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.
Status of the Claims
The claims filed 05/14/2026 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 Rejections not reiterated herein have been withdrawn.
Withdrawn
The rejection of claims 1, 3-8, and 10-14 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Riffey, WO 2020060923 A1 has been withdrawn because of Applicant’s amendment.
The rejection claims 1, 2, 3-8, and 10-14 under 35 U.S.C. 103 as being unpatentable over Riffey, WO 2020060923 A1 and Rashid, US 20150234094 has been withdrawn because of Applicant’s amendment.
The rejection of claims 1, 3-8, and 10-14 under 35 U.S.C. 103 as being unpatentable over Riffey, WO 2020060923 A1 and Bezwada, US 20150259464 has been withdrawn because of Applicant’s amendment.
The rejection of claims 1, and 3-14 under 35 U.S.C. 103 as being unpatentable over Riffey, WO 2020060923 A1 and Piotrowicz, US 20210268543 has been withdrawn because of Applicant’s amendment.
The combined teachings of the previous cited art did not expressly teach the polyurethane resin elastomer wherein a content of the water is higher than 1 mass% and lower than 50 mass% based on the polyurethane resin elastomer, in combination with wherein the polyethylene glycol is present in an amount of 20 mass% or higher and lower than 50 mass% based on 100 mass% of the constituents of the polyurethane resin elastomer.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 3-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Riffey does not expressly did not expressly teach the polyurethane resin elastomer wherein a content of the water is higher than 1 mass% and lower than 50 mass% based on the polyurethane resin elastomer, in combination with wherein the polyethylene glycol is present in an amount of 20 mass% or higher and lower than 50 mass% based on 100 mass% of the constituents of the polyurethane resin elastomer.
However, 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).
From Rashid, the skilled artisan would have clearly understood that most, if not all, medical devices made from polyurethanes are formulated with an amount of water which is within, or overlapping with, the range recited in claim 1.
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).
The rejections have been modified to address Applicant’s amendment.
Rejections Addressing Applicant’s Amendment
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, 3-8, 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, 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).
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 from Riffey using the teachings of Vakili 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. 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. The skilled artisan would have been motivated to increase the hydrophilicity for improved polyurethane 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 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).
From Rashid, the skilled artisan would have clearly understood that most, if not all, medical devices made from polyurethanes are formulated with an amount of water which is within, or overlapping with, the range recited in claim 2.
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 overlaps significantly with the range suggested by Rashid for polyurethane medical devices.
It would have been obvious before the effective filing date of the presently claimed invention to modify polyurethane devices suggested by Riffey and Vakili by optimizing the amount of water in the polyurethane using techniques known from Rashid with a reasonable expectation of success. 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 in the same way. The skilled artisan would have been motivated to optimize the amount of water in the polyurethane to achieve a desired drug loading of water-soluble drugs. The skilled artisan would have had a reasonable expectation of success since each reference teaches medical devices formed from polyurethanes.
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 a 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, 3-8, 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 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, and Rashid, US 20150234094 as applied to claims 1, 3-8, and 10-14, 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 polyurethanes were formed into a number of devices 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 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 alternatives having utility as medical devices and useful for sustained drug release.
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, and Rashid, US 20150234094 as applied to claims 1, 3-8, and 10-14, 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) and reducing 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 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 similar to those of Riffey/Vakili.
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 were formed into a number of 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 Riffey 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 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 alternatives 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.
Applicant'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.
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.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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