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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/357,451, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application appears to be lacking sufficient disclosure to support the plurality of exposure windows, plurality of aligners and lacerators of claims 21, 33 and 37. If the Examiner has inadvertently overlooked any proper support within the prior-filed application, Applicant is please requested to provide direct citation for such support and reconsideration will be provided. The earliest priority having proper support appears to be the PCT filing (PCT/US2022/078352) dated 10/19/2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 4/19/2024 and 7/24/2025 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 21-25, 28-31 and 37-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vardi (US 2015/0359556).
Vardi discloses (see Fig. 3) a method and system for creating an interatrial aperture comprising the following claim limitations:
(claim 21) a catheter (100, Fig. 3) for lacerating a tissue (30, Fig. 3), comprising one or more exposure windows (i.e., distal aperture/window of catheter 100 at cone 60 and having needle 122 disposed therein; and/or i.e., recessed window between pins 120/120a housing collapsed blades 116 therein, as shown in Fig. 3); one or more lacerators (122, Fig. 3; and/or 116, Fig. 3), wherein the one or more lacerators (122) are configured to lacerate the tissue (30) and are deployed at or from the one or more exposure windows (as expressly shown in Fig. 3; [0088]; distal actuation of needle 122 to pierce tissue 30 expressly disclosed); and one or more aligners (60, Fig. 3; 117/120/120a, Fig. 3), wherein the one or more aligners (60) are deployable and configured to (i.e., capable of), when deployed, promote contact between the one or more lacerators (122) and the tissue (30) (as shown in Fig. 3; [0073]; [0079]; [0088]; cone 60 keeps lacerator 122 centered on the tissue 30 to be cut and also may further pull tissue 30 to a second lacerator 116);
(claim 22) wherein: the one or more exposure windows comprise a first exposure window (i.e., distal aperture/window of catheter 100 at cone 60 and having needle 122 disposed therein); the first exposure window is arranged in the catheter (100) to enable a lacerator (122) of the one or more lacerators to pierce the tissue (30) to create an opening in the tissue (30) (as shown in Fig. 3; [0088]); and a first aligner (60) of the one or more aligners is arranged to, when deployed, promote contact between the tissue (30) and a lacerator (116/122) of the one or more lacerators when at least a part of the catheter (100) is disposed in the opening of the tissue (30) (as shown in Fig. 3; [0071]; [0073]; [0077]-[0079]; [0088]);
(claim 23) wherein: the one or more exposure windows further comprise a second exposure window (i.e., recessed window between pins 120/120a housing collapsed blades 116 therein, as shown in Fig. 3); and the second exposure window is arranged in the catheter (100) to enable the lacerator (116) of the one or more lacerators (122/116) to slice the tissue (30) when the lacerator (116) of the one or more lacerators is deployed at or from the second exposure window of the catheter (100) (as shown in Fig. 3; [0077]-[0079]);
(claim 24) wherein: the one or more exposure windows comprise a first exposure window (i.e., distal aperture/window of catheter 100 at cone 60 and having needle 122 disposed therein) and a second exposure window (i.e., recessed window between pins 120/120a housing collapsed blades 116 therein, as shown in Fig. 3); and the one or more lacerators comprise: a first lacerator (122) advanceable through the catheter (100) such that the first lacerator (122) is exposable through the first exposure window (as shown in Fig. 3; [0088]; distal actuation of needle to pierce tissue 30 expressly disclosed); and a second lacerator (116, Fig. 3) advanceable through the catheter (100) such that the second lacerator (116) is exposable through the second exposure window (as shown in Fig. 3; [0077]-[0079]; blades 116 expressly extendable/exposable from catheter 100 to cut tissue 30);
(claim 25) wherein: the one or more exposure windows comprise a first exposure window (i.e., distal aperture/window of catheter 100 at cone 60 and having needle 122 disposed therein) and a second exposure window (i.e., recessed window between pins 120/120a housing collapsed blades 116 therein, as shown in Fig. 3); the first exposure window is an axial opening at a distal end of the catheter (100) (as expressly shown in Fig. 3), wherein at least one of the one or more lacerators (122) is configured to (i.e., capable of) lacerate the tissue (30) when the at least one of the one or more lacerators (122) is deployed at or from the first exposure window (as expressly shown in Fig. 3; [0088]; distal actuation of needle to pierce tissue 30 expressly disclosed); and the second exposure window is an opening in a radially outer wall of the catheter (100), wherein at least one of the one or more lacerators (116) is configured to (i.e. capable of) lacerate the tissue (30) when the at least one of the one or more lacerators (116) is deployed at or from the second exposure window (as shown in Fig. 3; [0077]-[0079]; blades 116 expressly extendable/exposable from catheter 100 to cut tissue 30);
(claim 28) wherein: the one or more aligners comprise an aligner (117/120/120a, Fig. 3) rotatably coupled to the catheter (100) (as shown in Fig. 3); and the one or more lacerators comprise a first lacerator (116) coupled to the aligner (120) at a distal end of the first lacerator (116) and coupled to a control wire ([0081]; i.e., actuator rod/wire) at a proximal end of the first lacerator (116), wherein the control wire ([0081]) is axially movable in the catheter (100) (as shown in Fig. 3; [0081]; an actuator rod/wire proximally extending to the handle is expressly disclosed for rotating/pivoting blades 116 radially outward via pivots 118/120/120a);
(claim 29) wherein: distal movement of the control wire ([0081]) in the catheter (100) causes the first lacerator (116) to be exposed through a first exposure window (i.e., recessed window between pins 120/120a housing collapsed blades 116 therein, as shown in Fig. 3) of the one or more exposure windows and causes rotation of the aligner (117) away from the catheter (100) and into a deployed configuration (configuration as shown at right blade 116 in Fig. 3; [0081]); and proximal movement of the control wire in the catheter ([0081]) causes the first lacerator (116) to be withdrawn into the catheter (100) and causes rotation of the aligner (117) toward the catheter (100) and into a collapsed configuration (configuration as shown at left blade 116 in Fig. 3; [0081]);
(claim 30) wherein: distal movement of the control wire ([0081]; i.e., actuator control rod/wire) in the catheter (100) causes a first length of the first lacerator (116) to be exposed through the first exposure window (configuration as shown at right blade 116 in Fig. 3; [0081]); the aligner (117/120/120a) is configured to (i.e., capable of) promote contact between the first length of the first lacerator (116) and the tissue (30) at or near the first exposure window for slicing the tissue (30) with the first length of the first lacerator (116) when the aligner is in the deployed configuration (configuration as shown at right blade 116 in Fig. 3; [0077]; [0081]);
(claim 31) wherein: the one or more exposure windows comprise a first exposure window (i.e., distal aperture/window of catheter 100 at cone 60 and having needle 122 disposed therein) and a second exposure window (i.e., recessed window between pins 120/120a housing collapsed blades 116 therein, as shown in Fig. 3); the first exposure window is an axial opening at a distal end of the catheter (100) (as shown in Fig. 3); the second exposure window is an opening in a radially outer wall of the catheter (100) (as shown in Fig. 3); the one or more aligners comprise an aligner (117/120/120a) rotatably coupled to the catheter (100) at a position between the first exposure window and the second exposure window (as shown in Fig. 3; pivoting blade arms between the lateral recesses and the distal lumen tip); and the catheter (100) further comprises: a control wire ([0081]; i.e., actuator rod/wire proximally extending from blades 116 to device handle) axially movable in the catheter (100) ([0081]); a first lacerator (122, Fig. 3) of the one or more lacerators, wherein the first lacerator (122) is configured to be (i.e., capable of) advanced through the catheter (100) such that the first lacerator (122) is exposable through the first exposure window to pierce the tissue (30) (as expressly shown in Fig. 3; [0088]; distal actuation of needle to pierce tissue 30 expressly disclosed); and a second lacerator (116, Fig. 6) of the one or more lacerators, wherein: a distal end of the second lacerator (116) is coupled to the aligner (120); a proximal end of the second lacerator (116) is coupled to the control wire ([0081]; i.e., actuator rod/wire proximally extending from blades 116 to device handle); distal movement of the control wire in the catheter (100) causes the second lacerator (116) to be exposed through the second exposure window to slice the tissue (30) and causes rotation of the aligner (117/120/120a) away from the catheter (100) and into a deployed configuration (configuration as shown at right blade 116 in Fig. 3; [0077]; [0081]) in which the aligner promotes contact between the second lacerator (116) and the tissue (30) at or near the second exposure window (as shown in Fig. 3; [0081]; an actuator rod/wire proximally extending to the handle is expressly disclosed for rotating/pivoting blades 116 radially outward via pivots 118/120/120a); and proximal movement of the control wire in the catheter (100) causes the second lacerator (116) to be withdrawn into the catheter (100) and causes rotation of the aligner (117) toward the catheter (100) and into a collapsed configuration (configuration as shown at left blade 116 in Fig. 3; [0081]);
(claim 37) A method, comprising: advancing a catheter (100, Fig. 3) toward a tissue (30, Fig. 30); piercing the tissue (30) at or near a first exposure window (i.e., distal aperture/window of catheter 100 at cone 60 and having needle 122 disposed therein) of the catheter (100) to generate an opening in the tissue (30) (as expressly shown in Fig. 3; [0079]; step of piercing a hole in tissue expressly disclosed); advancing at least a portion of the catheter (100) through the opening in the tissue (30) (as expressly shown in Fig. 3; [0077]-[0079]); deploying one or more aligners (117/120/120a) to promote contact between a lacerator (116, Fig. 3) and the tissue (30) when the lacerator (116) is deployed at or from a second exposure window (i.e., recessed window between pins 120/120a housing collapsed blades 116 therein, as shown in Fig. 3) of the catheter (100) (configuration as shown at right blade 116 in Fig. 3; [0077]; [0079]; [0081]); and slicing the tissue (30) at or near the second exposure window of the catheter (100) ([0077]-[0079]);
(claim 38) further comprising advancing a control wire distally through the catheter (100) ([0081]; i.e., actuator control rod/wire extending proximally from blades 116 to handle), wherein advancing the control wire distally: exposes the lacerator (116) through the second exposure window to slice the tissue (30) (configuration as shown at right blade 116 in Fig. 3; [0077]-[0079]; [0081]); and rotates a first aligner (117) of the one or more aligners away from the catheter (100) from a collapsed configuration (i.e., left blade 116 in Fig. 3) to a deployed configuration (i.e., right blade 116 in Fig. 3) in which the first aligner (117) promotes contact between the lacerator (116) and the tissue (30) when the lacerator (116) is exposed through the second exposure window (configuration as shown at right blade 116 in Fig. 3; [0077]-[0079]; [0081]); and
(claim 39) wherein: advancing the control wire ([0081]; i.e., actuator control rod/wire) distally exposes a first length of the lacerator (116) through the second exposure window (configuration as shown at right blade 116 in Fig. 3; [0081]); and rotation of the first aligner (117) of the one or more aligners away from the catheter (100) promotes contact between the first length of the lacerator (116) and the tissue (30) (configuration as shown at right blade 116 in Fig. 3; [0077]; [0081]); and
(claim 40) further comprising deploying a second aligner (60, Fig. 3) of the one or more aligners to promote positioning of the catheter (100) with respect to the tissue (30) for piercing of the tissue (30) at or near the first exposure window (as shown in Fig. 3; [0073]; [0079]; [0088]; cone 60 keeps lacerator 122 centered on the tissue 30 to be cut and also may further pull tissue 30 to a second lacerator 116).
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(s) 26 is rejected under 35 U.S.C. 103 as being unpatentable over Vardi as applied to claim 21 above, and further in view of Schultheis (US 2022/0273324).
Vardi, as applied above, discloses a method and system for creating an interatrial aperture comprising all the limitations of the claim except for wherein at least one of the one or more lacerators comprises a thulium fiber laser configured to pass laser energy through or towards the tissue at or near the one or more exposure windows to lacerate the tissue.
Schultheis teaches a similar method and system for valve treatment wherein at least one of the one or more lacerators comprises a thulium fiber laser (see claim 21; [0040]; [0060]; [0080]-[0082]; [0106]-[0108]) configured to (i.e., capable of) pass laser energy through or towards the tissue at or near the one or more exposure windows to lacerate the tissue. Accordingly, Schultheis teaches that it is known that mechanical tissue cutters and thulium laser tissue cutters are elements that are functional equivalents for breaking up and lacerating/fracturing tissue. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the thulium laser tissue cutters taught by Schultheis for the mechanical tissue cutters of Vardi because both elements were known equivalents for breaking up and lacerating/fracturing tissue within the valve repair art. The substitution would have resulted in the predictable results of providing a means for breaking up and lacerating/fracturing tissue to the Vardi device.
Claim(s) 27 and 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Vardi as applied to claims 21 and 31 above, and further in view of Miller et al. (US 2012/0302935) (i.e., regarding claims 26 and 32); and/or Vardi in view of Miller et al. (US 2012/0302935) (i.e., regarding claims 33-36).
Vardi discloses (see Fig. 3) a method and system for creating an interatrial aperture comprising the following claim limitations:
(claim 33) A system for lacerating a tissue (30, Fig. 3), comprising: a catheter (100, Fig. 3) comprising: one or more exposure windows (i.e., distal aperture/window of catheter 100 at cone 60 and having needle 122 disposed therein; and/or i.e., recessed window between pins 120/120a housing collapsed blades 116 therein, as shown in Fig. 3); one or more lacerators (122, Fig. 3; and/or 116, Fig. 3), wherein the one or more lacerators are configured to (i.e., capable of) lacerate the tissue (30) and are deployed at or from the one or more exposure windows (as expressly shown in Fig. 3; [0088]; distal actuation of needle 122 to pierce tissue 30 expressly disclosed); and one or more aligners (60, Fig. 3; 117/120/120a, Fig. 3), wherein the one or more aligners are deployable and configured to (i.e., capable of), when deployed, promote contact between the one or more lacerators (122) and the tissue (30) when the one or more lacerators (122) are deployed at or from the one or more exposure windows (as shown in Fig. 3; [0073]; [0079]; [0088]; cone 60 keeps lacerator 122 centered on the tissue 30 to be cut and also may further pull tissue 30 to a second lacerator 116);
(claim 34) wherein: the one or more exposure windows comprise a first exposure window (i.e., distal aperture/window of catheter 100 at cone 60 and having needle 122 disposed therein), wherein the first exposure window is an axial opening at a distal end of the catheter (100) (as shown in Fig. 3); the one or more exposure windows comprise a second exposure window (i.e., recessed window between pins 120/120a housing collapsed blades 116 therein, as shown in Fig. 3), wherein the second exposure window is an opening in a radially outer wall of the catheter (100) (as shown in Fig. 3); the one or more aligners (117/120/120a) comprise an aligner rotatably coupled to the catheter (100) (as shown at pivots in Fig. 3); and the catheter (100) further comprises: a control wire ([0081]; i.e., actuator ontrol rod/wire proximally extending from blades 116 to device handle) axially movable in the catheter (100) ([0081]); a first lacerator (122, Fig. 3) of the one or more lacerators, wherein the first lacerator (122) is configured to be (i.e., capable of) advanced through the catheter (100) such that the first lacerator (122) is exposable through the first exposure window to lacerate the tissue (30) (as expressly shown in Fig. 3; [0088]; distal actuation of needle to pierce tissue 30 expressly disclosed); and a second lacerator (116, Fig. 3) of the one or more lacerators, wherein: a distal end of the second lacerator (116) is coupled to the aligner (120); a proximal end of the second lacerator (116) is coupled to the control wire ([0081]; i.e., actuator rod/wire proximally extending from blades 116 to device handle); distal movement of the control wire in the catheter (100) causes the second lacerator (116) to be exposed through the second exposure window to lacerate the tissue (30) and causes rotation of the aligner (117/120/120a) away from the catheter (100) and into a deployed configuration (configuration as shown at right blade 116 in Fig. 3; [0077]; [0081]) in which the aligner promotes contact between the second lacerator (116) and the tissue (30) at or near the second exposure window (as shown in Fig. 3; [0081]; an actuator rod/wire proximally extending to the handle is expressly disclosed for rotating/pivoting blades 116 radially outward via pivots 118/120/120a); and proximal movement of the control wire in the catheter (100) causes the second lacerator (116) to be withdrawn into the catheter (100) and causes rotation of the aligner (117) toward the catheter (100) and into a collapsed configuration (configuration as shown at left blade 116 in Fig. 3; [0081]); and
(claim 35) further comprising a second catheter (150, Fig. 3), wherein: the catheter (100) is positionable through the second catheter (150) (as shown in Fig. 3); and the second catheter (150) comprises a second aligner configured to (i.e., capable of) promote contact between the first lacerator (122) and the tissue (30) when the first lacerator (122) is deployed at or from the first exposure window (as shown in Fig. 3; [0077]-[0078]; second catheter 150 expressly disclosed to guide an align the lacerator 122 as the first catheter 100 exits the distal end of the second catheter 150 and directed towards the tissue to be treated).
Vardi, as applied above, discloses a method and system for creating an interatrial aperture comprising all the limitations of the claim except for an energy source couplable to the first lacerator comprising an optical fiber configured to pass laser energy and the second lacerator comprises one or more electrodes configured to be activated to transmit energy to the tissue, the transmitted energy passing towards the tissue through the at least one of the one or more lacerators deployed at or from the one or more exposure windows.
Miller teaches a similar method and system for tissue cutting comprising an energy source couplable to the first lacerator comprising an optical fiber configured to pass laser energy (see Abstract; [0037]; laser cutting/ablation devices expressly disclosed) and the second lacerator comprises one or more electrodes (see Abstract; [0037]; one or more electrodes expressly disclosed) configured to be (i.e., capable of) activated to transmit energy to the tissue, the transmitted energy passing towards the tissue through the at least one of the one or more lacerators to lacerate or cut tissue. Accordingly, Miller teaches that it is known that mechanical cutting blades and optical laser and/or electrode cutters are elements that are functional equivalents for lacerating and cutting tissue. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the optical laser taught by Schultheis for the mechanical first lacerator of Vardi and substituted the electrodes taught by Schultheis for the mechanical second lacerator of Vardi because all elements were known equivalents for lacerating and cutting tissue within the tissue repair art. The substitution would have resulted in the predictable results of providing a means for lacerating and cutting tissue to the Vardi device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771