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 .
Status of Claims
Applicant’s amended claims and specification filed on May 24, 2023 is/are acknowledged. Amended claim(s) 9-20 are currently under examination.
Priority
Please note, Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement (IDS)
The information disclosure statement (IDS) submitted on May 24, 2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Please note, all of the Foreign Patent Documents cited were submitted with partial English translations of the Abstract only. Accordingly, only the English-translated portions of the documents were considered.
Drawings
Please note that due to the quality of some of the drawing(s), the information contained therein may not be legible which may affect examination or Applicant’s reliance upon information contained therein (see for example, FIG. 9). Applicant is encouraged to review the drawings and make appropriate corrections as needed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 9-16, 19, and 20 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Jo, et al. (US 2008/0279969).
The instant claim(s) is/are of record, generally drawn to the following: a method of ameliorating or treating an androgen-dependent disorder, the method comprising administering a composition comprising Phyllostachys pubescens extract as an effective component to a subject in need thereof.
Jo et al., generally teaches the use of bamboo extract to prevent or treat symptoms related to decreased androgen, including change of hair (broadly inclusive of alopecia) (Abstract; Specification, paragraph [0002]), as required in claim(s) 9-20. Furthermore, Jo et al, further broadly discloses the composition may be used to treat symptoms related to decreased androgen caused by male climacteric (i.e. andropause) (Abstract), which is well-known in the art to be associated with decrease in body hair (See Abstract of Wespes. S., Male andropause: myth, reality, and treatment. Int J Impot Res. 2002 Feb;14 Suppl 1:S93-8), as required in claim(s) 9-20.
Jo et al., teaches the bamboo extract can be used by extracting bamboo with water, organic solvent or mixing solvent thereof, including C1-C4 alcohols (Specification, paragraphs [0036-0040]), as required in claim 10. Jo et al., teaches that the composition may preferably comprise P. pubescens from bamboo leaf (Specification, paragraph [0034]-[0035]), as required in claim 11. Moreover, Jo et al., teaches that the composition can be used as a “medicine or health care product including food products prepared and processed in the form of tablet, capsule, powder, granule, solution, pill, etc.” both orally and parenterally (Specification, paragraph [0045]-[0046]), as required in claim(s) 13-15. Jo et al., teaches the composition may comprise a pharmaceutically acceptable carrier, excipient, etc. (Specification, paragraph [0045]), as required in claim 16. Jo et al., teaches the composition may be administered parenterally (broadly inclusive of topical application) (Specification, [0045]), as required in claim(s) 17 and 18.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 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.
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 CFR 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.
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lolli, et al. “Androgenic alopecia: a review” Endocrine (2017) 57:9–17. doi: 10.1007/s12020-017-1280-y. Epub 2017 Mar 28.
The instant teachings of Jo, et al. are of record above.
Jo, et al. is silent regarding the P. pubescens extract is prepared in a cosmetic, as required in claim(s) 17 and 18.
However, Lolli, et al. teaches androgenic alopecia (AGA) is characterized by progressive hair follicular miniaturization and can eventually lead to a bald appearance. (See page 9; “Abstract” & “Introduction” Sections). Lolli, et al. further teaches treatment for AGA includes pharmacotherapy, surgery and cosmetic aids. (see page 13; “Treatment” Section)
Thus, a person of ordinary skill in the art would reasonably expect that a composition for treating hair loss, which is intended generally to improve appearance, may comprise a cosmetic product, particularly where treatment for AGA comprises a finite number of alternatives, including cosmetic aids. This reasonable expectation of success would have modified the artisan to administer the P. pubescens extract in a cosmetic form, especially where, as discussed above, Jo, et al. teaches parenteral modes of administration (broadly inclusive of, for example, topical application).
Jo et al. and Lolli, et al. is/are relied upon for the reasons discussed above. If not expressly taught by the references, based upon the overall beneficial teaching provided by these references with respect to modes of administration of the P. pubescens extract in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable forms of P. pubescens extract to administer) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants' composition with the composition of the prior art (including
compositions within the processes thereof), the burden is on applicant to show a novel or
unobvious difference between the claimed product and the product of the prior art. See In
re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67,
205 USPQ 594 (CCPA 1980), and "as a practical matter, the Patent Office is not
equipped to manufacture products by the myriad of processes put before it and then
obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
Currently, no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vani G. Verkhovsky whose telephone number is (571)272-3777. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at (571) 272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.G.V./Examiner, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655