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 .
Status of Application, Amendments, And/Or Claims
The Applicants amendments/remarks received 5/5/2026 are acknowledged. Claims 4-9 are amended; claims 1-3 and 10 are canceled; no claims are withdrawn; claims 12-22 are new; claims 4-9 and 11-22 are pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statement submitted on 5/5/2026 has been considered by the examiner.
Claim Objections
The objection to claim 5, as set forth at pp. 6 of the previous Office Action, is withdrawn in view of the amendment of the claim.
Claim Rejections - 35 USC § 112
The rejection of claims 4-9 and 11 under 35 U.S.C. § 112(a), as set forth at pp. 6-8 of the previous Office Action, is withdrawn in view of the amendment of the claims.
The rejection of claims 5-9 under 35 U.S.C. § 112(b), as set forth at pp. 8-9 of the previous Office Action, is withdrawn in view of the amendment of the claims.
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 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.
Claims 4, 6-9, 11-13 and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Riordan et al., US 2012/0195969 (cite A, PTO-892, 12/19/2022; herein “Riordan”) in view of Silva et al., US 8778679 (cite B, PTO-892, 12/19/2022; herein “Silva”).
Claims 4-9 and 11-22 are drawn to compositions not methods. The limitations in claims 4, 18-19 and 22 directed to processes of producing the composition are considered to be product-by-process limitations and as noted in MPEP § 2113: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). There is no indication in the instant specification that serial collection of the conditioned media provides any physical, structural or functional difference to conditioned media. Product-by-process limitations are considered only insofar as the method of production imparts distinct structural or chemical characteristics or properties to the product. In this case, the serial collection of the conditioned media at 3-day intervals would not be expected to impart distinctive structural characteristics to the conditioned media (final product) relative to the collection of a single conditioned media.
Riordan teaches compositions for treatment of acne by topical administration, i.e., cosmetic compositions, comprising products generated from the culture of stem or progenitor cells (Abst.) wherein the products generated from the culture of stem or progenitor cells are in stem cell conditioned culture media [0010] and the stem cells are Wharton’s Jelly stem cells ([0075-6], [0127]), i.e., cosmetic compositions comprising conditioned media from ULSCs (Wharton’s Jelly stem cells). Wharton’s Jelly stem cells are umbilical lining stem cells (ULSCs) as taught by Silva.
Silva teaches that umbilical cord lining is the gelatinous cord material (i.e., Wharton’s jelly) (col. 4, ll. 3-5) and teaches that ULSCs are obtained by culturing the pieces of cord lining (Wharton’s jelly) on a substrate by contacting the gelatinous surface of the cord lining with the substrate for a time sufficient for the cells to migrate from the cord lining to the substrate (col. 3, l. 57 – col. 4, l. 27).
Hence, the conditioned media produced by Riordan is conditioned media of umbilical lining stem cells (ULSCs) because Silva discloses that umbilical cord lining stem cells are Wharton’s jelly stem cells.
Riordan teaches producing conditioned media from the ULSCs (i.e., Wharton’s jelly stem cells) by culturing the cells in RPMI media without phenol red or fetal bovine serum and filter sterilizing the conditioned media [0127]. Riordan plates the Wharton’s jelly-derived umbilical cord lining mesenchymal stem cells in T75 flasks, cultures the cells until the cells are confluent, trypsinizes the cells and plates them in new T75 flasks wherein they are cultured in RPMI media without serum or phenol red for the production of conditioned media [0127]. Confluent cells passaged 1:1 to new flasks would be about 80-90% confluent due to process losses due to cells not being removed from the prior substrate, lost due to adherence to tubes and pipettes and/or cells damaged or killed in the process; hence, a person of ordinary skill in the art at the time of filing would have found it obvious that the Wharton’s jelly-derived umbilical cord lining mesenchymal stem cells in Riordan are at a confluence of about 80-90% when the conditioned media is produced.
The therapeutic factors in Riordan’s ULSC conditioned media would inherently comprise SCF, VEGF, GM-CSF, IL-4, IL-7, IL-8, TNF-α, MIP-1β, MCP-1, chondroitin sulfate, hyaluronic acid, collagen I, collagen II and high molecular weight hyaluronic acid because the therapeutic factors in conditioned media produced by propagating ULSCs in the method made obvious by Riordan in view of Silva would inherently be the therapeutic factors in the ULSC conditioned media in the claimed compositions because the method made obvious by Riordan in view of Silva uses the same cells (ULSCs) at the same confluency (80-90%) by the same process (collecting conditioned media in an in vitro cell culture system in media without serum, lipids, exogenous growth factors or dexamethasone) as the production of the instantly claimed compositions.
That the conditioned media produced in the method made obvious by Riordan in view of Silva would comprise the therapeutic factors, collagens and hyaluronic acids at the concentrations and molecular weights listed in claims 4, 6-9, 13 and 20-22 before further processing flows from the facts that the instant method uses the same cells (ULSCs) for making conditioned media by the same process (propagating ULSCs in an in vitro cell culture system) at the same confluence which would result in a conditioned media, before further processing, with the same therapeutic factors as in the instantly disclosed method. M.P.E.P. § 2112 states, "The claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” and “Something that is old does not become patentable upon the discovery of a new property, use, or application.” Even if applicant in the instant disclosure had identified properties of the conditioned media that Riordan did not or could not test for, in this case the identification of the therapeutic factors in the conditioned media, such an identification would not render these limitations of claims 4, 6-9, 13 and 20-22 patentable since the compositions produced in the instant disclosure and by Riordan in view of Silva would appear to be identical.
Riordan teaches that the cosmetic compositions produced from the conditioned media from the ULSCs can comprise about 0.0005% to about 1.0% of EDTA [0101]. Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to produce the cosmetic compositions of claims 4, 6-9, 13 and 17-22 comprising ULSC conditioned media without serum, lipids, exogenous growth factors or dexamethasone because Riordan makes obvious producing cosmetic compositions comprising conditioned medium from ULSCs in RPMI media without additional components wherein 0.0005% to about 1.0% of EDTA is added to the cosmetic composition; therefore, claims 4, 6-9, 13 and 17-22 are prima facie obvious.
Regarding claim 11, Riordan teaches that the conditioned media is to be filter sterilized [0127]; hence, a person of ordinary skill in the art at the time of filing would have found it obvious to produce cosmetic compositions which are sterile; therefore, claim 11 is prima facie obvious.
Regarding claim 12, Riordan teaches that the umbilical cords are human umbilical cords [0076]; thus, the ULSCs in Riordan are human ULSCs; hence, a person of ordinary skill in the art at the time of filing would have found it obvious to produce cosmetic compositions comprising conditioned media from human ULSCs; therefore, claim 12 is prima facie obvious.
Response to Arguments
Applicant's arguments filed 5/5/2026 have been fully considered but they are not persuasive. Arguments of the Applicant’s Response on pp. 5-6 regarding the claim objections and rejections under 35 U.S.C. §§ 112(a), 112(b) and on the ground of nonstatutory double patenting are moot as the rejections have been withdrawn.
Regarding the rejection of claims 4, 6-9 and 11 under 35 U.S.C. § 103 over Riordan in view of Silva, Applicant argues (pp. 6-9) that “a skilled person in the art would have not have reasonably expected that the conditioned medium disclosed in Riordan would be the same as the conditioned medium of the claimed composition” (p. 8, 1st full ¶). This is unpersuasive, as discussed below, but, more importantly, the claims are drawn to a composition not to the opinions of artisans. Applicant appears to be arguing that Riordan does not explicitly state that the media for producing the conditioned media is “without serum, without lipids, without exogenous growth factors and without dexamethasone”; hence, Applicant appears to argue, Riordan’s media may have some nebulous, undisclosed amounts of something forbidden from the media in claim 4. This is completely unpersuasive as the claims are drawn to a composition not a method and Riordan’s conditioned media of ULSCs is produced by culturing the ULSCs in RPMI media without phenol red or FBS [0127]. RPMI media does not comprise serum, lipids, exogenous growth factors or dexamethasone; hence, Applicant’s argument regarding the expectations of artisans is moot because Riordan clearly teaches compositions comprising conditioned media from ULSCs wherein the conditioned media does not contain any serum, lipids, exogenous growth factors or dexamethasone.
Applicant appears to be confused about inherency on pp. 8-9 of the Remarks. The conditioned media produced in the method made obvious by Riordan in view of Silva would inherently comprise the therapeutic factors, collagens and hyaluronic acids at the concentrations and molecular weights listed in claims 4, 6-9, 13 and 20-22 before further processing because Riordan uses the same cells (ULSCs) for making conditioned media by the same process (propagating ULSCs in an in vitro cell culture system) at the same confluence (80-90%) using the same media (i.e., media without serum, lipids, exogenous growth factors or dexamethasone) as the instant claims which would result in a conditioned media, before further processing, with the same therapeutic factors as in the instantly claimed compositions.
The conditioned media of Riordan produced by the method set forth in the product-by-process limitations of the instant claims would necessarily, inherently, comprise the growth factors, cytokines, chemokines, glycosaminoglycans and collagens of the conditioned media used to produce the claimed compositions because using the same cells (ULSCs) for making conditioned media by the same process (propagating ULSCs in an in vitro cell culture system) at the same confluence (80-90%) using the same media (i.e., media without serum, lipids, exogenous growth factors or dexamethasone) as the instant claims would result in a conditioned media with the same therapeutic factors as the conditioned media in the instantly claimed compositions.
As M.P.E.P. § 2112 states, "The claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” and “Something that is old does not become patentable upon the discovery of a new property, use, or application.”
As MPEP § 2113 makes clear, once a rejection of product-by-process composition claims has been made, the burden shifts to the Applicant to show that the claimed composition is different from the prior art composition in a nonobvious manner. Applicant has failed to demonstrate or reasonably suggest that the claimed composition is non-obviously different from the compositions made obvious by Riordan in view of Silva; hence, the rejection is maintained with modification to address claim amendments and new claims.
Claims 4-9 and 11-22 are rejected under 35 U.S.C. 103 as being unpatentable over Riordan in view of Silva and Cohen et al., US 2013/0095061 (cite A, PTO-892, 6/2/2025; herein “Cohen”).
The discussion of Riordan and Silva regarding claims 4, 6-9, 11-13 and 17-22 set forth in the rejection above is incorporated herein.
Riordan makes obvious cosmetic compositions comprising a medium conditioned by ULSCs at a confluence of about 80-90% without serum, lipids, exogenous growth factors, or dexamethasone wherein the cosmetic composition can comprise excipients such as one or more carriers, binders, fillers, vehicles, disintegrants, surfactants, dispersion or suspension aids, thickening or emulsifying agents, isotonic agents, preservatives, lubricants, and the like or combinations thereof, including any disclosed in Remington: the Science and Practice of Pharmacy, Twenty-First Edition, Beringer et al. (Lippincott Williams & Wilkins, Philadelphia, Pa., 2006) which is incorporated by reference in Riordan [0099].
Riordan specifically discloses that the cosmetic composition may comprise polyethylene glycol (PEG; [0039], [0100]) but does not disclose a range of concentration of the PEG in the composition. Riordan discloses that the cosmetic composition may comprise parabens as a preservative [0121] and specifically discloses methylparaben ([0051], [0125]) but does not disclose a range of concentration of the parabens in the composition. Riordan discloses that the cosmetic composition may comprise polyurethane ([0051], [0125]) but does not disclose a range of concentration of the polyurethane in the composition. Riordan teaches that the cosmetic composition can comprise about 0.0005% to about 1.0% of EDTA ([0040], [0101]) as discussed in the rejection above.
However, a person of ordinary skill in the art at the time of filing would have found it obvious for the cosmetic compositions to comprise PEG at 1-10% by weight; vinyl pyrrolidone and polyurethane in amounts sufficient to allow the formulation to remain effective on the skin after exposure to water for at least 40 minutes; methylparaben, propylparaben and isobutylparaben at 0.001 to 10% by weight; and EDTA at 0.001 to 0.2% by weight in view of the disclosure of Cohen.
Cohen teaches similar cosmetic compositions comprising conditioned medium from umbilical cord stem cells for treating adverse or undesirable dermatological conditions (Title; Abst.) wherein the compositions can comprise 1 - 10% by weight polyethylene glycol [0069]; vinyl pyrrolidone and polyurethane “in amounts effective to allow the formulation embodied herein to remain effective on the skin after exposure to circulating water for at least 40 minutes” [0073]; 0.001 - 10% by weight methylparaben, propylparaben and isobutylparaben [0074]; and 0.001 - 0.2% by weight EDTA [0076].
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to produce the cosmetic compositions made obvious by Riordan in view of Silva wherein the compositions comprise PEG at 1-10% by weight; vinyl pyrrolidone and polyurethane in amounts sufficient to allow the formulation to remain effective on the skin after exposure to water for at least 40 minutes; methylparaben, propylparaben and isobutylparaben at 0.001 to 10% by weight; and EDTA at 0.001 to 0.2% by weight because Cohen teaches similar compositions can comprise these excipients in these amounts; therefore, claims 5 and 14-16 are prima facie obvious.
Response to Arguments
Regarding the rejection of claims 4-9 and 11 under 35 U.S.C. § 103 over Riordan in view of Silva and Cohen, Applicant does not present any argument specifically drawn to the rejection or to the teachings of Cohen. Instead, Applicant only argues that Cohen does not make up for the alleged deficiencies of Riordan and Silva (p. 9). Riordan and Silva are discussed on pp. 8-10 above. The rejection is maintained with modification to address claim amendments and new claims.
Double Patenting
The provisional rejection of claims 4, 6-9 and 11 on the ground of nonstatutory double patenting over claims 1-4 and 6-9 of copending Application No. 17390574 as set forth at pp. 18-22 of the previous Office Action, is withdrawn in view of the terminal disclaimer filed and approved 5/5/2026.
The rejection of claims 4, 6-9 and 11 on the ground of nonstatutory double patenting over claims 8-12 of copending Application No. 17501775, i.e., claims 1-6 of US Patent 12460179, as set forth at pp. 18-22 of the previous Office Action, is withdrawn in view of the terminal disclaimer filed and approved 5/5/2026.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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