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 the Claims
Claims 22-24, 30, 32, and 36-40 are currently pending.
Claims 22, 30, and 32 are amended.
Claims 1-21, 25-29, 31, 33-35, and 41-46 are cancelled.
Claims 22-24, 30, 32, and 36-40 have been considered on the merits.
Withdrawn Rejections
The rejections made onto claims 30, 32, and 42 under 35 U.S.C. 112(b) and under 35 U.S.C. 112(d) are withdrawn in light of the amendments made onto the claims submitted on 02/18/2026.
The 103 rejection made onto claims 44-46 employing the additional reference Walmsley et al (Jove, 2016) has been withdrawn in light of the cancellation of claims 44-46 in the reply submitted on 02/18/2026.
Maintained Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 22-24, 30-33, 36, and 39-46 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kleinsek et al (US20070065415A1), as evidenced by Philippeos et al (J. Investigative Dermatology, 2018).
Regarding claim 22, Kleinsek teaches methods of treating skin defects in human subjects through employing fibroblasts as required by claim 22 ([0001]/[0012]). Kleinsek teaches that the fibroblasts can be papillary, reticular, or pre-adipocyte fibroblasts ([0594]).
With regards to claims 23 and 24, Kleinsek teaches that the human dermal fibroblasts may be autologous or allogenic ([0003]/[0075]).
With regards to claim 36, Kleinsek teaches that the cells are able to be combined with a pharmaceutically acceptable carrier ([0589]).
Regarding claims 39-40, Kleinsek also teaches that the cells are employed in a method of wound healing or keloid scarring ([0594]). Further, Kleinsek teaches that currently collagen implants only provide temporary usefulness for wound healing and skin aging however, the use of living cells provides a long-term solution ([0002]).
Kleinsek meets the limitation of claim 22 wherein the isolated human dermal fibroblast subpopulations are CD39+ CD26-, CD39-, or CD39+ CD26+ fibroblasts due to Kleinsek’s recitation of the fibroblasts being papillary, reticular, or pre-adipocyte fibroblasts ([0594]). Although no longer claimed, specification describes “the human dermal fibroblasts are human papillary fibroblasts, characterized by expression of a cell surface phenotype CD45- CD31- CD324- CD90+ CD39+ CD26-“ ([0035]). Although no longer claimed, specification describes “the human dermal fibroblasts are human dermal reticular fibroblasts, characterized by expression of a cell surface phenotype CD45- CD31- CD324- CD90+ CD39-“ ([0035]). Although no longer claimed, specification describes “the human dermal fibroblasts are human dermal reticular fibroblasts, characterized by expression of a cell surface phenotype CD45- CD31- CD324- CD90+ CD39+ CD26+“ ([0035]). Thus, the specification defines the claimed expression profiles of fibroblast subpopulations as the papillary and reticular fibroblasts as described in Kleinsek. Additionally, Philippeos et al provides additional evidence that the expression profiles of the claimed cell subpopulations represent papillary and reticular as evidenced by Philippeos. Philippeos teaches that papillary fibroblasts are CD39+ and CD26- as required by claim 22 (Fig. 5 description). Philippeos teaches that reticular fibroblasts are either CD39- or CD39+/CD26+ as required by claim 22 (pg. 819, col. 2, para 2).
Therefore, the claims are anticipated by Kleinsek as evidenced by Philippeos.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 22-24, 30 and 32, and 36-40 are rejected under 35 U.S.C. 103 as being unpatentable over Rinkevich et al (Science, 2015), in view of Kleinsek et al (US20070065415A1), as evidenced by Philippeos et al (J. Investigative Dermatology, 2018).
Regarding claim 22, Rinkevich teaches a method of treating a skin disorder and scarring through the administration of an isolated subpopulation of dermal fibroblasts into the skin of the subject (pg. 11, col 1, last para- col. 2 para 1-3, 5 and col. 3, para 1-2). The dermal fibroblast subpopulation is isolated based on the expression of CD26 (a.k.a. DPP4) as required by claim 22 (pg. 11, col. 1, para 2). Rinkevich teaches that the isolated populations of fibroblasts are isolated based on CD45-, CD31-, and CD324- (a.k.a. CDH1) as required by claims 22, 30, 32, and 43 (pg. 1, col. 3, para 2, and pg. 11, col. 1, para 1). Further, Rinkevich teaches that CD90 was broadly expressed in the various dermal fibroblast populations as required by 30, 32, and 43 (pg. 7. col. 3, para 1). Rinkevich teaches that the isolated subpopulation is administered through intradermal injection as required by claim 37 (pg. 7, col. 3, para 4). The injection contains 2x105 cells as a dose of cells as required by claim 38 in a pharmalogically acceptable carrier (PBS) as required by claim 36 (pg. 12, col. 2, para 2). Rinkevich teaches that the fibroblasts are used to promote wound healing as required by claim 39 (abstract). Rinkevich teaches that the fibroblasts are used to treat a model of fibrosis as required by claim 40 (pg. 11, col. 2, last para). The isolated populations are taught to be isolated using flow cytometry as required by claim 22 (pg. 11, col. 1, para 2).
Rinkevich does not teach that the subject is a human subject or that the fibroblasts are human fibroblasts as required by claims 22. Rinkevich does not teach wherein the fibroblasts are autologous fibroblasts as required by claim 23. Rinkevich does not teach wherein the fibroblasts are allogenic fibroblasts as required by claim 24. Rinkevich does not explicitly teach that the cells have an expression profile of CD39+ and CD26- as required by claim 30. Rinkevich does not teach that the fibroblasts are papillary fibroblasts as required by claim 31. Rinkevich does not explicitly teach that the cells have an expression profile of CD39- or CD39+ and CD26+ as required by claim 32. Rinkevich does not teach that the fibroblasts are reticular fibroblasts as required by claim 33.
However, Kleinsek teaches methods of treating skin defects in human subjects through employing fibroblasts ([0001]/[0012]). Kleinsek teaches that the human dermal fibroblasts may be autologous or allogenic as required by claims 23 and 24 ([0003]/[0075]). Kleinsek teaches that the fibroblasts can be papillary, reticular, or pre-adipocyte fibroblasts as required by claims 31 and 33 ([0594]). Further, Kleinsek teaches that currently collagen implants only provide temporary usefulness for wound healing ad skin aging however, the use of living cells provides a long-term solution ([0002]).
Kleinsek meets the limitation of claim 22 wherein the isolated human dermal fibroblast subpopulations are CD39+ CD26-, CD39-, or CD39+ CD26+ fibroblasts due to Kleinsek’s recitation of the fibroblasts being papillary, reticular, or pre-adipocyte fibroblasts ([0594]). Although no longer claimed, specification describes “the human dermal fibroblasts are human papillary fibroblasts, characterized by expression of a cell surface phenotype CD45- CD31- CD324- CD90+ CD39+ CD26-“ ([0035]). Although no longer claimed, specification describes “the human dermal fibroblasts are human dermal reticular fibroblasts, characterized by expression of a cell surface phenotype CD45- CD31- CD324- CD90+ CD39-“ ([0035]). Although no longer claimed, specification describes “the human dermal fibroblasts are human dermal reticular fibroblasts, characterized by expression of a cell surface phenotype CD45- CD31- CD324- CD90+ CD39+ CD26+“ ([0035]). Thus, the specification defines the claimed expression profiles of fibroblast subpopulations as the papillary and reticular fibroblasts as described in Kleinsek. Additionally, Philippeos et al provides additional evidence that the expression profiles of the claimed cell subpopulations represent papillary and reticular as evidenced by Philippeos. Philippeos teaches that papillary fibroblasts are CD39+ and CD26- as required by claim 22 (Fig. 5 description). Philippeos teaches that reticular fibroblasts are either CD39- or CD39+/CD26+ as required by claim 22 (pg. 819, col. 2, para 2).
One of ordinary skill would find it obvious at the effective filling date of the instant invention to combine the method of wound healing in model mice taught Rinkevich with the method of wound healing taught in humans with Kleinsek to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Kleinsek teaches that currently collagen implants only provide temporary usefulness for wound healing ad skin aging however, the use of living cells provides a long-term solution ([0002]). One of ordinary skill in the art would have a reasonable expectation of success when combining Rinkevich with Kleinsek because both teach methods of wound/skin healing employing fibroblasts.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Declaration by Fiona Watt under 37 C.F.R. 1.132
Dr. Watt describes at points 14-16 of the declaration submitted on 02/18/2026 that the instant invention identified new fibroblast subpopulations that are actually spread between the dermal layers and that the subpopulations of the instant claims are identified based on characteristics and not simply their location in a particular dermal layer. Dr. Watt states that “the fact that our newly identified fibroblast subpopulations are spread between dermal layers means that the ‘papillary’ or ‘reticular’ fibroblasts obtained using the methods of the prior art (i.e., taking all fibroblasts from the pupillary or reticular layer, respectively) will actually result in a mixture of different fibroblast subpopulations we have now identified.
In response, this information is not found to be persuasive. Dr. Watt asserts that the subpopulations of the instant invention are distinct subpopulations of papillary and reticular fibroblasts to those of the prior art in general because the methods of the prior art perform separation of these subpopulations mechanically by separating the layers of the dermis that these subpopulations are known to reside and there may be a mixed population within these layers of the dermis when separating mechanically. Dr. Watt, the instant specification, as well as the inventor art Philippeos (art of record) refer to these “district subpopulations” as papillary and reticular fibroblasts, which are the same subpopulations known in the art. There has been no evidence provided of a material difference in the subpopulations that applicant defines as “papillary” or “reticular” from those in the prior art also defined as “papillary” and “reticular”, respectively. The relative purity of a population of “papillary” or “reticular” fibroblasts cannot be considered a factor in defining a “new” fibroblast subpopulation as asserted, when the “new” subpopulation is otherwise identical to the known subpopulation of the art. Additionally, the characterization of various CD marker profiles of known subpopulations of fibroblasts of the art amounts to the discovery of a new property of an old product/substance which does not render the old subpopulation patentable. The MPEP supports this at MPEP 2112 which states ““[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus 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” (MPEP 2112 (I)). Thus, this argument is not found persuasive.
Dr. Watt states at points 18-26 regarding the evidentiary reference Philippeos et al (inventor art of record) that Philippeos identified cell populations independent of where they are located within the dermal tissue. Philippeos describes that “CD39+CD26- fibroblasts which are mostly, but not exclusively, localized in the upper (papillary) dermis”, “CD36+ fibroblasts which are located in the lower (reticular dermis and include preadipocytes”, “CD39+CD26+ fibroblasts which are mostly, but not exclusively, located throughout the reticular dermis layer”, and “CD39- fibroblasts which are mostly, but not exclusively located throughout the reticular dermis layer”(point 20). Dr. Watt states that the fact that some fibroblast subpopulations are spread between dermal layers is evidenced by our statement ‘Thus, fibroblast identity is not restricted by special compartmentalization’” (point 21). Dr. Watt states that “this fact is supported by figures 3K and 3L of Philippeos. Which show that CD39 is enriched in the papillary dermal layer, but not that expression of CD39 is restricted to the papillary dermal layer” (point 22). Dr. Watt states that this evidence demonstrates that that Philippeos does not support inherency of the marker profiles of the papillary and reticular fibroblasts (point 24). Dr. Watt also asserts that if the papillary or reticular fibroblasts are isolated mechanically that “the fibroblasts obtained would be a mixture of the subpopulations identified above” (point 25).
In response, this argument is not found persuasive for various reasons addressed separately below.
Dr. Watt asserts at points 14-16 (addressed directly above) that the subpopulations are newly discovered. Dr. Watt appears to assert at points 18-26 that the subpopulations are identical to those of the prior art however when mechanically separated and isolated from the portions of the dermis known to contain specific cell types there is a small amount of overlap in cell subpopulations. In other words, in the papillary layer of the dermis, mostly papillary cells are found, however a small subset of reticular fibroblasts may also be present and additionally in the reticular layer of the dermis, mostly reticular fibroblasts are found, however a small subset of papillary fibroblasts may also be present. This information directly refutes the statements made at points 14-16 that these subpopulations are novel. Thus, the argument is not found persuasive.
The currently presented claim language requires that “the isolated subpopulation of human dermal fibroblasts are (i) CD39+ CD26- fibroblasts; or (ii) CD39- fibroblasts; or (iii) CD39+CD26+ fibroblasts”. This claim language is open ended and thus a population of mechanically separated papillary fibroblasts, possibly containing a small subsection of reticular fibroblasts, would still read on the currently present claims. Thus, the argument is not found persuasive.
Dr. Watt states that “this fact is supported by figures 3K and 3L of Philippeos. Which show that CD39 is enriched in the papillary dermal layer, but not that expression of CD39 is restricted to the papillary dermal layer” (point 22). The fact that papillary fibroblasts may also be present in other dermal layers does not mitigate the fact that “CD39 is enriched in the papillary dermal layer”. A person of skill in the art would easily read Kleinsek and choose to isolate (by any means) papillary fibroblasts of the papillary layer and apply them for a method of use in treating wrinkles, facial contour deformities, wound or scarring in a human subject. The fact that there may be additional papillary fibroblasts in alternative dermal layers does not materially effect the papillary fibroblasts contained and “enriched” in the papillary layer of the dermis. Thus, the argument is not found persuasive.
Dr. Watt states in relation to the art of record Kleinsek at points 27-31 that “Kleinsek only states that the fibroblasts are papillary, reticular or preadipocytes, without further characterization. Paragraph 99 (reproduced below with emphasis added) is the only explanation anywhere in Kleinsek as to how to obtain the isolated papillary or reticular fibroblast population for the method” (point 28). Kleinsek states that methods are known in the art to perform isolation of the desired cell subpopulations and provides multiple references incorporated herein by reference ([0099]). Dr. Watt argues that the references incorporated by Kleinsek teach only mechanical separation and that “as explained above, the presently claimed fibroblast subpopulations are newly identifies subpopulations that span different dermal layers, and are not spatially segregated”, therefore Kleinsek could not render the instant claims obvious.
In response, the arguments are not found persuasive.
Dr. Watt asserts at points 14-16 (addressed directly above) that the subpopulations are newly discovered. Dr. Watt appears to assert at points 18-26 that the subpopulations are identical to those of the prior art however when mechanically separated and isolated from the portions of the dermis known to contain specific cell types there is a small amount of overlap in cell subpopulations. In other words, in the papillary layer of the dermis, mostly papillary cells are found, however a small subset of reticular fibroblasts may also be present and additionally in the reticular layer of the dermis, mostly reticular fibroblasts are found, however a small subset of papillary fibroblasts may also be present. This information directly refutes the statements made at points 14-16 that these subpopulations are novel. Additionally, no evidence has been provided that the allegedly new subpopulations are any different than those of the prior art, other than that some of the known papillary fibroblasts and known reticular fibroblasts may be present in the reticular or papillary dermal layers, respectively. For example, Dr. Watt has not provided any evidence that say the “reticular fibroblasts” found in small amounts in the papillary dermal layer are any different from the reticular fibroblasts found in the reticular layer of the dermis and known in the art. Similarly, Dr. Watt has not provided any evidence that the “papillary fibroblasts” found in small amounts in the reticular layer are any different from the papillary fibroblasts found in the papillary layer of the dermis and known in the art. Thus, the argument is not found persuasive and the teaching of Kleinsek of employing papillary or reticular fibroblasts as evidenced by Philippeos anticipates the instant claims. The MPEP supports this at MPEP 2112 which states ““[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus 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” (MPEP 2112 (I)). Thus, this argument is not found persuasive.
Response to Arguments
Applicant's arguments filed 02/18/2026 have been fully considered but they are not persuasive.
Applicant argues (Remarks, pgs. 6-9) a nearly identical argument to that provided in the Declaration of Fiona Watt under 37 C.F.R. 1.132 (addressed above). Applicant argues that Philippeos does not provide support of inherency of the papillary and reticular fibroblasts of Kleinsek having the same expression profiles as claimed and as evidenced by Philippeos.
In response, the arguments are not found persuasive.
Applicant states that “Dr. Watt declares that before the priority date of the present application, no markers were known that could be used to isolate papillary or reticular fibroblasts from human skin. Dr. Watt asserts at points 14-16 (addressed directly above) that the subpopulations are newly discovered. Dr. Watt appears to assert at points 18-26 that the subpopulations are identical to those of the prior art however when mechanically separated and isolated from the portions of the dermis known to contain specific cell types there is a small amount of overlap in cell subpopulations. In other words, in the papillary layer of the dermis, mostly papillary cells are found, however a small subset of reticular fibroblasts may also be present and additionally in the reticular layer of the dermis, mostly reticular fibroblasts are found, however a small subset of papillary fibroblasts may also be present. This information directly refutes the statements made at points 14-16 that these subpopulations are novel. Additionally, no evidence has been provided that the allegedly new subpopulations are any different than those of the prior art, other than that some of the known papillary fibroblasts and known reticular fibroblasts may be present in the reticular or papillary dermal layers, respectively. For example, Dr. Watt has not provided any evidence that say the “reticular fibroblasts” found in small amounts in the papillary dermal layer are any different from the reticular fibroblasts found in the reticular layer of the dermis and known in the art. Similarly, Dr. Watt has not provided any evidence that the “papillary fibroblasts” found in small amounts in the reticular layer are any different from the papillary fibroblasts found in the papillary layer of the dermis and known in the art. Thus, the argument is not found persuasive and the teaching of Kleinsek of employing papillary or reticular fibroblasts as evidenced by Philippeos anticipates the instant claims. The MPEP supports this at MPEP 2112 which states ““[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus 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” (MPEP 2112 (I)). Thus, this argument is not found persuasive.
Applicant argues (Remarks, pg. 9-11) that Rinkevich does not cure the alleged deficiencies of Kleinsek failing to teach the specific CD marker profiles of the instant claim 22. Further that Applicant disagrees that Philippeos can be cited as prior art. Applicant also argues that “Rinkevich neither teaches nor considers the possibility of new, unidentified or unknown fibroblast subpopulations in humans”.
In response, this is not found persuasive. The alleged deficiencies of Kleinsek are addressed above at point 19 and in the response to the Declaration of Fiona Watt.
Additionally, Philippeos is not relied upon as a prior art but rather an evidentiary reference.
Finally, no evidence has been provided that the allegedly new subpopulations are any different than those of the prior art, other than that some of the known papillary fibroblasts and known reticular fibroblasts may be present in the reticular or papillary dermal layers, respectively. For example, Dr. Watt has not provided any evidence that say the “reticular fibroblasts” found in small amounts in the papillary dermal layer are any different from the reticular fibroblasts found in the reticular layer of the dermis and known in the art. Similarly, Dr. Watt has not provided any evidence that the “papillary fibroblasts” found in small amounts in the reticular layer are any different from the papillary fibroblasts found in the papillary layer of the dermis and known in the art. Thus, the argument is not found persuasive and the teaching of Kleinsek of employing papillary or reticular fibroblasts as evidenced by Philippeos anticipates the instant claims. The MPEP supports this at MPEP 2112 which states ““[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus 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” (MPEP 2112 (I)). Thus, this argument is not found persuasive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
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