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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities: Element 31 in FIG 1 is not described in the specification.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a locking element configured to be moved from a first to a second state” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shipley (20200054452) in view of Perszyk (20190083261).
With regards to claim 1, Shipley discloses a catheter device (FIG 2) for implanting a medical implant (FIG 2) comprising: an outer sheath (130) defining a lumen and extending along a longitudinal axis of the catheter device (FIG 2), an inner sheath (102) arranged in the lumen (Figs. 3A-3E) wherein the inner sheath extends along the longitudinal axis (FIG 2) and is connected to a support (120) configured to support the medical implant or to a connector ([0026]), a capsule (40) connected to a distal end of the outer sheath (130, FIG 2) the capsule being configured to cover the medical implant when the medical implant is arranged on the support or the connector ([0023]), and a handle (38). Shipley discloses a traveler (144) wherein the outer sheath (130) is connected to the traveler (Figs. 3A-3E). Shipley also discloses the traveler (144) includes an actuator (142a) on the handle (38) such that the traveler and thereby the outer sheath are moved in a proximal direction along the longitudinal axis with respect to the inner sheath when actuated, so that when actuator pulls the capsule (40) away from the medical implant in the proximal direction to deploy the medical implant ([0023], [0028], [0029]), and such that the traveler (144) and thereby the outer sheath (32) are moved in the distal direction along the longitudinal axis with response to the inner sheath (34) when the actuator is actuated, so that the capsule is moved over the medical implant to cover the medical implant ([0023], [0028], [0029]).
Shipley fails to disclose that the actuator is a rotatable deployment knob, and that the handle comprises: a grip portion , a rotatable deployment knob, and a traveler as claimed, wherein the deployment knob comprises a helical groove formed in an inside of the deployment knob, wherein the traveler engages into the helical groove such that the traveler and thereby the outer sheath are moved in a proximal direction along the longitudinal axis with respect to the inner sheath when the deployment knob is rotated in a first rotational direction and such that the traveler and thereby the outer sheath are moved in the distal direction along the longitudinal axis with respect to the inner sheath when the deployment knob is rotated in an opposite second rotation direction. Shipley also fails to disclose wherein the handle comprises a locking element configured to be moved from a first to a second state, wherein the locking element limits a movement of the traveler and therewith of the capsule in the distal direction in the first state, and wherein the locking element allows a further movement of the traveler and therewith of the capsule in the distal direction in the second state.
Perszyk also discloses a catheter device (16) for implanting a medical implant (Fig. 1A) comprising: an outer sheath (48) defining a lumen (FIG 1A, 8A) and extending along a longitudinal axis of the catheter device (FIG 1A), an inner sheath (40) arranged in the lumen (FIG 1A, 8A) wherein the inner sheath extends along the longitudinal axis (FIG 1A, 8A) and is connected to a support (52) configured to support the medical implant or to a connector ([0066]), a capsule connected to a distal end of the outer sheath (Fig. 1A) the capsule being configured to cover the medical implant when the medical implant is arranged on the support or the connector ([0058]), and a handle (12).
Perszyk teaches that the handle (12) comprises: a grip portion (36; [0046]), a rotatable deployment knob (37), and a traveler (42), wherein the outer sheath is connected to the traveler (FIG 1A, [0053], “The inner shaft 40 is fixedly attached to the hub 42 and the distal tip 50, and the distal tip is fixedly attached to the distal segment 54”), wherein the deployment knob comprises a helical groove (32) formed in an inside of the deployment knob (37), wherein the traveler (42) engages into the helical groove (32, [0050]), such that the traveler (42) and thereby the outer sheath (48) are moved in a proximal direction along the longitudinal axis with respect to the inner sheath (40) when the deployment knob (37) is rotated in a first rotational direction ([0066], where the traveler 42 is fixedly attached to the inner shaft 40, which is removably attached to the outer lead screw 32)and such that the traveler (42) and thereby the outer sheath (48) are moved in the distal direction along the longitudinal axis with respect to the inner sheath (40) when the deployment knob is rotated in an opposite second rotation direction ([0075]); wherein the handle (12) comprises a locking element (62; this element is interpreted under 112(f) as being manually moved by a user, see Pg 6 Line 10 of the instant application, and equivalents thereof) configured to be moved from a first to a second state ([0067]), wherein the locking element limits a movement of the traveler (42) and therewith of the capsule in the distal direction in the first state ([0071]), and wherein the locking element allows a further movement of the traveler (42) and therewith of the capsule in the distal direction in the second state ([0074]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted Shipley’s handle with Perszyk’s handle comprising a grip portion, a rotatable deployment knob, and a traveler, wherein the deployment knob comprises a helical groove formed in an inside of the deployment knob, wherein the traveler engages into the helical groove such that the traveler and thereby the outer sheath are moved in a proximal direction along the longitudinal axis with respect to the inner sheath when the deployment knob is rotated in a first rotational direction and such that the traveler and thereby the outer sheath are moved in the distal direction along the longitudinal axis with respect to the inner sheath when the deployment knob is rotated in an opposite second rotation direction with a reasonable expectation of success for yielding an actuation mechanism for moving the traveler and in turn the outer sheath and capsule. Further, it would have been obvious to one having ordinary skill in the art at the effective time of filing to have modified Shipley’s catheter device to include that the handle comprises a locking element configured to be moved from a first to a second state, wherein the locking element limits a movement of the traveler and therewith of the capsule in the distal direction in the first state, and wherein the locking element allows a further movement of the traveler and therewith of the capsule in the distal direction in the second state, as taught by Perszyk, in order to control the movement of the traveler ([0071]).
With regards to claim 2, Shipley as modified by Perszyk discloses the catheter device according to claim 1, and further that wherein in the first state the locking element is configured to set a limit to the movement of the traveler in the distal direction ([0071]) such that the capsule completely covers the implant when the traveler is positioned at said limit ([0075]) and the inner and outer sheath have not yet been permanently deformed during operation of the catheter device (it is noted that the limitation as claimed does not require the inner and outer sheaths be permanently deformed during operation).
With regards to claim 3, Shipley as modified by Perszyk discloses the catheter device according to claim 1, wherein in the second state the locking element is configured to allow further movement of the traveler and therewith of the capsule in the distal direction such that the implant is completely coverable by the capsule despite a permanent compression of the outer sheath and/or despite a permanent elongation of the inner sheath in the direction of the longitudinal axis (([0074]); the locking element is structured as claimed, thereby is configured to perform the function as claimed and it is noted that the limitation as claimed does not require a permanent compression of the outer sheath and/or despite a permanent elongation of the inner sheath in the direction of the longitudinal axis).
Claim(s) 4-7, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shipley (20200054452) in view of Perszyk (20190083261) as applied to claim 1 above, and further in view of You (20190021460).
With regards to claim 4, Shipley as modified by Perszyk discloses the catheter device according to claim 1, but fails to disclose wherein the handle comprises an elongated rod that is slidable along the longitudinal axis wherein when the locking element is in its first state, the rod is configured to be pressed by the traveler against the locking element to limit the movement of the traveler in the distal direction, wherein a first spring connected to the traveler is arranged between the traveler and the rod and is pretensioned against the rod when the traveler presses against the locking element.
You discloses a sliding deployment mechanism, and teaches wherein the handle (FIG 1, the whole shaft considered part of the handle, as it is part of what is manipulated by hand) comprises an elongated rod (51) that is slidable along the longitudinal axis ([0049]) wherein when the locking element (20) is in its first state, the rod (51) is configured to be pressed by the traveler (514) against the locking element (traveler and locking element communicate at 514 and 223) to limit the movement of the traveler in the distal direction ([0049]), wherein a first spring (55) connected to the traveler is arranged between the traveler (514) and the rod (51) and is pretensioned against the rod when the traveler presses against the locking element (FIG 7, see annotated figure below).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Shipley to include that wherein the handle comprises an elongated rod that is slidable along the longitudinal axis wherein when the locking element is in its first state, the rod is configured to be pressed by the traveler against the locking element to limit the movement of the traveler in the distal direction, wherein a first spring connected to the traveler is arranged between the traveler and the rod and is pretensioned against the rod when the traveler presses against the locking element, as taught by You, in order to improve on locking mechanisms found in existing catheter deployment systems, and as spring mechanisms are taught to greatly facilitate opening or closing ([0003]).
With regards to claim 5, Shipley as modified by Perszyk and You discloses the catheter device according to claim 4, wherein the locking element is configured to release the rod when the locking element is moved from the first state to the second state, wherein the rod is pushed in the distal direction by the first spring ([0052]).
With regards to claim 6, , Shipley as modified by Perszyk and You discloses the catheter device according to claim 5, wherein when the locking element is in the second state, further movement of the traveler in the distal direction pushes the rod against a stop to finally limit further movement of the traveler and therewith of the capsule in the distal direction (FIG 4), wherein the first spring is pretensioned by the traveler against the rod and a second spring is pretensioned by the rod against a guiding member that guides the rod and forms said stop (FIG 4).
With regards to claim 7, Shipley as modified by Perszyk and You discloses the catheter device according to claim 6, but fails to disclose wherein the handle comprises an actuator configured to be manually actuated by a user, wherein the actuator is operatively connected to the locking element such that the locking element is moved from the first state to the second state when the actuator is actuated by a user.
You further teaches the handle comprises an actuator configured to be manually actuated by a user (23, 24), wherein the actuator is operatively connected to the locking element such that the locking element is moved from the first state to the second state when the actuator is actuated by a user ([0053]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Shipley to include wherein the handle comprises an actuator configured to be manually actuated by a user, wherein the actuator is operatively connected to the locking element such that the locking element is moved from the first state to the second state when the actuator is actuated by a user, as taught by You, in order to operate the locking element to be moved between the first and second states ([0053]).
With regards to claim 12, Shipley as modified by Perszyk and You discloses the catheter device according to claim 6, wherein the deployment knob is rotatably supported on the guiding member of the handle (FIG 1A).
Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shipley (20200054452) in view of Perszyk (20190083261) and You (20190021460) as applied to claim 7 above, and further in view of Dingzhan (CN103603858B).
With regards to claim 8, Shipley as modified by Perszyk and You discloses the catheter device according to claim 7, but fails to disclose wherein the handle comprises a third spring configured to be pretensioned against the locking element when the locking element is moved from the first state to the second state.
Dingzhan also discloses a locking element (FIG 3). Dingzhan teaches a locking mechanism with a spring (7) configured to be pretensioned against the locking element (6) when the locking element is moved from the first state to the second state (FIG 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Shipley to include that the handle comprises a third spring configured to be pretensioned against the locking element when the locking element is moved from the first state to the second state, as taught by Dingzhan, in order to keep the system locked until the pin is pushed ([38] of English translation).
With regards to claim 9, Shipley as modified by Perszyk, You, and Dingzhan discloses the catheter device according to claim 8, and that the rod is configured to be pressed by the traveler against the locking element with said step to limit the movement of the traveler in the distal direction, but fails to disclose wherein the locking element comprises an opening having a narrow portion and an adjacent wider portion, and wherein the rod comprises a distal portion comprising a narrow section having a diameter that is smaller than a diameter of an adjacent proximal portion of the rod so that the rod forms a step, wherein when the locking element is in the first state said narrow section of the rod is arranged in the narrow portion of the opening.
Dingzhan further teaches wherein the locking element comprises an opening (4, 8) having a narrow portion (8) and an adjacent wider portion (4), and wherein the rod (2) comprises a distal portion comprising a narrow section having a diameter that is smaller than a diameter of an adjacent proximal portion of the rod so that the rod forms a step (FIG 3), wherein when the locking element is in the first state said narrow section of the rod is arranged in the narrow portion of the opening (FIG 6). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Shipley to include wherein the locking element comprises an opening having a narrow portion and an adjacent wider portion, and wherein the rod comprises a distal portion comprising a narrow section having a diameter that is smaller than a diameter of an adjacent proximal portion of the rod so that the rod forms a step, wherein when the locking element is in the first state said narrow section of the rod is arranged in the narrow portion of the opening, as taught by Dingzhan, in order to selectively lock and restrict the movement of the rod ([41] of English translation).
With regards to claim 10, Shipley as modified by Perszyk, You, and Dingzhan discloses the catheter device according to claim 9, but fails to disclose wherein when the locking element is moved from the first state to the second state, the rod is arranged in the wide portion of the opening so that the step is allowed to move through the wide portion of the opening of the rod by action of the first spring. Dingzhan further teaches wherein when the locking element is moved from the first state to the second state, the rod is arranged in the wide portion of the opening so that the step is allowed to move through the wide portion of the opening of the rod by action of the first spring (FIG 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Shipley to include that wherein when the locking element is moved from the first state to the second state, the rod is arranged in the wide portion of the opening so that the step is allowed to move through the wide portion of the opening of the rod by action of the first spring, as taught by Dingzhan, in order to selectively lock and restrict the movement of the rod ([41] of English translation).
With regards to claim 11, Shipley as modified by Perszyk, You, and Dingzhan discloses the catheter device according to claim 10, wherein when the second spring is pretensioned, moving the traveler and therewith the capsule in the proximal direction causes the second spring to also move the rod in the proximal direction (42, where the structure of this spring would have this behavior), but fails to disclose such that said narrow section of the rod moves into the wide portion of the opening of the locking element at a certain position of the traveler such that the third spring moves the locking element back into the first state in which said narrow section of the rod is arranged in the narrow portion of the opening of the locking element.
Dingzhan further teaches a locking mechanism in that said narrow section of the rod moves into the wide portion of the opening of the locking element at a certain position of the traveler such that the third spring moves the locking element back into the first state in which said narrow section of the rod is arranged in the narrow portion of the opening of the locking element (FIG 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Shipley to include that said narrow section of the rod moves into the wide portion of the opening of the locking element at a certain position of the traveler such that the third spring moves the locking element back into the first state in which said narrow section of the rod is arranged in the narrow portion of the opening of the locking element, as taught by Dingzhan, in order to keep the system locked until the pin is pushed ([38] of English translation).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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