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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 10 is objected to because of the following informalities:
In claim 10, the limitation “the shaft is made of a resin material” appears to be a duplicate of the same limitation found in claim 9, upon which claim 10 depends.
Appropriate correction is required.
Claim Interpretation
Claims 1 and 11 are considered to include product-by-process limitations. The cited prior art teaches all of the positively recited structure of the claimed apparatus or product. The determination of patentability is based upon the apparatus structure itself. The patentability of a product or apparatus does not depend on its method of production or formation. 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. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113).
In the instant case, the limitation of the shaft outer surface and the inner surface of the shaft accommodation portion being directly fusion-bonded is a method of production in an apparatus claim, and will therefore not be given patentable weight.
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.
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 1, 2, 5-8, 11-17, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2018/0071485 to Gupta et al. (“Gupta”) in view of U.S. Patent Publication No. 2016/0206858 to Ishida and U.S. Patent
Regarding claim 1, Gupta teaches a catheter (Fig. 6) comprising a shaft (12) that possesses a shaft longitudinal axis (longitudinal axis of 12), the shaft also possessing a distal end and a proximal end (distal and proximal end of 12), the shaft having a lumen (30) extending from the distal end of the shaft to the proximal end of the shaft, the shaft including a shaft proximal end surface (proximal end surface of 12) and a shaft proximal opening (opening at proximal end of 12) that is a proximal end of the lumen in the shaft (Fig. 6), and the shaft also including a radially outwardly facing shaft outer surface (outer surface of 12) extending continuously along the shaft in a proximal direction from the distal end of the shaft and terminating at the shaft proximal end surface (Fig. 6), the shaft also including a radially inwardly facing shaft inner surface (inner surface of 12) extending continuously along the shaft from the distal end of the shaft to the proximal end of the shaft, an entirely of the shaft outer surface being radially outward of the shaft inner surface (Fig. 6), a hub (20) attached to the proximal end of the shaft, the hub including a distal end (44) and a proximal end (42), the hub including a hub distal opening (62) at the distal end of the hub (Fig. 6), a shaft accommodation portion (generally designated by 14 in Fig. 6) in which is accommodated the proximal end of the shaft, and a hub proximal opening (opening created by 42) at the proximal end of the hub, the shaft accommodation portion extending from a proximal end of the shaft accommodation portion to a distal end of the shaft accommodation portion (Fig. 6), the shaft accommodation portion of the hub including an adjacent surface (64) at the proximal end of the shaft accommodation portion (Fig. 6), the adjacent surface of the shaft accommodation portion being positioned adjacent the shaft proximal end surface of the shaft (Fig. 6), the shaft accommodation portion having an inner surface (inner surface of 20 along 14) that extends from the distal end of the shaft accommodation portion to the proximal end of the shaft accommodation portion and that terminates at the adjacent surface (64) of the shaft accommodation portion (Fig. 6), the adjacent surface of the shaft accommodation portion including a hole (hole created by stop mechanism 64) that communicates with the hub proximal opening and that is positioned adjacent the shaft proximal opening (Fig. 6), an inner diameter of the hub distal opening (62) being larger than an inner diameter of the adjacent surface (64) of the shaft accommodation portion (Fig. 6), an inner diameter of the shaft accommodation portion, between the proximal end of the shaft accommodation portion and the distal end of the shaft accommodation portion, being smallest at the fusion surface (the smallest portion of 14 is part of the bonded surface that will be part of the fusion surface once modified hereafter). Gupta teaches a proximal portion of the shaft outer surface (see claim interpretation above) bonded to the hub along the shaft longitudinal axis to at least form a bonded surface therebetween that extends along the shaft longitudinal axis ([0059]), but does not explicitly mention the bonded surface being a “fusion” surface and the gap.
Ishida teaches an equivalent fusion surface ([0037], a catheter and hub being connected via fusion, which creates a fusion surface). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the bonded surface of Gupta with the fusion surface of Ishida for the predictable result of providing connection between a catheter and a hub. Additionally, bonded surfaces and fusion surfaces are understood as art-recognized alternative types of connected surfaces to obtain the predictable result of connecting two surfaces in a medical device.
Raven teaches a radially outwardly facing shaft outer surface (outer surface of 1/14/15) of a part of a proximal end (15) of a shaft that is accommodated in a shaft accommodation portion (10) of a hub (2) being spaced from an inner surface of the shaft accommodation portion (Fig. 2) so that a gap (between 15 and 11) exists between a shaft outer surface of the part (15) of the proximal end the shaft and the inner surface (11) of the shaft accommodation portion. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention have modified Gupta to have gap as taught by Raven, because such a modification is a simple substitution of one type of catheter shaft/hub design for another to obtain the predictable result of providing a connection between a shaft and an associated hub that does not allow further proximal movement of the catheter shaft. Once combined, the gap being located, in a direction of the shaft longitudinal axis, between the fusion surface and the shaft proximal end surface of the shaft.
Regarding claim 2, Gupta, Ishida, and Raven teach the catheter according to claim 1 as shown above, Raven further teaching the inner diameter of a shaft accommodation portion at the fusion surface is smaller than an outer diameter of the shaft proximal end surface (inner diameter of 10 is smaller than outer diameter of 15 in Fig. 2).
Regarding claim 5, Gupta, Ishida, and Raven teach the catheter according to claim 1 as shown above, Gupta further teaching the hub includes a distal end portion (44) that extends proximally from the hub distal opening, an inner surface of the hub in the distal end portion of the hub facing the shaft outer surface and being spaced from the shaft outer surface (the hub is spaced from the catheter via 62).
Regarding claim 6, Gupta, Ishida, and Raven teach the catheter according to claim 5 as shown above, Gupta further teaching the inner surface of the hub in the distal end portion of the hub is spaced at a differing distance from the shaft outer surface along the shaft longitudinal axis (62 shows differing diameters in Fig. 6).
Regarding claim 7, Gupta, Ishida, and Raven teach the catheter according to claim 1 as shown above, Raven further teaching the lumen in the shaft being widened at a proximal end portion of the shaft (Fig. 2), but do not teach the relative inner diameter diameters. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the inner diameter of the lumen in the shaft at the shaft proximal end surface of Raven to be larger than an inner diameter of the hole in the adjacent surface of the shaft accommodation portion, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the proximal end portion of the shaft of Raven would not operate differently with the claimed relative diameter, as this slightly larger diameter would be suitable for allowing fluid to flow from the hub through the shaft.
Regarding claim 8, Gupta, Ishida, and Raven teach the catheter according to claim 1 as shown above, Raven further teaching the shaft outer surface of a proximal end portion of the shaft (15) is outwardly flared so that an outer diameter of the proximal end portion of the shaft increases toward the shaft proximal end surface (Fig. 2).
Regarding claim 11, Gupta teaches a catheter (Fig. 6) comprising an elongated shaft (12) extending from a distal end of the elongated shaft to a proximal end of the elongated shaft so that the proximal end of the elongated shaft is on a proximal side of the distal end of the elongated shaft (Fig. 6), the elongated shaft including a lumen (30) extending along the elongated shaft and opening to the proximal end of the shaft at a shaft proximal opening (opening at proximal end of 12) while also opening to the distal end of the shaft (opening at distal end of 12), the elongated shaft including a shaft proximal end surface (proximal end surface of 12) at the proximal end of the elongated shaft, the elongated shaft also including a shaft outer surface (outer surface of 12) that faces radially outwardly, extends continuously in a proximal direction from the distal end of the elongated shaft to the proximal end (Fig. 6) of the elongated shaft and terminates at the shaft proximal end surface (proximal end surface of 12), the elongated shaft including a shaft inner surface (inner surface of 12) that surrounds the lumen, extends continuously in the proximal direction from the distal end of the elongated shaft to the proximal end of the elongated shaft and terminates at the shaft proximal end surface, an entirety of the shaft inner surface being radially inwardly of the shaft outer surface (Fig. 6), a hub (20) that includes a shaft accommodation portion (generally designated by 14 in Fig. 6) in which is accommodated a proximal portion of the elongated shaft (Fig. 6), the shaft accommodation portion possessing an inner diameter (inner diameter of 20 along 14), the hub also including a hub lumen (58) extending from a hub proximal opening at a proximal end (42) of the hub toward a distal end (44) of the hub, the hub lumen communicating with the shaft accommodation portion (Fig. 6), the hub also including a hub distal opening (62) at the distal end of the hub that communicates with the shaft accommodation portion of the hub, and a proximal portion of the shaft accommodation portion of the hub including an adjacent surface (64) that faces toward the shaft proximal end surface of the elongated shaft (Fig. 6). Gupta teaches the shaft outer surface of the proximal portion of the elongated shaft and an inner surface of the shaft accommodation portion being (see claim interpretation above) bonded to the hub along a portion of the elongated shaft ([0059]), but does not explicitly mention the surface of bonding being a fusion surface.
Ishida teaches an equivalent fusion surface ([0037], a catheter and hub being connected via fusion, which creates a fusion surface). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the bonded surface of Gupta with the fusion surface of Ishida for the predictable result of providing connection between a catheter and a hub. Additionally, bonded surfaces and fusion surfaces are understood as art-recognized alternative types of connected surfaces to obtain the predictable result of connecting two surfaces in a medical device.
Gupta and Ishida teach the fusion surface possessing an inner diameter that is smaller than all portions of the shaft accommodation portion of the hub position distally of the fusion surface (Fig. 6 of Gupta, the diameter at 14 is smaller than the diameter at 62), but do not teach the diameter of the fusion surface being smaller than all proximal portions of the shaft accommodation portion and the gap.
Raven teaches a radially outwardly facing shaft outer surface (outer surface of 1/14/15) of an elongated shaft (1/14/15) that extends continuously from a distal end of the elongated shaft to a proximal end of the elongated shaft (Fig. 2) including a portion that is spaced from an inner surface of a shaft accommodation portion (10) so that a gap (between 15 and 11) exists between the portion of the shaft outer surface of the elongated shaft (15) and the inner surface (11) of the shaft accommodation portion. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention have modified Gupta to have gap as taught by Raven, because such a modification is a simple substitution of one type of catheter shaft/hub design for another to obtain the predictable result of providing a connection between a shaft and an associated hub that does not allow further proximal movement of the catheter shaft. Once combined, the portion of the shaft outer surface of the elongated shaft being on the proximal side of the fusion surface. Raven further teaching an analogous fusion surface (portion of 2 along 10, Fig. 2) possessing an inner diameter that is a smaller than the inner diameter of all other portions of the shaft accommodation portion of the hub positioned proximally of the fusion surface (the inner diameter along 10 is smaller than the inner diameter of 11).
Regarding claim 12, Gupta, Ishida, and Raven teach the catheter according to claim 11 as shown above, Gupta further teaching the hub includes a distal end portion (formed around 62) extending proximally from the hub distal opening (Fig. 6), the distal end portion of the hub possessing an inner surface (inner surface of 48 at 62) that faces the shaft outer surface of the elongated shaft and that is spaced from the shaft outer surface of the elongated shaft (48 is spaced from 12 via 62, Fig. 6).
Regarding claim 13, Gupta, Ishida, and Raven teach the catheter according to claim 11 as shown above, Gupta further teaching the hub includes a distal end portion (formed around 62) extending proximally from the hub distal opening (Fig. 6), the distal end portion of the hub possessing an inner surface (inner surface of 48 at 6) that faces the shaft outer surface of the elongated shaft and that is spaced from the shaft outer surface so that a distal gap (62) exists between the inner surface of the distal end portion of the hub and the shaft outer surface of the elongated shaft (Fig. 6), a radial dimension of the distal gap varying along the elongated shaft (diameter of 62 varies, Fig. 6).
Regarding claim 14, Gupta, Ishida, and Raven teach the catheter according to claim 13 as shown above, Gupta further teaching the radial dimension of the distal gap at a distal part of the distal gap is larger than the radial dimension of the distal gap at a proximal part of the distal gap (distal gap of 62 is larger than the proximal gap of 62, Fig. 6).
Regarding claim 15, Gupta, Ishida, and Raven teach the catheter according to claim 1 as shown above, Raven further teaching the lumen in the shaft being widened at a proximal end portion of the shaft (Fig. 2), but do not teach the relative inner diameter diameters. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the inner diameter of the lumen in the shaft at the shaft proximal end surface of Raven to be larger than an inner diameter of the hole in the adjacent surface of the shaft accommodation portion, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the proximal end portion of the shaft of Raven would not operate differently with the claimed relative diameter, as this slightly larger diameter would be suitable for allowing fluid to flow from the hub through the shaft.
Regarding claim 16, Gupta, Ishida, and Raven teach the catheter according to claim 11 as shown above, Raven further teaching the shaft outer surface of a proximal end portion of the elongated shaft (15) is outwardly flared so that an outer diameter of the proximal end portion of the elongated shaft increases toward the shaft proximal end surface (Fig. 2).
Regarding claim 17, Gupta, Ishida, and Raven teach the catheter according to claim 11 as shown above, Raven further teaching a smallest inner diameter of the shaft accommodation portion at the fusion surface is smaller than an outer diameter of the shaft proximal end surface (outer diameter of 15 is larger than portions of 2 along 10).
Regarding claim 21, Gupta teaches a catheter (Fig. 6) comprising a shaft (12) that is elongated and extends from a distal end of the shaft to a proximal end of the shaft (Fig. 6), the shaft having a lumen (30) extending throughout the shaft, the shaft having an inner surface (inner surface of 12) that surrounds the lumen, that faces radially inwardly and that extends continuously in a proximal direction from the distal end of the shaft to the proximal end of the shaft (Fig. 6), the shaft including a shaft proximal end surface (proximal end surface of 12) and a shaft proximal opening (proximal opening of 12) that is a proximal end of the lumen in the shaft (Fig. 6), the shaft proximal end surface facing away from the distal end of the shaft (Fig. 6), and the shaft also having a shaft outer surface (outer surface of 12) extending continuously from the distal end of the shaft to the proximal end of the shaft, an entirety of the shaft outer surface being radially outwardly of the inner surface of the shaft (Fig. 6), a hub (20) attached to the proximal end of the shaft, the hub including a distal end and a proximal end (Fig. 6), the hub including a hub distal opening (62) at the distal end of the hub, a shaft accommodation portion (generally designated by 14 in Fig. 6) in which is accommodated the proximal end of the shaft, and a hub proximal opening (opening created by 42) at the proximal end of the hub, the shaft accommodation portion extending from a proximal end of the shaft accommodation portion to a distal end of the shaft accommodation portion so that the proximal end of the shaft accommodation portion is on a proximal side of the distal end of the shaft accommodation portion (Fig. 6) and so that the distal end of the shaft accommodation portion is on a distal side of the proximal end of the shaft accommodation portion (Fig. 6), the shaft accommodation portion of the hub including an adjacent surface (64) that is at the proximal end of the shaft accommodation portion and that faces towards the distal end of the hub, the adjacent surface of the shaft accommodation portion facing the shaft proximal end surface of the shaft (Fig. 6), the shaft accommodation portion having a radially inwardly facing inner surface (inner surface of 20 along 14) that extends continuously from the distal end of the shaft accommodation portion toward the proximal end of the shaft accommodation portion and that terminates at the adjacent surface of the shaft accommodation portion (Fig. 6), the adjacent surface of the shaft accommodation portion including a hole (hole at 64) that communicates with the hub proximal opening and that is positioned adjacent the shaft proximal opening (Fig. 6), and an inner diameter of the hub distal opening being larger than an inner diameter of the adjacent surface of the shaft accommodation portion (62 is larger than diameter at 14). Gupta teaches a proximal portion of the shaft outer surface being (see claim interpretation above) bonded to the hub along the shaft longitudinal axis to at least form a bonded surface therebetween that extends along the shaft longitudinal axis ([0059]), but does not explicitly mention the bonded surface being a “fusion” surface and the gap.
Ishida teaches an equivalent fusion surface ([0037], a catheter and hub being connected via fusion, which creates a fusion surface). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the bonded surface of Gupta with the fusion surface of Ishida for the predictable result of providing connection between a catheter and a hub. Additionally, bonded surfaces and fusion surfaces are understood as art-recognized alternative types of connected surfaces to obtain the predictable result of connecting two surfaces in a medical device. Once combined, Gupta further teaches the inner diameter of the shaft accommodation portion being smallest, along its entire longitudinal extent, at the fusion surface (the inner diameter of 20 along 14 is the smallest relative to diameter at 62).
Raven teaches a radially inwardly facing inner surface of the shaft accommodation portion (inner surface of 2 along 10/11/12) including a part (11) located on the proximal side of the fusion surface (Fig. 2, the analogous fusion surface would be the portion of 2 along 10), a radially outwardly facing shaft outer surface of the shaft (outer surface of 1/14/15) that extends continuously from the distal end of the shaft to the proximal end of the shaft including a part (15) located on the proximal side of the fusion surface (Fig. 2), the part of the radially inwardly facing inner surface of the shaft accommodation portion and the part of the radially outwardly facing shaft outer surface of the shaft facing one another and being spaced from one another so that a radial gap exists between the part of the radially inwardly facing inner surface of the shaft accommodation portion and the part of the radially outwardly facing shaft outer surface of the shaft (gap between 11 and 15), the radial gap being on the proximal side of the fusion surface and on the distal side of the adjacent surface (13) of the shaft accommodation portion of the hub (Fig. 2). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention have modified Gupta to have gap as taught by Raven, because such a modification is a simple substitution of one type of catheter shaft/hub design for another to obtain the predictable result of providing a connection between a shaft and an associated hub that does not allow further proximal movement of the catheter shaft.
Regarding claim 22, Gupta, Ishida, and Raven teach the catheter according to claim 21 as shown above, Rave further teaching the lumen in the shaft is expanded at a proximal end portion (15) of the elongated shaft but do not teach the relative inner diameter diameters. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the inner diameter of the lumen in the shaft at the shaft proximal end surface of Raven to be larger than an inner diameter of the hole in the adjacent surface of the shaft accommodation portion, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the proximal end portion of the shaft of Raven would not operate differently with the claimed relative diameter, as this slightly larger diameter would be suitable for allowing fluid to flow from the hub through the shaft.
Regarding claim 23, Gupta, Ishida, and Raven teach the catheter according to claim 22 as shown above, Raven further teaching the adjacent surface (13) of the shaft accommodation portion of the hub and the shaft proximal end surface of the shaft (15) are axially spaced apart from one another so that an axial gap exists between the adjacent surface of the shaft accommodation portion of the hub and the shaft proximal end surface of the shaft (Fig. 2).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gupta in view of Ishida and Raven as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2015/0127043 to Cope.
Regarding claim 9, Gupta, Ishida, and Raven teach the catheter according to claim 1 as shown above, Gupta further teaching the shaft is made of a resin material ([0062], polymer) but do not teach the wire.
Cope teaches a shaft including a reinforcing wire extending along the shaft ([0026], embedded wires). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft of Gupta to include a reinforcing wire as taught by Cope in order to enhance strength and/or flexibility ([0026]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gupta, Ishida, and Raven as applied to claim 11 above, and further in view of WO 2018/181184 to Oiwa (equivalent to U.S. Patent Publication No. 2020/0023101 which will be referred to hereafter).
Regarding claim 10, Gupta, Ishida, and Raven teach the catheter according to claim 9, Gupta further teaching the shaft is made of a resin material ([0062], polymer) but do not teach the pigment.
Oiwa teaches a pigment that does not transmit or absorb heat ([0018], heat resistance) in combination with a resin for a medical device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a pigment into the shaft of Gupta as taught by Oiwa to reduce discoloration, enhance visibility, and promote heat resistance ([0018]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gupta, Ishida, and Raven as applied to claim 11 above, and further in view of U.S. Patent Publication No. 2015/0127043 to Cope.
Regarding claim 19, Gupta, Ishida, and Raven teach the catheter according to claim 11 as shown above, Gupta further teaching the elongated shaft is made of a resin material ([0062], polymer) but do not teach the wire.
Cope teaches a shaft including a reinforcing wire extending along at least a portion of the longitudinal extent of the elongated shaft ([0026], embedded wires). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft of Gupta to include a reinforcing wire as taught by Cope in order to enhance strength and/or flexibility ([0026]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gupta, Ishida, and Raven as applied to claim 11 above, and further in view of WO 2018/181184 to Oiwa (equivalent to U.S. Patent Publication No. 2020/0023101 which will be referred to hereafter).
Regarding claim 20, Gupta, Ishida, and Raven teach the catheter according to claim 11 as shown above, Gupta further teaching the elongated shaft is made of a resin material ([0062], polymer) but do not teach the pigment. Oiwa teaches a pigment that does not transmit or absorb heat ([0018], heat resistance) in combination with a resin for a medical device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a pigment into the shaft of Gupta as taught by Oiwa to reduce discoloration, enhance visibility, and promote heat resistance ([0018]).
Response to Arguments
The drawings were received on 10/10/2025. These drawings are acceptable.
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to the specification objection have been fully considered and are persuasive. The specification objection has been withdrawn.
Applicant’s arguments and amendments with respect to the claim objections have been fully considered and are persuasive in-part. The claim objections have been withdrawn except for the objection to claim 10, which was not addressed in the response.
Applicant’s arguments and amendments with respect to the 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant’s arguments regarding the product-by-process limitation have been considered but are not persuasive. Examiner reiterates that the patentability of a product or apparatus does not depend on its method of production or formation. In any case, even if the method of production was given weight, Examiner submits that Ishida teaches fusion including heat-fusion, high-frequency fusion, etc. ([0037]) which are interpreted as being equivalent to “directly fusion-bonded” absent any additional method limitations, which again should be used in an apparatus claim.
Applicant’s arguments and amendments with respect to art rejections have been considered but are moot because the new ground of rejection does not rely on the Diettrich reference upon which Applicant’s arguments are directed and a new rejection has been issued over Gupta in view of Ishida and Raven as shown above in response to Applicant’s amendments.
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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/B.K./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783