DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 1/27/2026 wherein claims 1-4, 12-14 and 19 have been amended and claims 26-28 have been cancelled and claim 29 has been added.
Claims 1-4, 12-16, 19 and 29 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s arguments filed 1/27/2026 regarding the rejection of claims 1-4, 12-16 and 19 made by the Examiner under 35 USC 101 have been fully considered and found persuasive. This rejection has been withdrawn.
Applicant’s amendment cancelling claims 26-28 filed 12/20/2024 renders moot their rejection made under 35 USC 103 over Gow (US 2008/0193573). This rejection has been withdrawn.
Applicant’s arguments filed 1/27/2026 regarding the rejection of claims 1-4, 12-16 and 19 made by the Examiner under 35 USC 103 over Gow (US 2008/0193573) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 8/1/2024.
In regards to the 103 rejection, Applicant asserts the following:
B) The pending claims are distinguishable from the prior art which fails to describe the narrow weight ratios as claimed. The ranges described by Gow are so large that one would not identify a ratio of 3:6:1 as claimed. Moreover, this ratio has been found to result in the synergistic treatment of cancer.
In response to A, Applicant’s arguments are acknowledged but not considered persuasive.
Claim 1 is a composition which comprises high polar compounds (e.g. polysaccharides), medium polar compounds (e.g. curcumin) and non-polar compounds (e.g. ar-turmerone) in a ratio of about 3:6:1, respectively. Gow describes a composition which comprises 1) an essential oil fraction which comprises ar-turmerone in an amount of 0.001-100 mg, 2) a curcuminoid fraction comprising curcumin in an amount of 0.001-1000 mg, and 3) a polysaccharide fraction comprising numerous polysaccharides in an amount of 0.001-1000 mg (see [0005, 0158] and claim 10). Example 10 provides the following composition:
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the composition comprising 18 mg of the essential oil fraction (e.g. ar-turmerone), 90 mg of curcuminoid fraction (e.g. curcumin) and 30 mg polysaccharide fraction (e.g. polysaccharides) resulting in a ratio of polysaccharide: curcumin:at-tumreone fractions of 30:90:18 (1.7:5:1). Such a ratio is not all that different from the 3:6:1 ratio as claimed. Certainly, one of ordinary skill in the art would be capable of working with both the broad generic ranges and the narrower composition of Example 10 to arrive at other compositions capable of fighting disease. If such a manipulation was a ratio as claimed, then that would have been the product of ordinary skill and common sense rather than innovation.
Regarding the appeal to unexpected results, the Examiner is not persuaded as a) the basic extract composition is described by Gow, b) Gow teaches that the extract composition can be used in method of treating cancer and c) the claims are to a composition which are generally described by the prior art rather than a method of treating cancer. Although the record may establish evidence of secondary considerations which are indicia of nonobviousness, the record may also establish such a strong case of obviousness that the objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness. See MPEP 2145.
Rejections (maintained: claims 1-4, 12-16 and 19; new: claim 29)
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 1-4, 12-16, 19 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gow et al. (US 2008/0193573; of record).
Gow describes a composition containing curcuma species extracts.
The curcuma extract of Gow contains 1) an essential oil fraction which comprises turmerone, ar-turmerone, a-turmerone and/or b-turmerone in an amount of 0.001-100 mg, 2) a curcuminoid fraction comprising curcumin, demthoxycurcumin and/or bisdemethoxycurcumin in an amount of 0.001-1000 mg, 3) a turmerin fraction which contains a polypeptide protein in an amount of 0.001-100 mg and 4) polysaccharide fraction comprising numerous polysaccharides in an amount of 0.001-1000 mg (see [0005, 0158]). It is observed that the fractions of Gow include the species described by instant claims 1 and 12, e.g. polysaccharide, protein, curcumin, demethoxycurcumin, a-turmerone, etc.. Additionally, example 10 provides the following composition:
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, the composition of Example 10 comprising 18 mg of the essential oil fraction (e.g. ar-turmeron), 90 mg of curcuminoid fraction (e.g. curcumin) and 30 mg polysaccharide fraction (e.g. polysaccharides) resulting in a ratio of polysaccharide fraction (high polarity fraction): curcumin fraction (medium polarity fraction):ar-tumreone fraction (low polarity fraction) of 30:90:18 (1.7:5:1) (see instant claim 1). Such a ratio is considered very similar to the about 3:6:1 ratio as claimed. Certainly, one of ordinary skill in the art would be capable of working with both the broad generic ranges and the narrower composition of Example 10 to arrive at other extract compositions capable of fighting disease. If such a manipulation resulted in a ratio like that claimed, then that would have been the product of ordinary skill and common sense rather than innovation. It is also noted that the term ‘about’ encompasses value slightly above and below those identified which could potentially encompass the range of Gow’s Example 10.
Regarding claim 19, Gow suggests a composition comprising compounds described by the instant claims as being high polarity, medium polarity and non-polar and provides concentrations by which the compounds may be included. Thus, it would have been obvious to utilize and optimize the framework provided by Gow so as to produce a composition having the parameters, e.g. 11-15% high polarity polysaccharides, 41-44% medium polarity curcumin and 3-4% nonpolar ar-turmerone. See MPEP 2144.05(II)(A) which states that where 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
Example 9 and paragraph 0260-0261 disclose orally administering for treatment of cancers. These fractions contain curcuma, desmethoxycurcumin, turmerin fractions, and polysaccharide fractions (see [0260]) (see instant claim 16).
Excipients are included such as lactose (a pharmaceutically acceptable carrier) (see instant claim 12).
Regarding instant claim 29, this is a product-by-process limitation. However, Gow teaches that their extraction process involves multiple extraction processes (see [0124, 0170-0189]).
With regards to the requirements that the high polarity compounds are isolated from Curcuma longa using a high polarity solvent system having a dielectric constant greater than about 25 and a relative polarity value of less than about 0.6, the one or more medium polarity compounds are isolated from Curcuma longa using a medium system having a dielectric constant from about 5 to about 25 and relative polarity value of about 0.25 to about 0.6, and the limitation wherein the one or more non-polar compounds are isolated from Curcuma longa using a non-polar solvent system having a dielectric constant of less than about 5 and a relative polarity value of less than about 0.2 (see instant claim 3), these are product-by-process limitations (see instant claims 3, 4, 12-14 and 19). See MPEP 2113(I). The method by which the compounds are isolated is given little patentable weight because the result is a composition which comprises the same extract compounds as that taught by the prior art.
With regards to claim 12 which recites the composition is used for treating cancer or a pre-cancer, this is an intended use of the composition and is given little patentable weight as it does not materially limit the compositions’ structure but instead provides a potential means of use. See MPEP 2111.02(I).
The only difference between Gow and the instant claims is that Gow does not teach the specific combination of components as claimed in a single embodiment, or with sufficient specificity to be anticipatory. The specific combination of features claimed is disclosed within the teaching of Gow, but ‘such ‘picking and choosing’ within several variable does not necessarily give rise to anticipation. Where, as here, the reference does not provide any explicit motivation to select this specific combination of variables, anticipation cannot be found. However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” See MPEP 2141(I). Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within Gows's disclosure, to arrive at compositions comprising high polarity, medium polarity and non-polar compounds isolated from Curcuma longa in a ratio of about 3:6:1 by weight respectively with a reasonable expectation for success.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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