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 .
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.
Claim Objections
Claim 7 is objected to because of the following informalities: Claim 7 ends with a comma rather than a period; this is incorrect grammar. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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.
Claims 9-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 9-10 recite the phrase “quasi-drug” in parentheses. It is unclear whether the requirement of a quasi-drug is a required limitation or an optional limitation.
For the purposes of examination under prior art, the examiner understands the limitation drawn to a “quasi-drug” to be optional.
Claims 14-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p)(II). It is the examiner’s position that claims 14-21 recite both the required composition as well as a process for using that composition, and are therefore indefinite for the reasons set forth above. Regarding claims 21-22, the limitation regarding the amounts of kaempferol and genistein applied per day appear to further limit the method by which the claimed product is used, rather than the claimed product itself.
For the purposes of examination under prior art, claims 14-21 will be examined as if they have the same scope as claim 1 upon which these claims depend.
Claims 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 19-20 recite the phrase “such as.” This phrase is understood to render claims 19-20 indefinite for at least the following reasons.
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. The examiner notes that the language “such as” has been found to have been indefinite for this reason; see MPEP 2173.05(d), example (B) therein.
Claim 19 also recites the phrase “and the like.” This phrase also renders the claim indefinite; see MPEP 2173.05(d), example (E) therein.
For the purposes of examination, claims 19-20 will be examined with the understanding that they have the same scope as claim 1 upon which they depend.
Claim Rejections - 35 USC § 112(d) – Failure to Limit Parent Claim
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 21-22 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 appears to require kaempferol as the sole active ingredient; however, this appears to fail to include all of the limitations of claim 1 upon which claim 21 depends, because claim 1 requires both kaempferol and genistein. Claim 22 appears to require genistein as the sole active ingredient; however, this appears to fail to include all of the limitations of claim 1 upon which claim 21 depends, because claim 1 requires both kaempferol and genistein. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
For the purposes of examination under prior art, claims 21-22 are being examined with the understanding that they have the same scope as claim 1 upon which they depend.
Claim Interpretation
For the purposes of examination under prior art, claims 5-6 are understood by the examiner to be product-by-process claims. Such claims are definite; see MPEP 2173.05(p)(I). Product-by-process claims will be examined under prior art in accordance with the guidelines presented in MPEP 2113.
Claim Rejections - 35 USC § 103 – Obviousness
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) 1-6 and 9-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yun et al. (KR 20040009776 A) in view of Korkmaz et al. (US 2019/0110969 A1).
As an initial matter, Yun et al. (KR 20040009776 A) has been written in Korean. The examiner has provided an English-language translation through Google Patents at https://patents.google.com/patent/KR20040009776A/en?oq=KR+20040009776+ which was accessed by the examiner on 5 January 2026. All page and paragraph citations are to the English language translation; however, all material cited therein is understood by the examiner to have been present in the original Korean document.
Yun et al. (hereafter referred to as Yun) is drawn to genistein to promote hair growth, as of Yun, page 1, title and claims, relevant text reproduced below.
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The examiner notes for the record here that it appears that in the English translation of Yun, genistein is mis-spelled as “zenistein” as of some (but not all) locations in the reference; for the purposes of this rejection, the examiner understands “zenistein” to be a mis-spelling of “genistein.”
Yun does not teach kaempferol.
Korkmaz et al. (hereafter referred to as Korkmaz) is drawn to a composition for hair growth, as of Korkmaz, title and abstract. Korkmaz teaches the following, as of page 7, paragraph 0087, reproduced in part below with annotation by the examiner.
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Elsewhere in the reference, Korkmaz teaches that a 5-alpha reductase modulator stimulates hair growth, as of Korkmaz, paragraph 0207.
Korkmaz is not anticipatory because Korkmaz does not teach a single composition comprising genistein and kaempferol together.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the genistein of Yun with the kaempferol of Korkmaz to have formed a composition for treating hair loss. Yun is drawn to a composition comprising genistein for stimulating hair growth. Korkmaz teaches that kaempferol is a 5-alpha reductase modulator, which is capable of stimulating hair growth. As such, the skilled artisan would have been motivated to have combined the genistein of Yun with the kaempferol of Korkmaz to have predictably formed a composition capable of stimulating hair growth with a reasonable expectation of success. Combining prior art elements (e.g. genistein, as of Yun and Korkmaz, and kaempferol, as of Korkmaz) according to known methods to yield predictable results (stimulating hair growth) is prima facie obvious. See MPEP 2143, Exemplary Rationale A. Also see MPEP 2144.06(I).
As to claim 2, Yun teaches genistein in an amount of 0.0001% to 10%, as of page 1 of Yun. Korkmaz teaches alpha reductase inhibitors in amounts from about 0.05% to about 6.0%, as of Korkmaz, paragraph 0087, wherein the percentages are taught on the portion of the paragraph on the top left of page 8. Korkmaz also teaches that kaempferol is an alpha-reductase inhibitor, as of paragraph 0087; as such, the skilled artisan would have been motivated to have modified the kaempferol concentration to have been in the range taught by paragraph 0087 of Korkmaz. These amounts overlap with the required ranges. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
In the alternative as to claim 2, generally, differences in concentration between the claimed invention and the prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality appears to have been provided. Also, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of genistein and kaempferol for treating hair loss have been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of these compounds via routine experimentation.
As to claim 3, Korkmaz teaches epigallocatechin gallate, as of Korkmaz, paragraphs 0037, 0047, and 0244.
As to claim 4, the examiner notes that Korkmaz teaches concentrations of epigallocatechine gallate in paragraph 0047. It is unclear if this concentration is within the claimed range. Regardless, generally, differences in concentration between the claimed invention and the prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality appears to have been provided. Also, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of genistein, kaempferol, and epigallocatechine gallate for treating hair loss have been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of these compounds via routine experimentation.
As to claim 5, this claim appears to further limit the process by which the genistein and kaempferol have been prepared, and is therefore a product-by-process claim. Product-by-process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. See MPEP 2113(I). In this case, the structure implied by the steps is that of a composition comprising genistein and kaempferol, and this would have been obvious over the combination of Yun and Korkmaz as set forth above. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. See MPEP 2113(II). No such evidence has been provided so far in prosecution.
In the alternative as to claim 5, if the claim were to be interpreted as providing a purified product of genistein and kaempferol, this would not overcome the applied obviousness rejection. Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product nonobvious. See MPEP 2144.04(VII).
As to claim 6, the product-by-process rationale applied regarding claim 5 is also understood to apply to claim 6.
As to claim 9, the composition of Yun in view of Korkmaz is understood to read on the required pharmaceutical product because it comprises the same elements as required by the instant claims.
As to claim 10, Korkmaz teaches ointments, creams, suspensions, lotions, and other forms in paragraph 0205.
As to claim 11, the composition of Yun in view of Korkmaz is understood to read on the required pharmaceutical product because it comprises the same elements as required by the instant claims.
As to claim 12, this claim is rejected for essentially the same reason that claim 10 is rejected.
As to claim 13, the composition of Yun in view of Korkmaz is understood to read on the required functional food product because it comprises the same elements as required by the instant claims. Something which is old (e.g. genistein and kaempferol, as taught by Yun and Korkmaz) does not become patentable upon the discovery of a new property (that these elements can be used as a functional food), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Additionally, composition claims cover what a composition is, not what a composition does. See MPEP 2114(II), wherein the examiner understands the rationale provided in that section of the MPEP regarding apparatus claims to also be applicable to composition claims. As such, as the prior art has the same ingredients as the claimed invention, the skilled artisan would have understood that the prior art product to have read on the claimed product regardless of whether it was identified by the prior art as a functional food.
As to claim 14, this claim appears to further recite the biochemical pathway by which the claimed invention operates. Even if, purely en arguendo, this biochemical pathway was newly discovered by applicant, it would not have been sufficient to have overcome the applied rejection. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. See MPEP 2112(I). Also, see the rejection above under 35 U.S.C. 112(b).
As to claim 15, the rationale applied by the examiner regarding claim 14 also applies to claim 15.
As to claim 16, the rationale applied by the examiner regarding claim 14 also applies to claim 16.
As to claim 17, the rationale applied by the examiner regarding claim 14 also applies to claim 17.
As to claim 18, the rationale applied by the examiner regarding claim 14 also applies to claim 18.
As to claim 19, the rationale applied by the examiner regarding claim 14 also applies to claim 19.
As to claim 20, the rationale applied by the examiner regarding claim 14 also applies to claim 20.
As to claims 21-22, the further limitation regarding the amounts of kaempferol and genistein applied per day appear to further limit the method by which the claimed product is used, rather than the claimed product itself. As such, these claims are not understood to further limit claim 1 and are rejected for essentially the same reason that claim 1 is rejected. Also, see the rejection above under 35 U.S.C. 112(b).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yun et al. (KR 20040009776 A) in view of Korkmaz et al. (US 2019/0110969 A1), the combination further in view of Young-Sil et al. (Journal of the Korean Society of Industry Convergence, Vol. 17, Issue 3, 2014, pages 178-183).
Yun is drawn to genistein for hair loss treatment, and Korkmaz is drawn to kaempferol for hair loss treatment. See the above rejection over Yun in view of Korkmaz.
None of the above references teach yeast extract.
Young-Sil has been written in Korean, but includes an English abstract on page 178. This abstract teaches the use of yeast constituent abstract to treat hair loss as of the English abstract on page 178.
Young-Sil does not teach genistein or kaempferol.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the yeast extract of Young-Sil with the composition of Yun in view of Korkmaz. Yun and Korkmaz are drawn to compositions comprising genistein and kaempferol for treating hair loss. Young-Sil teaches that yeast extract may be used to treat hair loss. As such, the skilled artisan would have been motivated to have combined the yeast extract of Young-Sil with the genistein of Yun and the kaempferol of Korkmaz in order to have predictably treated hair loss with a reasonable expectation of success. Combining prior art elements (e.g. yeast extract, genistein, and kaempferol) according to known methods to yield predictable results (treating hair loss) is prima facie obvious. See MPEP 2143, Exemplary Rationale A. See also MPEP 2144.06(I).
As to claim 7, the yeast extract of Young-Sil reads on the claimed requirements.
As to claim 8, generally, differences in concentration between the claimed invention and the prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality appears to have been provided. Also, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of genistein, kaempferol, and yeast extract for treating hair loss have been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of these compounds via routine experimentation.
Additional Relevant Prior Art
As additional relevant prior art, the examiner cites Liao et al. (US 2003/0105030 A1). Liao et al. (hereafter referred to as Liao) is drawn to 5α-reductase inhibitors, as of Liao, title and abstract. Liao teaches the following, as of page 11, Table 3, reproduced below.
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The above-reproduced table from Liao teaches kaempferol and genistein on the same table. However, Liao is not understood to be anticipatory because, as best understood by the examiner, the above-reproduced table is drawn to separate compositions of genistein and kaempferol, and does not teach these ingredients together in the same composition. In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03, third paragraph in section. As best understood by the examiner, Liao is just as good as, but no better than the references cited above; this is at least because Liao is not anticipatory. As such, the examiner has not written an additional obviousness rejection over Liao.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612