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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 38, 45, 46, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-20 of U.S. Patent No. 12,129,331. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are directed to a heart valve comprising (made from) a polymer that has hard and soft segments, the soft segments being derived from compounds adhering to formula 1B(i)(a) in claim 1 and a polyol that is preferably a carbinol-terminated polydiorganosiloxane conforming with the formula in instant claim 46. A favored permutation of the compound described more generally in 1B(i)(a) is provided in instant claim 45. The hard segments of claim 38 are, according to claim 48, incorporated by the copolymerization of chain extenders.
It is noted here that the polymer disclosed in patent claim 17 is, in combination (ii), obtained from the same precursors as are recited in instant claims 45, 46, and 48 which disclose most preferred incarnations of the linked macrodiol, polyol, and chain extender respectively of instant claim 38.
Claims 38, 40, 41, 42, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 62, 63, and 64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1/2, 10, 10, 1/2, 1/2, 1/2, 1/2, 1/2, 1/2, 7, 8, 8, 7, 7/8, 10, 10, 19, 19, and 19 of U.S. Patent No. 12,. Although the claims at issue are not identical, they are not patentably distinct from each other.
Where claims 38, 42, and 45-49 are concerned, essentially the same rationale applies. While it is acknowledged that the instant claims are directed to a heart valve comprising a polymer whereas the patent claims are directed to a polymer, the polymer described in patent claim 1 is encompassed within the scope of the combined subject matter of instant claims 38, 45, 46, and 48. Framed in the context of U.S. restriction practice, had these claims been presented in the same application, they would have been related as combination/subcombination with the heart valve constituting the combination and the polymer the subcombination. One of the criteria that must be established to restrict under combination/subcombination is that the combination must not require all the particulars of the subcombination. However, as established above, the exact same precursors as are outlined in combination (ii) of the patent claim 1 are disclosed in instant claims 45 and 46, which describe particularly preferred embodiments of the linked macrodiol and polyol components of instant claim 38. Hence, the combination does require all the particulars of the subcombination thus establishing them as not patentably distinct.
Instant claims 50 and 53 further limit instant claim 48 in the same manner that patent claim 7 is further limiting of patent claim 6.
Instant claims 51 and 52 further limit instant claim 48 in the same manner that patent claim 8 is further limiting of patent claim 6.
Whereas there is no patent claim that expressly discloses the employment of a combination of 1,2-ethylenediamine and 1,3-bis-(4-hydroxybutyl)-1,1,3,3-tetramethyldisiloxane, as instant claim 54 does, patent claims 7 and 8 individually say that the chain extenders may comprise the former and the latter respectively, where “comprise” is suggestive that more than one chain extender may be used. To the extent that patent claims 7 and 8 disclose exactly the same compounds as are recited in instant claim 54, and to the extent that it may be inferred that more than one chain extender can be used, the subject matter of claim 54 is prima facie obvious.
Instant claims 40, 41, 55, and 56 all embrace the utilization of MDI as the isocyanate that links the different active hydrogen group-containing compounds together in the polymer consistent with the requirement of patent claim 10.
Allowable Subject Matter
Claims 59 and 61 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARC S ZIMMER whose telephone number is (571)272-1096. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heidi Kelley can be reached at 571-270-1831. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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October 9, 2026
/MARC S ZIMMER/Primary Patent Examiner, Art Unit 1765
