DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The instant application is a Continuation of application 18/321,238 filed 22 May 2023, now U.S. Patent 11,857,701, which is a Continuation of application 17/369,067 filed 7 July 2021, now U.S. Patent 11,744,926, which is a Continuation of application 16/400,259 filed 1 May 2019, now U.S. Patent 11,058,802, which is a Continuation of application 15/596,685 filed 15 May 2017, now U.S. Patent 10,314,950, which is a Continuation of application 14/803,258 filed 20 July 2015, now U.S. Patent 9,656,001, which was a Continuation of application 13/269,344 filed 7 October 2011, now U.S. Patent 9,095,558, which claims the benefit of provisional application 61/391,299 filed 8 October 2010.
Status of the Claims
Claims 4-20 are pending, presented for examination, and rejected as set forth below.
Claim Interpretation
The instant claims are directed to multilayered hydrogel films, with a first layer being a desiccated, amorphous, translucent, anti-adhesive and non-attractive to cells combination of a defined concentration of hyaluronic acid and alginate fused to a second film layer of a composition including collagen which is adhesive to cells. Applicant’s Claim 1 defines the composition as “a wrap,” but applicants are aware that claim language reciting the intended use of a composition otherwise fully set forth by structural elements recited in the claim are non-limiting on the structure claimed. See Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003) (indicating that a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate). Dependent claims specify that the hyaluronic acid or sodium alginate is uncrosslinked, or is present in concentrations at or below 33%, or is either non-cytotoxic or negatively charged and hydrophilic, unpatterned, non-synthetic, or is a cast film. Additional dependent Claims specify the type of alginate to be included, or indicate that the film “consists essentially of” the combination of hyaluronic acid and alginate. Applicants are reminded that the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976). Absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" is construed as equivalent to "comprising.” PPG Industries v. Guardian Industries, 156 F.3d 1351, 1355, 48 USPQ2d at 1355 (Fed. Cir. 1998). Neither applicants’ claims nor the disclosure as originally filed appears to provide this identification; the claims “consisting essentially of” any recited elements will be treated as equivalent to claims “comprising” the recited elements. Dependent define the physical dimensions of the film, indicate that the first layer does not include calcium, or that the film incorporates an anionic polymer. Claim 11 indicates that the first film layer is to be bioabsorbable in a manner controlled by the ratio of hyaluronic acid to alginate present.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claim 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-37 of U.S. Patent No. 11,857,701.
The Claims of the ‘701 patent encompass bilayer films described as a “nerve wrap” comprising a first layer anti-adhesive and non-attractive to cells having a defined concentration of hyaluronic acid and alginate adhered to a second layer of collagen that is adhesive to cells. Dependent claims specify the uncrosslinked nature of the hyaluronic acid, an upper limit to the concentration thereof, or reflect the crosslinked nature of the alginate, alternatively requiring the alginate include the calcium or sodium salt thereof. Properties the first layer are to possess are recited by additional dependent claims, or limit the hydrogel film to one consisting essentially of the hyaluronic acid and alginate. Dimensions and other physical characteristics of the apparatus are recited by additional dependent claims, as is the exclusion of calcium or the inclusion of anionic polymers. These limitations, albeit in different combinations and arrangements, are recited by the claims of the present application as alternative embodiments of the multilayered hydrogel films, with a first layer being a desiccated, amorphous, translucent, anti-adhesive and non-attractive to cells combination of a defined concentration of hyaluronic acid and alginate fused to a second film layer of a composition including collagen which is adhesive to cells of the present claims. As such, the combination and rearrangement of these limitations represent obvious modifications of the devices of the ‘701 patent.
Claim 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-37 of U.S. Patent No. 9,095,558 in view of JP2004507472 (machine translation provided, all references are to the machine translation).
The Claims of the ‘558 patent encompass desiccated, amorphous, flexible, porous hydrogels combining a first layer of hyaluronic acid and negatively charged alginate crosslinked with calcium cations, and a second layer of uncrosslinked hyaluronic acid and negatively charged alginate crosslinked with calcium fused together, with the first layer anti-adhesive and the second layer adhesive to cells. Dependent claims specify the inclusion of a pore network, or that active agents are incorporated into the composition, or that the amount of hyaluronic acid present in the composition fall within certain concentrations. The compositions of the ‘558 patent do not include collagen as the layer which is adhesive to cells, which is cured by the teachings of the JP’472 publication, which describes bilayer matrices for use in tissue repair and regeneration. (Abs). The ’472 publication indicates that these layers can be mechanically gelled onto or chemically bonded together, addressing the “fused” nature of the instant claims. [0006-07]. A composition where HA is present in one layer and collagen the other is particularly preferred. [0011]. The ’472 publication indicates that the COL layer promoted the attachment and proliferation of cells in an animal model. [0058-59]. On the basis of the art recognizing fusing films containing in one layer hyaluronic acid and the other collagen where the collagen layer is described as promoting the adhesion of cells, the use of collagen in place of the cell-adherent HA component of the ‘558 patent would have been prima facie obvious. See Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985)(indicating that it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect).
Claim 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-37 of U.S. Patent No. 9,656,001, in view of JP2004507472.
The Claims of the ‘001 patent encompass translucent, desiccated, amorphous, non-cytotoxic, porous hydrogels combining a first layer of hyaluronic acid and negatively charged alginate crosslinked with cations, ultimately in dependent claims calcium, and a second layer of uncrosslinked hyaluronic acid and negatively charged alginate crosslinked with cations, in dependent claims ultimately calcium, fused together, with the first layer anti-adhesive and the second layer adhesive to cells, coated onto a substrate via ester bonds through a biopolymer having a defined concentration of hyaluronic acid in the composition. Dependent claims specify the inclusion of a pore network, or that active agents are incorporated into the composition, or that the hydrogel apparatus may be used in a certain manner. The compositions of the ‘558 patent do not include collagen as the layer which is adhesive to cells, which is cured by the teachings of the JP’472 publication, which describes bilayer matrices for use in tissue repair and regeneration. (Abs). The ’472 publication indicates that these layers can be mechanically gelled onto or chemically bonded together, addressing the “fused” nature of the instant claims. [0006-07]. A composition where HA is present in one layer and collagen the other is particularly preferred. [0011]. The ’472 publication indicates that the COL layer promoted the attachment and proliferation of cells in an animal model. [0058-59]. On the basis of the art recognizing fusing films containing in one layer hyaluronic acid and the other collagen where the collagen layer is described as promoting the adhesion of cells, the use of collagen in place of the cell-adherent HA component of the ‘558 patent would have been prima facie obvious. See Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985)(indicating that it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect).
Claim 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-37 of U.S. Patent No. 10,314,950, in view of JP2004507472.
The Claims of the ‘950 patent encompass hydrogels combining a first translucent, desiccated, amorphous, non-synthetic and non-cytotoxic layer of hyaluronic acid and negatively charged alginate crosslinked with cations, ultimately in dependent claims calcium, and a second translucent, desiccated, amorphous, non-synthetic and non-cytotoxic layer of uncrosslinked hyaluronic acid and negatively charged alginate crosslinked with cations, ultimately in dependent claims calcium, fused together, with the first layer anti-adhesive and the second layer adhesive to cells. Dependent claims specify the inclusion of a pore network, or that active agents are incorporated into the composition, or that the amount of hyaluronic acid present in the composition fall within certain concentrations, or that the hydrogel be coated onto a substrate via ester bonds through a biopolymer. The compositions of the ‘558 patent do not include collagen as the layer which is adhesive to cells, which is cured by the teachings of the JP’472 publication, which describes bilayer matrices for use in tissue repair and regeneration. (Abs). The ’472 publication indicates that these layers can be mechanically gelled onto or chemically bonded together, addressing the “fused” nature of the instant claims. [0006-07]. A composition where HA is present in one layer and collagen the other is particularly preferred. [0011]. The ’472 publication indicates that the COL layer promoted the attachment and proliferation of cells in an animal model. [0058-59]. On the basis of the art recognizing fusing films containing in one layer hyaluronic acid and the other collagen where the collagen layer is described as promoting the adhesion of cells, the use of collagen in place of the cell-adherent HA component of the ‘558 patent would have been prima facie obvious. See Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985)(indicating that it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect).
Claims 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent 11,744,926 in view of JP2004507472.
The Claims of the ‘926 patent encompass hydrogels combining a first translucent, desiccated, amorphous, non-synthetic and non-cytotoxic layer of hyaluronic acid and negatively charged alginate crosslinked with cations, ultimately in dependent claims calcium, and a second translucent, desiccated, amorphous, non-synthetic and non-cytotoxic layer of uncrosslinked hyaluronic acid and negatively charged alginate crosslinked with cations, ultimately in dependent claims calcium, fused together, with the first layer anti-adhesive and the second layer adhesive to cells. Dependent claims specify the inclusion of a pore network, or that active agents are incorporated into the composition, or that the amount of hyaluronic acid present in the composition fall within certain concentrations, or that the hydrogel be coated onto a substrate via ester bonds through a biopolymer. The compositions of the ‘067 application do not include collagen as the layer which is adhesive to cells, which is cured by the teachings of the JP’472 publication, which describes bilayer matrices for use in tissue repair and regeneration. (Abs). The ’472 publication indicates that these layers can be mechanically gelled onto or chemically bonded together, addressing the “fused” nature of the instant claims. [0006-07]. A composition where HA is present in one layer and collagen the other is particularly preferred. [0011]. The ’472 publication indicates that the COL layer promoted the attachment and proliferation of cells in an animal model. [0058-59]. On the basis of the art recognizing fusing films containing in one layer hyaluronic acid and the other collagen where the collagen layer is described as promoting the adhesion of cells, the use of collagen in place of the cell-adherent HA component of the ‘558 patent would have been prima facie obvious. See Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985)(indicating that it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect).
Allowable Subject Matter
While no claims are presently in condition for allowance, Applicants claims are critically directed to a hydrogel film which is “desiccated,” which are “fused” or laminated bilayers of hyaluronic acid and ionic alginate compounds. The examiner, in reviewing the disclosure and evidence presented, has concluded that Applicants claim language describing the nature of the films is attributable to the exceptionally thin nature of the films which are claimed, and serves to distinguish the claimed invention from the prior art bilayer alginate compositions in a nonobvious way. As applicants have indicated via their submissions in the Information Disclosure Statement filed 22 May 2023, the formation of such desiccated, translucent, and thin bilayers to this day presents a technical challenge in terms of properly fusing or laminating such thin layers reliably to provide membranes with the desired properties as are presently claimed, while avoiding the problem of delamination of the layers once fused. Applicants discussion of and reliance upon the disclosures of Kang (An Effect of Alginate on the Stability of LDH Nanosheets in Aqueous Solution and Preparation of Alginate/LDH Nanocompositions, 100 Carbohyd. Poly. 158 (2014)), Jejurikar (A Novel Strategy for Preparing Mechanically Robust Ionically Cross-Linked Alginate Hydrogels, 6 Biomed. Mater. 025010 (2011)), and Gleghorn (Adhesive Properties of Laminated Alginate Gels for Tissue Engineering of Layered Structures, 85A J Biomed. Mater. Res. 611 (2008)) (all of record) in the parent cases of the instant application are particularly informative, both in terms of establishing the relative dimensions of the prior art (i.e., Gleghorn - 2mm; Jejurikar – 500 micron thick) versus instantly claimed bilayer alginate structures as well as establishing the lack of reliability or predictability in terms of expectations of success which a skilled artisan at the time of the instant application would have expected in terms of formulating a flexible, translucently thin alginate bilayer structure.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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