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 .
Claims 1-5, 8, 9 and 22-24 are presented for examination.
Claims 11-18 and 20-21 are withdrawn from examination.
The amendments and remarks filed on 01/30/2026 have been received and entered.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/30/2026 has been entered.
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.
Claim 23 is 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 23 is indefinite as to the Phrase “said extract is supercritical”. The phrase is a relative term and does not set forth the metes and bounds of the claimed invention.
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 1-5, 8, 9 and 22- 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed
toa judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without
significantly more.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the
four categories of invention that Congress deemed to be the appropriate subject matter of a patent:
processes, machines, manufactures and compositions of matter. The latter three categories define
"things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series
of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term 'process' means process, art, or
method, and includes a new use of a known process, machine, manufacture, composition of matter, or
material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must
not be directed to a judicial exception unless the claim as a whole includes additional limitations
amounting to significantly more than the exception. The judicial exceptions (also called "judicially
recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be
outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas,
laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. V. CLS Bank
Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology V. Myriad
Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed
information on the judicial exceptions.
Analysis of the flowchart
Step 1, is the claim to a process, machine, manufacture or composition of matter?
Yes. The claim is drawn to a composition of matter.
Step 2A. Prong one: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Yes, the claims are drawn to a composition in a form selected from the group consisting of: a soft
gel capsule, a beverage, a shot, a gummy, and a powder, comprising a total carotenoid content
ranging between 1 and 30% by weight, the composition comprising: phytoene in the amount of
55-65% (w/w) of the total carotenoids in said composition, phytofluene in the amount of 10-20%
(w/w) of the total carotenoids in said composition, zeta carotene in the amount of 15-25% (w/w)
of the total carotenoids in said composition, tocopherol in the amount of 10-30% (w/w) of the
total carotenoids in said composition, lycopene in the amount of less than 5% (w/w) of the total
carotenoids in said composition, and an acceptable carrier, and wherein said composition is a
tomato extract.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than
the judicial exception?
No. The claim(s) of 1-5, 8, 9 and 22-24 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, as there is no indication that extraction has caused the component of an natural compound that comprises the claimed compositions to have any
characteristics that are different from the naturally occurring component of an natural compound.
Claims 1-5, 8, 9, 22 and 23 -24 require a carrier being present in the composition. However, there is no
indication that the carrier claimed in the compositions result in a markedly different characteristic for
the composition as compared to the components that occur in the nature.
For the reasons described above, the claimed compositions are not markedly different from their closest
naturally occurring counterparts and thus are product of nature judicial exceptions. The claims do not
include additional elements that are sufficient to amount to significantly more than the judicial
exception because the claims do not recite any additional elements beyond the claimed compositions
themselves. Also, this is a product claim and since there are no claimed method steps, there are no
additional elements that apply, rely on, or use the judicial exception in a manner that imposes a
meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something
significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
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.
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.
Claim(s) 1-5, 8-9, 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Zelkha et al. (US 20170354704) in view of Zelkha et al. (US 20100233256).
Zelkha teaches a composition comprising lycopene, one or both of phytoene and phytofluene, and
phytosterols, wherein the concentration of lycopene is in the range of 0.3%-2% (w/w) and wherein the
weight ratio of said lycopene to one or both of phytoene and phytofluene is in the range of 1:1 to 1:2.5.
See The abstract. Zelkha teaches that in the composition the concentration of phytosterol is at least
2%. See Para [0007]. Zelkha teaches the concentration of vitamin E, being at least 2%. See Para [0008].
The concentration of one or both of phytoene and phytofluene at a total concentration of between
0.25% and 3%. See Para [0009]. Zelkha teaches that the composition may also comprise one or more
additional pharmacologically-active components including, but not limited to, additional carotenoids,
vitamin E and polyphenols, such as carnosic acid. Preferred examples of additional carotenoids include
phytoene, phytofluene, lutein, zeaxanthin, beta-carotene, astaxanthin. Other carotenoids, however,
may also be present in the composition. See Para [0013]. The use of the composition in the field of
food is taught in Para [0001]. Zelkha ('704) teaches The present invention is primarily directed to a
reduced-lycopene tomato-derived composition, comprising lycopene and one or both of phytoene and
phytofluene, wherein the concentration of said lycopene is in the range of 0.3% to 2% (weight/weight),
and wherein the weight ratio of said lycopene to one or both of phytoene and phytofluene is in the
range of 1:1 to 1:2.5. In addition, said composition further comprises phytosterols. See Para [0006].
Zelkha ('704) makes clear that the composition is a tomato extract. Zelkha ('704) teaches that the
compositions can be formulated in any solid or liquid dosage form known in the art, including but not
limited to, tablet, caplet, capsule, microcapsule, pellet, pill, powder, syrup, gel, slurry, granule,
suspension, dispersion, emulsion, liquid, solution, dragee, bead and beadlet. See Para [0056]. Zelkha
('704) does not specifically teach the use of zeta carotene. Zelkha ('256) teaches a composition of
tomato extract, which the lycopene is provided in the composition as a natural compound. In some
embodiments, lycopene is provided as an extract, example, as an extract of tomato oleoresin, such as
Lyc-O-Mato.RTM. In some embodiments, the oleoresin further comprises at least one agent selected
from the group consisting of tocopherols, beta-carotene, phytoene, phytofluene, phytosterols, tomato
oil, and phospholipids. See para [0019] and [0030]. Zelkha ('256) teaches that the composition further
comprises at least one carotenoid other than lycopene and lutein. Carotenoids useful in the
compositions can be naturally occurring carotenoids found in, for example, tomato products (e.g.,
tomatoes, tomato sauce, ketchup and the like). See Para [0040}. Zelkha ('256) teaches that examples of carotenoids include but are not limited to alpha.-carotene, beta.-carotene, zeta-carotene, alpha.-
cryptoxanthin, beta.-cryptoxanthin, phytoene, phytofluene, zeaxanthin, astaxanthin, canthaxanthin, and
combinations thereof. See Para [0041]. Zelkha ('256) teaches that lycopene and lutein, alone or in
combination with other carotenoids or adjuvants as herein described, are added to functional foods,
dietary supplements or drinks in order to lower blood pressure. The compositions can also be dispensed
as dry formulation, for example as powder, granules, microcapsules or capsules, for reconstitution as a
liquid, dispersion, emulsion or suspension. See Para [0023]. The addition of the composition to food as
claimed in claims 22 and 23 is taught by Zelkha (256). The selection of food is considered to be within
the skill of the artisan.
It would have been obvious to a person skilled in the art to add zeta carotene to the composition of
Zelkha (704), motivated by the teaching of Zelkha ('256), which teaches zeta carotene is one of carotene
used in a composition having lycopene, phytoene, phytofluene, tocopherol and phytosterols.
The determination of optimum proportions are amounts are considered to be within the skill of artisan
in the absence of evidence to the contrary. Applicant's attention is drawn to In re Aller, 220 F.2d 454,
456, 105 USPQ 233, 235 (CCPA 1955), where the court states "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."
Response to Arguments
Applicant's arguments regarding 101 rejection have been noted. Applicant in his response argues that “The synergistic effect arises from the specific combination and concentration of components as claimed, which does not exist in nature. Naturally-occurring tomatoes do not contain total carotenoids at 1-30% (w/w), nor do they contain the specific ratios of phytoene, phytofluene, and zeta carotene recited in claim 1. The synergistic MPO inhibition is a functional characteristic of the human-engineered composition with its dramatically elevated carotenoid content, not an inherent property of naturally occurring tomatoes”. It is the examiner’s position that claims are drawn to a “tomato extract”. Therefore, the extracted component from a tomato already exit in tomato. Furthermore, applicant might be using a process for extraction of the products from tomato, which give applicant a different concentrations of each component. However, the claims are not drawn to a process of obtaining the ingredients from tomato. The same arguments goes for obviousness rejection. The difference in the claimed concentration and ingredients being in the tomato relates to the process for extraction of the components and not the composition. Since the composition already exists in tomato. The inhibition of myeloperoxidase and reduced toxicity to fibroblasts is related to a method of use and a not composition per se. furthermore, the composition of the prior art is expected to have the same property in the absence of evidence to the contrary.
In conclusion applicant extracts components from tomato. Therefore, all such components and their concentrations are already exist in the tomato. The synergistic effect is the inherent property of components existed in tomato. Applicant’s obtaining different concentrations of each component from tomato relates to the process of obtaining such ingredients and not a composition, which already exists in tomato. Furthermore, the relied upon references teach all the claimed components being present in tomato.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617