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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Examiner have withdrawn 112 and 101 rejections in the previous office action of 03/20/2025.
Examiner have maintained 103 rejections with modification.
Examiner has made a new prior art rejection based on Applicants’ amendments. The Election of Species Requirement is maintained, for now, to give Applicants an opportunity to narrow “curcuminoids” to one or more species.
Therefore, the Markush search will not be extended to additional species in this Office Action.
New 112 and 102 rejection are made in this office action.
Claims 1-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I there being no allowable generic or linking claim. Election was made without traverse in the reply filed February 4th 2025.
Claims 16, 19-21, and 31 are examined.
Additional Markush searching will not be conducted in After Final. Please file RCE to resume Markush searching.
Current Status of 17/611,730
This Office Action is in response to the amended claims of 07/28/2025.
Claims 16 and 19 are currently amended; claim 20 is original; and claims 21 and 31 were previously presented.
Claims 16, 19-21, and 31 are examined in this office action.
Priority
Effected filing date is 5/17/2019 based on provisional application no. 62/849,373.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks of 07/28/2025. Examiner have reviewed these remarks and amendments.
Regarding 112 rejections, applicant amended claim 19 to depend on claim 16, thus overcoming 112(d) rejection. Therefore 112 rejection is withdrawn.
Regarding 101: Applicant amended claim 16 to include specific combination of curcuminoids and vitamin B6. Applicant amended claim 16 by incorporating the limitation “comprising a combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin” and vitamin B6. The combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin and vitamin B6 is found in turmeric a natural occurring plant (Singh, J. “Tumeric-Curcuma Longa Benefits, Uses, Dosage & Side Effects” Agust 1, 2016, page 1-33)) . Thus 101 rejection is maintained.
Regarding 102 rejection, applicant amended claim 16 by incorporating the limitation “comprising a combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin” and vitamin B6. Since Vincent et.al does not teach combination of curcuminoids, 102 rejection is withdrawn.
Regarding 103 rejection, applicant amended claim 16 by incorporating the limitation “comprising a combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin” and vitamin B6. The amended claim 16 does not distinguish the scope of independent claim 16 from the prior art of record.
Applicant further argued:
Office failed to provide motivation to combine the reference for reasonable expectation.
The composition has surprising results for colon tumor.
Examiner Response:
Examiner disagrees, the motivation for combining European commission, Chinese patent and Vincente et.al is stated in paragraph [36] of non-final office action of 03/20/2025.
Applicant claim of surprising results for treatment of colon tumor is not persuasive. Nothing in claims16 states the composition as a medicament for colon tumor. Also, nothing in the claims preclude the use of composition as intended for colon cancer.
Thus 103 rejection is maintained.
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).
Response to Amendment
Claim Rejections - 35 USC § 112
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 16, 19-21, and 31 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.
Examiner interprets “curcumin, demethoxycurcumin, and bisdemethoxycurcumin” each as separate “curcuminoids”. Claim 16 recites the limitation “comprising one or more curcuminoids comprising a combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin;and vitamin B6” which is contradictory because the limitation “one or more curcuminoids” is interpreted as one curcuminoids in the composition but the limitation “combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin” is interpreted as the composition must contain all the components curcumin, demethoxycurcumin, bisdemethoxycurcumin; and vitamin B6. The contradictory limitations “one or more curcuminoids” and the limitation “combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin” in claim 16 fails to particularly point out and distinctly claim the subject matter of claim 16, thus renders metes and bounds of claim 16 indefinite. Thus claim 16 is rejected for being indefinite.
Claims 19-21, and 31 are also rejected as indefinite because they refer back to claim 16 but do not remedy the bases for the rejection of claim 16.
Applicants should note that the various percentages of curcumin, demethoxycurcumin, and bisdemethoxycurcumin must all contribute to a total weight percentage of 100% as Applicants consider revision of their dependent claims. A claim permitting 100% of curcumin (claim 31) is indefinite since it lacks antecedent basis with/conflicts with an interpretation of claim 16 requiring a combination of the curcumin, demethoxycurcumin, and bisdemethoxycurcumin.
Claim Rejections - 35 USC § 101(maintained)
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16, 19-21, and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. The claim(s) recite(s) comprising one or more curcuminoids comprising a combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin;and vitamin B6 that are naturally occurring in turmeric (Singh, J. “Tumeric-Curcuma Longa Benefits, Uses, Dosage & Side Effects” August 1, 2016, page 1-33)). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these claims do not impose meaningful limitation on the judicial exception (JE) and hence are mere drafting efforts designed to monopolize the judicial exception. In addition, rejected claims comprising weight percentages and other concentrations constitute “well-understood, routine, conventional activity composition/formulation.
Step 1: Is the claim directed to a process, machine, manufacture, or composition of matter?
Yes, 16, 19-21, and 31 are directed to compositions.
Revised Step 2A:
Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes 16, 19-21, and 31 are directed to a composition comprising one or more curcuminoids comprising a combination of curcumin (Singh J. page 9), demethoxycurcumin, and bisdemethoxycurcumin (Singh J page 3);and vitamin B6 (Singh J, page 26) (therefore claims 16, 19-21, and 31 are naturally occurring/natural phenomenon. Any composition, such as the composition of claims 16, 19-21, and 31 are also viewed as being naturally occurring/natural phenomena.
Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No. By adding language such as “combination” and “% weight” the composition of claim 16, 19-21, and 31 Applicants are not imposing meaningful limitations on the JE and therefore, claims drawn to “combination” and “% weight” without more, are viewed as mere drafting efforts designed to monopolize the judicial exception. Moreover, the “combination” and “% weight” is interpreted as doing nothing more than “adding insignificant extra-solution activity to the judicial exception”. See MPEP 2106.05(g).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The “combination” and “% weight” limitation of the rejected claims does not amount to significantly more than the judicial exception for the reasons, above. Furthermore, it constitutes “well-understood, routine, conventional activity”. It is well-known in the art how to add any compound, including this naturally occurring one, into a composition/formulation and how to formulate specific weight percentage(s).
Therefore, claims 16-17, 19-21, and 31 are not patent eligible subject matter under 35 USC 101.
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).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 16 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neurofelix (DE 202018101715).
Neurofelix (DE 202018101715) published 06/21/2018) disclose composition comprising a combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin;and vitamin B6 (claim 5 and 7 also see exemplary embodiment 7), thus anticipating claim 16. Examiner interprets this teaching as including the instant claim 16 limitations: “A composition comprising one or more curcuminoids” and “a combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin;and vitamin B6”. Neurofelix further teaches vitamin B6 is also known as pyridoxine(paragraph [0008]) thus anticipating claim 21, which state vitamin B6 is in the form of pyridoxine.
Claim 16 is rejected under pre-AIA 35 U.S.C. 102(g) as being anticipated by Singh, J. (“Tumeric-Curcuma Longa Benefits, Uses, Dosage & Side Effects” August 1, 2016, page 1-33))
Singh J, discloses composition, comprising one or more curcuminoids comprising a combination of curcumin (page 9), demethoxycurcumin, and bisdemethoxycurcumin (page 3);and vitamin B6 (page 26) that are naturally occurring in turmeric thus anticipating claim 16.
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).
Claim Rejections - 35 USC § 103(maintained with modification)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16, 19-21 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over
Neurofelix (DE 202018101715) published 06/21/2018)
In view of
Chinese Patent (CN102462674)
In further view of
Anisel et.al. (PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS 7th edition, 1999)
1. Determining the scope and contents of the prior art.
Neurofelix (DE 202018101715) teaches claims 16 and 21.
Chinese Patent teaches the composition of curcumin and/or demethoxycurcumin, and/or bisdemethoxycurcumin can be used to prevent cardiovascular disorder (Abstract), partially teaching claims 19-20 and 31.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Neurofelix does not teach the concentration of curcumin and/or demethoxycurcumin, and/or bisdemethoxycurcumin to treat cardiovascular disorder.
Chinese Patent does not teach composition of curcuminoids with vitamin B6 or the concentration of curcumin and/or demethoxycurcumin, and/or bisdemethoxycurcumin to treat cardiovascular disorder.
Anisel et.al. does not teach composition of curcuminoids with vitamin B6 or the concentration of curcumin and/or demethoxycurcumin, and/or bisdemethoxycurcumin to treat cardiovascular disorder and the dosage of compound of formula (I) with dosage of vitamin B6 or the concentration of curcumin and/or demethoxycurcumin, and/or bisdemethoxycurcumin.
3. Resolving the level of ordinary skill in the pertinent art.
One ordinary skilled in the art is an artisan motivated to develop drug composition to better treat cardiovascular disorder.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person of ordinary skilled in the art would be motivated to develop composition for treatment of cardiovascular disease by combining the teaching of Neurofelix, a composition comprising combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin; and vitamin B6 (Neurofelix claims 5 and 7 also see exemplary embodiment 7) to treat cardiovascular disease because curcumin and/or demethoxycurcumin, and/or bisdemethoxycurcumin can be used to prevent cardiovascular disorder (Chinsee patent, Abstract). Addition of vitamin B6 to a composition comprising combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin(Chinsee patent, Abstract) is expected to have same or better effect in treating cardiovascular diseases, since combination vitamin B6 with composition comprising combination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin is already known in the art (Neurofelix claims 5 and 7 also see exemplary embodiment 7). Hence it would be prima facia obvious to combine the teaching of Neurofelix with the teaching of Chinese patent to obtain a composition which is expected to treat cardiovascular disease better or same as that of the composition disclosed in Neurofelix or Chinese patent, thus partially teaching all the element of claims 19-20 and 31.
Claims 19-20 and 31 are drawn to percentage curcumin and/or demethoxycurcumin, and/or bisdemethoxycurcumin. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. Furthermore, the Applicants’ claims or specification do not indicate these percentage curcumin and/or demethoxycurcumin, and/or bisdemethoxycurcumin to be critical. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, differences in percentage composition will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are 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) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
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).
Conclusion
No claims are allowed as written.
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.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625