The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4-1-2025 has been entered.
The amendment filed on 4-1-2025 is acknowledged. Claims 26 and 29-32 13 have been amended. Claims 13, 15-18 and 23-25 have been canceled. Claims 33-24 have been added. Claims 26-34 are currently under examination.
Claim Rejections Withdrawn
The rejection of claims 13, 15-18 and 23-25 under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of mental steps, mathematic concepts, organizing human activity, or a natural law without significantly more is withdrawn. Cancellation of said claims has rendered the rejection moot.
The rejection of claims 13, 15-18 and 23-32 under 35 U.S.C. 103 as being unpatentable over Zhao et al. (U.S. Patent Application Publication US 2015/0119415) and Apte et al. (U.S. Patent Application Publication U.S. 2018/0122510) is withdrawn in light of the amendment thereto.
The rejection of claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the term “instructing” is withdrawn in light of the amendment thereto.
New Grounds of Rejection
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 26-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of mental steps, mathematic concepts, organizing human activity, or a natural law without significantly more.
Applicant is directed to MPEP 2106 and the recent Federal Register notice (FR89, no 137 (7/17/2024) p 58128-58138) for the most current and complete guidelines in the analysis of patent- eligible subject matter. The current MPEP (9th Edition, Rev. 07.2022), published in February 2023 is the primary source for the USPTO’s patent eligibility guidance.
With respect to step (1): yes, the claims are drawn to a statutory category and recite processes.
With respect to step (2A) (1): yes, the claims recite an abstract idea, law of nature and/or natural phenomenon. The claims recite the use of a natural product, to achieve weight-loss. The claims also embrace the natural law describing the naturally occurring correlations between an increase in Phascolarctobacterium bacteria in the gut, and the ability to lose weight following the Mayo Clinic protocol. "Claims directed to nothing more than abstract ideas, natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04).
In claim 26, a “human probiotic formulation” that comprises certain levels of live Phascolarctobacterium is self-administered by a human patient, followed by a “nutritional intervention” and an “exercise intervention.”
The Examiner probed the specification for the nature of the Phascolarctobacterium, the nature of the probiotic formulation, and the nature of each intervention, and whether any “markedly different characteristics” existed.
As set forth in MPEP 2106, related to natural products, and the “markedly different” analysis:
“For a process claim, the general rule is that the claim is not subject to the markedly different analysis for nature-based products used in the process. This is because the analysis of a process claim should focus on the active steps of the process rather than the products used in those steps. … (claims are directed to a process of creating a preparation of multi-cryopreserved hepatocytes, not to the preparation itself).
“However, in the limited situation where a process claim reciting a nature-based product is drafted in such a way that there is no difference in substance from a product claim, the claim is subject to the markedly different analysis for the recited nature-based product. These types of claims are drafted in a way that focuses on the product rather than the process steps.
“For example, consider a claim that recites, in its entirety, "a method of providing an apple." Under the broadest reasonable interpretation, this claim is focused on the apple fruit itself, which is a nature-based product. Similarly, claims to detecting naturally occurring cell-free fetal DNA (cffDNA) in maternal blood were held to be directed to the cffDNA, because the "existence and location of cffDNA is a natural phenomenon [and thus] identifying its presence was merely claiming the natural phenomena itself." Rapid Litig. Mgmt., 827 F.3d at 1048, 119 USPQ2d at 1374, (explaining the holding in Ariosa Diagnostics, Inc. v. Sequenom, 788 F.3d 1371, 115 USPQ2d 1152 (Fed. Cir. 2015)).
Here, the claims self-administer a nature-based product (Phascolarctobacterium), and perform steps already in and of themselves that are related to weight-loss: diet and exercise.
The Phascolarctobacterium is one type of microorganism naturally present in the gut of mammals, as shown by Wu et al. (Exp Ther Med Vol. 14 No 4, p3122-3126). The specification, at page 2, notes that in mammals, particularly in humans, an elevated level of Phascolarctobacterium, and reduced level of Veillonella bacteria as well as reduced levels of Dialister bacteria can indicate the subject is more likely to respond to obesity treatments, including diet and exercise.
According to MPEP 2106, characteristics to be used in the “markedly different” analysis include:
“Appropriate characteristics can be expressed as the nature-based product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis. Non-limiting examples of the types of characteristics considered by the courts when determining whether there is a marked difference include:
• Biological or pharmacological functions or activities;
• Chemical and physical properties;
• Phenotype, including functional and structural characteristics; and
• Structure and form, whether chemical, genetic or physical.
Examples of biological or pharmacological functions or activities include, but are not limited to:
iii. the properties and functions of bacteria such as the ability to infect certain leguminous plants, Funk Bros., 333 U.S. at 130-31, 76 USPQ2d at 281-82; …
Examples of phenotypic characteristics include, but are not limited to:
i. functional and structural characteristics such as the shape, size, color, and behavior of an organism, Roslin, 750 F.3d at 1338, 110 USPQ2d at 1672.
Examples of structure and form include, but are not limited to:
i. physical structure or form such as the physical presence of plasmids in a bacterial cell, Chakrabarty, 447 U.S. at 305 and n.1, 206 USPQ2d at 195 and n.1;
and
iv. the genetic makeup (genotype) of a cell or organism, Roslin, 750 F.3d at 1338-39, 110 USPQ2d at 1672-73.”
The Specification provides no special characteristics of Phascolarctobacterium. The specification does not isolate and cultivate Phascolarctobacterium. No particular functions, activities, properties, phenotypes, or genotypes of Phascolarctobacterium are provided by the specification.
No source of Phascolarctobacterium is provided by the specification, beyond its identification in fecal samples by means of DNA analysis.
No protocols, culture requirements, or necessary elements for culturing Phascolarctobacterium to the required dosages for administration are provided by the specification.
MPEP 2106 sets forth how markedly different characteristics were identified for a type of bacteria, by the Courts:
“In Chakrabarty, the Supreme Court identified a claimed bacterium as a nature-based product having markedly different characteristics. This bacterium had a changed functional characteristic, i.e., it was able to degrade at least two different hydrocarbons as compared to naturally occurring Pseudomonas bacteria that can only degrade a single hydrocarbon. The claimed bacterium also had a different structural characteristic, i.e., it was genetically modified to include more plasmids than are found in a single naturally occurring Pseudomonas bacterium. The Supreme Court considered these changed characteristics to be "markedly different characteristics from any found in nature" due to the additional plasmids and resultant capacity for degrading multiple hydrocarbon components of oil. Therefore, the bacterium was eligible. Diamond v. Chakrabarty, 447 U.S. 303, 310, 206 USPQ 193, 197 (1980).”
The Phascolarctobacterium of the claims has no differing structural nor any differing functional characteristics in comparison to Phascolarctobacterium found in nature.
The Examiner probed the specification for a definition of a “human probiotic formula” and found none. The only recitation of a “probiotic formula” occurs at page 7 and sets forth no particular limitations, ingredients, excipients, et al.
“In some cases, a composition containing live Phascolarctobacterium can be administered orally as a probiotic formulation or can be administered as a fecal transplantation formulation.”
The BRI of a “human probiotic formula” appears to be any formulation to which the live (or lyophilized, live) bacteria can be added, including any pill, foodstuff, or beverage.
The specification, at pages 6-7 identify “compositions comprising live Phascolarctobacterium” as follows:
“For example, an obese or over weight human that was not assessed for an elevated level of gut Phascolarctobacterium, a reduced level of gut Veillonella, and/or a reduced level of gut Dialister can be administered, or instructed to self-administer, a composition containing live Phascolarctobacterium.
“A composition containing live Phascolarctobacterium for use as described herein can include any appropriate amount of live Phascolarctobacterium.
For example, a composition containing live Phascolarctobacterium can include from about 103 to about 1011 live Phascolarctobacterium.
Other ingredients that can be included within a composition containing live Phascolarctobacterium include, without limitation, carbohydrate based bulking agents for capsule dosage form, conventional excipients for tablet dosage form, carbohydrate based bulking agents and/or cryo-lyoprotectants for freeze-dried dosage form, and flavor enhancers, sweeteners, and/or viscosity enhancers for liquid dosage form.
In some cases, a composition containing live Phascolarctobacterium can be administered orally as a probiotic formulation or can be administered as a fecal transplantation formulation.”
As such, the Phascolarctobacterium in a human probiotic formulation as set forth in claim 26 has no markedly different characteristics than naturally occurring Phascolarctobacterium.
The claims using a nature-based product are then assessed to determine whether the steps of the claims provide an integration of the natural product into a practical application (Step 2A-2) or whether the steps of the claims comprise steps which provide significantly more than the natural product (Step 2B.)
The steps of claim 26 are
1) self-administration of a natural product
2) a nutritional intervention
3) a physical intervention, such as exercise.
At step 2-A-2, limitations the courts have found indicative of integration into a practical application are set forth in the MPEP 2106.04-05.
Claim 26 does not meet any of these recognized types of integration. The type most closely aligned to the claims is: “applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition.”
However, no particular disease or medical condition is identified in claim 26.
The self-administration of Phascolarctobacterium is not related to the identification of a human as needing Phascolarctobacterium, having a lower level of Phascolarctobacterium than a certain group, nor being overweight or obese.
Additionally, the generically-stated nutritional intervention and exercise intervention are in and of themselves related to weight-loss, and these merely link the JE to the concept of “weight loss” “dieting” or “lifestyle intervention”.
The generically-stated diet and exercise limitations were carefully considered in respect to this rejection. No particular nutritional intervention is set forth in the claims, and the specification refers to it as “dieting” throughout, and indicates the overall healthy eating protocol of the Mayo Clinic Obesity Treatment Research Program (p11). No particular physical intervention is set forth in the claims, and the specification refers to it as “exercise” throughout, and the activity listed in the specification is walking at least 10K steps. These are insufficient to integrate a JE into a practical application.
“In addition, a specific way of achieving a result is not a stand-alone consideration in Step 2A Prong Two. However, the specificity of the claim limitations is relevant to the evaluation of several considerations including the use of a particular machine, particular transformation and whether the limitations are mere instructions to apply an exception. See MPEP §§ 2106.05(b), 2106.05(c), and 2106.05(f). For example, in Parker v. Flook, 437 U.S. 584, 198 USPQ 193 (1978), the Supreme Court noted that the "patent application does not purport to explain how to select the appropriate margin of safety, the weighting factor, or any of the other variables" in the claimed mathematical formula, "[n]or does it purport to contain any disclosure relating to the chemical processes at work, the monitoring of process variables, or the means of setting off an alarm or adjusting an alarm system." 437 U.S. at 586, 198 USPQ at 195. The Court found this failure to explain any specifics of how to use the claimed formula informative when deciding that the additional elements in the claim were insignificant post-solution activity and thus not meaningful enough to render the claim eligible. 437 U.S. at 589-90, 198 USPQ at 197”
In considering whether claim 26 recites limitations which integrate the natural product into a practical application, the Vanda decision and related sections of MPEP 2106.05 were reviewed.
“The claims in Vanda recited a method of treating a patient having schizophrenia with iloperidone, a drug known to cause QTc prolongation (a disruption of the heart’s normal rhythm that can lead to serious health problems) in patients having a particular genotype associated with poor drug metabolism. 887 F.3d at 1121, 126 USPQ2d at 1269-70. In particular, the claims recited steps of: (1) performing a genotyping assay to determine if a patient has a genotype associated with poor drug metabolism; and (2) administering iloperidone to the patient in a dose range that depends on the patient’s genotype. Id. Although Vanda’s claims recited a law of nature (the naturally occurring relationship between the patient’s genotype and the risk of QTc prolongation) like the claims in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 101 USPQ2d 1961 (2012), the Federal Circuit distinguished them from the Mayo claims based on the differences in the administration steps. In particular, the court explained that Mayo’s step of administering a drug to a patient was performed in order to gather data about the recited laws of nature, and this step was thus ancillary to the overall diagnostic focus of the claims. 887 F.3d at 1134-35, 126 USPQ2d at 1280. In contrast, Vanda’s claims used the recited law of nature to more safely treat the patients with the drug, thereby reducing the patient’s risk of QTc prolongation. 887 F.3d at 1135, 126 USPQ2d at 1280. Accordingly, the court held Vanda’s claims eligible at the first part of the Alice/Mayo test (Step 2A) because the claims were not "directed to" the recited judicial exception. 887 F.3d at 1136, 126 USPQ2d at 1281.”
The rejected claims are more closely aligned to Mayo, than Vanda. The claims do not identify a particular patient subset, nor does administering Phascolarctobacterium appear to change how the nutritional and exercise interventions are carried out, nor do the claims change anything about the relationship between increased Phascolarctobacterium and an increased ability to lose weight using routine, well-known Weight Loss protocols.
The MPEP continues:
“Examples of "treatment" and prophylaxis" limitations encompass limitations that treat or prevent a disease or medical condition, including, e.g., acupuncture, administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like. For example, an immunization step that integrates an abstract idea into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases is considered to be a particular prophylaxis limitation that practically applies the abstract idea. See, e.g., Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1066–68, 100 USPQ2d 1492, 1500-01 (Fed. Cir. 2011).”
The administration of Phascolarctobacterium in the “probiotic formulation” followed by routine extra-solution activity of diet and exercise “are not affirmative limitations because they are merely indicating how the claimed invention might be used.”
Once an invention has been analyzed under step 2A-2, and found not to integrate the natural product into a practical application, step 2B seeks to identify whether the claim sets forth limitations that amount to significantly more than the natural product.
“An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added));”
The elements in addition to the natural product- the nutritional intervention, and the exercise intervention are not akin to any of the considerations identified by the Courts to demonstrate whether the additional elements amount to an inventive concept: These elements do not improve the functioning of a computer, or comprise an improvement to any other technical field (Trading Technologies Int’l v IBG, TLI Communications). They do not require or set forth a particular machine (Ultramercial v. Hulu, LLC., Alice Corp. Pty. Ltd v. CLS Bank Int’l), they do not effect a transformation of matter, nor do they provide an unconventional step. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception are insufficient to provide significantly more (as discussed in Alice Corp., CyberSource v. Retail Decisions, Parker v. Flook, Versata Development Group v. SAP America).
The elements in addition, the nutritional and exercise interventions, were shown to be extra-solution activity, as well as being well understood, routine and conventional in the treatment of overweight patients. The Mayo Clinic protocol is widely administered to patients who are overweight or obese, to attempt to induce weight loss, with or without the identification of levels of Phascolarctobacterium or any other microorganism (see Mikhail et al. Contemporary Clinical Trials Communications, Vol. 10, p36-41.)
With respect to the dependent claims:
Claims 27-28 modify the dose of Phascolarctobacterium, which does not provide any markedly different characteristics of Phascolarctobacterium, nor any non-routine administration elements.
Claims 29-31 state that administration occurs in certain intervals until a desired weight loss is achieved. These do not provide any markedly different characteristics of Phascolarctobacterium, nor do they provide any non-routine applications or elements.
Claim 32-34 affirm that the well-known activities of nutritional intervention and /or exercise invention are carried out, which have already been shown to be insufficient to provide significantly more than the natural product.
The claims have all been examined to identify the presence of one or more judicial exceptions. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether the additional limitations integrate the judicial exception into a practical application. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether those additional limitations provide an inventive concept which provides significantly more than those exceptions. Individually, the limitations of the claims and the claims as a whole have been found lacking.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Conclusion
No claim is allowed.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 September 27, 2025