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 .
Claim Status
The amended claim set filed 17 Apr 2026 is acknowledged. Claims 1-20 are currently pending. Of those, claims 1-4, 6-7, 12-16 and 18-20 are currently amended, and no claims 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 Claims 8-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Response to Arguments
The Applicants’ arguments filed 17 April 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 20 Jan 2026 will be referred to as “NFOA.”
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 has been amended to recite administering “an effective amount of a composition comprising live cells, killed cells, cell components, and/or supernatant from a Faecalibacterium prausnitzii culture or extracts thereof, wherein the Faecalibacterium prausnitzii used to make the composition has a 16S rRNA gene sequence comprising at least one sequence selected from GenBank (NCBI) accession numbers KJ957841 to KJ957877, to a subject in need thereof.” Applicant argues that [0022] of the provisional application supports the use of live cells, killed cells, and supernatant. The examiner agrees with this argument. Applicant also argues that [0022] of the provisional application supports the use of cell components. The examiner disagrees with this argument. There is no support in the quoted section of the specification that supports the range of “cell components” claimed, whose broadest reasonable interpretation could include any sub-structure that is from the cell (e.g. lipids, proteins, amino acids, small molecules, etc.). The priority document only supports the use of cell components in combination with supernatant. However, the claimed 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, applicant’s support is noted for at least one composition that does not cause hypoglycemia. The claim is supported, except for the lack of support for parent claim 1 noted above.
Regarding claim 4, applicant’s support is noted for the amended claim. The claim is supported, except for the lack of support for parent claim 1 noted above.
Regarding claim 11, applicant argues that the Hb A1C limitation is explicitly supported in the provisional. The examiner agrees; this feature was not noted as lacking support in the NFOA. Applicant also argues that “a person of ordinary skill in the art would understand that obesity and excess body fat correspond to elevated BMI values. It is well understood that a BMI over 25 is the clinical threshold for overweight status, and is simply a clinical measurement of the obesity condition explicitly disclosed in the Provisional Application.” The examiner disagrees with this argument. Bianchi et al. (2007; PTO-892 mailed 20 Jan 2026) teaches three different definitions of obesity in Table 1, none of which is BMI being over 25. Therefore, even if the claimed BMI limit is one possible clinical threshold for overweight status, one of ordinary skill in the art at the time of filing would not have recognized which threshold was intended. So, the general disclosure of “obesity” and “excess body fat” does not support the specific limitation claimed.
Regarding claim 19, claim 19 as amended does not recite using two or more strains, so the argument is moot. Instead, the claim recites that the F. prausnitzii “has” (singular verb) two or more 16S rRNA sequences selected from the GenBank sequences. The argument does not point out support for a single F. prausnitzii strain that has two or more 16S rRNA sequences and the support in the provisional is not apparent. See also the new 35 U.S.C. 112(a) rejection of this claim below.
The following effective filing dates have been used when searching the art: The effective filing date of claims 1-7, and 10-20 is 30 July 2021.
Objection(s) and Rejection(s) Withdrawn
The objections to the drawings (NFOA par. 15) are withdrawn in view of the drawings filed 17 Apr 2026, but see the objections to the new drawings below.
The objections to the claims (NFOA par. 17-18) are withdrawn in view of the claim amendments and arguments.
The rejections of claims 1-7 and 10-20 under 35 U.S.C. 112(b) (NFOA par. 20-24) are withdrawn in view of the claim amendments and arguments.
The rejection of claims 1-7 and 10-20 under 35 U.S.C. 103 as being unpatentable over Kawahara et al. alone (NFOA par. 37-42) are withdrawn in view of the claim amendments to require certain 16S rRNA sequences not taught by Kawahara and because this rejection required the presence of bacterial cells.
The double patenting rejections over copending Application No. 17/652,274 and 18/175,244 (NFOA par. 53-68) are withdrawn in view of the instant claim amendments to require certain 16S rRNA sequences not taught by the copending applications and the products of the copending claims requiring the presence of cells.
Drawings
The drawings filed 17 Apr 2026 are objected to because:
The amendment filed 17 Apr 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the amendment to change the labels on Figures 1-2 and 4-6 adds new matter because it adds additional experimental data for the samples “FPZ-S”, “FPZ-4” and “FPZ-L”. Applicant has not pointed out support for the new labels from the specification as filed, and the examiner has not found apparent support in the specification for the old label being equivalent to the new label. Applicant is required to cancel the new matter in the reply to this Office Action or to point out how the amendment is supported by the original specification.
Figures 4A-B are objected to because they do not comply with 37 C.F.R. 1.84 and/or do not show the details described in the specification. Specifically, the text does not use solid black lines and is small. In combination, these features makes the text difficult to interpret and reproduce (see example below). Reference is made to the following sections of 37 C.F.R. 1.84:
(l) Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. …
(p) Numbers, letters, and reference characters. … (3) Numbers, letters, and reference characters must measure at least .32 cm. (1/8 inch) in height. They should not be placed in the drawing so as to interfere with its comprehension. Therefore, they should not cross or mingle with the lines. They should not be placed upon hatched or shaded surfaces. When necessary, such as indicating a surface or cross section, a reference character may be underlined and a blank space may be left in the hatching or shading where the character occurs so that it appears distinct.
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Figure 5A is objected to because the smaller size in the newly submitted drawings makes it so that the different shapes of the two samples cannot be clearly distinguished.
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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.
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 102
Claims 1-5, 7, 12-13, 16, 18 and 20 remain rejected, and claim 19 is newly rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kawahara et al. (WO-20182 30695-A1, 2018; PTO-892 mailed 20 Jan 2026) 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 mailed 20 Jan 2026).
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 27766, or Faecalibacterium prausnitzii TY-2 (Accession No. NITE ABP-02743)” [0007 (8-3)]. The bacteria processed product (“FPZ”) can be 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].
The claim has been amended to recite the process by which the composition is made (“wherein the Faecalibacterium prausnitzii used to make the composition has a 16S rRNA gene sequence comprising at least one sequence selected from GenBank (NCBI) accession numbers KJ957841 to KJ957877”). See MPEP 2113: “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).” The claimed F. prausnitzii requires the presence of two specific rRNA sequences listed in GenBank, but these rRNA sequences are not proteins. So there is no evidence or reason to believe that the supernatant or protein complexes (i.e. cell components) of F. prausnitzii taught in Kawahara differs from the claimed F. prausnitzii in any way because these products do not comprise the cells’ genomes or rRNAs. Therefore, the method is the same as the claimed method because it administers the same product in the same way, even if the administered product was produced by a different method (purification from different bacteria).
Regarding claim 2, the Faecalibacterium product can be administered to a human or non-human animal [0007 (8)], which can include dogs and cats [0086].
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 19, the claim has been amended to recite the process by which the composition is made (“wherein the Faecalibacterium prausnitzii used to make the composition has a 16S rRNA gene sequence comprising two or more sequences selected from GenBank (NCBI) accession numbers KJ957841 to KJ957877”). See MPEP 2113: “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).” The claimed F. prausnitzii requires the presence of two specific rRNA sequences listed in GenBank, but these rRNA sequences are not proteins. So there is no evidence or reason to believe that the supernatant or protein complexes (i.e. cell components) of F. prausnitzii taught in Kawahara differs from the claimed F. prausnitzii in any way because these products do not comprise the cells’ genomes or rRNAs. Therefore, the method is the same as the claimed method because it administers the same product in the same way, even if it was produced by a different method (purification from different bacteria).
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 3-4, 16, and 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, 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 3-4, 16, and 18 are presumed to be inherently present, absent evidence to the contrary.
Response to Arguments
Applicant argues (Remarks pg. 11) that Kawahara does not disclose or suggest F. prausnitzii strains having 16S rRNA gene sequences corresponding to GenBank accession numbers KJ957841 to KJ957877. Kawahara does not anticipate the claims because it does not teach the specific F. prausnitzii strains claimed.
This argument has been carefully considered but is not found persuasive. This feature was addressed in the updated rejection above, see par. 20, 29. The claim is not limited to compositions comprising the cells, and the argument does not address how the supernatant and non-nucleic acid cell components would differ based on the presence of the 16S rRNA sequence(s) in the bacteria. See MPEP 2113 for applicant’s burden in products-by-process: “"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).”
Applicant argues (Remarks pg. 11) that Faecalibacterium prausnitzii ATCC 27768 was reclassified as F. moorei following the work of Fitzgerald et al. (2018).
This argument has been carefully considered but is not found persuasive. The Examiner thanks the applicant for noting this, however, Kawahara also teaches other F. prausnitzii strains. Also, as noted in response to the other argument, this argument does not provide evidence that there is a non-obvious difference between the supernatant and non-nucleic acid cell components from the other F. prausnitzii strains disclosed in Kawahara and the strains claimed.
Claim Rejections - 35 USC § 103
Claims 1-5, 7, 10-14, and 17-20 remain 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 mailed 20 Jan 2026) in view of Bianchi et al. (2007; hereafter Bianchi; PTO-892 mailed 20 Jan 2026).
Claims 1-5, 7, 12-13, 16, and 18-20 are anticipated by Kawahara, 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 Bianchi teaches 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.
Response to Arguments
Applicant argues (Remarks pg. 12-13) that Kawahara does not teach or suggest F. prausnitzii strains having 16S rRNA gene sequences corresponding to the GenBank accession numbers, and Bianchi does not teach any specific F. prausnitzii strains so it does not cure the deficiency of Kawahara.
The argument has been carefully considered but is not found persuasive. The claim is not limited to compositions comprising the cells, and the argument does not address how the supernatant and non-nucleic acid cell components would differ based on the presence of the 16S rRNA sequence(s) in the bacteria. See MPEP 2113 for applicant’s burden in products-by-process: “"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).”
Applicant argues (Remarks pg. 12-13) that there is no teaching, suggestion, or motivation in the cited references that would lead to selecting the specific F. prausnitzii strains having 16S rRNA gene sequences corresponding to the GenBank accession numbers because the strains were isolated from calves and piglets and are not known in the art to have any utility in treating glucose metabolism disorders prior to the instant disclosure. KSR and Kerkhoven do not apply because the strains in claim 1 as amended were not previously known or suggested for this use.
The argument has been carefully considered but is not found persuasive. The arguments about Kerkhoven are moot because it is not cited in the maintained rejection. The argument about KSR is not persuasive because using the supernatant and cell components from F. prausnitzii to treat glucose metabolism disorders is part of the anticipation rejection. The argument does not address the modifications to the subject population that are made based on Bianchi to choose subjects with certain medication histories and body properties from within the broader patient population disclosed in Kawahara.
New Rejection(s)
Improper Incorporation by Reference
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. See MPEP 608.01(p).I.A: “"Essential material" is defined in 37 CFR 1.57(d) as that which is necessary to (1) provide a written description of the claimed invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a); (2) describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or (3) describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f). In any application that is to issue as a U.S. patent, essential material may only be incorporated by reference to a U.S. patent or patent application publication.”
Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g). Specifically, the “GenBank (NCBI) accession numbers KJ957841 to KJ957877” that have been added to the claims are now essential material. The attempt to incorporate the sequences by reference to GenBank is improper.
Also, the attempt to incorporate subject matter into this application by reference to the GenBank accessions is ineffective because the root words “incorporate” and/or “reference” have been omitted, see 37 CFR 1.57(c)(1).
The incorporation by reference will not be effective until correction is made to comply with 37 CFR 1.57(c), (d), or (e). If the incorporated material is relied upon to meet any outstanding objection, rejection, or other requirement imposed by the Office, the correction must be made within any time period set by the Office for responding to the objection, rejection, or other requirement for the incorporation to be effective. Compliance will not be held in abeyance with respect to responding to the objection, rejection, or other requirement for the incorporation to be effective. In no case may the correction be made later than the close of prosecution as defined in 37 CFR 1.114(b), or abandonment of the application, whichever occurs earlier.
Any correction inserting material by amendment that was previously incorporated by reference must be accompanied by a statement that the material being inserted is the material incorporated by reference and the amendment contains no new matter. 37 CFR 1.57(g).
Warning about Future Claim Objections
Applicant is advised that should claim 6 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 6 recites: “The method of claim 1, wherein the composition comprises Faecalibacterium prausnitzii cells, cell components, and supernatant, wherein the Faecalibacterium prausnitzii cells, cell components, and supernatant have been dried”. Claim 15 recites: “The method of claim 1, wherein the composition comprises Faecalibacterium prausnitzii cells, cell components, and supernatant, and wherein the Faecalibacterium prausnitzii cells, cell components, and supernatant have been dried.” The claims differ only in that claim 15 has the extra word “and”, emphasized above, but the extra word does not change the claim scope because both claim constructions require both wherein clauses.
Claim Rejections - 35 USC § 112
Claims 1-7 and 10-20 are each rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of “live cells, killed cells, cell components, and/or supernatant from a Faecalibacterium prausnitzii culture or extracts thereof,” is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The following groupings do not share a single structural similarity: (1) Products comprising whole bacterial cells (live cells, killed cells); (2) Products comprising macromolecules that can be identified as originating from F. prausnitzii (some cell components like proteins, some supernatants, and some extracts); (3) Products that cannot be identified as originating from F. prausnitzii (some cell components like amino acids, some supernatants like those that have been filtered, and some extracts). Each grouping is limited by comprising non-overlapping structures (cells, macromolecules, or neither), so they do not share a structural similarity.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites “live cells, killed cells, cell components, and/or supernatant from a Faecalibacterium prausnitzii culture or extracts thereof”. The claim is indefinite because the use of “and/or” in the middle of the list makes it unclear what options can be chosen from. Specifically, it is unclear whether “from a Faecalibacterium prausnitzii culture” limits only the supernatant or all four of “live cells, killed cells, cell components, and/or supernatant” and whether “or extracts thereof” refers to only supernatant extracts or extracts from all four of “live cells, killed cells, cell components, and/or supernatant”. Claims 2-5, 7, 10-14, and 16-20 are also rejected because they depend from claim 1 and do not obviate this rejection. Claims 6 and 15 are not rejected because they require the specific structure of “cells, cell components, and supernatant”.
Regarding claims 1 and 19, these claims recite the term “sequences selected from GenBank (NCBI) accession numbers KJ957841 to KJ957877.” The claims contain the trademark/trade names GenBank and NCBI. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe specific nucleotide sequences and, accordingly, the identification/description is indefinite. Additionally, the reference to GenBank accession numbers is indefinite because the nucleic acid sequence associated with the accession number may be updated or changed over time as new research is performed. Therefore, a GenBank accession number does not clearly identify a specific sequence. Claims 2-7 and 10-20 are also rejected because they depend from claim 1 and do not obviate this rejection. In the interest of compact prosecution, the accession numbers will be searched by text only. The sequences cannot be searched in USPTO sequence databases because they were not provided as a sequence listing.
If applicant wishes to claim the sequences that were associated with the GenBank accession number at the filing date, it is recommended that applicant review the requirements for sequence listings and avoiding new matter. The Sequence Help Desk can be reached at 571-272-2510 or SequenceHelpDesk@uspto.gov.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 and 10-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Regarding claims 1 and 19, the claims recite a F. prausnitzii that “has” (singular verb) more than one sequence selected from GenBank (NCBI) accession numbers KJ957841 to KJ957877 (“at least one” and “two or more”, respectively). However, the specification does not adequately describe a strain of bacteria comprising more than one of the sequences, and therefore these newly added limitations constitute new matter.
Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”). Applicant pointed to paragraphs [0011-0013], [0025-0027], and Method 1.17 from the as-filed application. A careful review of these paragraphs reveals that that the best support for the newly added limitation is in Method 1.17: “1.17. Any foregoing method wherein the Faecalibacterium prausnitzii used to make the FPZ has a 16S rRNA gene sequence comprising a sequence selected from GenBank (NCBI) accession numbers KJ957841 to KJ957877.”
However, this sentence describes bacteria having a (single) 16S rRNA gene sequence. This sentence does not describe bacteria that have more than one of these 16S rRNA gene sequences. The other locations in the specification also do not disclose bacteria with multiple 16S rRNA gene sequences. Accordingly, the newly added limitations constitute new matter. Claims 2-7 and 10-20 are also rejected because they depend from claim 1 and do not obviate this rejection.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/EST).
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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