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 .
Response to Amendment
This office action is responsive to the amendment filed on 23 June 2026. As directed by the amendment: claims 1, 3-6, 11-12, 14-15, and 19-20 have been amended; no claims have been canceled or added. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 23 June 2026, with respect to the rejection(s) of claim(s) 1, 19, and 20 under 35 U.S.C. §102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Buck et al (US 6004280).
Claim Objections
Claim 5 is objected to because of the following informalities: in line 2: “about 1 about 0.4 cm to 2.0 cm” should be “. 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.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 7-9, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buck et al (US 6004280).
Regarding claim 1, Buck discloses:
An inner support catheter (11; Figs. 1-4) comprising: an elongated catheter body (12) comprising a distal region (13) with a constrained linear shape (Col. 4:33-36 – body 12 can be substantially straightened, which is linear) and an unconstrained shape (Fig. 3); wherein the distal region (13) comprises a distal first section (24) and a proximal second section (23) that forms a major curve (Fig. 1) with the distal first section (24) in the unconstrained shape, wherein the distal first section (24) is distally located relative to the proximal second section (23) in the constrained linear shape; and, where in the unconstrained shape the distal first section (24) and the proximal second section (23) do not lie substantially in any single common plane (Fig. 3).
Regarding claim 2, Buck discloses:
The inner support catheter of claim 1, wherein a distal tip (27) of the distal first section (24) is positioned proximally of the major curve (Fig. 1).
Regarding claim 7, Buck discloses:
The inner support catheter of claim 1, wherein the distal first section (24) further comprises a first minor curve (27).
Regarding claim 8, Buck discloses:
The inner support catheter of claim 7, wherein the first minor curve (27) curves in a direction generally away from the proximal second section (23) (Fig. 3 – the section 27 curves away from the plane that the proximal second section 23 occupies).
Regarding claim 9, Buck discloses:
The inner support catheter of claim 7, wherein the first minor curve (27) has a curvature less than a curvature of the major curve (Col. 5: 17-25 – the curve of the proximal second section 23 is a larger radius of curvature compared to the tighter curve of distal section 27).
Regarding claim 19, Buck discloses:
An inner support catheter (11; Figs. 1-4) comprising: an elongated catheter body (12) comprising a distal region (13) with an unconstrained shape (Fig. 3); wherein the distal region (13) comprises a first distal section (23) that forms a major curve (Fig. 1) with a second distal section (24) in the unconstrained shape (Fig. 3); and, wherein the unconstrained shape (Fig. 3) the first distal section (23) is positioned at a non-parallel angle relative to the second distal section (24) (Fig. 3 – the first distal section 23 is at an angle A with respect to the horizontal axis and the second distal section 24 is at an angle B) and wherein a free distal tip (14) of the distal region (13) is positioned in a generally proximal orientation (Fig. 1); wherein the unconstrained shape (Fig. 3) further comprises a first reference plane (see Image 2 below) and a second reference plane (Image 2) that is about perpendicular to the first reference plane (Image 2); and wherein, in the unconstrained shape (Fig. 3), a distance between the free distal tip (14) of the distal region (13) and the second distal section (24) includes a first non-zero distance component relative to the first reference plane (Image 2) and a second non-zero distance component relative to the second reference plane (Image 2).
Image 2. Annotated portion of Fig. 3
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Regarding claim 20, Buck discloses:
An inner support catheter (11; Figs. 1-4) comprising: an elongated catheter body (12) comprising an unconstrained shape means (Fig. 3 – a distal section 24 and a proximal section 23 do not lie substantially in any single common plane) for accessing a carotid artery in an aortic arch (Col. 2:1-4 – the device 11 is fully capable of being used to access a carotid artery in an aortic arch).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3-6, 10, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Buck.
Regarding claim 3, Buck discloses:
The inner support catheter of claim 1, wherein the distal first section (24) is positioned at an angle relative to a reference place (see Image 1 below) in which the proximal second section (24) substantially lies (Fig. 3).
Image 1. Annotated portion of Fig. 3
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Buck discloses all of the elements of the claim but is silent regarding the angle being “within an inclusive range of 5 and 45 degrees.” However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Buck to have a relative angle of 5 to 45 degrees inclusive because it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Buck would not operate differently with the claimed angle and, since the distal portion 13 is intended to be a three-dimensional shape with the distal first portion 24 in a different plane from the proximal second portion 23, the device would function appropriately having the claimed relative angle. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the angle “may” be one of several angles between 1 and 45 degrees (instant ¶0081).
Regarding claim 4, Buck teaches the inner support catheter of claim 3, wherein it would be obvious to a person of ordinary skill in the art to make the distal first section positioned at an angle of about 15 degrees relative to the reference plane for the reasons detailed in the rejection of claim 3.
Regarding claim 5, Buck teaches the inner support catheter of claim 3 but is silent regarding how far the distal tip 14 of the distal first section 24 is positioned, specifically that the “distal tip of the distal first section is positioned at an inclusive range of about 0.4 cm to 2.0 cm away from a face of the reference plane.” However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Buck to have the distal tip of the distal first section is positioned at an inclusive range of about 0.4 cm to 2.0 cm away from a face of the reference plane because it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Buck would not operate differently with the claimed angle and, since the distal portion 13 is intended to be a three-dimensional shape with the distal tip 14 at a distance from the proximal second portion 23, the device would function appropriately having the claimed relative distance. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the distance “may” be a distance of any value in the range (instant ¶0084).
Regarding claim 6, Buck teaches the inner support catheter of claim 5, wherein it would be obvious to a person of ordinary skill in the art to make the distal tip of the distal first section is positioned at a length from the proximal second section that is about parallel to the reference plane within an inclusive range of about 1.3 cm to about 6.3 cm away from the proximal second section for the reasons detailed in the rejection of claim 5.
Regarding claim 10, Buck discloses the inner support catheter of claim 1 but is silent regarding “the distal first section is within an inclusive range of about 5 cm to 8 cm.” However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Buck to make the distal first section have a length within an inclusive range of about 5 cm to 8 cm because it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Buck would not operate differently with the claimed length and, since the device is between 60-70 cm in total, the device would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length “may” be within the claimed range (instant ¶0085).
Regarding claim 15, Buck discloses the inner support catheter of claim 1 and further discloses the inner support catheter (11) having a soft distal tip (14), the distal first section (24) with a greater stiffness than the distal tip (14), and the proximal second section (23) with the greatest stiffness (Col. 7:1-10). However, Buck is silent regarding “the inner support catheter has a stiffness at 80 mm from a distal tip of the inner support catheter within a range of about 308.6 gf and 606.5 gf, and a stiffness at 100 mm from the distal tip of the inner support catheter of about 556.4 gf and 1243.8 gf.” Buck discloses unspecified stiffnesses that correlate with the claimed relative stiffnesses from the distal tip to a proximal-most section. As such, the stiffness at specific portions of the catheter is disclosed to be a result effective variable that affects the position holding performance of the device. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Buck to have specific stiffnesses within the claimed ranges, as it involves only adjusting the composition of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Buck by making the stiffnesses along its length to be within a range of about 308.6 gf and 606.5 gf and of about 556.4 gm and 1243.8 gf at different sections as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 16, Buck discloses the inner support catheter of claim 1 and further discloses the inner support catheter (11) having a soft distal tip (14), the distal first section (24) with a greater stiffness than the distal tip (14), and the proximal second section (23) with the greatest stiffness (Col. 7:1-10). However, Buck is silent regarding “the inner support catheter has an average stiffness at 80 mm from a distal tip of the inner support catheter of about 457.6 gf, and an average stiffness at 100 mm from the distal tip of the inner support catheter of about 900.1 gf.” Buck discloses unspecified stiffnesses that correlate with the claimed relative stiffnesses from the distal tip to a proximal-most section. As such, the stiffness at specific portions of the catheter is disclosed to be a result effective variable that affects the position holding performance of the device. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Buck to have specific stiffnesses within the claimed ranges, as it involves only adjusting the composition of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Buck by making the stiffnesses along its length to be about 457.6 gf and about 900.1 gf at different sections as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 17, Buck teaches the inner support catheter of claim 15, wherein it would be obvious to a person of ordinary skill in the art to make a stiffness at about 20 mm within a range of about 7.0 gf and 520.5 gf for the reasons detailed in the rejection of claim 15.
Regarding claim 18, Buck teaches the inner support catheter of claim 16, wherein it would be obvious to a person of ordinary skill in the art to make an average stiffness at 20 mm of about 192.9 gf for the reasons detailed in the rejection of claim 15.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Buck in view of Tsai et al (US 2016/0136393).
Regarding claim 11, Buck discloses the inner support catheter of claim 1 but is silent regarding “a low friction coating disposed on the major curve and having a lower friction surface than adjacent areas of the distal region.” However, Tsai teaches a catheter (Abstract), thus being in the same field of endeavor, with different segments with specific properties (¶0033-0034), including using lubricious coatings to reduce the friction between various components within tortuous bends to allow ease of movement through lumens (¶0068). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the catheter of Buck to incorporate a low friction coating disposed on specific segment of the catheter as taught by Tsai in order to provide sufficient structure to allow ease of movement through lumens, as recognized by Tsai.
Regarding claim 12, Buck discloses the inner support catheter of claim 1 but is silent regarding “a low friction coating disposed on only a portion of the distal region.” However, Tsai teaches a catheter (Abstract), thus being in the same field of endeavor, with different segments with specific properties (¶0033-0034), including using lubricious coatings to reduce the friction between various components within tortuous bends to allow ease of movement through lumens (¶0068). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the catheter of Buck to incorporate a low friction coating disposed on specific segment of the catheter as taught by Tsai in order to provide sufficient structure to allow ease of movement through lumens, as recognized by Tsai.
Regarding claim 13, Buck discloses the inner support catheter of claim 1 but is silent regarding “a first friction portion, a second friction portion adjacent the first friction portion, and a third friction portion adjacent the second friction portion; wherein the second friction portion has reduced friction relative to the first friction portion and the third friction portion; and wherein the second friction portion is located over at least the major curve.” However, Tsai teaches a catheter (Abstract), thus being in the same field of endeavor, with different segments with specific properties (Fig. 1B; ¶0033-0034), including using lubricious coatings to reduce the friction between various components within tortuous bends to allow ease of movement through lumens (¶0068). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the catheter of Buck to incorporate a low friction coating disposed on specific segment of the catheter as taught by Tsai in order to provide sufficient structure to allow ease of movement through lumens, as recognized by Tsai.
Regarding claim 14, Buck in view of Tsai teaches the inner support catheter of claim 13, wherein the second friction portion modified by Tsai in the rejection of claim 13 is within an inclusive range of 5-15 times less friction than the first friction portion and the third friction portion (Tsai; ¶0069 – a reduction of 90% friction is 10 times less friction, which is within the range of 5-15).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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