DETAILED ACTION
Status of Claims
Claims 1-7 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Non-Final
Claim Objections
The following claims are objected to because of the following informalities:
A. Claim 4 is objected to because the claim should read:
4. The method of claim 1, wherein the Aucuba japonica extract is extracted with water, a C1 to C4
B. Claim 5 is objected to because the claim should read:
5. The method of claim 1, wherein the Aucuba japonica extract is extracted with a 20% to[[-]] 40% (w/w) aqueous ethanol solution.
Appropriate correction is required.
Claim Rejections – 35 U.S.C. § 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 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 pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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.
Claims 1-7 are rejected under 35 U.S.C. § 103 as being unpatentable over KIM (KR 10-1849301 B1, Publ. Apr. 16, 2018; as evidenced by US 2021/0030828 A1, Publ. Feb 4, 2021; hereinafter, “Kim”), in view of SEO (Seo, E-J, et al., Antiangiogenic Activity and Pharmacogenomics of Medicinal Plants from Traditional Korean Medicine, Evidence-Based Complementary and Alternative Medicine, 2013. vol. 2013. Article ID. 131306, pp. 1-13; hereinafter, “Seo”).
Paragraph numbers for Kim refer to US 2021/0030828 A1 as an English language translation for KR 10-1849301 B1.
Kim is directed to:
COMPOSITION FOR PREVENTING OR TREATING DRY EYE SYNDROME, CONTAINING AUCUBA JAPONICA EXTRACT
ABSTRACT
Provided is a composition for preventing, alleviating or treating dry eye syndrome, containing an Aucuba japonica extract as an active ingredient. The composition containing an Aucuba japonica extract can be effectively used in the prevention, alleviation or treatment of dry eye syndrome.
Kim, title & abstract. In this regard, Kim exemplifies a reflux extract of Aucuba japonica:
Example 1. Preparation of Reflux Extract of
Aucuba japonica
[0027] The leaf and stem of Aucuba japonica were collected two times, in June and September of 2017, at two places around Donnaeko Valley (Sanghyo-dong, Seogwipo-si, Jeju Special Self-Governing Province, Korea) and one place near Songdang-ri Haeoreum (Gujwa-eup, Jeju-si). The samples are kept in a sample storage room of Jeonbuk University.
[0028] Then, 50 g of the Aucuba japonica (a mixture of leaf and stem) was added to 1500 mL of 30% ethanol (w/w) and a 30% ethanol reflux extract was obtained by conducting reflux extraction once at 100° C. for 3 hours.
Kim, par. [0027]-[0028], Ex. 1. Kim also teaches a claim embodiment drawn to a functional health food composition comprising an Aucuba japonica extract as an active ingredient:
7. A functional health food composition for preventing or alleviating dry eye syndrome, comprising an Aucuba japonica extract as an active ingredient.
8. The functional health food composition according to claim 7, wherein the Aucuba japonica extract is an ethanol extract or a hot water extract.
9. The functional health food composition according to claim 7, wherein the Aucuba japonica extract is an extract of the leaf or stem of Aucuba japonica.
Kim, claims 7-9.
Regarding independent claim 1 and the requirements:
1. A method for treating macular degeneration, the method comprising:
administering a composition comprising an effective amount of Aucuba japonica extract to a subject in need thereof.
Kim clearly teaches “50 g of the Aucuba japonica (a mixture of leaf and stem) [that] was added to 1500 mL of 30% ethanol (w/w)” in order to obtain a “30% ethanol reflux extract” (Kim, par. [0028], Ex. 1), which is:
a “composition comprising an effective amount of Aucuba japonica extract” of claim 1, and
a composition of claims 3-5:
3. The method of claim 1, wherein the Aucuba japonica extract is extracted from a leaf, a stem or a mixture thereof of Aucuba japonica.
4. The method of claim 1, wherein the Aucuba japonica extract is extracted with water, a C1-4 lower alcohol or a mixture solvent thereof.
5. The method of claim 1, wherein the Aucuba japonica extract is extracted with a 20-40% (w/w) aqueous ethanol solution.
With regard to the range requirements of claims 4-5, it is noted that MPEP § 2144.05 (I), states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d, 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” Although Kim teaches “treating dry eye syndrome, containing an Aucuba japonica extract as an active ingredient” (Kim, abstract), Kim, however, DOES NOT EXPRESSLY TEACH the patient population of “treating macular degeneration” and a “subject in need thereof” per the requirements of claim 1, as well as the requirements of claim 2 for “age-related macular degeneration”:
2. The method of claim 1, wherein the macular degeneration is age-related macular degeneration.
which is well within the purview of the ordinarily skilled artisan.
Seo, for instance, is directed to:
Antiangiogenic Activity and Pharmacogenomics of Medicinal Plants from Traditional Korean Medicine
Aim. In the present study, we investigated the antiangiogenic properties of 59 plants used in traditional Korean medicine. Selected phytochemicals were investigated in more detail for their modes of action. Methods. A modified chicken-chorioallantoicmembrane (CAM) assay using quail eggs was applied to test for antiangiogenic effects of plant extracts. A molecular docking in silico approached the binding of plant constituents to the vascular endothelial growth factor receptors 1 and 2 (VEGFR1, VEGFR2). Microarray-based mRNA expression profiling was employed to correlate the 50% inhibition concentrations (IC50) of a panel of 60 NCI cell lines to these phytochemicals. Results. Extracts from Acer mono leaves, Reynoutria sachalniensis fruits, Cinnamomum japonicum stems, Eurya japonica leaves, Adenophora racemosa whole plant, Caryopteris incana leaves-stems, and Schisandra chinensis stems inhibited angiogenesis more than 50% in quail eggs. Selected phytochemicals from Korean plants were analyzed in more detail using microarray-based mRNA expression profiles andmolecular docking to VEGFR1 and VEGFR2. These results indicate multifactorial modes of action of these natural products. Conclusion. The antiangiogenic activity of plants used in traditional Korean medicine implicates their possible application for diseases where inhibition of blood vessel formation is desired, for example, cancer, macular degeneration, diabetic retinopathy and others.
Seo, title & abstract. In this regard, Seo discloses Antiangiogenic effects of 59 Korean plant extracts, inter alia, Aucuba japonica:
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Seo, p. 3, Fig. 1.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use Kim’s “Aucuba japonica (a mixture of leaf and stem)” in a “30% ethanol reflux extract” (Kim, par. [0028], Ex. 1), as well as a function food thereof (Kim, claims 7-9) for treating macular degeneration per Seo (Seo, abstract). One would have been motivated to do so with a reasonable expectation of success since both Kim and Seo are concerned with similar problems in the art, namely eye treating compositions containing “Aucuba japonica extract” (Kim, abstract), and “antiangiogenic activity of plants used in traditional Korean medicine implicates” for “possible application for diseases where inhibition of blood vessel formation is desired, for example, [...], macular degeneration” (Seo, abstract), inter alia, Aucuba japonica (Seo, p. 3, Fig. 1). Further, it is well within the skill of the ordinary artisan to select a known eye-treating composition, namely Kim’s composition containing Aucuba japonica (Kim, abstract), for treating macular degeneration (Seo, p. 3, Fig. 1) in order to obtain the advantage of “antiangiogenic activity” in a condition such as “macular degeneration” for which “inhibition of blood vessel formation is desired.” Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results.
Thus, the prior art renders claims 1-5 obvious.
Regarding claim 6 and the requirements:
6. The method of claim 1, wherein the composition is a pharmaceutical composition further comprising a pharmaceutically acceptable diluent and/or a pharmaceutically acceptable carrier.
Kim teaches “When the composition is a pharmaceutical composition, it may contain a pharmaceutically acceptable diluent or carrier.” Kim, par. [0020].
Thus, the prior art renders claim 6 obvious.
Regarding claim 7 and the requirements:
7. The method of claim 1, wherein the composition is a functional health food composition further comprising a sitologically acceptable carrier and/or a sitologically acceptable additive.
Kim teaches “A sitologically acceptable carrier or additive may be used for the formulation of the health food, and any carrier or additive known to be usable in the art for the preparation of the formulation to be prepared may be used.” Kim, par. [0018].
Thus, the prior art renders claim 7 obvious.
Conclusion
Claims 1-7 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611
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