DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 03/03/2026.
Claims 1-31 previously presented and currently pending.
Claims 3-4, 8, 10, 12, 14-18, 20-21, 23-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/10/2025.
Claims 1-2, 5-7, 9, 11, 13, 19, 22, 27-31 are subject of this office action,
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Claim Rejections - 35 USC § 112(b)
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 1-2, 5-7, 9, 11, 13, 19, 22, 27-31 are 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.
The terms “partially” in claim 1, and the term “substantially” in claim 7 are relative terms which render the claim indefinite. The terms not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification and the claims do not set forth the meets and bounds of the terms. How much of the hydrogel precursor can extend into the substrate? It can be 1% up to 100% as further broaden by the term “at least” prior to “partially”. The same for the term “substantially”, how much is the cross linking of the hydrogel precursor considered substantially uncrosslinked?
Regarding claims 27, 28 and 30, the expression “at least about” does not set forth the metes and bounds of the claim. Recourse to the specification does not define the expression. The expression permits two contradicting interpretation of the claims. The term “at least" permits values equal to the value recited following the term and more than that value with no upper limit to the value, and the term “about” permits values below and above the claimed value, usually 10% unless otherwise defined in the specification.
Regarding claim 31, the expression “no more than about” does not set forth the metes and bounds of the claim. Recourse to the specification does not define the expression. The expression permits two contradicting interpretation of the claims. The expression “no more than" permits values equal to the recited value following the expression and less than that value with no lower limit to the value, and the term “about” permits values below and above the claimed value, usually 10% unless otherwise defined in the specification.
For all the 112/b rejections above, the boundaries of coverage is not imposed by the disclosure. It is important that a person of ordinary skill in the art be able to interpret the metes and bounds of the claims so as to understand how to avoid infringement of the patent that ultimately issues from the application being examined. See MPEP § 2173.02.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5-7, 9, 11, 13, 19, 22, 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over any of Ladet (US 2011/0251699, IDS filed 12/04/2023) or Keereweer et al. (US 2022/0133943, previously cited on PTO 892), each reference combined with either Hedrich et al. (US 2016/0136235, previously cited on PTO 892) or the auricle by Dreesmann et al. (“The pro-angiogenic characteristics of a cross-linked gelatin matrix”, previously listed on PTO 892, and copy is provided).
Applicant Claims
Claim 1 is directed to a medical patch comprising a biocompatible substrate and a hydrogel precursor presenting a surface along one side of the biocompatible substrate, the hydrogel precursor comprising an electrophilic-hydrogel precursor having a plurality of electrophilic functional groups and a nucleophilic-hydrogel precursor having a plurality of nucleophilic functional groups, wherein the biocompatible substrate comprises thermally crosslinked gelatin, wherein the hydrogel precursor extends at least partially into a surface of the biocompatible substrate to form a cohesive hydrogel precursor structure, wherein the cohesive hydrogel precursor structure comprises a blend layer and/or separate adjacent layers of the electrophilic-hydrogel precursor and the nucleophilic-hydrogel precursor, and wherein the medical patch presents a shattered surface of the cohesive hydrogel precursor structure that is adhered to the biocompatible substrate.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Ladet teaches sealant to repair tissues comprising a porous layer combined with dry materials that are activated to form a hydrogel upon contact with aqueous physiological fluids. The porous layer contains materials that are activated by the presence of aqueous physiological fluids, e.g. body fluids, to induce in situ formation of a hydrogel providing sealing properties to the sealant. The sealant can be in the form of a bioabsorbable patch. The patch comprises a porous layer, a first hydrogel precursor, a second hydrogel precursor, optionally one or more additional layers, wherein said first hydrogel precursor is present in a layer selected from said porous layer and said one or more additional layers, and said second hydrogel precursor is present in a layer selected from said porous layer and said one or more additional layers. In other words, the patch has a structure comprising a porous layer, a first hydrogel precursor, a second hydrogel precursor, wherein said first hydrogel precursor and said second hydrogel precursor are present in said porous layer (abstract; ¶¶ 0003-0005, 0128-0129). The reference teaches the first and second hydrogel precursors are kept separate from each other, e.g. first precursor in the pores of the substrate and the second precursor is applied to another layer such that the portion that contains the first precursor is free of any second hydrogel precursor (¶¶ 0132-0135). The first hydrogel precursor has nucleophilic functional groups, such as amines, the second hydrogel precursor having electrophilic functional groups, such as N-hydroxysuccinimides (¶¶ 0007-0008, 0150-0154). The porous layer comprises a self-crosslinked compound, e.g. gelatin (¶¶ 0009, 0141-0142). The porous layer can have a first portion comprising a first hydrogel precursor and a second portion comprising a second hydrogel precursor with no additional layers (¶¶ 0024-0025, 0160; claims 22, 31-40), or first precursor is present in the porous layer and the second precursor is present in an additional layer (¶¶ 0035-0042). The porous film has thickness of 0.1 mm to 10 mm (¶ 0168). The films stored in container (¶¶ 0191-0192, 0200, 0215, 0216).
Keereweer teaches biocompatible flexible hemostatic sheet comprising cohesive porous carrier sheet comprising spaces. The spaces comprising plurality of reactive polymer particles comprising (i) electrophilic polymer carrying plurality reactive electrophilic groups and (ii) a nucleophilic polymer contains plurality reactive nucleophilic groups that are capable of reacting with the reactive electrophilic groups of the electrophilic polymer to form a hydrogel. The sheet stops bleeding during surgical procedure and seals wounds. Due to flexibility of the sheet, it can be applied to irregularly shaped bleeding site (abstract; ¶¶ 0026-0033, 0067, 0074). The reactive electrophilic groups are preferably succinimidyl esters, and reactive nucleophilic groups are preferably amine groups in the form of particle agglomerates (¶¶ 0083-0096, 0112). The hemostatic sheet has thickness of 0.5-25 mm, e.g. 1-10mm, 1.5-5 mm, and width of 25-200 mm and length of 25-200 mm (¶¶ 0055-0056). The sheet can be a laminate comprising alternate layers of carrier and layers of reactive polymer, wherein the polymers from the polymer layers enter the carrier sheet layers (¶ 0058). The water absorption capacity of the sheet is at least 50%, e.g. 100-800%, 200-500% (¶ 0060). The carrier sheet can be gelatin foam (¶¶ 0047-0048; example 1). The sheets are sealed in a package (¶ 0131, claim 16).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Ladet teaches crosslinked porous layer that can be gelatin, and suggest heating of gelatin, the reference does not teach gelatin with sufficient specificity as claimed by claim 1. While Keereweer teaches gelatin foam carrier, and teaches porous carrier, the references does not teach crosslinked gelatin foam as claimed by claim 1.
Hedrich teaches crosslinked gelatin is a biocompatible polymer forming hydrogel and is preferred as hemostatic and wound sealing as it forms barrier for blood flow. Gelatin can be used with polymers containing reactive groups. Crosslinking can be carried hydrothermally. Crosslinked gelatin can absorb 200-2000% of its weight water. When applied to the tissue it forms a layer (abstract; ¶¶ 0007-0024, 0076).
Dreesmann teaches crosslinked gelatin sponge is biocompatible and stimulates angiogenesis. Gelatin sponge is produced by foaming, and thermal crosslinking (see the entire document, and in particular: abstract; sections 2.2, 3.1, 3.2; conclusion).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide biocompatible tissue sealant comprising porous crosslinked film that can be gelatin, and polymers comprising reactive groups as taught by Ladet, and confidently use crosslinked gelatin as a porous film taught as by Hedrich or Dreesmann. One would have been motivated to do so because Hedrich teaches crosslinked gelatin is preferred as hemostatic and wound sealing biocompatible polymer that forms hydrogel, and can be used with polymers containing reactive groups, and because Dreesmann teaches crosslinked gelatin sponge is biocompatible and stimulates angiogenesis. One would reasonably expect formulating biocompatible tissue sealant comprising porous gelatin crosslinked film and polymers comprising reactive groups that has a good hemostatic and angiogenic effects.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide biocompatible flexible hemostatic sheet comprising cohesive porous gelatin foam carrier sheet comprising spaces comprising plurality of reactive polymer particles as taught by Keereweer, and use crosslinked gelatin as a porous film as taught by Hedrich or Dreesmann. One would have been motivated to do so because Hedrich teaches gelatin is preferred as hemostatic and wound sealing biocompatible polymer that forms hydrogel, and can be used with polymers containing reactive groups, and because Dreesmann teaches crosslinked gelatin sponge is biocompatible and stimulates angiogenesis. One would reasonably expect formulating tissue biocompatible sealant comprising porous gelatin crosslinked film and polymers comprising reactive groups and has a good hemostatic and angiogenic effects.
Regarding claim 1 that the patch structure comprising biocompatible substrate and hydrogel precursor, both Ladet and Keereweer teach the claimed structure,
Regarding the claimed electrophilic and nucleophilic hydrogel precursor comprising multiple functional groups as claimed by claim 1, both Ladet and Keereweer teach the claimed hydrogel precursor.
Regarding the biocompatible substrate comprises thermally crosslinked gelatin as claimed by claim 1, combination of the cited references teaches this limitation, Hedrich teaches crosslinked gelatin and Dreesmann teaches thermally crosslinked gelatin foam.
Regarding the limitation of claim 1 that hydrogel precursor extends at least partially into a surface of the biocompatible substrate to form a cohesive hydrogel precursor structure, Ladet teaches hydrogel precursor is present in the porous layer, i.e. extending into the porous layer, and Keereweer teaches the precursors are in the porous layer.
Regarding the limitation of claim 1 that separate adjacent layers of the electrophilic-hydrogel precursor and the nucleophilic-hydrogel precursor, Ladet Keereweer both teach separate layer comprising the hydrogel precursors.
Regarding the limitation of claim 1 that patch presents a shattered surface of the cohesive hydrogel precursor structure that is adhered to the biocompatible substrate, both Ladet and Keereweer teach electrophilic and nucleophilic precursor are present in different portions on the substrate, i.e. shattered. Further, Ladet teaches the first and second hydrogel precursors are kept separate from each other, e.g. first precursor in the pores of the substrate and the second precursor is applied to another layer such that the portion that contains the first precursor is free of any second hydrogel precursor (¶¶ 0132-0135), this will form shattered cohesive layer. Furthermore, Keereweer teaches the reactive polymers are in the form of particles agglomerates (¶ 0112) that implies shattered surface.
Regarding foamed gelatin as claimed by claim 2, Ladet, Keereweer and Dreesmann teach foamed gelatin.
Regarding capability of the biocompatible substrate of absorbing from 100 wt% to 2500 wt% water relative to dry patch weight as claimed by claim 5, Keereweer teaches 100-800%, and Hedrich teaches 200-2000% that both fall within the claimed value. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding claim 6 that the substrate when dry or wet is non-adhesive to surgical gloves or gauze wetted with a non-buffered solution, this property is expected from the prior art substrate comprising crosslinking gelatin foam.
Regarding claim 7 that both the electrophilic-hydrogel precursor and the nucleophilic-hydrogel precursor are substantially uncrosslinked, this is taught by both Ladet and Keereweer that teach precursor are activated and crosslinked when exposed to body fluid that implies that precursors are present in the patch uncrosslinked.
Regarding the blend layer claimed by claim 9, both references suggests presence of the hydrogel precursor in a layer or more prior to crosslinking.
Regarding claim 11 that the patch having thickness from about 0.25 to 10 mm, and a width and length that are independently from about 1 cm to about 15 cm, Ladet teaches thickness of 0.1 mm to 10 mm and Keereweer teaches thickness of 0.5-25 mm, and width of 25-200 mm, i.e. 0.25-2 cm, and length of 25-200 mm i.e. 0.25-2 cm. All the claimed dimensions overlap with that taught by the cited references. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5]. In any event, one having ordinary skill in the art would determine the size and thickness of the patch based on specific intended use.
Regarding claim 13 that the patch when dry is sufficiently flexible that it can be wrapped around a 42-inch mandrel without breaking, Keereweer teaches flexible material comprising the claimed foam and hydrogel precursor, and Ladet teaches the same structure, therefore, and capability to wrap the prior art material/structure is an expected property absent evidence to the contrary.
Regarding claim 19 that the nucleophilic-hydrogel precursor has protonated nucleophilic functional groups comprising amine, this is taught by both Ladet and Keereweer. Applicants failed to show unexpected results obtained from protonated nucleophilic functional groups over non-protonated.
Regarding claim 22 that the electrophilic-hydrogel precursor has electrophilic functional groups comprising a succinimidyl ester, this is taught by both Ladet and Keereweer.
Regarding storage stability of the patch as claimed by claims 27 and 28, this is an expected from the prior art structures comprising the same ingredients since materials and their properties are inseparable.
Regarding packaging the patch in moisture resistant package as claimed by claim 29, this is taught by Keereweer. One having ordinary skill in the art would have used moisture resistant package because the current patch is activated by moisture.
Regarding full absorption of the patch in no more than 9 days as claimed by claim 30, this is an expected property of the patch produced by combination of the prior art comprising the claimed elements. The patch/sheet/film are taught by the prior art as bioabsorbable.
Regarding burst pressure claimed by claim 31, this is an expected property of the patch produced by combination of the prior art comprising the claimed elements.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 03/03/2026 have been fully considered but they are not persuasive.
Claim Rejections - 35 USC 112(b)
Claim 1
Regarding the phrase "at least partially", applicants argue that according to the ordinary and customary meaning of "at least" and "partially", the hydrogel precursor can extend into the substrate to any extent as long as at least it partially extends into the substrate. Penetration of the precursor layer into the substrate is described, for example, at page 27, lines 6-22. One of ordinary skill in the art would be able to ascertain the scope of claim 1 based on ordinary, plain meaning of "at least partially" as well as from the specification.
In response to this argument, and with careful review to the specification and in particular page 27, lines 6-22, it is noted this text of the specification recites in part:
“…..The precursor layer can penetrate partially into the substrate. In some embodiments, a significant fraction of the precursor layer would remain on top of the substrate to present a dry precursor layer for application of the patch…… While in general, the patch can have these ratios of thicknesses for the substrate and hydrogel precursor coating, in some embodiments, it is desirable for the dry substrate to be at least as thick as the dry hydrogel precursor layer, in further embodiments at least about 60%, in some embodiments from 65% to 95%, and in other embodiments from about 70% to about 90% of the dry patch thickness is the substrate thickness….”
Therefore, the expression “at least partially” as claimed is not defined in the specification. Rather the specification defines partial extension of the hydrogel precursor layer from 50% to 90% into the dry substrate, and not referring to any degree of extension without limits as implied by the expression “at least partially”. Note that the term “at least” magnify the extent of “partial extension” of the hydrogel precursors into the substrate more than defined in the specification.
Claim 7
Applicants argue that the term "substantially" is described at page 23, first paragraph, last sentence that states: "If the precursors are substantially uncrosslinked, the properties of the fully hydrated precursors are not significantly altered, and flow properties and rheology do not measurably change for the precursor composition relative to the as formed uncrosslinked composition, although these properties can change quickly once crosslinking is allowed to begin." Thus, one of ordinary skill in the art would be able to ascertain the scope of claim 7 based upon the specification.
In response to this argument, it is argued that the paragraph applicants are referring to, and the entire specification do not define the term “substantially” in order to define how much crosslinking of hydrogel precursors to be performed.
Claims 27, 28 and 30
Applicants argue that the term "about" does not necessarily render a claim indefinite (MPEP 2173.05(b)). Page 103, lines 18-20 indicate how this terminology should be interpreted. "The use of the term "about" herein refers to expected uncertainties in the associated values as would be understood in the particular context by a person of ordinary skill in the art." With this explicit guidance, the meaning seems clear.
In response to this argument, it is argued that the issue here is not the term “about”, rather it is the expression “at least about” that comprises two contradicted terms: “at least” and “about”. Therefore the expression permits two contradicted interpretation of the claims. The term “at least" permits values equal to the value recited following the term and more than that value with no upper limit to the value, and the term “about” permits values below and above the claimed value, usually 10% unless otherwise defined in the specification.
Claim 31
Applicants argue that the term “about” is clear. The specification describes testing to determine burst pressure and specific results for ten samples were obtained. See page 31, line 11 to page 32, line 15 and Example 2, Part C, beginning at page 51, line 10. One skilled in the art knows and understands that all measurements are associated with errors related to accuracy and precision. The scope of the invention should not be limited to one person's reading of millimeters of mercury (mmHg) compared to another's. One of ordinary skill in the art would be able to determine if their medical patch infringes claim 31 by measuring burst pressure and determining if the pressure is 150 mm Hg within the limits of error.
With all the respect to applicant’s response, it is argued that the issue here is not the term “about”, rather it is the expression “at least about” as recited in the claim. The expression comprises two contradicted terms: “at least” and “about”. Therefore the expression permits two contradicting interpretation of the claims. The term “at least" permits values equal to the value recited following the term and more than that value with no upper limit to the value, and the term “about” permits values below and above the claimed value, usually 10% unless otherwise defined in the specification.
Claim Rejections - 35 USC 103
Applicants argue that the present invention is has two features: 1) gelatin is thermally crosslinked that is different from chemically crosslinking, and 2) the claimed medical patch has shattered surface of the cohesive hydrogel precursor structure. The shattered surface is a fractured surface with microfractures and/or cracks and the like across the surface.
In response to these arguments, it is argued that 1) thermally crosslinked gelatin is taught by both secondary references, Hedrich and Dreesmann, as set forth in this office action. 2) Shattered surface is suggested by the cited references as discussed above, absent claiming of any specific structure or shapes, e.g. microfractures, cracks, etc., of the shattered surface. Further, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., shattered surface is a fractured surface with microfractures and/or cracks) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicants argue that none disclose a shattered surface formed in the context of contact with a cohesive hydrogel structure. The Examiner asserted that a shattered surface is described by Ladet and Keereweer because the references teach electrophilic and nucleophilic hydrogel precursors present in different portions on the substrate. However, on the precursor is not penetrating into the substrate.
In response to this argument, it is argued that the references suggest the shattered structure. Ladet and Keereweer teach electrophilic and nucleophilic precursor are present in different portions on the substrate, i.e. shattered. Further, Ladet teaches the first and second hydrogel precursors are kept separate from each other, e.g. first precursor in the pores of the substrate and the second precursor is applied to another layer such that the portion that contains the first precursor is free of any second hydrogel precursor (¶¶ 0132-0135), this will form shattered cohesive layer. Furthermore, Keereweer teaches the reactive polymers are in the form of particles agglomerates (¶ 0112) that implies shattered surface. In absence of claiming specific shattering structure, the prior art readd on the claims.
Applicants argue that the claims are interpreted in view of the specification. Ladet describes the need to keep the hydrogel precursors separated from each other until use and further describes the hydrogels in separate portions of a porous substrate, but there is no further description of what this means. [0024]-[0025]. Compression or fracturing is not described. Keereweer describes haemostatic sheets in which dry fibrous carrier structures or foams are impregnated with dry reactive polymer particles using a shaking machine [0212]-[0218].
In response to this argument, it is argued that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As argued above, the references suggest irregular surface made by the presence of the first and second precursor separately in different layers, or in the form of agglomerate of particles can be understood by one having ordinary skill in the art as shattered hydrogel precursors. Note that applicants do not claim any specifics of the shattered precursors in terms of shape, distribution, etc. It is well established that the claims are given the broadest reasonable interpretation during examination in light of the supporting disclosure as it would be interpreted by one of ordinary skill in the art, In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023,1027-28 (Fed. Cir. 1997); In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359,1364[, 70 USPQ2d 1827] (Fed. Cir. 2004). Further, it has been held that the words of the claim must be given their plain meaning unless the plain meaning is inconsistent with the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989); Chef America, Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1372, 69 USPQ2d 1857 (Fed. Cir. 2004). In the present case,
Applicants argue that none of the references disclose thermally crosslinked gelatin as a substrate or as any other component, Ladet describes functionalized collagen is chemically crosslinked with glycosaminoglycan such as acetylated chitosan [0009], [0144], [0146]. Keereweer describes haemostatic sheets made from a fibrous carrier structure impregnated with reactive polymer particles [0038]-[0040]. The fibrous carrier structure is described as having a felt structure formed by matting or pressing polymeric fibers together to form a cohesive material, or from a woven or knitted structure [0054], [0066]. Gelatin foam and cellulose foam are used as comparative substrates [0215]-[0216].
In response to this argument, applicant’s attention is directed to Ladet that teaches in paragraph [0141] that: “The term gelatine here includes commercial gelatine made of collagen that has been denatured by heating….”. Keereweer teaches gelatin can be used as a fibrous carrier, even if non preferred embodiment, in any event Hedrich teaches foamed gelatin and Dreesmann teach crosslinked gelatin as set forth in this office action.
Applicants argue that Hedrich describes use of granular preparations of biocompatible polymers such as gelatin. The gelatin is chemically crosslinked using glutaraldehyde. No thermally crosslinked sheets of gelatin are described. Dreesmann describes development of an insoluble matrix described as a gelatin sponge. Crosslinking of gelatin is carried out chemically using methanal, commonly known as formaldehyde or glutaraldehyde.
In response to this argument, it is argued that Ladet teaches heating gelatin, Hedrich is relied upon for teaching foamed gelatin that is hydrothermally crosslinked, and Dreesmann is relied upon for teaching thermal crosslinking of gelatin. The references satisfy the purpose for which they are applied.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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