DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1-2, 5-6, 8-10, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aitken et al. (US 2019/0233572), when taken with Maiden et al. (US 6,367,929).
Regarding claims 1-2, 5-6, 8-9, and 16-17: Aitken et al. (US ‘572) discloses processes of graft polymerizing a grafting composition onto a substrate [abstract; 0002; 0006-0012; 0027-0029], wherein Example 2 [Ex. 2; 0311-0312; Table 2, Ex. 2] reacts the lenses of Example 1 {Polymer A} [Ex. 1; 0310; Table 1] with a monomer solution containing MPC (2-methacryloyloxyethyl phosphorylcholine {CAS 67881-98-5; Compound B} [0308]), FM-1 and PEG200 (polyethylene glycol, Mn = 200 g/mol [0309]; diluent [0230] {Solvent D}) [Ex. 2; 0311-0312; Table 2, Ex. 2]. Aitken et al. (US ‘572) discloses the grafting composition can contain a polymer wetting agent [0206], such as PVP [0216-0220], having a Mw of greater than about 5,000 Daltons; between about 150,000 Daltons to about 2,000,000 Daltons {Polymer C} [0207].
Aitken et al. (US ‘572) does not specifically disclose Ex. 2 containing a wetting agent having a Mw of greater than about 5,000 Daltons; between about 150,000 Daltons to about 2,000,000 Daltons. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a wetting agent having a Mw of greater than about 5,000 Daltons; between about 150,000 Daltons to about 2,000,000 Daltons based on the invention of Aitken et al. (US ‘572), and would have been motivated to do so since Aitken et al. (US ‘572) discloses the grafting composition can contain a polymer wetting agent [0206], such as PVP [0216-0220], having a Mw of greater than about 5,000 Daltons; between about 150,000 Daltons to about 2,000,000 Daltons [0207]. Additionally, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) [see MPEP 2144.06].
Maiden et al. (US 6,367,929) provides evidence that wetting agents {ex. PVP} do not covalently bond {react with monomers} during polymerization (6:1-35).
Regarding claim 10: Aitken et al. (US ‘572) discloses the basic claimed medical device [as set forth above with respect to claim 9].
Aitken et al. (US ‘572) does not specifically disclose an artificial joint. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim [see MPEP 2111.02].
Regarding claim 18: Aitken et al. (US ‘572) discloses the monomer solution contains MPC at a concentration ~ 0.96 mol/L [Ex. 2; 0311].
Aitken et al. (US ‘572) does not specifically discloses the monomer solution contains MPC at a concentration 0.10 to 0.25 mol/L. However, differences in concentration will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) [see MPEP 2144.05].
Claim(s) 11-12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aitken et al. (US 2019/0233572), when taken with Maiden et al. (US 6,367,929).
Regarding claims 11-12 and 15: Aitken et al. (US ‘572) discloses grafting compositions [abstract; 0002; 0006-0012; 0027-0029], wherein Example 2 [Ex. 2; 0311-0312; Table 2, Ex. 2] reacts the lens of Example 1 {Polymer A} [Ex. 1; 0310; Table 1] with a monomer solution containing MPC (2-methacryloyloxyethyl phosphorylcholine {CAS 67881-98-5; Compound B} [0308]), FM-1 and PEG200 (polyethylene glycol, Mn = 200 g/mol [0309]; diluent [0230] {Solvent D}) [Ex. 2; 0311-0312; Table 2, Ex. 2]. Aitken et al. (US ‘572) discloses the grafting composition can contain a polymer wetting agent [0206], such as PVP [0216-0220], having a Mw of greater than about 5,000 Daltons; between about 150,000 Daltons to about 2,000,000 Daltons {Polymer C} [0207].
Aitken et al. (US ‘572) does not specifically disclose Ex. 2 containing a wetting agent having a Mw of greater than about 5,000 Daltons; between about 150,000 Daltons to about 2,000,000 Daltons. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a wetting agent having a Mw of greater than about 5,000 Daltons; between about 150,000 Daltons to about 2,000,000 Daltons based on the invention of Aitken et al. (US ‘572), and would have been motivated to do so since Aitken et al. (US ‘572) discloses the grafting composition can contain a polymer wetting agent [0206], such as PVP [0216-0220], having a Mw of greater than about 5,000 Daltons; between about 150,000 Daltons to about 2,000,000 Daltons [0207]. Additionally, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) [see MPEP 2144.06].
Maiden et al. (US 6,367,929) provides evidence that wetting agents {ex. PVP} do not covalently bond {react with monomers} during polymerization (6:1-35).
Claim(s) 4 and 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aitken et al. (US 2019/0233572) as applied to claim 1 above, and further in view of Li et al. (US 2013/0188124), when taken with McGarvey, P. W.; Hoffmann, M. M. Tenside Surf. Det. 2018, 55, 203.
Regarding claim 4: Aitken et al. (US ‘572) discloses the basic claimed method [as set forth above with respect to claim 1]; wherein Aitken et al. (US ‘572) discloses contact lenses [0027-0028].
Aitken et al. (US ‘572) does not disclose an inorganic salt. However, Li et al. (US ‘124) discloses a process of modifying contact lenses by graft polymerization [abstract; 0163-0164], wherein the surface modification solution includes an electrolyte such as sodium chloride, potassium chloride, sodium bromide, etc. [0255-0256]. Aitken et al. (US ‘572) and Li et al. (US ‘124) are analogous art because they are concerned with a similar technical difficulty, namely the surface modification of contact lenses by graft polymerization. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined an electrolyte such as sodium chloride, potassium chloride, sodium bromide, etc., as taught by Li et al. (US ‘124) in the invention of Aitken et al. (US ‘572), and would have been motivated to do so since Li et al. (US ‘124) discloses the surface modification solution includes an electrolyte to increase the ionic strength and minimize zwitterionic polymer precipitation [0255-0256].
McGarvey et al. (Tenside Surf. Det. 2018, 55, 203) provides evidence for the solubility of salts (ex. NaCl, KCl, KBr) in PEG 200 [Table 2].
Regarding claims 7-10: Aitken et al. (US ‘572) discloses the basic claimed method [as set forth above with respect to claim 1]; wherein Aitken et al. (US ‘572) discloses polymer materials for medical devices [0003].
Aitken et al. (US ‘572) does not disclose a polyolefin or an aromatic polyether ketone as the polymeric substrate. However, Li et al. (US ‘124) discloses a process of modifying medical devices by graft polymerization [abstract; 0163-0164], wherein the medical device substrate can be a polyolefin or PEEK [0242]. Aitken et al. (US ‘572) and Li et al. (US ‘124) are analogous art because they are concerned with a similar technical difficulty, namely the surface modification of medical devices by graft polymerization. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined a medical device substrate containing a polyolefin and/or PEEK, as taught by Li et al. (US ‘124) in the invention of Aitken et al. (US ‘572), and would have been motivated to do so since Li et al. (US ‘124) discloses the medical device substrate can be a polyolefin or PEEK [0242].
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim [see MPEP 2111.02].
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aitken et al. (US 2019/0233572) as applied to claim 11 above, and further in view of Li et al. (US 2013/0188124), when taken with McGarvey, P. W.; Hoffmann, M. M. Tenside Surf. Det. 2018, 55, 203.
Regarding claim 14: Aitken et al. (US ‘572) discloses the basic claimed liquid [as set forth above with respect to claim 11]; wherein Aitken et al. (US ‘572) discloses contact lenses [0027-0028].
Aitken et al. (US ‘572) does not disclose an inorganic salt. However, Li et al. (US ‘124) discloses a process of modifying contact lenses by graft polymerization [abstract; 0163-0164], wherein the surface modification solution includes an electrolyte such as sodium chloride, potassium chloride, sodium bromide, etc. [0255-0256]. Aitken et al. (US ‘572) and Li et al. (US ‘124) are analogous art because they are concerned with a similar technical difficulty, namely the surface modification of contact lenses by graft polymerization. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined an electrolyte such as sodium chloride, potassium chloride, sodium bromide, etc., as taught by Li et al. (US ‘124) in the invention of Aitken et al. (US ‘572), and would have been motivated to do so since Li et al. (US ‘124) discloses the surface modification solution includes an electrolyte to increase the ionic strength and minimize zwitterionic polymer precipitation [0255-0256].
McGarvey et al. (Tenside Surf. Det. 2018, 55, 203) provides evidence for the solubility of salts (ex. NaCl, KCl, KBr) in PEG 200 [Table 2].
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 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.
Conclusion
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.
See attached form PTO-892.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL F PEPITONE whose telephone number is (571)270-3299. The examiner can normally be reached on 7:00 AM - 3:30 PM.
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/MICHAEL F PEPITONE/Primary Examiner, Art Unit 1767
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