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 .
Acknowledgments
This Office action is in response to the preliminary amendment filed on 7/26/2024. Thus, claims 1-17 are pending for examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/8/23 and 11/19/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-17 are objected to because of the following informalities:
In regards to claim 1, the term “the inserted windings” and “the windings” in line 10-11 should be changed to “the inserted plurality of windings” and “the plurality of windings” respectively. Claims 2-16 are objected to by virtue of depending on an objected claim.
Similarly, for purposes of consistency and clarity the applicant is advised to similarly change the recitations of “the windings” to “the plurality of windings” in claims 2, 3, 4, and 7.
In regards to claim 15, the term “wherein the number of pitch per inch” in line 1 should be changed to “wherein a number of pitch per inch” because claim 15 is the first time a number of pitch per inch has been recited for the second coil.
In regards to claim 17, the phrase “positioning at least some of windings of the second coil in a region of the first coil including a plurality of adjacent coils by screwing …” in line 7-8 should be changed to “positioning at least some of a plurality of windings of the second coil in a region of the first coil including a plurality of windings.
Appropriate correction is required.
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) 1-13, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (10512753).
Regarding claim 1, Nguyen discloses a catheter (100; e.g. Fig 1), comprising: a tubular elongated body (Fig 1), wherein the tubular elongated body extends along a longitudinal axis between a proximal end and a distal end (e.g. Fig 1; 106, 104), and the tubular elongated body has a lumen (e.g. 108); wherein, at least a portion of the tubular elongated body is defined by a first coil (212), and the first coil comprises a plurality of windings extending along and around the longitudinal axis (e.g. Fig 4), wherein, the first coil comprises at least one first region arranged near the distal end of the tubular elongated body and including a plurality of adjacent windings (212; Fig 4; first region is near distal end where 212 engages with 216; col 9, ln 17-22), the first region has a plurality of windings inserted from at least one second coil therein (second coil 216; col 9, ln 17-22; where the first and second coil are interwound between the spaces between 212 and 214; the broadest reasonable interpretation of the term “inserted” is to put or thrust in”. Here, 216 is interwoven with 212 and 214 and is thus put in between 212 and 214), and the inserted windings of the second coil are positioned between the windings of the first coil (Fig 4; 216 is positioned between 212 and 214; col 9, ln 17-22); and the first coil further comprises at least one second region including a plurality of adjacent windings (Fig 4; the second region being proximal to the distal end where 212 and 214 are interwoven with 216), wherein the second region does not have windings inserted from the second coil (Fig 4; 212 does not have any windings inserted from 216 proximal to the point where the proximal end 218 of 216 ends).
Regarding claim 2, Nguyen discloses wherein in the first region, at least some of the windings of the second coil abut against some of the windings of the first coil (Fig 4; col 9, lns 17-22; 216 is interwoven with 212 and 214 and thus engages with 212 by being inserted into the space between 212 and 214).
Regarding claim 3, Nguyen discloses wherein when the catheter is pushed or pulled along the longitudinal axis of the tubular elongated body, at least some of the windings of the second coil are configured to be pushed against some of the windings of the first coil in the first region (Fig 1, 4; col 9, lns 17-22; 216 is interwoven with 212 and 214 and thus engages with 212 by being inserted into the space between 212 and 214 so when the catheter is pushed or pulled, the windings of 216 will push against some of the windings of 212 in the first region by being inserted into the space between 212 and 214).
Regarding claim 4, Nguyen discloses wherein at the first region, the windings of the second coil have substantially the same diameter as the windings of the first coil (Fig 4; col 7, lns 49-51 and 53-56; here 212 and 214 have the same wound inner and outer diameter and 216 has substantially the same diameter as 212 as shown in Fig 4 and col 9, lns 17-22 when interwound with 212 and 214).
Regarding claim 5, Nguyen discloses wherein the windings of the at least one second coil are inserted between the windings of the first coil by screwing the second coil into the first coil along the longitudinal axis (Fig 4 and col 9, lns 17-22; Here “inserted between … by screwing” is a product-by-process limitation, see MPEP 2113, and meets the structure implied by the step of screwing by being interwound and put in between 212 and 214). It is also noted that note that col 8, ln 48-55 which discloses that 212 and 214 may be formed separately and manipulated together to fit together. The way to fit together two spiral wound structures is by screwing. Similarly, 216 is a spiral wound structure formed separately from 212 and 214 and is and/or would similarly be fully capable of being manipulated, e.g. screwed, into 212 and 214 so as to fit together).
Regarding claim 6, Nguyen discloses wherein the first region is disposed at a predetermined position of the first coil along the longitudinal axis to provide the tubular elongated body with an axially varying strength distribution (Fig 4; col 9, lns 5-9; the first region is disposed a distal position of the catheter and 216 provides an axially varying strength distribution in the first region that varies from the second region, e.g. region of 212 and 214, by being comprised of different material which inherently has different axial strength characteristics).
Regarding claim 7, Nguyen discloses further comprising a third coil (214) having a plurality of windings (Fig 4, 6), wherein some of the windings of the third coil are located between the windings of the second coil and are not located between the windings of the first coil (Fig 4, 6; col 9, lns 17-22; 212 and 214 are interwoven with another and the last winding of 214 at the distal end would be interwound with 216 but not interwoven with 212 as the distal winding of 214 is distal to the distal end of 212 so that distalmost winding is not interwoven between windings of 212, see Fig 6. Note, Webster’s dictionary defines “some” as “being one, a part, or an unspecified number of something” so one winding meets the limitation of some of the windings. The applicant is strongly advised to further structurally define the third coil in relation to the first and second coils, but when doing so application is also strongly advised to carefully consider the pertinent art cited on the PTO 892 form and discussed below in the Conclusion section).
Regarding claim 8, Nguyen discloses wherein a wire for any one of the coils is a flat wire (e.g. see col 9, lns 4-9; wound flat wire for 216).
Regarding claim 9, Nguyen discloses wherein any one of the coils is a helical spring (e.g. 212 is a wound spiral helical spring; Fig 4, 6).
Regarding claim 10, Nguyen discloses wherein any one of the coils is a single-strand wire spring or a multi-strand wire spring (e.g. 212 is a single strand wound spiral helical spring; Fig 4, 6).
Regarding claim 11, Nguyen discloses wherein the first coil (212) and second coil (216) are made of the same materials (e.g., see col 7, lns 26-28 where 212 can be a radiopaque material like platinum or a platinum alloy, such as 92% platinum/8% tungsten, and col 9, lns 5-8 where 216 can be a radiopaque material like platinum or a platinum alloy, such as 92% platinum/8% tungsten).
Regarding claim 12, Nguyen discloses wherein the first coil (212) and second coil (216) are made of different materials (e.g., see col 8, lns 22-27 where 212 can be nickel-titanium alloy and col 9, lns 5-8 where 216 can be a radiopaque material like platinum or a platinum alloy, such as 92% platinum/8% tungsten).
Regarding claim 13, Nguyen discloses wherein the pitch of the first coil undergoes gradual transition along the longitudinal axis from a first number of pitch per inch at the proximal end to a second number of pitch per inch (Fig 4, showing pitch of 212 gradually transitioning from proximal end to distal end).
Regarding claim 17, Nguyen discloses a method for manufacturing an elongated catheter (100; e.g. Fig 1), the elongated catheter having a longitudinal axis extending between a proximal end and a distal end (e.g. Fig 1; 106, 104) and having a lumen (108), the method comprising: arranging a first end of a first coil (212) near the proximal end of the catheter (e.g. 212 at 201; Fig 4), and arranging a second end of the first coil near the distal end of the catheter (e.g. 212 at 203; Fig 3-4); providing a second coil (216; Fig 4); and positioning at least some of the plurality of windings of the second coil in a region of the first coil including a plurality of adjacent windings (see claim objection above) by screwing a winding at one end of the second coil into the first coil along the longitudinal axis from the second end of the first coil (col 9, ln 17-22; col 8, ln 48-55; here 216 is interwound with 212 and 214 by being inserted within spaces between 212 and 214. In col 8, lns 48-55 Nguyen discloses that 212 and 214 may be formed separately and manipulated together to fit together. The way to fit together two spiral wound structures is by screwing. Similarly, col 9, ln 5-9 and 17-22 discloses that 216 is a separate spiral wound structure with proximal end 218 and distal end 220 shown in Fig 4. 216 is interwound with 212 and 214 by being inserted into spaces of 212 and 214. To fit together 216 with 212 and 214 to insert 216 into 212 and 214 the coil 216 would be screwed by winding end 218 into the second/distal end of 212 and 214).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen, as applied to claim 13 above, in view of Stern (10610666). Regarding claim 14-15, Nguyen, discloses that the pitch per inch can be vary (e.g. Fig 4-8; col 9, ln 67-col 10, ln 6). However, Nguyen does not expressly disclose wherein for the first coil the first number of pitch per inch is 80 and the second number of pitch per inch is 40 or 26 or less than 26, or wherein a number of pitch per inch of the second coil is 40 or 26 or less than 26.
Stern teaches that it is known to have a catheter having an elongate body with first (e.g. 18; Fig 1-2) and second (e.g. 20; Fig 1-2) coils, wherein the first coil the first number of pitch per inch is 80 and the second number of pitch per inch is 40 or 26 or less than 26, or wherein a number of pitch per inch of the second coil is 40 or 26 or less than 26 (col 16, ln 52-col 17, lns 11; where 80 pitch per inch is 0.0125 pitch/inch, 40 is 0.025 pitch/inch and 26 is 0.038 pitch/inch and Stern discloses that 18 and 20 can range from 0.004 to 0.13 pitch/inch, and the pitch can continuously vary along the length such that the proximal end pitch is different than the distal portion pitch) for the purpose of providing a stiffness or flexibility that varies along the length to tailor the structural characteristics to the desired application of the catheter (col 16, lns 49-52, 64-67). 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 pitch per inch of the first and second coil as taught by Nguyen to be within the claimed range as taught by Stern for the purpose of providing a stiffness or flexibility that varies along the length to tailor the structural characteristics to the desired application of the catheter (col 16, lns 49-52, 64-67).
Additionally and/or alternatively, 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 pitch per inch of the first and second coils as taught by Nguyen such that the first number of pitch per inch is 80 and the second number of pitch per inch is 40 or 26 or less than 26, or wherein a number of pitch per inch of the second coil is 40 or 26 or less than 26 since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (e.g. see ¶¶43-47 of application’s PGPub, indicating that in different embodiments the pitch per inch may be within the claimed range).
Claim 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen, as applied to claim 1 above, in view of Davis et al (20230064188). Nguyen discloses the invention substantially as claimed except for expressly disclosing wherein at the first region, the first coil and the second coil have an outer diameter range of 0.5588-0.6604 mm and an inner diameter range of 0.4826-0.5842 mm.
Davis et al teaches that it is known to have a catheter having a coil (3204) and radiopaque marker (3040; which has a helical slot - ¶117 – and is configured to be screwed into the distal end of helical coil), where the radiopaque marker has an outer diameter range of 0.5588-0.6604 mm (¶151; outer diameter between 0.025 inches and 0.0385 inches which overlaps the claimed range) and an inner diameter range of 0.4826-0.5842 mm (¶151; inner diameter between 0.020 inches and 0.035 inches which overlaps the claimed range; Fig 2 generally shows the coil and radiopaque marker generally match in size to they are coaxial and share the same diameter so the catheter has a constant inner/outer diameter; see also ¶117 where the helical coil is screwed into the helical slot of the marker while preserving the inner diameter of the lumen and outer diameter of the catheter) for the purpose of providing a coil and radiopaque marker in a tubular shape that provides the catheter has a constant inner/outer diameter (¶151). 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 diameter ranges of the first/second coils as taught by Nguyen with the diameter sizes within the claimed range as taught by Davis et al for the purpose of providing a coil and radiopaque marker in a tubular shape that provides the catheter has a constant inner/outer diameter (¶151).
Additionally and/or alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to wherein at the first region, the first coil and the second coil have an outer diameter range of 0.5588-0.6604 mm and an inner diameter range of 0.4826-0.5842 mm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (e.g. see ¶48 of application’s PGPub, indicating that in an embodiment the coil inner/outer diameters may be within the claimed range).
Additionally, and/or alternatively, it is noted that Davis et al discloses in ¶153 that components that are part of orburator 1100 may include all the same as components previously listed (e.g. coil 3204 and radiopaque marker 3040) and that varying characteristics of numbers properties, including outer diameter, inner diameter, and wall thickness, may be made as a result effective variable for purposes of providing varying characteristics of one section of the catheter relative to another (¶151) depending on desired clinical performance (e.g. flexibility, trackability) (¶92). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the inner/outer diameters of the coils of Nguyen to have inner/outer diameters within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, 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 inner/outer diameters of the coils of Nguyen to have inner/outer diameters within the claimed range 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, 20 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Additionally, and/or alternatively, in the event Nguyen is found to not teach the step of “screwing” a winding at one end of the first and into the second coil as set forth in the rejection of claim 17 above, the following rejection is applicable:
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Davis et al (20230064188). Nguyen disclose the invention substantially as set forth in claim 17 discuss above and incorporated herein by reference. In the event Nguyen is found to not teach the step of positioning at least some of a plurality of windings of the second coil in a region of the first coil including a plurality of adjacent windings by screwing a winding at one end of the second coil into the first coil along the longitudinal axis from the second end of the first coil (see claim objection above):
Davis et al teaches that it is known to have a helical coil (3204) and helical radiopaque marker (3040; ¶117; Fig 2), and discloses the step of positioning at least some of a plurality of windings of the second coil in a region of the first coil including a plurality of adjacent windings by screwing a winding at one end of the second coil into the first coil along the longitudinal axis from the second end of the first coil (see Fig 2 and ¶117 states in a mechanical fit implementation the radiopaque marker may have a helical slot extending at least 360 degrees. Webster’s dictionary defines “some” as “being one, a part, or an unspecified number of something” so one winding meets the limitation of some of the windings. So the radiopaque marker forms a coil having at least one winding as claimed. ¶117 states that to provide the mechanical interference fit implementation the distal end of the helical coil, e.g. 3204, is screwed into the helical slot in the marker band. So, a winding at one end of the second coil (e.g. proximal end formed with the helical coil of the radiopaque marker) is screwed into the second end of the first coil (e.g. distal end of helical coil 3204) for the purpose of providing a mechanical interference fit implementation while preserving the inner diameter of the lumen and outer diameter of the catheter across the joint (¶117). Thus, if necessary, 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 step of connecting the first and second coil as taught by Nguyen with the step of screwing a winding of one end of the second coil into the second end of the first coil as taught by Davis et al for the purpose of providing a mechanical interference fit implementation while preserving the inner diameter of the lumen and outer diameter of the catheter across the joint (¶117).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 Form. Specifically:
Screwing a coil into another:
Samson et al (5462523) – e.g., see coils 118, 116; col 4, lns 66-67; Fig 2-3.
Otsuka et al (2023/0339124) – e.g., see coils 3, 5; ¶43; all figures.
Green et al (2014/0046302) – e.g., see coils 20, 30; Fig 8-10.
Plassman et al (2015/0258306) – e.g., see coils 108, 110; ¶¶27-30; Fig 1-2.
Matlock et al (2019/0076629) – e.g. Figs 8-10.
Multi-coiled catheters:
Martin (2020/0391009) – applicant is strongly advised to carefully review, e.g., see discussion of Martin relative to present claims set forth in the PCT/IB2022/050131 international search report, especially for how Martin teaches the present claim limitations and the third coil subject matter of claim 7. When considering potential claim amendments applicant is strongly advised to carefully review Martin’s disclosure, especially, the teachings regarding the third coil.
Mullins et al (2022/0233814) – e.g. Fig 16, 18.
To expedite prosecution in the event the applicant has any questions or proposed claim amendments to discuss the applicant is invited to contact the examiner at the telephone number listed below.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew M. Gilbert whose telephone number is (571)272-7216. The examiner can normally be reached 9:00 am - 5:30 pm (EST), Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW M GILBERT/Primary Examiner, Art Unit 3700