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 .
Claim Status
Applicant’s remarks and amendments, filed 25 March 2026 in response to the non-final rejection mailed 29 December 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 25 March 2026 replaces all prior versions and listings of the claims.
Claims 1-12 are pending. Claims 3-11 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 12 is newly added. Claims 1 and 2 are amended. Claims 1, 2, and 12 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s arguments and amendments, on page 8 of the reply filed 25 March 2026 with respect to the rejection of Claim 2 under 35 USC § 112(b) have been fully considered. The rejection of Claim 2 is withdrawn due to amendment of the claim.
Applicant’s arguments and amendments, on pages 15-18 of the reply filed 25 March 2026 with respect to the rejection of Claims 1 and 2 under 35 USC § 101 have been fully considered. The rejections of Claims 1 and 2 are withdrawn due to amendment of the claims to include a dosage form of a solid powder.
Applicant’s arguments and amendments, on pages 8-15 of the reply filed 25 March 2026 with respect to the rejection of Claims 1 and 2 under 35 USC § 102(a)(1) have been fully considered. The rejections of Claims 1 and 2 are withdrawn due to amendment of the claims.
Information Disclosure Statement
The information disclosure statement filed 22 January 2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. In the instant case, a copy of the examination report dated 2025-10-31 was not provided. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claim 12 is objected to because “drying the banana flower water extraction liquid;” should instead read --drying the banana flower water extraction liquid; and--. Appropriate correction is required.
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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 1, 2, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 10,588,932 B2) in view of Muhammad Suffi et al. (Healthscope, 2021, 113-118) and Handa et al. (Extraction Techniques for Medicinal and Aromatic Plants, 2008, 263 pages).
The instant claims are as of record, drawn to a banana flower extract comprising N-β-citroyldopamine (Compound I / Formula I) and/or 6,2’,3’,6’-O-tetraacetyl-3-O-trans-p-coumaroylsucrose (Compound II / Formula II) and compositions for increasing hair root diameter and enhancing hair follicle robustness comprising the banana flower extract in the form of a solid powder and a carrier.
Lin et al. teach a method for promoting hair growth comprising a banana stamen (flower) extract (as required for instant Claims 1 and 12). The banana stamen extract is prepared by collecting banana flowers, washing the flower stamens with water, and then combining the stamens and water in a (1-5):(4-20) ratio. The stamens are then extracted via cold-sonication at 35-55°C for 30-90 minutes, and the crude extract is filtered through a 300 mesh screen to obtain the extract of the invention (Lin et al., col. 3, lines 12-28; as required for instant Claims 1, 2, and 12). When the extract is used as a composition, it is further added into a carrier or other adjuvant known in the art (Lin et al., col. 8, lines 26-28; as required for instant Claims 1 and 12). The extract has the effect of inhibiting hair loss (enhanced follicle robustness, see e.g., instant specification at [0128] wherein less hair loss is equated to better hair follicle stability; Lin et al., col. 2, line 33; col. 8, line 16; as required for instant Claim 12).
While Lin et al. do not teach the individual compounds comprised within the extract, e.g., N-β-citroyldopamine and/or 6,2’,3’,6’-O-tetraacetyl-3-O-trans-p-coumaroylsucrose (as required for instant Claims 1, 2, and 12). The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the water extract of the present invention and the water extract of Lin et al. are the same. Both are water extracts of banana stamens, and thus the presence of N-β-citroyldopamine and/or 6,2’,3’,6’-O-tetraacetyl-3-O-trans-p-coumaroylsucrose in the extracts is inherent, especially in the absence of evidence to the contrary. See MPEP §§ 2112-2112.02.
The cited reference discloses a banana stamen extract prepared by collecting banana flowers; washing the flower stamens with water; combining the stamens and water in a (1-5):(4-20) ratio; extracting the stamens via cold-sonication at 35-55°C for 30-90 minutes; and filtering the extract (Lin et al., col. 3, lines 12-28). This appears to be identical to the presently claimed composition since it is formulated and/or obtained from the same component materials using a similar process wherein banana flowers and their stamens are collected; banana flowers are added to 50°C water in a 1:4 weight ratio; the flowers are extracted at 50°C for 50 minutes; and the extract was filtered (Specification, [0059]-[0060]). The compounds N-β-citroyldopamine and/or 6,2’,3’,6’-O-tetraacetyl-3-O-trans-p-coumaroylsucrose were further isolated from this water extract using re-extraction and elution, indicating that water extracts of banana flowers prepared in the same manner would inherently comprise these compounds. The “comprising” composition claims do not exclude additional components, e.g., the other components of the water extract and merely require the presence of N-β-citroyldopamine and/or 6,2’,3’,6’-O-tetraacetyl-3-O-trans-p-coumaroylsucrose.
Additionally, while Lin et al. do not disclose the specific effects of increasing hair root diameter (instant Claim 1), the same composition (e.g., a water extract of banana flower stamens) applied to the same patient population (e.g., a patient in need of a hair treatment) would necessarily have the effect of increasing hair root diameter, even if that effect was not specifically analyzed, absent evidence to the contrary. The discovery of a previously unknown property of a prior art composition does not render the old composition patentably new. See MPEP § 2112(I).
Lin et al. do not teach wherein the banana flower liquid extract is dried to obtain a solid powder (instant Claims 1 and 12), nor do they teach n-butanol liquid-phase partition extraction (instant Claim 2).
Muhammad Suffi et al. teach that crude banana blossom extracts partitioned with n-butanol and dichloromethane have different anti-inflammatory effects (Muhammad Suffi et al., Anti-inflammatory, page 116).
Handa et al. teach that extracts obtained from plants can be prepared in different classes including powdered extracts (Handa et al., 1.2., page 22) which can be obtained via spray drying (drying the extraction liquid) and mixed with suitable diluents or excipients and blended to obtain a homogenous mixture which can be used for filling capsules or making tablets (solid powder; Handa et al., 1.2.2.2.4., pages 30-31).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide the composition of Lin et al. as a powder as taught by Handa et al. and to perform n-butanol fractionation as taught by Muhammad Suffi et al. A skilled artisan would be motivated to provide a powdered form of the extract because it can then be blended into a homogenous mixture which can be used for making solid powder tablets and could do so with a reasonable expectation of success because it providing a powdered extract is well-known in the art of plant extracts. Additionally, a skilled artisan would be motivated to perform liquid-phase partition extraction with n-butanol because different fractions have different effects, as shown by the different anti-inflammatory effects of various fractions of banana flower extracts as taught by Muhammad Suffi et al. Finally, a skilled artisan would be motivated to provide the n-butanol fraction of banana blossom extracts due to inhibition of IL-6 and NOX, which are inflammatory mediators (Muhammad Suffi et al., Anti-inflammatory, page 116).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, 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, 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).
Response to Arguments
Applicant's arguments filed 25 March 2026 have been fully considered but they are not persuasive. Applicant argues that because Lin et al. fails to disclose that the banana stamen extract comprises N-β-citroyldopamine and/or 6,2’,3’,6’-O-tetraacetyl-3-O-trans-p-coumaroylsucrose, the preparation process, and the dosage form, it would not have been obvious to a skilled artisan that those compounds were present and thus a skilled artisan would not know about the effects of increasing hair root diameter or enhancing follicle robustness.
This argument is not persuasive because while Lin et al. do not teach the individual compounds comprised within the extract, they do disclose a banana stamen extract prepared by collecting banana flowers; washing the flower stamens with water; combining the stamens and water in a (1-5):(4-20) ratio; extracting the stamens via cold-sonication at 35-55°C for 30-90 minutes; and filtering the extract (Lin et al., col. 3, lines 12-28). This appears to be identical to the presently claimed composition since it is formulated and/or obtained from the same component materials using a similar process wherein banana flowers and their stamens are collected; banana flowers are added to 50°C water in a 1:4 weight ratio; the flowers are extracted at 50°C for 50 minutes; and the extract was filtered (Specification, [0059]-[0060]). The compounds N-β-citroyldopamine and/or 6,2’,3’,6’-O-tetraacetyl-3-O-trans-p-coumaroylsucrose were further isolated from this water extract using re-extraction and elution, indicating that water extracts of banana flowers prepared in the same manner would inherently comprise these compounds. The “comprising” composition claims do not exclude additional components, e.g., the other components of the water extract and merely require the presence of N-β-citroyldopamine and/or 6,2’,3’,6’-O-tetraacetyl-3-O-trans-p-coumaroylsucrose.
Lin et al. do disclose that the extract has the effect of inhibiting hair loss (enhanced follicle robustness, see e.g., instant specification at [0128] wherein less hair loss is equated to better hair follicle stability; Lin et al., col. 2, line 33; col. 8, line 16). While applicant argues that because Lin et al. did not provide mechanical stress and thus did not demonstrate stability/robustness, the instant specification indicates that less hair loss means better hair follicle stability/robustness, and thus inhibition of hair loss would also fall under this description of follicle stability/robustness. Additionally, while Lin et al. do not disclose the specific effects of increasing hair root diameter, the same composition (e.g., a water extract of banana flower stamens) applied to the same patient population (e.g., a patient in need of a hair treatment) would necessarily have the effect of increasing hair root diameter, even if that effect was not specifically analyzed, absent evidence to the contrary (e.g., lack of efficacy of a liquid extract and/or demonstrated criticality of providing the extract as a solid powder). The discovery of a previously unknown property of a prior art composition does not render the old composition patentably new. See MPEP § 2112(I).
It is unclear how the argument regarding dihydrotestosterone for use in prostate care is related to Lin et al., which only mentions dihydrotestosterone (at col. 1, line 59) and the prostate (at col. 1, line 60) once each. The invention of Lin et al. is drawn to use of a banana stamen extract for promoting hair growth and thus it is unclear how the hormonal profiles presented in the table on pages 12-13 of the response is related to the instant rejections.
Applicant’s arguments with respect to the solid powder dosage form and n-butanol fractionation preparation method have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., patient populations with differing hormonal profiles; high concentration of active ingredients; transformative process; low concentration of 10 μg/mL; inhibition of dihydrotestosteron) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
No claims are allowed.
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.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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