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 1-37 are currently pending.
Claims 38-95 are cancelled.
Claims 1-37 have been considered on the merits.
Specification
The use of the terms StrataGraft™ and ExpressGraft™, which is a trade name or a mark used in commerce, has been noted throughout this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. Based upon an analysis with respect to the claim as a whole, the claims do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
The claims are directed to:
A composition of allogeneic cultured keratinocytes comprising keratinocytes, dermal fibroblasts, and murine collagen.
The claims are directed to a composition using only a nature-based product, i.e., a skin construct, this nature-based product is analyzed to determine whether it has markedly different
characteristics from any naturally occurring counterpart(s) in their natural state. In this regard, the
disclosed multilayered skin exists entirely in nature (e.g., same genotype and phenotype potential and structure).
The art teaches that multilayered skin “mimic the biochemical and morphologic properties of human skin, known as skin-equivalent (organotypic) cultures” (see abstract of Margulis et al, Methods Mol Biol., 2005; 289:61-70). Further, Margulis, like the instant specification, teaches culture of keratinocytes and fibroblasts, which “enable the generation of human epidermal tissues that show in vivo-like tissue architecture and phenotype” (abstract, Margulis et al).
The art also teaches about collagen, specifically human and mouse collagen. Ihanamaki et al teaches that “Phylogenetically, most of the collagens are highly conserved between different species, which suggests that collagens also share similar functions in mice and men” (abstract, “Collagens and collagen-related matrix components in the human and mouse eye”).
The claims thus encompass a multilayered skin that is identical (no difference in characteristics) to naturally occurring multilayered skin. Since there is no difference between the multilayered skin claimed and naturally occurring multilayered skin, the multilayered skin do not have markedly different characteristics, and thus are a “product of nature” exception. In re Roslin Institute (Edinburgh), 750 F.3d
1333, 1338-39 (Fed. Cir. 2014). Accordingly, the claimed invention is directed to an exception. Because
the claimed invention does not include any additional features that could add significantly more to the
exception, the claimed culture does not qualify as eligible subject matter, and should be rejected under
35 U.S.C. § 101.
PNG
media_image1.png
311
389
media_image1.png
Greyscale
Step 2A has recently been revised to include two prongs (Federal Register / Vol. 84, No. 4 / Monday, January 7, 2019):
PNG
media_image2.png
447
453
media_image2.png
Greyscale
An examination of Step 2A in the revised 101 guidance, with respect to the claimed invention, the answer is yes since the claimed invention comprises naturally occurring products (judicial exceptions), in the instant case these naturally occurring products are a skin composition. When examining the claimed invention with regards to Step 2A prong 1, the answer is yes since the claimed invention encompasses naturally occurring products. When examining the claimed invention with regards to Step 2A prong 2, the answer is no since the claimed invention does not recite additional elements that integrate the judicial exception, in the instant case a skin composition, into a practical application.
It is only the recited limitations in the claims that are examined under 101 and not aspects such as what the multilayered skin is capable of treating or used for (i.e. a skin composition for transplant). In this case only the skin composition is examined with respect to its status as a judicial exception. It is again emphasized that the claimed invention is a composition and not a method.
An examination of Step 2B, the answer is no with respect to the claimed invention. There are no other additional elements recited in the claim that would amount to significantly more than the judicial exceptions. The skin composition as claimed encompasses a composition that is indistinguishable from those that exist in nature and there are no limitations that add any additional elements to the claimed skin composition. The skin composition has the same function as it does in nature and the fact that they may exist in an isolated system does not change the skin composition in a significant or meaningful way to amount to more than the judicial exception.
The only factors which can be examined under 101 in the claimed composition are those that are recited in the claim i.e. a skin composition. How the skin composition was obtained and the knowledge of using it is not considered with respect to a composition claim, it is only the judicial exceptions themselves that are analyzed under 101 and in this case all of the components in the claimed composition are naturally-occurring products and thus qualifies as a judicial exception.
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.
Claims 31-32 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.
Claim 31 recites the limitation "the foil pouch" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 32 recites the limitation "the foil" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim Interpretation
Claims 14-19 provide limitations which are directed towards an intended use of the claimed composition, which carries little patentable weight.
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 1, 4, 7, 10, 12, 21, 23-25, 33, and 35 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Allen-Hoffmann et al (US20170339943A1), referred to as Allen-Hoffmann 1.
Regarding claim 1, Allen-Hoffmann 1 teaches a composition of a cultured skin which comprises an allogeneic cellularized scaffold with dermal fibroblasts, murine collagen, and keratinocytes ([0066]). Specifically, regarding the term “allogeneic”, the cells utilized come from cell lines derived from a different individual than the intended recipient of the cultured skin construct, which is inherently allogeneic.
Regarding claim 4, Allen-Hoffmann 1 teaches that the composition is sterile which meets the limitations of the composition comprising no detectable pathogens ([0035]).
Regarding claim 7, Allen-Hoffmann 1 teaches that the dermal fibroblasts are human dermal fibroblasts ([0070]).
Regarding claim 10, Allen-Hoffmann 1 teaches that the keratinocytes are cultured for 43 passages because Allen-Hoffmann teaches that the keratinocytes maintained a stable rate of growth through at least 59 passages ([0037]).
Regarding claim 21, Allen-Hoffmann 1 teaches that the cells used in the composition are human cells and therefore meets the limitation of “wherein mouse cells are not used in the manufacture of the composition”.
Regarding claim 25, Allen-Hoffmann 1 teaches wherein the composition is incubated at 37°C and 5% CO2 for at least 25 days ([0066]-[0072]).
Regarding claim 33, Allen-Hoffmann 1 teaches through omission that the composition is substantially free of antimicrobial compositions selected from mafenide acetate, silver-containing antimicrobials, chlorhexidine solution, and combinations thereof. Allen-Hoffmann does not teach the inclusion of any of the listed antimicrobial compositions.
Regarding claim 35, Allen-Hoffmann 1 teaches that a single subcutaneous injection of keratinocytes into immunodeficient mice does not result in tumor formation at all ([0042]), which meets the limitations of not resulting in tumor formation by 23 weeks post-injection.
Regarding claims 23-24, the recites testing standards and results of testing are considered a functional characterization of the claimed composition and do not impose additional structural limitations; the prior art composition would inherently meets such criteria.
Therefore, Allen-Hoffmann 1 anticipates the claims.
Claims 1, 5, 7-9, 10, 21, 23-24, 30, and 33-34 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Allen-Hoffmann et al (US20140271583A1), referred to as Allen-Hoffmann 2, as evidenced by FDA (FDA product entry for: StrataGraft, 2024).
Regarding claim 1, Allen-Hoffmann 2 teaches a composition of a cultured skin which comprises an allogeneic cellularized scaffold with normal human dermal fibroblasts, collagen, and keratinocytes ([0066]). Specifically, regarding the term “allogeneic”, the cells utilized come from cell lines derived from a different individual than the intended recipient of the cultured skin construct, which is inherently allogeneic.
Regarding claim 5, Allen-Hoffmann 2 teaches that the cells are able to be engineered to secrete or deliver proteins such as vascular endothelial growth factor (VEGF), a growth factor and specialized cytokine, which meets the limitations of the composition secreting growth factors and cytokines ([0058]).
Regarding claim 7, Allen-Hoffmann 2 teaches that the dermal fibroblasts are human dermal fibroblasts ([0061]).
Regarding claim 8, Allen-Hoffmann 2 teaches that the composition further comprises ECM proteins ([0062]).
Regarding claim 9, Allen-Hoffmann 2 teaches that the composition further comprises glycerin ([0085]).
Regarding claim 10, Allen-Hoffmann 2 teaches that the keratinocytes are cultured for 43 passages because Allen-Hoffmann teaches that the keratinocytes maintained a stable rate of growth through at least 59 passages ([0037]).
Regarding claim 21, Allen-Hoffmann 2 teaches that the cells used in the composition are human cells and therefore meets the limitation of “wherein mouse cells are not used in the manufacture of the composition” ([0061]).
Regarding claim 30, Allen-Hoffmann 2 teaches that the composition is stored inside a foil pouch until used ([0052]).
Regarding claim 33, Allen-Hoffmann 2 teaches through omission that the composition is substantially free of antimicrobial compositions selected from mafenide acetate, silver-containing antimicrobials, chlorhexidine solution, and combinations thereof. Allen-Hoffmann 2 does not teach the inclusion of any of the listed antimicrobial compositions.
Regarding claim 34, Allen-Hoffmann 2 teaches by omission that the methods of using the composition do not contain an antimicrobial composition or administering an antimicrobial composition within the claimed composition. Additionally, Allen-Hoffmann 2 teaches that there was a significant improved efficacy with employing the claimed composition as compared to an autograft, in that by month 3 only 4.3% of sites required a second graft when the claimed composition, Stratagraft™, was employed whereas 102.1% of the control autograft treatment sites needed additional autografts ([0118]).
Regarding claims 23-24, the recites testing standards and results of testing are considered a functional characterization of the claimed composition and do not impose additional structural limitations; the prior art composition would inherently meets such criteria.
Allen-Hoffmann meets the limitations of claim 1 because Allen-Hoffmann 2 teaches the use of StrataGraft™ as the allogeneic cultured keratinocyte composition ([0041] and examples). Allen-Hoffmann meets the limitation of the collagen being murine collagen as evidenced by FDA. FDA teaches that the composition defined by the tradename StrataGraft™ has the proper name of “allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat” (pg. 1, “proper name”). Therefore, Allen-Hoffmann as evidenced by FDA meets the limitation of claim 1.
Therefore, Allen-Hoffmann 2 anticipates the claims.
Claims 1, 5-6, 13-21, and 23-24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Smiell et al (WO2021062359).
Regarding claim 1, Smiell teaches a composition of a cultured skin which comprises an allogeneic cellularized scaffold with normal human dermal fibroblasts, murine collagen, and keratinocytes ([0038]-[0039]). Specifically, regarding the term “allogeneic”, the cells utilized come from cell lines derived from a different individual than the intended recipient of the cultured skin construct, which is inherently allogeneic.
Regarding claim 5, Smiell teaches that the cells are able to be engineered to secrete or deliver proteins such as vascular endothelial growth factor (VEGF), a growth factor and specialized cytokine, as well as IL-12, a cytokine, which meets the limitations of the composition secreting growth factors and cytokines ([0039]).
Regarding claim 6, Smiell teaches that the composition induces no immune rejection within 12 months of topical use ([0093]/[0129]).
Regarding claim 13, Smiell teaches that the cellularized scaffold construct is trimmed to the shape of a wound bed or burn ([0056]).
Regarding claim 14, Smiell teaches that a single scaffold is applied to a single patient ([0062]).
Regarding claim 15, Smiell teaches that the cellularized scaffold construct is trimmed to the shape of a wound bed or burn ([0056]), and that the wound may be 100 cm2 ([0048]).
Regarding claim 16, Smiell teaches that the cellularized scaffold construct is trimmed to the shape of a wound bed or burn ([0056]), and that the wound may be anywhere from 1-199 cm2 ([0048]).
Regarding claim 17, Smiell teaches that the cellularized scaffold construct is trimmed to the shape of a wound bed or burn ([0056]), that the wound may be 100 cm2 ([0048]), and is used to treat Deep-Partial Thickness (DPT) thermal burns ([0086]).
Regarding claim 18, Smiell teaches that the cellularized scaffold construct is trimmed to the shape of a wound bed or burn ([0056]), and that the wound may be anywhere from 1-199 cm2 ([0048]).
Regarding claim 19, Smiell teaches that the composition provides durable wound closure at a thermal burn treatment site 3 months without autograft placement ([0058]/[0052]).
Regarding claim 20, Smiell teaches that the product is a xenotransplantation product because Smiell teaches that the product is meant for transplantation and it contains xenograft type structure due to the murine collagen ([0038]-[0040]).
Regarding claim 21, Smiell teaches that the cells used in the composition are human cells and therefore meets the limitation of “wherein mouse cells are not used in the manufacture of the composition” ([0038]-[0039]).
Regarding claims 23-24, the recites testing standards and results of testing are considered a functional characterization of the claimed composition and do not impose additional structural limitations; the prior art composition would inherently meets such criteria.
Therefore, Smiell anticipates the claims.
Claims 1, 7, 11, 13, 21, and 23-24 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nanchahal et al (Burns, “Allogeneic skin substitutes applied to burns patients”, 2002).
Regarding claim 1, Nanchahal teaches a composition of a cultured skin which comprises an allogeneic cellularized scaffold with normal human dermal fibroblasts, murine collagen, and keratinocytes (pg. 254, col. 2, para 2).
Regarding claim 7, Nanchahal teaches that the dermal fibroblasts are human dermal fibroblasts (pg. 254, col. 2, para 2).
Regarding claim 11, Nanchahal teaches that the dermal fibroblasts are cultured for 5-7 passages (pg. 255, col. 1, para 1).
Regarding claim 13, Nanchahal teaches that the cellularized scaffold construct is trimmed to the shape of a wound bed or burn (pg. 255, col. 1, para 3)
Regarding claim 21, Nanchahal teaches that the cells used in the composition are human cells and therefore meets the limitation of “wherein mouse cells are not used in the manufacture of the composition” pg. 254, col. 2, para 2).
Regarding claims 23-24, the recites testing standards and results of testing are considered a functional characterization of the claimed composition and do not impose additional structural limitations; the prior art composition would inherently meets such criteria.
Therefore, Nanchahal anticipates the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 1, 2, 3, and 12, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Allen-Hoffmann et al (US20170339943A1), referred to as Allen-Hoffmann 1.
Regarding claims 2-3, 12, and 25, the limitations of the independent claim are taught above.
Regarding claim 2, Allen-Hoffmann 1 teaches that the keratinocytes are karyotypically stable ([0036]).
Regarding claim 3, Allen-Hoffmann 1 teaches that the keratinocytes do not exhibit anchorage-independent growth ([0041]).
Regarding claim 12, Allen-Hoffmann 1 teaches that the human keratinocyte cells are derived from a cell bank which contains no detectable pathogens ([0036]).
Regarding claim 35, Allen-Hoffmann 1 teaches that a single subcutaneous injection of keratinocytes into immunodeficient mice does not result in tumor formation at all ([0042]), which meets the limitations of not resulting in tumor formation by 23 weeks post-injection.
Allen-Hoffmann 1 does not teach that dermal fibroblasts are karyotypically stable as required by claim 2. Allen-Hoffmann 1 does not teach that the dermal fibroblasts do not exhibit anchorage-independent growth as required by claim 3. Allen-Hoffmann 1 does not teach that the composition is derived from fibroblast cell banks that contain no detectable pathogens as required by claim 12.
Regarding claims 2 and 12, Allen-Hoffman 1 teaches that the keratinocytes are karyotypically stable and are derived from a cell bank which contains no detectable pathogens ([0036]). Allen-Hoffman 1 teaches that genetically-uniform, pathogen free human keratinocytes, which are karyotypically stable are useful for the application of genomic gene expression approaches to provide skin equivalent cultures with properties more similar to human skin ([0036]).
One of ordinary skill in the art would be motivated to include not just keratinocytes, but also dermal fibroblasts which are both karyotypically stable and derived from a cell bank with no detectable pathogens based upon the disclosure of Allen-Hoffmann 1. One of ordinary skill in the art would be motivated to make such a combination because Allen-Hoffmann teaches that genetically-uniform, pathogen free human keratinocytes, which are karyotypically stable are useful for the application of genomic gene expression approaches to provide skin equivalent cultures with properties more similar to human skin ([0036]). One of ordinary skill in the art would have a reasonable expectation of success when including dermal fibroblasts which are karyotypically stable and pathogen free because these aspects of cells are known to provide a more human skin like construct ([0036]).
Regarding claim 3, Allen-Hoffmann 1 teaches that the keratinocytes do not exhibit anchorage-independent growth ([0041]). Allen-Hoffmann 1 teaches that “Anchorage-independent growth is highly correlated to tumorigenicity in vivo” and for this reason Allen-Hoffmann tested the anchorage-independent growth characteristics of Keratinocytes in both in vitro and in vivo assays ([0041]-[0043]).
One of ordinary skill in the art would be motivated to include not just keratinocytes, but also dermal fibroblasts which do not exhibit anchorage-independent growth as taught by Allen-Hoffmann. One of ordinary skill in the art would be motivated to make such a combination because Allen-Hoffmann 1 teaches that “Anchorage-independent growth is highly correlated to tumorigenicity in vivo” and for this reason Allen-Hoffmann tested the anchorage-independent growth characteristics of Keratinocytes in both in vitro and in vivo assays ([0041]-[0043]). One of ordinary skill in the art would have a reasonable expectation of success when including dermal fibroblasts which do not exhibit anchorage-independent growth because anchorage-independent growth is known to highly correlate with tumorigenicity in vivo ([0041]).
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, 22, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Allen-Hoffmann et al (US20140271583A1), referred to as Allen-Hoffmann 2, as evidenced by FDA (FDA product entry for: StrataGraft, 2024), in view of Forsell et al (US20130013068A1).
Regarding claims 22, 31, and 32, the limitations of the independent claim are taught above.
Regarding claim 31, Allen-Hoffmann 2 teaches wherein the foil pouch does not contact the composition during packaging, shipping, or clinical use because the foil pouch is taught to be a secondary packaging ([0052]).
Regarding claim 32, Allen-Hoffmann 2 teaches wherein the composition is cryopreserved within the foil until use ([0052]).
Allen-Hoffmann 2 does not teach that the composition further comprises a packaging material gamma irradiated at a target minimum dose of 30.0 kGy as required by claim 22.
However, Forsell teaches a composition of an allograft for use in treating wounds of the soft tissue (abstract).
Forsell teaches an irradiation dose of 5-35 kGy to sterilize the graft for storage ([0022]).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the skin construct taught by Allen-Hoffmann 2 with the irradiation of a tissue construct at 30 kGy for storage taught by Forsell to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Forsell teaches an irradiation dose of 5-35 kGy to sterilize the graft for storage ([0022]). One of ordinary skill in the art would have a reasonable expectation of success when combining Allen-Hoffmann 2 with Forsell because both are in the area of tissue constructs for use in soft tissue wound healing.
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 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Allen-Hoffmann et al (US20170339943A1), referred to as Allen-Hoffmann 1, in view of Lamberti et al (Included in IDS dated 02/21/2024; Food Reviews International, “Aluminum Foil as a Food Packaging Material in Comparison with Other Materials”, 2007).
Regarding claims 26-27, the limitations of the independent claim are taught above.
Allen-Hoffmann 1 does not teach that the composition further comprises a packaging layer having an oxygen transmission less than 0.003 cc/100 in2 /24 hours as required by claim 26. . Allen-Hoffmann 1 does not teach that the composition further comprises a packaging layer having an oxygen transmission less than 0.0065 g/100 in2 /24 hours as required by claim 26.
However, Lamberti is in the field of packaging materials (abstract).
Regarding claim 26, Lamberti discloses a packaging layer having oxygen transmission less than 0.003 cc/100 in2 /24 hours, more specifically 0.02-0.045 cm3/m2/ 24 hours, which equates to 0.0013-0.029 cc/100 in2 / 24 hours (see table 4, pg. 413).
Regarding claim 27, Lamberti discloses a packaging layer having oxygen transmission less than 0.0065 g/100 in2 /24 hours, more specifically 0.04 g/m2/day, which equates to 0.004 g/100cm2/day 24 hours (see table 3, pg. 413).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the skin construct taught by Allen-Hoffmann 1 with the packaging material taught by Lamberti to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Lamberti teaches most of the deteriorating effects in stored products are the result of moisture, oxygen, and light (pg. 413, para 1). One of ordinary skill in the art would have a reasonable expectation of success when combining Allen-Hoffmann 1 with Lamberti because the packaging material is selected to have a good resistance to oxygen permeability to avoid deteriorating effects to the contents of the package.
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 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Allen-Hoffmann et al (US20170339943A1), referred to as Allen-Hoffmann 1, in view of Yancheng Dachang Packaging Technology (CN112140681A; machine translation by Google Patents), referred to as “Yancheng”.
Regarding claim 28, the limitations of the independent claim are taught above.
Allen-Hoffmann 1 does not teach that the composition further comprises a 30 gauge aluminum foil pouch as required by claim 28.
However, Yancheng is in the field of packaging materials (abstract).
Regarding claim 28, Yancheng teaches an aluminum foil pouch which can vary from 100-1000 microns (abstract), which equates to 0.1 to 1 mm. A 30 gauge layer would be 0.3 mm layer which falls within the range disclosed by Yancheng. Yancheng describes the foil pouches as “antistatic, ultraviolet-proof, moisture-proof, oxygen-proof, light-proof, cold-resistant, oil-resistant, high-temperature-resistant, fresh-keeping, oxygen-proof, [and] easy-sealing” (pg. 2, last para).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the skin construct taught by Allen-Hoffmann 1 with the packaging material taught by Yancheng to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Yancheng describes the foil pouches as “antistatic, ultraviolet-proof, moisture-proof, oxygen-proof, light-proof, cold-resistant, oil-resistant, high-temperature-resistant, fresh-keeping, oxygen-proof, [and] easy-sealing” (pg. 2, last para). One of ordinary skill in the art would have a reasonable expectation of success when combining Allen-Hoffmann 1 with Yancheng because the packaging material is selected to have a superior qualities to avoid deteriorating effects to the contents of the package.
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 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Allen-Hoffmann et al (US20170339943A1), referred to as Allen-Hoffmann 1, in view of Linvill et al (US20190329928A1).
Regarding claim 29, the limitations of the independent claim are taught above.
Allen-Hoffmann 1 does not teach that the composition further comprises an 18pt cardboard carton comprising an opacity percentage of 99.74% as required by claim 29.
However, Linvill is in the field of cardboard packaging materials (abstract).
Regarding claim 29, Linvill teaches an 18pt cardboard carton, which inherently has an opacity percentage of 99.74% due to being 18 pt cardboard ([0026]).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the skin construct taught by Allen-Hoffmann 1 with the packaging material taught by Linvill to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because the 18 pt cardboard carton of Linvill is made through a process which mitigates cracking yielding a more flexible and stronger cardboard coated carton ([0019]). One of ordinary skill in the art would have a reasonable expectation of success when combining Allen-Hoffmann 1 with Linvill because the packaging material is selected to have a superior qualities to avoid deteriorating effects to the contents of the package.
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.
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.
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, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/ Primary Examiner, Art Unit 1632
Prosecution Insights