DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 24, 2025 has been entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 21-24, 26-30, 32-35, 37, and 38 are pending.
4. In the reply filed on March 4, 2024, applicant elected Cichorium endivia var. latifolium and Lactuca sativa var. crispa for species A and pre-diabetes for species B without traverse.
5. Claims 24, 30, and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
6. Claims 21-23, 26-29, 32-34, and 37-38 are examined on the merits.
7. The declaration of Gerard Housey and Monica Balash, filed July 24, 2025, has been received and considered.
Claim Rejections - 35 USC § 103
8. Claim(s) 21-23, 26-29, 32-34, and 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Housey (US 2016/0022752).
This reference teaches a method for treating an IRS mediated disease or condition such as pre-diabetes or simulating IRS2-dependent signal transduction in a cell or subject by administering aqueous extracts from Cichorium endivia var. latifolium and Lactuca sativa var. crispa. The reference teaches that the extract provides at least 3.6 x 104 insulin equivalents units in 1 millimeter. In addition, the reference teaches that the method can include the administration of an antidiabetic agent, insulin, metformin, exenatide, vildagliptin, sitagliptin, a DPP4 inhibitor, meglitinide, exendin-4, liraglutide, or a GLP1 agonist. The reference also teaches that the composition can be formulated as a capsule, tablet, or powder form (see paragraphs 39, 103, 104, and claims 2, 4, 5, 12, and 13).
The reference teaches that the pharmaceutical composition can also contain chromium (see paragraph 102). However, the reference does not teach a specific embodiment with chromium in combination with the plant extracts. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these reference that these substances are useful for treating IRS related conditions, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating a single compositions to treat IRS related conditions. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
The reference teaches that the pharmaceutical composition or nutritional supplement is administered orally twice per day (see paragraphs [0082] and [0102]). However, the reference does not teach administration of the composition 30-60 minutes before meals. The reference does specifically suggest that the time of administration can be varied based on a variety of factors (see paragraph [0145]). Thus, it would have been obvious to one ordinary skill in the art to optimize the administration time to achieve optimal results. Therefore, this modification of administration time would have been obvious in view of the prior art.
Response to Arguments
Applicant's arguments filed July 24, 2025 have been fully considered but they are not persuasive. Applicant argues that the claimed invention is allowable over the prior art based on the unexpected results shown for the combination for two members of the Asteraceae family as set forth in the declaration of Gerard Housey and Monica Balash. However, the results shown in the declaration are not considered to render the claimed invention allowable over the prior art. The declaration compares the individual result for C. endivia var. latifolium with a combination of C. endivia var. latifolium, Lactuca sativa, and Artemisia dracunculus. However, A. dracunculus is not required in the current claims. The claims require extracts from two plants where C. endivia var. latifolium and L. sativa var. cripsa are the elected species. Thus, the results are not commensurate in scope with the elected invention or the current scope of the claims.
In addition, unexpected results must stem from a difference between the claimed invention and what is taught in the prior art. In this case, Housey specifically teaches a combination of C. endivia var. latifolium and L. sativa var. cripsa. Thus, any results shown for the combination of these two ingredients, unexpected or otherwise, would be inherent in the composition taught by the prior art.
Double Patenting
10. Claims 21-23, 26-29, 32-34, and 37-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,633,446 in view of Housey (US 2016/0022752) for the reasons set forth in the previous Office action.
Applicant has requested that this rejection be held in abeyance until allowable subject matter is indicated. The request is noted. The rejection is currently still considered valid at this time for the reasons set forth in the previous Office action.
11. Claims 21-23, 26-29, 32-34, and 37-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-17 of copending Application No. 18/664,874 (reference application) in view of Housey (US 2016/0022752)
The reference application claims treating IRS mediated diseases or conditions with a botanical extract with 1 x 104 insulin equivalent units in 1 milliliter where the extracts are from Cichorium endivia var. latifolium and Lactuca sativa var. crispa. Both sets of claims also teach administration of an antidiabetic agent, insulin, metformin, exenatide, vildagliptin, sitagliptin, a DPP4 inhibitor, meglitinide, exendin-4, liraglutide, or a GLP1 agonist.
The reference application claims do not recite the use of chromium. However, Housey teaches that chromium is useful in the treatment of IRS mediated disease (see paragraph 102). Thus, based on a known shared utility, the artisan would reasonably expect that chromium could be used with success in the method claimed by the reference application. This reasonable expectation of success would have motivated the artisan to modify the reference application’s claims to include the use of chromium.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. No claims are allowed.
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/SUSAN HOFFMAN/ Primary Examiner, Art Unit 1655
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