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 .
Response to Amendment
Claim 1 has been amended, and claims 17 and 45-46 canceled, in the amendments dated 1/6/26.
Claim Interpretation
In Claim 1 limitation “the mesh zeta potential is about -4.2 MV to 1 mV facilitating pro-inflammatory cytokine binding,” the limitation “facilitating…cytokine binding” is a functional limitation which appear to be the intended result of the claimed zeta potential, and thus is not given further patentable weight.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 6-7, 9-11, 15-16, 18-20, 26-31, 33, 36-38, 43-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klueh et al. [US 2014/0275905 A1, hereinafter “Klueh”] in view of Chaouat et al. [“A Novel Cross-linked Poly(vinyl alcohol) (PVA) for Vascular Grafts,” Hereinafter “Chaouat”] and Yuan et al. ["Surface characteristics influencing bacterial adhesion to polymeric substrates," hereinafter “Yuan” newly cited].
Regarding claim 1, Klueh discloses a composition comprising a mesh [“surgical mesh,” Par. 0006], but fails to teach the mesh comprising PVA-P [Klueh teaches the mesh may be made of “a variety of biocompatible materials, including but not limited to cellulose, polypropylene, polyesters, and…PET,” Par. 0082]. However, Chaouat teaches, in a composition for “membrane devices suitable for biomedical applications” [Abstract], the membrane comprising phosphate crosslinked poly(vinyl alcohol) polymer (PVA-P) [“Poly(vinyl alcohol)…polymer…cross-link[ed] with sodium trimetaphosphate,” Abstract]. The advantage of phosphate crosslinked PVA-P as a material in biomedical applications include PVA-P’s “excellent film-forming, emulsifying, and adhesive properties” [Col. 1, Page 2855] while the “mild cross-linking would confer interesting mechanical properties…without using toxic additives,” [Col. 1, Page 2856]; the features including “high mechanical strength,” [Section 4., Col. 1, page 2860]. Thus, forming Klueh’s composition comprising a mesh to comprise phosphate crosslinked PVA-P would have been obvious to one of ordinary skill in the art at the time of filing in order to confer desirable qualities on the mesh for biomedical applications, such as emulsifying and adhesive properties, while having high mechanical strength in a process that does not require toxic additives.
It is not clear whether the zeta potential, nonporous, and/or hydrophilic properties are intrinsic to a crosslinked PVA-P mesh or not [the specification appears to disclose that the zeta potential is a feature of the density of cross-linking, Par. 0068]. If they are intrinsic, then they are taught by the above references. In the case they are not:
Yuan teaches, in a polymeric substrate for surgical use, the substrate is hydrophilic and has a negative zeta potential [see Abstract: “The superhydrophilic substrate with negative zeta potential”]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the mesh of the modified Klueh to be hydrophilic and have a negative zeta potential as taught by Yuan in order to limit bacterial binding [Yuan, Abstract: “The superhydrophilic substrate with negative zeta potential exhibited limited bacterial binding, due to the reduced hydrophobic interaction and possible repulsive interaction between bacteria and surface. The findings of this study can be utilized for an effective surface design to circumvent bacterial adhesion as an alternative solution to using antibiotics.”]
Regarding the exact zeta potential: Yuan teaches that zeta potential is a result-effective variable [E. Coli has an overall negative charge, and thus the zeta potential determines the repulsion between the surface and this bacteria, see Yuan, section “Bacterial adhesion to PS substrates.”]. Applicant discloses a range of “about” which may vary by as much as 30% of a reference level [Specification Par. 0031] and discloses a range and does not allege criticality of the claimed range, or unexpected results in the claimed range. Thus, selecting a specific zeta potential amounts to routine optimization of a result-effective variable which is readily achieved by one of ordinary skill.
Regarding the limitation “facilitating pro-inflammatory cytokine binding,” this functional limitation which appear to be the intended result of the claimed zeta potential, and thus is not given further patentable weight.
Claim 2: the modified Klueh discloses the apparatus set forth above. Klueh further teaches the mesh comprises a network of structures [Fig. 37] that are coated with a material [Par. 0192]. As set forth above, Chaouat teaches the use of PVA-P. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh to form the mesh to comprise a network of structures coated with PVA-P as taught by Chaouat in order to confer desirable qualities on the mesh, such as emulsifying and adhesive properties, while having high mechanical strength in a process that does not require toxic additives.
Claim 3: Klueh further discloses said mesh comprises a first side and a second side [see Fig. 37; the mesh is shown as generally planar, thus having a first and second side]. Regarding “the first side is positioned to be in contact with a weakened tissue….” This constitutes the intended use of the mesh, and is not given further patentable weight.
Claim 4: Klueh teaches the apparatus may comprise growth factors [Par. 0008], Integrins [Par. 0177], and/or Fibronectin [Par. 0008]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh by adding growth factors, integrins, and/or fibronectin in order to facilitate healing and/or cell adhesion. Regarding these being on the first side: Klueh does not disclose the placement of these factors. However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the above apparatus to place the growth factors, integrin, and/or fibronectin on the first side because this amounts to selecting one from a limited list of placement options (first side or second side. Note that first AND second side also includes the first side).
Claim 6: Klueh further discloses wherein the first side of the mesh is coated with growth factors, integrins, fibronectin, and/or vitronectin [“coating the implantable device with the extracellular matrix containing fibronectin and vascular endothelial growth factor.,” Par. 0008].
Claim 7: Klueh teaches in some embodiments the mesh may comprise decellularized tissue matrix [“acellularized human or animal tissues,” Par. 0082]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh to form the mesh to comprise decellularized tissue because this is known as a biocompatible material for surgical mesh and thus this amounts to selecting one from a limited list of base materials for the mesh. Regarding the first side comprises decellularized tissue matrix, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the above apparatus to place the decellularized tissue matrix on the first side because this amounts to selecting one from a limited list of placement options (first side or second side. Note that first AND second side also includes the first side).
Claim 9: the modified Klueh discloses The composition of claim 7, including the decellularized tissue matrix. Regarding the first side of the mesh being coated with the decellularized tissue matrix, Klueh discloses the process of coating [Pars. 0110-0112]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh such that the first side of the mesh is coated with decellularized tissue matrix because coating is a disclosed method of adding material to the mesh, and this amounts to selecting one from a limited number of ways of adding the decellularized tissue.
Claim 10: Klueh discloses the composition of claim 3, wherein the surface of the first side is micropatterned [Fig. 37].
Claim 11: Klueh discloses the micropattern comprises a hexagonal pattern [see Fig. 37. The surface has a hexagonal micropattern].
Claim 15: Klueh fails to disclose the thickness of the mesh. However, Chaouat teaches a thickness of the PVA film being 344 +/1 13 .mu.m, which is close to the claimed ranges which include 300.mu.m. Forming the film of a given thickness depends in part on the thickness of the object to be repaired [see Chaouat, Page 2856, Col. 2, section 2.3.] Forming the film to be in a range of 200-300.mu.m would have been obvious to one of ordinary skill in the art at the time of filing because this allows the device to match or come close to the thickness of the body part to be repaired [Chaouat, ibid.]. Note that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close [MPEP 2144.05.I]
Claim 16: Chaouat teaches an elastic modulus greater than 80 kPa [Youngs’ modulus of 2 x 10^5 kPa; see Table 1, Page 2857]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh to have an elastic modulus as taught by Chaouat because this ensures that the apparatus will have a desired degree of stiffness/flexibility suitable for surgical use.
Claim 18: Klueh further teaches the mesh may comprise antibiotic, anti-inflammatory, and/or analgesic drugs [anti-inflammatory; see Pars. 0174-0175]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh to further comprise anti-inflammatory factors in order to stop inflammation [Par. 0175].
Claim 19: Klueh further teaches the mesh comprises controlled release drugs [Pars. 0174-0175] drug delivery nanoparticles [Par. 0056]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh to further comprise the anti-inflammatory factors as controlled release drug delivery nanoparticles in order to stop inflammation [Par. 0175] and in order to improve their delivery.
Regarding claim 20, the modified Klueh teaches the apparatus as set forth above with respect to claim 1. Klueh discloses manufacturing a coated mesh [Fig. 37] and Chaouat teaches a method of forming cross-linked PVA-P. As cited with respect to claim 1 and 2 above, forming Klueh’s composition by a method comprising manufacturing a mesh comprised of or coated with phosphate crosslinked PVA-P would have been obvious to one of ordinary skill in the art at the time of filing in order to confer desirable qualities on the mesh for biomedical applications, such as emulsifying and adhesive properties, while having high mechanical strength in a process that does not require toxic additives.
Claim 26: the modified Klueh discloses the method set forth above. Klueh further discloses the mesh comprises a network of structures [Fig. 37] that are coated with a material [Par. 0192]. As set forth above, Chaouat teaches the use of PVA-P. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Klueh to form the mesh to comprise a network of structures coated with PVA-P as taught by Chaouat in order to confer desirable qualities on the mesh, such as emulsifying and adhesive properties, while having high mechanical strength in a process that does not require toxic additives.
Regarding claim 27, the modified Klueh discloses the apparatus as set forth above with respect to claim 1. Klueh further teaches a method of repairing a weakness or opening in a tissue of an individual, comprising the step of positioning the composition at the weakness or opening [Klueh discloses “meshes that are used in reconstructive surgery including hernia surgery,” Par. 0192. Thus, Klueh inherently discloses repairing an opening in a tissue by positioning the mesh at the opening]. Thus, the modified Klueh together teach the method of repairing a weakness or opening in a tissue of an individual, comprising the step of positioning the composition of claim 1 at the weakness or opening. As cited with respect to claim 1 and 2 above, using the modified Klueh’s composition in the method of Klueh would have been obvious to one of ordinary skill in the art at the time of filing in order to confer desirable qualities on the mesh for biomedical applications, such as emulsifying and adhesive properties, while having high mechanical strength in a process that does not require toxic additives.
Regarding claim 28, Klueh discloses the mesh is used to repair a hernia [Par. 0192]. It is not explicitly disclosed that this is hernia in a muscular wall; however, in Par. 0003, Klueh describes the problems with “groin quadrature and abdominal wall” in typical mesh hernia repair. Based on the above teachings, one of ordinary skill would understand that the hernia to which Klueh refers is in a muscular wall and thus the mesh is to be used to repair a muscular wall. Alternatively, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method to repair a muscular wall because this amounts to applying a known structure to a known method ready for improvement to yield predictable results.
Claim 29. Klueh discloses the method is used for hernia repair [Par. 0192].
Claim 30: Klueh discloses the composition as set forth with respect to claims 3 and 4 above, and thus teaches the method using the claimed composition.
Claim 31: Klueh discloses the composition as set forth with respect to claims 3 and 7 above, and thus teaches the method using the claimed composition.
Claim 33: Klueh discloses the opening is a hernia. [Par. 0192]
Claim 36: Klueh teaches, in some embodiments, local inflammation is reduced following placement of the composition [see Par. 0189]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Klueh to reduce local inflammation following placement as taught in the second embodiment because this promotes healing and improves quality of life for the patient.
Claim 37: Klueh teaches, in some embodiments, the growth factors, integrins, fibronectin, and/or vitronectin stimulates healing of the weakness or opening [pars 0124-0125 describe how growth factors improve healing]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Klueh to add growth factors to stimulate healing as taught in the second embodiment because this promotes healing and improves quality of life for the patient.
Claim 38: Klueh teaches, in some embodiments, a decellularized tissue matrix [Par. 0082] is used in the composition. Furthermore, Klueh teaches the composition stimulates healing of the weakness or opening [Par. 0186, e.g.]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Klueh to form the mesh to comprise decellularized tissue because this is known as a biocompatible material for surgical mesh and thus this amounts to selecting one from a limited list of base materials for the mesh. Regarding the decellularized tissue matrix stimulating healing, the composition as a whole does this and thus the matrix which forms a part of the mesh helps to perform this function as well.
Claim 43: the modified Klueh discloses the composition as set forth with respect to claims 18 above, and thus teaches the method using the claimed composition.
Claim 44: the modified Klueh discloses the composition as set forth with respect to claims 19 above, and thus teaches the method using the claimed composition.
Claim(s) 5, 8, 21, 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klueh in view of Chaouat and Yuan, as applied to claim 4, 7, or 20 above, and further in view of Watschke [US 20160213815 A1]
Claim 5: The modified Klueh discloses the apparatus set forth above but fails to disclose 3D printing. However, Watschke discloses a composition including a surgical mesh which includes growth factors and/or fibronectin [Par. 0028] which is 3D printed [Par. 0062]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh by forming the device including growth factors to be 3-D printed as taught by Watschke because this amounts to selecting one from a limited list of suitable ways for forming a mesh with growth factor/fibronectin [see Watschke Par. 0062]. Regarding this being the first side, this would have been obvious to form the first side and second side in this manner, and having the first side having the growth factors/fibronectin amounts to selecting one from a limited number (2) of sides available.
Claim 8: the modified Klueh discloses the apparatus set forth above but fails to disclose 3D printing. However, Watschke discloses a composition including a surgical mesh which includes decellularized tissue matrix [Par. 0026] which is 3D printed [Par. 0062]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh by forming the device including decellularized tissue matrix to be 3-D printed as taught by Watschke because this amounts to selecting one from a limited list of suitable ways for forming a mesh with decellularized tissue matrix [see Watschke Par. 0062]. Regarding this being the first side, this would have been obvious to form the first side and second side in this manner, and having the first side having the growth factors/fibronectin amounts to selecting one from a limited number (2) of sides available.
Claim 21: the modified Klueh discloses the apparatus set forth above, including the mesh being a network of structures comprising PVA-P, but fails to disclose 3D printing. However, Watschke discloses a composition including a surgical mesh which is 3D printed [Par. 0062]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh by forming the device including network of structures comprising PVA-P to be 3-D printed as taught by Watschke because this amounts to selecting one from a limited list of suitable ways for forming a mesh [see Watschke Par. 0062].
Claim 23: Chaouat further teaches PVA is mixed with sodium trimetaphosphate solution prior to “printing” [“An aqueous solution (7.5 mL) of 15% (w/v) sodium trimetaphosphate (Sigma-Aldrich) was added to the PVA solution,” Page 2860 Col. 1] followed by polymer cross-linking during a drying process [“PVA membranes were only obtained by a progressive drying of alkaline PVA solutions (at least 24 h) during which the water evaporation led to an increase in the cross-linker concentration and reorganization of PVA macromolecular chains,” Chaouat Page 2859, Col. 1]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method by mixing PVA with sodium trimetaphosphate solution prior to printing followed by polymer cross-linking during a drying process because this ensures high cross-linked density [Chaouat, ibid.]. Note that printing is taught as set forth with respect to claim 21 above.
Regarding claim 24: the modified Klueh discloses the method set forth above. Watschke teaches the 3D printing as set forth with respect to claim 5 above. The combined above references Klueh-Chaouat-Watschke thus inherently teach the first side of the mesh is 3D printed onto the mesh as growth factors, integrins, fibronectin, and/or vitronectin as claimed.
Regarding claim 25: the modified Klueh discloses the method set forth above. Watschke teaches the 3D printing as set forth with respect to claim 8 above. The combined above references Klueh-Chaouat-Watschke thus inherently teach the first side of the mesh is 3D printed onto the mesh as decellularized tissue matrix as claimed.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klueh in view of Chaouat, Yuan, and Watschke, as applied to claim 21 above, and further in view of Thomas [“Development of a hybrid scaffold for cartilage tissue generation”]
Claim 22: Klueh as modified above teaches 3D printing and PVA-P, but fails to disclose a pre-polymer solution polymerizing. Thomas teaches a method of depositing a pre-polymer solution that polymerizes to PVA-P during the printing process [“A PVA-scaffold assembly was prepared as follows; 3ml aliquots of viscous partially hydrolyzed (+87.0-89.0%) PVA (Celvol 205 [Avg. MW 31, 000 – 50,000], Celanese Ltd., TX, USA) was poured into polystyrene weighing boats and allowed to set for 24 hours in an open environment under ambient conditions. Subsequently, the end surface of a scaffold was placed in the centre of the dish, on top of the partially set film, which was allowed to set creating the final PVA-scaffold assembly,” Page 47]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Klueh by forming the solution to include a deposits a pre- polymer solution that polymerizes to PVA-P because this amounts to selecting one of a limited list of ways of preparing the PVA polymer. Furthermore, regarding the printer depositing the solution that polymerizes during the printing process, the above references would have rendered this obvious to one of ordinary skill in the art, with the printing being taught by the above references.
Claim(s) 12, 32, 34, 35, 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klueh in view of Chaouat and Yuan, as applied to claim 3, 31, 33 or 27 above, and further in view of Lichtenstein et al. [US Pat. 5593441, hereinafter “Lichtenstein”].
Regarding claim 12, the modified Klueh discloses the composition set forth above but fails to disclose the second side being substantially smooth and flat. However Lichtenstein teaches a mesh having a second side wherein the second side is substantially smooth and flat [14, Fig. 1B]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh to form the second side as substantially smooth and flat as taught by Lichtenstein in order to provide a physical barrier which isolates the abdominal viscera, preventing intestinal adhesion and fistulization [Lichtenstein col. 3 lines 13-21]
Regarding claim 32, the modified Klueh discloses the method set forth above but fails to specify which directions the sides face. However, Lichtenstein teaches a mesh is positioned such that the first side faces the weakness or opening, and the second side faces a direction opposing the wall [Fig. 1B and Col. 3 lines 5-17]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Klueh to form the first side to face the weakness or opening and the second side to face a direction opposing the wall as taught by Lichtenstein in order to combine the strength, handling, and fibroblastic stimulation of a prosthetic mesh with the low adhesion incidence of a physical barrier which isolates the abdominal viscera, preventing intestinal adhesion and fistulization [Lichtenstein col. 3 lines 13-21]
Regarding claim 34, the modified Klueh discloses the method set forth above but fails to disclose the type of hernia. However, Lichtenstein teaches a mesh implanted in a hernia opening which is incisional or umbilical [Col. 6 lines 16-17]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Klueh by placing the composition on an opening which is an incisional or umbilical hernia as taught by Lichtenstein because this amounts to modifying a known method ready for improvement to yield predictable results [using the composition of the modified Klueh in a mesh implantation taught by Lichtenstein, including the flat second surface of Lichtenstein, but which is improved by the use of PVA-P in the mesh for the reasons set forth with respect to claim 1 above].
Regarding claim 35, the modified Klueh discloses the method set forth above but fails to disclose no adhesion. However Lichtenstein teaches a method wherein there is no adhesion of the composition to one or more peritoneal and/or visceral organs or tissues [Col. 3 lines 15-16]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Klueh by preventing adhesion to organs as taught by Lichtenstein because this prevents fistulization [Lichtenstein col 3 line 17]
Regarding claim 39, Klueh fails to disclose whether or not the mesh degrades. However, Lichtenstein teaches, in a method of implanting surgical mesh, wherein the mesh degrades in the individual [Col. 4 lines 7-8]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Klueh to have the mesh degrade as taught by Lichtenstein because this is desirable in certain applications where temporary defects are repaired [Lichtenstein Col. 4 lines 7-10].
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klueh in view of Chaouat and Yuan, as applied to claim 1 above, and further in view of Lozano et al. [US 2020/0289249 A1, hereinafter “Lozano”]
Regarding claim 13: Klueh discloses ways to increase the tensile strength [Par. 0176] but fails to disclose what it is. Chaouat teaches the PVA-P film having a high tensile strength [ Page 2858, Col. 2], but also fails to disclose numbers. However, Lozano teaches a mesh for hernial repair which has a tensile strength of greater than 20kPa [Par. 0084]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh by forming the composition mesh to have a tensile strength of greater than 20 kPa as taught by Lozano because this is the minimum tensile strength needed to withstand typical abdominal pressure [Lozano Par. 0084]. Note that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close [MPEP 2144.05.I]. Greater than 20 kPa is close to the claimed range of greater than 23 kPa and therefore the claimed range is obvious over Lozano.
Claim(s) 14, 40-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klueh in view of Chaouat and Yuan, as applied to claim 1 or further in view of Lichtenstein as applied to claim 39 above, and further in view of Hussain et al. [US 3960150 A].
Regarding claim 14, the modified Klueh-Chaouat together disclose the mesh which contains crosslinked PVA-P, but fails to teach the mesh is degradable at a rate that is a function of crosslinking. However, Hussain teaches, in a biocompatible device which may include phosphate cross-linked PVA-P [Col. 20 lines 22-49], the device is degradable at a rate that is a function of crosslinking of the PVA-P [“By varying the degree of cross-linking, the rate of drug release and biodegradation can be varied over wide limits,” Col. 21 lines 58-59]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Klueh to have the device be degradable at a rate controlled by cross linking because this allows the manufacturer to make a mesh which can biodegrade at the appropriate rate for the given medical use.
Regarding claims 40 and 41, the modified Klueh teaches the controllable rate of degradation which is controlled by the number of phosphate crosslinking groups in the device (the mesh is taught by Klueh and the degradation of mesh by Lichtenstein as set forth with respect to claim 39 above] as set forth with respect to claim 14 above, and thus inherently teaches the same method.
Regarding claim 42, the modified Klueh discloses the above method. Hussain further teaches control of the degree of cross-linking by controlling the ratio of metal to polymer in the initial solution [Col. 21 lines 40-45]. One of ordinary skill, upon reviewing the above teachings, would reasonably be apprised that the control of sodium trimetaphosphate (STMP) to PVA ratio in Chaouat controls the degree of crosslinking. Furthermore, this appears to be a statement of a natural phenomenon or law and thus does not lend patentable distinction to the method.
Response to Arguments
Applicant's arguments filed 1/6/26 have been fully considered. The examiner agrees that previously-cited Shokry fails to teach the zeta potentials now claimed in amended claim 1. However, Yuan has been introduced which teaches that the zeta potential of a polymer surface in a surgical device is a result-effective variable which determines the attraction or repulsion of E. Coli.
Regarding the cytokine binding, this appears to be the result of the claimed range of zeta potentials, and thus is not given further patentable weight [the specification discloses that positively charged cytokines will be attracted to a negatively charged surface, so the negative surface of Yuan would also attract cytokines whether or not this is explicitly disclosed].
ConclusionApplicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771