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 .
Claims 7 and 8 are pending and are currently under consideration.
Claims 7 and 8 are currently amended.
Claims 1-6 are cancelled.
Withdrawn Rejections
Rejections not reiterated herein are deemed to be withdrawn.
Rejections Maintained and Made Again in view of Applicant’s Amendments
Claim Rejections - 35 USC § 112
Claim Rejections – 35 USC § 112 (a) or First Paragraph (pre-AIA )
35 USC § 112 First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7 and 8 are rejected under 35 U.S.C. 112, first paragraph, because the specification does not reasonably provide enablement for any extract of Elaeagnus multiflora Thunb fruit treating benign prostatic hyperplasia as claimed in claims 7 and 8, which include, for instance, treating benign prostatic hyperplasia with water (such as water that can be extracted from the fruit of Elaeagnus multiflora Thunb.). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to utilize the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 11, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CAFC 1988).
Wands states on page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
The nature of the invention is treating benign prostatic hyperplasia, where the relative level of skill of those in the art is deemed to be high.
The claims are broadly drawn to a method of treating benign prostatic hyperplasia by administering an extract of Elaeagnus multiflora Thunb. to a subject.
The specification teaches with regard to the Elaeagnus multiflora Thunb only that there is an extract, however, the specification does not specifically articulate which extract of the Elaeagnus multiflora Thunb. There are no working examples of that discuss the specific extract of Elaeagnus multiflora Thunb being utilized to treat benign prostatic hyperplasia. Thus, the scope of the claims is extremely broad compared to the guidance and exemplification provided in the specification. The scope of the claims must bear a reasonable correlation with the scope of enablement. See In re Fisher, 166 USPQ 1924 (CCPA 1970).
The state of the prior art is such that it is well established in the art that the treatment of a disorder such as benign prostatic hyperplasia requires significant research, testing, and trial-and-error in order to arrive at a treatment of a disorder. The state of the art recognizes that it would be highly unpredictable. One of ordinary skill in the art could not predictably extrapolate the teachings in the specification to know which extracts of Elaeagnus multiflora Thunb would be able to treat benign prostatic hyperplasia. With respect to the broad scope of "a method for treatment of benign prostatic hyperplasia”, the specification discloses various treatments utilizing an unspecified extract of Elaeagnus multiflora Thunb, however, the specification does not provide sufficient guidance or direction as to the general the specific extract being utilized or how one establishes treatment of benign prostatic hyperplasia. The specification does not enable the genus because where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one particular species, what other species will work. See MPEP 2164.03. One of skill in the art would neither expect nor predict the appropriate functioning of the active to treat as is claimed.
In view of the lack of predictability of the art to which the invention pertains, the lack of guidance and direction provided by Applicant, and the absence of working examples, undue experimentation would be required to practice the claimed method with a reasonable expectation of success, absent specific and detailed description in Applicant's specification of how to effectively practice the claimed method and absent working examples providing evidence which is reasonably predictive that the claimed method would treat benign prostatic hyperplasia with any extract of Elaeagnus multiflora Thunb commensurate in scope with the claimed invention.
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.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al (KR 2017-0005632)(Citations made from English Translation provided herewith) as evidenced by Xie et al (Adult Urology, 2007).
Kim teaches a composition comprising an Elaeagnus multiflora Thunb. extract, preferably from the fruit (see entire document, for instance, Abstract, and page 15, claim 1, and page 8, second paragraph). Said extract is obtained by water or C1 to C4 extraction (see entire document, for instance, claim 2). It is noted that Kim several times mistranslates the common name for Elaeagnus multiflora Thunb as either yam or gardenia. Kim further teaches that the extract is present in an amount of 0.1 mg/kg/day to 2000 mg/kg/day (see entire document, for instance, page 8, fifth paragraph). The composition is taught as being formulated as a food or granule, tablet, capsule, suspension, emulsion, etc. (see entire document, for instance, page 8, fourth and seventh paragraphs). Kim teaches that obesity creates problems with the prostate as well as causing issues of hyperplasia (see entire document, for instance, page 6, third and fifth paragraphs). As such, when Kim treats obesity, it necessarily treats benign prostatic hyperplasia since the reduction in obesity would treat the condition. It is noted that Xie evidences that enlargement of the prostate is also known as benign prostatic hyperplasia (see as evidence, Xie, entire document, for instance, page 680, left column, first paragraph). Xie also evidences that obesity and BMI are significantly associated with the risk of BPE (benign prostate enlargement) and with prostate volume (see as evidence, Xie, entire document, for instance, page 683, left column, first paragraph under Comment).
Response to Arguments
Applicant argues in the remarks filed 08/26/2025 that the prior art is drawn to obesity, and not necessarily enlarged prostate. Applicant’s argument is not found persuasive. Specifically, Xie teaches utilizing the instantly claimed composition for treating obesity, wherein obesity is significantly tied to enlarged prostate. It is noted that MPEP 2131.05 states “Arguments that the alleged anticipatory prior art is nonanalogous art’ or teaches away from the invention’ or is not recognized as solving the problem solved by the claimed invention, [are] not germane’ to a rejection under section 102.” Twin Disc, Inc. v. United States, 231 USPQ 417, 424 (Cl. Ct. 1986) (quoting In re Self, 671 F.2d 1344, 213 USPQ 1, 7 (CCPA 1982)). See also State Contracting & Eng ’ g Corp. v. Condotte America, Inc., 346 F.3d 1057, 1068, 68 USPQ2d 1481, 1488 (Fed. Cir. 2003). In the instant fact pattern, the prior art teaches administering the same composition (a fruit extract of Elaeagnus multiflora Thunb. fruit) to the same patient population (those who have enlarged prostates, as evidenced by Xie who provides a significant link between obesity and enlarged prostates), wherein therefore, the method is anticipated.
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) 7 and 8 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (KR 2017-0005632)(Citations made from English Translation provided herewith) in view of Xie et al (Adult Urology, 2007).
Kim teaches a composition comprising an Elaeagnus multiflora Thunb. extract, preferably from the fruit (see entire document, for instance, Abstract, and page 15, claim 1, and page 8, second paragraph). Said extract is obtained by water or C1 to C4 extraction (see entire document, for instance, claim 2). It is noted that Kim several times mistranslates the common name for Elaeagnus multiflora Thunb as either yam or gardenia. Kim further teaches that the extract is present in an amount of 0.1 mg/kg/day to 2000 mg/kg/day (see entire document, for instance, page 8, fifth paragraph). The composition is taught as being formulated as a food or granule, tablet, capsule, suspension, emulsion, etc. (see entire document, for instance, page 8, fourth and seventh paragraphs). Kim teaches that obesity creates problems with the prostate as well as causing issues of hyperplasia (see entire document, for instance, page 6, third and fifth paragraphs).
Kim, while teaching that a treatment for obesity, and teaching that obesity creates problems with the prostate as well as causing issues of hyperplasia, does not expressly teach that the method of treating benign prostatic hyperplasia with the composition of Kim.
Xie teaches that enlargement of the prostate is also known as benign prostatic hyperplasia (see Xie, entire document, for instance, page 680, left column, first paragraph). Xie also teaches that obesity and BMI are significantly associated with the risk of BPE (benign prostate enlargement) and with prostate volume (see Xie, entire document, for instance, page 683, left column, first paragraph under Comment).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention, to utilize the composition of Kim for treating a patient who has benign prostatic hyperplasia. One would have been motivated to do so since Kim teaches that the composition treats obesity, wherein Kim teaches that obesity creates problems with the prostate as well as causing issues of hyperplasia and Xie teaches that obesity is associated with enlarged prostates. As such, by treating the obesity, one would be treating both the prostate as well as improving the body for addressing hyperplasia. There would be a reasonable expectation of success since Kim expressly teaches that said composition is useful for treating obesity.
Response to Arguments
Applicant argues in the remarks filed 08/26/2025 that the prior art is drawn to obesity, and not necessarily enlarged prostate. Applicant’s argument is not found persuasive. Specifically, Xie teaches utilizing the instantly claimed composition for treating obesity, wherein obesity is significantly tied to enlarged prostate. It is noted that the art is not required to teach the same reasoning for adding components as Applicant, MPEP 2144 (IV) states “the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by Applicant. See, e.g., In re Kahn, 411 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).” In the instant fact pattern, the prior art teaches administering the same composition (a fruit extract of Elaeagnus multiflora Thunb. fruit) to the same patient population (those who have enlarged prostates, as evidenced by Xie who provides a significant link between obesity and enlarged prostates), wherein therefore, the method is anticipated.
Applicant further argues that there is no motivation to modify the teachings of Kim, and specifically for the treatment of benign prostatic hyperplasia. Applicant’s argument is not found persuasive in light of the grounds of rejection set forth above, and specifically, because of the teachings of Xie which directly link benign prostatic hyperplasia with obesity.
Applicant further argues that there is no reasonable expectation of success in treating of enlarged prostates in light of the teaching of Kim. Applicant’s argument is not found persuasive in light of the grounds of rejection set forth above, and specifically, because of the teachings of Xie which directly link benign prostatic hyperplasia with obesity. Further, it is noted that MPEP 2143.02 states “[o]bviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976)”.
Conclusion
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 TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611