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 .
DETAILED ACTION
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.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1-14 and 16-19, in the reply filed on Jul. 27, 2026 is acknowledged. Claims 20 and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
The traversal is on the grounds that the groups of inventions share the special technical feature. Specifically, Applicant argues that the shared technical feature of the present cellular composition requires a mixed population of fibroblast cells and Schwann cells located within the 3D cell growth material whereas Muller does not disclose that Schwann cells are located within the 3D cell growth material (Remarks pg. 1 para. 5). Applicant argues that Muller teaches that both sides of a collagen sponge are seeded with fibroblasts with Schwann cells on top of the sponge which is different from the claimed invention where both Schwann cells and fibroblasts are within the 3D cell growth material (Remarks pg. 1 last para. to pg. 2 para. 2). Applicant further argues that the technical effect of positioning the Schwann cells within the 3D cell growth material is the ability to enhance neurite outgrowth in a physiologically relevant manner as shown in the instant specification and this is not taught by Muller (Remark pg. 2 para. 3 to pg. 3 para. 1).
This is not found persuasive because as indicated by the rejections below, the groups do not share the special technical feature which contributes over the prior art at the time the invention was made.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-14 and 16-19 are presented for examination on the merits.
Status of the Claims
Claims 1-14, 16-20 and 35 are currently pending.
Claims 20 and 35 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-14 and 16-19 have been considered on the merits.
Specification
The disclosure is objected to because of the following informalities: the use of trademarks.
The use of the terms Triton® X-100 on pg. 30 para. 1; and Alexa Fluor® on pg. 30 para. 4, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is 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.
In claim 2, the phrase “wherein the cellular composite comprises a layer of the mixed population of fibroblast cells and Schwann cells between the keratinocyte cell layer and the 3D cell growth material”, renders the claim and its dependents indefinite, since it is unclear if this limitation is referring to a second mixed population of mixed population of fibroblasts, since in claim 1 the mixed population of fibroblast cells and Schwann cells are part of the 3D cell growth material. For the purposes of compact prosecution, the phrase will be interpreted to mean that there is an addition layer between the keratinocyte cell layer and the 3D cell growth matrix containing fibroblast and Schwann cells.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1, 4-7, 9-14, 16, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muller et al. (Acta Biomaterialia, 2018) (ref. of record).
With respect to claims 1, Muller teaches a cellular composite containing keratinocyte cell layer, a sponge (3D growth material) and neuronal cell layer where the sponge is located between the keratinocyte cell layer and the neuronal cell layer and where the sponge contains fibroblasts within and with Schwann cells on top (the 3D cell growth material comprises a mixed population of fibroblasts and Schwann cells) and (abstract, pg. 95 Col. 1 last para. to Col. 2 para. 2 and Fig. 4). Further with respect to the interpretation of “a mixed population of fibroblast cells and Schwann cells”, there is no requirement that the cells be uniformly blended and a mixed population would include the presence of multiple cell types organized into specific layers.
With respect to clams 4 and 5, Muller teaches the cell composite containing neurites that extend from the neuronal layer (abstract, pg. 96 Col. 1 last para. and Fig. 4).
With respect to clams 6 and 7, Muller teaches the 3D cell growth material is a collagen sponge (a porous scaffold containing a polymer) (abstract and pg. 95 Col. 1 last para.).
With respect to claims 9 and 10, Muller teaches the cellular composite within a cell culture medium (the 3D growth medium would be coated with the medium which is a solution) (pg. 95 Col. 1 last para. to Col. 2 para. 1).
With respect to claims 11 and 12, Muller teaches the keratinocytes are in a layer in the cellular composite (would either be a monolayer or a multilayer) and the keratinocytes are human (pg. 95 Col. 2 para. 2 and Fig. 4).
With respect to claims 13 and 14, Muller teaches the neuronal cells are iPS-derived sensory neurons and were differentiated from human skin fibroblast cell lines and a human peripheral blood mononuclear cell line (pg. 94 Col. 2 para. 4 and pg. 95 Col. 2 first para.).
With respect to claim 16, Muller teaches the neurons are in a layer in the cellular composite (would either be a monolayer or a multilayer) (pg. 95 Col. 2 para. 1 and Fig. 4).
With respect to claim 18, Muller teaches the fibroblasts are human (mammalian) (pg. 95 Col. 1 last para.). With respect to claim 19, Muller teaches the Schwann cells are human (pg. 94 Col. 2 para. 4 and last para.).
Therefore, the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1, 2, 4-7, 9-14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (Acta Biomaterialia, 2018) (ref. of record) in view of Schutte et al. (Tissue Engineering Part C: Methods, 2012).
With respect to claims 1, Muller teaches a cellular composite containing keratinocyte cell layer, a sponge (3D growth material) and neuronal cell layer where the sponge is located between the keratinocyte cell layer and the neuronal cell layer and where the sponge contains fibroblasts within and with Schwann cells on top (the 3D cell growth material comprises a mixed population of fibroblasts and Schwann cells) and (abstract, pg. 95 Col. 1 last para. to Col. 2 para. 2 and Fig. 4). Further with respect to the interpretation of “a mixed population of fibroblast cells and Schwann cells”, there is no requirement that the cells be uniformly blended and a mixed population would include the presence of multiple cell types organized into specific layers.
With respect to clams 4 and 5, Muller teaches the cell composite containing neurites that extend from the neuronal layer (abstract, pg. 96 Col. 1 last para. and Fig. 4).
With respect to clams 6 and 7, Muller teaches the 3D cell growth material is a collagen sponge (a porous scaffold containing a polymer) (abstract and pg. 95 Col. 1 last para.).
With respect to claims 9 and 10, Muller teaches the cellular composite within a cell culture medium (the 3D growth medium would be coated with the medium which is a solution) (pg. 95 Col. 1 last para. to Col. 2 para. 1).
With respect to claims 11 and 12, Muller teaches the keratinocytes are in a layer in the cellular composite (would either be a monolayer or a multilayer) and the keratinocytes are human (pg. 95 Col. 2 para. 2 and Fig. 4).
With respect to claims 13 and 14, Muller teaches the neuronal cells are iPS-derived sensory neurons and were differentiated from human skin fibroblast cell lines and a human peripheral blood mononuclear cell line (pg. 94 Col. 2 para. 4 and pg. 95 Col. 2 first para.).
With respect to claim 16, Muller teaches the neurons are in a layer in the cellular composite (would either be a monolayer or a multilayer) (pg. 95 Col. 2 para. 1 and Fig. 4).
Although, Muller teaches the mixed population of fibroblasts cells and Schwann cells contain fibroblast cells and Schwann cells at a cell number ratio of 0.8:1 (800,000:1,000,000) (pg. 95 Col. 1 last para.), Muller does not teach the ratio of about 1:1 to about 20:1 as recited in claim 17. Although Muller does not teach the range of ratio of fibroblast cells to Schwann cells recited in claim 17, one of ordinary skill in the art would recognize that the cell ratios of cell types in a cellular composition is a result effective variable and that the ratio of the cell types would be matter of routine optimization depending on the desired final concentration of cell types.
With respect to claim 18, Muller teaches the fibroblasts are human (mammalian) (pg. 95 Col. 1 last para.). With respect to claim 19, Muller teaches the Schwann cells are human (pg. 94 Col. 2 para. 4 and last para.).
Muller does not teach the cellular composite containing an additional layer of a mixed population of fibroblast cells and Schwann cells between the keratinocyte cell layer and the 3D cell growth material as claim 2 is being interpreted to mean as explained in the rejections under 35 U.S.C. §112 (b).
However, Schutte teaches skin contains a hypodermis layer containing Schwann cells and dermal fibroblasts beneath the keratinocyte layer (Fig. 1).
Accordingly, at the effective time of filling of the claimed invention, one of ordinary skill in the art would have been motivated to modify the cellular composite of Muller to include an additional layer containing a mixed population of fibroblast cells and Schwann cells between the keratinocyte cell layer and the 3D cell growth material for the benefit of mimicking a known cell layer that occurs naturally in skin as taught by Schutte. It would have been obvious to one of ordinary skill in the art to modify the skin cellular composite taught by Muller include additional layers of cells known to exist in skin as taught by Schutte. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to the cellular composition of Muller, since Muller teaches the cellular composition already containing these cells and Schutte teaches the layer of a mixed population of fibroblasts and Schwann cells beneath a keratinocyte layer naturally occurs. Additionally, it would have been obvious to place this layer between the 3D growth material and the keratinocyte layer to provide structural support.
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.
Claims 1, 3, 4-7, 9-14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (Acta Biomaterialia, 2018) (ref. of record) in view of Bray et al. (Experimental Dermatology, 2020).
With respect to claims 1, Muller teaches a cellular composite containing keratinocyte cell layer, a sponge (3D growth material) and neuronal cell layer where the sponge is located between the keratinocyte cell layer and the neuronal cell layer and where the sponge contains fibroblasts within and with Schwann cells on top (the 3D cell growth material comprises a mixed population of fibroblasts and Schwann cells) and (abstract, pg. 95 Col. 1 last para. to Col. 2 para. 2 and Fig. 4). Further with respect to the interpretation of “a mixed population of fibroblast cells and Schwann cells”, there is no requirement that the cells be uniformly blended and a mixed population would include the presence of multiple cell types organized into specific layers.
With respect to clams 4 and 5, Muller teaches the cell composite containing neurites that extend from the neuronal layer (abstract, pg. 96 Col. 1 last para. and Fig. 4).
With respect to clams 6 and 7, Muller teaches the 3D cell growth material is a collagen sponge (a porous scaffold containing a polymer) (abstract and pg. 95 Col. 1 last para.).
With respect to claims 9 and 10, Muller teaches the cellular composite within a cell culture medium (the 3D growth medium would be coated with the medium which is a solution) (pg. 95 Col. 1 last para. to Col. 2 para. 1).
With respect to claims 11 and 12, Muller teaches the keratinocytes are in a layer in the cellular composite (would either be a monolayer or a multilayer) and the keratinocytes are human (pg. 95 Col. 2 para. 2 and Fig. 4).
With respect to claims 13 and 14, Muller teaches the neuronal cells are iPS-derived sensory neurons and were differentiated from human skin fibroblast cell lines and a human peripheral blood mononuclear cell line (pg. 94 Col. 2 para. 4 and pg. 95 Col. 2 first para.).
With respect to claim 16, Muller teaches the neurons are in a layer in the cellular composite (would either be a monolayer or a multilayer) (pg. 95 Col. 2 para. 1 and Fig. 4).
Although, Muller teaches the mixed population of fibroblasts cells and Schwann cells contain fibroblast cells and Schwann cells at a cell number ratio of 0.8:1 (800,000:1,000,000) (pg. 95 Col. 1 last para.), Muller does not teach the ratio of about 1:1 to about 20:1 as recited in claim 17. Although Muller does not teach the range of ratio of fibroblast cells to Schwann cells recited in claim 17, one of ordinary skill in the art would recognize that the cell ratios of cell types in a cellular composition is a result effective variable and that the ratio of the cell types would be matter of routine optimization depending on the desired final concentration of cell types.
With respect to claim 18, Muller teaches the fibroblasts are human (mammalian) (pg. 95 Col. 1 last para.). With respect to claim 19, Muller teaches the Schwann cells are human (pg. 94 Col. 2 para. 4 and last para.).
Muller is silent to whether the Schwann cells are myelinating or non-myelinating and does not teach the cell composite where the Schwann cells are non-myelinating as recited in claim 3.
However, Bray teaches that the skin contains both myelinating and non-myelinating Schwann cells (pg. 94 Col. 1 last para. and Fig. 2). Bray further teaches that the majority of the nerve fibers in the sub-epidermal nerve plexus are unmyelinated and associated with non-myelinating Schwann cells (pg. 94 Col. 2 para. 1).
Accordingly, at the effective time of filling of the claimed invention, one of ordinary skill in the art would have been motivated to modify the cellular composite of Muller to include non-myelinating Schwann cells for the benefit of mimicking the cellular composition that occurs naturally in skin as taught by Bray. It would have been obvious to one of ordinary skill in the art to modify the skin cellular composite taught by Muller include non-myelinating Schwann cells, since these cells are known to naturally occur in skin as taught by Bray. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to the cellular composition of Muller, since Muller teaches the cellular composition containing Schwann cells and Bray teaches skin contains non-myelinating Schwann cells.
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.
Claims 1, 4-14, 16, 18 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (Acta Biomaterialia, 2018) (ref. of record) in view of Murphy et al. (US 2013/0190210 A1).
With respect to claims 1, Muller teaches a cellular composite containing keratinocyte cell layer, a sponge (3D growth material) and neuronal cell layer where the sponge is located between the keratinocyte cell layer and the neuronal cell layer and where the sponge contains fibroblasts within and with Schwann cells on top (the 3D cell growth material comprises a mixed population of fibroblasts and Schwann cells) and (abstract, pg. 95 Col. 1 last para. to Col. 2 para. 2 and Fig. 4). Further with respect to the interpretation of “a mixed population of fibroblast cells and Schwann cells”, there is no requirement that the cells be uniformly blended and a mixed population would include the presence of multiple cell types organized into specific layers.
With respect to clams 4 and 5, Muller teaches the cell composite containing neurites that extend from the neuronal layer (abstract, pg. 96 Col. 1 last para. and Fig. 4).
With respect to clams 6 and 7, Muller teaches the 3D cell growth material is a collagen sponge (a porous scaffold containing a polymer) (abstract and pg. 95 Col. 1 last para.).
With respect to claims 9 and 10, Muller teaches the cellular composite within a cell culture medium (the 3D growth medium would be coated with the medium which is a solution) (pg. 95 Col. 1 last para. to Col. 2 para. 1).
With respect to claims 11 and 12, Muller teaches the keratinocytes are in a layer in the cellular composite (would either be a monolayer or a multilayer) and the keratinocytes are human (pg. 95 Col. 2 para. 2 and Fig. 4).
With respect to claims 13 and 14, Muller teaches the neuronal cells are iPS-derived sensory neurons and were differentiated from human skin fibroblast cell lines and a human peripheral blood mononuclear cell line (pg. 94 Col. 2 para. 4 and pg. 95 Col. 2 first para.).
With respect to claim 16, Muller teaches the neurons are in a layer in the cellular composite (would either be a monolayer or a multilayer) (pg. 95 Col. 2 para. 1 and Fig. 4).
Although, Muller teaches the mixed population of fibroblasts cells and Schwann cells contain fibroblast cells and Schwann cells at a cell number ratio of 0.8:1 (800,000:1,000,000) (pg. 95 Col. 1 last para.), Muller does not teach the ratio of about 1:1 to about 20:1 as recited in claim 17. Although Muller does not teach the range of ratio of fibroblast cells to Schwann cells recited in claim 17, one of ordinary skill in the art would recognize that the cell ratios of cell types in a cellular composition is a result effective variable and that the ratio of the cell types would be matter of routine optimization depending on the desired final concentration of cell types.
With respect to claim 18, Muller teaches the fibroblasts are human (mammalian) (pg. 95 Col. 1 last para.). With respect to claim 19, Muller teaches the Schwann cells are human (pg. 94 Col. 2 para. 4 and last para.).
Muller does not teach the cellular composite where the 3D cell growth material is a gel or a hydrogel as recited in claims 6 and 8.
However, Murphy teaches an engineered tissue or a cellular composite containing a 3D cellular growth material that is a hydrogel and where the tissue is skin (0003, 0004, 0062, 0065, 0100, and 0165-0166).
At the time of the claimed invention, one of ordinary skill in the art would have been motivated to modify the teachings of Muller in such a way that the 3D cell growth material is a hydrogel for the purpose being able construct a cellular composite. Furthermore, it would have been obvious to one skilled in the art to have further modified Muller such that the 3D cell growth material is a hydrogel, since cellular composites of skin were known to contain hydrogels as taught by Murphy. Such a modification merely involves the substitution of one known type of 3D cell growth material for another for constructing a cellular composite. Furthermore the substitution of one known material, hydrogel, for another known material, a porous scaffold would have yielded predictable results (e.g. the manufacture of the cellular composite by Muller) to one of ordinary skill in the art.
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.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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