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 .
Information Disclosure Statement
The IDS form(s) submitted on 8/26/2025, 5/01/2024, 8/11/2023, and 12/23/2021 is/are in compliance with the requirements of the provisions of 37 CFR 1.97. Accordingly, the information disclosure(s) are being considered by the examiner.
Election/Restrictions
Claim 22-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected process of use, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/25/2025.
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 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 11,083,871 B2. Although the claims at issue are not identical, they are not patentably distinct from each other claimed instrument is anticipated by the “needle configured to ablate tissue” previously claimed
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. US 11,083,871 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed instrument is anticipated by the “needle configured to ablate tissue” previously claimed
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. US 11,083,871 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed instrument is anticipated by the “needle configured to ablate tissue” previously claimed
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. US 11,083,871 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed instrument is anticipated by the “needle configured to ablate tissue” previously claimed
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. US 11,083,871 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed instrument is anticipated by the “needle configured to ablate tissue” previously claimed
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. US 11,083,871 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed instrument is anticipated by the “needle configured to ablate tissue” previously claimed
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(s) 7 is/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 pre-AIA the applicant regards as the invention.
Claim 7 recite(s) “the clutch”. There is insufficient antecedent basis for this/these limitation(s) within the claim. Examiner suggest changing the dependency of claim 7 to claim 5.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 29-30 and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0187519 A1 to Harris et al.
In regard to claim 29:
A catheter (Fig. 1, element 110), comprising: an instrument (Fig. 4 elements 123, 112needle element 120. Considered an instrument under broadest reasonable interpretation due to Merriam-Webster definition: implement especially: one designed for precision work) slidably disposed within an inner lumen of the catheter (Fig. 4 element 120), the instrument being coupled to at least one protrusion (Portion of element 140 disposed in cavity 151, Para. 28 “A portion of slider 140 may be disposed within a cavity 151 defined by a housing 150”, considered coupled to the instrument due to para. 29 “The movement of slider 140 is translated via third elongate shaft 120 to distal end 123 of third elongate shaft 120”); a retraction stop coupled to the catheter (see annotated Fig. 2 below, proximal end of fig. 1 element 151, para. 28 “housing 150 may be fixed to first elongate shaft 110”); a deployment stop coupled to the catheter (see annotated Fig. 2 below, distal end of fig. 1 element 151, para. 28 “housing 150 may be fixed to first elongate shaft 110”) and disposed distal to the retraction stop (Fig. 4 element 410); and an advancing mechanism (Figs. 1 and 2 elements 140, 152, 150, and 155) configured to move the instrument (Para. 29 “a physician may urge slider 140 distally while visually observing the travel of slider 140 relative to indicia 152 of housing 150. The movement of slider 140 is translated via third elongate shaft 120 to distal end 123 of third elongate shaft 120” (emphasis added)) relative to the catheter between a first position, wherein the at least one protrusion contacts the retraction stop (See annotated Fig. 2 below first position considered to be when element 140 is fully retracted to the proximal end of channel element 151, such that the portion of element 140 within element 151 abuts the proximal end of channel 151), and a second position, wherein the at least one protrusion contacts the deployment stop (Fig. 2 below second position considered to be when element 140 is fully extended to the distal end of channel element 151, such that the portion of element 140 within element 151 abuts the distal end of channel 151).
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Annotated Fig. 2
In regard to claim 30:
The catheter of claim 29, taught by Harris in view Thagalingam as described in parent claim rejection above.
Harris teaches, wherein the deployment stop is a distal end of a groove (Distal end of fig. 1 element 151) formed in a sidewall (element 150) of the catheter (element 110) that is configured to receive the at least one protrusion (para. 28 “housing 150 may be fixed to first elongate shaft 110” is therefore considered a sidewall of catheter element 110. Element 151 is a groove formed into element 151).
In regard to claim 34:
The catheter of claim 29, taught by Harris in view Thagalingam as described in parent claim rejection above.
Harris teaches, wherein a position of the deployment stop relative to the retraction stop can be adjusted (Fig. elements 430, 432, and 414. Para. 41 “form a stop mechanism 414 with the proximal end of proximally extending circular wall”. Para. 44 “Needle depth control device 430 may include an inner surface 438 with a first thread 439 disposed thereon. A section of outer surface 122 of needle 120 may contain a second thread 452 that is the reciprocal of and may selectively engage first thread 439 upon movement of needle 120 toward the distal end of catheter 100. It will be appreciated that the threads 452 may be continuous, although only a portion of the threads are shown in the partial cut-away view through needle depth control device 430. Although in the embodiment shown in FIG. 4 second thread 452 on needle 120 is shown to extend beyond the length of needle depth control device 430, other embodiments are possible in which second thread 452 may extend for longer and/or shorter distances. The extent of the engagement of first thread 439 and second thread 452 may be controlled from proximal end 124 of needle 120 by turning needle 120 to engage needle 120 with needle depth control device 430 in both the distal and proximal directions. Distal end 436 of needle depth control device 430 may function as a stop collar when it contacts the stop mechanism 414 upon needle 120 being urged toward distal end 103 of catheter 100. Therefore, the injection depth may be limited by setting needle depth control device 430 to a predetermined distance. Although the predetermined distance may be selected at the proximal end of catheter 100, the distance is controlled at the distal end of catheter 100 by the needle depth control device 430. Unlike FIG. 3, in FIG. 4, needle depth control device 430 may be located nearer to distal end 123 of needle 120, for example, within about 1-3", than in FIG. 3, which may be 10-15" or more away from the distal end of the needle.”
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 1-4, 8-11, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0187519 A1 to Harris et al. in view of US 2006/0253183 A1 to Thagalingam et al.
In regard to claim 1:
A catheter (Fig. 1, element 110), comprising: an instrument (Fig. 4 needle element 120. Considered an instrument under broadest reasonable interpretation due to Merriam-Webster definition: implement especially: one designed for precision work) slidably disposed within an inner lumen of the catheter (Fig. 4 element 120), the instrument being coupled to at least one protrusion (Fig. 4 elements 432, via element 430); a retraction stop (see annotated Fig. 4 below); an advancing mechanism (Fig. 2 elements 140, 152, 150, and 155) configured to selectively engage the instrument to urge the instrument distally relative to the catheter (Para. 29 “A physician using catheter 100 in a surgical procedure may move distal end 123 of third elongate shaft 120 a known distance relative to distal end 113 of first elongate shaft 110 to set the desired injection depth. For example, a physician may urge slider 140 distally while visually observing the travel of slider 140 relative to indicia 152 of housing 150. The movement of slider 140 is translated via third elongate shaft 120 to distal end 123 of third elongate shaft 120. In accordance with an embodiment of the present invention, in FIG. 1, there may be substantially a one-to-one relationship between the movement of slider 140 relative to indicia 152 of housing 150 and the movement of distal end 123 of third elongate shaft 120 relative to distal end 113 of first elongate shaft 110” (emphasis added). The advancement mechanism is considered so configured due to the indicia providing the physician the ability to selectively move the instrument a specific measured distance with the advancement mechanism.).
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Annotated Fig. 4
Harris does not appear to explicitly disclose the biasing element as claimed. Thagalingam teaches, a biasing element (Fig. 1 element 156) coupled to the instrument (Para. 96 “The catheter handle 112 also has a sliding retraction/extension mechanism with a lever 146 coupled to a retraction spring 156”) and configured to urge the instrument proximally such that the at least one protrusion abuts against the retraction stop (considered a functional limitation to which element 156 (retraction spring) is considered fully capable of providing retraction of the needle element 120 taught by Harris such that the protrusions (Harris elements 432) abut against the retraction stop (see annotated Fig. 4 above)).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing to modify the, catheter taught by Harris to include a biasing element as taught by Thagalingam. This would have been motivated by improving patient safety. It would have been known to one of ordinary skill in the art at the time of filing, needles are sharp, and can cause damage to the vasculature of the patient during entry and removal of the catheter. Therefore, one of ordinary skill in the art would have been motivated at the time of filing to bias the needle taught by Harris to be in the retracted position to prevent accidental harm to the patient by the needle tip being exposed during entry or removal of the catheter in use.
In regard to claims 2-3:
The catheter of claim 1, taught by Harris in view Thagalingam as described in parent claim rejection above.
Harris in view of Thagalingam teach, wherein the catheter is steerable using one or more control cables extending through the catheter (Thagalingam teaches, Para. 31 “The device may further comprise a pull wire connected to a metal ring located at the distal portion of the catheter enabling the catheter to be flexed and deflexed as required.”), wherein the one or more control cables terminate at a position proximal to the retraction stop (Thagalingam teaches, Para. 95 “As shown in FIG. 1, a pull wire 142 is connected at one end to a metal ring 140 attached to the inside of the outer catheter body 120 and at the other end to a level 148 on the catheter handle 112. Manipulation of the lever 148 enables the distal catheter tip to be flexed and deflexed to facilitate catheter placement.” Harris teaches the retraction stop at the distal end of the catheter as detailed in parent claim rejection above).
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify the catheter taught by Harris to be steerable by pull wires as taught Thagalingam. This would have been motivated by Thagalingam para. 11 “Thus, a need clearly exists for surgical equipment that can create thermal ablation lesions using a percutaneously or endoscopically delivered intramural needle to deliver electrical energy and that allows a user to steer a catheter to the area of interest and secure the catheter firmly to the myocardium with a fixation helix. The equipment must make efficient use of space to allow a maximum diameter needle to be deployed” (emphasis added). Thagalingam does teach a dual use however efficient use of space in a catheter and the ability to steer the catheter would have been recognized by one of ordinary skill in the art as universal benefit to catheters, even those outside of ablation catheters such as the injection catheter taught by Harris. Harris teaches the area of interest as the heart (para. 34 “FIG. 2 is a diagrammatic view including catheter 100 and a patient 200 with a heart 210 and a vascular system 220 including a blood vessel 230 defining a blood vessel lumen 232,”) and therefore one of ordinary skill in the art would have been motivated by Thagalingam’s teaching of a steering catheter to reach the heart.
In regard to claim 4:
The catheter of claim 1, taught by Harris in view Thagalingam as described in parent claim rejection above.
Harris teaches, wherein the advancing mechanism includes a tab coupled to a proximal portion of the instrument (Fig. 1 element 140).
In regard to claim 8:
The catheter of claim 1, taught by Harris in view Thagalingam as described in parent claim rejection above.
Harris teaches, wherein the advancing mechanism includes one or more predetermined distance increments that can be selected to urge the instrument distally by the predetermined distance (Fig. 1 elements 152, para. 28 “a plurality of indicia 152 may be disposed on a face 155 of housing 150 proximate slider 140. Indicia 152 may indicate a desired injection depth for third elongate shaft 120 measured, generally, in millimeters.”).
In regard to claim 9:
The catheter of claim 1, taught by Harris in view Thagalingam as described in parent claim rejection above.
Thagalingam teaches, wherein the biasing element (Fig. 1 element 156) is positioned in a proximal portion of the catheter within a handle assembly (Fig. 1 element 156 at a proximal end of the catheter within the handle element 112).
In regard to claim 10:
The catheter of claim 1, taught by Harris in view Thagalingam as described in parent claim rejection above.
Harris teaches, wherein the retraction stop (see annotated Fig. 4 below ) is positioned such that a distal tip of the instrument is proximal to a distal tip of the catheter when the at least one protrusion is abutting against the retraction stop (Fig. 4 retraction stop considered to be position such that the distal tip of the instrument is proximal to a distal tip of the catheter as the relative dimensional relationships in Fig. 4 show the proximal travel between the proximal end of element 430 and the retraction stop to be greater than distance the distal tip is exposed from the distal end of the catheter.).
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In regard to claim 11:
The catheter of claim 10, taught by Harris in view Thagalingam as described in parent claim rejection above.
Harris teaches, wherein the advancing mechanism is configured to advance the instrument distally such that the distal tip of the instrument is distal to the distal tip of the catheter (Para. 28 “plurality of indicia 152 may be disposed on a face 155 of housing 150 proximate slider 140. Indicia 152 may indicate a desired injection depth for third elongate shaft 120 measured, generally, in millimeters.”, Fig. 4 element 152 shows an injection depth up to 5 mm)
In regard to claim 37:
The catheter of claim 29, taught by Harris in view Thagalingam as described in parent claim rejection above.
Harris does not appear to explicitly disclose the biasing element as claimed. Thagalingam teaches, further comprising a biasing element (Fig. 1 element 156) coupled to the instrument (Para. 96 “The catheter handle 112 also has a sliding retraction/extension mechanism with a lever 146 coupled to a retraction spring 156”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing to modify the, catheter taught by Harris to include a biasing element as taught by Thagalingam. This would have been motivated by improving patient safety. It would have been known to one of ordinary skill in the art at the time of filing, needles are sharp, and can cause damage to the vasculature of the patient during entry and removal of the catheter. Therefore, one of ordinary skill in the art would have been motivated at the time of filing to bias the needle taught by Harris to be in the retracted position to prevent accidental harm to the patient by the needle tip being exposed during entry or removal of the catheter in use.
Allowable Subject Matter
Claim(s) 5-6, 12, 31-33 and 35-36 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.
Claim 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark A Igel whose telephone number is (571)272-7015. The examiner can normally be reached Monday through Thursday 11 am to 5 pm EST.
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/M.A.I./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783