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 .
Election/Restrictions
Claims 15 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/4/26.
Applicant's election with traverse of group I in the reply filed on 3/4/26 is acknowledged. The traversal is on the ground(s) that the search and examination could be made without serious burden. This is not found persuasive because group I and group II are related as process of making and product made. In the instant case, the product as claimed can be made by another and materially different process. For instance, group II requires a sintering step to transform crack into recesses in the outer resin layer whereas group I does not. Thus, the recesses in the product of Invention be formed via laser ablation. Additionally, the product as claimed can be made by a coextrusion/lamination step and a material removal step. Further, claim 1 is a product-by-process, which is limited by and defined by the process, determination of patentability is based on the product itself, and not on its method of production (See MPEP § 2113). The method of production is not limited to making the product as claimed, and the product can be made by other processes, involve different classification, different prior art, and different prior art. The requirement is still deemed proper and is therefore made FINAL.
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(s) 1-3 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Iwasaki et al. US 6503193
Regarding claims 1-3, Iwasaki et al. discloses an elongated medical instrument comprising: a base material part; and an outer layer part (may consider part 13 or 14) formed by coating a resin or resin suspension on an outer peripheral surface of the base material part (tube 12 is coated with a resin layer or sheath 13 made of synthetic resin, figure 2), the outer layer part comprising, at an outer surface of the outer layer part: disposed recesses and protrusions (column 1, lines 40-55, resin layer outer circumferential surface being provided with at least one groove or protrusion or a plurality of grooves and/or protrusions), but fails to disclose the recesses being irregular and the protrusions each having an outer peripheral surface formed as an outer peripheral side of an adjacent one of the recesses, wherein the recesses extend linearly in a circumferential direction and in a longitudinal direction of the elongated medical instrument (column 1, lines 40-55).
Although the references does not disclose the claimed phrase “drying the coasted resin suspension” or “recesses formed from cracks generated by drying the coated resin suspension” this limitation is being treated as a product by process limitation. It is noted that “[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). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2.
It would have been an obvious matter of design choice to modify the Iwasaki et al., to have irregularly spaced recesses, since applicant has not disclosed that having irregularly spaced solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs, such as recesses spaced in a patter or equally along the length of the instrument. Furthermore, absent a teaching as to criticality that the recesses may be irregularly spaced, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Regarding claim 7, wherein: the base material part comprises: a tubular body (figure 2, may consider tubular body 11) ; and a reinforcing body 12 provided on an outer peripheral side of the tubular body (figure 2, braided tube 12) , and the outer layer part covers the tubular body and the reinforcing body (figure 2).
Claim(s) 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Iwasaki et al. US 6503193 in view of Pepin US 2003/0125710 in view of Miyata et al. US 2014/0236124.
Regarding claim 8, Iwasaki et al. discloses the medical instrument essentially as claimed, but fails to disclose an adhesive layer provided between the reinforcing body and the outer layer part, the adhesive layer comprising a resin having increased adhesion with the reinforcing body and the outer layer part relative to an adhesion between the reinforcing body and the outer layer part, or an intermediate resin layer to as to cover the tubular body and bury the reinforcing body, the outer part covers the tubular body, the reinforcing body, and the intermediate resin layer, the intermediate resin layer and the outer layer are formed of different resins.
Pepin discloses a layered tubular body comprising an adhesive layer between an inner and outer layer part, the adhesive layer comprising a resin having increased adhesion with the inner part and the outer layer part relative to an adhesion between the inner and outer part (paragraph 0040-45), catheter shaft comprising multiple layers, a middle layer being an epoxy, and an outer layer being a resin layer the layers may be varied or layers omitted as desired (paragraph 0040-45), epoxy being a thermosetting resin having strong adhesion with surface coatings (paragraph 0040). Pepin teaches the attachment between layers of an elongate medical instrument, such as with an epoxy or resin to provide increased adhesive properties and altering the stiffness of the tubular catheter body (paragraph 0040), the layers being selectively curable epoxy as required for each layer (paragraph 0042), a first and third layer comprising epoxy (paragraph 0045), or combinations as required with epoxy or another curable material (paragraphs 0014 0045), but fails to explicitly disclose the resin in the adhesive layer is a fluororesin having an adhesive functional group being perfluroalkoxyalkane having an adhesive functional group, or an intermediate resin layer, the intermediate resin layer and the outer layer part are formed of different resins.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide fluororesin having an adhesive functional group being perfluroalkoxyalkane, 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. Absent a teaching as to criticality that the resin in the adhesive layer is a fluororesin having an adhesive functional group being perfluroalkoxyalkane having an adhesive functional group or an additional resin, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification to provide a sufficient adhesive layer for attachment between components and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Miyata et al. teaches an elongate medical instrument comprising various layers, the layers being formed of different resins to provide different adhesive strengths and flexibility (paragraph 0008).
Therefore, it would have been obvious to one having ordinary skill in the art to provide an adhesive layer between the reinforcing body and outer layer part, as taught by Pepin, to provide additional adhesion and strength within the medical instrument tubular body, and to provide a first and second different resin for the intermediate resin layer and the outer layer, as taught by Miyata et al., as required to provide the desired adhesive strength and flexibility in the catheter portion.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakane et al. US 2006/0073264 in view of Koike US 2013/0006221.
Regarding claims 1, 2, 3, Sakane et al. discloses an elongated medical instrument 1 comprising: a base material part 11 (paragraph 0007, metal wire); and an outer layer part 13 formed by coating a resin or resin suspension on an outer peripheral surface of the base material part (paragraph 0007, 0059 fluororesin coating including particulate matter forming a layer on a surface of a metal wire), and drying the coated resin suspension (paragraph 0008, applying solution to the surface and drying the solution), the outer layer part comprising, at an outer surface of the outer layer part (outside surface of coating), protrusions 14, each having an outer peripheral surface formed as an outer peripheral side (figures 2, 7).
Sakane et al. discloses an uneven or irregular surface with the irregular protrusions (for example, figure 0054, 0066; figure 5, 7; fluoresin coating layer has an uneven shape), but fails to explicitly disclose irregularly disposed recesses formed by the cracks generated by drying, or recesses formed by the cracks, the protrusions formed adjacent one of the recesses.
Koike discloses a guidewire or elongated medical instrument comprising a base (tungsten wire 3a, figure 2A) and an outer layer part (coating layer 3a or 13b, figures 2A, 4A-4C), the guidewire comprising at least one recess and one protrusion (abstract, figures 4A-4C), modifications on the wire surface provided on the surface formed by sputtering, spraying or laser abrasion (paragraph 0038), the guidewire having an uneven shape causing an anchoring effect to occur (paragraph 0009), the protrusions or recesses formed adjacent (figures 4A-4C, protrusions and recesses of uneven surface along the guidewire surface), wherein the recesses extend linearly and irregularly in a circumferential direction of the elongated medical instrument and in a longitudinal direction of the elongated medical instrument (figures 2A, 2B, 4A-4C).
Although the references does not disclose the claimed phrase “recesses formed from cracks generated by drying the coated resin suspension” this limitation is being treated as a product by process limitation. It is noted that “[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). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2.
Therefore, it would have been obvious to one having ordinary skill in the art to modify Sakane et al. with recesses formed adjacent to the protrusions, as taught by Koike, as known in the art to provide an uneven or irregular surface on an outer surface of a guidewire including both protrusions and recesses adjacent one another along the outer peripheral side of the outer peripheral surface to provide the anchoring effect or characteristics as desired.
Regarding claims 4 and 5, Sakane et al. discloses wherein the resin suspension comprises fluororesin particles (paragraph 0033, 0037), the fluororesin particles may be selected from a variety of fluororesin particles (paragraph 0033, such as PFA), but fails to explicitly disclose the fluororesin particles being perfluoroalkoxyalkane particles. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide fluororesin particles being perfluoroalkoxyalkane particles, 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. Applicant discloses any thermoplastic resin may be used as the material of gthe outer layer (paragraph 0119). Absent a teaching as to criticality that the fluororesin particles must be perfluoroalkoxyalkane particles, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Regarding claim 6, Salane et al. discloses wherein the elongated medical instrument is a guide wire (paragraph 0004, 0007) comprising: the base material part (for example, core wire 11) ; a coil member disposed on the outer peripheral surface of the base material part in a first region (taught in prior art, paragraph 0004, to reduce the frictional resistance between the catheter and the guide wire); and the outer layer part disposed on the outer peripheral surface of the base material part in a second region that is proximal to the first region (Examiner notes the first and second region may be considered any part or any region of the guide wire, as no further limitations are required, and therefore may be interpreted as claimed). Salane et al. teaches in the background, that a coil member may be disposed on the outer peripheral surface of the base material part in a first region (paragraph 0004, to reduce the frictional resistance between the catheter and the guide wire), but fails to explicitly disclose a coil member on the guidewire in a first region.
Koike further teaches a base material part (core shaft 2, figure 3A); a coil member disposed on the peripheral surface of the base material part in a first region (coil body 13, figure 3A), and the outer layer part disposed on the outer peripheral surface of the base material part in a second region that is proximal to the first region (figure 3A, base 2 is proximal coil 13 at the distal end). Examiner notes the first and second region may be considered any part or any region of the guide wire, and therefore may be interpreted as claimed as the coil is provided with the protrusions and recesses, as the first and second regions may each contain the coil or the protrusions or recesses.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the elongated medical instrument to have a coil member may be disposed on the outer peripheral surface of the base material part in a first region, the second region being proximal to the first region, as taught by Koike, for providing the guidewire having a coil distal end as known in the art to enhance maneuverability or flexibility during placement of the guidewire.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 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, Darwin Erezo can be reached at (571) 272-4695. 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.
/CHRISTINA C LAUER/Examiner, Art Unit 3771
Prosecution Insights