0DETAILED 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 .
Election/Restrictions
Claims 14 – 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/3/2023. Claims 1, 3, and 5 – 13 are currently pending and have been considered below.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/12/2022, 12/19/2023, 5/16/2024, and 5/22/2025 have been considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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.
Claims 3, 8, and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites, “the bendable body.” There is insufficient antecedent basis for this limitation in the claim. Neither claim 1 nor claim 3 recites a body or any element that is claimed as being bendable.
Claim 8 recites, “wherein the at least one lumen portion was not noticeably altered by the process of welding the at least two guide rings to the inner liner.” The term “noticeably” renders the claim indefinite, because it is unclear what the conditions are for the lumen portion to be altered such that the alteration is noticeable. For example, does this claim indicate that, when viewing with the naked eye, one cannot observe that any alteration has taken place? Or does the claim require that, when viewed under a microscope, one cannot observe that any alteration has taken place? Or, does the claim indicate that even if an alteration is visible, the alternation might not be noticeable if the alteration does not result in any functional changes to the device, as compared to if the at least two guide rings were attached to the inner liner by some means other than welding?
Claim 11 contains the trademark/trade name PEBAX. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a thermoplastic elastomer (see Applicant’s filed specification at paragraph [0035]) and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 recites, “[t]he apparatus of claim 1, comprising a plurality of guide rings disposed collectively along the inner liner.” However, claim 1 recites, “at least two guide rings disposed collectively along the inner liner.” The phrase “at least two” is considered to be “a plurality.” Therefore, claim 13 does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 6 – 8, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arcaro et al. (US 2019/0125534).
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]).
PNG
media_image1.png
529
629
media_image1.png
Greyscale
Fig. 4 of Arcaro
PNG
media_image2.png
476
784
media_image2.png
Greyscale
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 bendable body 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 noticeably altered by the process of welding the at least two guide rings to the inner liner (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); please see also the 112(b) rejection associated with this claim).
Regarding claim 13, Arcaro discloses a plurality of guide rings (Figs. 4, 5A, 5B, “guide 82,” “guide 84” [0135]) disposed collectively along the inner liner (Figs. 4, 5A, 5B).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Arcaro et al. (US 2019/0125534) 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 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 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 PEBAX.
Altmann is directed to a catheter [Title]. Altmann discloses wherein a guide ring (Fig. 3B, “multi-lumened tubing 19” [0034]), formed from PEBAX (“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]; please see the 112(b) rejection above regarding the name PEBAX).
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 PEBAX, 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 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH KERR whose telephone number is (571)272-3073. The examiner can normally be reached M - F, 8:30 AM - 4:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Steven Crabb can be reached at 571-270-5095. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELIZABETH M KERR/Primary Examiner, Art Unit 3761