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 .
Claim Rejections - 35 USC § 112
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 6, 8, 14, 16, 20 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.
Regarding claims 6, 8, 20, the claims are indefinite for reciting both a product and process, therefore the claims are only limited to the structure implied by the steps. See MPEP 2113 (“[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”).
Claim 14 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 type of plastic and, accordingly, the identification/description is indefinite.
Claim 16 recites the limitation "the epoxy fusing process" in line 9. There is insufficient antecedent basis for this limitation in the claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 8, 10, 12-13, 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US Patent No. 5,456,680), hereinafter ‘Taylor’, in view of Follmer et al. (US Patent No. 5,827,242), hereinafter ‘Follmer’.
Regarding claim 1, Taylor teaches a laser catheter device (catheter 10, Fig. 1), comprising:
an inner tube defining a lumen (lumen body 22, Fig. 1), the inner tube having a central axis;
a ring of optical fibers (optical fiber bundle 46, Fig. 5) surrounding the inner tube and the inner lumen, the optical fibers oriented parallel with the central axis (claim 1, optical fibers extend within catheter body);
a jacket (outer jacket 18, Fig. 5) surrounding the ring of optical fibers and secured to the ring of optical fibers (col. 4, ll. 30-35, accommodates the optical fiber bundle);
an annular marker (marker band 28, Fig. 2) disposed over an end of the ring of optical fibers; and
a member (mandrel 30, Fig. 2) oriented parallel with the central axis and secured to a portion of the inner tube (claim 1, parallel to longitudinal axis).
Taylor does not teach that the member is a metal strip or wire, or that it has a distal end attached to the annular marker.
Follmer teaches a catheter with reinforcement elements (abstract), further comprising:
a metal strip or wire (axial reinforcement element 18, Fig. 1) oriented parallel with the central axis and secured to a portion of the inner tube (col. 5, ll. 36-39, can be a metal), the metal strip or wire having a distal end attached to the annular marker (Fig. 2, attached to radiopaque marker 20).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Taylor to incorporate the teachings of Follmer to include a metal strip with the distal end attached to the marker. Doing so would enable the portion of the tube to have relatively high tensile strength for reinforcement, as recognized by Follmer (col. 5, ll. 36-46).
Regarding claim 2, Taylor and Follmer teach the device according to claim 1. Follmer teaches the device further comprising:
wherein the metal strip or wire comprises a stiffening rod (col. 5, ll. 44-46, axial reinforcement element extends along portion of catheter body that is desired to be reinforced) operative to stiffen the portion of the ring of optical fibers coinciding with the stiffening rod along the central axis (col. 2, ll. 7-26, improved strength characteristics, specifically tensile strength), wherein the distal end of the stiffening rod is attached to the annular marker (Fig. 2, axial reinforcement element 18 is attached to radiopaque marker 20).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Taylor to incorporate the teachings of Follmer to include a stiffening rod attached to the annular marker. Doing so would reinforce that segment of the catheter body, as recognized by Follmer (col. 5, ll. 45).
Regarding claim 3, Taylor and Follmer teach the device according to claim 1. Follmer teaches the device (as detailed in the above rejection of claim 2) further comprising:
a stiffening rod (col. 5, ll. 44-46, axial reinforcement element extends along portion of catheter body that is desired to be reinforced) operative to stiffen the portion of the ring of optical fibers coinciding with the stiffening rod along the central axis (col. 2, ll. 7-26, improved strength characteristics, specifically tensile strength), wherein the distal end of the metal strip or wire is attached to the annular marker (Fig. 2, axial reinforcement element 18 is attached to radiopaque marker 20).
Taylor teaches the device further comprising:
wherein the metal strip or wire is different from the stiffening rod (Fig. 8, different portions of the mandrel), and a proximal end of the metal strip or wire (distal portion 34, Fig. 8) opposite the distal end is attached to the stiffening rod (tapered portion 50, Fig. 8) (see below).
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Fig. 2, instant application
Fig. 8, Taylor (US Patent No. 5,456,680)
Neither Taylor or Follmer explicitly disclose separating the metal strip or wire and stiffening rod.
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 have modified Taylor and Follmer to separate the member into separate units, one of which being the metal strip/wire and the other a stiffening rod. One of ordinary skill would have found it obvious to try separating the member into separate units/portions with a reasonable expectation of successfully stiffening the device in the manner disclosed. Furthermore, see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961); MPEP 2144.04(V)(C).
It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to try forming the member from two pieces (metal strip/wire and a stiffening rod), since applicant has not disclosed that making the two pieces separate solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the single member.
Regarding claim 4, Taylor and Follmer teach the device according to claim 3. Taylor teaches the device further comprising:
wherein the metal strip or wire is more flexible than the stiffening rod (col. 7, ll. 3-9, stiffness is decreased at tip, Fig. 12).
Regarding claim 5, Taylor and Follmer teach the device according to claim 1. Follmer teaches the device further comprising:
wherein an inner surface of the annular marker is attached to the distal end of the metal strip or wire (Fig. 2, attached to radiopaque marker 20).
Regarding claim 6, the limitation “soldered” is a product by process limitation (see 112(b) rejection) and the only limitation required by the claim is that the inner surface of the annular marker is attached to the wire, as was rejected in claim 5.
Regarding claim 8, Taylor and Follmer teach the device according to claim 1. The limitation “secured… by heat fusion” is a product by process limitation (see 112(b) rejection).
Taylor teaches the device further comprising:
wherein the jacket comprises a plastic and is secured to the ring of optical fibers and the annular marker (col. 4, ll. 48-55, outer jacket can be made with plasticized vinyl resins).
Regarding claim 10, Taylor and Follmer teach the device according to claim 1. Taylor teaches the device further comprising:
wherein the annular marker comprises a radiopaque material (col. 4, ll. 60-61, radiopaque tip marker band).
Regarding claim 12, Taylor and Follmer teach the device according to claim 1. Taylor teaches the device further comprising:
wherein the inner tube comprises plastic (col. 4, ll. 63-66, polyethylene or polyester elastomer tubing).
Regarding claim 13, Taylor teaches a method of manufacturing (col. 6, ll. 20-21, method of making) a laser catheter device (catheter 10, Fig. 1), comprising:
forming an assembly including an inner tube defining a lumen (lumen body 22, Fig. 1), the inner tube having a central axis; and
a ring of optical fibers (optical fiber bundle 46, Fig. 5) surrounding the inner tube and the inner lumen, the optical fibers oriented parallel with the central axis (claim 1, optical fibers extend within catheter body);
adding an end assembly including an annular marker (marker band 28, Fig. 2) disposed over an end of the assembly, and
a member (mandrel 30, Fig. 2) oriented parallel with the central axis (claim 1, parallel to longitudinal axis); and
securing a plastic jacket (outer jacket 18, Fig. 5) (col. 4, ll. 48-55, outer jacket can be made with plasticized vinyl resins) over the assembly including securing the plastic jacket to the ring of optical fibers and to the annular marker (col. 4, ll. 30-35, accommodates the optical fiber bundle) by a heat fusing process (col. 6, ll. 33-37, heat treatment).
Taylor does not teach that the member is a metal strip or wire, or that it has a distal end attached to the annular marker.
Follmer teaches a catheter with reinforcement elements (abstract), further comprising:
a metal strip or wire (axial reinforcement element 18, Fig. 1) oriented parallel with the central axis (col. 5, ll. 36-39, can be a metal) and having a distal end attached to the annular marker (Fig. 2, attached to radiopaque marker 20).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Taylor to incorporate the teachings of Follmer to include a metal strip with the distal end attached to the marker. Doing so would enable the portion of the tube to have relatively high tensile strength for reinforcement, as recognized by Follmer (col. 5, ll. 36-46).
Regarding claim 15, Taylor and Follmer teach the method according to claim 13. Follmer teaches the method further comprising:
wherein the metal strip or wire comprises a stiffening rod (col. 5, ll. 44-46, axial reinforcement element extends along portion of catheter body that is desired to be reinforced) operative to stiffen the portion of the ring of optical fibers coinciding with the stiffening rod along the central axis (col. 2, ll. 7-26, improved strength characteristics, specifically tensile strength), wherein the distal end of the stiffening rod is attached to the annular marker (Fig. 2, axial reinforcement element 18 is attached to radiopaque marker 20).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Taylor to incorporate the teachings of Follmer to include a stiffening rod attached to the annular marker. Doing so would reinforce that segment of the catheter body, as recognized by Follmer (col. 5, ll. 45).
Regarding claim 16, Taylor and Follmer teach the method according to claim 13. Follmer teaches the method (as detailed in the above rejection of claim 15) further comprising:
wherein the end assembly further includes a stiffening rod (col. 5, ll. 44-46, axial reinforcement element extends along portion of catheter body that is desired to be reinforced) operative to stiffen the portion of the ring of optical fibers coinciding with the stiffening rod along the central axis (col. 2, ll. 7-26, improved strength characteristics, specifically tensile strength); and
the distal end of the metal strip or wire is attached to the annular marker (Fig. 2, axial reinforcement element 18 is attached to radiopaque marker 20).
Taylor teaches the method further comprising:
wherein the metal strip or wire is separate from the stiffening rod (Fig. 8, different portions of the mandrel); and
a proximal end of the metal strip or wire (distal portion 34, Fig. 8) opposite the distal end is attached to the stiffening rod (tapered portion 50, Fig. 8); and
wherein the epoxy fusing process also secures the plastic jacket to the annular marker (Col. 6, ll. 33-37, heat/epoxy treatment).
Neither Taylor or Follmer explicitly disclose separating the metal strip or wire and stiffening rod.
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 have modified Taylor and Follmer to separate the member into separate units, one of which being the metal strip/wire and the other a stiffening rod. One of ordinary skill would have found it obvious to try separating the member into separate units/portions with a reasonable expectation of successfully stiffening the device in the manner disclosed. Furthermore, see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961); MPEP 2144.04(V)(C).
It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to try forming the member from two pieces (metal strip/wire and a stiffening rod), since applicant has not disclosed that making the two pieces separate solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the single member.
Claims 17, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US Patent No. 5,456,680) in view of Dittman et al. (US Pre-Grant Publication 2004/0220549), hereinafter ‘Dittman’.
Regarding claim 17, Taylor teaches a laser catheter device (catheter 10, Fig. 1) further comprising:
a tube (lumen body 22, Fig. 1) defining an inner lumen, the inner tube having a central axis;
a ring of optical fibers (optical fiber bundle 46, Fig. 5) surrounding the inner lumen, the optical fibers oriented parallel with the central axis (claim 1, optical fibers extend within catheter body);
a jacket (outer jacket 18, Fig. 5) surrounding the ring of optical fibers and secured to the ring of optical fibers (col. 4, ll. 30-35, accommodates the optical fiber bundle); and
an annular marker (marker band 28, Fig. 2) disposed over an end of the ring of optical fibers.
Taylor does not teach that the jacket is secured to a textured outer surface of the annular marker.
Dittman teaches a delivery catheter with reinforcement components (abstract), further comprising:
wherein the annular marker includes a textured outer surface, and the jacket is secured to the textured portion ([0031], roughened outer surface, Fig. 2).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Taylor to incorporate the teachings of Dittman to include connecting the annular marker to the jacket via a roughened outer surface. Doing so would allow for the mechanical connection of components, as recognized by Dittman [0031].
Regarding claim 20, Taylor and Dittman teach the device according to claim 17. The limitation “secured… by heat fusion” is a product by process limitation (see 112(b) rejection).
Taylor teaches the device further comprising:
wherein the jacket comprises a plastic and is secured to the ring of optical fibers (col. 4, ll. 48-55, outer jacket can be made with plasticized vinyl resins).
Claims 7, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US Patent No. 5,456,680) in view of Follmer et al. (US Patent No. 5,827,242), further in view of Dittman et al. (US Pre-Grant Publication 2004/0220549).
Regarding claim 7, Taylor and Follmer tech the device according to claim 1, but do not teach that the jacket is secured to a textured outer surface of the annular marker.
Dittman teaches a delivery catheter with reinforcement components (abstract), further comprising:
wherein the annular marker includes a textured outer surface, and the jacket is secured to the textured portion ([0031], roughened outer surface, Fig. 2).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Taylor and Follmer to incorporate the teachings of Dittman to include connecting the annular marker to the jacket via a roughened outer surface. Doing so would allow for the mechanical connection of components, as recognized by Dittman [0031].
Regarding claim 18, Taylor and Dittman teach the device according to claim 17. Taylor teaches the device further comprising:
a member (mandrel 30, Fig. 2) oriented parallel with the central axis and secured to the jacket (claim 1, parallel to longitudinal axis).
Taylor does not teach that the member is a metal strip or wire, or that it has a distal end attached to the annular marker.
Follmer teaches a catheter with reinforcement elements (abstract), further comprising:
a metal strip or wire (axial reinforcement element 18, Fig. 1) oriented parallel with the central axis and secured to the jacket (col. 5, ll. 36-39, can be a metal), the metal strip or wire having a distal end attached to the annular marker (Fig. 2, attached to radiopaque marker 20).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Taylor and Dittman to incorporate the teachings of Follmer to include a metal strip with the distal end attached to the marker. Doing so would enable the portion of the tube to have relatively high tensile strength for reinforcement, as recognized by Follmer (col. 5, ll. 36-46).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US Patent No. 5,456,680) in view of Follmer et al. (US Patent No. 5,827,242), further in view of McDermott et al. (US Pre-Grant Publication 2022/0176075), hereinafter ‘McDermott’.
Regarding claim 9, Taylor and Follmer teach the device according to claim 1. Follmer teaches that the axial reinforcement element can be a metal (col. 5, ll. 36-39), but not that it comprises stainless steel.
McDermott teaches a steerable catheter system (abstract), further comprising:
wherein the metal strip or wire (neutral axis support wires 130, Fig. 1) comprises stainless steel ([0040], can be made of stainless steel).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Taylor and Follmer to incorporate the teachings of McDermott to include a metal strip made of stainless steel. Doing so would reduce axial compression via an axially stiff material, as recognized by McDermott [0040].
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US Patent No. 5,456,680) in view of Follmer et al. (US Patent No. 5,827,242), further in view of Dittman et al. (US Pre-Grant Publication 2004/0220549), further in view of McDermott et al. (US Pre-Grant Publication 2022/0176075).
Regarding claim 19, Taylor, Follmer, and Dittman teach the device according to claim 1. Follmer teaches that the axial reinforcement element can be a metal (col. 5, ll. 36-39), but not that it comprises stainless steel.
McDermott teaches a steerable catheter system (abstract), further comprising:
wherein the metal strip or wire (neutral axis support wires 130, Fig. 1) comprises stainless steel ([0040], can be made of stainless steel).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Taylor, Follmer and Dittman to incorporate the teachings of McDermott to include a metal strip made of stainless steel. Doing so would reduce axial compression via an axially stiff material, as recognized by McDermott [0040].
Claims 11, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US Patent No. 5,456,680) in view of Follmer et al. (US Patent No. 5,827,242), further in view of Chou (US Pre-Grant Publication 2020/0289136), hereinafter ‘Chou’.
Regarding claim 11, Taylor and Follmer teach the device according to claim 10. Taylor teaches that the radiopaque tip marker band is made of platinum or radiopaque alloy (col. 4, ll. 60-61), but not that it is a platinum-iridium alloy.
Chou teaches a catheter with reinforcement fibers [0150], further comprising:
wherein the marker (radiopaque marker 224a, Figs. 8B, 8C) comprises a platinum-iridium alloy ([0205], marker may be platinum/iridium band).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Taylor and Follmer to incorporate the teachings of Chou to include a marker made of a platinum-iridium alloy. Doing so would allow for the marker to be radiopaque without the flexibility of the tip being impacted, as recognized by Chou [0205].
Regarding claim 14, Taylor and Follmer teach the method according to claim 13. Taylor teaches that the jacket is plastic (col. 4, ll. 48-55), but not that the jacket is a Pebax jacket.
Chou teaches a catheter with reinforcement fibers [0150], further comprising:
wherein the plastic jacket comprises a Pebax jacket ([0105], outer jacket can be constructed of PEBAX).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Taylor and Follmer to incorporate the teachings of Chou to include an outer jacket made of Pebax. Doing so would provide mechanical integrity to the inner components, as recognized by Chou [0105].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Storbeck et al. (US Pre-Grant Publication 2015/0290423) teaches an elongated shaft with a reinforcement member.
Yourgenlow et al. (US Patent No. 11,565,082) teaches an enhanced flexibility catheter.
Tschida (US Pre-Grant Publication 2023/0022616) teaches a medical device for vascular condition treatment.
Yee et al. (US Patent No. 11,207,497) teaches a catheter with enhanced tensile strength.
Racchini et al. (US Pre-Grant Publication 2017/0196690) teaches a delivery device.
van Sloten et al. (US Pre-Grant Publication 2006/0224113) teaches a catheter with reinforcement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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