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 .
Status of the Claims
Claims 2 and 4 have been cancelled. Claims 1, 3, 8, 11, and 13 have been amended. Claims 5-7, 9, 10, and 12 are as previously presented. Claims 14-26 remain withdrawn. Therefore, claims 1, 3, and 5-13 are currently pending and have been considered below.
Response to Amendment
The amendment filed on 5/20/2026 has been entered. Applicant’s amendment overcomes the previously set -forth 112(b) and 112(d) rejections.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 3, 6 – 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Arcaro et al. (US 2019/0125534) in view of Clarke et al. (US 2002/0115963).
Regarding claim 1, Arcaro discloses an apparatus comprising:
an inner liner (Figs. 4, 5A, 5B, “shaft 80” [0135]) having a hollow chamber extending the length of the inner liner (“shaft 80 is formed as a hollow tube” [0137]);
at least two guide rings (Figs. 4, 5A, 5B, “guide 82,” “guide 84” [0135]) disposed collectively along the inner liner (Figs. 4, 5A, 5B);
at least one lumen portion (Fig. 4, “passages 90” in guide ring 82, and “passages 102” in guide ring 86; “the plurality of passages 90 include a stake member passage 92, a first constraint passage 94, and a second constraint passage 96, although greater or fewer (e.g., one, four, ten, etc.) are contemplated” [0140]; “passages 102, also described as channels or lumens. As shown, the plurality of passages 102 include a stake member passage 104, a first constraint passage 106, and a second constraint passage 108, although greater or fewer (e.g., one, four, ten, etc.) are contemplated” [0144]; “each of the plurality of passages 90 of the proximal guide 82 is aligned with each of the plurality of passages 102 of the distal guide 84” [0146]) extending through each of the at least two guide rings (Fig. 1) and being parallel with the hollow chamber (Fig. 4);
wherein the at least two guide rings are welded to the inner liner or wherein the at least two guide rings are fixed by welding (“each of the proximal guide 82, the distal guide 84, and the intermediate guide 86 is coupled to the shaft 80 (e.g., by welding, crimping, press-fit, adhesives, or other techniques)” [0157]).
Arcaro does not expressly disclose wherein the at least two guide rings are made of a less light-absorbing material than the inner liner. Additionally, while Arcaro discloses wherein the at least two guide rings are welded to the inner liner or wherein the at least two guide rings are fixed by welding, Arcaro does not expressly disclose “laser” welding.
Regarding the claimed “laser welding”, it is noted that claim 1 is directed to a product (an “apparatus”), and the claimed “laser welding” describes a process related to forming the product. Therefore, claim 1 is a ‘product-by-process’ claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP § 2113-I.
Regarding the claimed materials and the claimed welding, Clarke is directed to “through-transmission welding of catheter components” [Title]. Figs. 4 and 5 of Clarke show a catheter comprising "catheter shaft 20" [0028] and a balloon 30 comprising "balloon neck 39" [0032]. Balloon neck 39 surrounds shaft 20, and balloon neck 39 is an outer circumferential element that is laser welded to inner shaft 20, as described in [0032]; balloon neck 39 is described as being formed from a "thermoplastic polymer that is transparent or translucent to red and near-infrared energy so that there is little or no absorption of energy as it passes through the neck", while shaft 20 is described as "made from a thermoplastic polymer that is opaque to red and near-infrared energy so that it absorbs the laser beam and is directly heated thereby" [0032]: "In accordance with the present invention, balloon neck 39 is welded to catheter shaft using energy in the red and near-infrared range. The preferred source of energy is a laser beam having the following characteristics: a wavelength of 630-1580 nm; a spot size of approximately 580 microns (0.023 inches) in diameter; and a power level of approximately 0.6-0.8 watts. The preferred generator of red and near-infrared energy can be either a continuous ND:YAG laser, or a low power diode laser. To heat the joint area, the laser beam is transmitted radially into the assembly through balloon neck 39 and impinging on shaft 20. Neck 39, and typically entire balloon 30, are formed from a thermoplastic polymer that is transparent or translucent to red and near-infrared energy so that there is little or no absorption of energy as it passes through the neck. Consequently, no part of balloon neck 39 is heated directly by the laser beam. The preferred balloon polymer is polyurethane block amide copolymer, although other materials such as nylon (polyamide) have also been shown to work in the invention. In catheter shaft 20, at least the distal section is made from a thermoplastic polymer that is opaque to red and near-infrared energy so that it absorbs the laser beam and is directly heated thereby" [0032].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the at least two guide rings are made of a less light-absorbing material than the inner liner, so that joining an outer circumferential element to an inner shaft can be achieved as described above. Additionally, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein “laser” welding is utilized to join the at least two guide rings to the inner liner. Laser welding is a known type of welding means, applied to a known apparatus, to achieve predictable results.
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Fig. 4 of Arcaro
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Figs. 5A and 5B of Arcaro
Regarding claim 3, Arcaro discloses wherein one lumen portion in each of the at least two guide rings are situated so as to form a lumen in the apparatus such that a wire can be slid through the lumen (lumen portions 90 in guide ring 82, and lumen portions 102 in guide ring 86, are described as “passages” [0146]; Fig. 4 shows that the passages are aligned, and as such, are capable of having a wire slid though each passage).
Regarding claim 6, Arcaro discloses at least six guide rings (“Although three guides 82, 84, 86 are shown, any number of guides (e.g., one, two, four, nine, etc.) are contemplated” [0135]), wherein at least two guide rings each contain at least nine lumen portions (“the plurality of passages 90 include a stake member passage 92, a first constraint passage 94, and a second constraint passage 96, although greater or fewer (e.g., one, four, ten, etc.) are contemplated” [0140]; “the plurality of passages 102 include a stake member passage 104, a first constraint passage 106, and a second constraint passage 108, although greater or fewer (e.g., one, four, ten, etc.) are contemplated” [0144]).
Regarding claim 7, Arcaro discloses at least nine wires, each extending through at least two guide rings (as described above, each of the guide rings 82 and 86 can have, for example, ten passages (that is, ten passages 90 in guide ring 82, and ten passages 102 in guide ring 86); the passages are described as being “stake member passage[s]” or “constraint passage[s]”: “the plurality of passages 90 include a stake member passage 92, a first constraint passage 94, and a second constraint passage 96” [0140]; “the plurality of passages 102 include a stake member passage 104, a first constraint passage 106, and a second constraint passage 108” [0144]; the stake member is described as being a wire, and the constrains are described as being wires: “the stake member 30 is formed as a wire, strand, fiber or the like” [0171]; “each of the plurality of constraints 28 is formed as a fiber, strand, wire, combinations thereof or the like” [0170]).
Regarding claim 8, Arcaro discloses wherein the at least one lumen portion was not altered by the process of welding the at least two guide rings to the inner liner such that when inserting a wire through the lumens portion, the wire mobility is impaired (there is nothing in the disclosure of Arcaro to suggest that the welding process (“each of the proximal guide 82, the distal guide 84, and the intermediate guide 86 is coupled to the shaft 80 (e.g., by welding, crimping, press-fit, adhesives, or other techniques)” [0157]) results in the at least one lumen portion being noticeably altered; additionally, the functionality of the lumen portions (passages 90 in guide ring 82, and passages 102 in guide ring 86) remains intact, since the passages remain capable of receiving stake members and constraints (described above)).
Regarding claim 13, Arcaro discloses more than two guide rings (Figs. 4, 5A, 5B, “guide 82,” “guide 84,” “guide 86” [0135]) disposed collectively along the inner liner (Figs. 4, 5A, 5B).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Arcaro et al. (US 2019/0125534) in view of Clarke et al. (US 2002/0115963), further in view of Stern et al. (US 2018/0250498).
Regarding claim 5, Arcaro does not expressly disclose an outer liner disposed around the at least two guide rings and extending the length of the inner liner.
Stern is directed to a catheter [Abstract]. Stern discloses an outer liner disposed around a guide / support element and extending the length of the inner liner (Fig. 2 shows outer liner / “outer jacket 22,” [0090] which comprises sections 22A through 22I [0091], around a guide / “support element 20” [0122], which comprises elements 20A and 20B, and extending the length of the “inner liner 18” [0090]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an outer liner disposed around the at least two guide rings and extending the length of the inner liner. According to Stern, “elongated body 12 includes an inner liner, support element, and outer jacket, which may configure elongated body 12 to better transmit the torque applied to a relatively proximal portion to a relatively distal portion of elongated body 12, resist kinking or otherwise undesirable deformation upon rotation of catheter 10, and/or exhibit a high degree of responsiveness from the relatively proximal portion 17A of elongated body 12” [0065].
Claims 9 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Arcaro et al. (US 2019/0125534) in view of Clarke et al. (US 2002/0115963), further in view of Watanabe et al. (US 2018/0111327).
Regarding claim 9, Arcaro does not expressly disclose wherein the weld between the at least two guide rings and the inner liner extends at least half of the circumference of the guide rings inner diameter and inner liner outer diameter.
Watanabe is directed to a laser welding apparatus and method [Title], that can be used for welding plastic components such as “catheter tubes for medical use” [0276]. Watanabe discloses wherein a weld between a ring (Fig. 9A, ring / “plastic component 1e” [0160]) and a round element (Fig. 9A, round element / “round bar-shaped plastic component 2e” [0160]) extends at least half of the circumference of the ring inner diameter and round element outer diameter (“by rotating the tubular plastic component 1e and the round bar-shaped plastic component 2e during irradiation of the laser beam 9, the entire circumference of the plastic components 1e and 2e can be efficiently welded” [0161]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the weld between the at least two guide rings and the inner liner extends at least half of the circumference of the guide rings inner diameter and inner liner outer diameter. This allows for forming a secure bond between the two elements; namely, the guide ring and the inner liner.
Regarding claim 10, Arcaro does not expressly disclose wherein the weld between the at least two guide rings and the inner liner extends the full circumference of the guide rings inner diameter and inner liner outer diameter.
Watanabe discloses wherein a weld between a ring (Fig. 9A, ring / “plastic component 1e” [0160]) and a round element (Fig. 9A, round element / “round bar-shaped plastic component 2e” [0160]) extends the full circumference of the ring inner diameter and round element outer diameter (“by rotating the tubular plastic component 1e and the round bar-shaped plastic component 2e during irradiation of the laser beam 9, the entire circumference of the plastic components 1e and 2e can be efficiently welded” [0161]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the weld between the at least two guide rings and the inner liner extends the full circumference of the guide rings inner diameter and inner liner outer diameter. This allows for forming a secure bond between the two elements; namely, the guide ring and the inner liner.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Arcaro et al. (US 2019/0125534) in view of Clarke et al. (US 2002/0115963), further in view of Altmann et al. (US 2016/0113582) and Stern et al. (US 2018/0250498).
Regarding claim 11, Arcaro does not expressly disclose wherein both the inner liner and the at least two guide rings are formed from thermoplastic elastomers.
Altmann is directed to a catheter [Title]. Altmann discloses wherein a guide ring (Fig. 3B, “multi-lumened tubing 19” [0034]), formed from thermoplastic elastomers (“the material for the tubing 19 is braided polyurethane or thermoplastic elastomer (TPE), for example, polyether block amide (PEBAX®)” [0034]).
Stern is also directed to a catheter [Title]. Stern discloses wherein an inner liner is formed from a thermoplastic elastomer (Fig. 2, “inner liner 18”; “Inner liner 18 may be composed of different materials including, for example, one or more thermoplastic elastomers” [0071]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein both the inner liner and the at least two guide rings are formed from thermoplastic elastomers, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. MPEP 2144.07.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Arcaro et al. (US 2019/0125534) in view of Clarke et al. (US 2002/0115963), further in view of Nakamura (US 2011/0245612).
Regarding claim 12, Arcaro does not expressly disclose wherein the inner liner contains between 0.1 and 5 percent carbon black.
Nakamura is directed to a flexible tube for an endoscope [Abstract]. Nakamura discloses wherein a liner (Fig. 2, “casing laser 36” [0029]) contains between 0.1 and 5 percent carbon black (“The casing layer is preferably colored black so as to prevent scattering of the illumination light inside the body cavity and any undesirable leakage of light from the endoscope. Examples of the black pigment that may be used for black coloration include carbon black, …” [0042]; “ the content of the black pigment contained in the casing layer is preferably in the range of 0.5% by mass to 5% by mass relative to the total mass of the composition constituting the casing layer, and the content is more preferably in the range of 1% by mass to 3% by mass” [0043]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the inner liner contains between 0.1 and 5 percent carbon black. This prevents scattering of illumination light within the inner liner.
Response to Arguments
Applicant’s arguments, see page 8, filed 5/20/2026, with respect to the rejection of claim 1 under 35 U.S.C. 102 have been fully considered and are persuasive, in view of Applicant’s amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendment.
Applicant's arguments, see pages 8-9, regarding Watanabe, Stern, Altmann, and Nakamura have been fully considered but they are not persuasive. Watanabe is directed to a laser welding apparatus and method [Title], that can be used for welding plastic components such as “catheter tubes for medical use” [0276]. Watanabe is considered to be in the same field of endeavor as Applicant’s invention, therefore, Watanabe is analogous art. Similarly, Stern is directed to a catheter [Title], Altmann is directed to a catheter [Title], and Nakamura is directed to a flexible tube for an endoscope [Abstract]. Therefore, each of these references is in the same field of endeavor as Applicant’s invention, and is analogous art. Furthermore, claim 1 is directed to a product (an “apparatus”), and the claimed “laser welding” describes a process related to forming the product. Therefore, claim 1 is a ‘product-by-process’ claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP § 2113-I.
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.
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/ELIZABETH M KERR/Primary Examiner, Art Unit 3761
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