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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 07/10/2024.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 06/17/2026 is acknowledged. The traversal is on the ground(s) that the applicant believes the special technical feature is narrower in scope than what was described in the restriction. This is not found persuasive because although the applicant recites specific extraction methods for the spent carotenoid of capsicum annum, Metha teaches the same extraction method as will be evident from the rejection below. Additionally, the method of making the composition is a Group (II) being restricted and not merely the special technical feature. The particular amounts of the compounds found within an extract are optimizable as this is commonly done in the art and this is routine.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/17/2026.
Claims 1-10 are being examined on the merits.
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 1-10 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. Claim 1 recites “at least in part, from material spent from purifying carotenoids” and it is not clear what this limitation is requiring. Does it mean the starting material has to go through an extraction process first or the material has been used in some way before extraction? If so, what has to happen to the material before the extraction takes place? There is no definition or example of what spent material is and so this limitation is confusing.
For compact prosecution the limitation will be interpreted as meaning that the material has gone through an extraction process already.
Claim Rejections - 35 USC § 101
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 1-10 are rejected under 35 U.S.C. 101 because the claimed composition is directed to a product of nature without significantly more. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising plant components the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products a capsicum annum extract composition the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within plants. Plant extracts are made by partitioning the starting plant material into separate compositions based upon some property such as solubility in a solvent, with the soluble compounds being in one composition and the insoluble being in another composition, which compositions are then generally separated into the solvent extract of that plant versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the plant material. Plant extracts are purified by removing unwanted plant material from the remaining solvents. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the plant in an unseparated form, even when purified, which is chemically identical to the extracted compounds. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the plants they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the applicant is only claiming the compounds found with the plant in particular amounts and nothing more.
Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)). The only other elements to consider are the intended uses and outcomes for the extract. The applicant claims wherein the composition aids in melanin inhibition, removing and preventing dandruff, aids in hair growth, increases levels of AQP-3 mRNAs, increases tear break up time, increases tear production volume, and reduces tear osmolarity when administered orally, decreases defects and abrasions in the corneal epithelium and reduces damage to ocular surfaces by reducing oxidative stress when administered orally, wherein the composition reduces degradation and apoptotic cell death in the cornea by reducing serum MMP-2& MMP-9 levels when administered orally and wherein the composition reduces the expression of the IL-2, IL-6, and MMP-9 genes and down regulates the expression of the TNF-α and IL-4 genes. These are all intended uses for the extract as the extract would have to be administered in some way to exert any specific effect. These do not amount significantly more than the recited judicial exceptions.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Claim Rejections - 35 USC § 103
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.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sevanti Mehta (WO2020112524A1).
Regarding claim 1, Mehta teaches a capsicum annum extract composition includes capsanthin in the range from 50% to 80%, zeaxanthin in the range from 5% to 15%, and cryptoxanthin in the range from 1% to 5%. A method for manufacturing a composition includes extracting carotenoids from capsicum annum fruits using a solvent or solvents, enriching the carotenoids using super critical fluid extraction, hydrolyzing the carotenoids, and purifying the carotenoids using counter current extractions (see abstract).
Mehta teaches “for example, 250 kilograms of deseeded, flaked capsicum annum fruits with ASTA color value from 2000 to 2400 unite may be placed in a 2000 titer capacity reactor with an agitator. A volume of methanol (lOOOL) may be added and the mixture may be stirred for 6 hours at 60°C. The methanol layer may be filtered and collected. This methanol extraction may be repeated three times for efficiency purposes”. With the broadest reasonable interpretation this methanol extraction being repeated three times for efficiency purposes would meet the limitation of a spent material undergoing more than one extraction.
Regarding claim 2, Mehta teaches the capsanthin to comprise of trans-capsanthin (3R,3’S,5’R)-3,3’-Dihydroxy-β,κ-caroten-6’-one), the zeaxanthin comprises trans-zeaxanthin (3R, 3′R‐β,β‐carotene‐3,3′‐diol ), and the cryptoxanthin comprises beta-cryptoxanthin (3R,6'R)-4',5'-Didehydro-5',6'-dihydro-β,β-caroten-3-ol (see 0027).
Regarding claims 3-10, pertaining to the activities being claimed, these are all intended uses of the extract which would have to be administered in some way in order to exert the effects being claimed. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
Mehta does not specifically teach that the extract is from material spent from purifying carotenoids or teach the specific amounts of the compounds being in the particular ranges. However Mehta teaches the same extraction techniques which is countercurrent extraction of carotenoids of Capsicum annum and adjusting the particular components in the extract is common and conventionally done in the art. Reducing or diluting the number of compounds within the extract to meet the instantly claimed ranges would have been obvious for reasons of being able to create more of the Capsicum annum extract composition. 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).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical 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.
It would have been obvious to use material spent from purifying carotenoids using countercurrent extraction because this would mean, with the broadest reasonable interpretation, to extract the components more than once as to make sure all the compounds have been extracted and nothing is left behind. Doing so would have been obvious and would most likely end with the reduced number of components being in the ranges of :1%-1.5% zeaxanthin in the range from 0.5% to 1%; and cryptoxanthin in the range from 0.1% to 0.5%, as disclosed and Mehta teaches repeating the extraction process three times. Reducing the amount of carotenoids is well within the purview of any skilled artisan especially given that the reduced number does not appear to be a critical component of the invention.
There would have been a reasonable expectation of success in arriving at the instant invention given the relied upon art because the art teaches of capsicum annum extracts containing the instantly claimed components and modifying the amount of those components distinguish the applicant’s invention over the prior art.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JACOB A BOECKELMANExaminer, Art Unit 1655 /ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
Prosecution Insights