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
This application is a national stage application under 35 U.S.C. § 371 of
International Application No. PCT/IL2021/050524, filed 05/06/2021, which claims the priority benefit of Pro Application No. 63/021,188, filed 05/07/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on dates 08/07/2023, 08/08/2024, 06/09/2025, and 09/21/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant's election without traverse of Group I, claims 1-14 with a species election of zeta carotene, in the reply filed 09/21/2025 is acknowledged.
Claims 1-13 and 15-19 are pending. Claims 4-13 and 17 have been amended. Claims 15-19 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 4-7 and 9-10 have been withdrawn from further consideration as being drawn to a non-elected species of zeta-carotene. Claims 1-3, 8, and 11-14 are examined herein insofar as they read on the elected invention and species.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 cites that pro-lycopene is present in a concentration of 1-15% w/w in a composition wherein dependent claim 3 cites pro-lycopene is present in at least 40% w/w of the composition which is a broader range than the limitations of claim 1 and therefore fails to narrow the scope of the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The abstract of the disclosure is objected to because the phrase “such as” is indefinite as currently written. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-3, 8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Zelkha (WO 2012/137209 Al) in view of Levy (US PAT. 7,144,586 B2).
The instant claims are directed to a composition comprising 1-15% w/w pro-lycopene an additional 15-25% w/w carotenoid, 2-5.5% tocopherol and an acceptable carrier.
Zelkha et al. teach a pharmaceutical composition comprising lycopene in an amount of 6-15%, tocopherol in an amount of 1.5-4.0% w/w and beta-carotene in 0.2-1.0% w/w [0027]. Zelkha also discloses an embodiment wherein a pharmaceutical composition comprises a pharmaceutically acceptable carrier with 2-15% lycopene, tocopherol and beta-carotene [0034b]. Zelkha also discloses “While the most preferred embodiment of the present invention comprises lycopene as the carotene along with the phytosterol, applicants have found that it is also possible to use other carotenes, particularly those which have a similar structure to that of the lycopene. These thus include, in addition to lycopene, beta-carotene, lutein and astaxanthine. Applicants have thus found that these additional carotenes possess similar synergistic effects such as the anti-inflammatory effects discussed above. Thus, in the remainder of this disclosure, although emphasis is placed upon lycopene, it is understood that these additional carotenes, particularly including beta-carotene, lutein and astaxanthine, can be substituted for the lycopene emphasized herein.” [0061].
However, Zelkha et al. fail to specifically disclose zeta-carotene in a composition with a phytosterol of pro-lycopene.
Levy et al. teach a daily administration of a composition which comprises a phytoestrogen and carotenoid lycopene and zeta-carotene in an amount of 2-10 mg which are preferred because they do not exhibit substantial provitamin A activity (col. 6, lines 36-58)
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to recognize the teachings of Zelkha of a pharmaceutical composition comprising 2-15% lycopene, carotenoids and 2-15% tocopherol could be improved by using the compound of 2-10 mg zeta-carotene because of Levy’s disclosure that zeta-carotene and lycopene do not exhibit provitamin A activity. See MPEP 2144 and MPEP 2143.
A person of ordinary skill in the art would have been motivated to combine the compounds of prolycopene, zeta-carotene and tocopherol in a pharmaceutical composition because Zelkha disclosed other carotenes having similar structures to lycopene may be used as emphasized by Zelkha’s teachings, of which pro-lycopene and lycopene differ only in structural orientation and not structural connectivity. Levy’s teachings would have led a skilled artisan to select zeta-carotene due to its vitamin A activity in a composition with lycopene and would have given one of ordinary skill a reasonable expectation of success in combining lycopene, tocopherol and zeta-carotene compounds into a pharmaceutical composition would naturally be expected to exhibit similar pharmaceutical characteristics.
Conclusion
All claims are rejected, no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623