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 .
DETAILED ACTION
Election/Restrictions
Claims 1-5, 7, 10, and 14-26 are pending.
Applicant’s election of Group III, claims 16-26, in the reply filed on 6/23/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 1-5, 7, 10, 14, and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 16-26 are examined on the merits.
Claim Objection
Claims 16-26 have been objected for depending upon withdrawn claims. Claim 16 recites “an effective amount of the elderberry extract according to claim 1” at lines 2-3. However, claim 1 has been withdrawn from consideration. Applicant is required to rewrite the claims in independent form. Claims 17-26 are objected as they are dependent upon claim 16.
Claim Rejections –35 USC § 112, 2nd
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 21 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 21 recites the following limitations in the claims, and there are insufficient antecedent basis for these limitations in the claims:
“said SARS-COV-2 variant” in claim 21, at line 1.
Therefore, the metes and bounds of claims are rendered vague and indefinite. The lack of clarity renders the claims very confusing and ambiguous since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16, and 18-26 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by D1 (DATABASE WPI Week 202010 Thomson Scientific, London, GB; AN 2020-A9377H
XP002806230, & CN 111 840 353 A (WUHU XUNENG AUTOMATION EQUIP DESIGN
CO) 30 October 2020 (2020-10-30) (see IDS filed on 5/20/24).
D1 teaches preparing an elderberry extract having preventive and therapeutic effects on virus such as H1N1, involving taking an elderberry extract, performing the first ultrafiltration membrane separation process on the elderberry extract to obtain the elderberry extract clear solution, and obtaining the elderberry clarified liquid (thus a liquid concentrate, thus claim 18 is met) (see Abstract) (IDS filed on 5/20/24). It is necessary that the claimed ultrafiltered elderberry extract would perform the claim designated function, which is to prevent the SARS-CoV2 infection (thus claim 16 is met, thus a healthy stage or a asymptomatic disease stage, thus claim 19 is met), including isolate Wuhand-Hu-1 or variant included in claim 21, thus claims 20 and 21 are met), and to stimulate increased expression of IL-6, TNF-α, and/or IL-23, in immune cells, and/or to inhibit a viral replication of said SARS-CoV-2 (thus claim 26 is met).
D1 teaches an elderberry extract with anthocyanins is 25% is obtained (thus claim 23 is met), where the anthocyanins are cyanidin-3-glucoside (thus claim 22 is met) as the standard product and cyanidin-3,5-diglucoside (see Abstract). D1 teaches the molecular weight of the ultrafiltration membrane with molecular weight I is 5000-20000 Daltons (thus claims 24 and 25 are met).
Therefore, the reference is deemed to anticipate the instant claim above.
Claim Rejections –35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 16-26 are rejected under 35 U.S.C. 103(a) as being unpatentable over D1 as applied to claims 16, and 18-26 above, and further in view of BORODUSKE et al (BORODUSKE et al, Wild Sambucus nigra L. from north-east edge of the species range: A valuable germplasm with inhibitory capacity against SARS-CoV2 S-protin RBD and hACE2 binding in vitro, Industrial Crops & Products 165 (2021) 113438) (see IDS filed on 6/15/26).
The teachings of D1 are set forth above and applied as before.
The teachings of D1 do not specifically teach the claimed dosage or form in claim 17 or treating SARS-CoV2 infection.
BORODUSKE et al teach Berries and flowers of Sambucus nigra L. tree are well known for their ability to mitigate symptoms of upper respiratory disorders related to reported antiviral properties. Industrial application and commercial cultivation of S. nigra is largely limited to a few widely grown cultivars. Restricted genetic diversity of cultivated S. nigra can be disadvantageous if new industrial applications are discovered. In this study wild S. nigra populations located on the north-east edge of the species natural range were explored by assessing genetic origin, berry and flower anti-oxidative potential, and berry rutin content. Best performing wild S. nigra extracts were selected for an assessment of previously unreported biological activity- inhibitory capacity against SARS-CoV2 S1 protein receptor binding domain (RBD) binding to recombinant human angiotensin -converting enzyme 2 (ACE2) receptor in vitro based on competitive enzyme linked immunosorbent assay (ELISA). Inter-simple sequence repeat (ISSR) marker-based genetic characterization suggested that explored wild S. nigra populations result from wild gene pool expanding northwards with admixture of historically introduced cultivated S. nigra. Average values of total phenolic content, anti-radical activity, and total flavonoids content of wild S. nigra populations did not exceed those of cv. 'Haschberg'. Concentration-dependent inhibition of ACE2-SARS-CoV2 S-protein RBD binding was demonstrated in vitro for elderberry fruits and flowers extracts (IC50 of 1.66 mg DW ml(-1) and 0.532 mg DW ml(-1), respectively). Wild elderberry fruit extract exhibited higher inhibitory capacity than the extract from berries of cv 'Haschberg'. This study validates the requirement for S. nigra wild germplasm bioprospecting and opens up directions for further research of new anti-SARS-CoV2 industrial applications of S. nigra (see Abstract). BORODUSKE et al teach elderberries are shown to mitigate symptoms of respiratory disorders during influenza infection (page 1, right column, last paragraph).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the elderberry extract to treat SARS-CoV2 infection since BORODUSKE et al teach to do so. Regarding the dosage or form in claim 17, determining an appropriate dosage or form is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 9:00 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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