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 .
DETAILED ACTION
This office action is a response to Applicant’s amendments/remarks after non-final rejection filed 6/5/2026.
As filed, claims 1, 2, 5, 6, and 14-23 are pending, wherein claims 14-23 are new; and claims 3, 4, and 7-13 are cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/2/2026 has been considered by the Examiner.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 6/5/2026, with respect to claims 1-6, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The § 112(b) indefinite rejection of claim 6 is withdrawn per amendments.
The § 112 fourth paragraph rejection of claims 3 and 6 is withdrawn per amendments and cancellation of claim 3.
The § 102(a)(1) rejection of claims 3 and 4 by Suk, as evidenced by Shin, is withdrawn per cancellation of the claims.
The § 102(a)(1) rejection of claims 1, 2, 5, and 6 by Suk, as evidenced by Shin, is maintained because Applicant’s remarks are not persuasive. In addition, the Examiner finds that preventing hair damage is an intended effect from the hydrangenol of Suk when it is used to prevent hair loss and promote hair growth. This is further supported when both the hydrangenol of Suk and the instant hydrangenol use the same mechanism, (i.e. promoting the proliferation of dermal papilla cells) to improve hair condition. As discussed in the previous office action, it is also an inherent feature of hydrangenol to increase the tensile strength of the hair and alleviate roughness of hair cuticles, which inherently prevent or improve hair damage.
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(pg. 15 of the instant specification)
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(paragraph 0091 of the English translation)
The claim objection of claims 2-5 is withdrawn per amendments and cancellation of claims 3 and 4.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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 14 and 16-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant’s amendment with respect to amended claim 14 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the newly added limitation of “hydrangenol is administered at amount of 2 mg/ml or less”.
The instant specification and the originally filed claim (i.e. filed 12/29/2023) only provide support for the following:
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(pg. 21, experimental example 4)
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(pg. 22, experimental example 5)
The abovementioned examples only provided support for 2 mg/ml in the amount of hydrangenol administered and thus, any amount less than 2 mg/ml is considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Applicant’s amendment with respect to amended claim 16 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the newly added limitation of “hydrangenol is included in an amount of 0.001 to 5 wt% on a total weight of the formulation ”.
The instant specification and the originally filed claim (i.e. filed 12/29/2023) only provide support for the following:
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(pg. 6)
The abovementioned embodiment only provided support for the abovementioned subgenera of wt%, and thus, “0.001 to 5 wt%” in the abovementioned limitation creates a new subgenus of wt%, which is considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Applicant’s amendment with respect to amended claim 17 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the newly added limitation of “hydrangenol is administered for 30 minutes or more”.
The instant specification and the originally filed claim (i.e. filed 12/29/2023) only provide support for the following:
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(pg. 21, experimental example 4)
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(pg. 22, experimental example 5)
The abovementioned examples only provided support for 30 minutes in the time that hydrangenol is administered and thus, any time more than 30 minutes is considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Applicant’s amendment with respect to amended claims 18 and 19 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the newly added limitation of “increasing a tensile strength of the hair by at least 1.06%” in claim 18 and “alleviating roughness of hair cuticles by at least 0.975%” in claim 19.
The instant specification and the originally filed claim (i.e. filed 12/29/2023) only provide support for the following:
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(pg. 22, experimental example 4)
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(pg. 23, experimental example 5)
The abovementioned examples failed to provide support for the abovementioned percentages and thus, 1.06% and 0.975%, respectively, are considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Claim Interpretation
The Examiner finds the claim construction of claims 20-22 as a product by process limitation (i.e. the hydrangea serrata extract and its extraction method) in a process claim (i.e. the method of improving a hair condition). In other words, the patentability of the instantly claimed process is based on the hydrangea serrata extract itself, and not its method of extraction.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 5, 6, and 18-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foreign Patent No. KR10-2016-0081204 (see IDS filed 12/29/2023) and its machine-generated English translation, hereinafter Suk, as evidenced by “Chemical Constituents from leaves of Hydrangea serrata and Their Anti-photoaging Effects on UVB-Irradiated Human Fibroblast”, hereinafter Shin.
Regarding claims 1, 2, 5, 6, and 18-23, Suk, for instance, teaches a composition comprising an extract of Hydrangea Serrata as an active ingredient in a solid dosage form (e.g. tablets, pills, etc.) for preventing hair loss and promoting hair growth. The extract has shown to promote proliferation of dermal papilla cells.
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(paragraph 0011 of the English translation)
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(paragraph 0010 of the English translation)
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(paragraph 0091 of the English translation)
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(paragraph 0040 of the English translation)
Although Suk did not explicitly teach hydrangenol for preventing hair loss and promoting hair growth, the Examiner finds that hydrangenol is identified as the main ingredient out of ten compounds isolated from Hydrangea Serrata extract, according to evidentiary reference Shin. Therefore, the Examiner finds that a person of ordinary skill in the art would read the abovementioned Suk and Shin publications and “at once envisage” that hydrangenol is present in the Hydrangea Serrata extract of Suk, thereby inherently preventing hair loss and promoting hair growth via promoting proliferation of dermal papilla cells.
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(pg. 426, right column,
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(pg. 426, Fig. 1)
Although Suk, as evidenced by Shin, did not explicitly teach that hydrangenol inhibits 5α-reductase, increases the tensile strength of hair by at least 1.06% or alleviates roughness of hair cuticles by at least 0.975%, the Examiner finds that the abovementioned therapeutic activities are inherent features of hydrangenol as taught by Suk, as evidenced by Shin. According to MPEP 21121(I) and (II), the discovery of a previously unappreciated feature of hydrangenol, as taught by Suk and Shin, does not render the abovementioned therapeutic activities patentable to the Applicant. In addition, such inherent therapeutic activities did not have to recognize at the time of invention by Suk and Shin.
Lastly, the Examiner finds that preventing hair damage is an intended effect from the hydrangenol of Suk when it is used to prevent hair loss and promote hair growth. This is further supported when both the hydrangenol of Suk and the instant hydrangenol use the same mechanism (i.e. promoting the proliferation of dermal papilla cells) to promote hair growth and prevent hair damage, respectively.
As mentioned above, the Examiner finds that hydrangenol of Suk inherently alleviate hair damage because hydrangenol inherently inhibits 5α-reductase, increases the tensile strength of hair by at least 1.06% or alleviates roughness of hair cuticles by at least 0.975%.
All of which led to the abovementioned anticipation.
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(pg. 15 of the instant specification)
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(paragraph 0091 of the English translation)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 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.
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Suk, as evidenced by Shin.
Regarding claims 14-17:
Determining the scope and contents of the prior art:
Suk, as evidenced by Shin, for instance, teaches the abovementioned process. In addition, Suk, as evidenced by Shin, teaches that hydrangenol can be administered in an amount of 0.1 to 500 mg, or 1 to 100 mg, per kg of body weight per day
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(paragraph 0042 of the English translation)
Ascertaining of the difference between the prior art and the claim at issue:
Suk, as evidenced by Shin, did not explicitly teach the following:
Hydrangenol is administered at amount of 2 mg/ml or less;
hydrangenol is included in an amount of 0.0001 to 5 wt% based on a total weight of the formulation;
hydrangenol is included in an amount of 0.001 to 5 wt% based on a total weight of the formulation; and
hydrangenol is administered for 30 minutes or more.
Finding of prima facie obviousness --- rationale and motivation:
The Examiner does not find the abovementioned amounts or administration time as result-effective variables because the Applicant fails to demonstrate these parameters to impart any unexpected or novel aspect to the instant process (i.e. no comparative example). “[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). See MPEP 2144.05. Accordingly, these parameters are viewed as routine experimentation to optimize the instant process, and not a patentable distinction.
Conclusion
Claims 1, 2, 5, 6, and 14-23 are rejected.
Claims 3, 4, and 7-13 are cancelled.
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.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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