 2025 is acknowledged. Claims 1-20 are currently pending. Of those, claim 10 is currently amended, claims 3-7 have been amended relative to the original claims, and claims 11-20 are new. Claims 8-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12 Nov 2025. No claims are cancelled. Claims 1-7 and 10-20 will be examined on the merits herein.
For clarity of the record, references to the specification will use the paragraph numbers from the specification as originally filed 20 Jan 2023.
Priority
The instant application claims priority to provisional application 63/059,130 (filed 30 July 2020) and is a continuation-in-part of PCT/US21/43971 (filed 30 July 2021). What follows is the examiner’s claim-by-claim analysis of effective filing date for the claims currently under examination. If the applicant disagrees with this examiner’s determination of effective filing date for any claim, the applicant may identify text within the prior applications that provides support the claimed language.
Regarding claim 1, the instant claim recites administering “materials derived from one or more Faecalibacterium prausnitzii cultures, including [one or more of] live cells, killed cells, cell components, and/or supernatant from such cultures”. However, the provisional application only contemplates the use of “cell components and supernatant.” This feature is found in the PCT application. Also, dependent claims of claim 1 are not supported by the provisional application for the same reason.
Regarding claim 3, the instant claim recites “wherein the FPZ does not cause a hypoglycemic effect in the subject” who is defined in claim 1 as “a subject in need … of prophylaxis, treatment or mitigation of a disease or condition characterized by impaired glucose metabolism”. The provisional application does not support the claim because hypoglycemia is not mentioned, so it does not teach that there is not a hypoglycemic effect. The PCT application does not support the claim because the discussion of hypoglycemia is limited to “a subject having normal blood glucose levels” or “healthy mice” instead of the full scope of subjects required by the instant claim.
Regarding claim 4, the instant claim recites “which is a method of prophylaxis wherein the subject has normal fasting blood glucose and/or normal Hb A1c levels but is at elevated risk of developing a disease or condition characterized by impaired glucose metabolism.” The provisional application does not teach “normal” fasting blood glucose or Hb A1c levels or “elevated risk”, but this is found in the PCT application.
Regarding claim 11, the provisional application does not teach BMI, but this is found in the PCT application.
Regarding claim 19, the provisional application does not teach two or more different strains of F. prausnitzii, but this is found in the PCT application.
The following effective filing dates have been used when searching the art: The effective filing date of claim 3 is 30 Jan 2023. The effective filing date of claims 1-2, 4-7, and 10-20 is 30 July 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1 May 2023 and 1 Nov 2024 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action.
Drawings
The drawings are objected to because:
Figures 1-2 and 4-6 use abbreviations that are not defined in the specification, specifically FPS, FPS24, and FPSL. The drawings cannot be understood because it is unclear what experimental conditions/compositions these terms refer to.
Figure 4B presents a table that uses white text on a dark background. This text is insufficiently legible and does not comply with 37 CFR 1.84(a)(1), which states that for non-color drawings (like the instant Figure 4B), “India ink, or its equivalent that secures solid black lines, must be used for drawings”. The figure must be amended to use solid black lines for the text.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), and/or an amendment to the specification to overcome the grounds of objection 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 Objections
Regarding claims 1, 6, 15, and 19, the species name Faecalibacterium prausnitzii should be italicized to match spelling conventions in the art at the time of filing.
Regarding claim 14, the claim is objected to because it has a period in the middle of the claim: “insulin. analog.” MPEP 608.01(m) states: Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).
Claim Interpretation
Regarding the term Faecalibacterium prausnitzii used in the claims, Fitzgerald et al. (2018; PTO-892) teaches that the species F. prausnitzii was split into two new species level taxa: F. prausnitzii sensu stricto (neotype strain A2–165T = DSM 17677T = JCM 31915T) and F. moorei sp. nov. (type strain ATCC 27768T = NCIMB 13872T) (Abstract). Therefore, at the time of filing, several years after the work of Fitzgerald et al, one of ordinary skill in the art would have understood the term F. prausnitzii to not refer to F. moorei.
Claim Rejections - 35 USC § 112(b)
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 1-7 and 10-20 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.
Regarding claim 1, the phrase “e.g.” means the same as "for example", and the phrase “including”, both render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). One of ordinary skill in the art would not be able to determine what diseases and conditions, or what materials are claimed. In the interest of compact prosecution, in this action, the limitations are interpreted as not being required. So claim 1 is interpreted as a method of prophylaxis, treatment or mitigation of any disease or condition characterized by impaired glucose metabolism (not only the ones listed), comprising administering an effective amount of a composition ("FPZ") comprising any materials derived from one or more Faecalibacterium prausnitzii cultures (not limited to the components listed), to a subject in need thereof. This rejection also applies to claims 2-7 and 10-20 because they depend from claim 1 and do not obviate this grounds of rejection.
Regarding claim 2, the phrase “companion animal” is a term that does not have a well understood definition in the field and is also not defined in the specification. For example, it is unclear whether the mice used in the specification’s examples fall within the claimed scope as some mice are pets and other mice are wild animals. In the interest of compact prosecution, search was conducted using any possible animal species that could potentially be kept as a pet.
Regarding claim 6, the phrase “e.g.” means the same as "for example", and renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). One of ordinary skill in the art would not be able to determine what types of drying are claimed. In the interest of compact prosecution, in this action, the limitations are interpreted as not being required, and any type of drying would meet the claim limitation.
Regarding claim 15, the claim recites the limitation "the Faecalibacterium prausnitzii cells, cell components, and supernatant". There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not require the presence of Faecalibacterium prausnitzii cells, cell components, and supernatant, it only requires generic “materials derived from one or more Faecalibacterium prausnitzii cultures” and even the more specific example language requires “live cells, killed cells, cell components, and/or supernatant from such cultures” rather than requiring the presence of all three of cells, cell components, and supernatant. One of ordinary skill in the art would find the scope of claims 1 and 15 unclear due to the lack of antecedent basis for the limitation in claim 15. In the interest of compact prosecution, the claim is interpreted as limiting the FPZ composition to those comprising Faecalibacterium prausnitzii cells, cell components, and supernatant.
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.
Claims 1-5, 7, 12-13, 16, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kawahara et al. (WO-2018230695-A1, 2018; PTO-892) with an English translation provided in the form of Kawahara et al. (US-20210145897-A1, a national stage application from the PCT application; hereafter Kawahara; PTO-892).
Regarding claim 1, Kawahara teaches “A method for preventing or treating a fat-associated disease and/or inflammation, the method comprising administering a Faecalibacterium bacterium or a processed product thereof to a human or a non-human animal” [0007 (8)], and teaches that “the fat-associated disease [can be] a metabolic syndrome-associated disease or non-alcoholic fatty liver disease (NAFLD)” [0007 (8-2)]. “The Faecalibacterium bacterium [can be] Faecalibacterium prausnitzii ATCC (registered trademark) 27768, Faecalibacterium prausnitzii ATCC 27766, or Faecalibacterium prausnitzii TY-2 (Accession No. NITE ABP-02743)” [0007 (8-3)]. The bacteria processed product (“FPZ”) can be viable or dead bacterial cells, culture supernatants, or processed products that include sonicated bacterial cells, extracts from the cell such as products where cell walls are removed, protein complexes [0032].
Regarding claim 2, the Fecalibacterium product can be administered to a human or non-human animal [0007 (8)], which can include dogs and cats [0086], and can also include mice [0086, 0094].
Regarding claim 3, Kawahara did not find that there was a hypoglycemic effect on the mice when administered [0098, 0103-0104, 0112-0113].
Regarding claim 4, Kawahara teaches administering F. prausnitzii to “C57BL/6J mice at 8 weeks old [that] were given a high-fat high-fructose diet” [0110], and the instant specification provides evidence that C57BL/6J mice are pre-diabetic [0036] (i.e. have an elevated risk for developing diabetes) but have normal fasting blood glucose at 2 months (instant Figure 1A, [0037-0038]). Kawahara also teaches that the mice are at elevated risk for developing liver fibrosis [0112-0113].
Regarding claim 5, Kawahara teaches administering to subjects with metabolic syndrome [0007 (8-2), 0051, Example 3]. Also, Kawahara teaches administering F. prausnitzii to “C57BL/6J mice at 8 weeks old [that] were given a high-fat high-fructose diet” [0110], and the instant specification provides evidence that that C57BL/6J mice are pre-diabetic [0036].
Regarding claim 7, Kawahara teaches “the present invention can be used to prepare various types of formulations (compositions, pharmaceutical compositions, food compositions, or cosmetic compositions” [0064].
Regarding claim 12, Kawahara teaches the administration can be 1 time per day [0062, 0094].
Regarding claim 13, the administration was for 20 weeks in the example [0094].
Regarding claim 18, Kawahara teaches that “HOMA-IR, which is an indicator of insulin resistance, was significant improved by administration of F. prausnitzii ATCC 27768 (FIG. 5)” [0098].
Regarding claim 20, Kawahara teaches the composition can be formulated with food or drinks [0076], or can be mixed with a pharmaceutically acceptable carrier [0068].
Regarding claims 3, 16, 18, these claims only describe effects on the subject that occur after the method’s step of administering an effective amount of a composition comprising materials derived from one or more F. prausnitzii cultures to a subject in need. Kawahara teaches the same composition comprising materials derived from one or more F. prausnitzii cultures, as described above, and also teaches the same method of administering the composition to a subject in need. MPEP 2112.01.I states: when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. As the claim and Kawahara teach the same product administered in the same way to the same subject population, the functional limitations of claims 3, 16, and 18 are presumed to be inherently present, absent evidence to the contrary.
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 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 1-7, 12-13, 15-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kawahara et al. (US-20210145897-A1, filed 2018, published 20 May 2021; hereafter Kawahara; PTO-892).
Regarding claims 6 and 15, Kawahara teaches the bacteria processed product (“FPZ”) can be viable or dead bacterial cells, culture supernatants, or processed products that include sonicated bacterial cells, extracts from the cell such as products where cell walls are removed, protein complexes [0032], and teaches that the product can be dried [0032].
Regarding claim 19, Kawahara teaches that “the Faecalibacterium bacterium [can be] Faecalibacterium prausnitzii ATCC (registered trademark) 27768, Faecalibacterium prausnitzii ATCC 27766, or Faecalibacterium prausnitzii TY-2 (Accession No. NITE ABP-02743)” [0007 (8-3)], and provides evidence that ATCC 27768 and TY-2 both are effective [Experimental Example B, 0110, 0113].
Kawahara does not teach a FPZ product that comprises all of F. prausnitzii cells, cell components and supernatant, as in claims 6 and 15. Kawahara does not teach a FPZ product that comprises two or more different strains of F. prausnitzii, as in claim 19.
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the Kawahara bacteria processed product by combining cells, cell components and supernatants, or by combining two disclosed F. prausnitzii strains, thereby arriving at the claimed invention, because "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See also MPEP 2144.06. Kawahara teaches that all of cells, cell components, supernatants, and multiple different strains can individually be used in a method for preventing or treating a fat-associated disease and/or inflammation, so it would be obvious to combine them as in the claims.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case all elements (i.e. the composition comprising cells, comprising cell components, comprising supernatant, compositions from multiple strains, and methods of using all of these compositions) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 1-7 and 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kawahara et al. (US-20210145897-A1, filed 2018, published 20 May 2021; hereafter Kawahara; PTO-892) in view of Bianchi et al. (2007; hereafter Bianchi; PTO-892).
Claims 1-7, 12-13, 15-16, and 18-20 are either anticipated by or obvious over Kawahara alone, as laid out above.
Kawahara teaches that their method is “for preventing or treating a fat-associated disease and/or inflammation” [Abstract], and specifically teaches use with “a metabolic syndrome-associated disease or non-alcoholic fatty liver disease (NAFLD).” [0007 (8-2)]. Kawahara teaches “ Metabolic syndrome, also called “visceral fat syndrome”, is associated with various diseases and abnormalities, including lipid metabolic abnormalities and carbohydrate metabolic abnormalities. Those with metabolic syndrome are highly likely to develop symptoms and diseases, such as arteriosclerosis, fatty liver, hyperlipemia, obesity, hypertension and diabetes mellitus.” [0002] “Metabolic syndrome is a condition that includes a cluster of diseases and abnormalities. Examples of the diseases and abnormalities include obesity (for example, lipid metabolic abnormalities, fatty liver, etc.), carbohydrate metabolic abnormalities, abnormal insulin resistance, heart diseases such as angina pectoris and myocardial infarction, arteriosclerotic diseases (for example, cerebral infarction, arteriosclerosis obliterans, etc.), etc.” [0051].
Kawahara teaches effects that are relevant to this subject population including reduction in weight gain, liver weight, and fat around the epididymis [0098], improvement in an indicator of insulin resistance and reduced insulin levels [0098], reduced cholesterol levels [0103], reduced fatty liver and liver fibrosis [0104, 0113], and reductions in serum inflammatory cytokines [0107].
Kawahara does not teach that the subject is also receiving one or more anti-diabetic drugs, wherein the antidiabetic drug is chosen from the group consisting of: metformin, sulfonylureas, meglitinides, thiazolidinediones, DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors, as in claim 10. Kawahara does not teach that the subject is a human with a body-mass index (BMI) of over 25, and wherein the subject has an Hb A1C level of 5.7 percent or higher, as in claim 11. Kawahara does not teach the subject is also receiving insulin or an insulin analog, as in claim 14. Kawahara does not teach the subject is also receiving one or more of blood thinners, blood pressure medications, and statins, as in claim 17.
Bianchi teaches that “metabolic syndrome (MS) [is] a cluster of metabolic abnormalities with insulin resistance as its central component, … and is associated with an increased risk of cardiovascular disease and Type 2 diabetes mellitus (T2DM)” (Abstract). Bianchi teaches that subjects with metabolic syndrome are treated with metformin (claim 10) or insulin (claim 14) if hyperglycemia is a risk factor (Figure 2). Bianchi teaches that subjects with metabolic syndrome are treated with statins if atherogenic dyslipidemia is a risk factor, and are treated with angiotensin-converting enzyme inhibitor, angiotensin receptor blockers and other drugs to reduce blood pressure if hypertension is a risk factor (claim 17, Figure 2). Kawahara teaches that subjects with metabolic syndrome can have obesity (Figure 2) and that the obesity criteria is defined as BMI being greater than 30 (Table 1, i.e. over 25, see claim 11). Kawahara teaches that subjects with metabolic syndrome can have diabetes, and that the goal is for the Hb A1c level to be below 6.5% (Figure 2, i.e. greater than 5.7%, see claim 11).
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the Kasahara method of administering a F. prausnitzii composition to specifically humans with metabolic syndrome receiving insulin or metformin or with Hb A1c levels of 5.7% or higher, as is taught to be a standard of care in Bianchi, rather than the broader genus of humans with metabolic syndrome, thereby arriving at the invention of claims 10-11 and 14, because Kawahara specifically points out that the subject population of those with metabolic syndrome can have carbohydrate metabolic abnormalities and diabetes, and because Kawahara teaches that the F. prausnitzii composition would be beneficial in this population due to the observed improvement in an indicator of insulin resistance and reduced insulin levels. Therefore the combination would be desirable to improve the symptoms specifically in this subset of humans with metabolic syndrome. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.”
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the Kasahara method of administering a F. prausnitzii composition to specifically humans with metabolic syndrome and obesity with BMI over 25, as is taught as a diagnostic criteria in Bianchi, rather than the broader genus of humans with metabolic syndrome, thereby arriving at the invention of claim 11, because Kawahara specifically points out that the subject population of those with metabolic syndrome can have obesity and because Kawahara teaches that the F. prausnitzii composition would be beneficial in this population due to the observed prevention of weight gain. Therefore the combination would be desirable to improve the symptoms specifically in this subset of humans with metabolic syndrome. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.”
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the Kasahara method of administering a F. prausnitzii composition to specifically humans with metabolic syndrome receiving statins or blood pressure medications as is taught to be a standard of care in Bianchi, rather than the broader genus of humans with metabolic syndrome, thereby arriving at the invention of claim 17, because Kawahara specifically points out that the subject population of those with metabolic syndrome can have arteriosclerosis and hypertension, and because Kawahara teaches that the F. prausnitzii composition would be beneficial in this population due to the observed improvement in cholesterol levels. Therefore the combination would be desirable to improve the symptoms specifically in this subset of humans with metabolic syndrome. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.”
Additionally, for all of the above, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (Kawahara) teaches a method that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the specific subject population within metabolic syndrome for the generic, broader subject metabolic syndrome population used); the substituted element (i.e. the specific sub-populations) were already known and already shown to function as a population where the method would be useful, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting a narrower subject population for the broader population with a reasonable expectation of success (i.e. the substitution of the element would lead to predictable results). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6-7, 13, 15-16, 18, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/652,274 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, ‘274 claim 1 (and dependent claims) teaches a composition comprising cell components and supernatant from a killed Faecalibacterium prausnitzii culture adapted for delivery to poultry. ‘274 claim 20 is a method of making the composition of claim 1 that also specifies that the composition is suitable for consumption by poultry, and ‘274 claim 12, 16, 17, 18, 19 (and dependent claims) are each methods comprising administering to the poultry an effective amount of the composition of claim 1.
For the effect “of prophylaxis, treatment or mitigation of a disease or condition characterized by impaired glucose metabolism”, all subjects are in need of prophylaxis for these diseases or conditions because any subject could get the disease in the future, so the effect does not limit the subject population. ‘274 teaches the same composition comprising materials derived from one or more F. prausnitzii cultures, and also teaches the same method of administering the composition to a subject in need (generic poultry). MPEP 2112.01.I states: when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. As the claim and ‘274 teach the same product administered in the same way to the same subject population, the functional limitation of preventing disease is presumed to be inherently present, absent evidence to the contrary.
Regarding claim 2, there is no evidence of record preventing poultry from being a companion animal.
Regarding claim 6, 15, ‘274 claim 2 states that the Faecalibacterium prausnitzii cell components and supernatant are dried.
Regarding claim 7 and 20, ‘274 claim 7 states the composition can be a food supplement, ‘274 claim 8 states that the composition can be mixed with drinking water, and ‘274 claim 5 states that the composition can be mixed in a gel spray (i.e. pharmaceutical composition).
Regarding claim 13, ‘274 claim 13 states the period of administration is 30 days (i.e. at least one week).
Regarding claims 3, 16, 18, these claims only describe effects on the subject that occur after the method’s step of administering an effective amount of a composition comprising materials derived from one or more F. prausnitzii cultures to a subject in need. ‘274 teaches the same composition comprising materials derived from one or more F. prausnitzii cultures, as described above, and also teaches the same method of administering the composition to a subject in need. MPEP 2112.01.I states: when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. As the claim and ’274 teach the same product administered in the same way to the same subject population, the functional limitations of claims 3, 16, and 18 are presumed to be inherently present, absent evidence to the contrary.
Claims 1-3, 6-7, 13, 15-16, 18, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/175,244 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, ‘244 claim 1 (and dependent claims) teaches a composition comprising cell components and supernatant from a Faecalibacterium prausnitzii culture adapted for delivery to poultry. ‘244 claim 20 is a method of making the composition of claim 1 that also specifies that the composition is suitable for consumption by poultry, and ‘244 claim 12, 16, 17, 18, 19 (and dependent claims) are each methods comprising administering to the poultry an effective amount of the composition of claim 1.
For the effect “of prophylaxis, treatment or mitigation of a disease or condition characterized by impaired glucose metabolism”, all subjects are in need of prophylaxis for these diseases or conditions because any subject could get the disease in the future, so the effect does not limit the subject population. ‘244 teaches the same composition comprising materials derived from one or more F. prausnitzii cultures, and also teaches the same method of administering the composition to a subject in need (generic poultry). MPEP 2112.01.I states: when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. As the claim and ‘244 teach the same product administered in the same way to the same subject population, the functional limitation of preventing disease is presumed to be inherently present, absent evidence to the contrary.
Regarding claim 2, there is no evidence of record preventing poultry from being a companion animal.
Regarding claim 6, 15, ‘244 claim 2 states that the Faecalibacterium prausnitzii cell components and supernatant are dried.
Regarding claim 7 and 20, ‘244 claim 7 states the composition can be a food supplement, ‘244 claim 8 states that the composition can be mixed with drinking water, and ‘244 claim 5 states that the composition can be mixed in a gel spray (i.e. pharmaceutical composition).
Regarding claim 13, ‘244 claim 13 states the period of administration is 30 days (i.e. at least one week).
Regarding claims 3, 16, 18, these claims only describe effects on the subject that occur after the method’s step of administering an effective amount of a composition comprising materials derived from one or more F. prausnitzii cultures to a subject in need. ‘244 teaches the same composition comprising materials derived from one or more F. prausnitzii cultures, as described above, and also teaches the same method of administering the composition to a subject in need. MPEP 2112.01.I states: when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. As the claim and ’244 teach the same product administered in the same way to the same subject population, the functional limitations of claims 3, 16, and 18 are presumed to be inherently present, absent evidence to the contrary.
Conclusion
No claims are allowed.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645