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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 January 2026 has been entered.
Specification
The amendments to the specification were received on 09 January 2026. These amendments are acceptable and are held, in conjunction with the supplied amendments to the claims and accompanying remarks and arguments, to resolve the previously noted issued under 35 USC 112(a) and (b).
Claim Objections
Claim(s) 1, 4, 6, 8, 15, and 16 is/are objected to because of the following informalities:
Regarding Claim 1, Applicant recites the limitation “the dilator’s proximal end”, “the dilator’s tip”, and “the distal end of said dilator” which introduces elements (re: a proximal end, a distal end, and a tip) using definite articles (e.g. “the”). This is improper and these elements should be first introduced using the indefinite article “a” or an analog thereof.
Regarding Claim 4, Applicant recites “the dilator’s proximal end”. However, as noted above the use of definite articles to introduce claimed components is improper.
Regarding Claim 6, Applicant recites the limitation “the dilator’s proximal end”, “the dilator’s tip” which introduces elements (re: a proximal end and a tip) using definite articles (e.g. “the”). This is improper and these elements should be first introduced using the indefinite article “a” or an analog thereof.
Regarding Claim 8, Applicant recites the limitation “the dilator’s proximal end”, “the dilator’s tip” which introduces elements (re: a proximal end and a tip) using definite articles (e.g. “the”). This is improper and these elements should be first introduced using the indefinite article “a” or an analog thereof.
Regarding Claim 15, Applicant recites “the dilator’s proximal end” using an improper definite article “the” instead of the proper indefinite article.
Regarding Claim 19, Applicant recites the limitation “the dilator’s proximal end”, “the dilator’s tip” which introduces elements (re: a proximal end and a tip) using definite articles (e.g. “the”). This is improper and these elements should be first introduced using the indefinite article “a” or an analog thereof.
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.
Claim(s) 1, 8, 16, and dependents thereof is/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 Claim 1, Applicant recites the limitations “and the dilator’s tip…” appearing to introduce the element using the definite “the” as opposed to an indefinite “a” (or analog thereof). Applicant later recites “a tip located at the distal end of the dilator” after “the dilator’s tip” has been recited. Based on the inconsistent usage of definite and indefinite articles it is unclear if “the dilator’s tip” and the “a tip located at the distal end of the dilator” are referring to the same element.
Regarding Claim 8, Applicant recites the limitations “and the dilator’s tip…” appearing to introduce the element using the definite “the” as opposed to an indefinite “a” (or analog thereof). Applicant later recites “said dilator having a tip”. Based on the inconsistent usage of definite and indefinite articles it is unclear if “the dilator’s tip” and the “the dilator having a tip” are referring to the same element.
Regarding Claim 16, Claim 16 is dependent upon itself.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0246597 (“Broniec”) in view of CN 102671287 (“Luo”) and U.S. Publication No. 2005/0070949 (“Bakos”).
Regarding Claim 1, Broniec discloses a vascular access dilator apparatus (Fig. 1) comprising:
a hollow needle (not labeled; see Par. 21; Clm. 3);
a wire (5) insertable longitudinally into said needle (Par. 21; Clm. 3);
a blade (4) slidable on said wire (Par. 21; Clm. 3);
a malleable, tapered dilator (7) having a tip located at a distal end of said dilator (see Fig. 3), the dilator being insertable directionally in line with said wire (Par. 22; Clm. 33); and
a safety cover (2) retractable from said blade (see Fig. 2; Clm. 3).
Broniec discloses the invention substantially as claimed except that the dilator comprises a series of straight segments which decrease in diameter in the direction of said tip, with the straight segments being connected by angled segments located therebetween. Rather, Broniec discloses a smooth transition surface along the length of the dilator between sections of decreasing prescribed diameters (see Fig. 1 and 3; Par. 9). However, Luo discloses a related dilator (Fig. 4) for vascular access (Par. 3), the dilator comprising a tapered distal tip section (7) and a series of straight segments (11, 13, 15, 9), marked with the respective diameter, which decease in diameter in the direction of the tip (see Fig. 4, 5) wherein the straight segments are connected by angled segments (12, 14, 16) located between each of the straight segments (see Fig. 4, 5), wherein the straight and angled segments may all have the same wall thickness such that the dilator exhibits a consistent wall thickness which does not decrease in thickness between the dilator’s proximal end and the dilator’s tip (see Fig. 4, 5 – Par. 43), thereby allowing dilation to occur in discrete stages (Par. 7) increasing accuracy of the dilation diameter (Par. 37).
Relatedly, Bakos discloses a dilator (Fig. 5) which like those of Luo and Broniec includes marked (43) diameter segments (see Fig. 5). Bakos discloses that the transition between these diameter segments may be made as a series of straight segments (21A, 21B, 21C) connected together by respective angled segments (44 – see Fig. 5) and that these steps allow the clinician to “feel” the stepped increases in diameter at the angled transitions along with visual verification from the markers (see Par. 59).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the dilator of the invention of Broniec to have a constant diameter between the proximal end and the distal tip and comprise a series of straight wall segments separated by angled segments having a uniform thickness throughout, as disclosed by Luo, in order to allow a clinician to “feel” the transition between dilation diameters (Par. 59 – Bakos) to provide tactile confirmation associated with the visual markers and increasing the accuracy of dilation diameter through the use of discrete steps (Par. 37 – Luo).
Regarding Claims 2 and 9, Broniec discloses the malleable, tapered dilator has French sizes printed thereon (Par. 22 – Fig. 3).
Regarding Claim 3, Luo discloses that the taper of the angled segments may be between 3 and 15 degrees (Par. 11 – Luo) and Bakos discloses that the taper angle of the transitions may range from 3 degrees to 15 degrees (Par. 38 - Bakos). It would have been obvious for one having ordinary skill in the art at the time the invention was made to select the angle of taper of the invention of modified Broniec to comprise an angle of 5 degrees, a value within the range prescribed by Luo and Bakos, thereby selecting a suitable value for providing a sufficiently gradual transition to prevent damage to the tissue from more abrupt changes while preserving the tactile responsiveness of the transitions.
Regarding Claim 4, Broniec discloses a vascular access dilator system (Fig. 1) having:
a needle (Par. 21),
a wire (5),
a blade (4), and
a dilator (7) having a tip (see Fig. 43), the dilator being insertable directionally in line with the wire (see Fig. 1 – Par. 21)
a safety cover (2) retractable from said blade (see Fig. 2), whereby safe disposal of such blade after use is obtained (Clm. 3) and whereby said dilator is malleable (Abstract)
Broniec discloses the invention substantially as claimed except that the dilator comprises a series of straight segments which decrease in diameter in the direction of said tip, with the straight segments being connected by angled segments located therebetween. Rather, Broniec discloses a smooth transition surface along the length of the dilator between sections of decreasing prescribed diameters (see Fig. 1 and 3; Par. 9). However, Luo discloses a related dilator (Fig. 4) for vascular access (Par. 3), the dilator comprising a tapered distal tip section (7) and a series of straight segments (11, 13, 15, 9), marked with the respective diameter, which decease in diameter in the direction of the tip (see Fig. 4, 5) wherein the straight segments are connected by angled segments (12, 14, 16) located between each of the straight segments (see Fig. 4, 5), wherein the straight and angled segments may all have the same wall thickness such that the dilator exhibits a consistent wall thickness which does not decrease in thickness between the dilator’s proximal end and the dilator’s tip (see Fig. 4, 5 – Par. 43), thereby allowing dilation to occur in discrete stages (Par. 7) increasing accuracy of the dilation diameter (Par. 37).
Relatedly, Bakos discloses a dilator (Fig. 5) which like those of Luo and Broniec includes marked (43) diameter segments (see Fig. 5). Bakos discloses that the transition between these diameter segments may be made as a series of straight segments (21A, 21B, 21C) connected together by respective angled segments (44 – see Fig. 5) and that these steps allow the clinician to “feel” the stepped increases in diameter at the angled transitions along with visual verification from the markers (see Par. 59).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the dilator of the invention of Broniec to have a constant diameter between the proximal end and the distal tip and comprise a series of straight wall segments separated by angled segments having a uniform thickness throughout, as disclosed by Luo, in order to allow a clinician to “feel” the transition between dilation diameters (Par. 59 – Bakos) to provide tactile confirmation associated with the visual markers and increasing the accuracy of dilation diameter through the use of discrete steps (Par. 37 – Luo).
Regarding Claim 5, Luo discloses that the taper of the angled segments may be between 3 and 15 degrees (Par. 11 – Luo) and Bakos discloses that the taper angle of the transitions may range from 3 degrees to 15 degrees (Par. 38 - Bakos). It would have been obvious for one having ordinary skill in the art at the time the invention was made to select the angle of taper of the invention of modified Broniec to comprise an angle of 5 degrees, a value within the range prescribed by Luo and Bakos, thereby selecting a suitable value for providing a sufficiently gradual transition to prevent damage to the tissue from more abrupt changes while preserving the tactile responsiveness of the transitions.
Regarding Claim 6, Broniec discloses a method for introduction of a treatment device into a body vessel and safe disposal of apparatus therefor by a medical professional (Abstract; Par. 21; Clm. 3) comprising the steps of:
inserting a hollow needle into said vessel (Par. 21 – Clm. 3);
inserting a wire (5) longitudinally into said needle (Par. 21 – Clm. 3);
retracting said needle (Clm. 3);
sliding a blade (4) on said wire in the direction of said vessel (Par. 21, Clm. 3);
sing said blade to make an incision in the dermis surrounding said
vessel (Clm. 3);
withdrawing said blade (Clm. 3);
covering said blade with a safety cover (2) retractable therefrom (Par. 22-22, Clm. 3);
disposing of said covered blade (Par. 21, Clm.3 );
sliding a dilator (7) on said wire in the direction of said vessel (Par. 21-22; Clm. 3)
inserting said dilator into said vessel to the depth of the desired straight
segment using visual feedback accessible to said medical professional inserting said dilator based related to the visible level of insertion, whereby said dilator is placed in said vessel in a safe manner for proper dilation for introduction of a treatment device (Par. 21, 22, Clm. 3).
Broniec discloses the invention substantially as claimed except that the dilator comprises a series of straight segments which decrease in diameter in the direction of said tip, with the straight segments being connected by angled segments located therebetween. Rather, Broniec discloses a smooth transition surface along the length of the dilator between sections of decreasing prescribed diameters (see Fig. 1 and 3; Par. 9). However, Luo discloses a related dilator (Fig. 4) for vascular access (Par. 3), the dilator comprising a tapered distal tip section (7) and a series of straight segments (11, 13, 15, 9), marked with the respective diameter, which decease in diameter in the direction of the tip (see Fig. 4, 5) wherein the straight segments are connected by angled segments (12, 14, 16) located between each of the straight segments (see Fig. 4, 5), wherein the straight and angled segments may all have the same wall thickness such that the dilator exhibits a consistent wall thickness which does not decrease in thickness between the dilator’s proximal end and the dilator’s tip (see Fig. 4, 5 – Par. 43), thereby allowing dilation to occur in discrete stages (Par. 7) increasing accuracy of the dilation diameter (Par. 37).
Relatedly, Bakos discloses a dilator (Fig. 5) which like those of Luo and Broniec includes marked (43) diameter segments (see Fig. 5). Bakos discloses that the transition between these diameter segments may be made as a series of straight segments (21A, 21B, 21C) connected together by respective angled segments (44 – see Fig. 5) and that these steps allow the clinician to “feel” the stepped increases in diameter at the angled transitions along with visual verification from the markers (see Par. 59).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the dilator of the invention of Broniec to have a constant diameter between the proximal end and the distal tip and comprise a series of straight wall segments separated by angled segments having a uniform thickness throughout, as disclosed by Luo, in order to allow a clinician to “feel” the transition between dilation diameters (Par. 59 – Bakos) to provide tactile confirmation associated with the visual markers and increasing the accuracy of dilation diameter through the use of discrete steps (Par. 37 – Luo).
Regarding Claim 7, Luo discloses that the taper of the angled segments may be between 3 and 15 degrees (Par. 11 – Luo) and Bakos discloses that the taper angle of the transitions may range from 3 degrees to 15 degrees (Par. 38 - Bakos). It would have been obvious for one having ordinary skill in the art at the time the invention was made to select the angle of taper of the invention of modified Broniec to comprise an angle of 5 degrees, a value within the range prescribed by Luo and Bakos, thereby selecting a suitable value for providing a sufficiently gradual transition to prevent damage to the tissue from more abrupt changes while preserving the tactile responsiveness of the transitions.
Regarding Claim 8, Broniec discloses a vascular access dilator apparatus (Fig. 1) comprising:
a hollow needle (Par. 21);
a wire (5) insertable longitudinally into said needle (Par. 21);
a blade device (4) slidable on said wire (Par. 21); and
a malleable, tapered dilator (7, Abstract) being insertable directionally in line
with said wire (Par. 21-22), said dilator having a tip (Fig. 3);
Broniec discloses the invention substantially as claimed except that the dilator comprises a series of straight segments which decrease in diameter in the direction of said tip, with the straight segments being connected by angled segments located therebetween. Rather, Broniec discloses a smooth transition surface along the length of the dilator between sections of decreasing prescribed diameters (see Fig. 1 and 3; Par. 9). However, Luo discloses a related dilator (Fig. 4) for vascular access (Par. 3), the dilator comprising a tapered distal tip section (7) and a series of straight segments (11, 13, 15, 9), marked with the respective diameter, which decease in diameter in the direction of the tip (see Fig. 4, 5) wherein the straight segments are connected by angled segments (12, 14, 16) located between each of the straight segments (see Fig. 4, 5), wherein the straight and angled segments may all have the same wall thickness such that the dilator exhibits a consistent wall thickness which does not decrease in thickness between the dilator’s proximal end and the dilator’s tip (see Fig. 4, 5 – Par. 43), thereby allowing dilation to occur in discrete stages (Par. 7) increasing accuracy of the dilation diameter (Par. 37).
Relatedly, Bakos discloses a dilator (Fig. 5) which like those of Luo and Broniec includes marked (43) diameter segments (see Fig. 5). Bakos discloses that the transition between these diameter segments may be made as a series of straight segments (21A, 21B, 21C) connected together by respective angled segments (44 – see Fig. 5) and that these steps allow the clinician to “feel” the stepped increases in diameter at the angled transitions along with visual verification from the markers (see Par. 59).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the dilator of the invention of Broniec to have a constant diameter between the proximal end and the distal tip and comprise a series of straight wall segments separated by angled segments having a uniform thickness throughout, as disclosed by Luo, in order to allow a clinician to “feel” the transition between dilation diameters (Par. 59 – Bakos) to provide tactile confirmation associated with the visual markers and increasing the accuracy of dilation diameter through the use of discrete steps (Par. 37 – Luo).
Regarding Claim 9, Broniec discloses the malleable, tapered dilator has French sizes printed thereon (Par. 22 – Fig. 3).
Regarding Claim 10, Luo discloses that the taper of the angled segments may be between 3 and 15 degrees (Par. 11 – Luo) and Bakos discloses that the taper angle of the transitions may range from 3 degrees to 15 degrees (Par. 38 - Bakos). It would have been obvious for one having ordinary skill in the art at the time the invention was made to select the angle of taper of the invention of modified Broniec to comprise an angle of 5 degrees, a value within the range prescribed by Luo and Bakos, thereby selecting a suitable value for providing a sufficiently gradual transition to prevent damage to the tissue from more abrupt changes while preserving the tactile responsiveness of the transitions.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0246597 (“Broniec”) in view of CN 102671287 (“Luo”) and U.S. Publication No. 2005/0070949 (“Bakos”) as applied above, and further in view of U.S. Publication No. 2013/0197558 (“Ingold”) and U.S. Patent No. 5,531,754 (“Shackelford”).
Regarding Claims 11 and 12, Broniec, as modified, discloses the invention substantially as claimed except that that the blade device comprises:
an elongated blade having a sharpened end and having a cam mounted thereon; a housing having a longitudinal recessed channel; and
retractor means, wherein said blade is longitudinally retractable withing said housing and said blade device is slidable on a guide wire for use with a vascular dilator.
Rather Broniec discloses that the cover is retractable from the blade. However, Ingold discloses that such covers/blades (400; Fig. 10) may be replaced with one wherein the elongated blade (502) has a sharpened distal end and a housing (510) such that a retractor means (560, 562) can be used to longitudinally retract the blade within the housing, the blade being slidable on the guide wire for use with a vascular dilator (see at 508 Par. 37). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the retractable cover of the invention of Broniec with a retractable blade, as disclosed by Ingold, in order to predictably sheath the blade within the housing in a known, predictable manner based upon clinician preference for one style of cover over the other.
In the instant case Ingold fails to disclose that the retractable blade comprises a “cam mounted thereon”. Rather Ingold merely discloses retraction of the blade by only pushing/pulling the retractor arm (560) of connected to the blade.
However, Shackleford discloses a related retractable blade (Fig. 1) comprising an elongated blade (18) having a sharpened end and having a cam (62) mounted thereon;
a housing (12) having a longitudinal recessed channel; and
retractor means (14, 60), wherein said blade is longitudinally retractable withing said housing (see Fig. 4 and 1), wherein the retractor means comprises:
retractor arms (40, 47) connected to said elongated blade;
a retraction opening (see 30, at 26) within said housing into which said elongated blade is longitudinally housed (see Fig. 1 and 2); and a
sawtoothed structure (60) within said retraction opening;
wherein said sawtoothed structure engages said cam providing for retraction of said blade using said retractor arms (see Fig. 4) in order to assist in locking the position of the blade. It would have been obvious for one having ordinary skill in the art at the time the invention was made to modify the retractable blade of the invention of modified Broneic to include a cam and retractor means, as disclosed by Shackleford, in order to allow the relative position of the blade to be secured via a positive cam/sawtooth arrangement to help prevent accidental movement of the blade during use.
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0246597 (“Broniec”) in view of CN 102671287 (“Luo”), U.S. Publication No. 2005/0070949 (“Bakos”), and U.S. Publication No. 2013/0197558 (“Ingold”).
Regarding Claim 15, Broneic discloses a method (Par. 21-22; Clm. 3) for introduction of a treatment device into a body vessel and safe disposal of apparatus therefor by a medical professional comprising the steps of:
inserting a hollow needle into said vessel (Par. 21, Clm. 3);
inserting a wire (5) longitudinally into said needle (Par. 21, Clm. 3);
retracting said needle (Clm. 3);
sliding a blade (4) device having a sharpened end longitudinally on said
wire in the direction of said vessel (Par. 21, Clm. 3);
using said sharpened end of said blade device to make an incision in the dermis surrounding said vessel (Par. 21, Clm. 3);
covering the blade device with a safety cover (Par. 22, Clm. 3);
withdrawing said blade device (Par. 22, Clm. 3);
sliding a dilator (7) on said wire in the direction of said vessel (Par. 21-22; Clm. 3), said dilator having a tip (Fig. 3);
inserting said dilator into said vessel to the desired depth using visual feedback accessible to said medical professional inserting said dilator based on the visible level of insertion (see the French size indicia), whereby said dilator is placed in said vessel in a safe manner for proper dilation for introduction of a treatment device (Par. 22, Clm. 3).
Broniec discloses the invention substantially as claimed except that the dilator comprises a series of straight segments which decrease in diameter in the direction of said tip, with the straight segments being connected by angled segments located therebetween. Rather, Broniec discloses a smooth transition surface along the length of the dilator between sections of decreasing prescribed diameters (see Fig. 1 and 3; Par. 9). However, Luo discloses a related dilator (Fig. 4) for vascular access (Par. 3), the dilator comprising a tapered distal tip section (7) and a series of straight segments (11, 13, 15, 9), marked with the respective diameter, which decease in diameter in the direction of the tip (see Fig. 4, 5) wherein the straight segments are connected by angled segments (12, 14, 16) located between each of the straight segments (see Fig. 4, 5), wherein the straight and angled segments may all have the same wall thickness such that the dilator exhibits a consistent wall thickness which does not decrease in thickness between the dilator’s proximal end and the dilator’s tip (see Fig. 4, 5 – Par. 43), thereby allowing dilation to occur in discrete stages (Par. 7) increasing accuracy of the dilation diameter (Par. 37).
Relatedly, Bakos discloses a dilator (Fig. 5) which like those of Luo and Broniec includes marked (43) diameter segments (see Fig. 5). Bakos discloses that the transition between these diameter segments may be made as a series of straight segments (21A, 21B, 21C) connected together by respective angled segments (44 – see Fig. 5) and that these steps allow the clinician to “feel” the stepped increases in diameter at the angled transitions along with visual verification from the markers (see Par. 59).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the dilator of the invention of Broniec to have a constant diameter between the proximal end and the distal tip and comprise a series of straight wall segments separated by angled segments having a uniform thickness throughout, as disclosed by Luo, in order to allow a clinician to “feel” the transition between dilation diameters (Par. 59 – Bakos) to provide tactile confirmation associated with the visual markers and increasing the accuracy of dilation diameter through the use of discrete steps (Par. 37 – Luo).
Broniec, as modified, discloses the invention substantially as claimed except that that the blade device is retractable into the cover/housing. Rather Broniec discloses that the cover is retractable from the blade. However, Ingold discloses that such covers/blades (400; Fig. 10) may be replaced with one wherein the elongated blade (502) has a sharpened distal end and a housing (510) such that a retractor means (560, 562) can be used to longitudinally retract the blade within the housing, the blade being slidable on the guide wire for use with a vascular dilator (see at 508 Par. 37). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the retractable cover of the invention of Broniec with a retractable blade, as disclosed by Ingold, in order to predictably sheath the blade within the housing in a known, predictable manner based upon clinician preference for one style of cover over the other.
Regarding Claim 16, Luo discloses that the taper of the angled segments may be between 3 and 15 degrees (Par. 11 – Luo) and Bakos discloses that the taper angle of the transitions may range from 3 degrees to 15 degrees (Par. 38 - Bakos). It would have been obvious for one having ordinary skill in the art at the time the invention was made to select the angle of taper of the invention of modified Broniec to comprise an angle of 5 degrees, a value within the range prescribed by Luo and Bakos, thereby selecting a suitable value for providing a sufficiently gradual transition to prevent damage to the tissue from more abrupt changes while preserving the tactile responsiveness of the transitions.
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0246597 (“Broniec”) in view of CN 102671287 (“Luo”), U.S. Publication No. 2005/0070949 (“Bakos”), and U.S. Publication No. 2013/0197558 (“Ingold”) as applied above, and further in view of U.S. Patent No. 5,531,754 (“Shackelford”).
Regarding Claims 17 and 18, in the instant case Ingold fails to disclose that the retractable blade comprises a “cam mounted thereon”. Rather Ingold merely discloses retraction of the blade by only pushing/pulling the retractor arm (560) of connected to the blade.
However, Shackleford discloses a related retractable blade (Fig. 1) comprising an elongated blade (18) having a sharpened end and having a cam (62) mounted thereon;
a housing (12) having a longitudinal recessed channel; and
retractor means (14, 60), wherein said blade is longitudinally retractable withing said housing (see Fig. 4 and 1), wherein the retractor means comprises:
retractor arms (40, 47) connected to said elongated blade;
a retraction opening (see 30, at 26) within said housing into which said elongated blade is longitudinally housed (see Fig. 1 and 2); and a
sawtoothed structure (60) within said retraction opening;
wherein said sawtoothed structure engages said cam providing for retraction of said blade using said retractor arms (see Fig. 4) in order to assist in locking the position of the blade. It would have been obvious for one having ordinary skill in the art at the time the invention was made to modify the retractable blade of modified Broneic, as disclosed by Shackleford, in order to allow the relative position of the blade to be secured via a positive cam/sawtooth arrangement to help prevent accidental movement of the blade during use.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0246597 (“Broniec”) in view of CN 102671287 (“Luo”), U.S. Publication No. 2005/0070949 (“Bakos”), and U.S. Publication No. 2021/0106351 (“Hossack”).
Regarding Claim 19, Broniec discloses a vascular access dilator apparatus (Fig. 1) comprising:
a hollow needle (not labeled; see Par. 21; Clm. 3);
a wire (5) insertable longitudinally into said needle (Par. 21; Clm. 3);
a blade (4) slidable on said wire (Par. 21; Clm. 3);
a malleable, tapered dilator (7) having a tip located at a distal end of said dilator (see Fig. 3), the dilator being insertable directionally in line with said wire (Par. 22; Clm. 33); and
a safety cover (2) retractable from said blade (see Fig. 2; Clm. 3).
Broniec discloses the invention substantially as claimed except that the dilator comprises a series of straight segments which decrease in diameter in the direction of said tip, with the straight segments being connected by angled segments located therebetween. Rather, Broniec discloses a smooth transition surface along the length of the dilator between sections of decreasing prescribed diameters (see Fig. 1 and 3; Par. 9). However, Luo discloses a related dilator (Fig. 4) for vascular access (Par. 3), the dilator comprising a tapered distal tip section (7) and a series of straight segments (11, 13, 15, 9), marked with the respective diameter, which decease in diameter in the direction of the tip (see Fig. 4, 5) wherein the straight segments are connected by angled segments (12, 14, 16) located between each of the straight segments (see Fig. 4, 5), wherein the straight and angled segments may all have the same wall thickness such that the dilator exhibits a consistent wall thickness which does not decrease in thickness between the dilator’s proximal end and the dilator’s tip (see Fig. 4, 5 – Par. 43), thereby allowing dilation to occur in discrete stages (Par. 7) increasing accuracy of the dilation diameter (Par. 37).
Relatedly, Bakos discloses a dilator (Fig. 5) which like those of Luo and Broniec includes marked (43) diameter segments (see Fig. 5). Bakos discloses that the transition between these diameter segments may be made as a series of straight segments (21A, 21B, 21C) connected together by respective angled segments (44 – see Fig. 5) and that these steps allow the clinician to “feel” the stepped increases in diameter at the angled transitions along with visual verification from the markers (see Par. 59).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the dilator of the invention of Broniec to have a constant diameter between the proximal end and the distal tip and comprise a series of straight wall segments separated by angled segments having a uniform thickness throughout, as disclosed by Luo, in order to allow a clinician to “feel” the transition between dilation diameters (Par. 59 – Bakos) to provide tactile confirmation associated with the visual markers and increasing the accuracy of dilation diameter through the use of discrete steps (Par. 37 – Luo).
Luo discloses that the taper of the angled segments may be between 3 and 15 degrees (Par. 11 – Luo) and Bakos discloses that the taper angle of the transitions may range from 3 degrees to 15 degrees (Par. 38 - Bakos). It would have been obvious for one having ordinary skill in the art at the time the invention was made to select the angle of taper of the invention of modified Broniec to comprise an angle of 5 degrees, a value within the range prescribed by Luo and Bakos, thereby selecting a suitable value for providing a sufficiently gradual transition to prevent damage to the tissue from more abrupt changes while preserving the tactile responsiveness of the transitions.
Broniec, as modified, discloses the invention substantially as claimed except that blade is “magnetized”. However, Hossack discloses a related, guidewire tracking blade/nicking device used to gain access to the vasculature (Abstract), wherein the blade device can be magnetized to permit magnetic tracking with an entrained guidewire (Par. 16, 20). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the blade of modified Broniec to be magnetized, as disclosed by Hossack, in order to permit magnetic tracking of a guidewire to ensure that the magnetized blade follows “an optimal path from the skin surface to the required depth” (see Par. 20, Hossack).
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 05/18/2026
Prosecution Insights