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 Objections
Claims 2 – 6, 9 – 12, 14, 15, and 20 are objected to because of the following informalities: for consistency, the aforementioned claims should be amended to recite the extruded shaft in each instance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because:
Claim 1 sets forth an alcohol-resistant siliconized polycarbonate polyurethane that “comprises” various ingredients. However, the recited polycarbonate polyol, polysiloxane, isocyanate, and chain extender all presumably react to form the alcohol-resistant siliconized polycarbonate polyurethane. As such, these ingredients themselves are not comprised in the alcohol-resistant siliconized polycarbonate polyurethane. For the purposes of further examination, Claim 1 will be interpreted as setting forth an alcohol-resistant siliconized polycarbonate polyurethane prepared from the recited ingredients.
There is a lack of antecedent basis for the “the alcohol-resistant siliconized polycarbonate polyurethanes of the shaft and the extension tube” in Claim 11. Claim 11 does not set forth the extension tube comprises an alcohol-resistant siliconized polycarbonate polyurethane prior to this recitation. For the purposes of further examination, Claim 11 will be interpreted as depending on Claim 5, which does provide antecedent basis for the aforementioned limitation.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 sets forth the extension tube comprises an alcohol-resistant siliconized polycarbonate polyurethane that is identical to the chemical formulation of the shaft. Claim 6, which depends on Claim 5, sets forth the alcohol-resistant siliconized polycarbonate polyurethane of the shaft comprises an radiopacifier. Claim 8, which depends on Claim 6, sets forth the alcohol-resistant siliconized polycarbonate polyurethane of the extension tube is devoid of the radiopacifier. Claim 8 does then incorporate all limitations of Claim 6, as Claim 6 requires the shaft and extension tube compositions be the same while Claim 8 implicitly requires they be different (one with a radiopacifier and one without).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1 – 24 of U.S. Patent No. 11,746,181 in view of US 2018/0289924 to Levering et al. (hereinafter Levering). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variations upon each other.
The claims of U.S. Patent No. 11,746,181 differ from the instant claims in that they do not expressly teach the catheter comprises an extruded shaft comprising a lumen extending from a proximal end to a distal end of the shaft. However, such limitations are taught by Levering [0007]. Before the effective filing date of the instantly claimed invention, it would have been obvious to a person ordinary skill in the art to provide the catheter set forth in the claims of U.S. Patent No. 11,746,181 with the structure taught by Levering. The motivation would have been that it has been held that it is obvious to select a known material based on its suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960); and MPEP 2144.07. In the instant case, Levering shows that this particular structure is known in the art to be suitable structure for the preparation of catheters.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA RIOJA whose telephone number is (571)270-3305. The examiner can normally be reached Monday - Friday 10:00 am - 6:30 pm EST.
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/MELISSA A RIOJA/Primary Examiner, Art Unit 1764