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 .
Claims Pending
Claims 1-20 are currently under examination.
Claim Objections
Claims 1-20 objected to because of the following informalities:
In Claim 1, “apply pressure at an obstruction in the catheter:”, should read, - apply pressure at an obstruction in the catheter;- (Examiner's Note: replacement of the colon with a semicolon) (Examiner's Note: Claims 2-10 are dependent on claim 1, and as such are also objected to).
In Claim 5, “wherein the kink is sharply angled causing closure of the catheter” should read -, and wherein the kink is sharply angled causing closure of the catheter- (Examiner's Note: Or similar modification, as there is currently a lack of punctuation in the claim)
In claim 7, “wherein at an entry point the tip is configured in a wedge shape to be driven through the kink by the movement” should read -, and wherein at an entry point the tip is configured in a wedge shape to be driven through the kink by the movement- (Examiner's Note: Or similar modification, as there is currently a lack of punctuation in the claim)
In Claim 12, “apply pressure at a blockage in the catheter:”, should read, - apply pressure at a blockage in the catheter;- (Examiner's Note: replacement of the colon with a semicolon)
In Claim 11, “a stylet device configured to insert a lumen in catheter comprising” (line 3), should read - a stylet device configured to insert into a lumen in a catheter comprising- (Examiner's Note: As claim 1 aligns closely with claim 11, the recommended modification is based on the language of claim 1) (Examiner's Note: Claims 12-20 are dependent on claim 11, and as such are also objected to).
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:
Claim 10: The claim limitation “a housing of the electromechanical handle mechanism configured for ergonomic use to provide the movement to overcome the resistance of the kink in the catheter” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “housing” coupled with functional language “configured for ergonomic use to provide the movement to overcome the resistance of the kink in the catheter.” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “housing”.
Claim 20: The claim limitation “a housing of the electromechanical handle mechanism configured for ergonomic use to provide movement to overcome resistance of the kink” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “housing” coupled with functional language “configured for ergonomic use to provide movement to overcome resistance of the kink” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “housing”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
A housing with buttons, controls, or equivalents thereof, as described in Par. 36 of the disclosure filed on 05/20/2024.
A housing with buttons, controls, or equivalents thereof, as described in Par. 36 of the disclosure filed on 05/20/2024.
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 § 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 4-10 and 14-20 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.
Claims 4 and 14 recites the limitation “wherein the tip is configured in accordance with a flexible tip profile that comprises a tip length, a tip diameter, and a taper angle”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what is being claimed. For example, is the applicant intending to claim a specific length, diameter, or taper angle of the tip? While the applicant claims a “taper angle”, the corresponding detail within the specification indicates “The tapering of the tip angle 20 of the flexible tip 15 is designed or constructed with a lesser angle of a range of zero to five degrees to navigate the kink or a bend in the lead catheter.” (Par. 31 of applicant’s spec.), which indicates that the applicant’s definition of “tapering” includes zero degrees. However, if the angle is “zero”, then how can there be a taper? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any type of tip. Claims 5-10 and 15-20 are dependent on claims 4 and 14, respectively, and as such are also rejected.
The term “flexible” in claims 4 and 14 is a relative term which renders the claim indefinite. The term “flexible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to how “flexible” of a tip the applicant considers to be “flexible”. The specification merely recites “the flexible tip 15 is constructed of a material that allows for a certain amount of flexibility when pressed against a kink or bend in the lead catheter to prevent damage or perforating of the catheter if an inordinate amount of pressure is applied to overcome the kink or bend resistance.” (Par. 26 of applicant’s spec.), which provides no further detail regarding the specific material used for the tip itself, and merely further recites the relative term. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as a tip of any material.
Claims 5 and 15 recite the limitation “wherein the tip length of the flexible tip profile is half-tapered to penetrate the kink of the catheter”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what the applicant considers to be “half-tapered”. Is only a section of the tip itself tapered? Does half-tapered refer to the tapering angle? What does it mean to be “half-tapered”? When referring to tapering, the applicant’s specification states “The tapering of the tip angle 20 of the flexible tip 15 is designed or constructed with a lesser angle of a range of zero to five degrees to navigate the kink or a bend in the lead catheter.” (Par. 31 of applicant’s spec.). However, if the angle is “zero”, then how can there be a taper? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the tip will be interpreted as being at any angle.
The term “sharply” in claim 5 is a relative term which renders the claim indefinite. The term “sharply” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to how “sharply” of an angle the applicant considers the catheter to be kinked. The specification merely recites “a kink which is sharply angled causing an almost complete closure of the pathway of the lead lumen” (Par. 29 of applicant’s spec.), which provides no further detail regarding what the applicant considers to be “sharply angled”. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any level of bending or kinking.
Claims 7 and 17 recite the limitation “wherein the taper angle of the flexible tip profile is a lesser angle of a range of zero to five degrees to navigate the kink or a bend in the catheter” and “wherein the taper angle of the flexible tip profile is a lesser angle of a range of zero to five degrees to navigate about the kink in the catheter”, respectively , which fails to effectively define the metes and bounds of the claim as it is unclear as to the angle of the tip. The claim recites the “taper angle”, as “a lesser angle of a range of zero to five degrees”. However, if the angle is “zero”, then how can there be a taper? When referring to tapering, the applicant’s specification states “The tapering of the tip angle 20 of the flexible tip 15 is designed or constructed with a lesser angle of a range of zero to five degrees to navigate the kink or a bend in the lead catheter.” (Par. 31 of applicant’s spec.). As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any angle.
Claims 7 and 17 recite the limitations “wherein at an entry point the tip is configured in a wedge shape to be driven through the kink by the movement.” and “wherein at an entry point the tip is a wedge shape to be driven through the kink”, respectively, which fails to effectively define the metes and bounds of the claim as it is unclear as to what the applicant considers to be a “wedge” shape. “Wedge” is defined as “a piece of a substance (such as wood or iron) that tapers to a thin edge and is used for splitting wood and rocks, raising heavy bodies, or for tightening by being driven into something” (Merriam-Webster dictionary), which would then be interpreted in this case as a shape that tapers. However, when referring to tapering, the applicant’s specification states “The tapering of the tip angle 20 of the flexible tip 15 is designed or constructed with a lesser angle of a range of zero to five degrees to navigate the kink or a bend in the lead catheter.” (Par. 31 of applicant’s spec.). As such, it is unclear as to the manner in which the claim is intended to be interpreted. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the tip will be interpreted as being at any angle.
Claim 8 recites the limitation “wherein the tip is configured with a shaft that is offset from a centerline to navigate through the lumen while positioned at a side of the lumen for the movement around the kink or the bend in the catheter.”, which fails to effectively define the metes and bounds of the claim as it is unclear as to the specific structure of the tip and shaft. Is the shaft part of the tip? Is the tip simply connected to the shaft? Where is the centerline? Where is the centerline drawn from? Is the centerline referring to the centerline of the “second part of a body” from claim 1? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the tip being offset from a centerline of the body (Par. 32 of applicant’s spec.).
Claim 18 recites the limitation “the tip is offset from a centerline and positioned at a side of a lumen in the catheter to move around a kink”, which fails to effectively define the metes and bounds of the claim as it is unclear as to the specific structure of the tip and shaft. Is the shaft part of the tip? Is the tip simply connected to the shaft? Where is the centerline? Where is the centerline drawn from? Is the centerline referring to the centerline of the “second part of a body” from claim 11? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the tip being offset from a centerline of the second part of a body (Par. 32 of applicant’s spec.).
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 claims are generally directed towards an apparatus for assisting in a lead extraction procedure comprising a stylet. The stylet comprises a first part with a tip configured to remove obstructions in the lumen of a catheter, and a second part with a body connected to the tip.
Claim(s) 1 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US Pub. No. 20210186539) hereinafter Stein, and further in view of Loesener (US Pub. No. 20160008573) hereinafter Loesener.
Regarding claim 1, Stein discloses An apparatus to assist in a lead extraction procedure of a catheter (Fig. 1a, 2a, Par. 40 (LRS – 110)) (Par. 39, “In use, LRS 110 is inserted into lead interior 34 through opening 36 and then used to detach lead from binding tissue as will be described below.”), the apparatus comprising:
a stylet device configured to insert into a lumen of the catheter comprising (Fig. 1a, Fig. 2a, Par. 40 (LRS – 110 inserted into lead 30)) (Fig. 1A (lead – 30)) (Par. 17, “Lead as used herein refers to a cardiac lead or cardiac catheter.”):
a first part of a tip (Fig. 1a (LRS – 110, distal end 112)) (Par. 40, Fig. 1B, 2B, (distal end 112 of LRS 110)); and
wherein the tip of the stylet device (Par. 40, Fig. 1b, Fig. 2B, (distal end 112 of LRS – 110 with vibration generator 118)) (Par. 32, Fig. 1B, (vibration generator 118 at distal end 112)) is configured to:
apply pressure at an obstruction in the catheter (Par. 32, Fig. 1B, (vibration generator 118 at distal end 112)) (Fig. 2A (starting tissue disruption vibration)) (Fig. 2E, (pressure applied)) (Fig. 1 (LRS – 110)) (Fig. 1B,2A (distal end 112 of LRS – 110 with vibration generator 118 is capable of the indicated function)):
remove the obstruction by movement against the obstruction to cause a clearing of obstruction in lumen of the catheter (Par. 45, “A high resistance to vibration in steps 206 and 208 indicates that lead 30 is stuck in binding tissue 88. FIG. 2E illustrates a locking position where lead 30 is held in position by binding tissue 88. Therefore if the resistance is high, LRS 110 is vibrated with a high amplitude tissue disrupting vibration 160 as at step 209 and as shown in FIG. 2F. As described above, the vibration may be from internal generator 118 or controller generator 124 as in FIGS. 1A and 1B.”) (Fig. 2A (tissue disruption vibration)) (Fig. 1B,2A (distal end 112 of LRS – 110 with vibration generator 118 is capable of the indicated function)); and
enable opening of the catheter for a lead locking device (LLD) to navigate past during the lead extraction procedure (Par. 45, “A high resistance to vibration in steps 206 and 208 indicates that lead 30 is stuck in binding tissue 88. FIG. 2E illustrates a locking position where lead 30 is held in position by binding tissue 88. Therefore if the resistance is high, LRS 110 is vibrated with a high amplitude tissue disrupting vibration 160 as at step 209 and as shown in FIG. 2F. As described above, the vibration may be from internal generator 118 or controller generator 124 as in FIGS. 1A and 1B.”) (Par. 50, Fig. 2A (lead removal after blockage cleared)) (Fig. 1B,2A (distal end 112 of LRS – 110 with vibration generator 118 is capable of the indicated function)).
Stein fails to explicitly disclose a second part of a body wherein the body is configured at an end for connection to the tip when deployed in the lumen of the catheter.
However, Stein does disclose a second part of a body wherein the body is configured at an end to the tip when deployed in the lumen of the catheter (Fig. 1A, (non-distal part of LRS 110 towards proximal end 114)) (Fig. 1a, 2a, Par. 40 (LRS – 110)) (Par. 39, “In use, LRS 110 is inserted into lead interior 34 through opening 36 and then used to detach lead from binding tissue as will be described below.”).
Loesener teaches a second part (Fig. 30, stylet 1018) of a body wherein the body is configured at an end for connection to the tip when deployed in the lumen of the catheter (Fig. 30, (stylet tip – 1020 is observably connected to stylet 1018)) (Par. 130-131 (stylet 1018 and stylet tip 1020)) (Fig. 30 (lumen 1014b)).
Stein and Loesener are considered to be analogous art to the claimed invention as they are involved with catheter devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Stein with that of Loesener to explicitly include a second part of a body wherein the body is configured at an end for connection to the tip when deployed in the lumen of the catheter through the combination of references and explicitly treating the first part and second part as separate parts as it would have yielded the same or similar results and predictable result of allowing for modification and customization of the tip (Loesener (Par. 131)).
Regarding claim 11, Stein discloses An apparatus for assisting in navigating an endoscopic instrument (Par. 7 (cardiac lead)) (Fig. 1a, 2a, Par. 40 (LRS – 110)) (Par. 39, “In use, LRS 110 is inserted into lead interior 34 through opening 36 and then used to detach lead from binding tissue as will be described below.”), the apparatus comprising:
a stylet device configured to insert a lumen in catheter (Fig. 1a (LRS – 110))(Par. 40 (LRS – 110 inserted into lead 30)) (Fig. 1A (lead – 30)) (Par. 17, “Lead as used herein refers to a cardiac lead or cardiac catheter.”) comprising:
a first part of a tip (Fig. 1a (LRS – 110, distal end 112)) (Par. 40, Fig. 1B, 2B, (distal end 112 of LRS 110)); and
wherein the tip of the stylet device (Par. 40, Fig. 1b, Fig. 2B, (distal end 112 of LRS – 110 with vibration generator 118)) (Par. 32, Fig. 1B, (vibration generator 118 at distal end 112)) is configured to:
apply pressure at a blockage in the catheter (Par. 32, Fig. 1B, (vibration generator 118 at distal end 112)) (Fig. 2A (starting tissue disruption vibration)) (Fig. 2E, (pressure applied)) (Fig. 1 (LRS – 110)) (Fig. 1B,2A (distal end 112 of LRS – 110 with vibration generator 118 is capable of the indicated function)):
remove the blockage by movement of the tip pressing against the blockage in the catheter to overcome resistance of the blockage (Par. 45, “A high resistance to vibration in steps 206 and 208 indicates that lead 30 is stuck in binding tissue 88. FIG. 2E illustrates a locking position where lead 30 is held in position by binding tissue 88. Therefore if the resistance is high, LRS 110 is vibrated with a high amplitude tissue disrupting vibration 160 as at step 209 and as shown in FIG. 2F. As described above, the vibration may be from internal generator 118 or controller generator 124 as in FIGS. 1A and 1B.”) (Fig. 2A (tissue disruption vibration)) (Fig. 1B,2A (distal end 112 of LRS – 110 with vibration generator 118 is capable of the indicated function)); and
enable opening by removal of the blockage to thread the endoscopic instrument past during an endoscopic procedure (Par. 45, “A high resistance to vibration in steps 206 and 208 indicates that lead 30 is stuck in binding tissue 88. FIG. 2E illustrates a locking position where lead 30 is held in position by binding tissue 88. Therefore if the resistance is high, LRS 110 is vibrated with a high amplitude tissue disrupting vibration 160 as at step 209 and as shown in FIG. 2F. As described above, the vibration may be from internal generator 118 or controller generator 124 as in FIGS. 1A and 1B.”) (Par. 50, Fig. 2A (lead removal after blockage cleared)) (Fig. 1B,2A (distal end 112 of LRS – 110 with vibration generator 118 is capable of the indicated function)).
Stein fails to explicitly disclose a second part of a body for connection to the tip when deployed in the lumen.
However, Stein does disclose a second part of a body to the tip when deployed in the lumen (Fig. 1A, (non-distal part of LRS 110 towards proximal end 114)) (Fig. 1a, 2a, Par. 40 (LRS – 110)) (Par. 39, “In use, LRS 110 is inserted into lead interior 34 through opening 36 and then used to detach lead from binding tissue as will be described below.”).
Loesener teaches a second part (Fig. 30, stylet 1018) of a body for connection to the tip when deployed in the lumen (Fig. 30, (stylet tip – 1020 is observably connected to stylet 1018)) (Par. 130-131 (stylet 1018 and stylet tip 1020)) (Fig. 30 (lumen 1014b)).
Stein and Loesener are considered to be analogous art to the claimed invention as they are involved with catheter devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Stein with that of Loesener to explicitly include a second part of a body for connection to the tip when deployed in the lumen through the combination of references and explicitly treating the first part and second part as separate parts as it would have yielded the same or similar results and predictable result of allowing for modification and customization of the tip (Loesener (Par. 131)).
Claim(s) 2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein in view of Loesener as applied to claims 1 and 11 above, and further in view of Pedersen (US Pub. No. 20180353751) hereinafter Pedersen.
Stein and Loesener teach the device of claims 1 and 11 above.
Regarding claim 2, modified Stein fails to explicitly disclose the limitations of the claim.
However, Pedersen teaches wherein the obstruction in the catheter comprises a kink in the catheter (Fig. 14a (Observable bending in lead distal region 85)) (Par. 122, “The stylet serves to straighten a portion of the lead distal region 85 located in the chamber of the heart 35…”).
Stein, Loesener, and Pedersen are considered to be analogous art to the claimed invention as they are involved with catheter devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Stein and Loesener with that of Pedersen to include wherein the obstruction in the catheter comprises a kink in the catheter through the combination of references as it would have yielded the predictable result of aiding in the removal of the lead (Pedersen (Par. 122)).
Regarding claim 12, modified Stein teaches the device of claim 2 above, which comprises the device of claim 12. As the claims are similar, claim 12 is rejected in the same manner as claim 2.
Claim(s) 3-10 and 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein in view of Loesener and Pedersen as applied to claims 2 and 12 above, and further in view of Goode (US Pat. No. 10653440) hereinafter Goode.
Stein, Loesener, and Pedersen teach the device of claims 2 and 12 above.
Regarding claim 3, modified Stein fails to explicitly disclose the limitations of the claim.
However, Goode teaches wherein the tip of the stylet device is configured as rounded at the end to prevent damage or perforation to the lumen when pressed against the obstruction by the movement to clear the obstruction (Col. 14, lines 20-27 (rounded tip to prevent damage)).
Stein, Loesener, Pedersen, and Goode are considered to be analogous art to the claimed invention as they are involved with catheter devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Stein, Loesener, and Pedersen with that of Goode to include wherein the tip of the stylet device is configured as rounded at the end to prevent damage or perforation to the lumen when pressed against the obstruction by the movement to clear the obstruction through the combination of references as it would have yielded the predictable result of helping to minimize damage (Goode (Col. 14, lines 20-27)).
Regarding claim 13, modified Stein teaches the device of claim 3 above, which comprises the device of claim 13. As the claims are similar, claim 13 is rejected in the same manner as claim 3.
Regarding claim 4, modified Stein further discloses wherein the tip is configured in accordance with a flexible tip profile that comprises a tip length, a tip diameter, and a taper angle (Stein ((Fig. 1a,1b (LRS – 110, distal end 112)) (Par. 40, Fig. 1b,2b, (distal end 112 of LRS has the indicated profile))) (Examiner's Note: Interpreted under 112(b) as indicated above).
Regarding claim 14, modified Stein teaches the device of claim 4 above, which comprises the device of claim 14. As the claims are similar, claim 14 is rejected in the same manner as claim 4.
Regarding claim 5, modified Stein fails to explicitly disclose the limitation of the claim.
However, Stein does disclose wherein the tip length of the flexible tip profile is half-tapered to penetrate the catheter (Stein (Fig. 1a (LRS – 110, distal end 112)) (Par. 40, Fig.1B, 2B, (distal end 112 of LRS))) (Examiner's Note: Interpreted under 112(b) as indicated above).
Pedersen further teaches the kink of the catheter, wherein the kink is sharply angled causing closure of the catheter (Pedersen (Fig. 14a (Observable bending in lead distal region 85)) (Par. 122, “The stylet serves to straighten a portion of the lead distal region 85 located in the chamber of the heart 35…”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Stein, Loesener, Pedersen, and Goode with that of Pedersen to include wherein the tip length of the flexible tip profile is half-tapered to penetrate the kink of the catheter wherein the kink is sharply angled causing closure of the catheter for the reasoning as indicated in claim 2 above.
Regarding claim 15, modified Stein teaches the device of claim 5 above, which comprises the device of claim 15. As the claims are similar, claim 15 is rejected in the same manner as claim 5.
Regarding claim 6, modified Stein further discloses wherein the tip diameter is sized in accordance with a coil profile of the catheter to enable the tip to move inside the catheter and to prevent lodgement in a coil of the catheter (Stein ((Fig. 1a (LRS – 110, distal end 112)) (Par. 40, Fig. 1B,2B, (distal end 112 of LRS is observably inside of lead 30))).
Regarding claim 16, modified Stein teaches the device of claim 6 above, which comprises the device of claim 16. As the claims are similar, claim 16 is rejected in the same manner as claim 6.
Regarding claim 7, modified Stein fails to explicitly disclose the limitations of the claim.
However, Stein does disclose wherein the taper angle of the flexible tip profile is a lesser angle of a range of zero to five degrees (Stein ((Fig. 1a (LRS – 110, distal end 112)) (Par. 40, Fig. 1B,2B, (distal end 112 of LRS))) (Examiner's Note: Interpreted under 112(b) as indicated above), wherein at an entry point the tip is configured in a wedge shape to be driven through by the movement (Stein ((Fig. 1a (LRS – 110, distal end 112)) (Par. 40, Fig. 1B,2B, (distal end 112 of LRS))) (Examiner's Note: Interpreted under 112(b) as indicated above).
Pedersen further teaches the kink or a bend in the catheter (Pedersen (Fig. 14a (Observable bending in lead distal region 85)) (Par. 122, “The stylet serves to straighten a portion of the lead distal region 85 located in the chamber of the heart 35…”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Stein, Loesener, Pedersen, and Goode with that of Pedersen to include wherein the taper angle of the flexible tip profile is a lesser angle of a range of zero to five degrees to navigate the kink or a bend in the catheter wherein at an entry point the tip is configured in a wedge shape to be driven through the kink by the movement for the reasoning as indicated in claim 2 above.
Regarding claim 17, modified Stein teaches the device of claim 7 above, which comprises the device of claim 17. As the claims are similar, claim 17 is rejected in the same manner as claim 7.
Regarding claim 8, modified Stein fails to explicitly disclose the limitations of the claim.
However, Pedersen further teaches wherein the tip is configured with a shaft that is offset from a centerline to navigate through the lumen while positioned at a side of the lumen for the movement around the kink or the bend in the catheter (Pedersen (Fig. 14a (stylet distal end 535 is observably offset with respect to stylet central region 487))(Par. 122)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Stein, Loesener, Pedersen, and Goode with that of Pedersen to include wherein the tip is configured with a shaft that is offset from a centerline to navigate through the lumen while positioned at a side of the lumen for the movement around the kink or the bend in the catheter for the reasoning as indicated in claim 2 above.
Regarding claim 18, modified Stein teaches the device of claim 8 above, which comprises the device of claim 18. As the claims are similar, claim 18 is rejected in the same manner as claim 8.
Regarding claim 9, modified Stein fails to explicitly disclose the limitations of the claim.
However, Stein does disclose wherein an electromechanical handle mechanism attached to the stylet device (Stein (Par. 31-32, “System 100 further comprises controller 120. LRS 110 is attached at its proximal end 114 to controller 120....” (controller connected with motors))) comprises at least a rotational motor to rotate the tip to overcome resistance (Stein (Par. 32, “A non limiting example of a vibration generator 124 or 118 is shown in FIG. 1M where vibration generator 124 or 118 comprises a disc 126 attached to motor 127. A vibration cord 129 is attached to disc 126 at attachment point 128. As disc 126 is rotated in direction “A” by motor 127, vibration cord 129 is alternately pushed and pulled in direction “B”. Vibration cord 129 is attached to LRS 110 and the mechanical movement “B” translates into a mechanical vibration of LRS 110.”) (Fig. 2a, (disruption through vibration)) (Fig. 1B, (vibration generator 118 at distal end 112 of LRS 110))(Par. 42 (rotational vibrations))).
Pedersen further teaches the kink in the catheter to unkink the catheter (Pedersen (Fig. 14a (Observable bending in lead distal region 85)) (Par. 122, “The stylet serves to straighten a portion of the lead distal region 85 located in the chamber of the heart 35…”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Stein, Loesener, Pedersen, and Goode with that of Pedersen to include wherein an electromechanical handle mechanism attached to the stylet device comprises at least a rotational motor to rotate the tip to overcome resistance of the kink in the catheter to unkink the catheter for the reasoning as indicated in claim 2 above.
Regarding claim 19, modified Stein teaches the device of claim 9 above, which comprises the device of claim 19. As the claims are similar, claim 19 is rejected in the same manner as claim 9.
Regarding claim 10, modified Stein fails to explicitly disclose the limitations of the claim.
However, Stein does disclose a housing of the electromechanical handle mechanism configured for ergonomic use to provide the movement to overcome the resistance (Stein (Par. 31-32, “System 100 further comprises controller 120. LRS 110 is attached at its proximal end 114 to controller 120....” (controller 120 connected to disc and motors)(controller 120 connected to a controller user interface 122 that includes a keyboard and mouse to control LRS 110)) (Fig. 2a, (disruption through vibration)) (Fig. 1B, (vibration generator 118 at distal end 112))(Par. 42 (rotational vibrations))).
Pedersen further teaches the kink in the catheter (Pedersen (Fig. 14a (Observable bending in lead distal region 85)) (Par. 122, “The stylet serves to straighten a portion of the lead distal region 85 located in the chamber of the heart 35…”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Stein, Loesener, Pedersen, and Goode with that of Pedersen to include a housing of the electromechanical handle mechanism configured for ergonomic use to provide the movement to overcome the resistance of the kink in the catheter for the reasoning as indicated in claim 2 above.
Regarding claim 20, modified Stein teaches the device of claim 10 above, which comprises the device of claim 20. As the claims are similar, claim 20 is rejected in the same manner as claim 10.
Conclusion
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/ARI S PADDA/Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791
