DETAILED ACTION
Claims 4-6, 11-13 and 20 are currently pending in the instant application and are rejected.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1 December 2025 has been entered.
Election/Restrictions
Applicant’s election without traverse of group II and the species of
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in the reply filed on 21 October 2024 has been previously acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species does not appear allowable. However, the search and examination has been extended to the compound of formula:
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wherein R is CnH(2n-1) and n is an entire number multiple of 5; wherein n is selected from 5, 10, 15, 20, 25 or 30 or a pharmaceutically acceptable salt, hydrate, solvate, N-oxide, stereoisomer, diastereoisomer, enantiomer, atropisomer, or polymorph thereof.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 29 November 2025 have been fully considered and entered into the instant application. Applicant’s amendment has overcome the objection of claim 12 for being a substantial duplicate as claim 20 has been amended to add n is 20. The 35 USC 112(d) rejection of claims 4 and 6 has been overcome as claim 20 has been amended to add n is 20.
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.
Claims 4-6, 11-13 and 20 are 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. The instant claim 20 states:
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The term, “comprising”, is open-ended and thus, does not exclude additional, unrecited elements, according to MPEP 2111.03(I). Subsequently, it is unclear to the Examiner whether the above mentioned compound “comprising” the formula includes additional components or groups and what these additional components or groups are. Accordingly, the metes and bounds of this claim is unclear, which rendered this claim indefinite.
The term “comprising” or forms of the term are considered open-ended language and therefore include additional subject matter that is not described in the instant specification and is not particularly pointed out or distinctly claimed. The identity of the additional atoms, components, or groups is unknown and how to determine the identity of the additional atoms, components, or groups is not pointed out or distinctly claimed.
The term “compound” contradicts the open language "comprising." A "compound" is defined as a substance whose molecules consist of unlike elements and whose constituents cannot be separated by physical means. Grant & Hackh's Chemical Dictionary (5th Ed. 1987) at page 148. By contrast, a composition is defined as elements or compounds forming a material or produced from it by analysis. Id. In other words, a compound is a molecule with more than one element, and a composition is a mixture of two or more compounds or molecules.
The transitional term "comprising" is synonymous with "including", "containing", and "characterized by". "Comprising" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”).
Thus, a contradiction arises within the use of a “compound” “comprising” because a "compound" requires a definite chemical formula, and the open-ended term "comprising" does not exclude unrecited elements. Furthermore, "comprising", used in conjunction with "compound" fails to articulate exactly what subject matter is excluded from the claimed scope, thereby rendering the scope of claims 4-6, 11-13 and 20 indefinite.
It is suggested that claim 20 be amended to read “…comprising administering to the subject a therapeutically effective amount of a compound of formula:
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wherein R is CnH(2n-1) and n is an entire number multiple of 5; wherein n is selected from 5, 10, 15, 20, 25 or 30 or a pharmaceutically acceptable salt, hydrate, solvate, N-oxide, stereoisomer, diastereoisomer, enantiomer, atropisomer, or polymorph thereof.”
Regarding claims 4-6 and 11-13 these claims are dependent of claim 20 and they fail to correct the indefiniteness issue of claim 20 rendering these claims indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 4, 6, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alam et al. Asian Pacific Journal of Tropical Medicine 2016; 9(4); 402-409.
Alam et al. provides that Clinacanthus nutans, also known as snake grass, has a broad range of biological properties such as anti-diabetic activities (abstract). Page 404 provides that it is used to treat diabetes by boiling 7-21 fresh leaves in two glasses of water until the water level comes to one glass and serve twice daily. Page 404 also provides that the leaves contain 132-hydroxy-(132-S)-phaeophytin a and 132-hydroxy-(132-R)-phaeophytin a. See page 405 which provides:
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which corresponds to the compound of formula:
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wherein R is CnH(2n-1) and n is an entire number multiple of 5; wherein n is 20 of instant claim 20, to the formula of instant claim 4 wherein R is
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, and to the formula
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of instant claim 6. Therefore, as the prior art provides the administration of: 7-21 fresh leaves in two glasses of water until the water level comes to one glass and serve twice daily (page 404) and provides that the leaves contain 132-hydroxy-(132-S)-phaeophytin a and 132-hydroxy-(132-R)-phaeophytin a, the prior art reference provides the treatment of diabetes with the administration of the compounds of instant claims 4, 6, and 20.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ December 9 2025
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600