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 .
Election/Restrictions
Claims 11, 16, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/11/2026.
Applicant's election with traverse of the catheter of Figures 2A-B and the connection portion of Figures 5A-B and 9A-B in the reply filed on 3/11/2026 is acknowledged. The traversal is on the ground(s) that there is not a serious search burden. This is not found persuasive because each species has unique physical characteristics, requiring individual image searches for each species. The application is classified in A61B18/1492, which has over 85,000 different references. The species are unique enough that searching for one species would not necessarily overlap with a search for another species. Also, a thorough search for all species would require searching in additional classifications, resulting in a large search burden. Thus, there is a significant search burden.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 8 and 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.
Claim 8 recites the limitation "the proximal end grip portion" in line 2, line 3, and line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 also recites the limitation “the grip portion” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 additionally recites the limitation “the intermediate grip portion” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the proximal end grip portion" in line 2, line 3, and line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 also recites the limitation “the grip portion” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 additionally recites the limitation “the intermediate grip portion” in line 7. There is insufficient antecedent basis for this limitation in the claim.
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 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 1-3 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eggers et al. US 5843019, herein referred to as “Eggers”.
Regarding claim 1, Eggers discloses a catheter (Figure 2) comprising: a hollow shaft (Figures 4-5: hollow shaft 86); a distal end electrode provided on a distal end portion of the hollow shaft (Figure 2: active electrode 14); a proximal end electrode provided on a proximal end portion of the hollow shaft (Figure 5: return electrode terminal 136), and which is electrically connected to the distal end electrode via the hollow shaft (Col. 17, lines 9-20 and Col. 17, line 58 – Col. 18, line 6); and a connection portion configured to be attached to and detached from the proximal end electrode (Figure 5: plug 134), and which, by being attached to the proximal end electrode, electrically connects an external voltage output device and the proximal end electrode via a lead wire (Col. 17, line 58 – Col. 18, line 6).
Regarding claim 2, Eggers discloses the catheter according to claim 1, wherein the connection portion comprises a covering portion that covers the proximal end electrode when the connection portion is attached to the proximal end electrode (Figure 5: plug 134).
Regarding claim 3, Eggers discloses the catheter according to claim 2, further comprising: a grip portion provided on the proximal end portion of the hollow shaft (Figure 2: handle 64), the grip portion comprising: a distal end grip portion disposed on a distal end portion of the grip portion (Figure 5: distal end of housing 88); a proximal end grip portion disposed on a proximal end portion of the grip portion (Figure 5: proximal end of housing 88); and an intermediate grip portion disposed between the distal end grip portion and the proximal end grip portion, wherein the connection portion configures the intermediate grip portion (Figure 5: thumbscrew 100).
Regarding claim 10, Eggers discloses the catheter according to claim 3, wherein the distal end grip portion is configured to support the lead wire along a surface of the distal end grip portion when the intermediate grip portion is configured by the connection portion (Figure 5), and has, on a surface thereof, a concave portion in which a lead wire can be fitted (Figure 5: cavity 144).
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 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.
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 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Eggers in view of Milhous et al., US 20180236204, herein referred to as “Milhous”.
Regarding claim 4, Eggers discloses the catheter according to claim 3, but does not explicitly disclose a catheter further comprising: a replacement portion configured to be attached to and detached from the proximal end electrode, wherein when the connection portion is not attached to the proximal end electrode and the replacement portion is attached to the proximal end electrode instead of the connection portion, the replacement portion configures the intermediate grip portion that does not electrically connect the proximal end electrode and the voltage output device.
However, Milhous teaches a catheter ([0006]) further comprising: a replacement portion configured to be attached to and detached from the proximal end electrode (Figure 32: cover 240 is configured to be attached to and detached from catheter electrical contacts 114 and [0068]), wherein when the connection portion is not attached to the proximal end electrode and the replacement portion is attached to the proximal end electrode instead of the connection portion, the replacement portion configures the intermediate grip portion that does not electrically connect the proximal end electrode and the voltage output device (Figure 32: cover 240 and [0068], Figures 1 and 4 depict when the connection portion is attached).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Eggers so that it includes a replacement portion configured to be attached to and detached from the proximal end electrode, wherein when the connection portion is not attached to the proximal end electrode and the replacement portion is attached to the proximal end electrode instead of the connection portion, the replacement portion configures the intermediate grip portion that does not electrically connect the proximal end electrode and the voltage output device as taught by Milhous to preserve electrical integrity of the connector (Milhous [0068]).
Regarding claim 15, Eggers in view of Milhous discloses the catheter according to claim 4, and Eggers further discloses a catheter wherein the distal end grip portion is configured to support the lead wire along a surface of the distal end grip portion when the intermediate grip portion is configured by the connection portion (Figure 5), and has, on a surface thereof, a concave portion in which a lead wire can be fitted (Figure 5: cavity 144).
Claims 5-8, 12, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Eggers in view of Chong et al., US 20130282007, herein referred to as “Chong”.
Regarding claim 5, Eggers discloses the catheter according to claim 2, but does not explicitly disclose a catheter wherein: the covering portion: includes: a first cover portion having a first connection terminal that is connected to the lead wire; and a second cover portion joined with the first cover portion by a joint portion having a hinge structure, and is configured to open and close between: a closed state in which the covering portion is attached to the proximal end electrode and the proximal end electrode is held between the first cover portion and the second cover portion, and an open state in which the covering portion is detached from the proximal end electrode, and the first connection terminal is disposed in a position so as to make contact with the proximal end electrode when the connection portion is attached to the proximal end electrode.
However, Chong teaches a catheter wherein: the covering portion (Figure 1: handle 30): includes: a first cover portion having a first connection terminal that is connected to the lead wire (Figure 1b: connector 13); and a second cover portion joined with the first cover portion by a joint portion having a hinge structure ([0033]: “In addition, the shells can also be connected by a hinge on one side and a pair of releasably connected connectors so that the cavity inside the handle can be accessed by opening the shells or partly separating the shells from one another.”), and is configured to open and close between: a closed state in which the covering portion is attached to the proximal end electrode and the proximal end electrode is held between the first cover portion and the second cover portion (Figures 1-1b), and an open state in which the covering portion is detached from the proximal end electrode ([0033]: “In addition, the shells can also be connected by a hinge on one side and a pair of releasably connected connectors so that the cavity inside the handle can be accessed by opening the shells or partly separating the shells from one another.”), and the first connection terminal is disposed in a position so as to make contact with the proximal end electrode when the connection portion is attached to the proximal end electrode (Figure 1b: connector 13). In combination with Eggers, the plug 134 of Eggers has the hinge of handle 30 of Chong.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Eggers so that the covering portion includes: a first cover portion having a first connection terminal that is connected to the lead wire; and a second cover portion joined with the first cover portion by a joint portion having a hinge structure, and is configured to open and close between: a closed state in which the covering portion is attached to the proximal end electrode and the proximal end electrode is held between the first cover portion and the second cover portion, and an open state in which the covering portion is detached from the proximal end electrode, and the first connection terminal is disposed in a position so as to make contact with the proximal end electrode when the connection portion is attached to the proximal end electrode as taught by Chong so that the cavity inside the covering portion can be accessed (Chong [0033]).
Regarding claim 6, Eggers in view of Chong discloses the catheter according to claim 5, and Chong further discloses a catheter with a first cover portion and a second cover portion ([0033]: “In addition, the shells can also be connected by a hinge on one side and a pair of releasably connected connectors so that the cavity inside the handle can be accessed by opening the shells or partly separating the shells from one another.”). Eggers further discloses a catheter wherein: the covering portion comprises a groove portion in which the proximal end electrode can be fitted (Figure 5: recessed electrical receptable 142), and the groove portion is disposed in a position in which the first connection terminal makes contact with the proximal end electrode when the connection portion is attached to the proximal end electrode (Figure 5 and Col. 17, line 65 – Col. 18, line 2). In combination with Chong, the covering portion has a first cover portion and a second cover portion.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Eggers so that the covering portion includes a first cover portion and a second cover portion as taught by Chong so that the cavity inside the covering portion can be accessed (Chong [0033]).
Regarding claim 7, Eggers in view of Chong discloses the catheter according to claim 6, and Chong further discloses a catheter with a first cover portion and a second cover portion ([0033]: “In addition, the shells can also be connected by a hinge on one side and a pair of releasably connected connectors so that the cavity inside the handle can be accessed by opening the shells or partly separating the shells from one another.”). Eggers further discloses a catheter wherein : the covering portion comprises a seal portion that surrounds an outer periphery of the groove portion (Figure 5: plug 134 has a portion that surrounds recessed electrical receptable 142). In combination with Chong, the covering portion has a first cover portion and a second cover portion.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Eggers so that the covering portion includes a first cover portion and a second cover portion as taught by Chong so that the cavity inside the covering portion can be accessed (Chong [0033]).
Regarding claim 8, Eggers in view of Chong discloses the catheter according to claim 5, and Eggers further discloses a catheter wherein: the proximal end grip portion comprises a support portion that is provided on a distal end side of the proximal end grip portion and fixedly supports the proximal end electrode (Figure 5: proximal end of housing 88 supports electrode terminal 136 on the side), the support portion has a protrusion portion that protrudes from a central axis of the hollow shaft toward a direction of an outer periphery of the grip portion (Figure 5: proximal end of housing 88 protrudes toward the outer periphery of the grip portion), and the intermediate grip portion comprises a concave portion that is fitted with the support portion of the proximal end grip portion (Figure 5: cavity 144).
Regarding claim 12, Eggers discloses the catheter according to claim 3, but does not explicitly disclose a catheter wherein: the covering portion: includes: a first cover portion having a first connection terminal that is connected to the lead wire; and a second cover portion joined with the first cover portion by a joint portion having a hinge structure, and is configured to open and close between: a closed state in which the covering portion is attached to the proximal end electrode and the proximal end electrode is held between the first cover portion and the second cover portion, and an open state in which the covering portion is detached from the proximal end electrode, and the first connection terminal is disposed in a position so as to make contact with the proximal end electrode when the connection portion is attached to the proximal end electrode.
However, Chong teaches a catheter wherein: the covering portion (Figure 1: handle 30): includes: a first cover portion having a first connection terminal that is connected to the lead wire (Figure 1b: connector 13); and a second cover portion joined with the first cover portion by a joint portion having a hinge structure ([0033]: “In addition, the shells can also be connected by a hinge on one side and a pair of releasably connected connectors so that the cavity inside the handle can be accessed by opening the shells or partly separating the shells from one another.”), and is configured to open and close between: a closed state in which the covering portion is attached to the proximal end electrode and the proximal end electrode is held between the first cover portion and the second cover portion (Figures 1-1b), and an open state in which the covering portion is detached from the proximal end electrode ([0033]: “In addition, the shells can also be connected by a hinge on one side and a pair of releasably connected connectors so that the cavity inside the handle can be accessed by opening the shells or partly separating the shells from one another.”), and the first connection terminal is disposed in a position so as to make contact with the proximal end electrode when the connection portion is attached to the proximal end electrode (Figure 1b: connector 13). In combination with Eggers, the plug 134 of Eggers has the hinge of handle 30 of Chong.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Eggers so that the covering portion includes: a first cover portion having a first connection terminal that is connected to the lead wire; and a second cover portion joined with the first cover portion by a joint portion having a hinge structure, and is configured to open and close between: a closed state in which the covering portion is attached to the proximal end electrode and the proximal end electrode is held between the first cover portion and the second cover portion, and an open state in which the covering portion is detached from the proximal end electrode, and the first connection terminal is disposed in a position so as to make contact with the proximal end electrode when the connection portion is attached to the proximal end electrode as taught by Chong so that the cavity inside the covering portion can be accessed (Chong [0033]).
Regarding claim 18, Eggers in view of Chong discloses the catheter according to claim 5, and Eggers further discloses a catheter wherein the distal end grip portion is configured to support the lead wire along a surface of the distal end grip portion when the intermediate grip portion is configured by the connection portion (Figure 5), and has, on a surface thereof, a concave portion in which a lead wire can be fitted (Figure 5: cavity 144).
Regarding claim 20, Eggers in view of Chong discloses the catheter according to claim 6, and Eggers further discloses a catheter wherein: the proximal end grip portion comprises a support portion that is provided on a distal end side of the proximal end grip portion and fixedly supports the proximal end electrode (Figure 5: proximal end of housing 88 supports electrode terminal 136 on the side), the support portion has a protrusion portion that protrudes from a central axis of the hollow shaft toward a direction of an outer periphery of the grip portion (Figure 5: proximal end of housing 88 protrudes toward the outer periphery of the grip portion), and the intermediate grip portion comprises a concave portion that is fitted with the support portion of the proximal end grip portion (Figure 5: cavity 144).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Eggers in view of Wilson et al., US 6921396, herein referred to as “Wilson”.
Regarding claim 9, Eggers discloses the catheter according to claim 3, but does not explicitly disclose a catheter wherein: the distal end grip portion comprises a tapered portion having a diameter that decreases toward a distal end thereof, and the tapered portion has, on a surface, a spiral groove portion having a spiral groove shape.
However, Wilson teaches a catheter wherein: the distal end grip portion comprises a tapered portion having a diameter that decreases toward a distal end thereof (Figure 5: the portion between shaft 41 and groove 49), and the tapered portion has, on a surface, a spiral groove portion having a spiral groove shape (Figure 5: spiral grooves 47).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Eggers so that the distal end grip portion comprises a tapered portion having a diameter that decreases toward a distal end thereof, and the tapered portion has, on a surface, a spiral groove portion having a spiral groove shape as taught by Wilson to advance the device as it is rotated (Wilson Col. 4, lines 45-50).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Eggers in view of Milhous, further in view of Chong.
Regarding claim 13, Eggers in view of Milhous discloses the catheter according to claim 4, but does not explicitly disclose a catheter wherein: the covering portion: includes: a first cover portion having a first connection terminal that is connected to the lead wire; and a second cover portion joined with the first cover portion by a joint portion having a hinge structure, and is configured to open and close between: a closed state in which the covering portion is attached to the proximal end electrode and the proximal end electrode is held between the first cover portion and the second cover portion, and an open state in which the covering portion is detached from the proximal end electrode, and the first connection terminal is disposed in a position so as to make contact with the proximal end electrode when the connection portion is attached to the proximal end electrode.
However, Chong teaches a catheter wherein: the covering portion (Figure 1: handle 30): includes: a first cover portion having a first connection terminal that is connected to the lead wire (Figure 1b: connector 13); and a second cover portion joined with the first cover portion by a joint portion having a hinge structure ([0033]: “In addition, the shells can also be connected by a hinge on one side and a pair of releasably connected connectors so that the cavity inside the handle can be accessed by opening the shells or partly separating the shells from one another.”), and is configured to open and close between: a closed state in which the covering portion is attached to the proximal end electrode and the proximal end electrode is held between the first cover portion and the second cover portion (Figures 1-1b), and an open state in which the covering portion is detached from the proximal end electrode ([0033]: “In addition, the shells can also be connected by a hinge on one side and a pair of releasably connected connectors so that the cavity inside the handle can be accessed by opening the shells or partly separating the shells from one another.”), and the first connection terminal is disposed in a position so as to make contact with the proximal end electrode when the connection portion is attached to the proximal end electrode (Figure 1b: connector 13). In combination with Eggers, the plug 134 of Eggers has the hinge of handle 30 of Chong.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Eggers so that the covering portion includes: a first cover portion having a first connection terminal that is connected to the lead wire; and a second cover portion joined with the first cover portion by a joint portion having a hinge structure, and is configured to open and close between: a closed state in which the covering portion is attached to the proximal end electrode and the proximal end electrode is held between the first cover portion and the second cover portion, and an open state in which the covering portion is detached from the proximal end electrode, and the first connection terminal is disposed in a position so as to make contact with the proximal end electrode when the connection portion is attached to the proximal end electrode as taught by Chong so that the cavity inside the covering portion can be accessed (Chong [0033]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Eggers in view of Milhous, further in view of Wilson.
Regarding claim 14, Eggers in view of Milhous discloses the catheter according to claim 4, but does not explicitly disclose a catheter wherein: the distal end grip portion comprises a tapered portion having a diameter that decreases toward a distal end thereof, and the tapered portion has, on a surface, a spiral groove portion having a spiral groove shape.
However, Wilson teaches a catheter wherein: the distal end grip portion comprises a tapered portion having a diameter that decreases toward a distal end thereof (Figure 5: the portion between shaft 41 and groove 49), and the tapered portion has, on a surface, a spiral groove portion having a spiral groove shape (Figure 5: spiral grooves 47).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Eggers so that the distal end grip portion comprises a tapered portion having a diameter that decreases toward a distal end thereof, and the tapered portion has, on a surface, a spiral groove portion having a spiral groove shape as taught by Wilson to advance the device as it is rotated (Wilson Col. 4, lines 45-50).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Eggers in view of Chong, further in view of Wilson.
Regarding claim 17, Eggers in view of Chong discloses the catheter according to claim 5, but does not explicitly disclose a catheter wherein: the distal end grip portion comprises a tapered portion having a diameter that decreases toward a distal end thereof, and the tapered portion has, on a surface, a spiral groove portion having a spiral groove shape.
However, Wilson teaches a catheter wherein: the distal end grip portion comprises a tapered portion having a diameter that decreases toward a distal end thereof (Figure 5: the portion between shaft 41 and groove 49), and the tapered portion has, on a surface, a spiral groove portion having a spiral groove shape (Figure 5: spiral grooves 47).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Eggers so that the distal end grip portion comprises a tapered portion having a diameter that decreases toward a distal end thereof, and the tapered portion has, on a surface, a spiral groove portion having a spiral groove shape as taught by Wilson to advance the device as it is rotated (Wilson Col. 4, lines 45-50).
Conclusion
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/NORA W RHODES/Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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