MEDICAL DEVICE

DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/25/2026 has been entered. Information Disclosure Statement The information disclosure statement (IDS) submitted on 08/31/2026 has been considered by the examiner. Status of the Claims The claims filed 08/25/2026 are under consideration. Claims 1 and 3-14 are pending. Claims 1 and 14 are independent Claims 1 and 3-14 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn. Response to Arguments Applicant has argued that as demonstrated in the present specification, increasing polyethylene glycol content is not invariably beneficial. Applicant has argued that although polyethylene glycol can contribute to hydrophilicity and biocompatibility/hemocompatibility, excessive polyethylene glycol content can adversely affect important physical properties, including tensile strength and strength retention. Applicant has argued that the working examples instead demonstrate compositions that achieve an advantageous balance between water content, intermediate water, biocompatibility/hemocompatibility, and useful mechanical properties. These arguments are unpersuasive. The claimed invention is not limited to the working examples. It is not necessary that the prior art teach all the same advantages or results reported by applicant. See MPEP 2144, IV. Vakili teaches optimizing the amount of polyethylene glycol in polyurethanes to find an optimum balance between hydrophilicity and hydrophobicity to maximize biocompatibility and hemocompatibility (Vakili, e.g., pg. 532, Table 1 and section 2.1 and pg. 535, c1: ¶ 4 – pg. 538 conclusion). The skilled artisan may also have been motivated to increase the hydrophilicity to improve the material’s ability to release water soluble drugs and/or to improve the ability of the material to incorporate water soluble drugs (Riffey, e.g., pg. 1:25-37). Applicant has argued that Vakili does not disclose PEG content using the same basis required by claim 1. Applicant has argued that Vakili reports formulations in terms of the relative amounts of PEG and polycarbonate ("PC"), i.e., a PEG/PC relationship. Applicant argues Vakili does not establish that its numerical PEG designation represents the mass percentage of PEG relative to the entire polyurethane resin. Applicant has argued Vakili Does Not Suggest Increasing PEG to the Claimed Level on the claimed basis. Applicant has argued Vakili does not provide a general teaching to increase PEG content as much as possible. Applicant argues, Vakili reports that its PCU-PEG 20 and PCU-PEG 30 formulations exhibited similar hemocompatibility behavior due to their similar surface hydrophilicity and expressly concludes that "there is no need to increase the PEG content more than 20%." Applicant argues that even if a person of ordinary skill in the art understood Vakili's PCU-PEG 20 formulation as containing PEG in an amount of 20% relative to PC, it cannot reasonably be concluded from that disclosure that PEG constitutes 20 mass% or higher based on the entire polyurethane resin, including the isocyanate-derived and other constituents. The denominator employed by Vakili is materially different from the denominator expressly required by claim 1. These arguments are unpersuasive. As pointed out by Applicant Vakili reports PEG in an amount of 20%. The skilled artisan may have interpreted this as a measure of the relative amount of PEG based on the total mass of the polyurethane as seen in Vakili, Table 1, i.e., polycarbonate urethane is 100% in row one. Vakili, Table 1, clearly shows: PNG media_image1.png 160 600 media_image1.png Greyscale Line one of Table 1 indicates 100%, i.e., the total weight, is PCU. From table 1 the skilled artisan would reasonably infer that PCU is not simply the carbonate constituent of the polyurethane. Rather, the skilled artisan would consider “PCU” is the entire polyurethane polymer including all constituents, e.g., HDMI and BD and carbonate diol. The skilled artisan may have interpreted this table to mean that PEG 20 is 20 parts PEG to 80 parts PCU, i.e., 20 parts PEG per total mass (100) of the polyurethane polymer including all of its constituents. Even if, arguendo, Vakili only teaches a ratio of polyethylene glycol to polycarbonate, a 30% polyethylene glycol ratio still corresponds to 22.35 wt% based on the total polyurethane mass which is within the claimed range. For polymer synthesis details see Vakili, Polymer, 195, 2020 cited as reference 25 in Vakili, IJPMPB, 2020 at section 2.1 synthesis. Polycarbonate (PHMCD): 2000g/mol PEG 2000g/mol Hexamethylene diisocyanate (HDI): 168.20g/mol Butane diol (BD): 90.12g/mol Molar ratio of polyurethane components, macrodiol:HDI:BD::1:3:2 (Vakili, Polymer, e.g., pg.2, sections 2.1-2.2). Molar Ratio of PHMCD:PEG for 30% PEG is 0.7:0.3 Constituent Molar Ratio Molecular Weight (g/mol) Mass/polymer mole (g) Weight Percent (wt%) Polyhexamethylene carbonate diol (PHMCD) 0.7 2000.00 1400.00 52.14% Polyethyleneglycol (PEG) 0.3 2000.00 600.00 22.35% Hexamethylene diisocyanate (HDI) 3.0 168.20 504.59 18.79% 1,4-Butanediol (BDO) 2.0 90.12 180.24 6.71% Total 6.0 — 2684.83 100.00% Even if the PEG % in Vakili is a ratio with polyhexamethylene carbonate, 600.00g/mol divided by 2684.83 g/mol x 100% is 22.35% based on 100 mass% of the constituents in the polyurethane resin elastomer. Consequently, from Vakili, the skilled artisan would have understood that Riffey’s polymers could be modified by increasing the PEG mass% into the claimed range for improved biocompatibility and hemocompatibility. Further still Rashid, clearly teaches polyethylene glycol may make up from about 5-80wt% of the polyurethane, e.g., 25-50wt% (Rashid, e.g., 0205) to tailor the hydrophilicity and water content of a polyurethane. In summary, Riffey teaches the range of 2-15wt% based on the total weight (Riffey, e.g., pg. 6:7-17) which upper limit is close to the claimed range. Vakili teaches the amount of polyethylene glycol in a polyurethane may be optimized for desired properties depending on the need for biocompatibility and hemocompatibility, e.g., 20% or 22.35%, which is within the claimed range. And, the additional cited reference, Rashid, clearly teaches polyethylene glycol may make up from about 5-80wt% of the polyurethane, e.g., 25-50wt% (Rashid, e.g., 0205) to tailor the hydrophilicity of a polyurethane for a desired equilibrium water content which optimizes comfort, injury risk, and polymer mechanical properties. Applicant argues that Vakili expressly states that there is "no need to increase the PEG content more than 20%" because PCU-PEG 20 and PCU-PEG 30 showed similar hemocompatibility behavior. Applicant argues that Vakili would not have led that person to adopt the presently claimed feature in which PEG is present in an amount of 20 mass% or higher based on the entire polyurethane resin elastomer. Rather, Vakili both (1) measures PEG content on a different basis than the claims and (2) affirmatively indicates that increasing PEG beyond its "20" formulation is unnecessary. This argument is unpersuasive at least because 20% or 22.35% is within the claimed range. Further, this teaching in Vakili indicates that amounts greater than 20% would have been expected to offer similar biocompatible and hemocompatibility benefits, i.e., have similar desired properties. This is not a teaching away from PEG in amounts greater than 20%, particularly when viewed in the broader prior art context, e.g., Rashid’s range for suitable amounts of polyethylene glycol. Applicant has argued that Rashid Does Not Cure the Deficiencies of the Riffey/Vakili Combination. Applicant argues the mere fact that a different polyurethane material disclosed for a different purpose may absorb or contain a particular amount of water does not establish that the particular PEG/polycarbonate polyurethane resin allegedly resulting from the combination of Riffey and Vakili would likewise have that property. Applicant has argued Water content is dependent on the structure and composition of the material as a whole. Applicant has argued the Examiner therefore cannot simply import a water- content property from Rashid into a materially different polyurethane composition without a sufficient technical reason for doing so. Applicant argues the rejection thus appears to select separate teachings from different references for separate claim limitations-Riffey for a polyurethane medical-device material, Vakili for PEG- containing hydrophilic segments, and Rashid for water content without adequately establishing why a person of ordinary skill in the art would have combined those teachings in the particular manner required to produce the claimed polyurethane resin elastomer as a whole. These arguments are unpersuasive. The silicone containing polyurethanes of Rashid and polycarbonate polyurethanes of Riffey were known alternative polyurethanes for medical devices. Riffey teaches the polycarbonate containing polyurethanes offer improved ability to deliver water soluble drugs because polycarbonate containing polyurethanes offer improved solubility for water soluble drugs relative to silicone containing materials (Riffey, e.g., pg. 1:30-36). The prior art polyurethanes are not disclosed for different purposes. Each of Riffey (Riffey, entire document, e.g., Abstract, claims), Vakili (Vakili, entire document, e.g., pp. 531-532, Abstract and Introduction), and Rashid (Rashid, entire document, e.g., 0343) teach polyurethanes for use as medical devices. The polyurethanes in each of the cited references have the same polyethylene glycol and polyisocyanate constituents required by the claimed invention. The prior art teaches medical devices having the same polymer recited in the claimed invention. Based on the combination of polyethylene glycol (PEG) and isocyanate groups (NCO) the water absorbing properties are similar, in part due to the increased hydrophilicity offered by PEG as noted in Vakili. Further, Rashid explains that the water content of a polyurethane can be adjusted by modifying the OH:NCO ratio using an appropriate amount of PEG containing OH groups even for more hydrophobic polyurethanes containing silicone (Rashid, e.g., 0129-0130). Applicant argues the rejection does not adequately explain why a skilled artisan seeking to modify Riffey according to Vakili would further modify the resulting PEG/polycarbonate polyurethane according to the teachings of the contact-lens hydrogel/xerogel materials of Rashid, or why such a modification would reasonably have been expected to produce a polyurethane resin elastomer satisfying both the claimed PEG mass percentage and the claimed water content while maintaining the useful physical properties described in the present application. This argument is unpersuasive. Riffey clearly teaches it may be desired to modify the hydrophilicity of a polyurethane to allow for release of water-soluble drugs and facilitate formulation of drugs which are poorly soluble in the polyurethane (Riffey, e.g., pg. 1, Summary). Vakili teaches the amount of polyethylene glycol present in the polymer was a result effective parameter the skilled artisan would have modified for increasing hydrophilicity and improving biocompatibility as measured, e.g., by cell viability and hemocompatibility (Vakili, e.g., pg. 535, c1: ¶ 4 – pg. 538 conclusion). Vakili teaches the PEG/polycarbonate ratio may be varied to optimize the ratio of hydrophilic to hydrophobic segments to maximize biocompatibility and hemocompatibility (Vakili, e.g., pg. 532, Table 1 and ¶ 1). Rashid explains that the water content of a polyurethane can be adjusted by modifying the OH:NCO ratio using an appropriate amount of PEG containing OH groups (Rashid, e.g., 0129-0130). From Vakili and Rashid, it is clear the skilled artisan understood the amount of polyethylene glycol was effective to optimize the hydrophilicity of a polyurethane and water content of a polyurethane due to the hydrophilicity imparted by polyethylene glycol. Since the amount of PEG was a known result effective parameter useful to modify the hydrophilicity, biocompatibility, hemocompatibility, and water content of a polyurethane, the skilled artisan understood the amount of PEG could be optimized depending on the desired properties, and the skilled artisan would have further understood that the amount of PEG was effective to optimize water soluble drug formulation in the hydrogel and drug release from the hydrogel as desired by Riffey based on the increased hydrophilicity and degree of water content afforded by PEG as explained in Vakili and Rashid. Applicant argues the additional references do not remedy the failure of the base combination to teach or suggest polyethylene glycol present in an amount of at least 20 mass% based on 100 mass% of all constituents of the polyurethane resin elastomer, nor do they supply the missing reasoned basis for combining the cited teachings to obtain the claimed water-containing polyurethane elastomer as a whole. These arguments are unpersuasive for the reasons enumerated above. Vakili and Rashid offer reasons to modify Riffey’s medical devices with a polyurethane having an amount of PEG and water content in the claimed range with a reasonable expectation of success. 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1, 3, 6, 7, 8, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rashid, US 20150234094. Rashid teaches medical devices containing a polyurethane resin comprising water, polyethylene glycol (PEG), and polyisocyanate (Rashid, entire document, e.g., 0305, 0343, examples, and claims). Rashid teaches the amount of PEG may range from 11-35wt% (Rashid, e.g., 0305) or more generally 5-80wt%, 10-70wt%, 20-60wt%, 25-50wt%, 10-25wt%, or 15-25wt% (Rashid, e.g., 0205). Rashid exemplifies a polyurethane medical device comprising 6.48wt% of PEG 200 and PEG 2200 (Rashid, e.g., pg. 26, e.g., Table J) and a polyisocyanate, HDI. The polyurethane contains a water content of 40wt% which is within the claimed range (Rashid, e.g., pg. 26, e.g., Table K). Rashid explains that the water content of a polyurethane can be adjusted by modifying the OH:NCO ratio using an appropriate amount of PEG containing OH groups even for more hydrophobic polyurethanes containing silicone (Rashid, e.g., 0129-0130). Water content can be optimized for patient comfort and reduced risk of infection (Rashid, e.g., 0020, 0040, 0198, 0129-0130, 0198, 0202, and 0354-0355). Greater hydrophilicity is related to increased patient comfort (Rashid, e.g., 0101). From Rashid, the skilled artisan would have clearly understood that medical devices made from polyurethanes containing polyethylene glycol segments have equilibrium water content properties. The skilled artisan would have clearly understood that medical devices made from polyurethanes containing polyethylene glycol segments will contain an amount of equilibrium water which is within, or overlapping with, the claimed range. The amount of water may be tailored in a polyurethane medical device to promote comfort when placed in or on the body (Rashid, e.g., 0198). The water content may be easily modified by drying or hydrating as desired (Rashid, e.g., 0391-0392). Additionally, Rashid notes that generally the polyurethane in an aqueous medium will absorb water (Rashid, e.g., 0070). The claimed range of from 1mass% to 50mass% reads on dried hydrogels (xerogels) with a water content of less than 5 mass% (Rashid, e.g., 0071). The claimed range of from 1mass% to 50mass% reads on hydrated hydrogels with a water content of more than 10 mass% (Rashid, e.g., 0071). The embodiment of Table J differs from the claimed invention in that the amount of PEG (about 6.5wt%) is lower than the claimed range of 20-50wt%. However, the skilled artisan would have found it obvious to modify the exemplified polyurethanes such as found in Table J based on Rashid’s more general teachings. Because Rashid teaches the amount of polyethylene glycol may range over 5-80wt%, 10-70wt%, 20-60wt%, 25-50wt%, 10-25wt%, or 15-25wt% (Rashid, e.g., 0205), the skilled artisan would have been motivated to optimize the PEG content using these broader teachings to optimize hydrophilicity for comfort and reduced risk of injury/infection depending on the particular device and intended use. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05 It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify exemplified polyurethane medical devices of Rashid by optimizing the amount of polyethylene glycol in the range of 5-80wt%, 10-70wt%, 20-60wt%, 25-50wt%, 10-25wt%, or 15-25wt% with a reasonable expectation of success. The skilled artisan would have been motivated to optimize the amount of polyethylene glycol having a molecular weight in the claimed range to hydrophilicity and equilibrium water content for patient comfort and reduced risk of tissue damage and infection. The skilled artisan would have had a reasonable expectation of success since Rashid teaches greater amounts of PEG relates to a more hydrophilic material which enables equilibrium water contents tailored for patient comfort and safety as measured by reduced tissue damage due to dehydrating tissues and reduced risk of infection. The limitations of claims 6-8 are found in Rashid, e.g., 0081, 0098, and 0370. The limitations of claims 10-13 are found in Rashid, e.g., 0343. Accordingly, the subject matter of claims 1, 3, 6, 7, 8, and 10-14 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rashid, US 20150234094 as applied to claims 1, 3, 6, 7, 8, and 10-14 above, and further in view of Muse, US 20190153147. The teachings of Rashid enumerated above apply here. Rashid does not expressly teach the polyurethane elastomer further comprising a polycarbonate diol. Muse teaches polyurethanes may include a combination of polycarbonate polyol and polysiloxane (Muse, e.g., Abstract, claims). The combination of polycarbonate and silicone components results in medical devices which have an advantageous combination of properties, e.g., durability from polycarbonate and alcohol resistance from silicone and retention of additives, e.g., radiopacifying agents (Muse, e.g., 0047-0053). It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify polyurethanes medical devices containing polyethylene glycol and a polyisocyanate as understood by Rashid by including a polycarbonate polyol with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification for a desirable combination of properties including improved durability in combination with alcohol resistance to allow sterilization, and retention of radiopacifying agents. The skilled artisan would have had a reasonable expectation of success since Rashid teaches the medical device may be a catheter and because Muse teaches polyurethanes may be modified by combining silicone and polycarbonate segments for improved device properties. Accordingly, the subject matter of claim 4 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary. Claims 5, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rashid, US 20150234094 as applied to claims 1, 3, 6, 7, 8, and 10-14 above, and further in view of Bezwada, US 20150259464. The teachings of Rashid enumerated above apply here. Rashid expressly teaches devices in the form of tubes (hollow cylinder), rods (column), and films. To the extent that a sheet or plate may be distinct from a film, the skilled artisan understood that plates, sheets, and films were known forms useful as alternative devices. For example, Bezwada teaches polyurethanes formed into several medical devices having forms including, inter alia, tubes, sheets, plates, and films (Bezwada, e.g., 0181). Such forms have utility as devices alone or may be employed for sustained drug delivery. It would have been obvious before the effective filing date of the presently claimed invention to modify the shape of devices known from Rashid by molding the device into alternative shapes known and used in the polyurethane art such as sheets, plates, and films with a reasonable expectation of success. Since Rashid teaches devices molded from a polyurethane resin, the skilled artisan would have found it obvious to mold the devices in useful shapes known in the polyurethane art including sheets, plates or films with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success since each of the shapes were known alternatives having utility as medical devices. Rashid does not expressly teach the device having a thickness of more than 1 mm. Bezwada teaches materials may have a thickness of from about 1 micron to about 5 microns, or from about 1 cm to about 5 cm or more depending on the specific application (Bezwada, e.g., 0288-0289). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05 It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to optimize the thickness of a medical device as understood from Rashid according to the teachings of Bezwada with a reasonable expectation of success. The skilled artisan would have been motivated to optimize the thickness of the device for specific applications, e.g., from about 1 micron to about 5 microns for skin repair and the like. The skilled artisan would have had a reasonable expectation of success since Rashid teaches medical devices useful for wound healing. Accordingly, the subject matter of claims 5, and 10-14 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary. Claims 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rashid, US 20150234094 as applied to claims 1, 3, 6, 7, 8, and 10-14 above, and further in view of Piotrowicz, US 20210268543. The teachings of Rashid enumerated above apply here. The teachings of Rashid teach medical devices having the features of claim 1, but do not expressly teach the polyurethane further comprising a monohydric alcohol containing a fluorine atom as a constituent. Piotrowicz teaches modifying polyurethane resins with fluorinated monohydric alcohols (Piotrowicz, e.g., 0301 and 0305-0308 and 0323). The fluorinated monohydric alcohol additives are active on the surface (Piotrowicz, e.g., 0323) which renders the surface of the polymer resistant to bacterial adhesion (Piotrowicz, e.g., Title, Abstract, claims). This modification reduces risk of device failure, and local or systemic infection (Piotrowicz, e.g., 0004). Piotrowicz teaches this technique for modifying polyurethanes (Piotrowicz, e.g., 0131-0135, 0293, and, e.g., examples 2-14, 0372-0421). It would have been obvious before the effective filing date of the presently claimed invention to modify polyurethanes suggested by Rashid by incorporating fluorinated monohydric alcohols using techniques known from Piotrowicz to improve the medical devices in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to incorporate fluorinated monohydric alcohols to reduce bacterial adhesion on the surface of the device and reduce the risk of device failure, and local or systemic infection in the same way reported by Piotrowicz. The skilled artisan would have had a reasonable expectation of success since Piotrowicz expressly suggests the technique would be effective for polyurethanes like those of Rashid. Rashid expressly teaches devices in the form of tubes (hollow cylinder) and films. To the extent that a sheet or plate may be distinct from a film, the skilled artisan understood that plates, sheets, and films were known forms useful as alternative devices. For example, Piotrowicz teaches polyurethanes were known and used in several devices including, inter alia, tubes and plates (Piotrowicz, e.g., 0055) and films (Piotrowicz, e.g., 0296). Such forms have utility as devices alone, or may be employed for drug delivery (Piotrowicz, e.g., 0044, 0055, 0296, and claim 82). There does not appear to be any clear distinction between a film, a plate, and a sheet since they are all similarly shaped. The distinction is semantic without recitation of further structural features. It would have been obvious before the effective filing date of the presently claimed invention to modify the shape of devices known from the combined teachings of Rashid by molding the device into alternative shapes known and used in the polyurethane art such as sheets, plates, and films with a reasonable expectation of success. Since Rashid teaches medical devices molded from a polyurethane resin, the skilled artisan would have found it obvious to mold Rashid’s devices in useful shapes known in the polyurethane art including sheets, plates or films with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success since each of the shapes were known as alternatives, each having utility as medical devices and useful for sustained drug release. Accordingly, the subject matter of claims 9-14 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary. Claims 1, 3-4, 6-8, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Riffey, WO 2020060923 A1, Vakili, International Journal of Polymeric Materials and Polymer Biomaterials, 2020 as evidenced by Vakili, Polymer, 195, 2020, and Rashid, US 20150234094. Riffey teaches medical devices intended for contact with tissue, blood, or body fluids, i.e., implantable device which is prepared by melt processing into a desired shape, e.g., rod, tube or ring (Riffey, e.g., pg. 2, Detailed Description). It is clear Riffey teaches practicing a method comprising contacting the medical device with body tissue and/or fluids, i.e., implanting at a tissue site or in a tissue location, e.g., intravaginally, for, e.g., sustained release of drugs. Riffey teaches the device comprising a polyurethane comprising a diisocyanate and a polyethylene oxide, aka, polyethylene glycol (Riffey, e.g., claims and pp. 1-3). The polyethylene glycol is present in an amount in the claimed range, e.g., 8.21% (Riffey, e.g., pp. 5-6, example 2, e.g., pp. 12-13: table 2-1, e.g., 2D). The polyethylene glycol has a molecular weight in the claimed range, e.g., 500-2000 g/mol with 1003 g/mol exemplified (Riffey, e.g., pp. 5-6, example 2, e.g., pp. 12-13: table 2-1, e.g., 2D). Riffey teaches the amount of polyethylene glycol may range from about 2wt% to about 15 wt% (Riffey, e.g., pg. 6:7-17). But Riffey does not expressly teach the amount of polyethylene glycol ranging from 20-50wt%. Vakili, International Journal of Polymeric Materials and Polymeric Biomaterials, 2020 (published Dec 2020, see pg. 10/15), teaches polyurethane polymers containing polyethylene glycol like those of Riffey, e.g., hexamethylene diisocyanate, hexamethylene carbonate diol and polyethylene glycol. See Riffey, e.g., Table 1-1 and Vakili, e.g., pg. 532, Table 1 and section 2.1. Vakili teaches the amount of polyethylene glycol present in the polymer was a result effective parameter the skilled artisan would have modified for increasing hydrophilicity and improving biocompatibility as measured, e.g., by cell viability and hemocompatibility (Vakili, e.g., pg. 535, c1: ¶ 4 – pg. 538 conclusion). Vakili teaches the PEG/polycarbonate ratio may be varied to optimize the ratio of hydrophilic to hydrophobic segments to maximize biocompatibility and hemocompatibility (Vakili, e.g., pg. 532, Table 1 and ¶ 1). Line one of Vakili, Table 1, indicates 100%, i.e., the total weight, is PCU. The skilled artisan would reasonably infer that PCU is not simply the carbonate constituent of the polyurethane. Rather, the skilled artisan may have considered that PCU is the entire polyurethane polymer including all constituents, e.g., HDMI and BD and carbonate diol. The skilled artisan may have interpreted this table to mean that PEG 20 is 20 parts PEG to 80 parts PCU, i.e., 20 parts PEG per total mass (100) of the polyurethane polymer including all of its constituents. Even if, arguendo, Vakili only teaches a ratio of polyethylene glycol to polycarbonate, a 30% polyethylene glycol ratio still corresponds to 22.35 wt% based on the total polyurethane mass which is within the claimed range. For polymer synthesis details see Vakili, Polymer, 195, 2020 cited as reference 25 in Vakili, IJPMPB, 2020 at section 2.1 synthesis. Polycarbonate (PHMCD): 2000g/mol PEG 2000g/mol Hexamethylene diisocyanate (HDI): 168.20g/mol Butane diol (BD): 90.12g/mol Molar ratio of polyurethane components, macrodiol:HDI:BD::1:3:2 (Vakili, Polymer, e.g., pg.2, sections 2.1-2.2). Molar Ratio of PHMCD:PEG for 30% PEG is 0.7:0.3 Constituent Molar Ratio Molecular Weight (g/mol) Mass/polymer mole (g) Weight Percent (wt%) Polyhexamethylene carbonate diol (PHMCD) 0.7 2000.00 1400.00 52.14% Polyethyleneglycol (PEG) 0.3 2000.00 600.00 22.35% Hexamethylene diisocyanate (HDI) 3.0 168.20 504.59 18.79% 1,4-Butanediol (BDO) 2.0 90.12 180.24 6.71% Total 6.0 — 2684.83 100.00% Even if the PEG % in Vakili is a ratio with polyhexamethylene carbonate, 600.00g/mol divided by 2684.83 g/mol x 100% is 22.35% based on 100mass% of the constituents in the polyurethane resin elastomer. From this, the skilled artisan would have understood that Riffey’s polymers could be modified by increasing the PEG mass% into the claimed range for improved biocompatibility and hemocompatibility. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05 Further still Rashid, clearly teaches polyethylene glycol may make up from about 5-80wt% of the polyurethane, e.g., 25-50wt% (Rashid, e.g., 0205) to tailor the hydrophilicity and water content of a polyurethane. Rashid explains that the water content of a polyurethane can be adjusted by modifying the OH:NCO ratio using an appropriate amount of PEG containing OH groups even for more hydrophobic polyurethanes containing silicone (Rashid, e.g., 0129-0130). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05 It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify the amount of polyethylene glycol in a polyurethane elastomer as understood by Riffey using the teachings of Vakili and Rashid with a reasonable expectation of success. The amount of polyethylene glycol in the polyurethane polymer was recognized in the art as a result effective variable the skilled artisan would have routinely optimized to achieve desired hydrophilicity, biocompatibility, hemocompatibility, and equilibrium water content of the material. The skilled artisan would have been motivated to increase the amount of polyethylene glycol in for increased hydrophilicity in the same way reported by Vakili and Rashid for improved biocompatibility and hemocompatibility. The skilled artisan may also have been motivated to increase the hydrophilicity to improve the material’s ability to release water soluble drugs and/or to improve the ability of the material to incorporate water soluble drugs. See MPEP 2144.05. There does not appear to be any evidence of record commensurate in scope with the claimed invention showing the claimed range is critical. The skilled artisan would have had a reasonable expectation of success since Riffey and Vakili both teach similar polyurethane materials for implantable biomedical use. The combined teachings of Riffey and Vakili do not expressly teach the content of water is higher than 1 mass% and lower than 50 mass% based on the polyurethane resin elastomer. Rashid teaches polyurethane devices (Rashid, e.g., 0320-0321, 0343), wherein the polyurethane may be a hydrogel (Rashid, e.g., 0320-0321). The hydrogel polyurethane may contain 10% or more water (Rashid, e.g., 0070). Alternatively, devices may be in the form of a xerogel having a water content of less than 5wt% (Rashid, e.g., 0071). Rashid teaches devices in the form of sheets (Rashid, e.g., 0315), films or tubes (Rashid, e.g., 0343). Rashid explains that the equilibrium water content of a polyurethane can be tailored, e.g., by modifying the OH:NCO ratio using an appropriate amount of PEG containing OH groups even for hydrophobic polyurethanes containing silicone (Rashid, e.g., 0129-0130 and 0354-0355), because PEG is hydrophilic (Rashid, e.g., 0049, 0101, and 0348). From Rashid, the skilled artisan would have clearly understood that medical devices made from polyurethanes containing polyethylene glycol segments have equilibrium water content properties. The skilled artisan would have clearly understood that medical devices made from polyurethanes containing polyethylene glycol segments will contain an amount of equilibrium water which is within, or overlapping with, the claimed range. The amount of water may be tailored in a polyurethane medical device to promote comfort when placed in or on the body (Rashid, e.g., 0198). The water content may be easily modified by drying or hydrating as desired (Rashid, e.g., 0391-0392). Additionally, Rashid notes that generally the polyurethane in an aqueous medium will absorb water (Rashid, e.g., 0070). The claimed range of from 1mass% to 50mass% reads on dried hydrogels (xerogels) with a water content of less than 5 mass% (Rashid, e.g., 0071). The claimed range of from 1mass% to 50mass% reads on hydrated hydrogels with a water content of more than 10 mass% (Rashid, e.g., 0071). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05 The claimed range for water content overlaps significantly with the range suggested by Rashid for polyurethane medical devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify polyurethane devices suggested by Riffey, Vakili, and Rashid by optimizing the amount of water in the polyurethane as reported by Rashid with a reasonable expectation of success. The skilled artisan could have easily modified the amount of water by appropriate hydrating or drying of the material. The skilled artisan would have been motivated to optimize the amount of water in the ranges suggested by Rashid, both of which overlap with the claimed range, to configure the device as a hydrogel or xerogel for patient comfort in the same way. The skilled artisan would also have been motivated to optimize the amount of water in the polyurethane to achieve a desired drug loading of water-soluble drugs to arrive at a medical device effective to release water soluble drugs as desired by Riffey. The skilled artisan would have had a reasonable expectation of success since each reference teaches medical devices formed from polyurethanes and since Rashid teaches the water content may be tailored by the hydrophilicity of the material based on the content of polyethylene glycol. Applicable to claim 3: The diisocyanate may be, e.g., hexamethylene diisocyanate (Riffey, e.g., pg. 5, example 2, pg. 13: table 2-1). Applicable to claim 4: Riffey teaches the polyurethane further comprising a polycarbonate diol (Riffey, e.g., Abstract, pg.2, pp. 6-7, examples 1-2). Applicable to claim 5: Riffey teaches the device in the form of a film (Riffey, e.g., pg. 9:12-15). Applicable to claims 6-7: Riffey teaches the polyurethane resin is prepared without being an emulsion since Riffey teaches the polyurethane resin is extruded while reacting polyol with a polyisocyanate pre-polymer (Riffey, e.g., pg. 10: 9-12 and pg. 13:7-8, samples cast into molds and placed in an oven). Applicable to claim 8: The prior art polymer has the same composition as the claimed polymer. Thus, the prior art polyurethane is thermoplastic. Moreover, Riffey teaches the medical device may be formed by melt processing, injection molding or extrusion (Riffey, e.g., pg. 2, pg. 13, and pg. 16, embodiment 24), which indicates the material is thermoplastic since it may be shaped while melted. Applicable to claims 11 and 13: Riffey teaches the device in the form of a film (Riffey, e.g., pg. 9:12-15). Riffey does not explicitly call the film a sheet or a plate. However, there does not appear to be any clear distinction between a film, a plate, and a sheet since they are all similarly shaped. The distinction is semantic without recitation of further structural features. Applicable to claim 12: Riffey clearly names a tube (Riffey, e.g., pg. 2:14-26). This is at least a hollow cylinder. Applicable to claims 10-13: Rashid teaches polyurethane molded articles in the form of sheets and films. There does not appear to be any clear distinction between a film, a plate, and a sheet since they are all similarly shaped. The distinction is semantic without recitation of further structural features. Accordingly, the subject matter of claims 1, 3-4, 6-8, and 10-14 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary. Claims 5, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Riffey, WO 2020060923 A1, Vakili, International Journal of Polymeric Materials and Polymer Biomaterials, 2020 as evidenced by Vakili, Polymer, 195, 2020, and Rashid, US 20150234094 as applied to claims 1, 3-4, 6-8, and 10-14 above, and further in view of Bezwada, US 20150259464. The combined teachings of Riffey, Vakili, and Rashid enumerated above apply here. The combined teachings of Riffey, Vakili, and Rashid expressly teach devices in the form of tubes (hollow cylinder), rods (column), and films. To the extent that a sheet or plate may be distinct from a film, the skilled artisan understood that plates, sheets, and films were known forms useful as alternative devices. For example, Bezwada teaches polyurethane materials formed into several medical devices including those having forms, inter alia, tubes, sheets, plates, and films (Bezwada, e.g., 0181). Such forms have utility as devices alone or may be employed for sustained drug delivery. It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify the shape of devices known from the combined teachings of Riffey, Vakili, and Rashid by molding the device into alternative shapes known and used in the polyurethane art such as sheets, plates, and films with a reasonable expectation of success. Since Riffey teaches devices molded from a polyurethane resin, the skilled artisan would have found it obvious to mold the devices in useful shapes known in the polyurethane art including sheets, plates or films with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success since each of the shapes were known as alternatives having utility as medical devices and useful for sustained drug release. The combined teachings of Riffey, Vakili, and Rashid do not expressly teach the device having a thickness of more than 1 mm. Bezwada teaches materials may have a thickness of from about 1 micron to about 5 microns, or from about 1 cm to about 5 cm or more depending on the specific application (Bezwada, e.g., 0288-0289). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05 It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to optimize the thickness of a medical device as understood from Rashid according to the teachings of Bezwada with a reasonable expectation of success. The skilled artisan would have been motivated to optimize the thickness of the device for specific applications, e.g., from about 1 micron to about 5 microns for skin repair and the like. The skilled artisan would have had a reasonable expectation of success since Rashid teaches medical devices useful for wound healing. Accordingly, the subject matter of claims 10-14 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary. Claims 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Riffey, WO 2020060923 A1, Vakili, International Journal of Polymeric Materials and Polymer Biomaterials, 2020 as evidenced by Vakili, Polymer, 195, 2020, and Rashid, US 20150234094 as applied to claims 1, 3-4, 6-8, and 10-14 above, and further in view of Piotrowicz, US 20210268543. The combined teachings of Riffey, Vakili, and Rashid enumerated above apply here. The combined teachings of Riffey, Vakili, and Rashid teach medical devices having the features of claim 1, but do not expressly teach the polyurethane further comprising a monohydric alcohol containing a fluorine atom as a constituent. Piotrowicz teaches modifying polyurethane resins with fluorinated monohydric alcohols (Piotrowicz, e.g., 0301 and 0305-0308 and 0323). The fluorinated monohydric alcohol additives are active on the surface (Piotrowicz, e.g., 0323) which renders the surface of the polymer resistant to bacterial adhesion (Piotrowicz, e.g., Title, Abstract, claims), reduces risk of device failure, and local or systemic infection (Piotrowicz, e.g., 0004). Piotrowicz teaches this technique for modifying polyurethanes (Piotrowicz, e.g., 0131-0135, 0293, and, e.g., examples 2-14, 0372-0421). It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify polyurethanes suggested by the combined teachings of Riffey, Vakili, and Rashid by incorporating fluorinated monohydric alcohols using techniques known from Piotrowicz to improve the medical devices in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to incorporate fluorinated monohydric alcohols to reduce bacterial adhesion on the surface of the device and reduce the risk of device failure, and local or systemic infection in the same way reported by Piotrowicz. The skilled artisan would have had a reasonable expectation of success since Piotrowicz expressly suggests the technique would be effective for polyurethanes like those of Riffey/Vakili/and Rashid. Riffey expressly teaches devices in the form of tubes (hollow cylinder), rods (column), and films. To the extent that a sheet or plate may be distinct from a film, the skilled artisan understood that plates, sheets, and films were known forms useful as alternative devices. For example, Piotrowicz teaches polyurethanes formed into several medical devices having forms including, inter alia, tubes and plates (Piotrowicz, e.g., 0055) and films (Piotrowicz, e.g., 0296). Such forms have utility as devices alone, or may be employed for drug delivery (Piotrowicz, e.g., 0044, 0055, 0296, and claim 82). There does not appear to be any clear distinction between a film, a plate, and a sheet since they are all similarly shaped. The distinction is semantic without recitation of further structural features. It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify the shape of devices known from the combined teachings of Riffey, Vakili, and Rashid by molding the device into alternative shapes known and used in the polyurethane art such as sheets, plates, and films with a reasonable expectation of success. Since Riffey teaches medical devices molded from a polyurethane resin, the skilled artisan would have found it obvious to mold Riffey’s devices in useful shapes known in the polyurethane art including sheets, plates or films with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success since each of the shapes were known as alternatives, each having utility as medical devices and useful for sustained drug release. Accordingly, the subject matter of claims 9-14 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary. Conclusion No claim is allowed. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /WILLIAM CRAIGO/Examiner, Art Unit 1615