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 23 Dec 2025 is acknowledged. Claims 1-2, 5-9, 21-28, and 149 are currently pending. Of those, claims 1, 7-8, 21-22, 24-25, 27-28, and 149 are currently amended, and no claims are new. Claim 2 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 25 Aug 2025. Claims 3-4, 10-20, 29-148, and 150-184 are cancelled. Claims 1, 5-9, 21-28, and 149 will be examined on the merits herein.
Response to Arguments
The Applicants’ arguments filed 23 Dec 2025 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 24 Sep 2025 will be referred to as “NFOA.”
Objection(s) and Rejection(s) Withdrawn
The objection to the specification (NFOA par. 7) is withdrawn in view of the amended specification filed 23 Dec 2025.
The rejections of claim 10 under 35 U.S.C. 112(d) (NFOA par. 8) and 35 U.S.C. 112(b) (NFOA par. 9-10) are moot because the claim has been canceled.
The rejection of claims 1, 5-8, 21, 23-24, and 26-28 under 35 U.S.C. 102(a)(1) as being anticipated by Kaur et al. as evidenced by Chapman et al. (NFOA par. 34-40) is withdrawn in view of the claim amendments and arguments.
The rejection of claims 1, 5-8, 19, 21-24, 26-28, and 149 under 35 U.S.C. 103 as being unpatentable over Kaur et al. in view of Sun et al. and Cogliati et al. (NFOA par. 41-54) is withdrawn in view of the claim amendments and arguments.
The provisional double patenting rejection related to application 17/472,189 is withdrawn in view of the amendment to require specific species of Gluconacetobacter, Coprococcus, Veillonella, and Bifidobacterium.
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 § 112(a)
Claims 1, 5-9, 21-28 and 149 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for orally administering the CT10m or CT10x composition to treat Alzheimer’s disease and to treat amyloid plaques or reduce plaque burden, plaque number, or plaque size, and also being enabling for art-recognized treatment protocols using Lactobacillus and Bifidobacterium for treating Alzheimer’s disease and Parkinson’s disease, does not reasonably provide enablement for preventing diseases, or using any generic combination comprising the six listed microbial strains. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01. Although all factors were considered, the Wands factors that were most relevant for this decision are discussed in detail below.
The breadth of the claims: All claims but claim 149 are methods of treating or preventing Alzheimer's Disease (AD) or Parkinson's Disease (PD); claim 149 has the use of treating amyloid plaques or reducing plaque burden, plaque number, or plaque size in a subject diagnosed with AD or PD. The methods comprise administering to a subject in need thereof a composition comprising a plurality of microbial strains or microbial components thereof, wherein the plurality of microbial strains comprise at least Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Lactobacillus plantarum, Veillonella atypica, and Bifidobacterium breve. Claims 21-22 limit the total number of strains used by requiring that at least seven or 10 microbial strains be used, but do not limit the types of microbes administered. Claims 22-26 limit the route of administration. Claims 27-28 limit the concentration of microbial strains administered.
The amount of direction provided by the inventor and the existence of working examples: The specification teaches “Currently, there are no effective treatments for such diseases, including for ALS, PD, or AD,” [0002, see also 0121]. The specification describes the neurodegenerative diseases of PD, AD, and HD [0120-0143]. Specifically, the specification teaches that the different diseases have different causes (see causes of PD [0130], AD [0137], and HD [0142]), different symptoms (see symptoms of PD [0130], AD [0136], and HD [0142]), and different mechanisms of disease progression (see PD [0130], AD [0137], and HD [0143]). The specification also teaches that there is much uncertainty in each disease’s field, particularly in regard to how the diseases are affected by the microbiome (for example, see [0134]). The specification does not discuss the existing work in the field relating to probiotics for AD, PD, or HD.
What is enabled by the working examples is narrow in comparison to the breadth of the claims. Examples 6-7 investigate probiotic administration to a Tg2576 mouse model, which generates amyloid plaques to mimic AD [0262]. The Tg2576 mice are orally administered the CT10, CT10m, or CT10x compositions, which comprise defined amounts of live whole bacteria [defined 0264-0266]. Each composition contains Bifido. breve, G. hansenii, T. glycolicus, V. atypica, L. plantarum, Copro. catus, Clos. butyricum, P. barengoltzii, Bacillus subtilis, and Acidaminococcus sp.; CT10 contains 1*109 CFU per species, CT10m contains 2*109 CFU per species, and CT10x contains amounts varying between 1-3*109 CFU per species. Bacteria were administered orally [0263]. Many phenotypes are measured [Figures 20-29]. The CT10 composition did not significantly improve most phenotypes, the CT10x composition significantly improved most phenotypes, and the CT10m composition significantly improved some but not all phenotypes. For example, see Figure 21: only G5/ CT10x improved the plaque size, but both G4/CT10m and G5/ CT10x improved the plaque burden. G3/CT10 did not significantly improve either plaque size or plaque burden.
The state of the prior art and the level of predictability in the art: The art at the time of filing confirms the specification’s teaching that the example neurodegenerative diseases currently lack cures, and that much remains to be learned about the interaction of these diseases with the microbiome.
Naomi et al. (22 Dec 2021; hereafter Naomi) published a systematic review of research into the use of probiotics to treat Alzheimer’s disease using literature published before October 2021 (Section 2.1 on pg. 3). Therefore, this reference summarizes the state of the art at the time of filing even though it was published post-filing (see MPEP 2164.04(a)). Studies administering probiotics to animal models of AD are found in Table 1 (pg. 10-13) and clinical trials are found in Table 2 (pg. 16-17). Naomi summarizes the research as follows: “The results of all in vivo studies show that probiotic intervention is successful in improving the inflammatory and oxidative stress in AD-injected mice” (pg. 16 par. 2). “However, there is lack of evidence of the modulation of probiotics in patients with AD; impact of probiotics on the onset symptoms and progression of AD still remains unclear” (pg. 16 par. 3). “However, a publication biased towards positive results cannot be excluded… [W]e can conclude 90% of the study is done based on Bifidobacterium and Lactobacillus… Only 10% of the study focuses on Streptococcus and Clostridium species” (pg. 18 par 2). Therefore, Naomi teaches that while Lactobacillus and Bifidobacterium species seem promising as a treatment for AD due to the results of several studies that had been published before the time of filing, the majority of bacterial species listed in claim 1 have not been tested for any effect in AD at the time of filing.
Laar et al. (2019; PTO-892) is a review of the use of fecal microbiome transplantation (FMT) and probiotics in Parkinson’s disease. Laar summarizes the field as follows: “there are no good data in the public domain to support FMT at this moment in PD patients. FMT at this moment is a black box with too many unanswered questions, also with respect to safety concerns. Only the administration of species of Lactobacillus and Bifidobacterium over a time period of four to twelve weeks has repeatedly proven to be effective in treating constipation in PD. Also, no solid clinical data are available about the possible effects of probiotic treatment on motor symptoms or progression of PD.” (Abstract). Laar teaches that efforts to identify a microbiome composition correlated with PD have led to studies showing “partially reproducible changes in the PD microbiome… [that] do not converge on a specific signature or metabolic pathway for PD” (pg. S372 col. 2 par. 3). However, Laar notes that “These studies can only provide correlational evidence and cannot exclude reverse causation (they cannot exclude the possibility that PD itself results in dysbiosis/constipation)” (pg. S373 col. 1 par. 2). Laar notes that administration of Lactobacillus and Bifidobacterium have repeatedly been shown to improve constipation, but the evidence is poor for use of these species for motor or non-motor symptoms, and “referring to the microbiome studies in different PD cohorts, suppletion with Lactobacillus and Bifidobacterium does not look very rational, because both species have shown increased abundances in different populations” (pg. S375 col. 1 par. 2). Laar also notes that FMT and probiotics can pose health risks, particularly because the relative abundance of Lactobacillaceae and Bifidobacteria are already increased in PD (pg. S375 col. 2 par. 2-3).
Chidambaram et al. (16 Sep 2021; PTO-892) is an additional review of the interactions between the microbiome and neurodegenerative diseases. Chidambaram confirms the specification’s teachings that AD and PD each have different causes and symptoms (for AD, see pg. 11 col. 1 par. 3; for PD, see pg. 13 par. bridging cols.), and also teaches that each disease uses different animal models to reflect these differences (for example, AD uses Tg2576 or ADLPAPT mice, pg. 11 col. 1 par. 3-4; PD uses a human αSyn over-expressing mouse model, pg. 14 col. 1 par. 1). Therefore, Chidambaram provides evidence that results in one mouse model would not be expected by one of ordinary skill in the art to be relevant to other neurodegenerative diseases, and that amyloid plaques are specific to AD rather than shared across neurodegenerative diseases. Chidambaram also teaches a list of probiotic and FMT interventions for neurodegenerative disorders at the time of filing (Table 2 beginning on pg. 20); studies have been published for AD and PD. Finally, Chidambaram teaches that microbial components can promote neurodegenerative diseases. Bacterially-produced amyloid proteins (pg. 10 col. 2 par. 3) and LPS (pg. 11 col. 2 par. 2) have been correlated with AD, and circulating microbes and microbial metabolites can trigger systemic inflammation and promote AD (pg. 12 par. bridging cols.).
The art also explicitly teaches that the function of treating amyloid plaques or reducing plaque burden, plaque number, or plaque size is not shared across all combinations of four or more strains from the claimed list of microbial species. Kaur et al. (2020; PTO-892) administers the commercially available VSL#3 probiotic cocktail, which contains 8 bacterial strains in total: (1) Lactobacillus plantarum, (2) Bifidobacterium breve, (3) B. longum, and (4) B. infantis, as well as other species (pg. 1085 col. 1 par. 1) to a mouse model of AD, and found that probiotic treatment treated some symptoms (i.e. treatment of AD as defined in the instant specification at [0084]) but did not alter plaque load (pg. 1099 col. 1 par. 2). It is believed that the effects are due to changes in the gut microbiome and short-chain fatty acid (SCFA) levels (pg. 1099 col. 1 par. 2).
The quantity of experimentation needed to make or use the invention: The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success and without undue experimentation. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant specification is not enabling across the full scope because one cannot follow the guidance presented therein, or within the art at the time of filing, and practice the claimed method without first making a substantial inventive contribution.
First, for the function of “treating amyloid plaques or reducing plaque burden, plaque number, or plaque size in a subject diagnosed with Alzheimer's Disease (AD) or Parkinson's Disease (PD)” required for the method of claim 149, the instant specification shows only two compositions (CT10m and CT10x) that accomplish the required function. The art teaches that this function is not shared across all compositions comprising four or more microbial strains selected from Gluconacetobacter sp., Terrisporobacter glycolicus, Coprococcus sp., Lactobacillus plantarum, Clostridium butyricum, Paenibacillus sp., Veillonella sp., Bifidobacterium sp., Bacillus subtilis, and Acidaminococcus sp., (see Kaur and CT10 in Examples), teaches that some microbial components can worsen AD (see Chidambaram), and also teaches that it would not be possible to treat amyloid plaques in non-AD neurodegenerative diseases because those diseases do not have plaques (see Chidambaram). Therefore, the amount of experimentation needed to use the claimed invention would require many in vivo experiments in human clinical trials or art-recognized AD animal models in order to determine (1) which subsets of the claimed compositions comprising the six or more strains are capable of the effect, and (2) which administration routes and dosages are capable of the effect. Also, no amount of experimentation can treat amyloid plaques in diseases where amyloid plaques are present. The amount of experimentation required to use the claimed method, commensurate in scope to what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of successfully treating amyloid plaques or reducing plaque burden, plaque number, or plaque size in a subject diagnosed with a neurodegenerative disease, disorder, or condition.
Second, for the function of treating AD, the instant specification shows only two compositions (CT10m and CT10x) that accomplish the required function. The art teaches that this function is known for some compositions comprising Lactobacillus and Bifidobacterium, but the state of the art is still unclear (see Naomi), and the specification shows that these species being present is not enough to achieve the function with a reasonable expectation of success (see CT10). The art also teaches that some microbial components can worsen AD (see Chidambaram). Therefore, the amount of experimentation needed to use the claimed invention would require many in vivo experiments in human clinical trials or art-recognized AD animal models in order to determine (1) which subsets of the claimed compositions comprising four or more strains are capable of the effect, and (2) which administration routes and dosages are capable of the effect. The amount of experimentation required to use the claimed method, commensurate in scope to what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of successfully treating AD.
Third, for the function of treating PD, the instant specification does not show any examples supporting this function. The art teaches that administration of species of Lactobacillus and Bifidobacterium over a time period of four to twelve weeks has repeatedly proven to be effective in treating constipation in PD, but does not provide any guidance on combinations of strains that do not include those species or on treating any other symptoms or the disease itself. Therefore, the amount of experimentation needed to use the claimed invention would require many in vivo experiments in human clinical trials or art-recognized PD animal models in order to determine (1) which subsets of the claimed compositions comprising the six or more strains are capable of the effect, other than compositions that comprise L. plantarum and Bifidobacterium, and (2) which administration routes and dosages are capable of the effect, other than administering L. plantarum and Bifidobacterium for a time period of four to twelve weeks. The amount of experimentation required to use the claimed method, commensurate in scope to what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of successfully treating PD.
Third, for the function of preventing AD or PD, neither the instant specification nor the art shows any examples supporting this function. Therefore, there is no reason to believe that compositions within the claimed genus are capable of this function when administered, particularly when administered to subjects that may or may not develop these diseases (as compared to animal models that have been modified so the animals will develop the disease). The amount of experimentation needed to use the claimed invention would require many in vivo experiments in human clinical trials or animal models representative of the full population of subjects in need of prevention in order to determine whether there exist any compositions in the claimed groups that are capable of preventing these diseases, as well as additional experimentation to determine which compositions and how to administer them in order to have a reasonable expectation of success. The amount of experimentation required to use the claimed method, commensurate in scope to what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of successfully preventing AD or PD.
Fifth, for administration methods found in claims 23 and 25, the specification and art teach oral administration of bacterial compositions. Kaur teaches that their composition acts by the bacteria being present in the gut microbiome, which relies on oral administration of the composition. Chidambaram teaches that circulating microbes and microbial components can promote AD by increasing inflammation. Thus, there is no evidence in the specification or art supporting non-oral administration methods of bacteria for treating AD or PD, and evidence that non-oral administration methods can promote disease. In order to use other administration methods found in claims 23 and 25, one of ordinary skill would need to perform in vivo experimentation to determine whether the composition is still capable of treating disease symptoms when administered in other manners.
Therefore, claims 1, 5-9, 21-28, and 149 are rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112, first paragraph, for failing to meet the enablement requirement for the full scope claimed.
Response to Arguments
Applicant argues (Remarks pg. 8) that the scope of the claim has been amended and “The Office Action acknowledged this scope is enabled by the specification.”
This argument has been carefully considered but is not found persuasive. The examiner cannot find where the Office Action stated that the currently-claimed scope is enabled. Clarification is requested. Instead, the examiner stated in NFOA par. 11 the specification is “enabling for orally administering the CT10m or CT10x composition to treat Alzheimer’s disease and to treat amyloid plaques or reduce plaque burden, plaque number, or plaque size, and also being enabling for art-recognized treatment protocols using Lactobacillus and Bifidobacterium for treating Alzheimer’s disease and Parkinson’s disease,” which is broader than the use of compositions comprising six bacterial strains, administered in any manner.
Claims 1, 5-9, 21-28, and 149 remain 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.
MPEP 2163 states:
The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
An original claim may lack written description support when a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc).
Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate").
The breadth of the claims and the disclosures of the specification and the art are described above in the enablement rejection. The claims encompass a broad range of methods for treating AD or PD, and treating amyloid plaques or reducing plaque burden, plaque number, or plaque size, but the specification only adequately described two methods capable of treating AD or treating plaques: administering CT10m and CT10x (as well as a third method of administering CT10 that is not capable of the claimed functions). Therefore, the specification shows that the structure correlated with the claimed treatment functions is not the broad group of six more microbial strains or microbial components thereof; instead, the functional limitations of treating AD or treating plaques require a CFU dose in addition to requiring all 10 species of bacteria. Also, one of ordinary skill in the art would not have considered two different compositions representative of the full scope of compositions claimed, which can have any combination of six or more strains from the listed species.
The art broadens the structure-function correlation for the functions of treating AD and PD to include compositions comprising Lactobacillus and Bifidobacterium, for PD administered using an art-recognized protocol. However, the art does not identify a broader structure function correlation for plaque-related functions required by claim 149. The art also teaches that the use of probiotics other than Lactobacillus and Bifidobacterium are relatively unknown, so the use of these species to treat AD, PD, or plaques cannot be considered conventional. Also, one of ordinary skill in the art would not have considered the art’s description of compositions that comprise two specific genera of bacteria to be representative of claimed compositions that do not comprise those genera of bacteria. Additionally, the art teaches that microbial components like LPS may be harmful when administered to patients and teaches that the art-recognized mechanism of action relies on oral delivery of probiotics, rather than other routes of delivery. Therefore, one of ordinary skill in the art at the time of filing, when reading the specification in view of the art at the time of filing, would not have believed that the specification demonstrates possession of the claimed broad set of methods capable of achieving the claimed functional outcomes because it neither adequately describes a representative number of methods within the genus claimed nor does it show a structure-function correlation for the claimed functions. Therefore, claims 1, 5-9, 21-28, and 149 are rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112, first paragraph, for failing to meet the written description requirement for the full scope claimed.
Response to Arguments
Applicant argues (Remarks pg. 8-9) that “the present claims are directed to … the CT6 and CT6m compositions described in the application as filed. Applicant submits that a skilled person reading the specification as filed would readily understand that the CT6 and CT6m compositions could be used to treat a neurodegenerative disease, disorder, or condition, specifically Alzheimer's Disease or Parkinson's Disease.”
This argument has been carefully considered but is not found persuasive. The CT6 and CT6m compositions were not tested for any AD- or PD-related effect, they were tested in an ALS mouse model [Examples 1-4]. Applicant’s arguments have not described any connection between the demonstrated effects in an ALS model and the claimed effects for AD and PD, and do not provide any evidence to support their preferred conclusion about what a skilled person would understand. The arguments also do not rebut the finding that “the specification shows that the structure correlated with the claimed treatment functions is not the broad group of six more microbial strains or microbial components thereof; instead, the functional limitations of treating AD or treating plaques require a CFU dose in addition to requiring all 10 species of bacteria” (NFOA par. 32 and par. 31 above).
Double Patenting
Response to Arguments
Applicant argues for all double patenting rejections (Remarks pg. 10) that “Applications 17/472,189, 17/673,581, 18/073,511, 18/244,685, or 19/112,201 do not teach or suggest a methods of treating or preventing Alzheimer's Disease or Parkinson's Disease, let alone using the microbial strains as recited in the present claims.”
This argument has been carefully considered not is not found persuasive. The rejections of record pointed out how these features were taught by the claims of the references. The rejections have been updated to reflect the claim amendments where necessary. Also, applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Claims 1, 5-8, 21-24, 26-28 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 63-71 and 85-95 of copending Application No. 17/673,581 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘581 claim 63 (and its dependent claims) is an ingestible item comprising microbial strains from six to ten different genera; and wherein the plurality of microbial strains comprise six to ten of Gluconacetobacter sp., Terrisporobacter glycolicus, Coprococcus sp., Lactobacillus plantarum, Clostridium butyricum, Paenibacillus sp., Veillonella sp., Bifidobacterium sp., Bacillus subtilis, and Acidaminococcus sp. Dependent ‘581 claims 67-70 and 85-87 teach the use specifically of Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Veillonella atypica, and Bifidobacterium breve. Dependent ‘581 claims 88-95 require the compositions comprise 101 – 1012 CFUs (which anticipates the broader claimed 101 – 1015 CFUs) or the range above 106 CFUs.
One of ordinary skill in the art would consider it obvious to orally administer this probiotic composition to a human, because ‘581 specifically suggests the composition is ingestible and ‘581 teaches it can be a pharmaceutical composition. Therefore, there is no difference between the subject population suggested in ‘581 and the instant claims’ subject population because all humans are in need of prevention of AD or PD. The composition of the ‘581 claims and the instant claims are identical compositions administered in the same way to the same subject population, so the function would be present. 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). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. See MPEP 2112.01.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5-9, 21-28 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-10, 22-27, 149-152 of copending Application No. 18/073,511 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ’511 claim 1 (and its dependent claims) are a method of administering to a mammalian subject a composition comprising microbial strains of Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Lactobacillus plantarum, Veillonella atypica, and Bifidobacterium breve (six strains); and ‘511 claims 151-152 teach the composition can further comprise Clostridium butyricum, Paenibacillus sp., Acidaminococcus sp., and Bacillus subtilis (for a total of 10 strains). ‘511 claim 6 teaches that the subject can be human. ‘511 claims 7-9 teach the same limitations as instant claims 7-9; ‘511 claims 23-27 and 149 teach the same limitations as instant claims 23-28.
Therefore, there is no difference between the subject population suggested in ‘581 (humans) and the instant claims’ subject population because all humans are in need of prevention of AD or PD. The composition of the ‘581 claims and the instant claims are identical compositions administered in the same way to the same subject population, so the function would be present. 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). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. See MPEP 2112.01.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5-9, 21-24, 26-28 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-9, 11, 13, 19, 22-24 of copending Application No. 18/244,685 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘685 claim 1 (and its dependent claims) are a method of administering to a mammalian subject a composition comprising microbial strains of Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Lactobacillus plantarum, Veillonella atypica, and Bifidobacterium breve (six strains); and ‘685 claim 13 teaches the composition can further comprise Clostridium butyricum, Paenibacillus sp., Acidaminococcus sp., and Bacillus subtilis (for a total of 10 strains). ‘685 claims 5-9 teach the same limitation as the instant claims 5-9; ‘685 claim 19 teaches the administration routes of instant claims 23-24; ‘685 claim 22 teaches the composition formulations of claim 26; ‘685 claims 23-24 teach the CFU counts of instant claims 27-28. Of note, ‘685 teaches oral administration of the composition to humans (see ‘685 claims 6, 19).
Therefore, there is no difference between the subject population suggested in ‘685 (humans) and the instant claims’ subject population because all humans are in need of prevention of AD or PD. The composition of the ‘685 claims and the instant claims are identical compositions administered in the same way to the same subject population, so the function would be present. 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). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. See MPEP 2112.01.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5-9, 21-28 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-52, 75, 77-111, 120-150 of copending Application No. 19/112,201 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘201 claims 1, 3, 75 (and their dependent claims) are methods of administering a composition comprising microbial strains to a subject, ‘201 claims 16-19, 88-90 teach the strains are or comprise Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Lactobacillus plantarum, Veillonella atypica, and Bifidobacterium breve. ‘201 claims 5-9, 77-81 teach the same limitations about the subject as instant claims 5-9. ‘201 claims 21-28, 93-96, 98-100 teach the same limitations as instant claims 21-28. Of note, ‘201 teaches oral administration of the composition to humans (for example, see ‘201 claims 6, 23-24). ‘201 also teaches an ingestible composition comprising these strains, which would be obvious to orally administer (see ‘201 claims 29-52, 121-148, and especially 40-42, 48, 131-133).
Therefore, there is no difference between the subject population suggested in ‘201 (humans) and the instant claims’ subject population because all humans are in need of prevention of AD or PD. The composition of the ‘201 claims and the instant claims are identical compositions administered in the same way to the same subject population, so the function would be present. 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). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. See MPEP 2112.01.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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).
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645