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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claims 1 and 13 recite that the plurality of wing extend in a “helical profile”. A helical profile is not described in the disclosure nor recited in the original claims.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 13-15 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 17-19 of prior U.S. Patent No. 12,029,865. This is a statutory double patenting rejection.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-21 of U.S. Patent No. 12,029,865. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the elements of the application claim can be found in the patent claim.
Regarding claim 1 of the application, claim 17 of the patent recites a catheter (claim 17, lines 19-20) comprising: a hub body having a proximal portion and a distal portion, with an axis therebetween; a tubing extending from a distal end of the distal portion of the hub body (claim 17, lines 16-20); and a plurality of wings on the hub body, the plurality of wings extending in a helical profile about the hub body between the proximal portion and the distal portion such that for each wing of the plurality of wings a near end is circumferentially offset from a far end (claim 17, lines 21-25).
Regarding claim 2, 3, 10, 11, the corresponding claims of the patent appear to be identical recitations.
Regarding claim 12, the direction of the windings is interpreted to be a matter of obvious design choice, therefore claim 12 of the application is obvious over claim 21 of the patent.
Claims 4, 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,029,865 in view of Griffin et al (US 7,001,369).
Claim 4 differs from the claims of the patent in calling for a threaded portion located at a proximal end of the proximal portion. Griffin teaches a catheter hub having a threaded portion located at a proximal end of the proximal portion (fig. 1) to provide a secure connection to deliver fluids through the catheter. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hub of claim 17 of the patent to include threads as taught by Griffin to allow a fluid source to be securely attached to the catheter hub.
Claim 10 differs from claim 17 of the patent in calling for the tubing to comprise a structural component spirally extending along the tubing and having a winding direction and wherein the plurality of wings comprises a winding orientation from the near end to the far end. Griffin teaches a structural component (coil) extending along the tubing and having a winding direction (fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hub of claim 17 of the patent to include a structural component spirally extending along the tube as taught by Griffin to provide structural support to the catheter to prevent kinking.
Regarding claim 11 and 12, the winding direction is considered to be a matter of obvious design choice.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,029,865 in view of Ju et al (US 5,403,295).
Claim 5 differs from claim 17 of the patent in calling for a height of the plurality of wings is greatest adjacent to the near end. Ju teaches a catheter hub having wings where the height of the wings is greatest adjacent to the proximal end (fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hub of claim 17 of the patent to include the wing having a height greatest at the proximal end as taught by Ju to provide a larger gripping surface at the proximal end.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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