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.
The amendments and remarks filed on 06/03/2026 have been received and entered.
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.
Claim1-5, 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 and a gummy, 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 excipient selected from the group consisting of: calcium carbonate, calcium phosphate, starch, gelatin, vegetable oil, and polyethylene glycol, wherein the amounts of said zeta carotene and of any one of: said tocopherol, or phytoene in said composition synergistically inhibit myeloperoxidase (MPO) activity, wherein said composition is characterized by reduced toxicity to fibroblasts compared to a control tomato extract, and wherein said composition is a golden tomato extract composition
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 a natural compound that comprises the claimed compositions to have any characteristics that are different from the naturally occurring component of a natural compound. Claims 1-5, 8, 9, 22 and 23 -24 require specific excipients being present in the composition. However, there is no indication that the excipients 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 and certain carriers. 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
Claim(s) 1-5, 8-9 and 22-24 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 (‘704) 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 (‘704) teaches that in the composition the concentration of phytosterol is at least 2%. See Para [0007]. Zelkha (‘704) 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]. Zalkha (‘704) teaches that Other acceptable excipients and additives known to the person with skill in the art may be included in the compositions of the present invention, for example stabilizers, solubilizers, tonicity enhancing agents, buffer substances, preservatives, thickeners, complexing agents and other excipients, as well as additional therapeutic agents. See para [0061]. Zalkha (‘704) further teaches that a solubilizer can be for example, tyloxapol, fatty acid glycerol polyethylene glycol esters, fatty acid polyethylene glycol esters, polyethylene glycols, glycerol ethers or mixtures of those compounds. A specific example of a solubilizer is a polyoxyethylated castor oil for example, the commercial products Cremophor® or Cremophor® RH40. Another example of a solubilizer is tyloxapol. Such excipients read on the excipients applicant has claimed. See Para [0062]. The use of soft gel capsules is taught in 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 the type 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 have been noted. Applicant in his remarks argues that claim 1 is amended to add an acceptable excipient selected from the group consisting of calcium carbonate, calcium phosphate, starch, gelatin, vegetable oil, and polyethylene glycol, wherein the amounts of zeta carotene and of any one of tocopherol or phytoene synergistically inhibit myeloperoxidase (MPO) activity, wherein the composition is characterized by reduced toxicity to fibroblasts compared to a control tomato extract, and wherein the composition is a golden tomato extract composition. These features, taken together, establish markedly different characteristics from naturally occurring tomatoes. Further to the above, naturally occurring tomatoes, such as golden tomatoes, do not contain calcium carbonate, calcium phosphate, starch, gelatin, vegetable oil, or polyethylene glycol. The inclusion of these excipients in the claimed composition is therefore a structural difference that, by itself, distinguishes the claimed composition from any naturally occurring counterpart. These are non-naturally occurring formulation components that are essential for manufacturing the claimed dosage forms. Gelatin and vegetable oil are necessary structural components of soft gel capsules, providing the shell matrix and fill medium respectively. Starch and gelatin serve as gelling agents essential for gummy formulations. Calcium carbonate and calcium phosphate function as fillers and stabilizers in solid dosage forms. Polyethylene glycol serves as a plasticizer and solubilizer. These excipients transform the carotenoid extract into a manufactured pharmaceutical or nutraceutical product with specific physical form and delivery. It is the examiner’s position that the addition of excipients, such as a gel, starch, vegetable oil, calcium carbonate, calcium phosphate and polyethylene glycol would not create a markedly different composition than tomato extract. There is no evidence of record that such excipients would alter the chemical property or function of tomato extract. Placing the tomato extract in a soft gel capsule would not alter the chemical function or the property of the claimed tomato extract.
Applicant's arguments regarding the obviousness rejection have been noted. Applicant in his remarks alleges criticality to the toxicity of high concentrations of the prior art composition and the synergistic effect of the claimed combination in inhibiting myeloperoxidase activity. However, since Zelkha et al. (256, 704) teach all the components of the claimed invention, such synergistic activity is the expected property of Zelkha references in the absence of evidence to the contrary. Furthermore, the presented data are not commensurate in scope with the claimed language. The data uses one concentration of each ingredient. However, the claims are not draw to one concentration. Additionally, there is no comparison between the claimed composition and the composition taught by Zelkha references. And applicant has not shown the activity for each component and the activity for the combination of ingredients commensurate in scope with the claimed language. Since applicant alleges criticality to the specific proportions or amounts of ingredient in the claimed tomato extract in comparison with the prior art tomato extract, and the advantages of the claimed concentrations, there has to be a side-by-side comparison to the advantages of the claimed composition over the prior art composition commensurate in scope with the claimed language.
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 ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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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
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