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 . 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the electrical insulator abutting the electrical conductor (claim 1), an outer sheath surrounding the elongated hollow tube (claim 19) and a trace extending in a low around the opening of the tube (claim 20) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 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, 3-6 and 18-20 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.
Regarding claims 1, 3-6 and 18-20, claim 1 has been amended to recite that an electrical insulator abuts an electrical conductor. The application is entirely silent about such a feature. Instead, as can be seen in figure 10 for example, the electrical conductor (36) abuts the trace (46) which abuts the insulator (44). While “abut” does not appear in the specification, the common usage of the word requires a common boundary which is not true of the insulator and conductor as defined. Claims 3-6 and 18-20 depend from claim 1 and therefore also fail the written description requirement.
Regarding claim 19, the application provides no support for an outer sheath surrounding the tube. Figure 4 show a single element (18/30, note hash marks) which is described in the specification as an outer sheath comprising a tube ([0023]). Further, fig. 7, which only shows the exterior surface of the invention, also uses two numbers (18/30) to describe what is shown. Clearly, if there was a distinct sheath around a tube, both elements could not be numbered in a viewpoint which only shows the external surface. The specification never describes the sheath as distinct from the tube, much less outside the tube. On the contrary, the specification states that the outer sheath “is located directly on the outer blade” ([0025]). If the sheath was outside a tube, then the tube would be located directly on the outer blade not the sheath.
Regarding claim 20, the specification is silent about a trace extending around an opening at the distal portion of the tube. In fact, the limitations of claim 20 in conjunction with the remarkable breadth of the features in claim 1 results in the claimed invention being unsearchable. It appears Applicant has confused the opening at the distal portion of the tube with the opening at the distal portion of the blade. Figure 8, for example, shows the opening at the distal end of the tube (18), through which the electrical conductor extends, and the opening at the distal end of the blade (24). The trace (46) extends around the latter but not the former.
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, 3-6 and 18-20, 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.
Regarding claims 1, 3-6 and 18-20, claim 1 has been amended to recite that the trace is located on an exposed portion of the electrical insulator. What this language requires is unclear. The claim is worded as though it is a product by process, that the electrical insulator first exists with an “exposed” portion, then the trace is located on the exposed portion. This presents the problems that (a) it is not clear what the final product is by which product-by-process limitations are judged (MPEP 2113) and (b), it is not clear how the portion of the electrical insulator can be exposed if the trace is on that portion. The claim does not say that the trace is exposed, although that might not be much clearer given how many definitions there are of “exposed.” If what Applicant means is that the trace and/or insulator is exposed to the external environment, functional language can be useful. For example, “configured to contact tissue” at least requires the ability of the element to come into contact with tissue which would not be true for an element that exists only between two layers.
Regarding claim 20, the claim recites an electrical conductor connected to a lead which is connected to a trace. The trace extends from an opening in the tube, and yet the trace extends in a loop around the opening. It is not clear how the trace can be around the opening while the conductor extends away from the opening. It is also unclear where the lead is in this arrangement.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3, 5, 6, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Aluru (US 2014/0200581).
Regarding claims 1, 3, 5 and 19, Aluru discloses a medical instrument (apparatus is wholly redundant) that includes an elongate hollow tube (which can be subdivided into an outer shaft and an inner tube) with a wall defining an opening at a distal portion (112, fig. 2B), an electrical conductor extending “along” (i.e. close to and in the same direction) “a length” (i.e. any length) of the wall (portion of 105 within the tube, figs. 2C and 2E) between the two ends of the tube (i.e. that is the only way the conductor can connect the generator to trace), an electrical insulator abutting the conductor and extending from the hollow tube (150), a trace located on an exposed portion of the insulator (104) and a lead connecting the conductor and the trace (the portion of 105 outside of the tube and proximal to the trace, figs. 2B and 2C).
Regarding claim 6, this claim only recites that the trace comprises one part of a bipolar trace. The claim does not recite a generator for outputting bipolar energy, and does not recite the other part of the bipolar trace. Given a hypothetical generator and a hypothetical second electrode, any “trace” can comprise part of bipolar trace, including the trace of Aluru.
Regarding claim 18, if some proximal part of element 104 is defined as the “trace” than the distal part can be defined to be the “blade” since any electrode can be supplied with sufficient energy to cut something. Alternatively, the inner parts of 104 can be considered a “trace” and the edges can be considered one or more “blades” for similar reasons. All the resulting elements, the conductor, the lead, the trace and the blade, are electrically connected.
Claims 1, 3-6, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Bloom (US 9,226,792).
Regarding claims 1 and 3-6, Bloom discloses an instrument that includes a tube with a wall (130) along a length of which two RF conductors extend (some proximal, covered part of 142a-b, fig. 10). An electrical insulator abuts the conductors and extends from the hollow tube (144). Traces (the rounded distal parts of 142a-b) on the insulator are connected to the conductors by leads (the distal uncovered parts of 142a-b proximal to the traces). The ends of the conductors, which may include an arbitrary length of the conductor, are present at opposite ends of the tube (fig. 2 for one end and fig. 14 for the other end). If necessary, it is noted that Applicants figures (e.g. fig. 5) clearly shows that the ends of the conductor is not coterminal with the ends of the tube/sheath, so the limitation is being understood as extremely broad rather than indefinite. The two traces are bipolar (col. 5 lines 38-39) and could be used for cutting.
Regarding claim 18, the trace as defined above can be arbitrarily divided into any number of conductive parts due to the lack of claimed details, including any number of “outer blades.”
Regarding claim 19, the tube can be divided into any number of arbitrary tubular elements, including an outer sheath (first middle shaft, second middle shaft, etc.) and inner tube.
Claims 1, 3-6, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Dycus (US 2004/0116924).
Regarding claim 1,3-6, 18 and 19 Dycus discloses an instrument with an outer sheath/tube (12, fig. 1A) along a length of which two conductors extend (310a-b, fig. 17). These conductors extend to respective, bipolar traces (112, 122, fig. 14) by leads (i.e. any intervening conductive element between a “conductor” and “trace”). The traces are located on exposed electrical insulators (116, 114, [0091]) which extend from the outer sheath tube (fig. 7-8) and abut the conductors (figs. 14 and 16). The ends of the conductors are located at opposite ends of the hollow tube (fig. 16 at one end, fig. 18 at the other end). Once again, the lack of details allows the “trace” to be arbitrarily dividing into conductive parts, where any such part could be used to cut something (depending on the energy applied) and therefore can be considered a “blade.”
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, 3-6 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,766,288. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in a preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In the interest of compact prosecution, it is noted that the claims are remarkably broad and there are countless devices that would apply to claim 1. That claim recites, in essence, a tube and an insulator that have some relationship to three conductors. There is no clearly functional element so that the claimed invention barely even qualifies as a medical instrument. The disclosed invention of a debriding device has been used to guide the search extensively. But if the claims do not recite a debriding device, or at least the functional elements that make a device a debriding device, then any device with the claimed elements will be a barrier to patentability. There are claims directed to this invention which were allowed in the parent application. Applicant is advised to consider which features of that independent claim could be removed without materially impacting the patentable elements. If Applicant would care to discuss these issues, the examiner’s contact information can be found below.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL W FOWLER/Primary Examiner, Art Unit 3794