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 .
Disposition of Claims
Claims 2-21 are pending and rejected.
Claim 1 is canceled.
Information Disclosure Statement
The information disclosure statement filed July 18, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Specifically, while the following foreign patent documents have English translations, they do not include the original foreign patent document: BR0013237A, BR0116004A, MX225663B, MX226292B, MX246862B, MX265247B, MX284569B and MXPA03005028A.
Claim Objections
Claims 5 & 17 are objected to because of the following informalities:
Regarding Claim 5, Claim 5 recites the limitation “wherein the first sensor is formed from turns of the first wire around elongated body [emphasis added]” on Lines 1-2. This is grammatically incorrect and should read “wherein the first sensor is formed from turns of the first wire around the elongated body [emphasis added]”. Appropriate correction is required.
Regarding Claim 17, Claim 17 recites the limitation “wherein the first sensor is formed from turns of the first wire around elongated body [emphasis added]” on Lines 1-2. This is grammatically incorrect and should read “wherein the first sensor is formed from turns of the first wire around the elongated body [emphasis added]”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 18-19 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 Claim 18, Claim 18 recites the limitation “the second sensor is formed form a coil of the second wire [emphasis added]” on Lines 1-2. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, “the second sensor is formed form a coil of the second wire” is being interpreted as “the second sensor is formed form a coil of a second wire [emphasis added]”
Regarding Claim 19, Claim 19 is rejected as being dependent upon claims previously rejected under 35 U.S.C. § 112(b).
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.
Claims 2-3, 5-6, 11-13, 15, 17-18 & 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gardeski et al. (hereinafter "Gardeski") (US 2004/0097965).
Regarding Claim 2, Gardeski discloses a catheter (Fig. 2, 10; [0052]) comprising:
an elongated body ([0052]) having a proximal portion (Fig. 2, 41; [0059]) and a distal portion (Fig. 2, 45; [0045]), the elongated body including a working channel defined therein (Fig. 3, 22; [0052]);
a first sensor (Fig. 2, 42; [0059]) formed of a first wire (a copper wire; [0067]), the first sensor disposed on the distal portion of the elongated body ([0059]) and configured to detect a position of a distal end of the elongated body within a patient ([0059]); and
a second sensor (Fig. 2, 44; [0059]) disposed on the distal portion of the elongated body ([0059]) proximal to the first sensor (see Fig. 2), wherein a vector from a detected position of the second sensor to a detected position of the first sensor defines a rotational orientation of the elongated body ([0059]).
Regarding Claim 3, Gardeski discloses the catheter according to Claim 2. Gardeski further discloses wherein the elongated body is substantially rigid between the first and second sensors ([0057]).
Regarding Claim 5, Gardeski discloses the catheter according to Claim 2. Gardeski further discloses wherein the first sensor is formed from turns of the first wire around elongated body ([0059]), the first wire including first (Fig. 4A, a first wire portion of 30; [0063]) and second leads (Fig. 4A, a second wire segment of 30; [0063]) that are formed in a first twisted pair (Fig. 4A, 30; [0063]) proximal of the turns of the first wire (see Fig. 4A), the first twisted pair extending to the proximal portion of the elongated body ([0063]).
Regarding Claim 6, Gardeski discloses the catheter according to Claim 5. Gardeski further discloses wherein the second sensor is formed from a coil ([0059]) of a second wire (a copper wire; [0067]), the second wire including third (Fig. 4A, a first wire portion of 32; [0063]) and fourth leads (Fig. 4A, a second wire segment of 32; [0063]) that are formed in a second twisted pair proximal of the coil of the second wire (Fig. 4A, 32; [0063]), the second twisted pair extending to the proximal portion of the elongated body ([0063]).
Regarding Claim 11, Gardeski discloses the catheter according to Claim 2. Gardeski further discloses a third sensor (Fig. 2, 46; [0059]) formed of a third wire (a copper wire; [0067]) and disposed on the elongated body proximally of the second sensor (see Fig. 2).
Regarding Claim 12, Gardeski discloses the catheter according to Claim 11. Gardeski further discloses wherein the third sensor is configured to determine an arc of the catheter between the third sensor and the second sensor or between the third sensor and the first sensor ([0059]).
Regarding Claim 13, Gardeski discloses a catheter system (Fig. 2, 40; [0059]) comprising:
a catheter (Fig. 2, 10; [0052]) including:
an elongated body ([0052]) having a proximal portion (Fig. 2, 41; [0059]) and a distal portion (Fig. 2, 45; [0045]), the elongated body including a working channel defined therein (Fig. 3, 22; [0052]);
a first sensor (Fig. 2, 42; [0059]) formed of a first wire (a copper wire; [0067]) disposed on the distal portion of the elongated body ([0059]) and configured to detect a position of a distal end of the elongated body within a patient ([0059]);
a second sensor (Fig. 2, 44; [0059]) disposed on the distal portion of the elongated body ([0059]) proximal to the first sensor (see Fig. 2), wherein a vector from a detected position of the second sensor to a detected position of the first sensor defines a rotational orientation of the elongated body ([0059]); and
a handle (Fig. 2, 60; [0059]) longitudinally and rotatably fixed to the catheter ([0059]), the handle including an adapter (Fig. 2, 61; [0059]) in electrical communication with the first and second sensors ([0063]).
Regarding Claim 15, Gardeski discloses the catheter system according to Claim 13. Gardeski further discloses wherein the elongated body is substantially rigid between the first and second sensors ([0057]).
Regarding Claim 17, Gardeski discloses the catheter system of Claim 13. Gardeski further discloses wherein the first sensor is formed from turns of the first wire around elongated body ([0059]), the first wire including first (Fig. 4A, a first wire portion of 30; [0063]) and second leads (Fig. 4A, a second wire segment of 30; [0063]) that are formed in a first twisted pair (Fig. 4A, 30; [0063]) proximal of the turns of the first wire (see Fig. 4A), the first twisted pair extending to the proximal portion of the elongated body ([0063]).
Regarding Claim 18, Gardeski discloses the catheter system of Claim 17. Gardeski further discloses wherein the second sensor is formed from a coil ([0059]) of the second wire (a copper wire; [0067]), the second wire including third (Fig. 4A, a first wire portion of 32; [0063]) and fourth leads (Fig. 4A, a second wire segment of 32; [0063]) that are formed in a second twisted pair proximal of the coil of the second wire (Fig. 4A, 32; [0063]), the second twisted pair extending to the proximal portion of the elongated body ([0063]).
Regarding Claim 20, Gardeski discloses the catheter system of Claim 13. Gardeski further discloses a third sensor (Fig. 2, 46; [0059]) formed of a third wire (a copper wire; [0067]) disposed on the elongated body a known distance proximally of the second sensor (see Fig. 2).
Regarding Claim 21, Gardeski discloses the catheter system of Claim 13. Gardeski further discloses wherein the third sensor is configured to determine an arc of the elongated body between the third sensor and the second sensor or between the third sensor and the first sensor ([0059]).
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.
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.
Claims 4 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Gardeski et al. (hereinafter "Gardeski") (US 2004/0097965).
Regarding Claims 4 & 16, Gardeski discloses the catheter according to Claim 2 and the catheter system according to Claim 13, respectively.
Gardeski fails to explicitly disclose wherein a separation between the first and second sensors has a length of between 0.25 and 1.00 inch.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make length of the separation of the first and second sensors of Gardeski to be between 0.25 and 1.00 inch since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the first and second sensors would not operate differently with the claimed separation length. Further, Applicant places no criticality on the range claimed, indicating that “the distance D1 is… in a range of about 0.25 to about 1 inch” (see Para. [0081] of Applicant’s specification).
Claims 7 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gardeski et al. (hereinafter "Gardeski") (US 2004/0097965) in view of Costello et al. (hereinafter "Costello") (US 2017/0079546).
Regarding Claim 7, Gardeski discloses the catheter according to Claim 6. Gardeski fails to explicitly disclose wherein the first twisted pair is helically wound about the working channel between the first sensor and the proximal portion of the elongated body.
However, Costello teaches a catheter (Fig. 1, 50; [0037]) comprising:
an elongated body ([0011]) having a proximal portion (Fig. 14, 52; [0037]) and a distal portion (Fig. 1, 54; [0037]), the elongated body including a working channel defined therein (Fig. 2, 56; [0039]);
a sensor (Fig. 1, 58; [0039]) formed of a wire (Fig. 5, 71; [0040]), the sensor disposed on the distal portion of the elongated body ([0039]) and configured to detect a position of a distal end of the elongated body within a patient ([0039]);
wherein the sensor is formed from turns of the wire around elongated body ([0045]), the wire including first (Fig. 6, 76a; [0040]) and second leads (Fig. 6, 76b; [0040]) that are formed in a twisted pair ([0051]) proximal of the turns of the wire (see Fig. 6), the twisted pair extending to the proximal portion of the elongated body ([0051]); and
wherein the twisted pair is helically wound about the working channel between the sensor and the proximal portion of the elongated body ([0051]).
The advantage of helically winding the twisted pair about the working channel is to increase the fatigue life of the wire (Costello; [0051]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the first twisted pair as disclosed by Gardeski, to helically wind it about the working channel, as taught by Costello, to increase the fatigue life of the wire (Costello; [0051]).
Regarding Claim 14, Gardeski discloses the catheter system according to Claim 13. Gardeski fails to explicitly disclose a telescopic channel disposed over a portion of the elongated body and coupled to a distal end of the handle.
However, Costello teaches a catheter system (Fig. 1, 10; [0037]) comprising:
a catheter (Fig. 1, 50; [0037]) having an elongated body ([0011]) having a proximal portion (Fig. 14, 52; [0037]) and a distal portion (Fig. 1, 54; [0037]);
a handle (Fig. 1, 20; [0037]) longitudinally and rotatably fixed to the catheter ([0037]); and
a telescopic channel (Fig. 1, 30; [0037]) disposed over a portion of the elongated body ([0037]) and coupled to a distal end of the handle ([0037]).
The advantage of the telescopic channel is to provide lateral support for the elongated body (Costello; [0037]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the catheter system as disclosed by Gardeski, to include the telescopic channel taught by Costello, to provide lateral support for the elongated body (Costello; [0037]).
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 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-14 of U.S. Patent No. 11,975,157.
The claims of ‘157 disclose all the limitations of the instant claims except for wherein a separation between the first and second sensors has a length of between 0.25 and 1.00 inch.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make length of the separation of the first and second sensors of ‘157 to be between 0.25 and 1.00 inch since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the first and second sensors would not operate differently with the claimed separation length. Further, Applicant places no criticality on the range claimed, indicating that “the distance D1 is… in a range of about 0.25 to about 1 inch” (see Para. [0081] of Applicant’s specification).
Allowable Subject Matter
Claims 8-10 would be allowable if rewritten to overcome the double patenting rejections set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 19 would be allowable if rewritten to overcome the double patenting rejections and the rejections under 35 U.S.C. §112(b) set forth in this Office action and to include 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:
Regarding Claim 8, Gardeski, as previously modified by Costello, teaches the catheter according to Claim 7. Gardeski, Costello and any other prior art of record fail to disclose, teach or suggest, alone or in combination, wherein the coil is disposed within a wall of the elongated body and positioned between two adjacent helical wraps of the first twisted pair.
Regarding Claim 19, Gardeski discloses the catheter system of Claim 17. Gardeski, Costello and any other prior art of record fail to disclose, teach or suggest, alone or in combination, wherein the coil is disposed within a wall of the elongated body and positioned between two adjacent helical wraps of the first twisted pair.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chou et al. (US 2020/0015876) teaches an ablation system with force control.
Matlock et al. (US 2019/0076629) teaches a guidewire assembly with an intertwined core wire.
Palushi et al. (US 2019/0069959) teaches a sensor guided instrument with penetrating features.
Leeflang et al. (US 2016/0367236) teaches a telescoping catheter.
Lee et al. (US 2016/0331468) teaches an adjustable length medical instrument assembly with localization elements for tracking.
Costello et al. (US 2015/0126852) teaches a positioning catheter.
Sobe (US 2012/0017923) teaches a removable navigation system for a medical device.
Govari et al. (US 2010/0036285) teaches single-axis sensors on a flexible backbone.
Sobe (US 2004/0097804) teaches a system for mounting an medical positioning system (MPS) sensor on a catheter.
Osadchy et al. (U.S. 6,266,551) teaches a catheter calibration monitoring system.
Ko (U.S. 5,354,302) teaches a medical device for facilitating intra-tissue visual observation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN FLOYD LONDON whose telephone number is (571)272-4478. The examiner can normally be reached Monday - Friday: 10:00 am ET - 6:00pm ET.
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/STEPHEN FLOYD LONDON/Examiner, Art Unit 3795
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