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 .
Election/Restrictions
Applicant's election with traverse of Group IV (claims 22-27), drawn to a method of using an extract of the aerial parts of prunella vulgaris, in the reply filed on March 26th, 2026 is acknowledged. The traversal is on the ground(s) that 37 CFR 1.475 (b) provides that unity of invention may be present for combinations such as a product and process special unity of invention may be present for combinations such as: a product and a process specially adapted for the manufacture of said product; a product and a process of use of said product; and a product, a process of manufacture, and a use of the product. This is not found persuasive because 37 CFR 1.475 (b) does not provide exceptions that override. Claims 15-21 and 28 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the lack of unity (election) requirement in the reply filed on March 26th, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Applicant's election with traverse of species in the reply filed on M is acknowledged. The traversal is on the ground(s) that these variations represent alternative embodiments and closely related uses of the same extract. This is not found persuasive because each use is distin. Claim 24, and the subject matter of species C and E, are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 26th 2026.
Claims 22, 23, and 25-27 are pending and were examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The foreign priority date is September 6th, 2021.
Information Disclosure Statement
The information disclosure statement filed April 4th, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because illegibility in the translated abstract of CN108272858B. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
The drawings were received on March 4th, 2024. These drawings are acceptable.
Specification
The disclosure is objected to because of the following informalities: "Fischer" is a misspelling of "Fisher" (page 36, line 1 from the bottom).
Appropriate correction is required.
The use of the terms Avantec, Matrigel, Corning, Bachem, Sigma-Aldrich, PromoCell, Dogen, Cytox, Carl Zeiss, Thermo Scientific, Superfrost, Dako, Agilent, Thermo Fisher Scientific, click-iT, Alexa, Aristoflex, Nipaguard, Hostacerin, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following each term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 27 is objected to because of the following informalities: the meaning of the term "non-therapeutic" in the context of claim 27 is unclear, because claim 27 is drawn to a method intended to have therapeutic effects of treating disorders and/or damages in the hair follicles of a subject. The amendment of claim 27 by removing the term "non-therapeutic" would resolve this contradiction.
Claim 27 is objected for depending on withdrawn claim 15. Suggest incorporating the compositional components in independent claim 27.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 22, 23, 25, and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the steps of the process of using the composition (according to claim 15) for preventing and/or treating psychoemotional stress related disorders and/or damages on the hair follicles.
Claim Rejections - 35 USC § 112
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.
Claim 27 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating stress-induced disorders and/or damages in the hair follicles of a subject, does not reasonably provide enablement for preventing stress-induced disorders and/or damages in the hair follicles of a subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method intended for preventing and/or treating stress -induced disorders and/or damages in the hair follicles of a subject by applying a water extract of Prunella vulgaris to the skin and/or scalp. Thus, the claims taken together with the specification imply that applying a water extract of Prunella vulgaris the method prevents stress-induced disorders and/or damages in the hair follicles of a subject.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Roh et al. (Evid Based Complement Alternat Med. 2018, 2018, 1762478) recites cortisol synthesis and secretion in the adrenal glands, under control of the hypothalamic-pituitary-adrenal (HPA) axis, which is stimulated by stress (Introduction, paragraph 1). Roh et al. demonstrated a water extract of Prunella vulgaris inhibiting the expression of an enzyme 11β-hydroxysteroid dehydrogenase 1 (11β-HSD1) responsible for converting cortisone to cortisol in keratinocytes (in vitro) treated with cortisone, and decreasing the concentration of cortisol in keratinocytes treated with cortisone (Materials and Methods and Supplementary Figure 1). The authors identified the polyphenol rosmarinic acid as an active ingredient in these activities (Discussion, paragraph 4, and Supplementary Figure 1).
Chapman et al. (Physiol Rev, 2013, 93, 1139-1206) recites an enzyme 11β-HSD2 expressed in the skin that converts cortisol to cortisone (Chapman; Figure 1; I. Introduction, subheading F. Measurement of 11β-HSDs, paragraph 2; III. 11β-HSD2 Gene Structure, Enzymology, and Regulation, subheading E. 11β-HSD2: Tissue Distribution).
Thom (J Drugs Dermatol. 2016, 15 (8), 1001-1004) recites cortisol induced hair loss (Stress and the Hair Follicle, paragraph 2), and cortisol-induced damage to the proteoglycans in and around the hair follicles (Proteoglycans and Cortisol, paragraph 5).
The references cited above do not recite a method of applying a Prunella vulgaris extract that prevents stress-induced disorders and/or damages in the hair follicles of a subject, in which cortisol concentrations may deviate from that in in vitro keratinocytes. They likewise do not recite a method of applying a Prunella vulgaris extract that prevents disorders and/or damages to the or follicles resulting from the following stressors: environmental toxin exposure, radiation, pathogens, or mechanical stress.
Since the method of applying an extract of Prunella vulgaris to the skin and/or scalp that prevents disorders and/or damages to the hair follicles from a range of stress conditions, not modeled in vitro, but possible in vivo, remain largely unsolved, means for preventing stress-induced disorders and/or damages in the hair follicles of a subject organism is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. Roh et al. identified an active ingredient (rosmarinic acid) in a Prunella vulgaris extract that inhibits the expression of 11β-HSD1 and decreases the concentration of cortisol in keratinocytes treated with cortisone.
Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided treating stress-induced disorders and/or damages in the hair follicles of a subject by applying an extract of Prunella vulgaris to the skin and/or scalp (Examples 2.4-2.6). However, the specification does not provide preventing stress-induced disorders and/or damages in the hair follicles of a subject by applying an extract of Prunella vulgaris to the skin and/or scalp. Through the demonstrated biological activity of a Prunella vulgaris extract, the cited examples provide a reasonable expectation of success at treating stress-induced disorders and/or damages in the hair follicles of a subject by applying an extract of Prunella vulgaris to the skin and/or scalp. However, given that the cortisol concentrations of a subject could deviate from those in the exemplary models, and certain chemical and/or mechanical stressors may be present that are not modeled in the examples, preventing (understood as preventing entirely) stress-induced disorders and/or damages in the hair follicles of a subject by applying an extract of Prunella vulgaris to the skin and/or scalp is not within the scope of enabled subject matter.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Roh et al., Chapman et al., and Thom, and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to prevent stress-induced disorders and/or damages in the hair follicles of a subject by applying a water extract of Prunella vulgaris to the skin and/or scalp.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 22, 23, 25, and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a use, not a process, machine, manufacture, or composition of matter.
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 27 is rejected under 35 U.S.C. 103 as being unpatentable over Roh et al. (Evid Based Complement Alternat Med. 2018, 2018, 1762478), non-patent literature document 2 on the IDS received on 4/4/2024, abbreviated “Roh”; and further in view of Chapman et al. (Physiol Rev, 2013, 93, 1139-1206), abbreviated "Chapman"; and Thom (J Drugs Dermatol. 2016, 15 (8), 1001-1004).
Claim 15 recites “An extract of the aerial parts comprising the leaves, stems and flowers of Prunella vulgaris, the extract being obtained by a solid/liquid extraction in a solvent selected from water or a mixture of water and an alcohol, wherein:
it comprises 1 to 15%, preferably 2 to 12%, more preferably 3 to 10% by weight of one or more polyphenols, based on the total weight of the dry content of the extract;
it comprises less than 0,1%, preferably less than 0,01%, more preferably less than 0,001%, particularly 0% by weight of saponins, based on the total weight of the dry content of the extract;
the dry content of the extract represents at least 10 g/L (weight/volume of solvent), preferably at least 15 g/L, even more preferably at least 20 g/L”.
Claim 27 recites “A cosmetic non-therapeutic method intended for preventing and/or for treating the stress-induced disorders and/or damages in the skin and in the hair follicles of a subject by applying, onto the skin or the scalp on need, an effective amount of a composition comprising or consisting of an extract of the aerial parts of Prunella vulgaris according to claim 15”.
Roh recites the synthesis of cortisol in the adrenal cortex under the control of the hypothalamic-pituitary-adrenal (HPA) axis, which can be stimulated by stressors:
“Glucocorticoid (GC) hormones are released in response to various physiological stressors and psychological stress [1]. It regulates various biological processes which induce diverse responses including differentiation, proliferation, and apoptosis [2]. The major GC, hydrocortisone, or cortisol is mainly synthesized and secreted in the adrenal cortex and regulated by adrenocorticotropic hormone (ACTH) under the control of hypothalamic-pituitary-adrenal (HPA) axis [3]. Various stressors, such as inflammation, viral infection, or feeling of strain and pressure, can stimulate the HPA axis [4]. Extra-adrenal production of cortisol has recently reported in various tissues [5]. Skin cells have also been reported to synthesize cortisol through activation of the enzyme, 11β-HSD1 [6, 7]” (Introduction, paragraph 1).
Roh further recites detrimental effects of glucocorticoid hormones on skin health and the activity of 11β-HSD1 enzyme converting inactive cortisone to active cortisol:
“In skin, excessive GC production leads to marked skin integrity, including thinning and the dermal-epidermal junction (DEJ) flattening, decreased dermal cellularity, reduced collagen content, and dermal fibroblast proliferation [8–11]. Cortisol levels are regulated by isoenzymes of 11β-hydroxysteroid dehydrogenase 1 (11β-HSD1), which catalyzes the intracellular conversion of inactive cortisone into active cortisol” (Introduction, paragraph 2).
Roh recites extracting the aerial parts of Prunella vulgaris (broadly known in the art as comprising solid plant material), having been dried and ground into a fine powder (subheading 2.1; claim 15 limitations). Water was the extraction solvent (Roh, subheading 2.1; claim 15 limitations). The liquid extract was freeze dried, then dissolved in distilled water for further experiments (Roh, subheading 2.1; claim 15 limitations). Roh reported the Prunella vulgaris extract comprising 3.5 % rosmarinic acid, a polyphenol (Roh, subheading 3.1). Figure 1). Roh administered the Prunella vulgaris extract to HaCaT cells, keratinocytes (subheadings 2.2, 2.5, 2.6, and 2.9). The Prunella vulgaris extract inhibited both 11β-HSD1 expression and cortisol production in cortisone-induced HaCaT cells (subheadings 3.2 and 3.3). Roh further recites “Water extract of PV is mainly composed of rosmarinic acid and caffeic acid (Figure 1). Rosmarinic acid, a major constituent, showed independent inhibitory activity of 11β-HSD1, whereas caffeic acid was not observed (supplementary Figure 1)” (Discussion, paragraph 4). Supplementary Figure 1 of Roh shows a pre-treatment of rosmarinic acid independently inhibiting the production of cortisol in HaCaT cells treated with cortisone. According to Roh, Supplementary Figure 1, there was a statistically significant (P < 0.05) lower expression of “HSD11β1” (11β-HSD1, in view of the pervious quote from the Discussion) and cortisol concentration, for cultures treated with both cortisone and rosmarinic acid (100 and 200 μM) or cortisone and the Prunella vulgaris extract (100 and 200 ppm), relative to a control treated with cortisone but not rosmarinic acid, caffeic acid, or Prunella vulgaris extract. In the cell cultures not treated with rosmarinic acid, caffeic acid, or Prunella vulgaris extract; the expression of 11β-HSD1 and cortisol concentration was greater with cortisone treatment than without (p < 0.01) (supplementary Figure 1). Therefore, rosmarinic acid is shown to independently counteract both the cortisone-induced expression of 11β-HSD1 and the increase in cortisol concentration in HaCaT keratinocytes (supplementary Figure 1).
From the teachings of Roh, rosmarinic acid is a polyphenolic component of a Prunella vulgaris aerial parts extract, within 1-15%, and an independent active ingredient against the expression of 11β-HSD1 and cortisol production in keratinocytes (instant claim 27). Therefore, one of skill in the art would have had a reasonable expectation of success at applying a composition within the limitations of claim 15 to the skin inhibit cortisone-induced expression of 11β-HSD1 and cortisone-induced cortisol production in keratinocytes, and to achieve downstream physiological effects of these inhibitions (instant claim 27).
As of record above from Roh, the adrenal cortex synthesizes and secretes cortisol under the control of the hypothalamic-pituitary-adrenal (HPA) axis, which can be stimulated by stressors including a feeling of strain or pressure. The cortisol secreted under stress can be converted to the inactive cortisone by 11 beta-dehydrogenase II, 11β-HSD2 (Chapman, Figure 1, and I. Introduction, subheading F. Measurement of 11β-HSDs, paragraph 2). 11β-HSD2 is expressed in the skin epithelium (Chapman, III. 11β-HSD2 Gene Structure, Enzymology, and Regulation, subheading E. 11β-HSD2: Tissue Distribution). Therefore, cortisone levels in the skin would reasonably be elevated under stress. As of record above from Roh, a Prunella vulgaris extract, specifically the rosmarinic acid component, would decrease the conversion of cortisone to cortisol in skin tissue. Thom recites cortisol inhibiting the growth of hair: “After a period of acute or chronic stress many individuals will experience an increased amount of hair loss. In murine studies, chronic stress was significantly associated with hair growth inhibition, increased granulation of mast cells and perifollicular inflammation.8 Further studies, both in vitro and in vivo, have demonstrated that certain stress-mediating substances such as substance P, adrenocorticotropic hormone, prolactin, and cortisol actually inhibit the growth of hair.9-1”(Stress and the Hair Follicle, paragraph 2). Thom further recites cortisol-induced damage to the proteoglycans in and around the hair follicle “Specifically, high concentrations of cortisol in the body are known to have a damaging effect on proteoglycans in and around the hair follicle.10,18” (Proteoglycans and Cortisol, paragraph 5). Therefore, from Roh, in further view of Chapman and Thom, it would be obvious to one of skill in the art to apply to the skin or scalp a Prunella vulgaris aerial parts extract comprising the polyphenol rosmarinic acid (instant claim 27). Doing so, one of sill in the art would have a reasonable expectation of success at attenuating and/or treating stress-induced disorders and/or damages in the hair follicles of a subject (instant claim 27). A motivation of performing such a method would be in treating and/or preventing alopecia (hair loss) for perceived aesthetic enhancement (instant claim 27).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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