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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/12/2025 has been entered.
Status of Application, Amendments, And/Or Claims
The Applicants amendments/remarks received 8/14/2025 are acknowledged. Claims 4-7 and 9 are amended; claims 1-3 and 10 are canceled; no claims are withdrawn; claims 4-9 and 11 are pending and have been examined on the merits.
Priority
This application was filed as a divisional application (DIV) of U.S. Application Serial Number 15/248,629, filed 8/26/2016. This application claims benefit to U.S. Provisional Application Serial Number 62/213,537, filed 9/02/2015.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e), 120 or 121 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 62/213537, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application 62/213537 fails to disclose the compositions of claims 4-9 and 11 because the application does not disclose compositions comprising any of VEGF, GM-CSF, IL-3, IL-4, IL-6, IL-7, IL-8, IL-18, TNF-α, MIP1β, MCP1 or chondroitin sulfate. Hence, the effective filing date of instant claims 4-9 and 11 is the filing date of U.S. Application Serial Number 15/248,629, filed 8/26/2016.
Response to Arguments
Applicant's arguments filed 8/14/2025 have been fully considered but they are not persuasive.
Regarding priority, Applicant states “Applicant does not concede that earlier benefit is unavailable under 35 U.S.C. §§ 119(e)/120” (Remarks, p. 1) but does not present any arguments as to why earlier benefit should be available, nor does Applicant present any evidence or arguments contesting that Application 62/213537 fails to disclose the compositions of claims 4-9 and 11 because the application does not disclose compositions comprising any of VEGF, GM-CSF, IL-3, IL-4, IL-6, IL-7, IL-8, IL-18, TNF-α, MIP1β, MCP1 or chondroitin sulfate. Instead, Applicant states (p. 1) “because each reference currently applied predates even the Office's asserted date, the priority determination is immaterial to the present grounds of rejection. Applicant reserves the right to address priority if it becomes outcome-determinative.” Thus, the effective filing date of instant claims 4-9 and 11 remains the filing date of U.S. Application Serial Number 15/248,629, filed 8/26/2016.
Response to Amendment - format of claims
The amendment to the claims filed on 8/14/2025, i.e., after the final Office action mailed 6/2/2025, before the Advisory Action mailed 9/5/2025, does not comply with the requirements of 37 CFR 1.121(c) because the claims are not presented in ascending numerical order. Applicant was notified of the non-compliance on the Advisory Action mailed 9/5/2025 which included a Notice of Non-Compliant Amendment.
Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number. (emphasis added).
The claims have been entered and examined because the status of claim 10 is obvious; however, Applicant is implored to comply with the requirements of 37 CFR 1.121(c) in future filings as failure to comply may result in a Notice of Non-Compliant Amendment being mailed rather than examination.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites “0.3 % to 3 %” in line 3 and “0.001 % to 0.5 %” in line 6. There should not be a space between the numbers and the percent sign, i.e., the limitations should be “0.3% to 3%” and “0.001% to 0.5%”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claim 5 under 35 U.S.C. § 112(a), as set forth at pp. 4-5 of the previous Office Action is withdrawn in view of the amendment of the claims.
The rejection of claims 4-9 and 11 under 35 U.S.C. § 112(b), as set forth at pp. 5-7 of the previous Office Action is withdrawn in view of the amendment of the claims.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-9 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 4 recites a medium conditioned by ULSCs at a confluence of 75-95%. The instant disclosure does not recite, teach, suggest or imply a medium conditioned by ULSCs at a confluence of 75-95%, nor ULSCs at a confluence of 75-95%; hence, the limitation constitutes new matter. Claims 5-9 and 11 depend from claim 1; thus, claims 5-9 and 11 also constitute new matter. Thus, claims 4-9 and 11 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement for constituting new matter.
Additionally, claim 5 is drawn to a composition comprising vinyl pyrrolidone and polyurethane together in a total amount of 0.3% to 3% by weight. The instant disclosure does not disclose any composition comprising vinyl pyrrolidone and polyurethane together in a total amount of 0.3% to 3% by weight nor recite any ranges of vinyl pyrrolidone nor any ranges of polyurethane for the composition at all; hence, the limitation “vinyl pyrrolidone and polyurethane together in a total amount of 0.3 % to 3 % by weight” constitutes new matter. Therefore, claim 5 is additionally rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement by constituting new matter.
Additionally, claim 5 recites “methylparaben, propylparaben and isobutylparaben each 0.001 % to 0.5 % by weight”. The instant disclosure does not disclose any composition comprising methylparaben, propylparaben and isobutylparaben each 0.001 % to 0.5 % by weight nor recite 0.001 % to 0.5 % as a range of concentrations for methylparaben, propylparaben or isobutylparaben; hence, the limitation “methylparaben, propylparaben and isobutylparaben each 0.001 % to 0.5 % by weight” constitutes new matter. Therefore, claim 5 is additionally rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement by constituting new matter.
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 5-9 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.
The term “about” in claim 5, line 2; claim 6, line 2; claim 7, line 2; claim 8, line 2 and claim 9, line 2, is a relative term which renders the claims indefinite. The term “about” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention; hence, claims 5-9 are rejected under 35 U.S.C. 112(b) for indefiniteness.
Response to Amendment
The declaration under 37 CFR 1.132 filed 8/14/2025 by the sole inventor, Rafael Gonzalez, is insufficient to overcome the rejection of claims 4, 6-9 and 11 under 35 U.S.C. § 103 over Riordan in view of Silva or the rejection of claims 4-9 and 11 under 35 U.S.C. § 103 over Riordan in view of Silva and Cohen as set forth in the last Office action because: The declaration does not present any evidence or facts regarding the claimed factors produced and secreted into culture medium by umbilical cord lining stem cells nor disclose opinions by disinterested third party experts. Instead, the declaration only presents the opinion of the sole inventor, not supported by any factual evidence, that the conditioned media produced by Riordan in view of Silva would “likely” be different from the claimed composition even though the composition made obvious by Riordan in view of Silva meets every product-by-process limitation in the instant claims.
Specifically, the instant claims do recite that the ULSCs are in stationary phase nor does Riordan recite that the ULSCs are in log phase, rather, the claims recite the product-by-process limitation that the ULSCs are at a confluence of 75-95% which is prima facie obvious over Riordan in view of Silva because 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 cells damaged or killed in the process; hence, any assumption, on the part of the sole inventor, that the Wharton’s jelly-derived umbilical cord lining mesenchymal stem cells in Riordan are at a confluence other than the claimed 80-90% is unsupported.
In the declaration, the sole inventor assumes, without evidence, that a) the umbilical cord lining stem cells in the method made obvious by Riordan in view of Silva would be in log phase growth at the time of media conditioning, b) that the cells in the product-by-process limitations of the instant claims would be at or near stationary phase and c) that cells in log phase growth would produce substantially different conditioned media compositions, regarding the claimed factors, than the same cells at or near stationary phase. These assumptions could be experimentally tested or the prior art could be consulted to determine the metes and bounds of the production of the claimed growth factors, cytokines, glycosaminoglycans and collagens by umbilical cord lining stem cells in different growth phases; however, no evidence regarding the claimed factors is presented. Instead, the inventor asserts that differences in the production method, which are not claimed in the product-by-process limitations, would likely produce a different composition. This meager opinion evidence, which is not by a disinterested party, and which is based on production differences which are not even claimed in the product-by-process limitations is unpersuasive and the rejection of claims 4, 6-9 and 11 over Riordan in view of Silva and the rejection of claims 4-9 and 11 over Riordan in view of Silva and Cohen is maintained with modification to address claim amendments.
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 and 11 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 are drawn to compositions not methods. The limitations in claim 4 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 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 umbilical cord lining stem cells (ULSCs) recited in the claims are Wharton’s jelly stem cells as taught by Silva.
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 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 listed in claims 4 and 6-9 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 and 6-9 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 and 6-9 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 and 6-9 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.
Response to Arguments
Regarding the rejection of claims 4, 6-9 and 11 under 35 U.S.C. § 103 over Riordan in view of Silva, Applicant does not present any argument other than discussing the declaration of the sole inventor Rafael Gonzalez (Remarks, p. 3-4). The declaration is unpersuasive as addressed on pp 9-11 above.
Claims 4-9 and 11 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 and 11 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 which 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, claim 5 is 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; hence, the rejection is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 4, 6-9 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-9 of copending Application No. 17390574 (reference application; “’574” herein) in view of Riordan.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim
The factor-rich compositions of instant claims 4-9 and 11 are not patentably distinct from the factor-rich compositions of claims 1-4 and 6-9 of ‘574 save that the instant claims recite a cosmetic agent and that the instant claims recite that the media used for producing the ULSC conditioned media does not comprise serum, lipids, exogenous growth factors or dexamethasone while claims 1-4 and 6-9 of ‘574 only recite that the media is free of serum and exogenous growth factors.
Riordan teaches compositions for treatment of acne which can comprise conditioned medium produced from ULSCs (Wharton’s Jelly stem cells) (Abst.; [0010], [0075-6], [0127]) wherein the media for culturing the Wharton’s jelly stem cells (ULSCs) is RPMI media without phenol red or FBS [0127], and claims 1 and 7-8 of ‘574 recite that the medium to be conditioned by culturing the ULSCs is without serum or exogenous growth factors.
Riordan further 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 and 6-9 comprising ULSC conditioned media without serum, lipids, exogenous growth factors or dexamethasone because claims 1-4 and 6-9 of ‘574 recite producing such a conditioned medium and 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, instant claims 4 and 6-9 are prima facie obvious.
Hence, the composition of instant claim 4 is prima facie obvious over the composition of claim 1 of ‘574 further comprising the cosmetic agent (0.0005% to about 1.0% of EDTA) of Riordan.
Regarding instant claim 6, claim 1 of ‘574 recites that the growth factors in the composition are at a concentration of at least 20-2000 pg/ml; therefore, instant claim 6 is prima facie obvious.
Regarding instant claim 7, claim 2 of ‘574 recites that hyaluronic acid in the composition is at a concentration of at least 1 µg/ml; therefore, instant claim 7 is prima facie obvious.
Regarding instant claim 8, claim 3 of ‘574 recites that the hyaluronic acid in the composition is of a molecular weight up to about 2500 kDa; therefore, instant claim 8 is prima facie obvious.
Regarding instant claim 9, claim 4 of ‘574 recites that collagen in the composition is at a concentration of at least 0.281 µg/ml; therefore, instant claim 9 is prima facie obvious.
Regarding claim 11, claim 6 of ‘574 recites that the composition is sterile and 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.
This is a provisional nonstatutory double patenting rejection.
Claims 4, 6-9 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-12 of copending Application No. 17501775 (reference application; “’775” herein) in view of Riordan.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim
The factor-rich compositions of instant claims 4-9 and 11 are not patentably distinct from the factor-rich compositions of claims 8-12 of ‘775 save that the instant claims recite a cosmetic agent and that the instant claims recite that the media used for producing the ULSC conditioned media does not comprise serum, lipids, exogenous growth factors or dexamethasone while claims 8-12 of ‘775 only recite that the media is free of serum and exogenous growth factors.
Riordan teaches compositions for treatment of acne which can comprise conditioned medium produced from ULSCs (Wharton’s Jelly stem cells) (Abst.; [0010], [0075-6], [0127]) wherein the media for culturing the Wharton’s jelly stem cells (ULSCs) is RPMI media without phenol red or FBS [0127], and claims 8-12 of ‘775 recite that the medium to be conditioned by culturing the ULSCs is without serum or exogenous growth factors.
Riordan further 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 and 6-9 comprising ULSC conditioned media without serum, lipids, exogenous growth factors or dexamethasone because claims 8-12 of ‘775 recite producing such a conditioned medium and 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, instant claims 4 and 6-9 are prima facie obvious.
Regarding instant claim 6, claim 9 of ‘775 recites that the growth factors in the composition are at a concentration of at least 20-200 pg/ml; therefore, instant claim 6 is prima facie obvious.
Regarding instant claim 7, claim 10 of ‘775 recites that hyaluronic acid in the composition is at a concentration of at least about 1 µg/ml; therefore, instant claim 7 is prima facie obvious.
Regarding instant claim 8, claim 11 of ‘775 recites that the hyaluronic acid in the composition is of a molecular weight up to about 2500 kDa; therefore, instant claim 8 is prima facie obvious.
Regarding instant claim 9, claim 12 of ‘775 recites that collagen in the composition is at a concentration of at least about 0.281 mg/ml; therefore, instant claim 9 is prima facie obvious.
Regarding claim 11, claim 6 of ‘775 recites that the composition is sterile and 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.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Regarding the double patenting rejections, Applicant states (Remarks, p. 4) “To the extent any claims now pending in this application are found to be co-extensive with claims pending in another application by Applicant, Applicant will cancel any such claims upon the identification of allowable claims in this application or execute a terminal disclaimer if necessary”. Please see the rejections set forth above.
Conclusion
No claims are allowed.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651