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
This action is responsive to applicant’s amendment filed 11/12/2025.
Claims 10, 12-19 are pending.
The previous rejection of claims 10-19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of applicant’s amendment.
The previous rejection of claims 10, 12-17 and 19 under 35 U.S.C. 102a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Sharma et al (US2008/0218686), is withdrawn in view of applicant’s amendment.
The previous rejection of claims 10- 19 under 35 U.S.C. 102a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Belt (US2009/0306244), is withdrawn in view of applicant’s amendment.
Terminal Disclaimer
The terminal disclaimer filed on 11/12/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Patent No. 11338109 and Patent No. 12296110 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The previous rejections of claims 10-17 and 19 on the ground of non-statutory double patenting as being unpatentable over claims 1, 5, 7-15 of U.S. Patent No. 11,338,109 and claims 1-3, 5-9, 12 of U.S. Patent No. 12,296,110 are withdrawn in view of applicant’s amendment.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action.
Claim Rejections - 35 USC § 103
Claims 10, 12-19 are rejected under 35 U.S.C. 103 as obvious over Belt (US2009/0306244) in view of Madsen (CN1291762). The machine translation is relied upon below as an English-equivalent for the rejection purposes.
Regarding claims 10, 12-17, and 19, Belt discloses a packaged medical device comprises at least one medical device, which comprises a hydrophilic intermittent urinary catheter (para 0087) and wetting fluid in a package having a cavity for accommodation of the medical device (para 0128). The wetting fluid comprises water, at least 0.5 wt% of one or more aliphatic/alicyclic compound (5 wt% of glycerol, Table 1-claimed monomeric polyol) and 0.001-1 wt. % of a surfactant (para 0124). Belt discloses the wetting fluid further comprising additives that are known to the art (para 0125) but does not specially disclose the additional agent comprise a gum. Madsen discloses a method for sterilizing a medical device having a hydrophilic coating using radiation, the method comprising the steps of contact the medical device having such a coating with an aqueous liquid to wet the hydrophilic coating, said liquid comprising xanthan gum or their derivatives (para 0026). It would have been obvious to one of ordinary skill in the art before the filling date of the invention to add xanthan gum or their derivatives taught by Madsen to the wetting fluid of Belt, because Madsen disclose that addition of such polymer dramatically increases moisture retention and maintains a very low coefficient of friction. These compounds also protect these properties during sterilization using radiation when wetted with such a wetting liquid (para 0026).
Belt is silent about the viscosity and surface tension of the wetting fluid. Given that the wetting liquid of Belt comprises all the components of the claimed hydration medium, including the claimed polyol and surfactant, within the claimed ranges, a person having an ordinary skill in the art would reasonably expect the fluid of Belt to have the claimed viscosity and surface tension. The reference is anticipatory because it explicitly or inherently discloses every limitation recited in the claims. The claims also would have been obvious over the teachings of the reference because in the case "Where the claimed and prior art products are identical or substantially identical in composition, a prima facie case of either anticipation or obviousness has been established." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) and “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding claim 11, Belt discloses the medical product comprises a hydrophilic intermittent urinary catheter (para 0087).
Regarding claim 18, Belt discloses the wetting fluid comprises saline (para 0120).
Response to Arguments
Applicant’s arguments filed 11/12/2025 have been considered but are moot because the new ground of rejection does not apply in the prior rejection.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAIDUNG D NGUYEN whose telephone number is (571)270-5455. The examiner can normally be reached M-Th: 10a-3p.
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/HAIDUNG D NGUYEN/Primary Examiner, Art Unit 1761
2/25/2026
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