DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s argument in the Appeal Brief filed 10/16/2025 that Wijay’s Fig 5 cannot be used to teach that the distance between the distal-most edge of the spring-like element and a distal edge of the distal end portion is about 0.5 mm – because Wijay has not disclosed that this figure is to scale – is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of the Von Oepen et al. reference cited below and in view of the decision rendered in In re Kuhle, 526 F.2d 553, 188 UPQ 7 (CCPA 1975) and in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Claim Status
Applicant is reminded of the proper manner in which amendments to the claims must be made:
In the 5/6/2025 filing, claims 1 and 16 were indicated with the status identifier of “canceled”, but the text of both of these claims still remains. As per 37 C.F.R. 1.121, cancelled claims must be listed by only the claim number and the status identifier of “canceled”, without presenting the text of the claims. Therefore, the text of claims 1 and 16 should be removed upon the next filing.
In the 10/18/2024 filing, claim 14 included the text “wherein the longitudinally flexible tube extends beyond a distal end of the spring-like element, and” but the 5/6/2025 filing did not include this text. As per 37 CFR 1.121, all claims being amended must be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. Specifically, 37 CFR 1.121 requires the text of any deleted matter to be shown by strike-through or double brackets placed before and after the deleted characters if the deletion is five or fewer consecutive characters.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 26, 3, 5, 11, 12, 14, 15, 17, 18, 22 and 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Wijay et al. (US Pat 4,921,483).
Re claim 26, Wijay discloses a catheter C (Fig 3 with the tip T of Fig 5; it is noted that all reference characters cited below refer to Fig 3 unless otherwise noted) having a flexible and pushable catheter tip T (Fig 5), the catheter comprising: a balloon D having a proximal end (to the left in Fig 3) and a distal end (to the right in Fig 3) wherein said balloon is mounted on said catheter proximal of said catheter tip (as seen in Fig 3); and the catheter tip having a proximal end (to the left in Fig 5) and a distal end (to the right in Fig 5), comprising: a spring-like element 80 having a proximal end (to the left in Fig 5) and a distal-most edge (the right-most edge in Fig 5; labeled in Fig D below); a longitudinally flexible tube (the “elastomeric polymeric material” forming the portion of tip T labeled in annotated Fig C below – Col 10, Lines 19-21) comprising a spacer portion (labeled in annotated Fig C below), said spacer portion located at the proximal end of the spring-like element between the distal end of the balloon and the proximal end of said spring-like element (as seen in Fig 3); said spring-like element directly embedded in said longitudinally flexible tube (Col 4, Lines 23-35 and 44-50), said spring-like element and said longitudinally flexible tube extending along a common longitudinal axis of the catheter tip (as seen in Fig 5, wherein the common longitudinal axis extends horizontally in Fig 5); and a distal end portion (labeled in annotated Fig C below) located at the distal end of the catheter tip (as seen in Fig C below), the distal end portion having a frustoconical configuration (as seen in Fig 5, it tapers).
Wijay discloses that the distal-most edge of the spring-like element is positioned proximal of a distal edge (the right-most edge of the tip T in Fig 5; labeled in annotated Fig D below) of the distal end portion (as seen in Fig 5 and Fig C below), but does not explicitly disclose the numerical distance between the distal-most edge of the spring-like element and the distal end of the distal end portion. Therefore, Wijay does not explicitly disclose that the distal-most edge of the spring-like element is positioned about1 0.5 mm proximal of the distal edge of the distal end portion.
However, it would have been an obvious matter of design choice to modify Wijay to include the distance between the distal-most edge of the spring-like element and the distal end of the distal end portion as being about 0.5 mm since Applicant has not disclosed that having a distance of about 0.5 mm solves any stated problem2 or produces a novel or unexpected result and it appears that the device would perform equally well with a distance of about 0.5 mm or the distance utilized in Wijay. It has been held that design choice can serve as a basis for obviousness where the claimed feature solves no stated problem, the claimed feature produces no novel or unexpected results, and configurations in the prior art perform the same function as the claimed feature (In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975)). Additionally, it has been held that, where the only difference between the prior art and the claims is 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 is 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 USPQ 232 (1984)).
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Re claim 3, Wijay discloses that said longitudinally flexible tube is a flexible polymer material (Col 10, Lines 19-21).
Re claim 5, Wijay discloses that the flexible polymer material is selected from the group consisting of: block co-polymer, polyether block amide (PEBA), and polyurethane (“polyurethane” – Col 4, Lines 36-39).
Re claim 11, Wijay discloses that said spring-like element does not taper, said spring-like element having a single diameter from its proximal end to its distal end (as seen in Fig 5 of Wijay).
Re claim 12, Wijay discloses that the distal end portion provides radial rigidity to the catheter tip (Col 7, Lines 53-57), and wherein a material of the distal end portion is selected from the group consisting of: polyamide, nylon, PEBA, and a co-polymer material (“nylon” – Col 7, Lines 53-57).
Re claim 14, Wijay discloses that the longitudinally flexible tube is contiguous with a proximal end of the distal end portion (as seen in Fig C above).
Re claim 15, Wijay discloses that the distal end portion tapers distally to a distal edge of the catheter tip with a decreasing diameter taper (as seen in Fig C above).
Re claim 17, Wijay discloses that the distal end portion is contiguous with said longitudinally flexible tube (as seen in Fig C above).
Re claim 18, Wijay discloses that the distal end portion is contiguous with said spring-like element (as seen in Fig C above).
Re claim 22, Wijay discloses that the spring-like element is configured to allow flexibility of the catheter tip to bend along the common longitudinal axis (Col 7, Lines 47-50 set forth that the catheter is bendable and Col 8, Lines 25-35 set forth that the catheter traverses the vasculature; because the vasculature is tortuous, the tip must be able to bend along the common longitudinal axis).
Re claim 23, Wijay discloses that the distal end of the catheter tip is open (as seen in Fig 5).
Claims 6, 8, 9, and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wijay et al. (US Pat 4,921,483) in view of Schwartz et al. (US Pat 5,573,520).
Re claim 6, Wijay discloses all the claimed features except explicitly disclosing that the spring-like element is non-compressible in a direction along the common longitudinal axis. Schwartz, however, teaches a catheter tip (the distal portion of catheter 20 (Fig 2)) comprising a spring-like element 22 (Fig 2; “single filament coil, Col 6, Line 26) directly embedded in a longitudinally flexible tube 26 (Fig 2; Col 6, Lines 28-33) and non-compressible in a direction along a common longitudinal axis (as seen in Fig 2, adjacent coils are touching and, therefore, the spring-like element cannot be compressed further) for the purpose of providing flexibility without kinking (Col 4, Lines 49-52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wijay to include the spring-like element such that it is non-compressible in a direction along the common longitudinal axis, as taught by Schwartz, for the purpose of providing flexibility without kinking (Col 4, Lines 49-52).
Re claim 8, Wijay discloses all the claimed features except explicitly disclosing that the spring-like element comprises a region of tightly packed coils. Schwartz, however, teaches a catheter tip (the distal portion of catheter 20 (Fig 2)) comprising a spring-like element 22 (Fig 2; “single filament coil, Col 6, Line 26) directly embedded in a longitudinally flexible tube 26 (Fig 2; Col 6, Lines 28-33) and comprising a region of tightly packed coils (as seen in Fig 2, adjacent coils are touching) for the purpose of providing flexibility without kinking (Col 4, Lines 49-52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wijay to include the spring-like element such that it comprises a region of tightly packed coils, as taught by Schwartz, for the purpose of providing flexibility without kinking (Col 4, Lines 49-52).
Re claim 9, Wijay discloses that the spring-like element provides at least one of pushability and radial rigidity to said catheter tip (Col 8, Lines 3-10), but does not explicitly disclose the material of the spring-like element; therefore, Wijay does not disclose that a material of the spring-like element is selected from the group consisting of stainless steel, cobalt chronium, and nitinol. Schwartz, however, teaches a catheter tip (the distal portion of catheter 20 (Fig 2)) comprising a spring-like element 22 (Fig 2; “single filament coil, Col 6, Line 26) directly embedded in a longitudinally flexible tube 26 (Fig 2; Col 6, Lines 28-33), wherein the spring-like element provides at least one of pushability and radial rigidity to said catheter tip (Col 11, Lines 38-46) and includes a material selected from the group consisting of stainless steel, cobalt chromium, and nitinol (“stainless steel”, “nitinol” – Col 6, Lines 21-24) for the purpose of providing flexibility to the tip without kinking (Col 4, Lines 49-52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wijay to include the spring-like element such that it still provides at least one of pushability and radial rigidity while made of stainless steel or nitinol, as taught by Schwartz, for the purpose of providing flexibility without kinking (Col 4, Lines 49-52).
Re claim 21, Wijay discloses all the claimed features except that the spring-like element includes a radiopaque material. Schwartz, however, teaches a catheter tip (the distal portion of catheter 20 (Fig 2)) comprising a spring-like element 22 (Fig 2; “single filament coil, Col 6, Line 26) directly embedded in a longitudinally flexible tube 26 (Fig 2; Col 6, Lines 28-33), wherein the spring-like element includes a radiopaque material (“nitinol” – Col 6, Lines 21-24) for the purpose of providing flexibility to the tip without kinking (Col 4, Lines 49-52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wijay to include the spring-like element with nitinol (which is known to be radiopaque), as taught by Schwartz, for the purpose of providing flexibility to the tip without kinking (Col 4, Lines 49-52).
Claims 26, 3, 5, 11, 12, 14, 15, 17, 18, 22 and 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wijay et al. (US Pat 4,921,483) in view of Von Oepen et al. (PG PUB 2007/0260224)
Re claim 26, Wijay discloses a catheter C (Fig 3 with the tip T of Fig 5; it is noted that all reference characters cited below refer to Fig 3 unless otherwise noted) having a flexible and pushable catheter tip T (Fig 5), the catheter comprising: a balloon D having a proximal end (to the left in Fig 3) and a distal end (to the right in Fig 3) wherein said balloon is mounted on said catheter proximal of said catheter tip (as seen in Fig 3); and the catheter tip having a proximal end (to the left in Fig 5) and a distal end (to the right in Fig 5), comprising: a spring-like element 80 having a proximal end (to the left in Fig 5) and a distal-most edge (the right-most edge in Fig 5; labeled in Fig D above); a longitudinally flexible tube (the “elastomeric polymeric material” forming the portion of tip T labeled in annotated Fig C above – Col 10, Lines 19-21) comprising a spacer portion (labeled in annotated Fig C above), said spacer portion located at the proximal end of the spring-like element between the distal end of the balloon and the proximal end of said spring-like element (as seen in Fig 3); said spring-like element directly embedded in said longitudinally flexible tube (Col 4, Lines 23-35 and 44-50), said spring-like element and said longitudinally flexible tube extending along a common longitudinal axis of the catheter tip (as seen in Fig 5, wherein the common longitudinal axis extends horizontally in Fig 5); and a distal end portion (labeled in annotated Fig C above) located at the distal end of the catheter tip (as seen in Fig C above), the distal end portion having a frustoconical configuration (as seen in Fig 5, it tapers).
Wijay discloses that the distal-most edge of the spring-like element is positioned proximal of a distal edge (the right-most edge of the tip T in Fig 5; labeled in annotated Fig D above) of the distal end portion (as seen in Fig 5 and Fig C above), but does not explicitly disclose the numerical distance between the distal-most edge of the spring-like element and the distal end of the distal end portion. Therefore, Wijay does not explicitly disclose that the distal-most edge of the spring-like element is positioned about3 0.5 mm proximal of the distal edge of the distal end portion.
Von Oepen4, however, teaches providing a distal end portion 116 (Fig 6; formed of polymer (Para 40) and tapered (Para 12, “The outer surface of the catheter tip head can define various shapes, including rounded, tapered, and bulbous shapes”) like in Wijay) at a distal end of a catheter tip 100 (Fig 6) such that a distal edge 118B (Fig 6) of the distal end portion is positioned about 0.5 mm distal to a distal-most edge (where body portion 112 directly meets distal end portion 116, as seen in Fig 6) of a spring-like element 120 (Para 39, “the axial length of the head outer surface 32 here is approximately 0.5 mm”); Von Oepen teaches that providing the distal end portion such that its distal-most edge is about 0.5 mm distal to the distal-end of the spring-like element (and, thus, the distal-most edge of the spring-like element is positioned about 0.5 mm proximal of the distal edge of the distal end portion) assists the catheter in traveling through a vessel (Para 39). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wijay to include the distal end portion such that it is approximately 0.5 mm in length with the distal-most edge of the spring-like element being positioned about 0.5 mm proximal of the distal edge of the distal end portion, as taught by Von Oepen, for the purpose of assisting the catheter in travel through a vessel (Para 39).
Re claim 3, Wijay discloses that said longitudinally flexible tube is a flexible polymer material (Col 10, Lines 19-21).
Re claim 5, Wijay discloses that the flexible polymer material is selected from the group consisting of: block co-polymer, polyether block amide (PEBA), and polyurethane (“polyurethane” – Col 4, Lines 36-39).
Re claim 11, Wijay discloses that said spring-like element does not taper, said spring-like element having a single diameter from its proximal end to its distal end (as seen in Fig 5 of Wijay).
Re claim 12, Wijay discloses that the distal end portion provides radial rigidity to the catheter tip (Col 7, Lines 53-57), and wherein a material of the distal end portion is selected from the group consisting of: polyamide, nylon, PEBA, and a co-polymer material (“nylon” – Col 7, Lines 53-57).
Re claim 14, Wijay discloses that the longitudinally flexible tube is contiguous with a proximal end of the distal end portion (as seen in Fig C above).
Re claim 15, Wijay discloses that the distal end portion tapers distally to a distal edge of the catheter tip with a decreasing diameter taper (as seen in Fig C above).
Re claim 17, Wijay discloses that the distal end portion is contiguous with said longitudinally flexible tube (as seen in Fig C above).
Re claim 18, Wijay discloses that the distal end portion is contiguous with said spring-like element (as seen in Fig C above).
Re claim 22, Wijay discloses that the spring-like element is configured to allow flexibility of the catheter tip to bend along the common longitudinal axis (Col 7, Lines 47-50 set forth that the catheter is bendable and Col 8, Lines 25-35 set forth that the catheter traverses the vasculature; because the vasculature is tortuous, the tip must be able to bend along the common longitudinal axis).
Re claim 23, Wijay discloses that the distal end of the catheter tip is open (as seen in Fig 5).
Claims 6, 8, 9, and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wijay et al. (US Pat 4,921,483)/Von Oepen et al. (PG PUB 2007/0260224) in view of Schwartz et al. (US Pat 5,573,520).
Re claim 6, Wijay/Von Oepen discloses all the claimed features except explicitly disclosing that the spring-like element is non-compressible in a direction along the common longitudinal axis. Schwartz, however, teaches a catheter tip (the distal portion of catheter 20 (Fig 2)) comprising a spring-like element 22 (Fig 2; “single filament coil, Col 6, Line 26) directly embedded in a longitudinally flexible tube 26 (Fig 2; Col 6, Lines 28-33) and non-compressible in a direction along a common longitudinal axis (as seen in Fig 2, adjacent coils are touching and, therefore, the spring-like element cannot be compressed further) for the purpose of providing flexibility without kinking (Col 4, Lines 49-52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wijay to include the spring-like element such that it is non-compressible in a direction along the common longitudinal axis, as taught by Schwartz, for the purpose of providing flexibility without kinking (Col 4, Lines 49-52).
Re claim 8, Wijay/Von Oepen discloses all the claimed features except explicitly disclosing that the spring-like element comprises a region of tightly packed coils. Schwartz, however, teaches a catheter tip (the distal portion of catheter 20 (Fig 2)) comprising a spring-like element 22 (Fig 2; “single filament coil, Col 6, Line 26) directly embedded in a longitudinally flexible tube 26 (Fig 2; Col 6, Lines 28-33) and comprising a region of tightly packed coils (as seen in Fig 2, adjacent coils are touching) for the purpose of providing flexibility without kinking (Col 4, Lines 49-52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wijay to include the spring-like element such that it comprises a region of tightly packed coils, as taught by Schwartz, for the purpose of providing flexibility without kinking (Col 4, Lines 49-52).
Re claim 9, Wijay discloses that the spring-like element provides at least one of pushability and radial rigidity to said catheter tip (Col 8, Lines 3-10), but does not explicitly disclose the material of the spring-like element; therefore, Wijay/Von Oepen does not disclose that a material of the spring-like element is selected from the group consisting of stainless steel, cobalt chronium, and nitinol. Schwartz, however, teaches a catheter tip (the distal portion of catheter 20 (Fig 2)) comprising a spring-like element 22 (Fig 2; “single filament coil, Col 6, Line 26) directly embedded in a longitudinally flexible tube 26 (Fig 2; Col 6, Lines 28-33), wherein the spring-like element provides at least one of pushability and radial rigidity to said catheter tip (Col 11, Lines 38-46) and includes a material selected from the group consisting of stainless steel, cobalt chromium, and nitinol (“stainless steel”, “nitinol” – Col 6, Lines 21-24) for the purpose of providing flexibility to the tip without kinking (Col 4, Lines 49-52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wijay to include the spring-like element such that it still provides at least one of pushability and radial rigidity while made of stainless steel or nitinol, as taught by Schwartz, for the purpose of providing flexibility without kinking (Col 4, Lines 49-52).
Re claim 21, Wijay/Von Oepen discloses all the claimed features except that the spring-like element includes a radiopaque material. Schwartz, however, teaches a catheter tip (the distal portion of catheter 20 (Fig 2)) comprising a spring-like element 22 (Fig 2; “single filament coil, Col 6, Line 26) directly embedded in a longitudinally flexible tube 26 (Fig 2; Col 6, Lines 28-33), wherein the spring-like element includes a radiopaque material (“nitinol” – Col 6, Lines 21-24) for the purpose of providing flexibility to the tip without kinking (Col 4, Lines 49-52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wijay to include the spring-like element with nitinol (which is known to be radiopaque), as taught by Schwartz, for the purpose of providing flexibility to the tip without kinking (Col 4, Lines 49-52).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 It is noted that the term “about” has not been defined by the Specification as having specific boundaries (for example, the Specification does not set forth that the term “about” means “up to 20% of the recited value”); therefore, the term “about” is interpreted in the same manner as would be interpreted by one of ordinary skill in the art.).
2 Significance has been provided to the material and tapered shape of the distal end portion (Para 25,30,32 – radial rigidity, stiffness and pushability) but not the length between the distal-most edge of the spring-like element and the distal edge of the distal end portion.
3 It is noted that the term “about” has not been defined by the Specification as having specific boundaries (for example, the Specification does not set forth that the term “about” means “up to 20% of the recited value”); therefore, the term “about” is interpreted in the same manner as would be interpreted by one of ordinary skill in the art.).
4 It is noted that this reference was utilized in earlier Office Actions, but it was a different embodiment that was utilized (that of Figure 8). The arguments previously presented to Figure 8 do not apply to the embodiment of Fig 6 as the shapes of catheter tip heads of Fig 6 and Fig 8 are different.