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. The amendment filed July 5, 2026 has been received and 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 Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.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 1, 3-7, 9, 10, 13-21, 23, 26, and 28-33 are pending.
Election/Restrictions
4. In the reply filed on January 16, 2026, applicant elected Group I, now claims 1, 3-7, 9, 10, 13, 14, 18 and 19, gum arabic for species A, 6-gingerol for species B, and quillaja for species C with traverse. Please note that claim 15 has been amended to read on a method of administering the composition of claim 1 and would have been grouped with Group IV if originally presented in this manner.
5. Claims 15-17, 20, 21, 23, 26, and 28-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
6. Claims 1, 3-7, 9, 10, 13, 14, 18 and 19 are examined on the merits in regards to the elected species.
Claim Rejections - 35 USC § 101
7. Claims 1, 3-7, 9, 10, 13, 14, 18 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more for the reasons set forth in the previous Office action.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues that the amendments to the claims overcomes the rejection because “The combination of components in these amounts is not a product of nature or a natural product.” However, as discussed in the previous Office action, each of the claimed ingredients is a naturally occurring product. There is no evidence that combining the claimed ingredients in the claimed concentrations produces a product with a markedly distinct characteristic in comparison with the closest occurring natural counterpart. Thus, the claims are not considered to be directed to patent eligible subject matter. Therefore, the rejection is still considered valid for the reasons of record.
Claim Rejections - 35 USC § 103
8. Claim(s) 1, 3-7, 9, 10, 13, 14, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2008/0160116) in view of Schrader (US 2012/0322750).
Li teaches a gingerol composition contained in oleoresin extracted from ginger (Zingiber officinale). The reference teaches that the oleoresin is combined with gum arabic. The reference teaches that the gingerol component contains 6-gingerol and saponins (see paragraphs 123, 172, 177, 179, 181, 198). In addition, the reference teaches that the oleoresin is extracted using CO2 extraction. Furthermore, the reference teaches that the gingerols are present in an amount of at least 5% or 10%. The reference also teaches that the composition can be mixed with carriers such as maltodextrin and formed into particles of various sizes including 150 to 700 microns. The reference teaches that the composition is formulated into oral and transdermal formulations suitable for humans and animals (see paragraphs 2, 7-13, 44, 114-116, 119-120, 132-137).
The reference does not specifically teach including quillaja saponin in the composition. However, Li does teach that the gingerol ingredients are insoluble in water (see paragraphs 61-67).
Schrader teaches using a combination of gum arabic and quillaja saponin to improve the water solubility of water insoluble ingredients in order to better formulate the insoluble ingredients for pharmaceutical, cosmetic, and food uses. Schrader teaches that the quillaja saponin is obtained from an extract from quillaja containing 50% saponins (see abstract, paragraphs 1, 20-23, and Example 1). Thus, it was well known in the art that gingerols are water insoluble and that a combination of gum arabic and quillaja saponin was highly effective at formulating insoluble ingredients to allow for their dispersion in water. Based on this known use of gum arabic and quillaja saponin, an artisan of ordinary skill would have reasonably expected that the gingerol composition taught by Li could be improved by the addition of gum arabic and quillaja saponin to achieve a water soluble product containing the gingerols. This reasonable expectation of success would have motivated the artisan to modify Li to include the addition of gum arabic and quillaja saponin to the gingerols. Thus, applicant’s claimed combination is considered to be an obvious modification of what was known in the art at the time of the invention.
The references do not specifically teach adding the ingredients together in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Schrader teaches that the concentration of both the saponin ingredient and the gum arabic can be varied (see paragraph 29). Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
9. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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