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 .
DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/10/2025 has been considered here.
Status of Claims
Claims 1-13 are now pending and will be examined on the merits herein.
Claim Rejections - 35 USC § 112: Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 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 a method for the reduction of extracellular to intracellular water ratio increase in weight loss interventions for treatment of overweight and obesity, comprising orally administering a composition comprising β-escin up to five times per day, during or after a meal, in a total dose from 0.015 to 0.20 mg β-escin/kg per day, and continuing said administration from at least 21 days to 6 months, does not reasonably provide enablement for any and all methods of prevention of extracellular to intracellular water ratio increase in weight loss interventions for treatment of overweight and obesity, comprising orally administering any and all compositions comprising β-escin up to five times per day, during or after a meal, in a total dose from 0.015 to 0.20 mg β-escin/kg per day, and continuing said administration from at least 21 days to 6 months. 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 enablement requirement is considered based on the following eight Wands factors (MPEP 21.64.01(a)): (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.
The breadth of the claims: The scope of the instant claims are broad and reads on any and all methods of prevention of extracellular to intracellular water ratio increase in weight loss interventions for treatment of overweight and obesity, comprising orally administering any and all compositions comprising β-escin up to five times per day, during or after a meal, in a total dose from 0.015 to 0.20 mg β-escin/kg per day, and continuing said administration from at least 21 days to 6 months, which is not supported by the instant specification.
The nature of the invention: The claim invention is directed to a method of prevention of extracellular to intracellular water ratio increase in weight loss interventions for treatment of overweight and obesity comprising orally administering a composition comprising β-escin.
The state of the prior art and The level of predictability in the art: Both references, PL 405318 A1 (Bilski, 2015; as submitted on IDS of 03/10/2025; machine translation from PE2E via FIT) and PGPUB 2013023488 A1 (Wu, 2013; as submitted on IDS of 03/10/2025), teach compositions comprising beta-escin for use in weight loss. Wu specifically teaches that the composition is for reducing intracellular lipid accumulation in a cell (see Wu, abstract). While both of these references teaching that compositions comprising beta-escin are used for reducing weight, there would have to be significant research and testing done to show that any and all compositions comprising beta-escin would be used for the same purpose.
The amount of direction provided and The existence of working examples: There is no evidence in the specification that the instant invention is capable of preventing extracellular to intracellular water ratio increase in weight loss interventions for treatment of overweight and obesity. Further, it is not clear how the prevention of the water ratio increase can be shown in a susceptible subject or predicted in a subject in order to be prevented. How can the composition be administered to a healthy subject where the water ratio increase may or may not occur and say that the increase was prevented before it happens or doesn’t happen. The only guidance and working example provided by the inventor comprises providing the composition to overweight patients in two dosages over time.
The quantity of experimentation needed to make or use the invention: Given the breadth of the claims and the data presented above, one of ordinary skill would have to undertake a burdensome amount of research to show how any and all methods of prevention of extracellular to intracellular water ratio increase in weight loss interventions for treatment of overweight and obesity, comprising orally administering any and all compositions comprising β-escin up to five times per day, during or after a meal, in a total dose from 0.015 to 0.20 mg β-escin/kg per day, and continuing said administration from at least 21 days to 6 months. It is not clear what specific embodiments would be required in order for one of ordinary skill in the art to practice the instant invention commensurate in scope with the claims.
The level of one of ordinary skill: The level of one of ordinary skill is high, i.e. advanced education and training.
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 1-13 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to laws of nature and natural phenomena without significantly more.
The claims recite natural phenomena. These judicial exceptions are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the 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:
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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 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 a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP §2106.05(d)
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)
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
Step (1): The answer to this step is yes since claims 1-13 are directed to a method (i.e., a process), which is a statutory category.
Step (2A): The answer to this step is yes because the claimed compositions are directed to laws of nature and natural phenomena, specifically administering an oral composition comprising beta-escin.
Prong 1:
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
Claim Analysis
Independent claim 1 recites “orally administering a composition comprising β-escin up to five times per day, during or after a meal, in a total dose from 0.015 to 0.20 mg β-escin/kg per day, and continuing said administration from at least 21 days to 6 months.”
In the instant case, the scope of the positively recited elements of the composition defines it in terms of naturally-occurring compounds, and as such the composition of the method is defined as consisting of naturally-occurring compounds. The composition of the claims is merely taking naturally occurring materials and combining them, which does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim and is nothing more than an attempt to generally link the product of nature a particular technological environment. While the claim does recite that the natural product (i.e. β-escin) in in a specific dosage amount, this is not a significant addition to the limitations of the claim. Further the dependent claims do teach the use of pharmaceutically acceptable excipients, which includes natural compounds such as water and alcohols for example. Therefore, the instant claim recites a product of nature.
Claim 2 recites the limitation of the composition comprising chokeberry extract, which is another naturally occurring product. Claims 3-4, and 11-13 merely recite the regimen of administration, not adding anything to the composition of the instant claims. Claims 7-13 simply recite more specific combinations of composition of claim 1, for example limiting the form of the composition to that of a solid or a liquid form (i.e. being present with water) are not significant additions and/or are additional natural products. Claim 9 does teach the use of other non-natural products possibly, however it also includes other natural products such as vitamins. Claim 10 recites the use of carbon dioxide in the composition however this is also a naturally occurring product. Therefore, the instant claims recite a product of nature.
There is no evidence within the specification that the compositions recited in claims 1-13 contain markedly different characteristics from their naturally-occurring counterparts.
Therefore, the answer to step 2A prong 1 is yes.
Prong 2:
The Prong Two analysis considers the claim as a whole. That is, the limitations containing the judicial exception as well as the additional elements in the claim besides the judicial exception need to be evaluated together to determine whether the claim integrates the judicial exception into a practical application.
Here, the instantly amended claims do not introduce any additional limitations which transform or improve on the judicial exceptions recited in claim 1 and do not do anything beyond generally linking the use of the judicial exception to a particular technological environment.
Therefore, the answer to step 2A prong 2 is no.
Step (2B):
Claims 1-13 do not recite additional elements which require analysis under step 2B.
Therefore, the answer to step (2B) is no.
Conclusion
Claims 1-13 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. §101.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over PL 405318 A1 (Bilski, 2015; as submitted on IDS of 03/10/2025; machine translation from PE2E via FIT) in view of US PGPUB 2013023488 A1 (Wu, 2013; as submitted on IDS of 03/10/2025).
In regard to claims 1-2, Bilski teaches a composition for supporting weight loss comprising beta-escin and extracts from chokeberry (see Bilski, abstract; page 3, paragraph 3).
In regard to claim 3, the composition is used after meals, three times a day (see Bilski, page 3, final full paragraph), which includes after the first meal of the day.
In regard to claim 6, the composition is taught be in the form of an oral liquid composition or aqueous solution (see Bilski, page 3, paragraphs 6-8).
In regard to claim 8, it is taught that the composition is made by dissolving the ingredients in water (see Bilski, page 3, paragraph 9-10).
In regard to claim 9, the composition is taught to comprise flavor enhancers, preservatives, and sweeteners, among other substances conventionally used in oral liquid compositions (see Bilski, page 3, paragraph 8).
The teachings of Bilski are silent on the dosages of beta escin of the instant claims, continuing the administration for 21 days to 6 months, the composition being the only weight loss intervention treatment, being administered fives times during the day during or after any meal, the composition being solid, and the composition comprising an anti-foaming agent and/or CO2.
In regards to claims 1 and 13, Wu teaches a composition for reducing intracellular lipid accumulation in a cell (see Wu, abstract) comprising beta escin (see Wu, Table 1). It is taught that the active compound dosage can be adjusted as necessary to suit observed effects of the treatment, but specifies that the dosage is from 1µg/kg to 100mg/kg (see Wu, paragraph 0226). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claims 5-6, it is taught that the composition is in the form of a tablet, capsule, powder (i.e. solids) or solution (i.e. liquid) (see Wu, paragraphs 0193 and 0196).
In regard to claim 10, the composition is taught to use carbon dioxide as a propellant in an aerosol composition (see Wu, paragraph 0211).
In regards to claim 1-13 it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a method of administering a composition as instantly claimed using the teachings of Bilski and Wu as both teach compositions being administered to help with weight loss using the same compound (i.e. beta escin) using similar methods (i.e. oral compositions). It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would be obvious to one with ordinary skill in the art to use the teachings of Bilski with the teachings of Wu according to the known method of treatment of obesity (see Wu, paragraphs 0110-0113) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
In regards to claims 1, 4, 7, and 12, it is taught that the composition is administered four or more times a day (see Wu, paragraph 0227). While it is not taught that the composition is administered five times a day during or after a meal or continued for 21 days to 6 months, it is taught that the “duration and frequency of the treatment, it is typical for skilled clinicians to monitor subjects in order to determine when the treatment is providing therapeutic benefit, and to determine whether to increase or decrease dosage, increase or decrease administration frequency, discontinue treatment, resume treatment or make other alteration to treatment regimen” (see Wu, paragraph 0227) and that the dosage is able to by adjusted to suit the observed effects of the treatment (see Wu, paragraph 0226). Using these teachings, it would be understood by one with ordinary skill in the art that the method of administration of the composition is a result effective variable that can be routinely optimized by the skilled artisan. Further in regards to claims 7 and 12, it is noted that the amount of drug is clearly a result effective variable that must be determined based on a variety of factors including the age, body weight, and health of the patient, the condition(s) to be treated and their severity, the route(s) of administration, the particular drug(s) used, adverse drug effects or toxicity, clinical response to treatment, etc., and is routinely optimized by the skilled artisan. Applicant is advised that recitation of dosages, without more, is generally insufficient to patentably distinguish over the prior art.
In regards to claim 11, Further, as the combination of teachings of Bilski and Wu would yield an identical composition as instantly claimed, the properties, such as the weight loss intervention of claim 13, of the composition would be the same. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art teaches an identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
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