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Claims 23-44 are pending in this application, Claims 32-44 area acknowledged as withdrawn, Claims 23-31 were examined on their merits.
Rejections/objections withdrawn
The objection to the Specification because the Abstract was too short to describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details, has been withdrawn due to the Applicant’s amendments to the Specification filed 11/10/2025.
The objection to the Specification due to the improper use of Trademarks has been withdrawn due to the Applicant’s amendments to the Specification filed 11/10/2025.
The objections to the claims due to minor informalities has been withdrawn due to the Applicant’s amendments to the claims filed 11/10/2025.
The rejection of Claims 25 under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AlA), 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inventor (or for applications subject to pre-AlA 35 U.S.C. 112, the applicant), regards as the invention, has been withdrawn due to the Applicant’s amendments to the claims filed 11/10/2025.
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.
Claims 23, 29, 30 and 31 are rejected under 35 U.S.C. § 103 as being unpatentable over Mashiko et al. (2018) in view of Petry et al. (2018), Li et al. (2018) as evidenced by Chan et al. (2017), all of record.
Mashiko et al. teaches a collagen sponge seeded/loaded with 1 x 105 (or 100,000) undifferentiated, heterologous Adipose Stem cells (ASC) and culturing/expanding for 5 days (Pg. 2, Paragraphs 2.1-2.3 and Pg. 3, Fig. 1A, 1B), and wherein the ASC cultured collagen sponge scaffolds were removed and implanted into a murine wound model, which accelerated wound healing (Pg. 8, Column 1, Lines 46- 50), and reading on Claims 23, 29 and 31.
Mashiko et al. did not teach a method wherein the collagen sponge is placed onto a semipermeable membrane floating over an ASC culture medium and incubating to grow and expand the ASC, while remaining undifferentiated and removing the ASC containing sponge from the semipermeable membrane to obtain an ASC-containing sponge, as required by Claim 23.
Petry et al. teaches culturing ASCs on collagen membranes under air-liquid interface (ALI) conditions (Pg. 2016, Fig. 5) wherein ALI induced significant epidermal stratification, particularly in collagen coated supports as well as the induction of epidermal differentiation markers (Pg. 2010, Abstract).
Li et al. teaches culturing ASC on a collagen-coated semipermeable membrane
(MILLICELL™ insert) floating over an ASC culture medium, and incubating for 12 days
(Pg. 1762, Column 1, Lines 1-21 and Fig. 1)
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the undifferentiated, expanded ASC comprising collagen sponge of Mashiko et al. with the use of ALI conditions as taught by Petry et al. because Petry teaches the beneficial effects of ALI on cultured ASC cells.
Those of ordinary skill in the art would have been motivated to make this modification because Petry teaches that ALI induces epidermal stratification and induction of epidermal differentiation markers which would be beneficial in skin wound healing, particularly in a collagen sponge wound healing scaffold. There would have been a reasonable expectation of success in making this modification because both references are reasonably drawn to the same field of endeavor, that is, the culture of ASC on collagen scaffolds.
It would have been further obvious to those of ordinary skill in the art before the
effective filing date of the claimed invention to modify the collagen sponge expansion of
undifferentiated, ASC under ALI conditions of Mashiko et al. and Petry et al. with
culturing of the ASC loaded collagen sponge semipermeable membrane (MILLICELL™
insert) floating over an ASC culture medium, as taught by Li et al. because this would
allow easier recovery, removal and subsequent implantation of the ASC comprising
collagen sponge cultured under ALI conditions than if the cells were cultured as a cell
sheet directly on the semipermeable membrane.
Those of ordinary skill in the art would have been motivated to make these modifications in order to obtain an ASC comprising bioscaffold which was cultured under ALI conditions and is suitable for implantation. There would have been a reasonable expectation of success in making these modifications because both references are reasonably drawn to the same field of endeavor, that is, the culture of ASC on collagen scaffolds.
With regard to Claim 30, Chan et al. evidences that MILLICELL™ inserts (such as those used by Li et al.) are made of polyethylene terephthalate membranes (Pg. 41375, Column 1, Lines 47-49).
With regard to Claim 31, Mashiko et al. teaches a collagen sponge seeded/loaded with 1 x 105 (or 100,000) undifferentiated, heterologous Adipose Stem cells (ASC) and culturing/expanding for 5 days (Pg. 2, Paragraphs 2.1-2.3 and Pg. 3, Fig. 1A, 1B), reading on the claimed “from about 5 days”.
Claims 23, 24, 25, 29, 30 and 31 are newly rejected under 35 U.S.C. § 103 as being unpatentable over Mashiko et al. (2018) in view of Petry et al. (2018), Li et al. (2017) and as evidenced by Chan et al. (2017), all of record, as applied to Claims 23, 29, 30 and 31 above, and further in view of Paganelli et al. (07/01/2019), cited in the IDS, as necessitated by Applicant’s amendments to the claims filed 11/10/2025.
The teachings of Mashiko et al., Petry et al., Li et al. and Chan et al. were discussed above.
None of the above cited references teach coating the cultured ASC comprising sponge with keratinocytes in keratinocyte culture media to allow the formation of a stratified epidermis over the surface of the covered ASC-containing sponge, as required by Claims 24;
covering the ASC-containing sponge with keratinocytes in keratinocyte culture medium to form a keratinocyte-covered ASC- containing sponge within the said cell culture insert;
incubating the keratinocyte-covered ASC-containing sponge under keratinocyte culture conditions thereby defining air interface conditions over the keratinocyte layer and allowing a stratified epidermis to grow on the surface of the ASC-containing sponge under said air interface conditions; and
removing the keratinocyte-covered ASC-containing sponge from the cell culture insert and obtaining an ASC-containing sponge covered with a stratified epidermis as a tissue substitute material, as required by Claim 25.
Paganelli et al. teaches covering an ASC-derived matrix on a semipermeable membrane (polycarbonate membrane) floating on keratinocyte growth medium (ALI interface) with keratinocytes and incubating (Pg. 48, Column 1, Lines 33-40 and 51-56), and the obtained scaffolding is already colonized by MSCs (Pg. 55, Column 1, Line 31) and is easily obtained from patients and is 100% biocompatible and represents a possible therapeutic tool since it appears to potentially grafted with keratinocyte layers, thus bypassing the classical two-step grafting procedure (Pg. 46, Column 2, Lines 8-13).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the culturing of an ASC loaded collagen sponge on a semipermeable membrane floating (ALI conditions) over an ASC culture medium, as taught by Mashiko et al., Petry et al., Li et al. and Chan et al. with the overlaying of the ASC sponge with keratinocytes and culturing under ALI conditions as taught by Paganelli et al. because this would provide a suitable skin bioscaffold for grafting. Those of ordinary skill in the art would have been motivated to make this modification in order to obtain an ASC comprising, keratinocyte coated bioscaffold which is easily obtainable from patients, is biocompatible and comprises MSC (ASC are a type of MSC) and is suitable for implantation. There would have been a reasonable expectation of success in making these modifications because both references are reasonably drawn to the same field of endeavor, that is, the generation of implantable cell scaffolds.
With regard to the limitation of Claim 24, “to allow the formation of a stratified epidermis over the surface of the covered ASC-containing sponge”;
and the limitations of Claim 25, “allowing a stratified epidermis to grow on the surface of the ASC- containing sponge under said air interface conditions” and “obtaining an ASC-containing sponge covered with a stratified epidermis as a tissue substitute material”, these are no more than the expected results from covering the ASC-containing sponge of Mashiko with the keratinocytes of Paganelli and culturing under the conditions described by Paganelli above.
With regard to the limitation of Claim 25 of, “removing the keratinocyte-covered
ASC-containing sponge from the hemi-permeable membrane”, Mashiko et al.
teaches wherein the ASC cultured collagen sponge scaffolds were removed and
implanted into a murine wound model, which accelerated wound healing (Pg. 8, Column
1, Lines 46-50) while Paganelli et al. teaches covering an ASC-derived matrix on a semipermeable membrane (polycarbonate membrane) floating on keratinocyte growth medium (ALI interface) with keratinocytes and incubating (Pg. 48, Column 1, Lines 33-40 and 51-56), thus it would have been obvious to the ordinary artisan to remove the keratinocyte covered ASC-containing sponge from a non-biological/biocompatible semipermeable membrane (such as the polycarbonate membrane of Paganelli) prior to implantation or grafting. Those of ordinary skill in the art would have been motivated to make this modification in order to obtain a keratinocyte-covered ASC-containing sponge which would be suitable for implantation/grafting.
There would have been a reasonable expectation of success in making these modifications because both references are reasonably drawn to the same field of endeavor, that is, the culture of ASC on collagen scaffolds.
Claims 23 and 26-31 are rejected under 35 U.S.C. § 103 as being unpatentable over Mashiko et al. (2018) in view of Petry et al. (2018), Li et al. (2017) and as evidenced by Chan et al. (2017), as applied to Claims 23, 29, 30 and 31 above, and further in view of Mir et al. (2018) and Gundersen et al. (US 2010/0292626 A1), all of record.
The teachings of Mashiko et al., Petry et al., Li et al. and Chan et al. were discussed above.
None of the above cited references teach covering the ASC-containing sponge with a silicone-polyurethane composite layer, as required by Claims 26-28.
Mir et al. teaches that polymer films are used in semi-permeable dressings because of their impermeability to bacteria and liquid and permeability to moisture vapor and air (Pg. 4, Column 2, Lines 22-26).
Gundersen et al. teaches a composite layer wound dressing comprising a skin- contacting layer of silicone adhesive and a support layer in the form of a polyurethane film (Pg. 4, Paragraph [0088] and Fig. 1).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the collagen sponge expansion of
undifferentiated, ASC under ALI conditions of Mashiko et al., Petry et al. and Li et al. by
coating the ASC-containing sponge with a silicone-polyurethane composite layer as
taught by Mir et al. and Gundersen et al. because this would provide a barrier which is
impermeable to bacteria, while being permeable to air and moisture and is suitable for
application to a wound, such as when the ASC-sponge is grafted into a wound. Those of ordinary skill in the art would have been motivated to make these modifications in order to obtain an ASC comprising bioscaffold which is sterile and capable of grafting into a wound in vivo. There would have been a reasonable expectation of success in making these modifications because at least the Mashiko reference is drawn to a skin wound treating bioscaffold and Mir and Gundersen are drawn to coverings suitable for wound covering.
Response to Arguments
Applicant’s arguments, see Remarks, filed 11/10/2025, with respect to the above withdrawn objections/rejection have been fully considered and are persuasive.
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive with regard to the pending rejections.
The Applicant argues that the ASC of Mashiko are not undifferentiated but are “primed”/differentiated to enhance wound healing and the ratio of ASCs to culture medium in the reference differs from that which would be achieved by the claimed method (Remarks, Pg.8, Lines 26-28 and Pg. 9, Lines 1-14).
This is not found to be persuasive for the following reasons, clearly Mashiko teaches collagen sponge seeded/loaded with 1 x 105 (or 100,000) undifferentiated, heterologous Adipose Stem cells (ASC) and culturing/expanding for 5 days (Pg. 2, Paragraphs 2.1-2.3 and Pg. 3, Fig. 1A, 1B). Applicant’s citation that the hASC were stimulated as if they were already placed on injured tissue and priming their responses, merely indicates that the cells were “primed” for differentiation not that they were actually differentiated. In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., the ratio of ASCs to culture medium in the reference) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Applicant argues that the undifferentiated cells of Petry are not growing and expanding in 3D as claimed because the reference cultures ASCs on membranes under ALI to induce differentiation of ASC into keratinocytes not for growing ASC, maintaining undifferentiated ASC, or enhancing their regenerative potential via secretome activity as claimed.
Applicant concludes the claimed ASC are not directly exposed to air but are loaded into/embedded within a scaffold sponge which is exposed to air while the cells are surrounded by medium (Remarks, Pg. 22-29 and Pg. 10, Lines 1-28).
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., enhancing [ASC] regenerative potential via secretome activity) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner notes that Petry was not cited for any teachings related to the differentiation status of the ASC noting that the purpose of the reference was to test the effects of culture conditions (media, 2D and 3D cultures and ECM molecules on transdifferentiation of ASC into a keratinocyte-like phenotype (see Abstract), but merely for the beneficial aspects of culturing of ASC under ALI conditions. The Examiner notes, as set forth above, that Mashiko teaches collagen sponge seeded/loaded with (therefore embedded within) 1 x 105 (or 100,000) undifferentiated, heterologous Adipose Stem cells (ASC) and culturing/expanding for 5 days (Pg. 2, Paragraphs 2.1-2.3 and Pg. 3, Fig. 1A, 1B). Applicant has not provided any evidence on the record that exposing such a culture to the ALI conditions of Petry would necessarily cause differentiation.
As Mashiko teaches the ASC are embedded within a collagen scaffold sponge as claimed, the ordinary artisan would expect that such a scaffold when exposed to an air-liquid interface, such as in Petry, would allow the embedded cells to remain surrounded by medium while the scaffold and not the cells are directly exposed to air.
Applicant asserts that Petry teaches a trans-well insert which is coated with fibronectin, laminin or other ECM protein which is not a 3D structure in which cells can be embedded (Remarks, Pg. 11, Lines 1-11).
In response to Applicant's arguments against the Petry reference individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As stated above, Mashiko teaches collagen sponge (which is a 3D structure) seeded/loaded with (therefore embedded within) 1 x 105 (or 100,000) undifferentiated, heterologous Adipose Stem cells (ASC). Further, Petry was not cited for its use of transwell inserts coated with other ECM proteins than collagen.
The Applicant alleges that the artisan reading Petry’s method of culturing ASC in culture inserts under ALI (direct contact with air to allow keratinocyte differentiation) which leads to 3D growth only in M10 media would not have been motivated to select the rhCP scaffold of Mashiko at an ALI to achieve the claimed method (Remarks, Pg. 11, Lines 12-20).
This is not found to be persuasive for the following reasons, as discussed above, Mashiko teaches collagen sponge (which is a 3D structure) seeded/loaded with (therefore embedded within) 1 x 105 (or 100,000) undifferentiated, heterologous Adipose Stem cells (ASC) and culturing thereof and Petry was not cited for its use of transwell inserts. As Mashiko teaches the ASC are embedded within a collagen scaffold sponge as claimed, the ordinary artisan would expect that such a scaffold when exposed to an air-liquid interface, such as in Petry, would allow the embedded cells to remain surrounded by medium while the scaffold and not the cells are directly exposed to air. Thus, the ordinary artisan would have been motivated to modify the 3D undifferentiated ASC scaffold culturing method of Mashiko with the ALI culturing technique of Petry because of the beneficial aspects of ALI on cultured ASC cells taught by Petry.
The Applicant argues that similar to Petry, Li teaches a 2D collagen coated transwell insert which is distinct from the claimed 3D scaffold sponge. Applicant further asserts that Li does not teach the claimed ASC loading density (Remarks, Pg. 11, Lines 21-29 and Pg. 12, Lines 1-11).
This is not found to be persuasive for the following reasons, Mashiko teaches collagen sponge (which is a 3D structure) seeded/loaded with (therefore embedded within) 1 x 105 (or 100,000) undifferentiated, heterologous Adipose Stem cells (ASC) and culturing thereof and Petry was not cited for its use of transwell inserts.
As Mashiko teaches the ASC are embedded within a collagen scaffold sponge as claimed, the ordinary artisan would expect that such a scaffold when exposed to an air-liquid interface, such as in Petry or Li, would allow the embedded cells to remain surrounded by medium while the scaffold and not the cells are directly exposed to air. Thus, the ordinary artisan would have been motivated to modify the 3D undifferentiated ASC scaffold culturing method of Mashiko with the ALI culturing techniques of Petry and Li because of the beneficial aspects of ALI on cultured ASC cells taught by Petry.
The Applicant argues that Li and Petry are drawn to culture conditions factors such as media and substrate contributing to epithelial differentiation of ASC and not to retaining undifferentiated ASC on top of coated substrates such that the possibility of obtaining a set of healing and angiogenic factors suitable for tissue healing when using the scaffold would not have been expected (Remarks, Pg. 12, Lines 12-18).
This is not found to be persuasive for the following reasons, in response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., obtaining a set of healing and angiogenic factors suitable for tissue healing when using the scaffold) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As stated above, neither Petry or Li was cited for the retention of undifferentiated ASC on top of coated substrates.
The Applicant argues that the alleged advantages of the claimed invention are not anticipated or would be envisioned by the combination of Mashiko, Petry and Li, there is no suggestion to modify Mashiko in view of Petry and Li and references are not combinable (Remarks, Pg. 12, Lines 19-25 and Pg. 13, Lines 11-28 and Pg. 14, Lines 1-21).
In response to Applicant's argument that Mashiko, Petry and Li are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, all of the references are drawn to the Applicant’s field of endeavor, that is, the culture of ASC with collagen scaffolds. The Examiner notes that the prior art is not required to anticipate or envision the alleged advantages of the claimed invention to be obvious. In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, it would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the undifferentiated, expanded ASC comprising collagen sponge of Mashiko with the use of ALI conditions as taught by
Petry and Li because Petry teaches the beneficial effects of ALI on cultured ASC cells.
Those of ordinary skill in the art would have been motivated to make this modification because Petry teaches that ALI induces epidermal stratification and induction of epidermal differentiation markers which would be beneficial in skin wound healing, particularly in a collagen sponge wound healing scaffold
The Applicant argues that the ordinary artisan would not have been motivated to modify the rhCP scaffold of Mashiko with the ALI condition of Petry and Li because Petry and Li teach ALI together with supplements/media to enable differentiation of ASC while Mashiko teaches the rhCP scaffold without supplements “primes” ASC and the rhCP scaffold has therapeutic potential itself (Remarks, Pg. 12, Lines 26-29 and Pg. 13, Lines 1-7).
This is not found to be persuasive for the following reasons, Mashiko teaches collagen sponge seeded/loaded with 1 x 105 (or 100,000) undifferentiated, heterologous Adipose Stem cells (ASC) and culturing/expanding for 5 days (Pg. 2, Paragraphs 2.1-2.3 and Pg. 3, Fig. 1A, 1B). Applicant’s citation that the hASC were “primed” merely indicates that the cells were “primed” for differentiation not that they were actually differentiated.
The Examiner notes that neither Petry or Li were cited for any teachings related to supplements (media, 2D and 3D cultures and ECM molecules) effects on transdifferentiation of ASC into a keratinocyte-like phenotype, but merely for the beneficial aspects of culturing of ASC under ALI conditions. Thus, those of ordinary skill in the art would have been motivated to modify the 3D sponge scaffold containing embedded undifferentiated ASC of Mashiko with the use of ALI conditions as taught by Petry and Li because Petry teaches that ALI induces epidermal stratification and induction of epidermal differentiation markers which would be beneficial in skin wound healing, particularly in a collagen sponge wound healing scaffold.
The Applicant argues that Chan does not remedy the teachings of the other cited references (Remarks, Pg. 13, Lines 8-10).
This is not found to be persuasive as Chan was cited only as an evidentiary reference directed to the composition of the semipermeable membrane insert used by Li.
The Applicant argues that Paganelli does not teach a 3D scaffold sponge for culturing ASC but instead the ASC self-produce a 3D matrix. Applicant notes that the reference grows cells in Vitamin C to stimulate the cells to differentiate and produce the ECM matrix (Remarks, Pg. 15, Lines 7-15).
In response to Applicant's arguments against the Paganelli reference individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As stated above, Mashiko teaches collagen sponge (which is a 3D structure) seeded/loaded with (therefore embedded within) 1 x 105 (or 100,000) undifferentiated, heterologous Adipose Stem cells (ASC). Further, Paganelli was not cited for its teaching of an ASC derived matrix, but for the covering thereof with keratinocytes while floating on a semipermeable membrane in keratinocyte growth medium. The Applicant’s assertion that the ASC of Paganelli are “differentiated” by exposure to culture medium with ascorbic acid is wholly unsupported by either the reference or any evidence on the record. The passage merely states that ASC were cultured in an “ECM-inducing medium”, and is silent with regard to the differentiation status of the ASC. Even if ascorbic acid causes ASC differentiation, Paganelli was not cited for its teaching of an ASC derived matrix caused by ascorbic acid induced differentiation of ASC, but for the covering of an cell comprising 3D matrix with keratinocytes while floating on a semipermeable membrane in keratinocyte growth medium.
The Applicant argues that the claimed invention uses a scaffold sponge as opposed to Paganelli, which is biodegradable in vivo and would not be exposed to ascorbic acid as in Paganelli.
Applicant argues there would be no motivation to combine the ASC-generated scaffold of Paganelli with the other cited prior art which use rhCP, media and other substrate supports not required by Paganelli (Remarks, Pg. 15, Lines 16-29 and Pg. 16, Lines 1-19).
This is not found to be persuasive for the following reasons, the claims do not require any transplantation or in vivo use of the claimed invention. As discussed above, Mashiko teaches an undifferentiated ASC embedded collagen sponge as claimed. As such, it would be expected to be biodegradable in vivo. Notwithstanding the fact that ascorbic acid is found in vivo in the bloodstream and would thus be expected to contact any implant, Paganelli was not cited for its teaching of an ASC derived matrix caused by ascorbic acid induced differentiation of ASC, but for the covering of a cell-comprising 3D matrix with keratinocytes while floating (an ALI) on a semipermeable membrane in keratinocyte growth medium. The Examiner maintains that it would have been obvious to those of ordinary skill in the art to modify the culturing of an ASC loaded collagen
sponge on a semipermeable membrane floating (ALI conditions) over an ASC culture
medium, as taught by Mashiko, Petry, Li and Chan with the overlaying of the ASC sponge with keratinocytes and culturing under ALI conditions as taught by Paganelli because this would provide a suitable skin bioscaffold for grafting. Those of ordinary skill in the art would have been motivated to make this modification in order to obtain an ASC comprising, keratinocyte coated bioscaffold which is easily obtainable from patients, is biocompatible and comprises MSC (ASC are a type of MSC) and is suitable for implantation.
The Applicant argues that Mir does not teach or suggest the claimed invention or remedy the alleged deficiencies of the other cited prior art (Remarks, Pg. 16, Lines 26-28).
In response to Applicant's arguments against the Mir reference individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner maintains the prior art makes obvious the claimed invention for reasons of record set forth above and in the prior action, noting that Mir was cited only for its teaching that polymer films are used in semipermeable dressings because of their impermeability to bacteria and liquid and permeability to moisture vapor and air.
The Applicant argues that Gundersen does not teach or suggest the claimed invention or remedy the alleged deficiencies of the other cited prior art (Remarks, Pg. 17, Lines 11-14).
In response to Applicant's arguments against the Gundersen reference individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Examiner maintains the prior art makes obvious the claimed invention for reasons of record set forth above and in the prior action, noting that Gundersen was cited only for its teaching of a composite layer wound dressing comprising a skin-
contacting layer of silicone adhesive and a support layer in the form of a polyurethane
film.
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.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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