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 .
Statutory 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.
Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 9 of prior U.S. Patent No. 12239776. This is a statutory double patenting rejection.
Nonstatutory 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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1 and 22 of U.S. Patent No. 12239776. Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations of the claims are found in the patented claims. Patented claim 1 recites more details than the current claim 1, e.g., a conductor that makes electrical contact with the cannula when the removable sheath is positioned over the cannula. Patented claim 22 recites more details than the current claim 1, e.g., a clamp and a syringe coupled to the cannula.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 11547787. Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations of the claims are found in the patented claims. Patented claim 1 recites more details than the current claim 1, e.g., a metallic inner sleeve that is posited around the cannula.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stoianovici et al. (US 6337994 B1), hereinafter referred to as “Stoianovici”.
Stoianovici teaches a system (see Figure 6) comprising:
a cannula (metallic inner stylet 14) having a distal tip (see Figure 6) and operable as a first electrode (stylet 14 are constructed of electrically conductive materials, see Col. 3 ln 24-25);
a removable sheath (outer sleeve 12; stylet 14 is removable from outer sleeve 12, see Col. 3 lines 29-37) positioned over the cannula (positioned over the stylet 14, see Figure 6), the sheath comprising a second electrode (sleeve 12 are constricted of electrically conductive material, see Col.3 lines 24-25) positioned adjacent a distal end of the sheath (the entire outer sleeve 12 is conductive making the second electrode adjacent to a distal end of sleeve 12) and an electrical insulation layer (20) between the cannula and the second electrode (see Figure 6), wherein the electrical insulation layer electrically insulates the cannula from the second electrode (non-conductive material 20 is disposed between the inner stylet 14 and the outer sleeve or barrel 12 so as to electrically isolate the stylet and the barrel sleeve, see Col. 3 lines 27-29); and
an impedance sensing system (impedance meter (30)) electrically coupled to the cannula (impedance meter 30 is connected to conductive inner stylet 14, see Col. 3 lines 51-63) and also electrically coupled to the second electrodes (impedance meter 30 is connected to conductive outer sleeve 12, see Col. 3 lines 51-63);
wherein the cannula, the second electrode, and the impedance sensing system are operable to measure impedance of tissue adjacent to the distal tip of the cannula (see Col. 3 lines 51-67; Col. 4 lines 1-9).
Conclusion
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/E.R./ (9/29/2025)
Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781