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 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 14-18 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.
Claim 14 recites “a second electrode” in line 1. It is unclear to the examiner if the claim requires two electrodes or just one second electrode. For examination purpose, the examiner is interpreting it to be just one electrode. Claim 14-18 depends on claim 14 and therefore are rejected. Claim 15-18 depend on claim 14 and therefore rejected.
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 14-18 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Miller et al. (US 2014/0296845).
Regarding claim 14, Miller discloses a second electrode for use in an ablation system, the second electrode comprising: an elongate body made of a superelastic material formed in a flat, ribbon shape or an ovular shape (fig.1-2, see also [0020]); and an extended axial portion along at least a portion of the elongate body with one or more twists that form into helical turns upon extension out of a delivery lumen (fig.1-2); wherein the extended axial portion includes a retracted state and an extended state, the extended state including a distal portion forming a helical coil (fig.1-2, see also [0020]).
Regarding claim 15, Miller discloses the second electrode of claim 14, wherein the helical coil, when extended, comprises three helical turns (fig.1-2 of Miller).
Regarding claim 16, Miller discloses the second electrode of claim 14, further comprising a piercing end (fig.1-2 of Miller).
Regarding claim 17, Miller discloses the second electrode of claim 14, wherein the second electrode is configured to rotate as the one or more twists in the extended axial portion are extended out of a keyway in the delivery lumen (fig.1-2 of Miller, see also [0026]).
Regarding claim 18, Miller discloses the second electrode of claim 14, wherein the second electrode is configured to pass through a keyway positioned within the delivery lumen, the keyway guiding the second electrode into forming the helical turns as it is extended (fig.1-2 of Miller, see also [0026]).
Claim Rejections - 35 USC § 103
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.
Claims 2-13 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al. (US 2008/0319436) in view of Miller et al. (US 2014/0296845).
Regarding claim 2, Daniel discloses a medical device system (fig.14) comprising: an introducer tube (fig.14; trocar body 1402) defining a lumen extending a length of introducer tube (fig.14, see also [0170]); a first electrode incorporated into at least a portion of the introducer tube including a distal end with a piercing tip configured to pierce through tissue ([0169]-[0170]); a second electrode (fig.14, electrode 1404) movably disposed within the lumen of the introducer tube (fig.14), the second electrode includes a retracted state within the lumen and an extended state wherein at least a distal portion of the second electrode extends out of the distal end of the introducer tube (fig.14). However, Daniel does not specifically disclose the second electrode forms a helical coil.
Miller teaches a coil electrode for use with radio frequency ablation apparatus, has a lead portion, and a helical portion coupled to the lead portion, the helical portion being formed of Nitinol (fig.1-2, see also [0020]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Daniel with electrode that forms helical coil as taught by Miller for the purpose of treating more surface area of the tissue.
Regarding claim 3, Daniel/Miller teaches the medical device system of claim 2, wherein the second electrode is made of a superelastic material ([0020] of Miller).
Regarding claim 4, Daniel/Miller teaches the medical device system of claim 2, wherein the second electrode has a flat, ribbon shape or an ovular shape ([0183] of Daniel).
Regarding claim 9, Daniel/Miller teaches the medical device system of claim 2, wherein the first electrode comprises a hollow needle (fig.14 of Daniel).
Regarding claim 10, Daniel/Miller teaches the medical device system of claim 2, wherein the second electrode includes an extended axial portion with one or more twists in the retracted state, wherein the one or more twists are configured to transition into helical turns upon extension into the extended state (fig.1-2 of Miller).
Regarding claim 11, Daniel/Miller teaches the medical device system of claim 2, wherein the second electrode, when extended, comprises three helical turns (fig.1-2 of Miller).
Regarding claim 12, Daniel/Miller teaches the medical device system of claim 2, wherein the introducer tube is configured to cause the second electrode to rotate within the lumen during extension (the introduce tube can rotate and may rotate the inside electrode together).
Regarding claim 13, Daniel/Miller teaches the medical device system of claim 2, wherein the second electrode has a piercing end (fig.1-2 of Miller).
Regarding claim 19, Daniel discloses an ablation system comprising: an introducer tube including (fig.14) a lumen extending a length of introducer tube and a first electrode forming at least a portion of an outer surface of the introducer tube (fig.14; electrode 1408); and a second electrode (fig.14; electrode 1404) movably disposed within the lumen of the introducer tube (fig.14), wherein the second electrode forms a retracted state within the lumen of the introducer tube (fig.14) and an extended state when extended distally out of a distal end of the lumen, and wherein in the extended state a portion of the second electrode extending out of the distal end of the lumen (fig.14, see also [0169]). However, Daniel does not disclose the second electrode including an elongate ribbon shaped body with an extended axial portion with a plurality of twists and forms a helical coil.
Miller teaches a coil electrode for use with radio frequency ablation apparatus, has a lead portion, and a helical portion coupled to the lead portion, the helical portion being formed of Nitinol (fig.1-2, see also [0020]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Daniel with electrode that forms helical coil as taught by Miller for the purpose of treating more surface area of the tissue.
Regarding claim 20, Daniel/Miller teaches the ablation system of claim 19, wherein the introducer tube includes a keyway (fig.4; tip 26 of Miller) adjacent the distal end (fig.4-5 of Miller), wherein the keyway is configured to interact with each twist of the plurality of twists as each twist is pushed distally past the keyway to transition each twist into a helical turn (fig4-5 of Miller).
Regarding claim 21, Daniel/Miller teaches the ablation system of claim 20, wherein the keyway is futher configured to cause the second electrode to rotate as each twist of the plurality of twists is pushed distally past the keyway (fig.4-5 of Miller).
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 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-8 of U.S. Patent No. US 11,478,296. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US 11,478,296 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 the 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.
US 11,478,296
18/951,300 (current Application)
1. A medical device system for delivery of energy to a region of a patient's anatomy, the medical device system comprising: an introducer tube including a piecing tip and defining a lumen therein, the introducer tube being configured to be inserted into the patient's anatomy, the introducer tube being a first electrode, the introducer tube comprising: an outer sheath section forming the first electrode; and an inner sheath section fixedly attached to the outer sheath section, wherein the outer sheath section comprises a circular cross-section and the inner sheath section comprises a non-circular inner hollow cross-section; and a second electrode being movable within the lumen of the introducer tube between a retracted position and an extended position, wherein in the retracted position, the second electrode is substantially disposed within the lumen, and wherein in the extended position, the second electrode extends at least partially beyond a distal end of the introducer tube, the first and second electrodes being configured to deliver an energy to a tissue, the inner sheath section being configured to key the second electrode into a predetermined orientation in the extended position, the inner sheath section preventing the second electrode from substantially rotating within the lumen of the introducer tube during movement into the extended position, the second electrode having a non-hollow solid rectangular cross-section, both the first electrode and the second electrode having piercing tips disposed at an end of the respective electrode, the piercing tips being configured to pierce though a tissue, wherein the cross-section configuration of the inner sheath section corresponds to an outer perimeter of the second electrode in order to prevent the second electrode from rotating within the introducer tube as the second electrode is moved longitudinally relative to the inner sheath section.
2. The medical device system of claim 1, the second electrode being a coil having a collapsed straightened configuration in the retracted position and an expanded helix configuration in the extended position.
2. (New) A medical device system comprising: an introducer tube defining a lumen extending a length of introducer tube; a first electrode incorporated into at least a portion of the introducer tube including a distal end with a piercing tip configured to pierce through tissue; a second electrode movably disposed within the lumen of the introducer tube, the second electrode includes a retracted state within the lumen and an extended state wherein at least a distal portion of the second electrode extends out of the distal end of the introducer tube and forms a helical coil.
3. The medical device system of claim 2, the coil having a substantially flat cross-sectional shape.
4. (New) The medical device system of claim 2, wherein the second electrode has a flat, ribbon shape or an ovular shape.
Claim 2, 14 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. (US 11,478,296) in view of Miller et al. (US 20140296845 ). Claim 10 teaches the claim 2, 14 and 19 except the second electrode forms a helical coil.
Miller teaches a coil electrode for use with radio frequency ablation apparatus, has a lead portion, and a helical portion coupled to the lead portion, the helical portion being formed of Nitinol (fig.1-2, see also [0020]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by U.S. Patent No. (US 11,478,296) with electrode to form helical coil as taught by Miller for the purpose of treating more surface area of the tissue.
Allowable Subject Matter
Claim 5-7 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: During the search of the prior art, the Examiner has failed to identify any reference which that, either alone or in combination discloses, suggests or renders obvious of wherein the second electrode includes a plurality of twists distributed along a length of the second electrode in the retracted state while also teaching each and every limitation set forth in independent claim 2.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
McIntyre (US 2007/0021745) teaches a second electrode for use in an ablation system, the second electrode comprising: an elongate body made of a superelastic material formed in a flat, ribbon shape or an ovular shape (fig.1-2, see also [0023]); and an extended axial portion along at least a portion of the elongate body with one or more twists that form into helical turns upon extension out of a delivery lumen (fig.1-2); wherein the extended axial portion includes a retracted state and an extended state, the extended state including a distal portion forming a helical coil (fig.1-2, see also [0023]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-2721213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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