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 present application claims status as a 371 (National Stage) of PCT/KR2022/014393 filed 09/27/2022, and claims priority under 119(a)-(d) to Korean Application No. KR10-2021-0130419 filed on 09/30/2021.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Korean Application No. KR10-2021-0130419.
Claim Status
Claims 1-11 were filed on 03/29/2024.
Information Disclosure Statement
The IDS(s) filed on 03/29/2024 and 06/10/2026, have been considered by the Examiner.
Claim Interpretation
For purposes of applying prior art, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation set forth below, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
The scope of “a peptide comprising”, is interpreted as open-ended requiring 100% identity to SEQ ID NO: 1 (i.e., DYNMKWIHVY) with any N-/C-terminal additions. Per MPEP 2111.03(I), the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. As such, a peptide that comprises SEQ ID NO: 1 (i.e., DYNMKWIHVY) would meet the claim limitation.
Claim Objections
Claim 9 is objected to because of the following informalities: typographical error. The claim’s preamble lacks the noun that describes the invention’s category (i.e., process, machine, manufacture or composition of matter). Appropriate correction is required. In order to advance prosecution, the preamble of claim 9 would be interpreted as “The composition of claim 8”.
Claim Rejections - 35 USC § 112
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.
1. Claim 2 is 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.II.A.3.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Nature of the Invention:
Claim 2is broadly directed to the peptide of claim 1, wherein the peptide comprises an amino acid sequence of SEQ ID NO: 1.
Applicants only reduced to practice one peptide comprising an amino acid sequence of SEQ ID NO: 1 (i.e., DYNMKWIHVY). However, a representative number of peptides comprising the amino acid sequence of SEQ ID NO: 1 that exhibit the claim activity of reducing the fat accumulated in cells, have not been reduced to practice. Therefore, any peptide comprising DYNMKWIHVY, would exhibit the function of reducing the fat accumulated in cells.
Since the claims requires a peptide comprising an amino acid sequence of SEQ ID NO: 1 (i.e., DYNMKWIHVY), the Specification must sufficiently demonstrate possession of a representative number of peptides comprising DYNMKWIHVY, that exhibit the desired function/activity, that results from the relationship, or correlation between structure and function, sufficient to allow one of skill in the art to identify possession of the full scope of the invention.
Conclusion regarding possession:
Applicant does not have sufficient breadth of disclosure, namely a representative number of species and/or with the structure: function relationship (SEQ ID NO: 1) necessary to effectively demonstrate possession of the invention, for the exceptionally large genus of peptides comprising an amino acid sequence of SEQ ID NO: 1, as recited in instant claim 1.
The species described are insufficient to serve as representative of the entire genus. The nature of experimentation necessary to identify the peptides comprising SEQ ID NO: 1 with the desired function/activity would be unusually high and the motivation to test all peptides would therefore be very low. Taking into consideration the factors outlined above, including the nature of the invention, the state of the art, the guidance provided by the Specification, it is concluded that the specification does not demonstrate sufficient written description to indicate possession of the invention as recited in the claim.
Reduction to practice of a single peptide comprising an amino acid sequence of SEQ ID NO: 1, is not sufficient representation of the entire genus of peptides that comprise DYNMKWIHVY and also exhibit the claimed function of reducing the fat accumulated in cells. Applicants are in possession of a single peptide comprising an amino acid sequence of SEQ ID NO: 1.
2. Claims 3-6 and 10-11 are 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.
Claims 3-6 and 10-11 are broadly directed a pharmaceutical composition comprising the peptide of claim 1, wherein the peptide of claim 1 comprises an amino acid sequence of SEQ ID NO: 1. The included dependent claims, while further limiting the composition, largely do not further limit the breadth of the claimed peptide, which therefore does not suffice as sufficient breadth limitation.
Applicants only reduced to practice one peptide comprising an amino acid sequence of SEQ ID NO: 1 (i.e., DYNMKWIHVY). However, a representative number of peptides comprising the amino acid sequence of SEQ ID NO: 1 that exhibit the claim functions (i.e., preventing or treating obesity), have not been reduced to practice. Therefore, any peptide comprising DYNMKWIHVY, would prevent or treat obesity.
Since the claims require a peptide comprising an amino acid sequence of SEQ ID NO: 1 (i.e., DYNMKWIHVY), the Specification must sufficiently demonstrate possession of a representative number of peptides comprising DYNMKWIHVY, that exhibit the desired function/activity, that results from the relationship, or correlation between structure and function, sufficient to allow one of skill in the art to identify possession of the full scope of the invention.
Conclusion regarding possession:
Applicant does not have sufficient breadth of disclosure, namely a representative number of species and/or with the structure: function relationship (SEQ ID NO: 1) necessary to effectively demonstrate possession of the invention, for the exceptionally large genus of peptides comprising an amino acid sequence of SEQ ID NO: 1 that prevent or treat obesity.
The species described are insufficient to serve as representative of the entire genus. The nature of experimentation necessary to identify the peptides comprising SEQ ID NO: 1 with the desired function of preventing or treating obesity would be unusually high and the motivation to test all peptides would therefore be very low. Taking into consideration the factors outlined above, including the nature of the invention, the state of the art, the guidance provided by the Specification, it is concluded that the specification does not demonstrate sufficient written description to indicate possession of the invention as recited in the claims.
Reduction to practice of a single peptide comprising an amino acid sequence of SEQ ID NO: 1, is not sufficient representation of the entire genus of peptides that comprise DYNMKWIHVY and also exhibit the claimed function of preventing or treating obesity. Applicants are in possession of a single peptide comprising an amino acid sequence of SEQ ID NO: 1.
3. Claims 7-9 are 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.
Claim 7 is broadly directed to a composition for promoting lipolysis comprising the peptide of claim 1 as an active ingredient. The included dependent claims, while further limiting the composition, largely do not further limit the breadth of the claimed peptide, which therefore does not suffice as sufficient breadth limitation.
Applicants only reduced to practice one peptide comprising an amino acid sequence of SEQ ID NO: 1 (i.e., DYNMKWIHVY). However, a representative number of peptides comprising the amino acid sequence of SEQ ID NO: 1 that exhibit the claim function of promoting lipolysis have not been reduced to practice. Therefore, any peptide comprising DYNMKWIHVY, would promote lipolysis.
Since the claims require a peptide comprising an amino acid sequence of SEQ ID NO: 1 (i.e., DYNMKWIHVY), the Specification must sufficiently demonstrate possession of a representative number of peptides comprising DYNMKWIHVY, that exhibit the desired function, that results from the relationship, or correlation between structure and function, sufficient to allow one of skill in the art to identify possession of the full scope of the invention.
Conclusion regarding possession:
Applicant does not have sufficient breadth of disclosure, namely a representative number of species and/or with the structure: function relationship (SEQ ID NO: 1) necessary to effectively demonstrate possession of the invention, for the exceptionally large genus of peptides comprising an amino acid sequence of SEQ ID NO: 1 that promote lipolysis.
The species described are insufficient to serve as representative of the entire genus. The nature of experimentation necessary to identify the peptides comprising SEQ ID NO: 1 with the desired function of promoting lipolysis would be unusually high and the motivation to test all peptides would therefore be very low. Taking into consideration the factors outlined above, including the nature of the invention, the state of the art, the guidance provided by the Specification, it is concluded that the specification does not demonstrate sufficient written description to indicate possession of the invention as recited in the claims.
Reduction to practice of a single peptide comprising an amino acid sequence of SEQ ID NO: 1, is not sufficient representation of the entire genus of peptides that comprise DYNMKWIHVY and also exhibit the claimed function of promoting lipolysis. Applicants are in possession of a single peptide comprising an amino acid sequence of SEQ ID NO: 1.
2. Claims 3-6 and 10-11 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 treating obesity, does not reasonably provide enablement for preventing obesity. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. Please note that claims 4-6 and 11 are also included in this rejection because of their dependency upon a rejected claim.
To address whether sufficient evidence supports the determination that the disclosure does not satisfy the enablement requirement and whether undue experimentation might be needed, the below factors are considered:
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The breadth of the claims: The claims are drawn to compositions comprising a peptide comprising the amino acid sequence of SEQ ID NO: 1. The intended use of the compositions is to prevent obesity, wherein “obesity” refers to a condition or disease in which body fat is excessively accumulated in the body due to energy imbalance, and/or to “obesity-related diseases” that may be caused by a condition with excessive body fat (see specification, pg. 7, para[0050]). Additionally, the breadth of the claim exacerbates the complex nature of the subject matter to which the present claims are directed, because the scope of “obesity” and “obesity-related diseases”.
The nature of the invention: The invention pertains to using a peptide comprising SEQ ID NO: 1, and compositions comprising the peptide to prevent obesity.
The state of the prior art: The art teaches that obesity is commonly defined as having too much body fat, and that a BMI of 30 or higher is the usual benchmark for obesity in adults (see Cleveland Clinic, “Obesity” Last updated on 09/10/2024, retrieved from https://my.clevelandclinic.org/health/diseases/11209-weight-control-and-obesity on 06/22/202, here in after “Cleveland Clinic”). Additionally, that BMI is calculated by measuring the average body weight against average body height (see Cleveland Clinic, pg. 1). On the most basic level, obesity happens when you consume more calories than your body can use; however many things may play a role in why you may eat more food than your body needs. For instance obesity may be caused as a side effect of certain medications (antidepressants, steroids, anti-seizure medications and beta-blockers); as a result of a physical or learning disability; due to genetics; as a result of hormonal disruptions due to lack of sleep and/or stress; and due to underlying health issues such as metabolic syndrome, polyendocrine metabolic ovarian syndrome, etc. (see Cleveland Clinic, pg. 2). The state of the prior art also teaches that medications such as appetite suppressants can intercept some of the pathways in the brain that affect hunger, and thus can help tackle obesity from another angle (see Cleveland Clinic, pg. 2). However, the art is silent about a peptide comprising SEQ ID NO: 1 (i.e., DYNMKWIHVY), because the instant sequence free of the art.
The level of one of ordinary skill: Practitioners in this art (medical clinicians, pharmacists, doctors, dietitians, nutritionist and/or pharmaceutical chemists) would presumably be highly skilled in the art for the prevention of obesity.
The level of predictability in the art: The instant claimed invention is highly unpredictable. If one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains (i.e., preventing obesity), then there is a lack of predictability in the art. Moreover, it is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The court has indicated that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. (See In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970)). This is because it is not obvious from the disclosure of one species, what other species will work. In the instant case, Applicants do not demonstrate that obesity can be prevented with a composition comprising an amino acid sequence of SEQ ID NO: 1.
The amount of direction provided by the inventor: The specification does not enable any person skilled in the art to which it pertains to use the invention commensurate in scope with the claims. There is a lack of adequate guidance from the specification with regard to the actual prevention of obesity as recited in the claims. Applicants fail to provide the guidance and information required to ascertain whether the claimed administration of a composition comprising SEQ ID NO: 1, prevents obesity and obesity-related diseases without resorting to undue experimentation. Applicants' limited disclosure is noted but is not sufficient to justify claiming preventing obesity and obesity-related diseases, as claimed.
The existence of working examples: The specification does not articulate the use of a peptide comprising SEQ ID NO: 1, for preventing obesity or obesity-related diseases. Instead, the working examples pertain to: confirmation of changes in expression of lipolysis-related genes in adipocytes (see instant specification, pg. 13, para[0096]); confirmation of changes in expression of lipolysis-related proteins in adipocytes (see instant specification, pg. 14, para[00102]); measurement of a lipolysis product (i.e., glycerol) in adipocytes (see instant specification, pg. 15, para[00108]); confirmation of increase expression of thermogenesis-related genes by the peptide of the present invention (see instant specification, pp. 15-17, para[00114-00120]). However the working examples lack evidence of 100% prevention of obesity or obesity-related diseases.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: Due to the breadth of the claim, preventing obesity by administering the claimed composition comprising a peptide comprising SEQ ID NO: 1 would require substantive experimentation, given that Applicants have only reduced to practice one peptide, and that one peptide is not a representative number of the claimed genus.
After applying the Wands factors and analysis to claims 3-6 and 10-11, in view of Applicant' s entire disclosure, and considering the In re Wright, In re Fisher and Genentech decisions discussed above, it is concluded that the practice of the invention as claimed in claims 3-6 and 10-11 would not be enabled by the written disclosure for a pharmaceutical composition for preventing obesity comprising the peptide of claim 1 as an active ingredient. Therefore, claims 3-6 and 10-11 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to prevent obesity.
Applicants can overcome the instant rejection by amending the claim language in claims 3-6 and 10-11 to recite “ameliorating, reducing or inhibiting fat accumulated in cells” or “promoting lipolysis” instead of preventing obesity.
Examiner’s Comment – Allowable Subject Matter
Claim 1 is free of the prior art. There is no teaching or suggestion in the art for a peptide comprising DYNMKWIHVY (i.e., SEQ ID NO: 1).
Claims 2--11 are rejected.
Claim 9 is objected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLAUDIA E ESPINOSA whose telephone number is (703)756-4550. The examiner can normally be reached Monday-Friday 9:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CLAUDIA ESPINOSA/ Patent Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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