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 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.
Status of the Claims
The current office action is made responsive to claims filed 10/06/2023.
Acknowledgement is made to the withdrawal of claims 3-4, 8, 12-13, 23-28, and 32-33.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 1-2, 5-7, 9-11, 14-22, 29-31, 34-36 are pending as rejected below. A complete action on the merits appears below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The claim limitation “means for coupling” in claim 19 has been interpreted under 35 U.S.C 112(f) or pre-AIA U.S.C. 112, sixth paragraph, because it uses “means” coupled with functional language without reciting sufficient structure to achieve the function. Furthermore, means is not proceeded by a structural modifier.
Since the claim limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 19 has been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5, 10-11, 14-22, 29-31, 34-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGrath (US 20100280311 A1).
Regarding claim 1, McGrath teaches a delivery sheath to catheter coupler (Fig. 1; adaptor 10), the coupler comprising:
(a) a cylindrical shaft (Fig. 1; second portion 24) extending along an axis, the cylindrical shaft being configured for longitudinal alignment with an insertion port (Fig. 1; connector 28) of a catheter delivery sheath (Fig. 1; endoscope 20), the cylindrical shaft including:
(i) a proximal end ([0009]),
(ii) a distal end ([0009], and
(iii) a lumen (Fig. 1; lumen 49) extending from the proximal end to the distal end along the axis, the lumen being sized to receive an end effector of a catheter ([0009]); and
(b) a coupling member (Fig. 1; first portion 22) attached to the cylindrical shaft, the coupling member being configured for selective securement to the catheter delivery sheath, the coupling member being configured to align the axis of the lumen with a longitudinal axis of the insertion port when the coupling member is selectively secured to the catheter delivery sheath.
Regarding claim 2, McGrath teaches the coupler of claim 1, the coupling member being fixedly attached to the cylindrical shaft ([0034]).
Regarding claim 5, McGrath teaches the coupler of any of claim 1, the cylindrical shaft being sized for insertion into the insertion port of the catheter delivery sheath ([0037]).
Regarding claim 10, McGrath teaches the coupler of any of claim 1, the coupling member including a cap (Fig. 4; distalmost portion of second portion 24).
Regarding claim 11, McGrath teaches the coupler of any of claim 1, the coupling member being configured to engage the catheter delivery sheath in a threadable manner ([0035]).
Regarding claim 14, McGrath teaches the coupler of any of claim 1, further comprising a catheter disposed in the lumen, the catheter being configured to fit within an anatomical structure (Fig. 5; medical device 50, [0039]).
Regarding claim 15, McGrath teaches the coupler of any of claim 1, further comprising a catheter delivery sheath (Fig. 1; endoscope 20) having an insertion port (Fig. 1; connector 28 configured for longitudinal alignment with the cylindrical shaft, the insertion port defining a longitudinal axis, the coupling member being configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively secured to the catheter delivery sheath ([0034]- [0036]).
Regarding claim 16, McGrath teaches a kit (Abstract), comprising:
(a) a catheter (Fig. 5; medical device 50) instrument including:
(i) a catheter having a distal end ([0039]), and
(ii) an end effector at the distal end of the catheter, the catheter and the end effector being sized to fit in an anatomical structure ([0005]- [0006]), the end effector including at least one electrode ([0004]- [0006]); and
(b) a coupler (Fig. 1; adaptor 10) including:
(i) a cylindrical shaft (Fig. 1; second portion 24) including:
(A) a proximal end ([0009]),
(B) a distal end ([0009]), and
(C) a lumen extending (Fig. 1; lumen 49) from the proximal end to the distal end along an axis, the lumen being sized to receive the end effector and the catheter, and
(ii) a coupling member (Fig. 1; first portion 22) attached to the cylindrical shaft.
Regarding claim 17, McGrath teaches the kit of claim 16, further comprising a catheter delivery sheath, the catheter delivery sheath including an insertion port (Fig. 1; connector 28) defining a longitudinal axis, the coupling member being configured for selective securement to the catheter delivery sheath, the coupling member being configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively secured to the catheter delivery sheath.
Regarding claim 18, McGrath teaches the kit of claim 17, the coupling member being configured to engage the catheter delivery sheath in at least one of a threadable manner ([0035]), a snap-fit manner, or a bayonet-style manner.
Regarding claim 19, McGrath teaches a kit (Abstract), comprising:
(a) a catheter instrument (Fig. 5; medical device 50) including:
(i) a catheter having a distal end ([0039]), and
(ii) an end effector at the distal end of the catheter, the catheter and the end effector being sized to fit in an anatomical structure ([0005]- [0006]), the end effector including at least one electrode ([0004]- [0006]); and
(b) a coupler (Fig. 1; adaptor 10) including:
(i) a cylindrical shaft (Fig. 1; second portion 24) including:
(A) a proximal end ([0009]),
(B) a distal end ([0009]), and
(C) a lumen (Fig. 1; lumen 49) extending from the proximal end to the distal end along an axis, the lumen being sized to receive the end effector and the catheter, and
(ii) a means for coupling (Fig. 1; first portion 22) attached to the cylindrical shaft.
Regarding claim 20, McGrath teaches the kit of claim 19, the means for coupling including threading ([0035]), a snap fit feature, a bayonet fit feature, or functional equivalents of threading, a snap fit feature, or a bayonet fit feature.
Regarding claim 29, McGrath teaches a delivery sheath to catheter coupler (Fig. 1; adaptor 10), the coupler comprising:
(a) a cylindrical shaft (Fig. 1; second portion 24) extending along an axis, the cylindrical shaft being configured for longitudinal alignment with an insertion port (Fig. 1; connector 28) of a catheter delivery sheath (Fig. 1; endoscope 20), the cylindrical shaft including:
(i) a proximal end ([0009]),
(ii) a distal end ([0009]), and
(iii) a lumen (Fig. 1; lumen 49) extending from the proximal end to the distal end along the axis, the lumen being sized to receive an end effector of a catheter ([0009])), the lumen including a frustoconical proximal portion (Fig. 1; lumen 49 contains the shape described as broadly as is currently claimed); and
(b) a cap (Fig. 4; distalmost portion of second portion 24) attached to the distal end of the cylindrical shaft, the cap being configured for selective alignment with the catheter delivery sheath, the cap being configured to align the axis of the lumen with a longitudinal axis of the insertion port when the coupling member is selectively aligned with the catheter delivery sheath.
Regarding claim 30, McGrath teaches the coupler of claim 29, the cap being configured for selective securement to the catheter delivery sheath ([0035]).
Regarding claim 31, McGrath teaches the coupler of any of claim 29, the cap being fixedly attached to the distal end of the cylindrical shaft ([0034]).
Regarding claim 34, McGrath teaches the coupler of any of claim 30, the cap being configured to engage the catheter delivery sheath in at least one of a threadable manner ([0035]), a snap-fit manner, an interference-fit manner, or a bayonet-style manner.
Regarding claim 35, McGrath teaches the coupler of any of claim 29, further comprising a catheter disposed in the lumen, the catheter being configured to fit within an anatomical structure (Fig. 1; medical device 50, [0039]).
Regarding claim 36, McGrath teaches the coupler of any of claim 29, further comprising a catheter delivery sheath having an insertion port (Fig. 1; connector 28) configured for longitudinal alignment with the cylindrical shaft, the insertion port defining a longitudinal axis, the coupling member being configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is aligned with the catheter delivery sheath.
Regarding claims 21-22, the method is considered inherent in the ordinary use of the device as taught by McGrath in claims 1-2, 5, 10-11, 14-22, 29-31, 34-36.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over McGrath (US 20100280311 A1) in view of Wahr (US 20190142511 A1).
Regarding claim 6, McGrath teaches the coupler of any of claim 1.
However, McGrath fails to teach the coupler further comprising an outwardly flared feature at one of the proximal or distal ends of the cylindrical shaft, the outwardly flared feature defining an angled surface leading into the lumen.
Wahr teaches a catheter and handle system including a catheter assembly with an insertion tube coupled to a handle assembly (Abstract). The catheter and handle assembly comprises a catheter assembly having an elongate shaft and an ablation assembly coupled to a distal end of the shaft and a handle assembly at a proximal portion of the shaft for inserting the catheter assembly to a delivery device such as an endoscope via an insertion port ([0043], [0050]). The ablation assembly may be retracted into an insertion tube for insertion via the insertion port ([0043]).
Wahr further teaches the distal end of the insertion tube as being flared so as to prevent the insertion tube from extending beyond the insertion port and into the working channel ([0058]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the flared end being located on the insertion tube, as is taught by Wahr, into the cylindrical shaft as is taught by McGrath, to produce the predictable result of preventing the insertion tube from extending beyond the insertion port and into the working channel, as is taught by Wahr, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 7, Wahr further teaches the coupler of claim 6, the outwardly flared feature being at the distal end of the cylindrical shaft, the outwardly flared feature being configured to prevent insertion of the cylindrical shaft into the insertion port of the catheter delivery sheath ([0058]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over McGrath (US 20100280311 A1) in view of Hirsch (US 20120101336 A1).
Regarding claim 9, McGrath teaches the coupler of any of claim 1.
However, McGrath fails to teach the coupling member including a vent opening for venting fluid from a space between the coupling member and the catheter delivery sheath when the coupling member is selectively secured to the catheter delivery sheath.
Hirsch teaches an endoscopic system having an endoscope, a controller and a branch connector ([0023], [0042]).
Hirsch further teaches the known use of a vent tube for venting air or other fluid from a surgical site so as to allow ambient or pressurized air to enter the system and flow to irrigation and also to expel or purge debris ([0043]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the vent, as is taught by Hirsch, into the endoscope as is taught by McGrath, to produce the predictable result of venting air or other fluids from a surgical site, as is taught by McGrath, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794