DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 25th of September 2025, has been entered.
Priority
The instant application, U.S. Application Number 16/798,180, filed 21st of February 2020, claims priority as a continuation of U.S. Application Number 15/620,531, filed 12 June 2017, which claims priority from provisional application 62/348,698, filed 10 June 2016.
Status of the Claims
In Applicant’s response and amendment filed Sept. 25, 2025, are acknowledged and entered. Applicant has amended claims 12, 31, and 39; and canceled claims 1-11, and 21-30.
Applicant elections without traverse of the invention directed to a wound packing material and system comprising the wound packing material, in the reply filed on 10/31/2022 is acknowledged.
Claims 12-20, and 31-41 are under consideration in this office action.
Withdrawn Objections & Rejections
Rejections and/or objections not reiterated from the previous office action are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 12, 31, and 39 are objected to because of the following informalities: abbreviation and clarity. At least claim 12, it is suggested that the recitation of the abbreviation “cc” would be spelled out in at least the first claim where it is cited.
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 12-20, and 31-41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
This rejection is a new rejection necessitated by amendments to the claims.
Claim 12, 31, and 39 recite “wherein the thickening agent has a ratio of between 1 and 20,000 units of thickening agent for every cc of the mixture of the concentrated bone marrow aspirate and the plasma concentrate;”. (see e.g. claim 12, lines 10-12). However, claims 12, 31, and 39 recite the claim limitation of “mixing the concentrated bone marrow aspirate, the plasma concentrate, and the thickening agent to generate the wound packing material” (lines 6-8). Although the claim recites the step of “mixing” a concentrated bone marrow aspirate, a plasma concentrate, and a thickening agent; however, the claims refers to this mixture as a “wound packing material” and not a “mixture”. Therefore, it is unclear to the person of ordinary skill in the art if there is another “mixture” that is being referred to in the claim. Thus, there is insufficient antecedent basis for this limitation in the claim. For compact prosecution, the claim limitation of “wherein the thickening agent has a ratio of between 1 and 20,000 units of thickening agent for every cc of a mixture of the concentrated bone marrow aspirate and the plasma concentrate” will be interpreted as referring to the mixture as the wound packaging material.
Claim Rejections - 35 USC § 103 Rejection
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 12-14, 16, 31-33 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Enyart, et al. (US 8,092,837; published 2012, prior art of record, hereinafter as “Enyart”) in view of Hao et al. (2010, Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi; English Abstract only; cited IDS 11/06/2020), Debels, et al. (Plas. Reconstr. Surg. Glob. Open; of record, published 2015, prior art of record), Hartwell et al (US 2015/0159066 A1, published 2015, prior art of record), Augustine et al., (US 2010/0010477, prior art of record), Akela, et al. (International Wound Journal 9.5: 505-516; cited IDS 11/06/2020; published 2012, prior art of record), Chahla et al. (2016, Jan. 13, The Orthopaedic Journal of Sports Medicine, prior art of record), and Pei, et al (CN1846790A, published 2006, prior art of record).
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to a rejection set forth in the non-final Official action mailed on March 26, 2025, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
Regarding claims 12 and 31, Enyart teaches methods for packing and treating wounds comprising a wound packing material that can be used as a wound filler and a wound sealer (see summary of the invention, abstract, col. 2, lines 26-57, col. 3, lns. 8-45; col. 6, para. 3; col. 9, para. 2)..
Regarding claims 12 and 31, concentrated bone marrow aspirate, Enyart teaches concentrated cells from bone marrow aspirate (see summary of the invention, abstract, col. 2, lines 26-57, col. 3, lns. 8-45; col. 6, para. 3; col. 9, para. 2). Further, Enyart teaches that the non-liquid biomaterial may comprise cells including stem cells such as bone marrow derived stem cells derived from bone marrow aspirate (col. 6, lines 50-54). Thus, this teaching would meet the concentrated bone marrow aspirate comprising multi-protein cells as the bone marrow derived stem cells, such as mesenchymal stem cells and hematopoietic stem cells are multipotent. Claim Interpretation Broadest Reasonable Interpretation: the concentrated bone marrow aspirate comprising multi-potent cells such as bone marrow cells reads on the claimed multi-potent cells.
Regarding claims 12 and 31, a plasma concentrate from blood, Enyart discloses a non-liquid biomaterial that may be used as a surgical sealant, a tissue filler, a wound dressing or a combination thereof, comprising a blood derived material such as concentrated plasma, platelet rich plasma (i.e. PRP), or a material derived from blood containing tissue aspirate such as bone marrow aspirate, a protein binding agent, and a polymerizing agent (see Abstract; col. 2, lines 44-57).
Regarding claims 12 and 31, thickening agent, Enyart discloses that the non-liquid biomaterial is formed by mixing with a polymerizing agent to produce as solids, gels, hydrogels or semi-solids (col. 5, lines 35-40).
Regarding claims 12 and 31, wound packaging material, Enyart discloses the non-liquid biomaterial is tissue filler and wound sealer (Abstract; para. 5, 13, 38, claim 15). Furthermore, Enyart teaches that is the intended purpose of using the non-liquid biomaterial for sealing of a surgical wound (para. 41). Thus, it would have been obvious to a person skilled in the art to apply the biomaterial to the wound as taught by Enyart et al. because the wound packing material is also known to be used as tissue filler or wound sealer.
Regarding claim 12 and 31, regarding the wound packing material without collagen, while Enyart teaches that a hemostatic agent (i.e. thickening agent) to activate platelets can be collagen (col. 5, lines 50-55), however, the species of the hemostatic agent as taught by Enyart are disclosed alternatively including gelatin sponge, collagen sponges, microfibrillar collagen, thrombin or venom derived factors (see e.g. col. 5, lines 52-55), and in the exemplary embodiment (see e.g. col. 6, lines 7-12) and claim 1 (see e.g. col. 10) utilize thrombin as the hemostatic agent in the non-liquid biomaterial. Therefore, Enyart uses thrombin as a hemostatic agent in a non-liquid biomaterial that is considered without collagen. Thus, the teaching of thrombin as taught by Enyart meets the claim limitation of a thickening agent (i.e. thrombin)(RE: claims 16, 33 and 36; see below).
Regarding claims 12 and 31, Enyart is silent to the step of applying a protective barrier material, and having an a-cellular dermis material to the would packing material.
However, the prior art of Hao et al. teach the use of a platelet rich plasma (PRP) gel with a-cellular xenogeneic dermal matrix that can accelerate the wound healing (see Abstract).
Accordingly, it would have been obvious to a person skilled in the art to use the acellular dermal matrix as taught by Hao et al. with the platelet rich plasma (PRP) preparation of wound packaging as taught by Evans et al. since the combined use accelerates wound healing. Thus, providing motivation to do. Further, Evans and Hao both disclose wound healing methods involving platelet rich plasma (PRP) (see e.g. Abstracts, respectively). Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Hao et al. does not explicitly teach the acellular dermal matrix is a bilayer matrix having a basement membrane.
However, the prior art of Debels et al. teaches an a-cellular (acellular) dermal allografts can be used as a protective barrier in deep partial-and full-thickness burn wounds to facilitate autologous split-thickness skin grafts (page 63-64). Further, a person of ordinary skill in the art would know that the dermal matrix is considered to inherently have a basement membrane that is bilayer as disclosed in the instant specification (para. 55).
Accordingly, it would have been obvious to a person skilled in the art to use a human acellular dermal matrix as taught by Hao and Debels with the PRP preparation for the method of treating wounds including burn treatment taught by Evans et al. (see e.g. Table 8) because the combined use was known to accelerate wound healing. Furthermore, Debels et al. teaches that a-cellular bilayered skin substitutes were commercially available and clinically proven to gain better results for skin and wound treatment (see e.g. page 66 and 69). Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Regarding claim 12 and 31, applying to tissue around the wound an additional amount of the material (comprising (i) and (ii)), Enyart et al. discloses that it can be used a sealant (abstract; col. 10, para. 3, lns. 35-40).
Further, the prior art of Hartwell et al teaches the method of wound dressing a patients wound needs at least three parts (e.g. wound packing, wound dressing, and a wound sealing)(abstract, para. 334, see Fig. 2 adjacent).
Accordingly, it would have been obvious to a person skilled in the art to use the method of Enyart et al. in treating wound using a non-liquid biomaterial and applying additional amount of the material as a sealant with a reasonable expectation of success. A person of ordinary skill in the art would have done so because Enyart et al explicitly teaches that the wound packaging material (i.e. non-liquid biomaterial) can be used as an adjunct to dural patches and applying a layer over the acellular dermal patch would seal holes around the dermal patch (col. 10, para. 3). Thus, one would have been motivated to use the wound packaging material of Enyart et al. to seal holes or voids (col. 10) around the acellular protective barrier that covered the tissue filler of Enyart packed in the patient’s wound. For example, see the obvious arrangement of elements as suggested by Hartwell Fig. 2, wherein the tissue filler of Enyart is within the wound (#2), the acellular protective layer should be above the wound (#13), and the sealer of Enyart is around the wound sealing the protective layer to the patient (#18).
Regarding claim 12 and 31, applying a plurality of layers of the wound packaging material to the wound, Enyart et al., discloses a tissue filler (see e.g. abstract), and a non-liquid biomaterial that may function as a barrier between two layers of tissue to prevent them from scarring or healing together (see e.g. col. 10). Hartwell et al teaches the methods of wound (see e.g. abstract, para. 334, see Fig. 2 adjacent). Further, Hartwell discloses that sufficient material (i.e. wound filler) is employed to afford a depth of approx. 5 mm (see e.g. page 26, para. 426).
Enyart et al., does not explicitly disclose applying a plurality of discrete layers of the wound packaging material to the wound.
However, the prior art of Augustine et al., discloses applying a plurality of discrete layers applied to the wound (i.e. contact layer and wound filler)(see e.g. para. 27-32). Further, Augustine discloses that the contact layer may be non-supportive or flexible to substantially conform to the topography of the wound bed (“w”)(i.e. corresponds to the depth of the wound)(see e.g. para. 28, fig. 1).
Accordingly, it would have been obvious to a person skilled in the art to use the method of Enyart et al. in treating wound using a non-liquid biomaterial and apply a plurality of discrete layers of the wound packaging material that responds to the depth of the wound (as taught by Hartwell and Augustine) with a reasonable expectation of success. A person of ordinary skill in the art would be motivated to do so because Hartwell discloses that wound packaging material is desirable in certain wounds like deeper wounds (para. 334). Further, Hartwell discloses that the wound packing material is sized or shaped to fit within the wound site so as to fill any empty spaces (para. 334). Additionally, Augustine discloses that a variety of materials may be used for the layers and that selection may depend on the patient’s condition (para. 28). Thus, providing motivation to do.
Regarding claims 13 and 31, Enyart et al is silent regarding the concentration of the multipotent cells in the concentrated bone marrow aspirate being between about 1,000 cells/ml and about 1 million cells/ml or at least a second concentration of at least two times the concentration of plasma extracted.
However, Akela et al teaches a concentrated bone marrow aspirate of that 2 × 106 cells/ml was adjusted in sterile PBS for instillation (1 ml) into the experimental wound site (page 507). Further, the prior art of Chahla et al. teaches that bone marrow aspirate would produce MSCs (multi-potent cells) after centrifugation using BMAC Harvest Smart PreP2 System (a centrifugal concentrator known in the art) at 2000-5700 CFU/ml (Table 2).
Further, there is nothing in the specification, prosecution or prior art to provide any indication as to the claimed range, thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(b), III.A. where the court held that claims reciting “about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
Accordingly, it would have been obvious to a person skilled in the art to have modified the concentrated cells from bone marrow aspirate of Enyart et al. and incorporate the claimed concentration range of multi-potent cells as taught by Akela and Chahla et al. because both teach method regarding optimizing the amount concentrated bone marrow aspirate. Further, Enyart et al. teaches that the blood derived material or the blood product solution including the concentrated cells of bone marrow aspirate may be concentrated using a centrifugal concentrator (col. 4, lines 1-5). Akela et al teaches that the collected from the marrow aspirate by volume reduction centrifuge ’buffy coat’ protocol known in the art. Therefore, a person of ordinary skill in the art would have been able to obtain an optimal number of cells and produce the concentrated bone marrow aspirate comprising multipotent cells as claimed with a reasonable expectation of success.
Regarding claims 13 and 31, new limitation of the thickening agent has a ratio between 1 and 20,000 units of thickening agent for every cc (i.e. 1mL) of the combined concentrated bone marrow aspirate and plasma concentrate, Enyart discloses a thickening agent (i.e. a hemostatic agent) thrombin (see e.g. col. 5,6, 10, and claim 1) in a non-liquid biomaterial that is considered without collagen. Further, Enyart discloses that thrombin and may be from “about 10 U/ml to about 1000 U/ml with respect to the blood product solution” (see e.g. col. 6, para. 1). Thus, the “blood product solution” corresponds to the claim limitation of bone marrow aspirate and plasma concentrate.
Further, MPEP § 2144.05 (II) states, “Generally, differences in time, concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
In the instant case, neither the specification nor Applicant have provided evidence of that the claimed ratio of the thickening agent has a ratio between 1 and 20,000 units of thickening agent for every cc (i.e. 1mL) of the combined concentrated bone marrow aspirate and plasma concentrate is critical, thus the teaching of “about 10 U/ml to about 1000 U/ml with respect to the blood product solution” (see e.g. col. 6, para. 1) as taught by Enyart, renders the claimed ratio of the thickening agent as obvious.
Accordingly, it would have been obvious to one of ordinary skill in the art to modify the ratio of thickening agent as taught by Enyart to the amount of blood product solution (i.e. combined concentrated bone marrow aspirate and plasma concentrate) with a reasonable expectation of success because Enyart discloses a ratio between 1 and 1,000 units of thickening agent for every cc (i.e. 1mL) of a blood product solution (see e.g. col. 6). Further, Enyart discloses that the blood product solution may be concentrated instead of or in addition to the blood derived material (see e.g. col. 3) Additionally, a person of ordinary skill in the art would have been able to modify the mixing ratio of the thickening agent to concentrated bone marrow and plasma concentrate (e.g. PRP)(i.e. blood product solution) because ratios can be routinely optimized based on their concentrations in the method of Enyart. Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Regarding claims 14, and 32, Enyart et al is silent regarding the ratio of the concentrated bone marrow aspirate comprising multipotent cells to the concentrated plasma being; 1.6:1 (claim 14); or 1.5:1 – 4:1 (claim 32).
However, Pei teaches a ratio of the concentrated marrow aspirate to the plasma concentrate is about 1:1 (abstract).
Further, MPEP § 2144.05 (II) states, “Generally, differences in time, concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
In the instant case, neither the specification nor Applicant have provided evidence of that the claimed ratio of the concentrated bone marrow aspirate comprising multipotent cells to the concentrated plasma is critical, thus the teaching of a 1:1 ratio of the concentrated bone marrow aspirate comprising multipotent cells to the concentrated plasma as taught by Pei et al, renders the claimed ratio of concentrate as obvious.
Accordingly, it would have been obvious to one of ordinary skill in the art to modify the amount of concentrated bone marrow aspirate to the concentrated plasma as taught by Enyart and incorporate the ratio of the concentrated marrow aspirate to the plasma concentrate as taught by Pei because both Enyart and Pei discloses methods related to platelet rich plasma (PRP). Furthermore, as the “concentrated” for bone marrow aspirate or “concentrate” for plasma is not particularly defined how much of concentration it requires, the amount regardless of volume or weight and the ratio thereof does not provide any particular patentable weight in determining the patentability of the claimed invention. This is because at different concentration rates of the ingredients, the mixing of these two particular ingredients would result in a different mixture with undefined concentration of cells and plasma. At least the mixing would result in a gelled material. Furthermore, it is submitted that the mixing ratio of the plasma concentrate (e.g. PRP) and the concentrated bone marrow aspirate comprising multi-potent cells (e.g. bone marrow derived stem cells) can be routinely optimized based on their concentrations in the method of Enyart with a reasonable expectation of success.
Regarding claims 16, 33 and 36, Enyart teaches a thickening agent or hemostatic agent such as thrombin. Claim Interpretation Broadest Reasonable Interpretation: the hemostatic agent of thrombin reads on the claimed thickening agent (see applicants specification page 16, para. 2).
Enyart is silent regarding the step of applying additional amount of thickening agent to an outer surface of the wound packing material.
Nevertheless, one skilled in the art would recognize the role of a thickening agent or hemostatic agent such as thrombin taught by Enyart et al. is to solidify the plasma concentrate (e.g. PRP) containing wound packing material. Thus, it would have been obvious to a person skilled in the art repeating the addition of thrombin to the wound packing material placed in the wound would be obvious for the same purpose of solidifying the wound packing material further as well as stopping any further bleeding.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Traversal:
Applicant asserts that independent claims 12, 31, and 39 have been amended to recite “wherein the thickening agent has a ratio of between 1 and 20,000 units of thickening agent for every cc of the mixture of the concentrated bone marrow aspirate and the plasma concentrate,” and argues that every claim limitation has not been taught or suggested in the prior art (i.e. Enyart, Hao, Debels, Hartwell, Akela, Chahla and Pei et al.)(Remarks, page 12-15).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
Applicants are reminded that the test for obviousness is not whether the features of a secondary reference maybe bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413,208 USPQ 871 (CCPA 1981). Further, MPEP 2123 (I) states that patents are relevant as prior art for all they contain, and that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments.
Contrary to Applicant’s belief, the prior art Enyart discloses a thickening agent (i.e. a hemostatic agent) thrombin (see e.g. col. 5,6, 10, and claim 1) may be from “about 10 U/ml to about 1000 U/ml with respect to the blood product solution” (see e.g. col. 6, para. 1), corresponding to the claim limitation of bone marrow aspirate and plasma concentrate.
Further, it is noted that MPEP § 2144.05 (II) states, “Generally, differences in time, concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
In the instant case, neither the specification nor Applicant have provided evidence of that the claimed ratio of the thickening agent has a ratio between 1 and 20,000 units of thickening agent for every cc (i.e. 1mL) of the combined concentrated bone marrow aspirate and plasma concentrate is critical, thus the teaching of “about 10 U/ml to about 1000 U/ml with respect to the blood product solution” (see e.g. col. 6, para. 1) as taught by Enyart, renders the claimed ratio of the thickening agent as obvious. Additionally, a person of ordinary skill in the art would have been able to modify the mixing ratio of the thickening agent to concentrated bone marrow and plasma concentrate (e.g. PRP)(i.e. blood product solution) because ratios can be routinely optimized based on their concentrations in the method of Enyart. Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success. As discussed above, the prior art (i.e. Enyart, Hao, Debels, Hartwell, Akela, Chahla and Pei et al.) teach or suggest the claim limitations of a method for treating a wound of a patient comprising a wound packing material.
Thus, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 15, 17, 18, and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Enyart, et al. (US 8,092,837; published 2012, prior art of record) in view of Hao et al. (Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi; English Abstract only, published 2010, cited by IDS 11/6/2020), Debels, et al. (Plas. Reconstr. Surg. Glob. Open; of record, published 2015, prior art of record), Hartwell et al (US 2015/0159066 A1, published 2015, prior art of record), Augustine et al., (US 2010/0010477, prior art of record), Akela, et al. (International Wound Journal 9.5: 505-516; cited IDS 11/06/2020; published 2012, prior art of record), Chahla et al. (2016, Jan. 13, The Orthopaedic Journal of Sports Medicine, prior art of record), and Pei, et al (CN1846790A, published 2006, prior art of record), as applied to claims 12 and 31, in further view of Adie et al. (WO 2011/135285; prior art of record) and Salamone et al. (US 2016/0303281; IDS ref. prior art of record).
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to a rejection set forth in the non-final Official action mailed on March 26, 2025, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
The teachings of Enyart et al., apply here as indicated above.
As stated supra, Enyart et al. teaches a non-liquid biomaterial that may be used as a surgical sealant, a tissue filler, a wound dressing or a combination thereof, comprising a blood derived material such as concentrated plasma, platelet rich plasma, or a material derived from blood containing tissue aspirate such as bone marrow aspirate, a protein binding agent, and a polymerizing agent (see Abstract; col. 2, lines 44-57). Hao et al. teaches the use of a platelet rich plasma (PRP) gel with a-cellular xenogeneic dermal matrix that can accelerate the wound healing (see Abstract). Debels et al. teaches an acellular bilayered used for skin and wound treatment which includes those comprising a layer of silicone regeneration template (see Table 3; p.66, 1st col.). Hartwell et al teaches the methods of wound dressing where a patients wound needs multiple layers (e.g. wound packing, dressing, and sealant)(abstract, para. 334, Fig. 1).
Regarding claims 17-18 and 34, as discussed supra, Enyart et al. discloses wherein mixing the concentrated bone marrow aspirate, the plasma concentrate, and the thickening agent to generate the wound packing material comprises mixing the concentrated bone marrow aspirate, the plasma concentrate, and the thickening agent in a container (col. 7, para. 2). Claim Interpretation Broadest Reasonable Interpretation: the container reads on the claimed vessel (specification para. 37).
Enyart et al. is silent regarding the wound packing being sized and shaped to a corresponding wound.
However, Adie et al. teaches the wound packaging material is sized or shaped as necessary for the size and type of wound it will be used in (page 16. Para. 1). Adie et al teaches the wound packing material is to fit the wound site so as to fill any empty spaces (p.5, lines 25-26). Further, Adie et al. teaches that the wound site may filled with a wound packing material, which is desirable for deeper wounds, and the wound dressing is then placed over the wound site and the wound packing material overlying the wound site (p.5, lines 20-28). Furthermore, in regard to instant claims, Salamone et al. teach a pseudoplastic microgel particle compositions intended as soft tissue/wound void filler and can be placed into or on a body defect, wound, burn, etc. (para. 44-45, 98). Specifically, the prior art of Salamone et al. teaches that the vessel may be a mold which may be the shape of the cavity which corresponds to the shape of the wound (para 49, 93, 222, and 228).
Accordingly, it would have been obvious to a person of ordinary skill in the art to modify the fit, size, and shape of the non-liquid biomaterial as taught by Enyart et al. to incorporate the fit, size and the shape of the wound site as taught by Adie et al because Salamone et al teaches a vessel that corresponds to the shape of the wound (para 49, 93, 222, and 228). A person of ordinary skill in the art would have used the vessel of Salamone and Adie et al. because Adie et al teaches that the wound packing material is preferably sized and shaped to fill any empty spaces in the wound prior to the wound packing material being applied to the wound. As the wound packing material of Enyart et al. is pre-shaped to fit the size and the shape of the wound as taught by Adie et al. and then the defined shape of the vessel as taught by Salamone et al would have the ability to fill the shape of the cavity with an interface between the microgel and wound tissue as taught by Salamone et al (para. 93). Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Regarding claim 15 and 35, Enyart et al. is silent regarding compressive dressing.
However, Hartwell et al teaches wound dressing include many different types of materials and multiple layers, for example, gauze with overlying drapes or multi-layer wound dressings (para. 2, 230, 253, 264, 334 and 401). Additionally, Hartwell et al teaches that if the wound cavity, enclosed by the drape and tissue, contracts under the force of atmospheric pressure and compresses the packing material or dressing (para. 401, Fig. 1, Table 1d). Further, Hartwell et al teaches that the packing material or other wound filler, that may need to be cut to shape (para. 400, Fig. 1). Further, the prior art of Adie et al teaches would dressing may be places over the wound site and would packaging material overlying the wound site (page 5, para. 3).
Accordingly, it would have been obvious to a person skilled in the art to combine the wound dressing of Enyart et al. and the method of Hartwell et al and the compressive dressing of Adie et al because Enyart, Hartwell and Adie et al. teach a wound dressing in combination with wound healing approach, as discussed above. Additionally, Enyart et al discloses surgical wounds and Adie et al teaches that wound packaging material may be desirable in deeper wounds (page 5, para. 3, respectively). Further, the prior art of Adie et al teaches that the compressive dressing may be preferable if the wound site is a deeper wound (page 25, para. 1). Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Thus, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Traversal:
Applicant argues that the cited prior art does not teach the amended claimed limitations (Remarks page 11-15).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive. Applicants’ arguments have been addressed above.
Claims 19-20 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Enyart, et al. (US 8,092,837; published 2012, prior art of record) in view of Hao et al. (2010, Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi; English Abstract only; cited IDS 11/06/2020), Debels, et al. (Plas. Reconstr. Surg. Glob. Open; of record, published 2015, prior art of record), Hartwell et al (US 2015/0159066 A1, published 2015, prior art of record), Augustine et al., (US 2010/0010477, prior art of record), Akela, et al. (International Wound Journal 9.5: 505-516; cited IDS 11/06/2020; published 2012, prior art of record), Chahla et al. (2016, Jan. 13, The Orthopaedic Journal of Sports Medicine, prior art of record), and Pei, et al (CN1846790A, published 2006, prior art of record), as applied to claims 12 and 31 above, and further in view of Binette et al (US20040078090A1, published 2004, prior art of record).
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to a rejection set forth in the non-final Official action mailed on March 26, 2025, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
As stated supra, Enyart et al. teaches a non-liquid biomaterial that may be used as a surgical sealant, a tissue filler, a wound dressing or a combination thereof, comprising a blood derived material such as concentrated plasma, platelet rich plasma, or a material derived from blood containing tissue aspirate such as bone marrow aspirate, a protein binding agent, and a polymerizing agent (see Abstract; col. 2, lines 44-57). Hao et al. teaches the use of a platelet rich plasma (PRP) gel with a-cellular xenogeneic dermal matrix that can accelerate the wound healing (see Abstract). Debels et al. teaches an a-cellular bilayer used for skin and wound treatment which includes those comprising a layer of silicone regeneration template (see Table 3; p.66, 1st col.). Hartwell et al teaches the method of wound dressing a patients wound needs at least two parts (e.g. wound packing and wound dressing)(abstract, para. 334, Fig. 1).
Regarding claims 19-20 and 37-38, Enyart et al. is silent regarding the skin fragments being applied to the wound packing material.
However, the prior art of Binette et al teaches applying skin fragments to an outer surface of the wound packing material (i.e. scaffold which is a gel)(para. 36, 44, 103, claims 50, 80) prior to placing the skin fragments and the wound packing material (para. 108).
Accordingly, it would have been obvious to a person skilled in the art to use the skin fragments as an additional agent in the non-liquid biomaterial used in the method of treating wounds taught by Enyart et al. in view of Binette because Binette et al teaches that tissue fragment encompasses an effective amount of viable cells that can migrate out of the tissue fragment and populate a scaffold (i.e. injectable gel or tissue)(abstract, claim 1). Thus, a person of ordinary skill in the art would use the skin fragments of Binette et al in the non-liquid biomaterial of Enyart et al. prior to the step of applying a wound dressing because Binette et al teaches that biological components like tissue fragments assist in healing or tissue repair (abstract). Thus, a person of ordinary skill in the art would have been able to uses the skin fragments of Binette et al in the non-liquid biomaterial of Enyart et al. prior to the application of a protective barrier comprising acellular dermis as a wound dressing covering (as taught by Hartwell and Debels et al.) the wound site treated with the non-liquid biomaterial of Enyart et al. with predictable results and a reasonable expectation of success.
Regarding claim 38, Enyart et al. is silent regarding the concentration of the skin fragments being at least 0.1 mg per cm2.
Regarding claims 38, Binette et al teaches applying the layer of skin fragments at the exterior surface of the wound packing material has a concentration of at least 0.1 mg of skin fragments per cm2. (para 84, claim 22).
Accordingly, it would have been obvious to a person skilled in the art to use the skin fragments as an additional agent in the non-liquid biomaterial used in the method of treating wounds taught by Enyart et al. in view of Binette because Binette teaches that biological components like tissue fragments assist in expediting healing and promoting regeneration of the affected tissue (abstract, para. 11, 90). Further, Binette et al teaches that tissue fragment encompasses an effective amount of viable cells that can migrate out of the tissue fragment and populate a scaffold (i.e. injectable gel or tissue)(abstract, claim 1). Thus, a person of ordinary skill in the art would have been able to uses the skin fragments of Binette et al in the non-liquid biomaterial of Enyart et al. prior to the application of a protective barrier comprising acellular dermis as a wound dressing covering (as taught by Hartwell and Debels et al.) the wound site treated with the non-liquid biomaterial of Enyart et al. with predictable results and a reasonable expectation of success.
Thus, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 39, 40, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Enyart, et al. (US 8,092,837; published 2012, prior art of record) in view of Debels, et al. (Plas. Reconstr. Surg. Glob. Open; of record, published 2015, prior art of record), Hartwell et al (US 2015/0159066 A1, published 2015, prior art of record), Augustine et al., (US 2010/0010477, prior art of record), Akela, et al. (International Wound Journal 9.5: 505-516; cited IDS 11/06/2020; published 2012, prior art of record), Chahla et al. (2016, Jan. 13, The Orthopaedic Journal of Sports Medicine, prior art of record), Adie et al. (WO 2011/135285; prior art of record), Binette et al (US20040078090A1, published 2004), Salamone et al. (US 2016/0303281; IDS ref. prior art of record), Seegert et al. (US 2005/0234485, prior art of record), and Leaper (World Wide Wounds, prior art of record, published 2002).
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to a rejection set forth in the non-final Official action mailed on March 26, 2025, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
Regarding claims 39, the preamble, Enyart et al. teaches methods for packing and treating wounds comprising a wound packing material that can be used as a wound filler and a wound sealer (abstract).
Regarding claims 39, extracting and concentrating bone marrow aspirate, Enyart et al. teaches concentrated cells from bone marrow aspirate (see summary of the invention, abstract, col. 2, lines 26-57, col. 3, lns. 8-45; col. 6, para. 3; col. 9, para. 2). Further, Enyart et al. teaches that the non-liquid biomaterial may comprise cells including stem cells such as bone marrow derived stem cells derived from bone marrow aspirate (col. 6, lines 50-54). Thus, this teaching would meet the concentrated bone marrow aspirate comprising multi-protein cells as the bone marrow derived stem cells, such as mesenchymal stem cells and hematopoietic stem cells are multipotent. Claim Interpretation Broadest Reasonable Interpretation: the concentrated bone marrow aspirate comprising multi-potent cells such as bone marrow cells reads on the claimed multi-potent cells.
Regarding claim 39, Enyart et al is silent regarding the concentration of the multipotent cells in the concentrated bone marrow aspirate being between about 1,000 cells/ml and about 1 million cells/ml or at least a second concentration of at least two times the concentration of plasma extracted.
However, Akela et al teaches a concentrated bone marrow aspirate of that 2 × 106 cells/ml was adjusted in sterile PBS for instillation (1 ml) into the experimental wound site (page 507). Further, the prior art of Chahla et al. teaches that bone marrow aspirate would produce MSCs (multi-potent cells) after centrifugation using BMAC Harvest Smart PreP2 System (a centrifugal concentrator known in the art) at 2000-5700 CFU/ml (Table 2).
Accordingly, it would have been obvious to a person skilled in the art to have modified the concentrated cells from bone marrow aspirate as taught by Enyart et al. with the claimed concentration range of multi-potent cells as taught by Akela and Chahla et al. to produce the concentrated bone marrow aspirate comprising multipotent cells as claimed because Enyart, Akela, and Chala et al., teach methods with cells and bone marrow aspirate, as discussed above. Further, Enyart et al. teaches that the blood derived material or the blood product solution including the concentrated cells of bone marrow aspirate may be concentrated using a centrifugal concentrator (col. 4, lines 1-5). Additionally, it is noted that there is nothing in the specification, prosecution or prior art to provide any indication as to the claimed range, thereby rendering the scope of the claim(s) unascertainable (See MPEP § 2173.05(b), III.A.). Furthermore, Akela et al teaches that a ’buffy coat’ protocol was known in the art to collected marrow aspirate by volume reduction centrifuge (see e.g. page 507). Therefore, a person of ordinary skill in the art would have been able to optimize the protocol to obtain the optimal number of cells with a reasonable expectation of success.
Regarding claims 39, extracting plasma concentrate from blood, Enyart et al. teaches a non-liquid biomaterial that may be used as a surgical sealant, a tissue filler, a wound dressing or a combination thereof, comprising a blood derived material such as concentrated plasma, platelet rich plasma, or a material derived from blood containing tissue aspirate such as bone marrow aspirate, a protein binding agent, and a polymerizing agent (see Abstract; col. 2, lines 44-57).
Regarding claim 39, It is noted that the limitation of a plasma concentration of the concentrated plasma being at least 2x of a concentration of the plasma as extracted, Enyart et al. teach the plasma concentrate is from about 1.5-fold to about 4 fold (col. 7, lines 26-32).
Regarding claims 39, obtaining a thickening agent, Enyart et al. teach that the non-liquid biomaterial is formed by mixing with a polymerizing agent to produce as solids, gels, hydrogels or semi-solids (col. 5, lines 35-40).
Regarding claims 39, as discussed supra, Enyart et al. discloses wherein mixing the concentrated bone marrow aspirate, the plasma concentrate, and the thickening agent to generate the wound packing material comprises mixing the concentrated bone marrow aspirate, the plasma concentrate, and the thickening agent in a container (col. 7, para. 2). Claim Interpretation Broadest Reasonable Interpretation: the container reads on the claimed vessel (specification para. 37).
Regarding claims 39, new limitation of the thickening agent has a ratio between 1 and 20,000 units of thickening agent for every cc (i.e. 1mL) of the combined concentrated bone marrow aspirate and plasma concentrate, Enyart discloses a thickening agent (i.e. a hemostatic agent) thrombin (see e.g. col. 5,6, 10, and claim 1) in a non-liquid biomaterial that is considered without collagen. Further, Enyart discloses that thrombin and may be from “about 10 U/ml to about 1000 U/ml with respect to the blood product solution” (see e.g. col. 6, para. 1). Thus, the “blood product solution” corresponds to the claim limitation of bone marrow aspirate and plasma concentrate.
Further, MPEP § 2144.05 (II) states, “Generally, differences in time, concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
In the instant case, neither the specification nor Applicant have provided evidence of that the claimed ratio of the thickening agent has a ratio between 1 and 20,000 units of thickening agent for every cc (i.e. 1mL) of the combined concentrated bone marrow aspirate and plasma concentrate is critical, thus the teaching of “about 10 U/ml to about 1000 U/ml with respect to the blood product solution” (see e.g. col. 6, para. 1) as taught by Enyart, renders the claimed ratio of the thickening agent as obvious.
Accordingly, it would have been obvious to one of ordinary skill in the art to modify the ratio of thickening agent as taught by Enyart to the amount of blood product solution (i.e. combined concentrated bone marrow aspirate and plasma concentrate) with a reasonable expectation of success because Enyart discloses a ratio between 1 and 1,000 units of thickening agent for every cc (i.e. 1mL) of a blood product solution (see e.g. col. 6). Further, Enyart discloses that the blood product solution may be concentrated instead of or in addition to the blood derived material (see e.g. col. 3) Additionally, a person of ordinary skill in the art would have been able to modify the mixing ratio of the thickening agent to concentrated bone marrow and plasma concentrate (e.g. PRP)(i.e. blood product solution) because ratios can be routinely optimized based on their concentrations in the method of Enyart. Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Regarding claims 39, Enyart et al. is silent regarding the wound packing being sized and shaped to a corresponding wound.
However, Adie et al. teaches the wound packaging material is sized or shaped as necessary for the size and type of wound it will be used in (page 16. Para. 1). Adie et al teaches the wound packing material is to fit the wound site so as to fill any empty spaces (p.5, lines 25-26). Further, Adie et al. teaches that the wound site may filled with a wound packing material, which is desirable for deeper wounds, and the wound dressing is then placed over the wound site and the wound packing material overlying the wound site (p.5, lines 20-28). Furthermore, in regard to instant claims, Salamone et al. teach a pseudoplastic microgel particle compositions intended as soft tissue/wound void filler and can be placed into or on a body defect, wound, burn, etc. (para. 44-45, 98). Specifically, the prior art of Salamone et al. teaches that the vessel may be a mold which may be the shape of the cavity which corresponds to the shape of the wound (para 49, 93, 222, and 228).
Accordingly, it would have been obvious to a person of ordinary skill in the art to modify the fit, size, and shape of the non-liquid biomaterial as taught by Enyart et al. to incorporate the fit, size and the shape of the wound site as taught by Adie et al because Salamone et al teaches a vessel that corresponds to the shape of the wound (para 49, 93, 222, and 228). A person of ordinary skill in the art would have used the vessel of Salamone and Adie et al. because Adie et al teaches that the wound packing material is preferably sized and shaped to fill any empty spaces in the wound prior to the wound packing material being applied to the wound. As the wound packing material of Enyart et al. is pre-shaped to fit the size and the shape of the wound as taught by Adie et al. and then the defined shape of the vessel as taught by Salamone et al would have the ability to fill the shape of the cavity with an interface between the microgel and wound tissue as taught by Salamone et al (para. 93). Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Regarding claims 39, wound packaging material, Enyart et al. discloses the non-liquid biomaterial is tissue filler and wound sealer (Abstract; para. 5, 13, 38, claim 15). Nevertheless, Enyart et al. teaches that is the intended purpose of using the non-liquid biomaterial for sealing of a surgical wound (para. 41). Accordingly, it would have been obvious to a person skilled in the art to apply the biomaterial to the wound of Enyart et al. with a reasonable expectation of success. One of ordinary skill would have been motivated to do so because wound packing material is also known as tissue filler or wound sealer.
Regarding claim 39, applying a plurality of layers of the wound packaging material to the wound, Enyart et al., discloses a tissue filler (see e.g. abstract), and a non-liquid biomaterial that may function as a barrier between two layers of tissue to prevent them from scarring or healing together (see e.g. col. 10).
Enyart et al., does not explicitly disclose applying a plurality of discrete layers of the wound packaging material to the wound.
However, the prior art of Hartwell et al teaches the methods of wound (see e.g. abstract, para. 334, see Fig. 2 adjacent). Further, Hartwell discloses that sufficient material (i.e. wound filler) is employed to afford a depth of approx. 5 mm (see e.g. page 26, para. 426). Additionally, the prior art of Augustine et al., discloses applying a plurality of discrete layers applied to the wound (i.e. contact layer and wound filler)(see e.g. para. 27-32). Further, Augustine discloses that the contact layer may be non-supportive or flexible to substantially conform to the topography of the wound bed (“w”)(i.e. corresponds to the depth of the wound)(see e.g. para. 28, fig. 1).
Accordingly, it would have been obvious to a person skilled in the art to use the method of Enyart et al. in treating wound using a non-liquid biomaterial and apply a plurality of discrete layers of the wound packaging material that responds to the depth of the wound (as taught by Hartwell and Augustine) with a reasonable expectation of success. A person of ordinary skill in the art would be motivated to do so because Hartwell discloses that wound packaging material is desirable in certain wounds like deeper wounds (para. 334). Further, Hartwell discloses that the wound packing material is sized or shaped to fit within the wound site so as to fill any empty spaces (para. 334). Additionally, Augustine discloses that a variety of materials may be used for the layers and that selection may depend on the patient’s condition (para. 28). Thus, providing motivation to do.
Regarding claim 39, the step of preparing the wound by cleaning the wound, debriding the wound and causing the wound to bleed, it is well known in the art that wound treatment involves cleaning of the wound and wound debridement to remove dead tissue is for optimize wound healing. For support, Leaper teaches that debridement is the removal of necrotic or foreign material from and around a wound to optimize wound healing as the debridement can reduce the risk of infection and sepsis and aid wound healing (Abstract). Thus, it would have been obvious to a person skilled in the art to clean and debride the wound prior to the packing the wound using the non-liquid biomaterial of Enyart et al. with a reasonable expectation of success.
In the instant case, “causing the wound the bleed” is a result of removing necrotic tissue from the wound (i.e. debridement) based on the disclosure of the instant specification rather than as an active step (see e.g. para. 41). Furthermore, it is understood that debridement of the wound often result in a bleeding. Thus, the limitation is interpreted that debriding the wound causes the bleeding in the wound.
Accordingly, it would have been obvious to a person skilled in the art to modify the method of Enyart et al. in treating a wound and incorporating the step of causing the wound to bleed (i.e. cleaning the wound) as taught by Leaper because a person of ordinary skill in the art would want to remove necrotic tissue from the wound (i.e. debridement that would cause the wound the bleed a result) to not result in an infection. Further, Leaper teaches that sharp debridement is also known as surgical procedure and will involve some bleeding (p.4, Possible complications). Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Regarding claim 39, Enyart is silent to the step of applying a protective barrier material, and having an a-cellular dermis material to the would packing material.
However, the prior art of Hao et al. teach the use of a platelet rich plasma (PRP) gel with a-cellular xenogeneic dermal matrix that can accelerate the wound healing (see Abstract).
Accordingly, it would have been obvious to a person skilled in the art to use the acellular dermal matrix as taught by Hao et al. with the platelet rich plasma (PRP) preparation of wound packaging as taught by Evans et al. since the combined use accelerates wound healing. Thus, providing motivation to do. Further, Evans and Hao both disclose wound healing methods involving platelet rich plasma (PRP) (see e.g. Abstracts, respectively). Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Hao et al. does not explicitly teach the acellular dermal matrix is a bilayer matrix having a basement membrane.
However, the prior art of Debels et al. teaches an a-cellular (acellular) dermal allografts can be used as a protective barrier in deep partial-and full-thickness burn wounds to facilitate autologous split-thickness skin grafts (page 63-64). Further, a person of ordinary skill in the art would know that the dermal matrix is considered to inherently have a basement membrane that is bilayer as disclosed in the instant specification (para. 55).
Accordingly, it would have been obvious to a person skilled in the art to use a human acellular dermal matrix as taught by Hao and Debels with the PRP preparation for the method of treating wounds including burn treatment taught by Evans et al. (see e.g. Table 8) because the combined use was known to accelerate wound healing. Furthermore, Debels et al. teaches that a-cellular bilayered skin substitutes were commercially available and clinically proven to gain better results for skin and wound treatment (see e.g. page 66 and 69). Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Regarding claim 39, applying to tissue around the wound an additional amount of the material (comprising (i) and (ii)), Enyart et al. discloses that it can be used a sealant (abstract; col. 10, para. 3, lns. 35-40).
Furthermore, the prior art of Hartwell et al teaches the method of wound dressing a patients wound needs at least three parts (e.g. wound packing, wound dressing, and a wound sealing)(abstract, para. 334, see Fig. 2 adjacent).
Accordingly, it would have been obvious to a person skilled in the art to use the method of Enyart et al. in treating wound using a non-liquid biomaterial and applying additional amount of the material as a sealant as taught by Hartwell et al., because Hartwell et al teaches the method of wound dressing a patients wound needs at least three parts (e.g. wound packing, wound dressing, and a wound sealing)(abstract, para. 334, see Fig. 2 adjacent). A person of ordinary skill in the art would have done so because Enyart et al explicitly teaches that the wound packaging material (i.e. non-liquid biomaterial) can be used as an adjunct to dural patches and applying a layer over the acellular dermal patch would seal holes around the dermal patch (col. 10, para. 3, and wherein the tissue filler of Enyart is within the wound (#2), the acellular protective layer should be above the wound (#13), and the sealer of Enyart is around the wound sealing the protective layer to the patient (#18) and see the obvious arrangement of elements as suggested by Hartwell Fig. 2). Thus, a person of ordinary skill in the art would have used the wound packaging material of Enyart et al. to seal holes or voids (see e.g. col. 10) around the a-cellular protective barrier that covered the tissue filler of Enyart et al., to pack the patient’s wound which would have had predictable results with a reasonable expectation of success.
Regarding claim 40, as stated supra, Enyart et al. is silent regarding applying a compressive dressing to a surface of the shaped wound packing.
However, Hartwell and Adie et al teaches shaping the wound packaging material is sized or shaped to fit the wound site (page 5, para. 3). Further, Adie et al teaches would dressing may be places over the wound site and would packaging material overlying the wound site (page 5, para. 3).
Accordingly, it would have been obvious to a person skilled in the art to apply compressive dressing as taught by Hartwell and Adie et al with the wound packing material of Enyart et al because Adie et al teaches that the compressive dressing may be preferable if the wound sire is a deeper wound (page 25, para. 1). Both Enyart and Hartwell and Adie et al teach wound packaging for deep wounds as discussed above. Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Regarding claim 41, as stated supra, Enyart et al. is silent regarding obtaining skin fragments from the patient.
However, as stated supra, Binette et al teach the use of skin fragments as a biologically active agent for a scaffold (i.e. gel composition) as a wound treatment (abstract, para. 36, 44, 103, 108, claims 1, 50, 80). The micronized tissue/skin of Salamone et al. is interpreted as skin fragments as claimed as the instant specification discloses micronized epidermal or dermal tissue as skin graft fragments (para. 9), as Seeger et al. teach that the skin particles are used for skin graft, the amount of skin particles applied to the wound site would be sufficient enough to cover the wound, and thus, one skilled in the art would modify the amount of skin particles or micronized skin taught by Seeger et al. and/or Salamone et al. in order to sufficiently cover the wound site to regenerate skin over the packed wound prior to the protective barrier with a reasonable expectation of success.
Accordingly, it would have been obvious to a person skilled in the art to use the skin fragments (as taught by Binette et al) as an additional agent in the non-liquid biomaterial (as taught by Enyart et al ) used in the method of treating wounds (as taught by Enyart et al. and Hartwell et al) with a reasonable expectation of success. One skilled in the art would have been motivated to use the skin fragments of Binette et al in the non-liquid biomaterial of Enyart et al. prior to the step of applying a wound dressing, i.e. a protective barrier of Adie et al., because Binette et al teaches that biological components like tissue fragments assist in healing or tissue repair (abstract). Additionally, the prior art of Salamone et al. teach that the micronized tissue is incorporated into the microgel (para. 68). Furthermore, the prior art of Seeger et al. teach applying skin particles, i.e. minced skin tissue, to a wound site for skin grafting in wound treatment (paras. 18, 31, 49). Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Traversal:
Applicant argues that the cited prior art does not teach the amended claimed limitations (Remarks page 11-15).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive. Applicants’ arguments have been addressed above.
Conclusion
No claim is allowed.
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JOSEPHINE GONZALES
Examiner
Art Unit 1631
/JOSEPHINE GONZALES/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
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