DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Amendments
Claim 47 has been amended to include the limitation of claim 56, which has been canceled. In addition, claims 48 and 53 have been amended to obviate claim objections.
Accordingly, claims 47-55 and 57-66 remain pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 9/18/2025 is in compliance with the provisions of 37 C.F.R. 1.97 and all references have been fully considered.
Claim Objections
RE: Objection to claims
The minor informalities in claims 48 and 53 have been corrected, thereby overcoming the claim objections.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
RE: Rejection of claim 60 under 35 U.S.C. 112(b) for indefiniteness
Applicant has deleted the indefinite phrase “such as”. Hence, the rejection has been withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
RE: Rejection of claims 47-54 and 57 under 35 U.S.C. 101 for being directed to natural products
Applicant disagrees with the examiner’s position, but has amended claim 47 to expedite examination by requiring that the claimed composition is “formulated for controlled release within the lower intestine or colon”. Applicant points out that this limitation was originally recited in claim 56, which was not included in the rejection. It is therefore asserted that the claims are now patent eligible.
The amendment is sufficient to overcome the rejection under 35 U.S.C. 101. Formulating a nature-based composition for controlled release within the lower intestine or colon makes said composition have markedly different characteristics compared to its closest naturally occurring counterpart because it causes a significant change in the bioavailability of the natural products present therein. The rejections of record have therefore been withdrawn.
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.
RE: Rejection of claims 47-52, 54, 57-60, and 62-66 under 35 U.S.C. 102(a)(2) as being anticipated by Goodman et al.
Traversal of rejections is based on claim 47 having been amended to incorporate the limitations of claim 56, which was previously not rejected under 35 U.S.C. 102(a)(2) over Goodman et al..
The traversal has been considered and is found persuasive. Goodman et al. does not disclose the limitation of claim 56. Thus, the anticipation rejections have been withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
RE: Rejection of claims 47-54, 57-60, and 62-66 under 35 U.S.C. 103 as being unpatentable over Goodman et al.; claims 47-52, 54-60, and 62-66 as being unpatentable over Goodman et al. in view of Sampson et al.; claims 47-52, 54, and 57-66 as being unpatentable over Goodman et al. in view of Scheperjans et al.
Applicant traverses the rejections because Goodman, alone or in combination with Sampson et al. or Scheperjans et al., allegedly fails to teach or suggest the claimed inventions. It is argued that Goodman lists numerous applicable bacterial species or strains (as the bacteria and/or the source of membrane preparations) and thus provides a multitude of possible bacterial combinations for therapy without sufficient guidance. Sampson et al. and Scheperjans et al. also do not cure Goodman’s deficiency. Moreover, applicant argues that there is no clear motivation to make the specific combination of features as claimed.
All arguments have been fully considered and are found unpersuasive. According to MPEP § 2131.02(II), a prior art that names the claimed species anticipates the claim regardless of the number of other named species. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught). So although the list of applicable bacteria spans multiple pages, it does not negate the fact that Bacteroides, Prevotella, and Faecalibacterium are taught to be suitable bacteria or source of bacterial MPs in the disclosed pharmaceutical composition.
In addition, the claims do not require that all three recited genera of bacteria should be present in the claimed composition. Claim 47 recites “wherein the one or more isolated microbial organisms comprise Bacteroides, Prevotella, Faecalibacterium, a mixture thereof, or a component derived thereform” (emphasis added). The conjunction “or” allows the claimed composition to contain only of these bacteria.
Furthermore, as discussed in the last office action, Sampson et al. provides a pharmaceutical composition comprising one or more bacteria for treating or inhibiting an amyloid disorder like Parkinson’s disease. In some embodiments, the one or more bacteria are selected from the group consisting of Bacteroides, Prevotella, Parabacteroides, Faecalibacterium, Clostridium, Eubacterium, Roseburia, Blautia, Coprococcus, Ruminococcus, Lactobacillus, Akkermansia, and Bifidobacterium (par. [0040]). Sampson et al. therefore supports Goodman’s teaching that Bacteroides, Prevotella, and Faecalibacterium are useful for treatment of Parkinson’s disease.
The rejections of record are considered proper but have withdrawn to address claim amendments.
New grounds of rejections
Claims 47-55, 57-60, and 62-66 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman et al. (Pub. No. WO 2020/172492 A2) in view of Sampson et al. (Pub. No. WO 2018/213204 A1).
Goodman et al. discloses pharmaceutical composition for treatment and/or prevention of a disease such as an inflammatory disease or dysbiosis. The pharmaceutical composition comprises bacterial membrane preparations (MPs) and whole bacteria, bacteria alone (i.e., MPs are absent), or MPs alone (i.e., bacteria are absent). In some embodiments, the MPs and/or bacteria are from one or more of bacterial species or strains listed in Table 1, Table 2, and/or Table 3 (par. [2], [54]-[56], [97]-[98]).
Goodman et al. is comparable to the following claims:
Regarding claim 47: the pharmaceutical composition comprising whole bacteria and/or bacterial MPs is the same as “A composition comprising: one or more isolated microbial organisms or a component of the isolated microbial organism”.
The whole bacteria include Bacteroides, Prevotella, and Faecalibacterium (Table 1, pages 33-34, 54, 75-76) and the bacterial MPs refer to bacterial purified membranes and its components (par. [34]), thereby meeting “wherein the one or more isolated microbial organisms comprise Bacteroides, Prevotella, Faecalibacterium, a mixture thereof, or a component derived therefrom”.
Being a pharmaceutical composition (par. [97]), which can alternatively be a food product, dietary supplement, or health food in the form of powder, tablet, capsule, liquid, paste, and jellies (par. [138]), satisfies “wherein the composition is formulated as a supplement, a powder, a pill, a tablet, a capsule, a pharmaceutical composition, a nutraceutical composition, or a probiotic composition”.
Goodman et al. differs from the instant claim in that it does not teach that the pharmaceutical compositions is “formulated for controlled release within the lower intestine or colon”.
Despite this, such pharmaceutical composition is well-known and routine in the art. Sampson et al., for example, teaches bacteria-containing pharmaceutical compositions for treating or inhibiting an amyloid disorder like Parkinson’s disease (par. [0040]), wherein the pharmaceutical compositions can be formulated for delivery to the lower small intestine, large intestine, and/or colon, or for inhibition of release in the stomach or upper gastrointestinal tract. Exemplary forms include enterically coated capsules that confer resistance to stomach acid such that contents are released in the vicinity of the desired application or at various times to extend the desired action (par. [0072], [0117], [0126]). Accordingly, a person with ordinary skill in the art before the effective filing date of the claimed invention would have modified Goodman et al.’s pharmaceutical composition by preparing it with pH- or time-dependent enteric coatings as taught by Sampson et al. and expect that such modification would provide the benefits of being able control the delivery of the one or more bacteria to the desired delivery site and times of action. The obviousness of the instant claim is based on some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Hence, claim 47 is obvious over Goodman et al. in view of Sampson et al..
Regarding claim 48: the embodiment of the bacteria being cultured and isolated from culture (par. [72], [406]-[410]) fulfills “wherein the isolated microbial organism is cultured bacteria”.
Regarding claim 49: the bacterial MPs include inner and/or outer membranes of Gram negative bacteria (par. [34]) is equivalent to “wherein the components of the isolated microbial organism comprise bacterial outer membrane vesicles derived from the isolated microbial organism”.
Regarding claim 50: an embodiment of the pharmaceutical composition contains bacteria alone (i.e., without bacterial MPs), wherein the bacteria from one or more of bacterial species or strains listed in Table 1, Table 2, and/or Table 3. Examples of listed bacteria include Prevotella histicola and Faecalibacterium prausnitzii (Table 1, pages 54, 75-76; par. [78]), which correspond to “wherein the composition consists essentially of Prevotella histicola and Faecalibacterium prausnitzii”.
Regarding claim 51: the pharmaceutical composition comprising bacterial MPs and/or bacteria such as Prevotella histicola and Faecalibacterium prausnitzii is the same as “wherein the composition comprises Prevotella histicola and Faecalibacterium prausnitzii, or a component thereof”.
Regarding claim 52: the teaching that the bacteria can be one or more of the listed bacterial species or strains indicates that Prevotella histicola and Faecalibacterium prausnitzii can be both present in the disclosed pharmaceutical composition, thus satisfying “wherein the P. histicola and the F. prausnitzii are in a single composition”.
Regarding claim 53: working examples disclose using pharmaceutical compositions containing between 1x104 and 5x109 bacterial cells such as one wherein the bacterial cells are Prevotella histicola (par. [385], [389]), which reads on “wherein the Prevotella histicola is present in an amount of at least 108 colony forming units (cfu)” but not “the Faecalibacterium prausnitzii is present in an amount of at least 108 cfu”.
Nonetheless, Goodman et al. teaches that the dosage to be administered can be determined by a person with ordinary skill in the art and it depends on various clinical factors. These factors include the subject’s species, size, age, sex, immunocompetence, the particular microorganism to be administered, duration and route of administration, and the kind/stage of disease. One with ordinary skill in the art can set or adjust the dose based on these clinical factors (par. [184]-[185]). Thus, in an embodiment of having both Prevotella histicola and Faecalibacterium prausnitzii in the pharmaceutical composition, the claimed amounts would have been found through routine experimentation and optimization.
Regarding claim 54: another example of applicable bacterial species is Bacteroides fragilis (Table 1, p. 34), which is identical to “further comprising Bacteroides fragilis”.
Regarding claim 55: the composition is further required to be “formulated in an acid-resistant formulation”.
Goodman et al. is different from the instant claims in that it does not specify the pharmaceutical composition to be acid-resistant.
As discussed above (see rejection for claim 47), Sampson et al. teaches formulating pharmaceutical compositions containing bacteria for delivery to the lower small intestine, large intestine, and/or colon, or for inhibition of release in the stomach or upper gastrointestinal tract such as by enterically coating capsules. One with ordinary skill in the art before the effective filing date of the claimed invention would have formulated the disclosed pharmaceutical composition with pH- or time-dependent enteric coating and predict that it would advantageously regulate the delivery of the one or more bacteria to the desired delivery site and times of action since enteric coatings confer resistance to stomach acid (par. [0072], [0117], [0126]). Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 57: the pharmaceutical composition can be combined with additional active materials or therapeutic including an anti-inflammatory agent (par. [126], [140], [180]) and therefore fulfills “further comprising an anti-inflammatory agent”.
Regarding claim 58: Goodman et al. discloses a method of treating a disease in a subject comprising administering to the subject the disclosed pharmaceutical composition (claims 76-77). In one embodiment, the disease being treated is a neurodegenerative and/or neurological disease like Parkinson’s disease (par. [223]). Since Parkinson’s disease is a type of synucleinopathy, Goodman et al.’s method is analogous to “A method of inhibiting, reducing, delaying, preventing, or ameliorating a synucleinopathy, or one or more symptoms of a synucleinopathy, the method comprising: administering to a subject in need the composition of claim 47”.
Regarding claim 59: Parkinson’s disease is a neurodegenerative disease and therefore meets “wherein the synucleinopathy is a neurodegenerative disorder, an enteric nervous system disorder, or inflammation associated thereto”.
Regarding claim 60: the prior art defines the term “subject” as any animal in need of treatment for a disease (par. [50]). Given that the disease being treated includes a neurodegenerative and/or neurological disease like Parkinson’s disease, the subject being administered with the disclosed composition is implied to have Parkinson’s disease, which satisfies “wherein said subject is one that has been identified or selected as being at risk for developing or already having Parkinson's disease, such as by clinical or diagnostic evaluation”.
Regarding claim 62: since Parkinson’s disease is characterized by increased aggregation of α-synuclein, the subject being treated necessarily has “an abnormal level of aggregation of a-synuclein (aSyn)”.
Regarding claim 63: the pharmaceutical composition can be used to treat dysbiosis within the gastrointestinal tract by regulating host immune cells such as by increasing secretion of anti-inflammatory cytokines and/or decreasing secretion of pro-inflammatory cytokines, reducing inflammation, or by changing metabolite production (par. [200], [226]-[228]). This results in a more balanced microbiome in the gastrointestinal tract, thereby fulfilling “wherein the method improves one or more gastrointestinal functions of the subject”.
Regarding claims 64 and 66: the prior art does not explicitly teach that the method leads to “wherein the method reduces aSyn aggregated in the subject” and “wherein the method increases levels of gut Prevotella histicola or Faecalibacterium prausnitzii”, respectively.
It should be noted that a chemical composition and its properties are inseparable. Thus, if the prior art teaches the chemical composition, the properties are necessarily present. With the presence of all the recited components, the disclosed pharmaceutical composition is deemed structurally the same as the composition being administered in the claimed method. MPEP § 2112 states that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). The disclosed pharmaceutical composition is therefore necessarily capable of reducing aSyn aggregated in the subject, as well as increasing levels of gut Prevotella histicola or Faecalibacterium prausnitzii, even though said properties are not acknowledged by Goodman et al..
Regarding claim 65: Goodman et al. teaches that the pharmaceutical composition can be used to treat inflammation such as neural inflammation (par. [196]), which is considered analogous to “wherein the method reduces neuroinflammation in the subject”.
Claims 47-55 and 57-66 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman et al. (Pub. No. WO 2020/172492 A2) in view of Sampson et al. (Pub. No. WO 2018/213204 A1) and Scheperjans et al. (Pub. No. US 2017/0191998 A1).
The teachings of Goodman et al. and Sampson et al. are described previously and applied herein. Goodman et al. and Sampson et al. are found to render claims 47-55, 57-60, and 62-66 obvious.
The composition of Goodman et al. and Sampson et al. is similar to the claim below:
Regarding claim 61: the subject is further required to be “selected as in need of the composition if a presence of Prevotella histicola or Faecalibacterium prausnitzii in an intestinal sample is lower than a predetermined level or control”.
Goodman et al. is different from the instant claims in that it does not teach that the subject being treated has a lower level of either bacterial species compared to a predetermined level or control.
Scheperjans et al., however, teaches methods for early detection of Parkinson’s disease and treatment or prophylaxis of said disease (Abstract; par. [0006]). The methods comprise obtaining a sample from a subject, determining the relative abundances of at least one Prevotellaceae taxa in the sample, and determining probability of the subject developing or having Parkinson’s disease based on the measured relative abundances (par. [0007]). This is based on the finding that a high relative abundance of Prevotellaceae indicates a low probability of the subject developing or having the disease. Preferably, the microbial taxa is Prevotella (par. [0044]-[0045]). A low relative abundance of Prevotella is one indicator that the subject has a high probability of developing or having Parkinson’s disease (par. [0049]). It would have been obvious for one with ordinary skill in the art to further modify Goodman et al.’s method by measuring the relative abundance of Prevotella such as P. histicola in the subject because it would allow early detection of Parkinson’s disease or identification of the subject as being at risk for having said disease. This is advantageous since the subject can receive early treatment. Obviousness is established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. Id.
Claim 61 is thus obvious over Goodman et al. in view of Sampson et al. and Scheperjans et al..
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651