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 .
Status of claims
Claims 1-15 as amended on 6/17/2025 are pending.
Claims 12-15 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/25/2024.
Claims 1-11 as amended on 6/17/2024 are under examination in the instant office action.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-11 as amended remain/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,127,338 (Hag et al), US 7,326,404 (Vuksan), Kim (Endocrinology, Diabetes and Metabolism, September 2014; DOI: 10.1530/EDM-14-0063; pages 1-4), Ma et al (Phytochemistry, 2015, 114, pages 109-113), Li et al (J Food Sci., 2017, 82 (10), pages 2487-2494), US 6,884,421 (Salimath et al), US 10,293,013 (Hariharan et al), Yoshinari et al (Nutrients, 2012, 4, pages 1518-1526), Cai et al (Med Chem., 2015, 11 (4), pages 383-390), Men Fenglin et al (IDS reference; Journal of Capital Normal University (Natural Science Edition), 2015, 36 (20), pages 39-42), US 8,747,917 (Kim et al), Kim et al (Nutrition Research and Practice, 2013, 7(3), pages 166-171) and US 10,632,136 (Cheng et al).
The cited US 6,127,338 (Hag et al) discloses a composition for oral administration for treating diabetes, wherein the composition comprises a lyophilized powder of peptides extracted from bitter melon or Momordica charantia; see abstract and example 1). (Notes: Common name of Momordica charantia is bitter melon; see par. 0006 of instant published application US 2022/0370541). The cited document US 6,127,338 (Hag et al) teaches that bitter melon peptide preparation is obtained by maceration of raw material of Momordica charantia in water and buffer, mixing, separating, centrifugation, filtration, concertation, freeze-drying (col. 4-5). The MW of peptides are about 10kDA and less, and they are comparable to insulin MW (col. 3, lines 49-51 and col.4, lines 35-37). The cited document US 6,127,338 (Hag et al) teaches that amount of active ingredient in the pharmaceutical composition is selected in view of specific administration and may be empirically determined by those of skill in the art (col. 7, lines 29-33).
The cited US 6,127,338 (Hag et al) explicitly recognizes anti-diabetic effect of bitter melon (Momordica charantia). But it is silent about incorporation of other plant- derived ingredients effective for treatment of diabetes that are recited in the pending claim 1.
However, all claim-recited ingredients have been known and used for treatment of diabetes alone or in combinations as discussed below.
US 7,326,404 (Vuksan) discloses an oral medicine comprising Panax quinquefolius (American ginseng) and konjac glucomannan for treating diabetes (see abstract).
The reference by Kim (Endocrinology, Diabetes and Metabolism, September 2014; DOI: 10.1530/EDM-14-0063; pages 1-4) discloses a composition with Astragalus membranaceus extract for treating diabetes (see abstract).
The reference by Ma et al (Phytochemistry, 2015, 114, pages 109-113) discloses a composition with Ganoderma lucidum for treating diabetes (see abstract).
The reference by Li et al (J Food Sci., 2017, 82 (10), pages 2487-2494) discloses a composition with Dioscorea opposita for treating diabetes (see abstract).
US 6,884,421 (Salimath et al) discloses a composition with wheat bran for treating diabetes (see abstract).
US 10,293,013 (Hariharan et al) discloses a composition with Psidium guajava for treating diabetes (see abstract; see col. 5, lines 7-9).
The reference by Yoshinari et al (Nutrients, 2012, 4, pages 1518-1526) discloses a composition with onion extract for treating diabetes (see abstract).
The reference by Cai et al (Med Chem., 2015, 11 (4), pages 383-390) discloses a composition with Lycium barbarum for treating diabetes (see abstract).
The IDS reference by Men Fenglin et al (Journal of Capital Normal University (Natural Science Edition), 2015, 36 (20), pages 39-42) discloses a composition with Gynura procumbens for treating diabetes (see English abstract on pages 41- 42).
US 8,747,917 (Kim et al) discloses a composition with coix seed or Coix lachhryma-jobi for treating diabetes (see abstract, see col. 4, lines 55-58).
The reference by Kim et al (Nutrition Research and Practice, 2013, 7(3), pages 166-171) discloses a composition with lotus leaf for treating diabetes (see abstract).
US 10,632,136 (Cheng et al) discloses a composition with xylo-oligosaccharide for treating diabetes (see abstract; col. 1, lines 49-51).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was file to add to the anti-diabetic bitter melon peptide-containing preparation of US 6,127,338 (Hag et al) additional plant derived materials including Panax quinquefolius, Astragalus membranaceus, Ganoderma lucidum, Dioscorea opposite, wheat bran, Psidium guajava, onion extract, Lycium barbarum, Gynura procumbens, coix seed, konjac glucomannan, lotus leaf and xylo-oligosaccharide with a reasonable expectation of success in providing a composition treating diabetes because all ingredients have been known for anti-diabetic effects and they have known, suggested and used for treatment of diabetes alone or in combinations. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed on 6/17/2025 have been fully considered but they are not all found persuasive.
The rejection of claims under 35 U.S.C. 101 has been withdrawn because the claimed product is provided in a freeze-dried form as encompassed by the inserted limitation drawn to a product-by-method-of-making steps.
With regard to claim rejection under 35 USC § 103 Applicants’ arguments are solely based on the disclosure by US 6,127,338 (Hag et al). Applicants argue that the cited bitter melon peptides (BMP) are extracted from bitter melon (Momordica charantia) by physical treatment and not by enzymatic treatment as encompassed by the limitations drawn to a product-by-method-of-making steps; and thus, the claimed peptides have different and/or low MW.
This argument is not found persuasive because product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. MPEP 2113.
In the instant case, pending claim 1 is not limited by MW of BMP; and the claim 5 (S16) encompasses MW of less than about 10-20 kDA. The US 6,127,338 (Hag et al) discloses that MW of peptides (BMP) extracted from bitter melon (Momordica charantia) by physical treatment have MW of about 10kDA and less, and they are comparable to insulin MW (col. 3, lines 49-51 and col. 4, lines 35-37). Thus, the ranges of peptide MWs are overlapping. Therefore, the final structures of products as claimed and as disclosed are the same or substantially similar regardless methods of making.
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Vera Afremova
September 15, 2025
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653