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 .
Information Disclosure Statement
The information disclosure statement filed November 7, 2024 has been entered and the references cited therein have been considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "320" and "325" are reversed between Figs. 3A and 3B and Figure 3C. In other words, in Figure 3C, the lines connecting the “pinion” and “rack” should be reversed. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 10 is 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.
In claim 10, the preamble should recite “claim 8” instead of “claims 8.” Furthermore, “the intermediate member” lacks proper antecedent basis.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 6-9 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lary (U.S. Patent Application Publication No. 2009/0125044) in view of Cunningham et al. (U.S. Patent Application Publication No. 2006/0074417).
In regard to claims 1, 2, 6-9 and 13-15, Lary teaches a medical device comprised of an incision device comprised of a catheter 28 with a cutting means 38 coupled to the distal end of the catheter 28 (see Fig. 2A). In Figures 5A and 5B, the cutting means 38 (blade 60) resides in a channel and is actuated to move between a retracted position (Fig. 3A) and a deployed position outside the channel (Fig. 3B). The blade 60 is attached to braces 67, 68 which in turn are attached to nuts 62, 64 so that when a screw rod 63 is turned by a controller 34, the nuts 62, 64 move away from one another causing the blade 60 to extend from the side of the catheter 28 (see Figs. 3A and 3B and para. 0046). While Lary teaches a mechanism for deploying the blade 60, it is not a gear mechanism. However, Cunningham et al. teach a similar medical device 100 with a cutting mechanism 140 that is deployed using a rack 142, 148 and pinion 160 mechanism (see para. 0081 and Figs. 4-7). Cunningham et al. thus demonstrate that the use of rack and pinion mechanisms to deploy a cutting blade are well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Lary with the rack and pinion mechanism of Cunningham et al., in lieu of the screw rod and nut mechanism, in order to deploy the blade 60 from the channel as the two structures are art-recognized equivalents for deploying a cutting blade. In regard to claim 12, see para. 0049 of Lary.
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, 2, 6-9 and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/940,674 in view of Cunningham et al. (U.S. Patent Application Publication No. 2006/0074417).
Claim 1 of copending application no. 18/940,674 teaches all of the features of claims 1, 2, 6-9 and 13-15 with the exception of a gear mechanism. However, as noted above, Cunningham et al. teach a similar medical device 100 with a cutting mechanism 140 that is deployed using a rack 142, 148 and pinion 160 mechanism (see para. 0081 and Figs. 4-7). Cunningham et al. thus demonstrate that the use of rack and pinion mechanisms to deploy a cutting blade are well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of claim 1 of copending application no. 18/940,674 with the rack and pinion mechanism of Cunningham et al., in order to deploy the blade 60 from the channel.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 6-9 and 12-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of copending Application No. 18/944,661 in view of Cunningham et al. (U.S. Patent Application Publication No. 2006/0074417).
Claims 1 and 10 of copending application no. 18/944,661 teaches all of the features of claims 1, 2, 6-9 and 12-15 with the exception of a gear mechanism. However, as noted above, Cunningham et al. teach a similar medical device 100 with a cutting mechanism 140 that is deployed using a rack 142, 148 and pinion 160 mechanism (see para. 0081 and Figs. 4-7). Cunningham et al. thus demonstrate that the use of rack and pinion mechanisms to deploy a cutting blade are well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of claims 1 and 10 of copending application no. 18/944,661 with the rack and pinion mechanism of Cunningham et al., in order to deploy the blade 60 from the channel.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 6-9 and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/954,953 in view of Cunningham et al. (U.S. Patent Application Publication No. 2006/0074417).
Claim 1 of copending application no. 18/954,953 teaches all of the features of claims 1, 2, 6-9 and 13-15 with the exception of a gear mechanism. However, as noted above, Cunningham et al. teach a similar medical device 100 with a cutting mechanism 140 that is deployed using a rack 142, 148 and pinion 160 mechanism (see para. 0081 and Figs. 4-7). Cunningham et al. thus demonstrate that the use of rack and pinion mechanisms to deploy a cutting blade are well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of claim 1 of copending application no. 18/954,953 with the rack and pinion mechanism of Cunningham et al., in order to deploy the blade 60 from the channel.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 16-20 are allowed.
Claims 3-5, 10 and 11 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach or fairly suggest either a force transmitting gear mechanism connected between the torsion gear mechanism and the rotatable gear actuator or an intermediate actuation member disposed between the force transmitting gear mechanism and the torsion gear mechanism. Cunningham et al. teaches only a torsion gear mechanism (see above). Brown et al. (PCT Publication No. WO 2015/048545) teaches a similar medica device with a single gear mechanism (see para. 0051).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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