DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
1216 as recited in [0041].
1128 as recited in [0045].
1110 as recited in [0060].
1122 as recited in [0060].
1120 as recited in [0060].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
150 in Figure 9A.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0076] recites “The flexibility profile 2000 shown in Figure 18.” The Examiner believes this is the incorrect figure and suggests amending this phrase to recite “The flexibility profile 2000 shown in Figure [[18]] 6A” to correct the figure.
[0076] recites “(gF).” The Examiner believes gF stands for the unit gram-force. If this is the case then the Examiner suggests amending [0076] to recite this unit to remove any ambiguity as to what gF stands for and what the unit is.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is 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.
Claim 1 recites “a flexible distal portion comprising: a distal tip…a transitional portion..”. Claim 11 recites “wherein the transitional portion comprises a substantially constant stiffness along a length of the distal tip.” Claim 11 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it is unclear how the transitional portion can comprise a substantially constant stiffness along a length of the tip when the transitional portion is a separate part of the flexible distal portion than the distal tip. For the purpose of examination, the recitation of “a length of the distal tip” is interpreted to be “a length of the flexible distal portion.”
Claim Rejections - 35 USC § 102
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) 1 – 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (US 2020/0205845 A1) (hereinafter referred to as “Yang”).
With regards to claim 1, Yang discloses (see Figures 12A – 12F, 30, and 34A) a neurovascular catheter (1222/3000) (see [0154] “the transitional guide sheath 1222 has a soft yet trackable distal segment described in further detail below, for example in connection with FIG. 30” and [0242] “the catheter 3000”) for insertion into an internal carotid artery (1206) of a patient (see [0241]), the neurovascular catheter comprising:
an elongate flexible body (see [0242] and the disclosed length from the manifold to distal tip) comprising a length of less than about 110 cm (see [0242] “the catheter 3000 may have an effective length from the manifold to distal tip from about 70 cm to about 150 cm,”), the elongate flexible body comprising:
a flexible distal portion (3032, 3034, 3036, 3038) (see Figure 30) comprising a length of between about 10 cm and about 18 cm (see [0290] which describes 3038 having a length of about 1 cm – 3 cm, 3036 having a length of about 4 cm – 6 cm, and 3034 having a length of about 4 cm – 6 cm, 3032 having a length of about 1 cm – 3 cm wherein the total length of 3032, 3034, 3036, 3038 equals a range of about 10 cm – 18 cm), the flexible distal portion comprising:
a distal tip (3038) configured to be positioned within a cavernous segment (1210) of the internal carotid artery (1206) (see Figures 12A – 12F, [0154], and [0241]);
a transitional portion (3034) proximal to the distal tip that is less flexible than the distal tip (see [0290] “A distal segment 3038 may have a length within the range of about 1-3 cm, and a durometer of less than about 35 D or 30 D. ...An adjacent proximal segment 3034 may have a length within the range of about 4-6 cm, and a durometer of about 35 D or less.” When the durometer of the distal segment 3038 is less than 30 D and the durometer of the adjacent proximal segment 3034 is less than 35 D but above 30 D), wherein the transitional portion is configured to be positioned within a petrous segment (1212) of the internal carotid artery (see Figures 12A – 12F, [0154] and [0241]); and
a support portion (3032) proximal to the transitional portion that is less flexible than the transitional portion (see [0290] “An adjacent proximal segment 3032 may have a length within the range of about 1-3 cm, and a durometer within the range of from about 35 D to about 45 D (e.g., 40 D).” When the durometer of the adjacent proximal segment 3032 is 35 D), wherein the support portion is configured to extend proximal to a base of the patient's skull (see Figures 12A – 12F and [0241]).
With regards to claim 2, Yang disclose the claimed invention of claim 1 and Yang further discloses wherein the elongate flexible body (see [0242] and the disclosed length from the manifold to distal tip) has a length of between about 98 cm and about 102 cm (see [0242] “the catheter 3000 may have an effective length from the manifold to distal tip from about 70 cm to about 150 cm”).
With regards to claim 3, Yang disclose the claimed invention of claim 1 and Yang further discloses wherein the flexible distal portion (3032, 3034, 3036, 3038) has a length of between about 12 cm and about 16 cm (see [0290] which describes 3038 having a length of about 1 cm – 3 cm, 3036 having a length of about 4 cm – 6 cm, and 3034 having a length of about 4 cm – 6 cm, 3032 having a length of about 1 cm – 3 cm wherein the total length of 3032, 3034, 3036, 3038 equals a range of about 10 cm – 18 cm).
With regards to claim 4, Yang disclose the claimed invention of claim 1 and Yang further discloses wherein the distal tip (3038) has a length of between about 15 mm to about 20 mm (see [0290] “A distal segment 3038 may have a length within the range of about 1-3 cm, and a durometer of less than about 35 D or 30 D.” Here 1 – 3 cm equates to 10 – 30 mm.).
With regards to claim 5, Yang disclose the claimed invention of claim 1 and Yang further discloses wherein the transitional portion (3034) has a length of between about 1.0 cm and 3.5 cm (see [0290] “An adjacent proximal segment 3034 may have a length within the range of about 4-6 cm, and a durometer of about 35 D or less.”) (Paragraph [0107] of the applicant’s disclosure provides a definition for the term “about.” About is defined to represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. It is the Examiner’s position that about 4 cm is about 3.5 mm because the transitional portion still performs the same desired function and result [0297] of Yang)
With regards to claim 6, Yang disclose the claimed invention of claim 1 and Yang further discloses wherein a proximal end (see Figure 30 at left side of 3034 section) of the transitional portion (3034) is positioned a distance of between about 5.5 cm and about 7.5 cm from a distal end (see at 3006 in Figure 30) of the flexible distal portion (3032, 3034, 3036, 3038) (see [0290] which describes 3038 having a length of about 1 cm – 3 cm, 3036 having a length of about 4 cm – 6 cm, and 3034 having a length of about 4 cm – 6 cm wherein when 3038 has a length of about 1 cm, 3036 has a length of about 4 cm, and 3034 has a length of about 4 cm the proximal end of the transitional portion 3034 is about 9cm from the proximal end) (Paragraph [0107] of the applicant’s disclosure provides a definition for the term “about.” About is defined to represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. It is the Examiner’s position that about 9 cm is about 7.5 cm because the transitional portion still performs the same desired function and result according to paragraph [0297] of Yang).
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) 7, 9, 11, 13, 15, 17 – 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang.
With regards to claim 7, Yang discloses the claimed invention of claim 1, and Yang further discloses wherein the distal tip (3038) comprises a substantially constant stiffness along a length of the distal tip (see [0290] “A distal segment 3038 may have a length within the range of about 1-3 cm, and a durometer of less than about 35 D or 30 D.” and [0297]).
Yang further discloses a variety of catheter embodiments having a flexural load that is substantially constant along the longitudinal length near the proximal end and rapidly decreasing the flexural load near the distal end. See [0297] of Yang. The catheter embodiments disclosed may have a flexural load less than or equal to about 1.0 lbF, about 0.75 lbF, about 0.5 lbF, about 0.4 lbF, about 0.3 lbF, about 0.2 lbF, or about 0.1 lbF at about 115 cm from the proximal end, and that when the catheters having different lengths, the foregoing dimensions can be scaled from the distal end of the catheter as a percentage of catheter length. Id. Yang discloses that the substantially constant stiffness of the distal tip is a result effective variable in the back-up support, trackability, pushability, and kink resistance characteristics of the catheter as it moves through the vasculature. See [0291] – [0294] and [0298] of Yang.
Yang is in the same field of endeavor as the claimed invention.
However, the difference between Yang and the instant claims is that Yang is silent with regards to wherein the substantially constant stiffness is between about 20 gF to about 30 gF.
Nonetheless the difference between Yang and the claimed invention was a known variation. Specifically, Yang teaches that the substantially constant stiffness along the length of the distal tip is less than or equal to about 0.1 lbF at about 115 cm from the proximal end of the catheter. See [0297] of Yang.
There were also design incentives for implementing the claimed variation. Specifically, Yang teaches that adjusting the flexural load across lengths of the catheter allows for tailoring the performance metrics of a catheter such as the back-up support, trackability, pushability and kink resistance for its intended function. See [0291] – [0294] of Yang. Therefore, as of the effective filing date of the claimed invention, the substantially constant stiffness of the distal tip being between about 20 gF to about 30 gF would have been recognized as predictable to one of ordinary skill in the art.
Furthermore, the claimed phrase “wherein the substantially constant stiffness is determined using a cantilever beam test with a 5 mm gage length and 4 mm displacement to determine a peak load value” is being treated as a product by process limitation. As set forth in MPEP 2113, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. See MPEP 2113. The patentability of a product does not depend on its method of production. See id. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. § 103 rejection may be made and the burden is shifted to the applicant to show an unobvious difference. See MPEP 2113(II).
With regards to claim 9, Yang discloses the claimed invention of claim 1, and Yang further discloses wherein the flexible distal portion (3032, 3034, 3036, 3038) further comprises a flexible portion (3036) (see [0290]) that extends proximal to the distal tip (3038) and comprises a stiffness that increases along a length of the flexible portion (see [0297] “Catheters according to the present invention have a flexural load that is substantially constant along the longitudinal length near the proximal end and a rapidly decreasing flexural load near the distal end.”).
Yang further discloses a variety of catheter embodiments having a flexural load that is substantially constant along the longitudinal length near the proximal end and rapidly decreasing the flexural load near the distal end. See [0297] of Yang. The catheters may have a flexural load less than or equal to about 1.0 lbF, about 0.75 lbF, about 0.5 lbF, about 0.4 lbF, about 0.3 lbF, about 0.2 lbF, or about 0.1 lbF at about 115 cm from the proximal end. Id. Further for catheters having different lengths, the foregoing dimensions can be scaled from the distal end of the catheter as a percentage of catheter length. Id. Yang discloses that the stiffness of the flexible portion is a result effective variable in the back-up support, trackability, pushability, and kink resistance characteristics of the catheter as it moves through the vasculature. See [0291] – [0294] and [0298] of Yang.
Yang is in the same field of endeavor as the claimed invention.
However, the difference between Yang and the instant claims is that Yang is silent with regards to wherein the flexible portion has a first stiffness at a first end of the flexible portion that is between about 20 gF to about 30 gF, and wherein the flexible portion has a second stiffness at a second end of the flexible portion that is between about 60 gF to about 65 gF.
Nonetheless the difference between Yang and the claimed invention was a known variation. Specifically, Yang teaches that the first stiffness at the first end of the flexible portion is less than 0.1 lbF and the second stiffness at the second end of the flexible portion is about equal to 0.1 lbF. See [0297] of Yang.
There were also design incentives for implementing the claimed variation. Specifically, Yang teaches that adjusting the flexural load across lengths of the catheter allows for tailoring the performance metrics of a catheter such as the back-up support, trackability, pushability and kink resistance for its intended function. See [0291] – [0294] of Yang. Therefore, as of the effective filing date of the claimed invention, the flexible portion having a first stiffness at a first end of the flexible portion that is between about 20 gF to about 30 gF, and wherein the flexible portion having a second stiffness at a second end of the flexible portion that is between about 60 gF to about 65 gF would have been recognized as predictable to one of ordinary skill in the art.
With regards to claim 11, Yang discloses the claimed invention of claim 1, and Yang further discloses wherein the transitional portion (3034) comprises a substantially constant stiffness along a length of the distal tip (see the 35 U.S.C. § 112(b) rejection above where this is interpreted to be the “flexible distal portion”) (see [0297] “The catheters may have a flexural load less than or equal to about 1.0 lbF, about 0.75 lbF, about 0.5 lbF, about 0.4 lbF, about 0.3 lbF, about 0.2 lbF, or about 0.1 lbF at about 115 cm from the proximal end. ”).
Yang further discloses a variety of catheter embodiments having a flexural load that is substantially constant along the longitudinal length near the proximal end and rapidly decreasing the flexural load near the distal end. See [0297] of Yang. The catheters may have a flexural load less than or equal to about 1.0 lbF, about 0.75 lbF, about 0.5 lbF, about 0.4 lbF, about 0.3 lbF, about 0.2 lbF, or about 0.1 lbF at about 115 cm from the proximal end. Id. Further for catheters having different lengths, the foregoing dimensions can be scaled from the distal end of the catheter as a percentage of catheter length. Id. Yang discloses that the substantially constant stiffness of the transitional portion is a result effective variable in the back-up support, trackability, pushability, and kink resistance characteristics of the catheter as it moves through the vasculature. See [0291] – [0294] and [0298] of Yang.
Yang is in the same field of endeavor as the claimed invention.
However, the difference between Yang and the instant claims is that Yang is silent with regards to wherein the substantially constant stiffness is between about 50 gF to about 70 gF.
Nonetheless the difference between Yang and the claimed invention was a known variation. Specifically, Yang teaches that the substantially constant stiffness can be less than or equal to about 0.2 lbF or 0.1 lbF. See [0297] of Yang.
There were also design incentives for implementing the claimed variation. Specifically, Yang teaches that adjusting the flexural load across lengths of the catheter allows for tailoring the performance metrics of a catheter such as the back-up support, trackability, pushability and kink resistance for its intended function. See [0291] – [0294] of Yang. Therefore, as of the effective filing date of the claimed invention, the substantially constant stiffness of the transitional portion being between about 50 gF to about 70 gF would have been recognized as predictable to one of ordinary skill in the art.
With regards to claim 13, Yang discloses the claimed invention of claim 1, and Yang further discloses wherein the support portion (3032) comprises a stiffness that increases along a length of the support portion (see [0297] “ Catheters according to the present invention have a flexural load that is substantially constant along the longitudinal length near the proximal end and a rapidly decreasing flexural load near the distal end.”).
Yang further discloses a variety of catheter embodiments having a flexural load that is substantially constant along the longitudinal length near the proximal end and rapidly decreasing the flexural load near the distal end. See [0297] of Yang. The catheters may have a flexural load less than or equal to about 1.0 lbF, about 0.75 lbF, about 0.5 lbF, about 0.4 lbF, about 0.3 lbF, about 0.2 lbF, or about 0.1 lbF at about 115 cm from the proximal end. Id. Further for catheters having different lengths, the foregoing dimensions can be scaled from the distal end of the catheter as a percentage of catheter length. Id. Yang discloses that the stiffness of the support portion is a result effective variable in the back-up support, trackability, pushability, and kink resistance characteristics of the catheter as it moves through the vasculature. See [0291] – [0294] and [0298] of Yang.
Yang is in the same field of endeavor as the claimed invention.
However, the difference between Yang and the instant claims is that Yang is silent with regards to wherein the support portion has a first stiffness at a first end of the support portion that is between about 60 gF to about 70 gF, and wherein the support portion has a second stiffness at a second end of the support portion that is at least 400 gF.
Nonetheless the difference between Yang and the claimed invention was a known variation. Specifically, Yang teaches that the first stiffness at the first end of the support portion is less than or equal to 0.2 lbF and the second stiffness at the second end of the support portion is less than or equal to about 1 lbF. See [0297] of Yang.
There were also design incentives for implementing the claimed variation. Specifically, Yang teaches that adjusting the flexural load across lengths of the catheter allows for tailoring the performance metrics of a catheter such as the back-up support, trackability, pushability and kink resistance for its intended function. See [0291] – [0294] of Yang. Therefore, as of the effective filing date of the claimed invention, the support portion having a first stiffness at a first end of the support portion that is between about 60 gF to about 70 gF, and wherein the support portion having a second stiffness at a second end of the support portion that is at least 400 gF would have been recognized as predictable to one of ordinary skill in the art.
With regards to claim 15, Yang discloses (see Figures 12A – 12F, 30, and 34A) a neurovascular catheter (1222/3000) (see [0154] “the transitional guide sheath 1222 has a soft yet trackable distal segment described in further detail below, for example in connection with FIG. 30” and [0242] “the catheter 3000”) for insertion into an internal carotid artery (1206) of a patient (see [0241]), the neurovascular catheter comprising:
an elongate flexible body (see [0242] and the disclosed length from the manifold to the distal tip) comprising a length of less than about 110 cm (see [0242] “the catheter 3000 may have an effective length from the manifold to distal tip from about 70 cm to about 150 cm”), the elongate flexible body comprising:
a flexible distal segment (3030, 3032, 3034, 3036, 3038) comprising a length of between about 10 cm and about 18 cm (see [0290] which describes 3038 having a length of about 1 cm – 3 cm, 3036 having a length of about 4 cm – 6 cm, and 3034 having a length of about 4 cm – 6 cm, 3032 having a length of about 1 cm – 3 cm, and 3030 having a length of about 1 cm – 3 cm wherein the total length of 3030, 3032, 3034, 3036, 3038 equals a range of about 11 cm – 21 cm), the flexible distal segment comprising:
a distal portion (3038, 3036) having a length between about 20 mm and 40 mm (see [0290] “A distal segment 3038 may have a length within the range of about 1-3 cm…An adjacent proximal segment 3036 may have a length within the range of about 4-6 cm” where the combined range length of 3038, 3036 is about 5 cm – 9 cm) (Paragraph [0107] of the applicant’s disclosure provides a definition for the term “about.” About is defined to represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. It is the Examiner’s position that about 5 cm – 9 cm is about 20 – 40 mm because the distal portion performs the same desired function and result as the claimed invention), the distal portion comprising:
a tracking tip (3038) configured to be positioned within a cavernous segment (1210) of the internal carotid artery (1206) (see Figures 12A – 12F, [0154], and [0241]), wherein the tracking tip has a length between about 10 mm and about 20 mm (see [0290] "A distal segment 3038 may have a length within the range of about 1-3 cm" Here 1 - 2 cm equates to 10 - 20 mm.); and
an increasing stiffness portion (3036) (see [0290] and [0297] “ Catheters according to the present invention have a flexural load that is substantially constant along the longitudinal length near the proximal end and a rapidly decreasing flexural load near the distal end.”) proximal to the tracking tip (see Figure 30), wherein the increasing stiffness portion has a length between about 5 mm and about 15 mm (see [0290] “An adjacent proximal segment 3036 may have a length within the range of about 4-6 cm”) (Paragraph [0107] of the applicant’s disclosure provides a definition for the term “about.” About is defined to represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. It is the Examiner’s position that the range of about 4 – 6 cm is about 5 – 15 mm because the increasing stiffness portion still performs the same desired function and result i.e., increasing in stiffness over the length according to [0297] of Yang);
a transitional portion (3034) proximal to the distal portion that is less flexible than the tracking tip (see [0290] “A distal segment 3038 may have a length within the range of about 1-3 cm, and a durometer of less than about 35 D or 30 D. ...An adjacent proximal segment 3034 may have a length within the range of about 4-6 cm, and a durometer of about 35 D or less.” Wherein when the durometer of the distal segment 3038 is less than 30 D and the durometer of the adjacent proximal segment 3034 is less than 35 D), wherein the transitional portion is configured to be positioned within a petrous segment (1212) of the internal carotid artery (1206) (see Figures 12A – 12F, [0154], and [0241]), wherein the transitional portion has a length of between about 30 mm and about 40 mm (see [0290] “An adjacent proximal segment 3034 may have a length within the range of about 4-6 cm” where about 4 cm is about 40 mm); and
a support portion (3030, 3032) proximal to the transitional portion (see Figure 30) that is less flexible than the transitional portion (see [0290] An adjacent proximal segment 3032 may have a length within the range of about 1-3 cm, and a durometer within the range of from about 35 D to about 45 D (e.g., 40 D). An adjacent proximal segment 3030 may have a length within the range of about 1-3 cm, and a durometer within the range of from about 50 D to about 60 D (e.g., about 55 D).” Wherein when the durometer of the adjacent proximal segment 3032 is 35 D and the proximal segment 3030 is a durometer ranging from 50 D to about 60 D both are less flexible than the durometer of the transitional portion 3034), wherein the support portion is configured to extend proximal to a base of a patient's skull (see Figures 12A – 12F and [0241]), wherein the support portion comprises a stiffness that increases proximally along a length of the support portion (see [0290] and [0297] “Catheters according to the present invention have a flexural load that is substantially constant along the longitudinal length near the proximal end and a rapidly decreasing flexural load near the distal end.”), wherein the support portion has a length between about 70 mm and about 80 mm (see [0290] where the length of 3030 is about 1 – 3 cm and the length of 3032 is about 1 – 3 cm; wherein the total length of about 6 cm is about 60 mm) (Paragraph [0107] of the applicant’s disclosure provides a definition for the term “about.” About is defined to represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. It is the Examiner’s position that about 6 cm is about 70 – 80 mm because the support portion still performs the same desired function and result i.e., increasing in stiffness over the length according to paragraph [0297] of Yang);
wherein a flexibility profile of the flexible distal segment is measurable with a cantilever beam test with a 5 mm gage length and 4 mm displacement to determine a peak load value (the claimed phrase “wherein a flexibility profile of the flexible distal segment is measurable with a cantilever beam test with a 5 mm gage length and 4 mm displacement to determine a peak load value” is being treated as a product by process limitation. As set forth in MPEP 2113, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. See MPEP 2113. The patentability of a product does not depend on its method of production. See id. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. § 103 rejection may be made and the burden is shifted to the applicant to show an unobvious difference. See MPEP 2113(II).
Yang further discloses a variety of catheter embodiments having a flexural load that is substantially constant along the longitudinal length near the proximal end and rapidly decreasing the flexural load near the distal end. See [0297] of Yang. The catheters may have a flexural load less than or equal to about 1.0 lbF, about 0.75 lbF, about 0.5 lbF, about 0.4 lbF, about 0.3 lbF, about 0.2 lbF, or about 0.1 lbF at about 115 cm from the proximal end. Id. Further for catheters having different lengths, the foregoing dimensions can be scaled from the distal end of the catheter as a percentage of catheter length. Id. Yang discloses that the stiffness along the catheter is a result effective variable in the back-up support, trackability, pushability, and kink resistance characteristics of the catheter as it moves through the vasculature. See [0291] – [0294] and [0298] of Yang.
Yang is in the same field of endeavor as the claimed invention.
However, the difference between Yang and the instant claims is that Yang is silent with regards to the following:
the peak load value in the tracking tip is less than about 30 gF;
the peak load value in the increasing stiffness portion increases from between about 20 gF and about 30 gF to between about 50 gF and about 70 gF over the length of the increasing stiffness portion;
the peak load value in the transitional portion is between about 50 gF and about 70 gF; and
the peak load value at a first end of the support portion is between about 50 gF and about 70 gF and at a second end of the support portion is at least about 400 gF.
Nonetheless the difference between Yang and the claimed invention was a known variation. Specifically, Yang teaches that the a flexural load based on the stiffness of the catheter is substantially constant along the longitudinal length near the proximal end and rapidly decreases near the distal end. See [0297] of Yang. Further Yang teaches that the catheter may have a flexural load less than or equal to about 1.0 lbF, about 0.75 lbF, about 0.5 lbF, about 0.4 lbF, about 0.3 lbF, about 0.2 lbF, or about 0.1 lbF at about 115 cm from the proximal end and decreasing from there to the distal end among other flexural loads at other various locations of the catheter length. Id.
There were also design incentives for implementing the claimed variation. Specifically, Yang teaches that adjusting the flexural load across lengths of the catheter allows for tailoring the performance metrics of a catheter such as the back-up support, trackability, pushability and kink resistance for its intended function. See [0291] – [0294] of Yang. Therefore, as of the effective filing date of the claimed invention, the peak load value in the tracking tip being less than about 30 gF; the peak load value in the increasing stiffness portion increases from between about 20 gF and about 30 gF to between about 50 gF and about 70 gF over the length of the increasing stiffness portion; the peak load value in the transitional portion being between about 50 gF and about 70 gF; and the peak load value at a first end of the support portion being between about 50 gF and about 70 gF and at a second end of the support portion being at least about 400 gF would have been recognized as predictable to one of ordinary skill in the art.
With regards to claim 17, Yang teaches the claimed invention of claim 15, and Yang further teaches wherein the flexible distal segment (3030, 3032, 3034, 3036, 3038) has a length of about 14 cm (see [0290] which describes 3038 having a length of about 1 cm – 3 cm, 3036 having a length of about 4 cm – 6 cm, and 3034 having a length of about 4 cm – 6 cm, 3032 having a length of about 1 cm – 3 cm, and 3030 having a length of about 1 cm – 3 cm wherein the total length of 3030, 3032, 3034, 3036, 3038 equals a range of about 11 cm – 21 cm).
With regards to claim 18, Yang teaches the claimed invention of claim 15, and Yang further teaches wherein the distal portion (3038, 3036) has a length of about 30 mm (see [0290] “A distal segment 3038 may have a length within the range of about 1-3 cm…An adjacent proximal segment 3036 may have a length within the range of about 4-6 cm” where the combined range length of 3038, 3036 is about 5 cm – 9 cm) (Paragraph [0107] of the applicant’s disclosure provides a definition for the term “about.” About is defined to represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. It is the Examiner’s position that about 5 cm – 9 cm is about 30 mm because the distal portion performs the same desired function and result as the claimed invention)
With regards to claim 19, Yang teaches the claimed invention of claim 15, and Yang further teaches wherein the tracking tip (3038) has a length of about 17 mm (see [0290] "A distal segment 3038 may have a length within the range of about 1-3 cm" Here the range 1 – 3 cm encompasses a length of about 17 mm.).
With regards to claim 20, Yang teaches the claimed invention of claim 15, and Yang further teaches wherein the increasing stiffness portion (3036) (see [0290] and [0297] “ Catheters according to the present invention have a flexural load that is substantially constant along the longitudinal length near the proximal end and a rapidly decreasing flexural load near the distal end.”) has a length of about 13 mm (see [0290] “An adjacent proximal segment 3036 may have a length within the range of about 4-6 cm”) (Paragraph [0107] of the applicant’s disclosure provides a definition for the term “about.” About is defined to represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. It is the Examiner’s position that the range of 4 – 6 cm is about 13 mm because the increasing stiffness portion still performs the same desired function and result i.e., increasing in stiffness over the length according to [0297] of Yang).
With regards to claim 21, Yang teaches the claimed invention of claim 15, and Yang further teaches wherein the transitional portion (3034) has a length of about 35 mm (see [0290] “An adjacent proximal segment 3034 may have a length within the range of about 4-6 cm”) (Paragraph [0107] of the applicant’s disclosure provides a definition for the term “about.” About is defined to represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. It is the Examiner’s position that the range of 4 – 6 cm is about 35 mm because the transitional portion still performs the same desired function and result i.e., according to [0297] of Yang);.
With regards to claim 22, Yang teaches the claimed invention of claim 15, and Yang further teaches wherein the support portion (3030, 3032) has a length of about 75 mm (see [0290] where the length of 3030 is about 1 – 3 cm and the length of 3032 is about 1 – 3 cm; wherein the total length of about 6 cm is about 75 mm) (Paragraph [0107] of the applicant’s disclosure provides a definition for the term “about.” About is defined to represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. It is the Examiner’s position that about 6 cm is about 75 mm because the support portion still performs the same desired function and result i.e., increasing in stiffness over the length according to paragraph [0297] of Yang).
With regards to claim 23, Yang discloses (see Figures 12A – 12F, 30, and 34A) a neurovascular catheter (1222/3000) for insertion into an internal carotid artery (1206) of a patient (see [0241]), the neurovascular catheter comprising:
a flexible distal segment (3030, 3032, 3034, 3036, 3038) of the neurovascular catheter for insertion into an internal carotid artery (1206) of a patient (see Figures 12A – 12F and [0241]), the flexible distal segment comprising:
a distal portion (3036, 3038) comprising:
a tracking tip (3038) configured to be positioned within a cavernous segment (1210) of the internal carotid artery (see Figures 12A – 12F, [0154], and [0241]), and
an increasing stiffness portion (3036);
a transitional portion (3034) configured to be positioned within a petrous segment (1212) of the internal carotid artery (see Figures 12A – 12F, [0154], and [0241]); and
a support portion (3030, 3032) configured to extend proximally to a base of a patient's skull (see Figures 12A – 12F and [0241]);
wherein a flexibility profile of the flexible distal segment is measurable with a cantilever beam test with a 5 mm gage length and 4 mm displacement to determine a peak load value (the claimed phrase “wherein a flexibility profile of the flexible distal segment is measurable with a cantilever beam test with a 5 mm gage length and 4 mm displacement to determine a peak load value” is being treated as a product by process limitation. As set forth in MPEP 2113, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. See MPEP 2113. The patentability of a product does not depend on its method of production. See id. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. § 103 rejection may be made and the burden is shifted to the applicant to show an unobvious difference. See MPEP 2113(II)).
Yang further discloses a variety of catheter embodiments having a flexural load that is substantially constant along the longitudinal length near the proximal end and rapidly decreasing the flexural load near the distal end. See [0297] of Yang. The catheters may have a flexural load less than or equal to about 1.0 lbF, about 0.75 lbF, about 0.5 lbF, about 0.4 lbF, about 0.3 lbF, about 0.2 lbF, or about 0.1 lbF at about 115 cm from the proximal end. Id. Further for catheters having different lengths, the foregoing dimensions can be scaled from the distal end of the catheter as a percentage of catheter length. Id. Yang discloses that the stiffness along the catheter is a result effective variable in the back-up support, trackability, pushability, and kink resistance characteristics of the catheter as it moves through the vasculature. See [0291] – [0294] and [0298] of Yang.
Yang is in the same field of endeavor as the claimed invention.
However, the difference between Yang and the instant claims is that Yang is silent with regards to the following:
the peak load value in the tracking tip is less than about 30 gF;
the peak load value in the increasing stiffness portion increases from between about 20 gF and about 30 gF to between about 50 gF and about 70 gF over the length of the increasing stiffness portion;
the peak load value in the transitional portion is between about 50 gF and about 70 gF; and
the peak load value at a first end of the support portion is between about 50 gF and about 70 gF and at a second end of the support portion is at least about 400 gF.
Nonetheless the difference between Yang and the claimed invention was a known variation. Specifically, Yang teaches that the a flexural load based on the stiffness of the catheter is substantially constant along the longitudinal length near the proximal end and rapidly decreases near the distal end. See [0297] of Yang. Further Yang teaches that the catheter may have a flexural load less than or equal to about 1.0 lbF, about 0.75 lbF, about 0.5 lbF, about 0.4 lbF, about 0.3 lbF, about 0.2 lbF, or about 0.1 lbF at about 115 cm from the proximal end and decreasing from there to the distal end. Id.
There were also design incentives for implementing the claimed variation. Specifically, Yang teaches that adjusting the flexural load across lengths of the catheter allows for tailoring the performance metrics of a catheter such as the back-up support, trackability, pushability and kink resistance for its intended function. See [0291] – [0294] of Yang. Therefore, as of the effective filing date of the claimed invention, the peak load value in the tracking tip being less than about 30 gF; the peak load value in the increasing stiffness portion increases from between about 20 gF and about 30 gF to between about 50 gF and about 70 gF over the length of the increasing stiffness portion; the peak load value in the transitional portion is between about 50 gF and about 70 gF; and the peak load value at a first end of the support portion being between about 50 gF and about 70 gF and at a second end of the support portion being at least about 400 gF would have been recognized as predictable to one of ordinary skill in the art.
With regards to claim 24, Yang teaches the claimed invention of claim 23, and Yang further teaches wherein the flexible distal segment (3030, 3032, 3034, 3036, 3038) has a length of between about 10 cm and about 18 cm (see [0290] which describes 3038 having a length of about 1 cm – 3 cm, 3036 having a length of about 4 cm – 6 cm, and 3034 having a length of about 4 cm – 6 cm, 3032 having a length of about 1 cm – 3 cm, and 3030 having a length of about 1 cm – 3 cm wherein the total length of 3030, 3032, 3034, 3036, 3038 equals a range of about 11 cm – 21 cm).
With regards to claim 25, Yang teaches the claimed invention of claim 23, and Yang further teaches wherein the distal portion (3038, 3036) has a length between about 20 mm and 40 mm (see [0290] “A distal segment 3038 may have a length within the range of about 1-3 cm…An adjacent proximal segment 3036 may have a length within the range of about 4-6 cm” where the combined range length of 3038, 3036 is about 5 cm – 9 cm) (Paragraph [0107] of the applicant’s disclosure provides a definition for the term “about.” About is defined to represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. It is the Examiner’s position that about 5 cm – 9 cm is about 20 – 40 mm because the distal portion performs the same desired function and result as the claimed invention).
With regards to claim 26, Yang teaches the claimed invention of claim 23, and Yang further teaches wherein the tracking tip (3038) has a length between about 10 mm and about 20 mm (see [0290] "A distal segment 3038 may have a length within the range of about 1-3 cm" Here 1 - 2 cm equates to 10 - 20 mm.).
With regards to claim 27, Yang teaches the claimed invention of claim 23, and Yang further teaches wherein the increasing stiffness portion (3036) has a length between about 5 mm and about 15 mm (see [0290] “An adjacent proximal segment 3036 may have a length within the range of about 4-6 cm”) (Paragraph [0107] of the applicant’s disclosure provides a definition for the term “about.” About is defined to represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. It is the Examiner’s position that the range of 4 – 6 cm is about 5 – 15 mm because the increasing stiffness portion still performs the same desired function and result i.e., increasing in stiffness over the length according to [0297] of Yang);.
With regards to claim 28, Yang teaches the claimed invention of claim 23, and Yang further teaches wherein the transitional portion (3034) has a length of between about 30 mm and about 40 mm (see [0290] “An adjacent proximal segment 3034 may have a length within the range of about 4-6 cm” where about 4 cm is about 40 mm).
With regards to claim 29, Yang teaches the claimed invention of claim 23, and Yang further teaches wherein the support portion (3030, 3032) has a length between about 70 mm and about 80 mm (see [0290] where the length of 3030 is about 1 – 3 cm and the length of 3032 is about 1 – 3 cm; wherein the total length of about 6 cm is about 60 mm) (Paragraph [0107] of the applicant’s disclosure provides a definition for the term “about.” About is defined to represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. It is the Examiner’s position that about 6 cm is about 70 – 80 mm because the support portion still performs the same desired function and result i.e., increasing in stiffness over the length according to paragraph [0297] of Yang).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yang et al. (US 10,179,224 B2).
Yang et al. (US 10,183,147 B2).
Yang et al. (US 10,183,146 B2).
Yang et al. (US 10,183,145 B2).
Yang et al. (US 10,441,745 B2).
Yang et al. (US 10,661,053 B2).
Yang et al. (US 10,835,711 B2).
Yang et al. (US 11,147,949 B2).
Takagi et al. (US 2010/0030165 A1).
Yang et al. (US 2017/0239447 A1).
Nagao et al. (US 2018/0093068 A1).
Yang et al. (US 2019/0336149 A1).
Yee et al. (US 2020/0297972 A1).
Yee et al. (US 2020/0306501 A1).
Aboytes et al. (US 2020/0008820 A1).
Nicholson et al. (US 2020/0315639 A1).
Roue et al. (US 2021/0093336 A1).
Yourgenlow et al. (US 2022/0001141 A1).
Yee et al. (US 2025/0387595 A1).
Jourdan et al. (US 2026/0000864 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
08/24/2026
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