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 .
Applicant’s representative correctly notes that the restriction requirement appears to have been performed on an old claim listing and that a preliminary amendment was filed on 12 June 2026 in which the composition claims were cancelled. Applicant compiled with all elections as set forth by the Examiner in the 06 July 2026 restriction requirement. Applicant’s elections are readable on the instant claim listing and have been applied.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 9-29) in the reply filed on 04 September 2026 is acknowledged.
No claims are withdrawn as a result of this election as the composition claims were already cancelled in a preliminary amendment on 12 June 2026.
Applicant’s election without traverse of:
A copper chlorin- Copper chlorin e6; -and-
Gene Expression-Upregulation of the FOS gene and downregulation of the IGHV3 in the reply filed on 04 September 2026 is acknowledged.
Claims 13, 15 & 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04 September 2026.
Claim Status
Applicant’s claim amendments in the response filed 04 September 2026 are acknowledged.
Claims 9-29 are pending.
Claims 1-8 are cancelled.
Claims 9, 13-17 & 22-24 are amended.
Claims 13, 15 & 25 withdrawn.
Claims 9-12, 14, 16-24 & 26-29 are under consideration.
Examination is to the extent of the following species:
A copper chlorin- Copper chlorin e6; -and-
Gene Expression-Upregulation of the FOS gene and downregulation of the IGHV3.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 23 January 2026 and 15 July 2026 have been fully considered by the examiner. A signed and initialed copy of each IDS is included with the instant Office Action.
Objections/Rejections
Drawings
The drawings are objected to because the labels on the figures are not consistent. Figures 1a, 1b, 2a, and 2b are labeled as “Figure 1a”, “Figure 1b”, “Figure 2a”, and “Figure 2b”. However, Figures 3-6 are labeled as “FIG. 3”, “FIG. 4”, “FIG. 5” and “FIG 6”. Applicant is required to consistently label the figure legends.
FIG. 3 is also objected to because it contains an illegible bibliographic reference at the top of the figure. Specifically:
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FIG. 3 also has a secondary figure label that appears to credit the illegible bibliographic reference.
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However this secondary label will confuse the printer should this application issue to patent; it will also be confusing to a person of ordinary skill reading the document. To be clear, the illegible bibliographic reference and the secondary “Fig. 1” legend/description is required to be removed. Applicant already cites Tumolo in the “BRIEF DESCRIPTION OF THE DRAWING” section (see Fig. 3 description).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: The “BRIEF DESCRIPTION OF THE DRAWING” does not refer to the figures by a consistent name/nomenclature. Paragraph [0045] refers to “Figures 1a and 1b” and “Figures 2a and 2b”. However, paragraph [0045] also refers to Figures 3-6 as ““FIG. 3”, “FIG. 4”, “FIG. 5” and “FIG 6”. Applicant is required to refer to the figures by a consistent nomenclature that matches that which they have selected for the figures in their figure legend.
Appropriate correction is required.
The specification is also objected to because it does not have the tradenames/trademarks properly denoted. This oversight is present throughout the entire specification. For examples, the use of the term “Transcutol P” (Table 1B), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term (emphasis added).
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.
Applicant is required to check their specification in its entirety for tradenames/trademarks and ensure that they are properly denoted (see also “Phospholipon” 90G in Table 1C).
Claim Objections
Claim 11 objected to because of the following informalities: claim 11 has a typographical error in line 2 reciting “or” instead of “of”. The claim should read “the dose is around 0.3 grams…per 700 cm2 of the area of human hair”.
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.
Claims 27-29 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.
Claim 27 contains the trademark/trade name S75 lecithin which is an abbreviation of the product “soybean lecithin S75” by Lipoid. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe soybean derived phospholipids with phosphatidylcholine content of 70% and, accordingly, the identification/description is indefinite.
Claims 28 & 29 are rejected under 35 USC 112(b) because they depend from indefinite claim 27 and do not clarify the issue.
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 26, 28 & 29 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.
Claims 26 & 28 ultimately depend from independent claim 9. Independent claim 9 recites “a post-treatment period of six weeks following the end of the treatment period”. The post-treatment period duration is limited to six weeks by claim 9. However, claims 26 & 28 expand the duration of the post treatment to “18 weeks following the end of the treatment period”. 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.
Claim 29 is rejected under 35 USC 112 (d) because it depends from rejected claim 28 and does not rectify the issue.
Claim Rejections - 35 USC § 103
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.
Claims 9, 14, 16, 18, 19 & 26 are rejected under 35 U.S.C. 103 as being unpatentable over McCook [(US 2012/0283235: Published: 11/08/2012; IDS-01/23/2026); as evidenced by Sodium Copper Chlorin E6 (https://www.pharmacompass.com/chemistry-chemical-name/sodium-copper-chlorin-e6; Retrieved: 09/28/2026)] in view of Mangan (US 2002/0119204; Published: 08/29/2002).
Claim Interpretation: The examiner notes that the term “approximately” is not defined by the instant specification. The examiner has interpreted this term with its plain meaning of “about”, “around” or “close to”.
With regard to the post-treatment duration, the examiner has interpreted this limitation “as comprising” the recited number of weeks in light of 35 USC 112(d) rejections and the claim 9 recitation of “the method comprising:…”which permits additional weeks.
With regard to claims 9 & 14, McCook in Example 46 teaches a chlorophyllin lotion (i.e. carrier; [0169] & [0170]). With regard to claims 9 & 14, McCook in Example 46 teaches the lotion comprises 0.01% sodium copper chlorophyllin (i.e. sodium copper chlorin; [0169] & [0170]). With regard to claim 9, while McCook is silent to the form of the sodium copper chlorophyllin in the Example 46 lotion; McCook teaches the porphyrin suitable for their invention includes “sodium and potassium salts of copper complex of chlorin e6” in their claim 2. McCook reiterates the suitability of the e6 form by teaching “fifth aspect of the present invention is directed to methods and formulations for the topical treatment of thinning hair or alopecia comprising topical administration of (i)…chlorin e6 … the chlorins or chlorin ethyl esters preferably in the form of the sodium or potassium salts of their copper and zinc complexes” [0014]. It would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified McCook’s Example 46 lotion by substituting the generically taught sodium copper chlorophyllin with sodium copper chlorophyllin e6 as taught by McCook because sodium copper chlorophyllin e6 is a form of sodium copper chlorophyllin suitable for methods and formulations for the topical treatment of thinning hair or alopecia as taught by McCook. The ordinary skilled artisan would have been motivated to do so, with an expectation of success in order to treat thinning hair or alopecia. With regard to claim 9, since McCook teaches the composition is used to treat thinning hair or alopecia and these conditions occur on the scalp, the sodium copper chlorophyllin taught by McCook is an active agent that increases a density or diameter of terminal hairs [0014]. With regard to claim 9, since McCook teaches the composition is used to treat thinning hair or alopecia and these conditions occur on the scalp, “the density or the diameter of the terminal hairs in the area of human hair” necessarily “has a first value prior to the treatment period and a second value at an end of the treatment period, wherein the second value is larger than the first value” since the composition is treating thinning hair or alopecia. With regard to claim 18, McCook in Example 46 teaches the lotion comprises 0.01% sodium copper chlorophyllin, 2.01% butylene glycol and 3.0% pentylene glycol (i.e. glycol solvents in an amount of 5.01%), and water ([0169] & [0170]). More broadly, McCook in Example 18 teaches a gel comprising sodium copper chlorin e6 in an amount of 0.02 percent [0110]. With regard to claim 18, as such, it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the amount of sodium copper chlorophyllin to be between 0.01% to 0.02% of the lotion composition because McCook teaches this range as suitable for topical formulations. With regard to claim 19, as evidenced by Sodium Copper Chlorin E6, chlorophyllin sodium copper salt, is a trisodium salt (see Chemistry and chemical structure; pg. 1). With regard to claim 18, McCook in Example 46 teaches the lotion comprises the emulsifier lecithin 85G in an amount of 0.02% and the emulsifiers glyceryl stearate and PEG-100 stearate in an amount of 3.0 % (i.e. a combined amount of 3.02%; [0169]). With regard to claim 18, McCook teaches inclusion of retinoids including vitamin A (i.e. an antioxidant) in an amount from about 0.05% to about 0.1% ([0033] & [0034]). With regard to claim 18, McCook in the Example 46 lotion teaches the non-aqueous solvents of caprylic/capric triglyceride, cetyl alcohol, and stearyl alcohol in a combined amount of 8.0% [0169].
McCook does not teach the method step of applying the composition to an area of human hair experiencing thinning resulting from ageing approximately once a day over a treatment period or that the “density or the diameter of the terminal hairs did not show regression from the second value to the first value within a post-treatment period of six weeks following the end of the treatment period”.
In the same field of invention, Mangan teaches a composition and method for growing hair (title). With regard to claim 9, Mangan teaches their invention relates to compositions and methods for stimulating growth of hair and that while the “mechanisms of how baldness occurs are not yet well known in detail”, “aging is believed to accelerate epilation and it is also believed that, as hair follicles age, they suffer depression of cell division ability and cell differentiation ability and depression of metabolic activity, leading to thinning of hair and epilation” ([0002] & [0016]). With regard to claim 9, Mangan teaches the mesenchyme extract of their invention “is effective for any alopecia” (emphasis added; [0026]). With regard to claim 9, Mangan teaches “patients average 10%-55% follicle regrowth after one treatment. The treatment grows hair on entire scalp including hair line”, indicating that “depression of cell division ability and cell differentiation ability and depression of metabolic activity” associated with aging is improved (i.e. the density of the terminal hairs has a first value prior to the treatment periods and a second value at the end of the treatment period in which the second value is larger than the first value; [0030]). With regard to claim 9, Mangan teaches an adjuvant therapy to their oral mesenchyme extract in which “the application of saliva to the scalp appears to increase efficacy. External topical application of saliva appears to be effective as an enzymatic catalyst and is thus is applied while taking the treatment” [0029]. With regard to claim 9, Mangan in their claim 15 teaches their method further comprises “topical application of saliva to said animal on a portion of said animal at which hair growth is desired, around the time of administering said composition”. With regard to claim 9, Mangan in their claim 13 teaches their method involves administering the composition twice daily for between 7 and 30 days (i.e. treatment period of 7-30 days; twice daily administration is approximately once per day since it is about or around once per day). As such, with regard to claim 9, the ordinary skilled artisan would immediately envisage twice daily administration (approximately once per day) of the topical saliva composition for 7-30 days because Mangan teaches its application “around the time of administering said composition” and this is the treatment period and frequency for application of the composition as taught by claim 13 of Mangan. With regard to claims 9 & 26 Mangan teaches in Examples 1, 3 & 7 administration of the extract composition to men that were 55, 41, and 59 years old respectively; these men retained their hair growth with “no hair loss or side effects” in the 11 month post treatment period (i.e. post-treatment period is 44 weeks which encompasses 6 weeks and 18 weeks; [0038], [0040] & [0044]).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rationale (F) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified Mangan’s method to treat hair thinning resulting from aging without post-treatment regression, by varying the method based upon McCook’s teachings by combining Mangan’s adjuvant topical saliva with McCook’s modified Example 46 lotion because both Mangan and McCook are drawn to methods and compositions to treat alopecia and it is obvious to modify similar methods in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to increase the efficacy of Mangan’s method by supporting the conditions for hair growth internally and externally by combining the Mangan’s saliva which is an enzymatic catalyst with McCook’s topical lotion which is taught for treating alopecia through topical delivery of sodium salts of copper chlorin e6.
With regard to the claim 9 recitation of “the expression of one or more genes is upregulated or down regulated” with FOS being upregulated and IGHV3 being downregulated and the claim 16 recitation of “the FOS is upregulated by 200% or more within 24 hours after topically applying the dose”, these results necessarily arise from practicing the recited method with the recited composition (see instant specification: Table 4; paragraphs [0040], [0104], [0109] & [0113]-[0116]). “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Further, "products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
With regard to the recited post-treatment duration, administration frequency, and amount of one or more active agents, the non-aqueous solvent, the glycol solvent, the surfactant or emulsifier, and the antioxidant, the combined teachings of McCook and Mangan suggest a method and composition having these parameters with values which overlap with the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 10 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over McCook and Mangan as applied to claims 9, 14, 16, 18, 19 & 26 above, and further in view of Rogaine [(Published: 01/20/2022) as evidenced by Wu (US 2004/0043961; Published: 03/04/2004)].
Claim Interpretation: As above.
The teachings of McCook and Mangan are described above. With regard to claim 10, McCook teaches the composition of Example 46 is a lotion. With regard to claim 10, as evidenced by Wu, lotions are liquid preparations [0047]).
Neither McCook nor Mangan teach the dose of the composition is around 0.001 grams to around 0.002 grams per cm2 of the area of human hair or around 0.3 grams to 2 grams per 700 cm2 of the area of human hair.
In the same field of invention of growing hair, with regard to claims 10 & 11, Rogaine teaches application of 1 ml of Rogaine to the scalp (an area which is 700 cm2 in human; pg. 27). With regard to claim 11, the ordinary skilled artisan knew that 1 ml water weighs approximately 1 gram. As such, with regard to claim 10, Rogaine teaches the amount administered is approximately 0.0014 grams per cm2 [Math: 1g/700 cm2 = 0.0014].
Here, rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the method suggested by the combined teachings of McCook and Mangan by adjusting the dose administered to the scalp to be 1 ml (yielding 1 gram per 700 cm2 and 0.0014 grams per cm2 ] as taught by Rogaine because McCook, Mangan and Rogaine are directed to composition and methods of growing hair by topical application of a composition to the scalp and it is obvious to modify similar methods in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, because this amount per area is suitable for application to the scalp for the compositions which treat thinning hair as taught by Rogaine.
With regard to the recited amounts per area, the combined teachings of McCook, Mangan and Rogaine suggest these parameters with values which fall within the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over McCook and Mangan as applied to claims 9, 14, 16, 18, 19 & 26 above, and further in view of EFSA (Published: 2015).
Claim Interpretation: As above.
The teachings of McCook and Mangan are described above.
Neither McCook nor Mangan teach the dose comprises around 20 to around 1000 μg of the copper chlorin.
EFSA teaches sodium or potassium salt of the Cu-chlorophyllins including Cu-Chlorin e6 as food additives (title; pg. 16, 30, & 31). With regard to claim 12, EFSA teaches human subjects ate 300 mg of the copper chlorophyllins (pg. 31). With regard to claim 12, EFSA teaches the FDA determined that an oral dose daily dose should not exceed 300 mg/day (pg. 39). With regard to claim 12, EFSA teaches there is limited data on the absorption, distribution, metabolism and excretion of Cu-chlorophyllins (pg. 30).
Here at least rationale (G) may be applied, in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the method suggested by the combined teachings of McCook and Mangan by adjusting the amount of sodium copper chlorin e6 to be up to 300 mg suggested by EFSA because EFSA teaches that there is limited data on the absorption, distribution, metabolism and excretion of Cu-chlorophyllins, with the FDA limiting the oral dose to 300 mg. The ordinary skilled artisan would have been motivated to do so, with an expectation of success in order to use the known quantity of 300 mg as a reference point to find the efficacious dose for treating hair that has thinned from aging without producing a toxic reaction in the subject.
With regard to the recited amount of copper chlorin, the combined teachings of McCook, Mangan, and EFSA suggest their parameter in amounts which overlap with the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 17 & 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over McCook and Mangan as applied to claims 9, 14, 16, 18, 19 & 26 above, and further in view of Medication for Hair Loss (Published: 2022).
Claim Interpretation: As above.
The teachings of McCook and Mangan are described above. Mangan in claim 13 teaches that composition for hair growth is administered between 7 and 30 days.
Neither McCook nor Mangan teach the treatment period is at least six months or at least 160 days.
With regard to claims 17, 20 & 21, Medication for Hair Loss teaches hair loss medication like topical minoxidil stops hair from falling out and that it may take four months to a year of twice daily application for hair to noticeably thicken with the dermatologist assessing how well the medication is working after 6 months (i.e. 180 days; pg. 4 & 5).
Here at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the method suggested by the combined teachings of McCook and Mangan by adjusting the treatment period to be 6 months (i.e. 180 days) as suggested by Medication for Hair Loss’s teachings because McCook, Mangan and Medication for Hair Loss are directed to compositions and methods to treat thinning hair and it is obvious to modify similar methods in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to use the standardized time frame used by dermatologists to assess whether a topical hair treatment composition is working.
With regard to the claim 17 recitation of “the IGHV3 is downregulated by 200% or more when measured at an end of the treatment period”, claim 21 recitation that the “IGHV3 comprises one or more subtypes…”, the claim 23 recitation that the expression of the IGHV3 is downregulated by at least 200%, and the claim 24 recitation that the expression of FOS is upregulated by at least 200%, these results necessarily arise from practicing the recited method with the recited composition (see instant specification: Table 4; paragraphs [0040], [0104], [0109] & [0113]-[0116]). The recited method and composition is suggested by the combined teachings of McCook, Mangan and Medication for Hair Loss. “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Further, "products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claims 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over McCook and Mangan as applied to claims 9, 14, 16, 18, 19 & 26 above, and further in view of Cronk (US 2008/0206156; Published: 08/28/2008; IDS-07/15/2026), Real Self (Published: 10/02/2016).
Claim Interpretation: As above. The claim 27 recitation of S75 lecithin is interpreted as soybean lecithin.
The teachings of McCook and Mangan are described above. With regard to claim 27, McCook teaches their Example 46 lotion comprises butylene glycol, and pentylene glycol. With regard to claim 27, McCook teaches inclusion of ascorbic acid/vitamin C in composition to treat thinning hair or alopecia (McCook’s claim 1; [0014]). With regard to claim 27, it would have been prima facie obvious to the ordinary skilled artisan to have added ascorbic acid/vitamin C to the Example 46 lotion based upon McCook’s teachings of its suitability for use in their invention. With regard to claim 27, McCook teaches inclusion of lecithin 85G (i.e. soy lecithin) in the Example 46 lotion and more broadly teaches the lecithin is derived from soybean [0028]. With regard to claim 28, Mangan teaches the post-treatment periods is 11 months (i.e. comprising 18 weeks). With regard to claim 29, McCook in the Example 46 lotion teaches inclusion of 0.8%, carbomer (i.e. viscosity control agent), 1.0% triethanolamine (i.e. preservative) and 0.5% lactic acid (pH adjusting agent). With regard to claim 29, while McCook is silent to the pH of the Example 46 lotion, McCook more broadly teaches that liposomal dispersions of the copper chlorin e6 has a pH of from 7.0 to 8.0 [0030]. It would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the method suggested by the combined teachings of McCook and Mangan by adjusting the pH of McCook’s Example 46 lotion to be from 7.0 to 8.0 because McCook teaches this pH is appropriate for the topically applied formulations of their invention.
Neither McCook nor Mangan teaches the non-aqueous solvent comprise SD alcohol, 190 proof or S75 lecithin.
In the same field of invention of spray medications involving the scalp that are supplied an amount sufficient to stimulate or maintain hair growth, Cronk teaches “this spray medication is transparent on the scalp and does not need to be rubbed into the skin of the scalp to be effective in stimulating or maintaining hair growth” and that the carrier solution is a pharmacological carrier solution [0030]. In the Examples, Cronk teaches Carrier 2 which comprises 16.8% SD alcohol, ethanol or isopropanol [0044]. The ordinary skilled artisan before the effective filing date knew that alcohol is a penetration enhancer and solvent.
In the same field of invention, with regard to claim 27, Real Self teaches minoxidil comprises 95% pure alcohol (i.e. the composition is 190 proof).
With regard to claim 27, it would have been prima facie obvious to have modified the method suggested by the combined teachings of McCook and Mangan by adding SD alcohol, 190 proof (i.e. 95%) to the Example 46 lotion as suggested by the combined teachings of Cronk and Real Self because McCook, Mangan, Cronk and Real Self are directed to compositions and methods to treat thinning hair/ alopecia and it is obvious to modify similar methods in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to deliver the sodium copper chlorophyllin e6 to the scalp without rubbing since SD alcohol is a known penetration enhancer used in scalp compositions as taught by Cronk. It would have been prima facie obvious to have selected of 190 proof (i.e. 95% alcohol) as a starting point for optimization since 95% alcohol (190 proof) is used to deliver minoxidil to the scalp as taught by Real Self.
With regard to the recited post-treatment duration; the amount of viscosity control agent, and preservative; and the pH of the composition, the combined teachings of McCook, Mangan, Cronk and Real Self teach these parameters with values which overlap with the recited ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
No claims are allowed.
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/LORI K MATTISON/Examiner, Art Unit 1619
/NICOLE P BABSON/Primary Examiner, Art Unit 1619
