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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "113" and "115" have both been used to designate the dilator in Fig. 2A (Examiner’s note: no GW is shown in Fig. 2A for reference number 113 to point to). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 9, 14, 15, 17, and 18 are objected to because of the following informalities:
Claims 9 and 18 recite “the top of incision assembly”, however this is not grammatically correct as there is no article (a/an/the) before the noun, therefore, the Examiner suggests the lines be amended to read “the top of the incision assembly”;
Claim 14 recites “provide at least one of: ….. to energize the”, however this is not grammatically correct, therefore the Examiner suggests the line be amended to read “provide at least one of: … energy to the”;
Claims 15 and 17 recite “a force” in lines 13 and 14, respectively, although the lines are understood by the Examiner to mean “the force” as the “force” was defined in previous lines, the Examiner suggests the lines be amended to read “the force” for the purpose of maintaining consistent language throughout the claims;
Appropriate correction is required.
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 1 – 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.
Regarding claims 1, 7, 8, 9, 15, 17, and 18, the phrases "reversibly extends" renders the claim indefinite because it is unclear if Applicant is intending the limitation to mean that the incision member and/or the stabilizing members are oriented in a reversed orientation relative to a more desired orientation of the incision member and/or the stabilizing member or if Applicant is intending the limitations to mean that the incision member and/or the stabilizing members have an unextended position and an extended position, wherein the unextended position is the reversed position of the extended position and the incision member and/or the stabilizing members can extend and unextend in the manner claimed. For the purpose of examination and based off Applicant’s disclosure, the Examiner will read the limitation to mean the latter.
Claim 14 recites the limitation "incision device" in lines 3 and 4. There is insufficient antecedent basis for this limitation in the claim. Additionally, the limitation renders the claim indefinite because it is unclear if Applicant is intending for the “incision device” to be the “incision assembly” or the “incision member”, wherein it is unclear if Applicant is intending for the claim to require that the extension / retraction and the energizing is proved to the entire incision assembly or only the incision member. For the purpose of examination and based off of Applicant’s disclosure, the Examiner will read the claim such that “incision device” is equal to the “incision member”.
Claims 2 – 14, 16, and 18 – 20 are rejected for being dependent on an indefinite 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 (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.
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, 5 – 9, 11, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barnes et al (US 2019/0262024 A1).
Regarding claim 1, Barnes discloses a device (soft tissue cutting device 100) capable of transecting pericardial tissue (abstract, paragraphs [0050], [0102], and Figs. 1, 8 – 13) (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. With that said, the device of Barnes is a tissue cutter capable of cutting pericardial tissue) comprising:
an elongated body (shaft 120) with a proximal end (proximal end 112) and a distal end (distal end 114), and extending along a longitudinal length (paragraphs [0102 – 0105] and Figs. 1, 8 – 13); and
an incision assembly (base plate 128 and blade 126) coupled to the distal end of the elongated body (paragraph [0103] and Figs. 8 – 13), the incision assembly comprising an incision member (blade 126) aligned with the longitudinal length of the elongated body (Fig. 8) and comprising respective first and second ends (left and right lateral ends of blade 126) coupled to the incision assembly (Fig. 8,9) (Examiner’s note: both ends of the blade 126 are attached to the base plate 128. Additionally, it is noted that the incision assembly includes the incision member, therefore, the ends of incision member are parts of the incision assembly; and because the ends are parts of the incision assembly they are coupled to the assembly),
wherein at least a portion of the incision member (blade 126) is structured to reversibly extend laterally from the elongated body (Examiner’s note: as discussed in the 112(b) rejection above, the Examiner is reading “reversibly extend” to mean to move from an extended position to an un-extended position; and as recited in paragraph [0109] the blade 126 (i.e., the incision member) moves upwards to an extended position and downward to an un-extended position).
Regarding claim 5, Barnes discloses further comprising an actuator (balloon 130) operably coupled to the incision assembly (base plate 128 and blade 126) (paragraph [0109] and Figs. 12,13) and structured to operably laterally retract and extend the incision assembly from the elongated body by respectively removing (deflating of the balloon) and applying (inflating of the balloon) a force (expansion / inflation force) to the incision assembly (base plate 128 and blade 126) (paragraph [0109] and Figs. 12,13).
Regarding claim 6, Barnes discloses wherein at least a portion of the incision member is a sharpened edge (cutting edge 132) (paragraph [0107] and Figs. 12,13).
Regarding claim 7, Barnes discloses wherein the elongated body (shaft 120) comprises an opening (opening 124) and the incision member structured to reversibly extend laterally from the opening (opening 124) (paragraphs [0106] and [0109], and Figs. 8,9,12,13).
Regarding claim 8, Barnes discloses further comprising one or more stabilizing members (balloons 136, 134a,b) configured to reversibly extend laterally from the elongated body (shaft 120) (paragraphs [0102], [0112], [0114], and Figs. 12,13).
Regarding claim 9, Barnes discloses further comprising: an opening (opening 124) positioned on the top of the incision assembly (base plate 128 and blade 126) (Figs. 12,13), the incision member (blade 126) structured to reversibly extend laterally from the opening (paragraphs [0106] and [0109], and Figs. 8,9,12,13); and two or more stabilizing members (balloons 136, 134a,b) positioned radially about the incision assembly and aligned on a bottom of the incision member (blade 126) (paragraphs [0102], [0112], [0114], and Figs. 12,13).
Regarding claim 11, Barnes discloses further comprising an introducer or a dilator (distal tip 122) adjacent the distal end of the incision assembly (base plate 128 and blade 126) (Examiner’s note: Applicant equates a “dilator” as a conical tapered nose cone structure, and as stated in paragraph [0105] and shown in Figs 8 – 11, the distal tip is a conical tapered nose cone structure; therefore, the distal tip 122 is considered as a dilator).
Regarding claim 14, Barnes discloses further comprising a controller (control) engaged to the incision assembly (paragraph [0122]), wherein the controller is structured to provide at least one of: rotation of the elongated body, extension and retraction of the incision device (paragraph [0122]), and/or to energize the incision device.
Claims 1 – 6, 8, 11, 14 – 17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoffman (US 2,816,552).
Regarding claim 1, Hoffman teaches a device (teat bistoury) (col. 1 lines 15 – 55, col. 2 lines 16 – 30, col. 2 line 55 – col. 3 line 5, col. 4 lines 7 – 60, and Figs. 9 – 13) capable of transecting pericardial tissue (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. Additionally, as stated in col. 4 lines 7 – 15 the construction and parts of the device in the embodiment of Figs. 9 – 13 are the same as those in the embodiment of Figs. 1 – 8, therefore, although the Examiner is relying upon the embodiment of Figs. 9 – 13, citations may be made to the structure and construction of parts in the embodiment of Figs. 1 – 8 for the purpose of showing the structure and construction of parts for the embodiment of Figs. 9 – 13) comprising:
an elongated body (barrel 14) with a proximal end and a distal end, and extending along a longitudinal length (Fig. 10);
an incision assembly (first collar 56, one of the blades 60, second collar 58) coupled to the distal end of the elongated body (col. 2 line 55 – col. 3 line 5 and Fig. 10), the incision assembly (first collar 56, one of the blades 60, second collar 58) comprising an incision member (one of the blades 60) aligned with the longitudinal length of the elongated body and comprising respective first and second ends (ends coupled to the collars) coupled to the incision assembly (col. 2 line 55 – col. 3 line 5 and Fig. 10), wherein at least a portion of the incision member (one of the blades 60) is structured to reversibly extend laterally from the elongated body (barrel 14) (col. 4 lines 7 – 60 and Figs. 9 – 13) (Examiner’s note: as discussed in the 112(b) rejection above, the Examiner is reading “reversibly extend” to mean to move from an extended position to an un-extended position).
Regarding claim 2, Hoffman discloses further comprising an actuator (rod 40) operably coupled to the incision assembly (first collar 56, one of the blades 60, second collar 58), the actuator traversing along the longitudinal length of the elongated body (barrel 14) from a first configuration (configuration when the rod 40 is removed from the barrel – discussed in col 2. Lines 55 – 65) disengaged with the incision member to a second configuration (configuration when within the barrel 14 via threaded attachment 44 – discussed in col. 2 lines 55 – 65) engaged with the incision member (one of the blades 60) such that in the second configuration the incision member is laterally extended from the elongated body (barrel 14) (Examiner’s note: as stated in col. 2 line 55 – col. 3 line 5 the blades have a normally contracted stated, which means that the blades are in the contracted state when the rod 40 (i.e., the actuator) is removed / disengaged from the incision assembly and thus the incision member, furthermore, when the rod 40 is coupled to the distal end of the barrel via the threaded attachment 44 and rotated, (as described in col. 4 lines 31 – 60), the blades flex / extend outward laterally from the barrel 14 (i.e., the elongated body). Thus, Hoffman discloses the limitations substantially as claimed).
Regarding claim 3, Hoffman discloses wherein the actuator (rod 40) is a rigid rod (col. 2 lines 55 – 60).
Regarding claim 4, Hoffman discloses wherein the incision member (one of the blades 60) is planar and rigidly flexible (col. 2 line 60 – col. 3 line 5 and Figs. 10,11).
Regarding claim 5, Hoffman discloses further comprising an actuator (rod 40) operably coupled to the incision assembly (first collar 56, one of the blades 60, second collar 58) and structured to operably laterally retract and extend the incision assembly from the elongated body (barrel 14) by respectively removing (Fig. 10) and applying (Fig. 11) a force (compression / torsional force) to the incision assembly (col. 4 lines 15 – 20, col. 4 lines 35 – 44, and Figs. 9 – 11).
Regarding claim 6, Hoffman discloses wherein at least a portion of the incision member (one of the blades 60) is a sharpened edge (col. 1 lines 45 – 54).
Regarding claim 8, Hoffman discloses further comprising one or more stabilizing members (the other blades 60 not designated by the Examiner as the “incision member) configured to reversibly extend laterally from the elongated body (col. 4 lines 31 – 60 and Figs. 9,11).
Regarding claim 11, Hoffman discloses further comprising a dilator (nose 48) adjacent the distal end of the incision assembly (Figs. 9 – 11) (Examiner’s note: Applicant equates a “dilator” as a conical tapered nose cone structure, and as stated in col. 2 lines 55 – 65 and shown in Figs 9 – 11, the distal tip is a bullet-shaped / conical tapered nose cone; therefore, the nose 48 is considered as a dilator).
Regarding claim 14, Hoffman discloses further comprising a controller (lever 90) engaged to the incision assembly (first collar 56, blades 60, second collar 58) (col. 2 lines 55 – 70, col. 4 lines 20 – 70, and Figs. 9 – 13), wherein the controller is structured to provide at least one of: rotation of the elongated body, extension and retraction of the incision device (col. 4 lines 20 – 70), and/or to energize the incision device.
Regarding claim 15, Hoffman discloses a device (teat bistoury) (col. 1 lines 15 – 55, col. 2 lines 16 – 30, col. 2 line 55 – col. 3 line 5, col. 4 lines 7 – 60, and Figs. 9 – 13) capable of transecting pericardial tissue (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. Additionally, as stated in col. 4 lines 7 – 15 the construction and parts of the device in the embodiment of Figs. 9 – 13 are the same as those in the embodiment of Figs. 1 – 8, therefore, although the Examiner is relying upon the embodiment of Figs. 9 – 13, citations may be made to the structure and construction of parts in the embodiment of Figs. 1 – 8 for the purpose of showing the structure and construction of parts for the embodiment of Figs. 9 – 13) comprising:
an elongated body (barrel 14) with a proximal end and a distal end, and extending along a longitudinal length (Fig. 10);
an incision assembly (first collar 56, one of the blades 60, second collar 58) coupled to the distal end of the elongated body (col. 2 line 55 – col. 3 line 5 and Fig. 10), the incision assembly (first collar 56, one of the blades 60, second collar 58) comprising an incision member (one of the blades 60) aligned with the longitudinal length of the elongated body and comprising respective first and second ends (ends coupled to the collars) coupled to the incision assembly (col. 2 line 55 – col. 3 line 5 and Fig. 10), wherein at least a portion of the incision member (one of the blades 60) is structured to reversibly extend laterally from the elongated body (barrel 14) (col. 4 lines 7 – 60 and Figs. 9 – 13), (Examiner’s note: as discussed in the 112(b) rejection above, the Examiner is reading “reversibly extend” to mean to move from an extended position to an un-extended position; and as recited in col. 4 lines 7 – 60 and shown in Figs. 9 – 13 the blades 60 (i.e., the incision member) moves upwards to an extended position and downward to an un-extended position, and thus the blades are reversibly extendable);
stabilizing members (the other blades 60 that are not designated as the “incision member”) adjacent to the incision assembly (first collar 56, one of the blades 60, second collar 58) structured to reversibly extend laterally from the elongated body (barrel 14) (col. 4 lines 31 – 60 and Figs. 9,11); and
an actuator (rod 40) operably coupled to the incision assembly (first collar 56, one of the blades 60, second collar 58) (col. 4 lines 31 – 60 and Figs. 9,11) and structured to operably laterally retract and extend the incision assembly from the elongated body by respectively removing (Fig. 10) and applying (Fig. 11) a force (compression / torsional force) to the incision assembly (first collar 56, one of the blades 60, second collar 58) (paragraph [0109] and Figs. 12,13), wherein when said actuator (rod 40) applies a force (compression / torsional force) (col. 4 lines 31 – 60 and Figs. 9,11) to the incision assembly (first collar 56, one of the blades 60, second collar 58), the incision assembly (first collar 56, one of the blades 60, second collar 58) flexes (bows) laterally and extends from the elongated body (col. 2 lines 60 – col. 3 line 5, col. 4 lines 31 – 60, and Fig. 11).
Regarding claim 16, wherein at least a portion of the incision member one of the blades 60) is a sharpened edge (col. 1 lines 45 – 54).
Regarding claim 17, Hoffman discloses a device (teat bistoury) (col. 1 lines 15 – 55, col. 2 lines 16 – 30, col. 2 line 55 – col. 3 line 5, col. 4 lines 7 – 60, and Figs. 9 – 13) capable of transecting pericardial tissue (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. Additionally, as stated in col. 4 lines 7 – 15 the construction and parts of the device in the embodiment of Figs. 9 – 13 are the same as those in the embodiment of Figs. 1 – 8, therefore, although the Examiner is relying upon the embodiment of Figs. 9 – 13, citations may be made to the structure and construction of parts in the embodiment of Figs. 1 – 8 for the purpose of showing the structure and construction of parts for the embodiment of Figs. 9 – 13) comprising:
an elongated body (barrel 14) with a proximal end and a distal end, and extending along a longitudinal length (Fig. 10);
an incision assembly (first collar 56, one of the blades 60, second collar 58) coupled to the distal end of the elongated body (col. 2 line 55 – col. 3 line 5 and Fig. 10), the incision assembly (first collar 56, one of the blades 60, second collar 58) comprising an incision member (one of the blades 60) aligned with the longitudinal length of the elongated body and comprising respective first and second ends (ends coupled to the collars) coupled to the incision assembly (col. 2 line 55 – col. 3 line 5 and Fig. 10), wherein at least a portion of the incision member (one of the blades 60) is structured to reversibly extend laterally from the elongated body (barrel 14) (col. 4 lines 7 – 60 and Figs. 9 – 13), (Examiner’s note: as discussed in the 112(b) rejection above, the Examiner is reading “reversibly extend” to mean to move from an extended position to an un-extended position; and as recited in col. 4 lines 7 – 60 and shown in Figs. 9 – 13 the blades 60 (i.e., the incision member) moves upwards to an extended position and downward to an un-extended position, and thus the blades are reversibly extendable);
two or more stabilizing members (two of the other blades 60 that are not designated as the “incision member”) positioned radially about the incision assembly (first collar 56, one of the blades 60, second collar 58) and aligned on a bottom of the incision member (first collar 56, one of the blades 60, second collar 58) (Figs. 2,10,11) and to reversibly extend laterally from the elongated body (col. 4 lines 7 – 60 and Figs. 9 – 13); and
an actuator (rod 40) operably coupled to the incision assembly (first collar 56, one of the blades 60, second collar 58) (col. 4 lines 31 – 60 and Figs. 9,11) and structured to operably laterally retract and extend the incision assembly from the elongated body by respectively removing (Fig. 10) and applying (Fig. 11) a force (compression / torsional force) to the incision assembly (first collar 56, one of the blades 60, second collar 58) (paragraph [0109] and Figs. 12,13), wherein when said actuator (rod 40) applies a force (compression / torsional force) (col. 4 lines 31 – 60 and Figs. 9,11) to the incision assembly (first collar 56, one of the blades 60, second collar 58), the incision assembly (first collar 56, one of the blades 60, second collar 58) flexes (bows) laterally and extends from the elongated body (col. 2 lines 60 – col. 3 line 5, col. 4 lines 31 – 60, and Fig. 11).
Regarding claim 19, wherein at least a portion of the incision member one of the blades 60) is a sharpened edge (col. 1 lines 45 – 54).
Claims 1, 6, 7, 8, 11, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lary (US 2009/0125044 A1).
Regarding claim 1, Lary discloses a device (myocardium transection 10) (abstract, paragraphs [0046 – 0049], and Figs. 5A,B,C) capable of transecting pericardial tissue (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88), the device comprising:
an elongated body (catheter 28) with a proximal end and a distal end, and extending along a longitudinal length (paragraphs [0047 – 0029] and Fig. 5A); and
an incision assembly (nuts 62,64 and blade 60) coupled to the distal end of the elongated body (catheter 28) (paragraph [0046] and Fig. 5A), the incision assembly (nuts 62,64 and blade 60) comprising an incision member (blade 60) aligned with the longitudinal length of the elongated body (Fig. 5A) and comprising respective first and second ends coupled to the incision assembly (nuts 62,64 and blade 60) (Fig. 5A), wherein at least a portion of the incision member is structured to reversibly extend laterally from the elongated body (Figs. 5A,B) (Examiner’s note: as discussed in the 112(b) rejection above, the Examiner is reading “reversibly extend” to mean to move from an extended position to an un-extended position).
Regarding claim 6, Lary discloses wherein at least a portion of the incision member (blade 60) is a sharpened edge (edge of blade 60) (Examiner’s note: the blade 60 is used to transect tissue, and in order to transect the tissue the blade must have a sharp edge).
Regarding claim 7, Lary discloses wherein the elongated body (catheter 28) comprises an opening (side of catheter 28 looking at Figs. 5A,B) the incision member structured to reversibly extend laterally from the opening (Figs. 5A,B).
Regarding claim 8, Lary discloses further comprising one or more stabilizing members (brace 58) configured to reversibly extend laterally from the elongated body (catheter 28) (paragraph [0048] and Fig. 5C).
Regarding claim 11, Lary discloses further comprising a dilator (distal end 30) adjacent the distal end of the incision assembly (paragraph [0042] and Fig. 5A).
Regarding claim 12, Lary discloses wherein the dilator (distal end 30) is structured for receiving a guidewire (guidewire 32) (paragraph [0042]).
Regarding claim 14, Lary discloses further comprising a controller (controller 34) engaged to the incision assembly (nuts 62,64 and blade 60) (paragraph [0046]), wherein the controller is structured to provide at least one of: rotation of the elongated body, extension and retraction of the incision device (paragraph [0046]), and/or to energize the incision device.
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 (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.
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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al (US 2019/0262024 A1), as applied to claim 1 above, and further in view of Long et al (US 2012/0220998 A1).
Regarding claim 13, as discussed above, Barnes discloses the tissue transection device of claim 1.
However, Barnes is silent regarding (i) wherein the pericardial transection device is sterilized.
As to the above, Long teaches a medical device for cutting tissue used within the body, wherein the medical device is sterilized before surgery for the purpose of killing harmful bacteria (abstract and paragraph [0101]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify to modify the device of Barnes to be sterilized, as taught by Long, for the purpose of killing harmful bacteria (paragraph [0101] – Long).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 2,816,552), as applied to claim 1 above, and further in view of Long et al (US 2012/0220998 A1).
Regarding claim 13, as discussed above, Hoffman discloses the tissue transection device of claim 1.
However, Hoffman is silent regarding (i) wherein the pericardial transection device is sterilized.
As to the above, Long teaches a medical device for cutting tissue, wherein the medical device is sterilized before surgery for the purpose of killing harmful bacteria (abstract and paragraph [0101]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify to modify the device of Lary to be sterilized, as taught by Long, for the purpose of killing harmful bacteria (paragraph [0101] – Long).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lary (US 2009/0125044 A1), as applied to claim 1 above, and further in view of Laufer et al (US 2016/0206345 A1).
Regarding claim 10, as discussed above, Lary discloses the tissue transection device of claim 1.
However, Lary is silent regarding (i) a retractable sheath covering the incision assembly.
As to the above, Laufer teaches a device (treatment device 100) for cutting tissue comprising an elongated body (shaft 110) and an incision assembly (cutting assembly 140) coupled to a distal end of the elongated body (shaft 110) comprising an incision member (cutting edge 142) coupled to the incision assembly and structured to reversibly extend out of an opening (opening 124) of the elongated body (shaft 110) (abstract, paragraphs [0040 – 0046], and Figs. 1,2A-C), the device further comprising a retractable sheath (sheath 164) covering the incision assembly for the purpose of having an added safety measure (paragraph [0045]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Lary to incorporate a retractable sheath, based on the teachings of Laufer, for the purpose of adding an extra safety measure to protect against unintended tissue cutting (paragraph [0045] – Laufer).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lary (US 2009/0125044 A1), as applied to claim 1 above, and further in view of Long et al (US 2012/0220998 A1).
Regarding claim 13, as discussed above, Lary discloses the tissue transection device of claim 1.
However, Lary is silent regarding (i) wherein the pericardial transection device is sterilized.
As to the above, Long teaches a medical device for cutting tissue, wherein the medical device is sterilized before surgery for the purpose of killing harmful bacteria (abstract and paragraph [0101]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify to modify the device of Lary to be sterilized, as taught by Long, for the purpose of killing harmful bacteria (paragraph [0101] – Long).
Claims 15 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lary (US 2009/0125044 A1) and in view of McDonald (US 2017/0027600 A1) and Carli et al (US 2008/0300636 A1).
Regarding claim 15, Lary discloses a device (myocardium transection 10) (abstract, paragraphs [0046 – 0049], and Figs. 5A,B,C) capable of transecting pericardial tissue (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88), the device comprising:
an elongated body (catheter 28) with a proximal end and a distal end, and extending along a longitudinal length (paragraphs [0047 – 0029] and Fig. 5A); and
an incision assembly (nuts 62,64 and blade 60) coupled to the distal end of the elongated body (catheter 28) (paragraph [0046] and Fig. 5A), the incision assembly (nuts 62,64 and blade 60) comprising an incision member (blade 60) aligned with the longitudinal length of the elongated body (Fig. 5A) and comprising respective first and second ends coupled to the incision assembly (nuts 62,64 and blade 60) (Fig. 5A), wherein at least a portion of the incision member is structured to reversibly extend laterally from the elongated body (Fig. 5B);
a stabilizing member (brace 58) adjacent to the incision assembly (nuts 62,64 and blade 60) structured to reversibly extend laterally from the elongated body (paragraph [0048] and Fig. 5C); and
an actuator (screw rod 63) operably coupled to the incision assembly (nuts 62,64 and blade 60).
However, Lary is silent regarding (i) comprising multiple stabilizing members and (ii) the actuator structured to operably laterally retract and extend the incision assembly from the elongated body by respectively removing and applying a force to the incision assembly, wherein when said actuator applies a force to the incision assembly, the incision assembly flexes laterally and extends from the elongated body.
As to (i), McDonald teaches a transection device (cardiac valve cutter 10) comprising an elongated body (elongated housing 9), an incision assembly (cutting wire 19), and a plurality of stabilizers (lower and upper pusher wires 21,22) that are structured to reversibly extend through an opening in the elongated body for the purpose of stabilizing the device (abstract, paragraphs [0023], [0027 – 0028], [0033], and Fig. 1).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Lary to incorporate additional stabilizers, based on the teachings of McDonald, for the purpose of adding additional stabilization to the device during the procedure.
As to (ii), Carli teaches a surgical cutting device (reduction instrument 1) comprising an elongated body (tube 20), an incision assembly (arms 13, 14, and blade 5) comprising an incision member (blade 5; which equates to the blade 60 of Lary) structured to reversibly extend laterally from the elongated body (abstract, paragraphs [0032 – 0039], and Figs. 1,2,8), and an actuator (rod 20) structured to operably laterally retract and extend the incision assembly (arms 13, 14, and blade 5) from the elongated body (tube 20) by respectively removing and applying a force (pushing force) to the incision assembly (paragraph [0036]), wherein when said actuator applies a force to the incision assembly, the incision assembly flexes laterally and extends from the elongated body (paragraphs [0036 – 0040] and Figs. 3 – 4).
It should be understood that Lary and Carli are known references in the art that teach tissue cutting device with a retractable blade (abstract, paragraphs [0046 – 0049], and Figs. 5A,B,C – Lary ; abstract, paragraphs [0032 – 0039], and Figs. 1,2,8 – Carli); and the examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one incision member, actuation means, and method of actuating the incision member for another incision member, actuation means, and method of actuating the incision member (i.e., substituting the blade, actuation rod, and means of actuating the blade out of the elongate body of Lary for that of Carli), and the results of the substitution would have been predictable and resulted in the modified device of Lary being able to function as intended to properly cut / transect tissue. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Regarding claim 16, as discussed above it would have been obvious to modify the device of Lary with additional stabilizers and with the blade / actuation means of McDonald and Carli, respectively. Additionally, the combination makes obvious wherein at least a portion of the incision member (blade 5) is a sharpened edge (Examiner’s note: although Carli does not recite wherein the blade 5 has a sharpened edge; it would be obvious to one of ordinary skill in the art for the blade 5 of Carli with the device of Lary to have a sharpened cutting edge for the purpose of being able to cut / transect the tissue as desired, as taught by Lary – paragraph [0035]).
Regarding claim 17, Lary discloses a device (myocardium transection 10) (abstract, paragraphs [0046 – 0049], and Figs. 5A,B,C) capable of transecting pericardial tissue (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88), the device comprising:
an elongated body (catheter 28) with a proximal end and a distal end, and extending along a longitudinal length (paragraphs [0047 – 0029] and Fig. 5A); and
an incision assembly (nuts 62,64 and blade 60) coupled to the distal end of the elongated body (catheter 28) (paragraph [0046] and Fig. 5A), the incision assembly (nuts 62,64 and blade 60) comprising an incision member (blade 60) aligned with the longitudinal length of the elongated body (Fig. 5A) and comprising respective first and second ends coupled to the incision assembly (nuts 62,64 and blade 60) (Fig. 5A), wherein at least a portion of the incision member is structured to reversibly extend laterally from the elongated body (Fig. 5B);
a stabilizing member (brace 58) adjacent to aligned on a bottom of the incision member (nuts 62,64 and blade 60) structured to reversibly extend laterally from the elongated body (paragraph [0048] and Fig. 5C) (Examiner’s note: as discussed in the 112(b) rejection above, the Examiner is reading “reversibly extend” to mean to move from an extended position to an un-extended position); and
an actuator (screw rod 63) operably coupled to the incision assembly (nuts 62,64 and blade 60).
However, Lary is silent regarding (i) comprising two or more stabilizing members positioned radially about the incision assembly and (ii) the actuator structured to operably laterally retract and extend the incision assembly from the elongated body by respectively removing and applying a force to the incision assembly, wherein when said actuator applies a force to the incision assembly, the incision assembly flexes laterally and extends from the elongated body.
As to (i), McDonald teaches a transection device (cardiac valve cutter 10) comprising an elongated body (elongated housing 9), an incision assembly (cutting wire 19), and a plurality of stabilizers (lower and upper pusher wires 21,22) that are structured to reversibly extend through an opening in the elongated body for the purpose of stabilizing the device (abstract, paragraphs [0023], [0027 – 0028], [0033], and Fig. 1).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Lary to incorporate additional stabilizers, based on the teachings of McDonald, for the purpose of adding additional stabilization to the device during the procedure. It should be noted that the prior art makes obvious radially spacing the additional stabilizing members about the incision assembly in order to increase the overall stability of the system in multiple planes; thus the combination above encompasses two or more stabilizers positioned radially about the incision assembly and along the bottom.
As to (ii), Carli teaches a surgical cutting device (reduction instrument 1) comprising an elongated body (tube 20), an incision assembly (arms 13, 14, and blade 5) comprising an incision member (blade 5; which equates to the blade 60 of Lary) structured to reversibly extend laterally from the elongated body (abstract, paragraphs [0032 – 0039], and Figs. 1,2,8), and an actuator (rod 20) structured to operably laterally retract and extend the incision assembly (arms 13, 14, and blade 5) from the elongated body (tube 20) by respectively removing and applying a force (pushing force) to the incision assembly (paragraph [0036]), wherein when said actuator applies a force to the incision assembly, the incision assembly flexes laterally and extends from the elongated body (paragraphs [0036 – 0040] and Figs. 3 – 4).
It should be understood that Lary and Carli are known references in the art that teach tissue cutting device with a retractable blade (abstract, paragraphs [0046 – 0049], and Figs. 5A,B,C – Lary ; abstract, paragraphs [0032 – 0039], and Figs. 1,2,8 – Carli); and the examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one incision member, actuation means, and method of actuating the incision member for another incision member, actuation means, and method of actuating the incision member (i.e., substituting the blade, actuation rod, and means of actuating the blade out of the elongate body of Lary for that of Carli), and the results of the substitution would have been predictable and resulted in the modified device of Lary being able to function as intended to properly cut / transect tissue. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Regarding claim 18, as discussed above it would have been obvious to modify the device of Lary with additional stabilizers and with the blade / actuation means of McDonald and Carli, respectively. Additionally, Lary further comprising: an opening positioned on the top of incision assembly (Fig. 5A,B of Lary), and the combination teaches wherein the incision member (blade 5 of Carli) is structured to reversibly extend laterally from the opening (paragraphs [0032 – 0039], and Figs. 1,2,8 – Carli) (Examiner’s note: it should be understood that the combination encompasses wherein the blade 5 flexes in and out (i.e., reversibly extends) of the window / opening in the catheter / elongated body of Lary).
Regarding claim 19, as discussed above it would have been obvious to modify the device of Lary with additional stabilizers and with the blade / actuation means of McDonald and Carli, respectively. Additionally, the combination makes obvious wherein at least a portion of the incision member (blade 5) is a sharpened edge (Examiner’s note: although Carli does not recite wherein the blade 5 has a sharpened edge; it would be obvious to one of ordinary skill in the art for the blade 5 of Carli with the device of Lary to have a sharpened cutting edge for the purpose of being able to cut / transect the tissue as desired, as taught by Lary – paragraph [0035]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lary (US 2009/0125044 A1) in view of McDonald (US 2017/0027600 A1) and Carli et al (US 2008/0300636 A1), as applied to claim 17 above, and further in view of Laufer et al (US 2016/0206345 A1).
Regarding claim 20, as discussed above, the combination Lary, McDonald, and Carli teaches the tissue transection device of claim 17.
However, the combination Lary, McDonald, and Carli is silent regarding (i) a retractable sheath covering the incision assembly.
As to the above, Laufer teaches a device (treatment device 100) for cutting tissue comprising an elongated body (shaft 110) and an incision assembly (cutting assembly 140) coupled to a distal end of the elongated body (shaft 110) comprising an incision member (cutting edge 142) coupled to the incision assembly and structured to reversibly extend out of an opening (opening 124) of the elongated body (shaft 110) (abstract, paragraphs [0040 – 0046], and Figs. 1,2A-C), the device further comprising a retractable sheath (sheath 164) covering the incision assembly for the purpose of having an added safety measure (paragraph [0045]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Lary in view of McDonald, and Carli, to incorporate a retractable sheath, based on the teachings of Laufer, for the purpose of adding an extra safety measure to protect against unintended tissue cutting (paragraph [0045] – Laufer).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Reger (US 5,071,424) teaches a reversibly extendable blade from an opening in a shaft, wherein the blade is flexible.
Lunsford et al (US 2010/0268175 A1) teaches a reversibly extendable blade for transecting tissue.
Contact Information
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/Andrew Restaino/Primary Examiner, Art Unit 3771