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 .
Priority
The instant application claims the priority benefit of U.S. Provisional Application No. 63/349340 filed on 6/06/2022 under 35 U.S.C. 119(e).
Claim Objections
Claims 1 and 11 are objected to because of the following informality: unnecessary use of a colon. It is recommended that the colon after the phrase “one or more of” in line 1 of claim 1 and line 3 of claim 11 be deleted.
Claims 1 is objected to since abbreviations for genus names are used without providing the full form. Any abbreviation should be defined when first recited in a set of claims by spelling out the full term followed by the abbreviation in parentheses. To resolve this minor informality, “C. cochlearium” and “L. acidophilus” in line 4 should be amended to “Clostridium cochlearium” and Lactobacillus acidophilus”, respectively.
Claim 2 is also objected to because the full meaning of the abbreviation “CFU” is missing. The first recited “CFU” (after “105” in line 3) should be amended to “Colony-Forming Units (CFU)”.
Claim 4 is objected to because the plural noun “multiple administrations” is incorrectly preceded by “a”.
Claim 5 is objected to since it recites a closed group of alternatives preceded by the phrase “selected from” but the last two limitations use the conjunction “or”. Appropriate correction is required.
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.
Claim 4 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The terms “more frequently” and “less frequently” in claim 4 is a relative term which renders the claim indefinite. It cannot be determined what is the basis or point of comparison for the frequency of multiple administrations (more or less frequently relative to what?). The term “more frequently” and “less frequently” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claims 11-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
The United States Patent and Trademark Office (USPTO) issued a revised guidance for evaluating subject matter eligibility, referred to as “2019 Revised Patent Subject Matter Eligibility Guidance”, which became effective on January 7, 2019 (see 84 Fed. Reg. 50) and updated on October 2019 and July 2024. In the instant application, claims 11-14 recite a law of nature and natural phenomenon. This judicial exception is not integrated into a practical application, and the claims do not include additional elements that are sufficient to amount to significantly more than said judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP 2106:
Step (1). Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A). Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application? Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See Vanda Memo
Applying the judicial exception with, or by use of, a particular machine. See MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP 2106.05(e) and Vanda Memo.
Step (2B). If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis in View of the Interim Guidance
The answer to Step (1) is “yes” since the claims are directed to a composition of matter, which is a statutory category.
The answer to Step (2A) is “yes” because the claimed probiotic composition is directed to a law of nature and natural phenomenon, specifically natural products.
Prong 1 – Claim 11 requires that the probiotic composition comprises “C. cochlearium” and “L. acidophilus”, both of which are found in the gastrointestinal tract of mammals like humans. Thus, the claim recites natural products.
Claim 12 further stipulates that the probiotic composition comprises “a pharmaceutically acceptable carrier”, which encompasses naturally occurring materials such as water and sugars. Combining a pharmaceutically acceptable carrier in the probiotic composition forms a mixture of natural products. There is no indication that the mixture of claim 12 is significantly different from “C. cochlearium” and “L. acidophilus” found in nature in terms of structure, property, or function (i.e., no markedly different characteristics).
Prong 2 – Claim 13 specifies that the probiotic composition is “formulated as a unit dosage” and claim 14 further defines the unit dosage to certain amounts. These additional elements do not induce a particular transformation/reduction, nor do they limit the natural products to a specific field of use. The recited judicial exception is therefore not integrated into a practical application.
The answer to Step (2B) is “no”. Formulating a probiotic composition with a pharmaceutically acceptable carrier and as a unit dosage are well-understood and routine in the art. For example, Janusz et al. (Pub. No. US 20200345791 A1) teaches a composition comprising at least one human isolate of SCFA-producing bacteria or mixtures thereof, such as C. cochlearium and L. acidophilus (par. [0006], [0044]), and pharmaceutically acceptable carrier (par. [0053]), wherein said composition can be formulated into a unit dosage form (par. [0115]).
Hence, claims 11-14 are directed to a judicial exception and do not qualify as eligible subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5, and 9-13 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Janusz et al. (Pub. No. US 20200345791 A1).
According to Janusz et al., gut microbiota plays an important role in managing obesity and its associated cardiometabolic disorders since some microbes in the gut produces short chain fatty acids (SCFA) like butyrate that are crucial for intestinal health and metabolic functions (par. [0003]). Levels of butyrate vary widely among individuals and can be increased by consuming fermentable fiber or administering butyrate-producing probiotic bacterial strains for delivery to the colon where SCFAs can be produced at their site of action, thereby providing health benefits such as healthy glucose control and weight management (par. [0005]).
Janusz et al. discloses a composition comprising at least one human isolate of SCFA-producing bacteria or mixtures thereof. In some embodiments, the bacteria are selected from a group consisting of Agathobacter rectalis, Anaerostipes caccae, A. hadrus, Butyricicoccus faecihominis, Clostridium butyricum, C. cochlearium, C. innocuum, Coprococcus comes, Flavonifactor plautii, Roseburia faecis, R. hominis, R. intestinalis, and R. inulinivorans (par. [0006], [0138]). Other probiotics are also suitable including Lactobacillus acidophilus (par. [0044]). The composition can also comprise a pharmaceutically acceptable excipient, carrier, or diluent (par. [0053]).
Janusz et al. also provides methods of using the disclosed composition including altering the composition of a subject’s microbiome for reduction of patient’s symptoms, prevention of a disease, or treatment of a disease/disorder like insulin sensitivity and obesity (par. [0104]-[0105], [0179], [0184]).
Janusz et al. reads on the instant application as follows:
Regarding claim 1: treating a disease/disorder like insulin sensitivity and obesity in a subject (par. [0099]-[0100], [0104]-[0105], [0179], [0184]) by administering a composition comprising at least one human isolate of SCFA-producing bacteria such as C. cochlearium, which can be combined with other probiotics like L. acidophilus (par. [0006], [0044], [0138]), is equivalent to “A method of improving one or more of: impaired insulin sensitivity, overweight, obesity, glucose homeostasis dysregulation, and gut microbiota profile dysregulation, comprising: administering… a probiotic composition, to a subject in need thereof”.
Janusz et al. teaches that an effective dose of the one or more bacterial species in humans is from about 103 to about 1011 Colony Forming Units (CFU) (par. [0116], [0166]). Accordingly, the composition comprising at least one human isolate of SCFA-producing bacteria like C. cochlearium and other probiotics like L. acidophilus (par. [0006], [0044], [0138]), wherein the one or more bacterial species are present at said effective amount, meets the limitation “an effective amount of isolated C. cochlearium, isolated L. acidophilus or a combination of isolated C. cochlearium and isolated L. acidophilus, formulated together or separately”.
Hence, claim 1 is anticipated by Janusz et al..
Regarding claim 3: administering the disclosed composition formulated as a unit dose or single dose (par. [0115]) is analogous to “wherein administering the effective amount comprises a single administration of isolated C. cochlearium, isolated L. acidophilus or a combination of isolated C. cochlearium and isolated L. acidophilus”.
Regarding claim 4: administering the disclosed composition formulated as multiple doses (par. [0115]) is the same as “wherein administering the effective amount comprises a multiple administrations of isolated C. cochlearium, isolated L. acidophilus or a combination of isolated C. cochlearium and isolated L. acidophilus”.
Regarding claim 5: the disclosed composition being administered at appropriate treatment intervals such as daily, every other day, or once a week (par. [0117]) satisfies “wherein the multiple administrations are performed at regular intervals selected from daily, weekly, monthly, or more frequently, or less frequently”.
Regarding claim 9: the composition being administered orally, enterally, or rectally (par. [0112]) fulfills “wherein administering the effective amount is via an enteral route”.
Regarding claim 10: the subject can be a human (par. [0099]), which is identical to “wherein the subject is human”.
Regarding claim 11: the disclosed composition comprising at least one human isolate of SCFA-producing bacteria like C. cochlearium and other probiotics like L. acidophilus corresponds to “A probiotic composition comprising: isolated C. cochlearium, isolated L. acidophilus or a combination of isolated C. cochlearium and isolated L. acidophilus”.
The instant claim also recites “for improving one or more of: impaired insulin sensitivity, overweight, obesity, glucose homeostasis dysregulation, and gut microbiota profile dysregulation”, which is considered an intended function. As such, it does not bear patentable weight in a claim directed to a product. Regardless, Janusz et al. teaches that the disclosed composition can be utilized to restore the subject’s microbiome to a healthy state or replenish native microbes, help support healthy weight management and maintenance of normal/healthy blood sugar levels, as well as treat a disease/disorder such as insulin sensitivity and obesity by (par. [0103]-[0106]).
Regarding claim 12: the pharmaceutically acceptable excipient, carrier, or diluent (par. [0053]) in the composition meets the additional requirement on claim 11 that the probiotic composition further comprises “a pharmaceutically acceptable carrier”.
Regarding claim 13: the disclosed composition containing an effective dose of the one or more bacterial species and being formulated into unit dosage form (par. [0115]) is the same as “formulated as a unit dosage comprising an effective amount of isolated C. cochlearium, isolated L. acidophilus or a combination of isolated C. cochlearium and isolated L. acidophilus”.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Janusz et al. (Pub. No. US 20200345791 A1).
The teachings of Janusz et al. are set forth above and applied herein. Janusz et al. is found to anticipate claims 1, 3-5, and 9-13.
Janusz et al. is comparable to the claims below:
Regarding claims 2 and 14: the effective dose of the one or more bacterial species in humans is taught to be from about 103 to about 1011 CFU such as 1010 CFU (par. [0116], [0166]), which reads on “wherein the effective amount of isolated C. cochlearium, isolated L. acidophilus or a combination of isolated C. cochlearium and isolated L. acidophilus, formulated together or separately, is in the range of 105 CFU to 1015 CFU, 106 CFU to 1014 CFU, 107 CFU to 1013 CFU, 108 CFU to 1012 CFU, 109 CFU to 1011 CFU, or 1010 CFU” and “wherein the unit dosage is in the range of 105 CFU to 1015 CFU, 106 CFU to 1014 CFU, 107 CFU to 1013 CFU, 108 CFU to 1012 CFU, 109 CFU to 1011 CFU, or 1010 CFU”.
Although the disclosed effective dose is not identical to any of the recited amounts or unit dosages, the courts have held that a prima facie case of obviousness exist when the claimed ranges "overlap or lie inside ranges disclosed by the prior art". In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). See MPEP 2144.05. And in this case, the disclosed effective dose overlaps with the claimed effective amount. It would have therefore been obvious to prepare a unit dosage containing the disclosed effective dose and administer it to the subject with reasonable expectation that it would alter the subject’s microbiome and help treat a disease or condition like insulin sensitivity and obesity.
Regarding claims 6-8: the method of claim 1 is further required to administer the C. cochlearium and/or L. acidophilus in an effective daily amount (in terms of CFU/day), which is not explicitly taught by the prior art.
But as discussed above, Janusz et al. teaches that the effective dose of the one or more bacterial species in humans is taught to be from about 103 to about 1011 CFU, and that the composition can be administered as a unit dose or multiple doses that can be taken daily. A person with ordinary skill in the art before the effective filing date of the claimed invention would have thus found the appropriate amount of the one or more bacterial species that can be administered each day through routine experimentation and optimization.
Conclusion
No claim is allowed.
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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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651