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 .
Claim Status
The amendment of 09/30/2025 has been entered. Claims 1-9, 19-24, and 35 are currently pending in this US patent application and were examined on their merits.
Withdrawn Rejections
All rejections of the claims set forth in the previous Office action are withdrawn in light of the amendment of 09/30/2025, which significantly amended the composition administered in the method of claim 1.
Claim Interpretation
The instant claims recite a method of administering a “Dunaliella algae preparation” comprising 9-cis beta-carotene and all-trans beta-carotene to various patients. Claims 8 and 23 further limit the species from the Dunaliella genus from which the preparation is obtained. The instant specification states that a “Dunaliella algae preparation” may be prepared by any known method and may be prepared as an extract, which the specification states is “any substance…extracted from Dunaliella, using enzymes, organic solvents, or hydrophilic solvents for extraction…The extracts may be…further processed (extracted) by any extraction method” (specification, page 36). As such, the broadest reasonable interpretation of the “Dunaliella algae preparation” as recited in claim 1 as amended on 09/30/2025 in light of the specification is any composition comprising 9-cis beta-carotene and all-trans beta-carotene because the structures of these chemical compounds are not influenced by the source from which they are obtained, and so any composition comprising 9-cis beta-carotene and all-trans beta-carotene can be interpreted as a “Dunaliella algae preparation” comprising 9-cis beta-carotene and all-trans beta-carotene based on the information provided in the instant specification, regardless of whether the prior art states that the beta-carotene isomers have been obtained from Dunaliella.
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 1-9, 19-24, and 35 are newly rejected as necessitated by amendment 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.
The terms “high” and “primarily” in claim 1 are relative terms that render the claim indefinite. The terms “high” and “primarily” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. How much beta-carotene must be present in a composition to qualify as a “high” level of beta-carotene, and how much of the composition must comprise the isomers 9-cis and all-trans for the beta-carotene to be “primarily” composed of these isomers? As such, one of ordinary skill in the art would be unable to determine the metes and bounds of the claimed invention, rendering it indefinite.
Because claims 2-9, 19-24, and 35 depend from claim 1 but do not provide any further clarification of the indefinite language therein, these claims are also indefinite. Therefore, claims 1-9, 19-24, and 35 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted the amounts of beta-carotene and of particular beta-carotene isomers in the composition administered to patients in the method of claim 1 to be any amount.
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.
Claims 1-9, 19-24, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by El-Baz et al., Int. J. Pharm. Bio. Sci. 7(4): B324-B331 (2016; cited on the IDS filed 09/28/2022), as evidenced by El-Baz et al., Asian J. Pharm. Clin. Res. 10(1): 134-139 (2017; cited on the IDS filed 09/28/2022; hereafter ‘El-Baz 2017’).
El-Baz teaches the oral administration of Dunaliella salina extract to Alzheimer’s Disease (AD) model rats (see entire document, including page B326, right column, paragraph 1; reads on claims 1-9, 19-24, and 35; see above under Claim Interpretation and under Claim Rejections – 35 USC 112 for the Examiner’s interpretation of the composition administered in the method of the instant claims; the Examiner further notes that claims 2-7, 19-22, and 35 recite only intended outcomes of performing the instantly claimed method, which do not receive patentable weight [see MPEP §§ 2111.02 and 2111.04]). The Dunaliella salina extract contains beta-carotene (page B329, left column, paragraph 1).
El-Baz 2017 teaches that Dunaliella salina contains an abundance of beta-carotene, including the 9-cis isomer (see entire document, including page 134, left column, paragraph 2, to right column, paragraph 1). As such, the Dunaliella salina extract containing beta-carotene taught by El-Baz would inherently contain 9-cis beta-carotene, as evidenced by El-Baz 2017.
Therefore, claims 1-9, 19-24, and 35 are anticipated by El-Baz, as evidenced by El-Baz 2017, and are rejected under 35 U.S.C. 102(a)(1).
Response to Arguments
Applicant has traversed the previous rejections of the claims under 35 U.S.C. §§ 112(a), 102(a)(1), and 103. However, these rejections have been withdrawn, as discussed above. As such, Applicant’s arguments are moot.
Conclusion
No claims are allowed.
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 Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 01/26/2026