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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 06/06/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/11/2025 is being considered by the examiner. The signed IDS form is attached with the instant office 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/26/2026 has been entered.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-3 and 9-10 are pending and being examined on the merits.
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.
Claims 1-3 and 9-10 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 1-3 recite “consists of 4'- dihydroxy-4-methoxydihydrochalcone (DMC 2)” and this appears to be new matter as this specific component was not previously described in the application before the amendment.
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 1-3 and 9-10 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.
Claims 1-3 recite “(DMC 2)” and this is confusing and indefinite for a few reasons. First it is unclear as to what this refers to. Is this an abbreviation for something in the claim, does this further limit the claim. Second, the applicant gives no specific definition of the term. Third the applicant references an example in the specifications that seems to describe the compound 2',4'- dihydroxy-4-methoxydihydrochalcone as (DMC-2) and so it is unclear how this is to be interpreted.
For expedited prosecution the term is being interpreted to mean 4'- dihydroxy-4-methoxydihydrochalcone because it appears the applicant is attempting to amend the claims to exclude the compound 2’-4'- dihydroxy-4-methoxydihydrochalcone, however since it isn’t defined in the specifications it should be removed from the claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong Wang et. al. (From IDS, filed on 06/11/2025, An Extract of Artmeisia dracunculus L. Enhances Insulin Receptor Signaling and Modulates Gene Expression in Skeletal Muscle in KKay Mice, J Nutr Biochem, 2010 May 5;22(1):71-78) and Ribnicky et. al. (US20070224301A1). This is a new rejection based on the amendments field on 01/26/2025.
Wang teaches “recent data has provided considerable information regarding the many bioactives that are found in Artemisia dracunculus L. (5, 11-14). As described, the total extract has been shown to decrease blood glucose in hyperglycemic animal models of diabetes and seems to enhance insulin sensitivity as a mode of action (9, 10). Furthermore, based on 3 of the diabetes related activities identified for the extract from in vitro studies and together with activity guided fractionation, 5 active compounds were isolated and recently identified (5, 12-14). The active compounds are comprised of chalcones, i.e., 2′,4′-dihydroxy-4-methoxydihydrochalcone, 2′,4-dihydroxy-4′-methoxydihydrochalcone and davidigenin, in addition to sakuranetin and 6-demethoxycapillarison (5, 12-14). Each of these compounds isolated from the extract of Artemisia dracunculus L. have significant in vitro effects, as demonstrated by activity guided fractionation, on processes contributing to carbohydrate metabolism including inhibiting aldose reductase enzyme, PTB-1B (protein tyrosine phosphatase 1B) activity and expression, or PEPCK overexpression (5, 12-14). Therefore, the activity of the total extract observed in vivo may result from the combined effects of at least 5 different compounds and at least 3 different activities. The precise nature of the interaction of all the bioactives at the whole body level has not yet been elucidated and technical issues in purifying enough of these phytochemicals continues to limit our testing of these compounds in the regulation of insulin action. However, these pre-clinical mechanisms did guide the experiments in the current study as to potential mechanisms operative in vivo” (see 4.0 Discussion).
Wang does not teach specifically that the activity may come from the compound 4′-dihydroxy-4-methoxydihydrochalcone, however teaches that it would be known to come from one of the 5 active known compounds which are known to lower blood glucose.
Rinbnicky discloses that “this invention comprises an extract of Artemisia dracunculus that can be used for the treatment and prevention of diabetes, diabetic complications, metabolic syndrome and other comorbidities that share the underlying commonality of insulin resistance. The invention includes the identity of six compounds from the extract that contribute to the activity of the extract by inhibiting protein tyrosine phosphatase-1B (PTP-1B) activity, phosphoenolpyruvate carboxykinase (PEPCK) gene expression or aldose reductase activity (ALR2). The compounds include 2′,4-dihydroxy-4′-methoxydihydrochalcone (see 0048 and 0064).
Ribnicky teaches wherein “it is desirable to provide purified compounds from a plant extract having specific activities to act synergistically or independently to provide an anti-diabetic effect. It is also desirable to provide compounds within the extract to effect insulin resistance and modulate enzymes involved in glucose metabolism to facilitate the control of diabetic and non-diabetic symptoms involved in a variety of disorders and diseases found in mammals” (see 0015).
“Also encompassed by the invention is the use of a pharmaceutical composition, wherein the use is selected from the group consisting of modulating glucose level in a mammal, modulating insulin resistance in a mammal, modulating insulin-stimulated glucose uptake in a mammal, modulating hepatic glucose level in a mammal, modulating the expression of PEPCK in a mammal, inhibiting PTP-1B activity and PTP-1B gene expression in a mammal, inhibiting ALR2 activity in a mammal, treating type 2 diabetes and hyperglycemia in a mammal” (see 0022).
Regarding claims 1-3, Ribnicky discloses “the methods of treatment of this invention, a typical treatment course may comprise administration of multiple doses on a daily basis of a composition comprising one or more compounds of the present invention in an amount effective to treat a disorder such as treating or ameliorating symptoms of diabetes, hyperglycemia, insulin resistance, modulating blood glucose levels, modulating hepatic glucose levels in a mammal, modulating PTP-1B activity, decreasing PEPCK, PEPCK expression, and modulating ALR2 activity in an individual” (see 0049).
Ribnicky discloses “administering an effective amount to a mammal of an extract from a plant such as Artemisia containing 2′,4′-dihydroxy-4-methoxydihydrochalcone. This would indicate a naturally derived components as claimed in claim 9. Additionally, Ribnicky discloses wherein the components are from ethanolic extracts of Artemisia dracunculus (see 0048) and so these components are the same as what is so broadly claimed. Ribnicky also discloses that the ethanolic extract of Artemisia dracunculus is indeed PM-5011 (see 0091).
Regarding claim 10, Ribnicky discloses oral administration of the composition (see 0051, 0053, 0055).
Ribnicky does not specifically disclose the compound is 4′-dihydroxy-4-methoxydihydrochalcone however this compound is strikingly similar in structure to 2’,4′-dihydroxy-4-methoxydihydrochalcone that persons having ordinary skill in the art would expect for the functions to be similar or indeed identical in nature. Ribnicky teaches that both compounds which are indeed similar in structure, come from the same ethanolic extract of PMI-5011 or Artemisia draunculus L. and so persons having ordinary skill in the art would expect the similar structured compounds to have similar functions.
The MPEP states “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c).(see MPEP 2144.09,I).
Therefore it would have been obvious to persons having ordinary skill in the art to use the compound 4′-dihydroxy-4-methoxydihydrochalcone for use in a method of reducing blood glucose because Ribnicky teaches that 2′,4′-dihydroxy-4-methoxydihydrochalcone is similar in structure and function to what the applicant is claiming and Wang teaches that 4′-dihydroxy-4-methoxydihydrochalcone is one of the 5 known active compounds for reducing blood glucose. Given this information it would have been prima facie obvious to use 4′-dihydroxy-4-methoxydihydrochalcone for a method of reducing blood glucose.
Response to Arguments
Applicant's arguments filed 01/26/2025 have been fully considered but they are not persuasive. The applicant argues that Ribnicky does not teach the compound 4'-dihydroxy- 4-methoxydihydrochalcone. Ribnicky teaches the similar structure 2',4'-dihydroxy-4-methoxydihydrochalcone and these are similar in structure. Therefore persons having ordinary skill in the art would expect them to have similar functions and this indeed seems to be the case as described and claimed by the instant applicant, because the applicant describes the structures to have the same effects.
As discussed in the MPEP: 2144.09, VII. “A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (affidavit evidence which showed that claimed triethylated compounds possessed anti-inflammatory activity whereas prior art trimethylated compounds did not was sufficient to overcome obviousness rejection based on the homologous relationship between the prior art and claimed compounds); In re Wiechert, 370 F.2d 927, 152 USPQ 247 (CCPA 1967) (a 7-fold improvement of activity over the prior art held sufficient to rebut prima facie obviousness based on close structural similarity)”.
Conclusion
No claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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