DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 15-20 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 pre-AIA the applicant regards as the invention.
Claim 15 recites the limitation "the radial cavity of the engaging body" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
To overcome this rejection, Examiner suggests amending claim 15, line 9 to recite “the engaging body defining a radial cavity along a length of the engaging body”. This is the same language used in claim 8, line 7.
Claims 16-20 are rejected based on their dependency from a rejected claim.
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.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cox (US Patent 7,331,972) in view of Griffiths (US Patent Publication 2014/0005689).
Claim 1: Cox’972 teaches a method of cutting a filament (390; under broadest reasonable interpretation, the term “filament” is interpreted to mean “a single thread or a thin flexible threadlike object, process, or appendage”; element 390 is a heart chord which is a thin flexible threadlike object) within a patient's body, the method comprising:
advancing a flexible outer sheath (305) within a patient (Figure 10);
the outer sheath (305) defining a radial cavity (322) along a length of the outer sheath and extending radially inwardly through a wall of the outer sheath, and having an engaging body (340) extendable therein, the engaging body defining a radial cavity (see annotated copy of Figure 3a below) along a length of the engaging body and further defining a hook shape (345) with a proximally-extending tip along a distal portion thereof (see annotated copy of Figure 3a below);
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capturing a portion of a filament (390), in a radial direction (Figure 3a), within the radial cavity of the outer sheath (Figure 3a) and within the radial cavity of the engaging body (this happens as the engaging member moves from the position in Figure 3a to the position in Figure 3b) with the filament extending transversely across the longitudinal axis of the outer sheath and the engaging body (Figure 3a, 3b); and
axially moving the engaging body relative to the outer sheath to cause the hook shape of the engaging body to move the filament proximally to be severed (Figure 3b; the filament will need to move proximally at least some amount to be engaged with the engaging body and severed).
Cox’972 does not teach a bushing coupled to the distal end of the outer sheath.
Like Cox’972, Griffiths'689 teaches a filament cutting device (paragraph [0001]) having an outer sheath (112) with a radial cavity (131) at its distal end for capturing a filament (paragraph [0034]). Griffiths'689 teaches the distal portion of the outer sheath (at 124) comprising the radial cavity (131) can be integral with the sheath (112) (paragraph [0033]), as in Cox’972 or, can be a removably attached separate element (paragraph [0033]).
In Applicant's invention, a bushing is a tubular element attached to the distal end of the outer sheath. Griffith'689 is considered to teach a bushing because it is the same structure. The substitution of one known element (an integral distal portion) for another (a bushing in the form of a removably attachable separate element) would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention because the substitution of the bushing would have yielded predictable results, namely, an outer sheath which can aid in filament cutting.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Cox’972 with a bushing (i.e. a removably attachable separate element 124), as taught by Griffiths'689, because Griffiths teaches either an integral distal portion or a separately attached distal portion will perform equally well. One of ordinary skill of the art therefore would expect the device of Cox’972 to perform equally well with the integral distal portion having a radial cavity or a separately attached distal tip having a cavity because Griffiths'689 teaches a similar device that performs equally well having either structure.
Claim 8: Cox’972 teaches a method of cutting a filament (390; under broadest reasonable interpretation, the term “filament” is interpreted to mean “a single thread or a thin flexible threadlike object, process, or appendage”; element 390 is a heart chord which is a thin flexible threadlike object) within a patient's body, the method comprising:
advancing a flexible outer sheath (305) within a patient (Figure 10) and allowing the flexible outer sheath to bend within tortuous internal anatomies of the patient (Figure 10 shows the catheter is advanced to the heart; column 4, lines 38-45 describes this);
the outer sheath (305) defining a radial cavity (322) along a length of the outer sheath and extending radially inwardly through a wall of the outer sheath, and having an engaging body (340) extendable therein, the engaging body defining a radial cavity (see annotated copy of Figure 3a in the rejection to claim 1 above) along a length of the engaging body;
capturing a portion of a filament (390), in a radial direction (Figure 3a), within the radial cavity of the outer sheath (Figure 3a) and within the radial cavity of the engaging body (this happens as the engaging member moves from the position in Figure 3a to the position in Figure 3b) with the filament extending transversely across the longitudinal axis of the outer sheath and the engaging body (Figure 3a, 3b); and
axially moving the engaging body relative to the outer sheath to cause the filament to be severed (Figure 3b; column 6, lines 64 to column 7, line 2).
Cox’972 does not teach a bushing coupled to the distal end of the outer sheath.
Like Cox’972, Griffiths'689 teaches a filament cutting device (paragraph [0001]) having an outer sheath (112) with a radial cavity (131) at its distal end for capturing a filament (paragraph [0034]). Griffiths'689 teaches the distal portion of the outer sheath (at 124) comprising the radial cavity (131) can be integral with the sheath (112) (paragraph [0033]), as in Cox’972 or, can be a removably attached separate element (paragraph [0033]).
In Applicant's invention, a bushing is a tubular element attached to the distal end of the outer sheath. Griffith'689 is considered to teach a bushing because it is the same structure. The substitution of one known element (an integral distal portion) for another (a bushing in the form of a removably attachable separate element) would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention because the substitution of the bushing would have yielded predictable results, namely, an outer sheath which can aid in filament cutting.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Cox’972 with a bushing (i.e. a removably attachable separate element 124), as taught by Griffiths'689, because Griffiths teaches either an integral distal portion or a separately attached distal portion will perform equally well. One of ordinary skill of the art therefore would expect the device of Cox’972 to perform equally well with the integral distal portion having a radial cavity or a separately attached distal tip having a cavity because Griffiths'689 teaches a similar device that performs equally well having either structure.
Claim 15: Cox’972 teaches a method of cutting a filament (390; under broadest reasonable interpretation, the term “filament” is interpreted to mean “a single thread or a thin flexible threadlike object, process, or appendage”; element 390 is a heart chord which is a thin flexible threadlike object) within a patient's body, the method comprising:
advancing a flexible outer sheath (305) within a patient (Figure 10) and allowing the flexible outer sheath to bend within tortuous internal anatomies of the patient (Figure 10 shows the catheter is advanced to the heart; column 4, lines 38-45 describes this);
the outer sheath (305) defining a radial cavity (322) along a length of the outer sheath and extending radially inwardly through a wall of the outer sheath and having a distal surface (near 362) and a proximal surface (near 360), the distal surface extending from a distal end radially inwardly and proximally to a proximal end adjacent a distal end of the proximal surface (Figure 3a, 3b), the outer sheath having an engaging body (340) extendable therein;
directing the filament, oriented transverse to the longitudinal axis of the outer sheath and the engaging body, along the radially-inwardly directed proximally-extending distal surface of the radial cavity of the outer sheath and into the radial cavity of the outer sheath and the radial cavity of the engaging body (Figure 3a, 3b).
axially moving the engaging body relative to the outer sheath to cause the filament to be severed (Figure 3b; column 6, lines 64 to column 7, line 2).
Cox’972 does not teach a bushing coupled to the distal end of the outer sheath.
Like Cox’972, Griffiths'689 teaches a filament cutting device (paragraph [0001]) having an outer sheath (112) with a radial cavity (131) at its distal end for capturing a filament (paragraph [0034]). Griffiths'689 teaches the distal portion of the outer sheath (at 124) comprising the radial cavity (131) can be integral with the sheath (112) (paragraph [0033]), as in Cox’972 or, can be a removably attached separate element (paragraph [0033]).
In Applicant's invention, a bushing is a tubular element attached to the distal end of the outer sheath. Griffith'689 is considered to teach a bushing because it is the same structure. The substitution of one known element (an integral distal portion) for another (a bushing in the form of a removably attachable separate element) would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention because the substitution of the bushing would have yielded predictable results, namely, an outer sheath which can aid in filament cutting.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Cox’972 with a bushing (i.e. a removably attachable separate element 124), as taught by Griffiths'689, because Griffiths teaches either an integral distal portion or a separately attached distal portion will perform equally well. One of ordinary skill of the art therefore would expect the device of Cox’972 to perform equally well with the integral distal portion having a radial cavity or a separately attached distal tip having a cavity because Griffiths'689 teaches a similar device that performs equally well having either structure.
Claim 2, 16: Cox’972 teaches moving the engaging body (340) by pulling on an actuation wire (330) coupled to the engaging body (340) (column 6, lines 64-67).
Claim 3, 9: Cox’972 teaches the radial cavity (322) of the outer sheath (305) has a distal surface (near 362) and a proximal surface (near 360), the distal surface extending from a distal end radially inwardly and proximally to a proximal end adjacent a distal end of the proximal surface (Figure 3a, 3b),
the method further comprising directing the filament, oriented transverse to the longitudinal axis of the outer sheath and the engaging body, along the radially-inwardly directed proximally-extending distal surface of the radial cavity of the outer sheath and into the radial cavity of the outer sheath and the radial cavity of the engaging body (Figure 3a, 3b).
Claim 4, 10, 17: Cox’972 teaches the proximal surface (near 360) and the distal surface (near 362) of the radial cavity (322) of the outer sheath are angled such that the radially outer portions of the proximal surface and the distal surface are further apart from each other compared to the radially inner portions of the proximal surface and the distal surface (Figure 3a shows the outer portions of distal and proximal surfaces are further apart than the inner portions of the distal and proximal surfaces);
the method further comprising directing the filament into the radial cavity of the outer sheath and the radial cavity of the engaging body with the outer sheath distally extended with respect to the engaging body such that the filament enters the widest portion of the radial cavity of the outer sheath (Figure 3a).
Claim 5, 12, 19: Cox’972 teaches severing the filament (390) by moving the filament against a cutting edge (342; column 6, lines 64 to column 7, line 2)
Claim 6, 13: Cox’972 teaches severing the filament against a cutting surface (342) of the engaging body (Figures 3a, 3b; column 6, lines 64 to column 7, line 2).
Claim 7, 14, 20: Cox’972 teaches moving the filament proximally to engage with and be severed by the radial cavity of the engaging body (Figures 3a, 3b).
Claim 11: Cox’972 teaches the engaging body (340) includes a hook shape with a proximally extending tip along a distal portion thereof (see the annotated figure in the rejection to claim 1 above),
The method further comprising axially moving the engaging body proximally relative to the outer sheath to cause the hook shape to move the filament proximally (Figures 3a, 3b; the filament will need to move proximally at least some amount to be engaged with the engaging body and severed).
Claim 18: Cox’972 teaches the engaging body defines a radial cavity (see annotated figure in the rejection to claim 1 above) along a length of the engaging body and further defining a hook shape (345) with a proximally-extending tip along a distal portion thereof (see annotated figure in the rejection to claim 1 above);
The method further comprising axially moving the engaging body proximally to cause the hook shape of the engaging body to move the filament proximally to be severed (Figure 3b; the filament will need to move proximally at least some amount to be engaged with the engaging body and severed), while extending transverse to the longitudinal axis of the engaging body, to be severed by relative movement of the outer sheath and the engaging body (Figures 3a, 3b).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Wednesday 9:30 am-5 pm and alternating Thursdays.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 7 October 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
