DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-11 are currently pending.
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.
3. Claim(s) 1-3, 6, 7, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ring (Malaysian Journal of Microbiology (2019), vol. 15, no. 5, pp. 373-378) with Shibata (BMC Medicine (2011), vol. 9, no. 69, 18 pages) providing definitions.
Ring teaches a method for treating diabetic foot ulcers by topically applying an ethanolic extract from Garcinia mangostana pericarp (see abstract, “Extraction of G. mangostana pericarp” section on page 374, and page 376, last paragraph). G. mangostana pericarp is synonyms with the outer fruit shell of mangosteen (see Shibata, first column on page 2).
4. Claim(s) 1-3, 6, 7, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanpinit (Journal of Herbal Medicine (2020), vol. 23, no. 100381, 8 pages) with Shibata (BMC Medicine (2011), vol. 9, no. 69, 18 pages) providing definitions.
Sanpinit teaches a method for treating diabetic foot ulcers by topically applying an aqueous ethanolic extract from Garcinia mangostana pericarp (see abstract, sections 2.1 and 2.4). G. mangostana pericarp is synonyms with the outer fruit shell of mangosteen (see Shibata, first column on page 2).
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, 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.
5. Claim(s) 1 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ring (Malaysian Journal of Microbiology (2019), vol. 15, no. 5, pp. 373-378).
The teachings of this reference are discussed above in paragraph 3. The reference does not specifically teach using the mangosteen extract in the concentrations claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The reference teaches the use of the extract in a pharmaceutical composition. Varying the concentration of an ingredient within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the extract produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
6. Claim(s) 1 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanpinit (Journal of Herbal Medicine (2020, vol. 23, no. 100381, 8 pages).
The teachings of this reference are discussed above in paragraph 4. The reference does not specifically teach using the mangosteen extract in the concentrations claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The reference teaches the use of the extract in a pharmaceutical composition. Varying the concentration of an ingredient within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the extract produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
7. Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ring (Malaysian Journal of Microbiology (2019), vol. 15, no. 5, pp. 373-378) in view of Chang (US 10,383,906).
The teachings of Ring are discussed above in paragraph 3. The reference teaches an alcoholic extract from the outer shell of the mangosteen. In addition, the reference teaches that the extract contains alpha-mangostin as an active ingredient (see page 376, last paragraph). However, the reference does not teach a water extract from the outer shell or a water or alcoholic extract from the inner shell. The reference also does not teach that the extract contains gamma-mangostin.
However, Chang teaches a water or alcoholic extract from the inner and outer rind (shell) of the mangosteen fruit. The reference teaches that each of these extracts contains both alpha and gamma mangostin. In addition, the reference teaches that the extracts have topical wound healing properties (see column 2, lines 36-59 and column 3, lines 13-35).
Thus, an artisan of ordinary skill in the art would reasonably expect that the method of treating diabetic foot ulcers with mangosteen extract taught by Ring could be performed with the water or alcoholic extracts from the inner and outer shell of the mangosteen fruit as taught by Chang because Chang teaches that the extracts contain the active ingredient alpha-mangostin and have wound healing properties. This reasonable expectation of success would have motivated the artisan to modify Ring to include the use of the mangosteen extracts taught by Chang. Thus, the stated claims are considered to be an obvious modification of what was known in the art at the time of the invention.
8. Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanpinit (Journal of Herbal Medicine (2020, vol. 23, no. 100381, 8 pages) in view of Chang (US 10,383,906).
The teachings of Sanpinit are discussed above in paragraph 4. The reference teaches an alcoholic extract from the outer shell of the mangosteen. In addition, the reference teaches that the extract contains alpha-mangostin as an active ingredient (see abstract). However, the reference does not teach a water extract from the outer shell or a water or alcoholic extract from the inner shell. The reference also does not teach that the extract contains gamma-mangostin.
However, Chang teaches a water or alcoholic extract from the inner and outer rind (shell) of the mangosteen fruit. The reference teaches that each of these extracts contains both alpha and gamma mangostin. In addition, the reference teaches that the extracts have topical wound healing properties (see column 2, lines 36-59 and column 3, lines 13-35).
Thus, an artisan of ordinary skill in the art would reasonably expect that the method of treating diabetic foot ulcers with mangosteen extract taught by Sanpinit could be performed with the water or alcoholic extracts from the inner and outer shell of the mangosteen fruit as taught by Chang because Chang teaches that the extracts contain the active ingredient alpha-mangostin and have wound healing properties. This reasonable expectation of success would have motivated the artisan to modify Sanpinit to include the use of the mangosteen extracts taught by Chang. Thus, the stated claims are considered to be an obvious modification of what was known in the art at the time of the invention.
9. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
Prosecution Insights