DETAILED ACTION
Examiner acknowledges receipt of the reply filed 6/22/2026, in response to the restriction requirement mailed 4/22/2026.
Claims 12-20 are pending. Claims 13-15 and 17-20 are withdrawn from further consideration for the reasons set forth below.
Claims 12 and 16 are being examined on the merits in this office 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 filing receipt dated 7/08/2024 has the following information:
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Election/Restrictions
Applicant’s election of Group 1 (claims 12-18) without traverse in the reply filed on 6/22/2026 is acknowledged.
Claims 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/2026.
Examiner acknowledges election of the following species:
Peptide: SEQ ID NO: 5
Functional property: increasing the expression of UCP-1
Claims 12 and 16 read on the elected species. Election was made without traverse in the reply filed on 6/22/2026.
Claims 13-15, 17, and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/2026.
Drawings
The drawings are objected to because Figs 3-5, 8 and 9 each contain multiple parts that should be designated A, B, C. The respective figure legend should also reflect the separate part of the figures. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
The use of the term Tween 80 (p 7 of the as-filed specification), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification refers to conflicting sequences for SEQ ID NOs: 2 and 4-8:
Table 1 provides the following sequences and SEQ ID NOs:
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Table 2 provides the following sequences. Note the different sequences assigned to SEQ ID NOs: 2 and 4-8.
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The abstract is objected to.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. See first sentence of the abstract. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claims 12 and 16 are objected to because of the following informalities:
Claim 12 should be amended to recite “comprising the [[an]] amino acid sequence”.
Claim 16 recites an acronym that should be written out in full name int eh first order of appearance within the claims.
Appropriate correction is required.
Improper Markush
Claims 12 and 16 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y).
The Markush grouping of peptides recited in claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: Claim 1 recites SEQ ID NOs: 1, 2, 3, and 5.
The recited peptides have different amino acid sequences and tertiary structures. The peptides have distinct sequences and peptide backbones. There is no evidence within the specification or the prior art of a common structural element (e.g., sequence) that relates to a common. Accordingly, the recited peptides are deemed to constitute an improper Markush group.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Sequence Interpretation/Claim Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising an amino acid sequence of SEQ ID NO: 1” requires only a dipeptide or more within SEQ ID NO: 1, “comprising the amino acid sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with or without additional amino acids at any N-/C-terminal ends or additional nucleotides at 5' /3' ends, “consisting of an amino acid sequence of SEQ ID NO: 1” would encompass any sequence of two or more consecutive amino acids (dipeptide or more) fully contained within SEQ ID NO: 1, and “consisting of the amino acid sequence of SEQ ID NO: 1” would be limited to the sequence of the amino acids as specified by SEQ ID NO: 1, and nothing more or less; "an amino acid selected from the group consisting of SEQ ID NOs: 1, 2 and 3” is any sequence of two or more consecutive amino acids (dipeptide or more) fully contained within SEQ ID NO: 1, 2 or 3; and “the amino acid selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
Please note that the Examiner is interpreting the scope of claim 12 as only requiring a dipeptide (two or more consecutive amino acids contained) within SEQ ID NO: 5 with or without additional amino acids at the N-/C-terminal ends (the claim recites “comprising an amino acid sequence … of SEQ ID NO: 5). Sequences that are longer than SEQ ID NO:5 also read on the elected species.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitations "the peptide” and “the expression”. There is insufficient antecedent basis for this limitation in the claim.
Written Description
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 12 and 16 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “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. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient” (MPEP § 2163).
A claimed genus may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure (MPEP § 2163(3)a(II)). The number of species that describe the genus must be adequate to describe the entire genus; if there is substantial variability, a large number of species must be described.
The analysis for adequate written description considers (a) actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure, and (d) representative number of samples.
In the instant case, claims 12 and 16 are drawn to a method of treating obesity, the method comprising administering a pharmaceutical composition comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 2, 3, and 5 as an active ingredient to a subject in need thereof.
The genus of instant claimed peptide/amino acid sequence is extremely broad, including any peptide/protein comprising the amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 2, 3, and 5. The peptide of instant SEQ ID NO: 1 is of the amino acid sequence YFR; the peptides of instant SEQ ID NOs: 2, 3, and 5 are fragments of ATPase inhibitor factor 1 (ATPIF1). The ATPIF1 sequence (SEQ ID NO:1) of Kim (KR20180107368 – previously cited) comprises instant SEQ ID NO:1 (at residues 33-35), SEQ ID NO:2 (at residues 26-32), and SEQ ID NO:5 (at residues 36-47).
The instant specification discloses that peptides of instant SEQ ID NO: 1-5 function as anti-obesity peptide.
The issue at question is whether a person of ordinary skilled in the art would be able to determine what structural feature/amino acid sequence is required for the instant claimed peptide/amino acid sequence to have the functional characteristics of being an anti-obesity peptide of or not.
(a) actual reduction to practice and (b) disclosure of drawings or structural chemical formulas:
In the instant case, the instant specification discloses peptides of SEQ ID NOs: 1, 2, 3, and 5 as examples of the instant claimed amino acid sequence/peptide.
Table 1 includes additional peptides that encompass SEQ ID NOs: 1, 2, 3, and 5. For instance, SEQ ID NO:1 is found in the longer peptide sequences of SEQ ID NOs: 4 and 6-8.
Furthermore, peptides of instant SEQ ID NOs: 1, 2, 3, and 5 are tested in the working examples in instant specification. Figs 1-3, 5, 7-10 relate to changes in expression and protein phosphorylation.
Fig 4 relates to changes in lipid droplet size (assessing SEQ ID NOs: 3, 5, and 8). SEQ ID NO:8 encompasses instant SEQ ID NOs: 1-3 (see Table 1). The specification did not assess lipid droplet sized as relating to smaller peptides of SEQ ID NOs: 1 and 2 (which differ in sequence from SEQ ID NOs: 3 and 5 which were assessed).
Fig 6 relates to changes in body weight and food intake (assessing SEQ ID NOs: 7 and 8). SEQ ID NOs: 7 and 8 include SEQ ID NOs: 1-3, but not SEQ ID NO:5. SEQ ID NOs: 1, 2, 3, and 5 were not specifically assessed with respect to changes in body weight (Ex 3). There is no evidence that smaller peptides of SEQ ID NOs: 1, 2, 3, and 5 contribute to changes in body weight (outside of the larger peptides of SEQ ID NOs:7 and 8).
Fig 11 relates to changes in muscle mass (assessing SEQ ID NOs: 7 and 8).
There is no guidance as to the number of samples/animals assessed. Thus, the statistical error and statistical relevance are unclear.
Taken all these together, other than the limited examples, the instant specification fails to describe what structural feature/amino acid sequence is required for the instant claimed peptide/amino acid sequence to have the functional characteristics of being an anti-obesity peptide.
(c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure:
As discussed above, in the instant case, based on the disclosure of instant specification, other than the limited examples, a person of ordinary skilled in the art would not be able to determine what structural feature/amino acid sequence is required for the instant claimed peptide/amino acid sequence to have the functional characteristics of having utility in treating obesity.
With regards to the instant claimed peptide/amino acid sequence having utility in treating obesity, Kim (KR20180107368 – previously cited) discloses a pharmaceutical composition containing ATPase inhibitor factor 1 (ATPIF1) as an active ingredient and methods for treating obesity, diabetes or diabetic complications (e.g. abstract, paras [0001]-[0005], [0008]-[0012], [0025]-[0027], [0077]-[0078], [0088]-[0089]; claims 1 and 6). Kim teaches a pharmaceutical composition containing ATPase inhibitor factor 1 (ATPIF1) as an active ingredient (e.g., paras [0074]-[0076]). Diabetes complications are one or more diseases selected from the group consisting of diabetic nephropathy, diabetic retinopathy, hyperlipidemia, and fatty liver (claim 4). The ATPIF1 sequence (SEQ ID NO:1) of Kim comprises instant SEQ ID NO:5 (at residues 36-47). Thus, SEQ ID NO:1 of Kim (ATPIF1 protein sequence) has 100% identity with instant SEQ ID NO:5. However, Kim et al do not teach any fragment of ATPIF1 being an anti-obesity peptide, and/or the core sequence of ATPIF1 that is important for its anti-obesity activity.
Therefore, based on the state of art, a person of ordinary skilled in the art would not be able to determine what structural feature/amino acid sequence is required for the instant claimed peptide/amino acid sequence to have the functional characteristics of being an anti-obesity peptide.
(d) representative number of samples:
In the instant case, the genus of instant claimed peptide/amino acid sequence is extremely broad, including any peptide/protein comprising the amino acid sequence selected from the group consisting of SEQ ID NOs: 1-3 and 5. The peptide of instant SEQ ID NO: 1 is of the amino acid sequence YFR; the peptides of instant SEQ ID NOs: 2, 3, and 5 are fragments of ATPase inhibitor factor 1 (ATPIF1).
And, as discussed in (a) and (b) above, the instant specification discloses peptides of SEQ ID NOs: 1-3 and 5 as examples of the instant claimed amino acid sequence/peptide.
Furthermore, peptides of instant SEQ ID NOs: 1-3 and 5 are tested in the working examples in instant specification. Fig 4 relates to changes in lipid droplet size (assessing SEQ ID NOs: 3, 5, and 8). SEQ ID NO:8 encompasses instant SEQ ID NOs: 1-3 (see Table 1). The specification did not assess lipid droplet sized as relating to smaller peptides of SEQ ID NOs: 1 and 2 (which differ in sequence from SEQ ID NOs: 3 and 5 which were assessed).
Fig 6 relates to changes in body weight and food intake (assessing SEQ ID NOs: 7 and 8). SEQ ID NOs: 7 and 8 include SEQ ID NOs: 1-3, but not SEQ ID NO:5. SEQ ID NOs: 1, 2, 3, and 5 were not specifically assessed with respect to changes in body weight (Ex 3).
There is no evidence that smaller peptides of SEQ ID NOs: 1, 2, 3, and 5 contribute to changes in body weight (outside of the larger peptides of SEQ ID NOs:7 and 8).
There is no guidance as to the number of samples/animals assessed. Thus, the statistical error and statistical relevance are unclear.
It is further noted, the SEQ ID NO: 1 STIC search results teaches that other than ATPIF1, there are many different proteins comprising the amino acid sequence of instant SEQ ID NO: 1 (YFR); and there is no evidence to indicate these other proteins exhibit any anti-obesity activity. See Score sequence results.
Peptides that are support treatment of obesity correlate with instant SEQ ID NOs: 7 and 8, and full-length ATPIF1 (as taught by Kim et al). There are no examples of body weight changes comprising or consisting of a peptide/fragment of SEQ ID NO:5.
Considering the broadness of the genus of instant claimed peptide/amino acid sequence, the instant specification fails to provide sufficient examples to describe the entire genus of instant claimed peptide/amino acid sequence to have the functional characteristics of being useful in treating obesity.
Taken all these together, considering the state of the art and the disclosure in instant specification, it is deemed that the instant specification fails to provide adequate written description for the claimed genus of peptide/amino acid sequence to have the functional characteristics of being an anti-obesity peptide; and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Enablement
Claims 12 and 16 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 with a peptide consisting of SEQ ID NOs: 7 or 8 or full-length ATPase inhibitor factor 1 (ATPIF1) (each of which comprise elected species SEQ ID NOs: 1-3), does not reasonably provide enablement for smaller peptides consisting of SEQ ID NOS: 1-3 or 5, much less all sequences that comprise SEQ ID NOs:1-3 and 5. There are no examples of a change in body weight as relating to a peptide/fragment consisting of SEQ ID NO:5, or comprising SEQ ID NO:5 other than full-length ATPIF1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the Examiner’s position that one skilled in the art could not practice the invention without undue experimentation.
(1) The nature of the invention and (5) The breadth of the claims:
The instant claims 12 and 16 are drawn to a method for treating obesity, the method comprising administering a pharmaceutical composition comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-3 and 5 as an active ingredient to a subject in need thereof.
(2) The state of the prior art and (4) The predictability or unpredictability of the art:
With regards to the instant claimed peptide/amino acid sequence(s) being an anti-obesity peptide, Kim (KR20180107368 – previously cited) discloses a pharmaceutical composition containing ATPase inhibitor factor 1 (ATPIF1) as an active ingredient and methods for treating obesity, diabetes or diabetic complications (e.g. abstract, paras [0001]-[0005], [0008]-[0012], [0025]-[0027], [0077]-[0078], [0088]-[0089]; claims 1 and 6). Kim teaches a pharmaceutical composition containing ATPase inhibitor factor 1 (ATPIF1) as an active ingredient (e.g., paras [0074]-[0076]). The ATPIF1 sequence (SEQ ID NO:1) of Kim (KR20180107368 – previously cited) comprises instant SEQ ID NO:1 (at residues 33-35), SEQ ID NO:2 (at residues 26-32), and SEQ ID NO:5 (at residues 36-47). However, Kim et al do not teach any fragment of ATPIF1 being an anti-obesity peptide, and/or the core sequence of ATPIF1 that is important for its anti-obesity activity.
It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. Adding to the unpredictability is that many treatment options may show promise in animal models, but may fail to show therapeutic improvement in clinical trials. There is no absolute predictability, even in view of the high level of skill in the art.
(3) The relative skill of those in the art:
MPEP 2141.03 states (in part)" A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR International Co. V. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. At 1396, 82 USPQ2d at 1396. The "hypothetical person having ordinary skill in the art' to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art." Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner's definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high.
(6) The amount of direction or guidance presented and (7) The presence or absence of working examples:
The peptides of instant SEQ ID NO: 1-3 and 5 are fragments of ATPIF1.
Table 1 includes additional peptides that encompass SEQ ID NOs: 1, 2, 3, and 5. For instance, SEQ ID NO:1 is found in the longer peptide sequences of SEQ ID NOs: 4 and 6-8.
Furthermore, peptides of instant SEQ ID NOs: 1, 2, 3, and 5 are tested in the working examples in instant specification. Figs 1-3, 5, 7-10 relate to changes in expression and protein phosphorylation. Fig 4 relates to changes in lipid droplet size (assessing SEQ ID NOs: 3, 5, and 8). SEQ ID NO:8 encompasses instant SEQ ID NOs: 1-3 (see Table 1). The specification did not assess lipid droplet sized as relating to smaller peptides of SEQ ID NOs: 1 and 2 (which differ in sequence from SEQ ID NOs: 3 and 5 which were assessed).
Fig 6 relates to changes in body weight and food intake (assessing SEQ ID NOs: 7 and 8). SEQ ID NOs: 7 and 8 include SEQ ID NOs: 1-3, but not SEQ ID NO:5. SEQ ID NOs: 1, 2, 3, and 5 were not specifically assessed with respect to changes in body weight (Ex 3). There is no evidence that smaller peptides of SEQ ID NOs: 1, 2, 3, and 5 contribute to changes in body weight (outside of the larger peptides of SEQ ID NOs:7 and 8).
There is no guidance as to the number of samples/animals assessed. Thus, the statistical error and statistical relevance are unclear.
The specification does not enable any person skilled in the art to which it pertains (i.e. obesity treatment) to make and/or use the invention commensurate in scope with the claims. There is a lack of adequate guidance from the specification or prior art with regard to the instant claimed peptide/amino acid sequence(s) and an actual method of treating obesity. Applicants fail to provide the guidance and information required to ascertain which particular peptide/amino acid sequence(s) will be effective for treating obesity without resorting to undue experimentation. Applicant's limited disclosure is noted but is not sufficient to justify claiming a method of treating obesity in a subject in need of with instant claimed peptide/amino acid sequence(s).
(8) The quantity of experimentation necessary:
Considering the state of prior arts and the disclosure in instant specification, one of ordinary skill in the art would be burdened with undue experimentation to treat obesity with instantly claimed peptide/amino acid sequence(s).
Claim Rejections - 35 USC § 102
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.
Claim(s) 12 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (KR20180107368 – previously cited).
Kim discloses a pharmaceutical composition containing ATPase inhibitor factor 1 (ATPIF1) as an active ingredient and methods for treating obesity, diabetes or diabetic complications (e.g. abstract, paras [0001]-[0005], [0008]-[0012], [0025]-[0027], [0077]-[0078], [0088]-[0089]; claims 1 and 6). Kim teaches a pharmaceutical composition containing ATPase inhibitor factor 1 (ATPIF1) as an active ingredient (e.g., paras [0074]-[0076]). Diabetes complications are one or more diseases selected from the group consisting of diabetic nephropathy, diabetic retinopathy, hyperlipidemia, and fatty liver (claim 4). The ATPIF1 sequence (SEQ ID NO:1) of Kim comprises instant SEQ ID NO:5 (at residues 36-47). Thus, SEQ ID NO:1 of Kim (ATPIF1 protein sequence) has 100% identity with instant SEQ ID NO:5. Accordingly, the limitations of claim 12 are satisfied.
Regarding claim 16, Kim discloses that ATPIF1 increases the expression of uncoupling protein 1 (UCP1) (e.g. paras. [0015], [0074]-[0075], [0135], Fig 7, Ex 7).
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). See M.P.E.P. § 2112.02.
Kim discloses teach administering ATPIF1 to treat obesity and diabetes, and that ATPIF1 increases expression of UCP1. While Kim do not teach the claimed effects of activation of thermogenesis or energy homeostasis in adipose tissue, they do perform the same steps of administering ATPIF1 to the claimed patient population (obese patients). Because the method steps of administering ATPIF1 to treat obesity and increasing expression of UCP1 are the same, Kim inherently teach the same effects of activation of thermogenesis or energy homeostasis in adipose tissue as in the current application. Kim therefore anticipates claim 16.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 12 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of copending Application No. 18258578 (hereinafter referred to as “the ‘578 application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 12, claim 1 of the ‘578 application recites a peptide consisting of an amino acid sequence represented by SEQ ID NO:2. Amino acid positions 36-47 of SEQ ID NO:2 of 100% identity with instant SEQ ID NO:5. Thus, SEQ ID NO:2 of the ‘578 application claims encompasses instant SEQ ID NO:5. claim 2 of the ‘578 application recites a method for treating obesity, comprising administering a pharmaceutical composition comprising a peptide of SEQ ID NO:2 is an active ingredient to an individual in need of treatment. Regarding claim 16, claim 6 of the ‘578 application recites wherein the pharmaceutical composition increases the expression of an uncoupling protein 1 gene, which activates thermogenesis and energy homeostasis and adipose tissue.
Conclusion
No claims are allowed.
Claims 12-20 are pending. Claims 13-15 and 17-20 are withdrawn.
Claims 12 and 16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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/KRISTINA M HELLMAN/Examiner, Art Unit 1654
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