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 .
Response to Arguments
Applicant's arguments, filed 01/20/2026, with respect to the rejections of the claims under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that Fujieda et al. (US 6,977,105) is non analogous art and is neither from the same field of endeavor (see arguments pg. 5-6) nor reasonably pertinent to the problem faced by the inventor (see arguments pg. 7-8).
The Examiner disagrees. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, it is the Examiner’s position that Fujieda is both from the same field of the inventor’s endeavor and is reasonably pertinent to the particular problem with which the inventor was concerned.
Applicant argues that Fujieda is not from the same field of endeavor because the disclosed tubing is not designed to be placed within the body of a patient and Applicant cites multiple portions of Fujieda’s disclosure where it is stated that the tubing can be used extracorporeally in support of this argument.
The Examiner disagrees that Fujieda must disclose the tubing is used within the body in order to be considered from the same field of endeavor and with Applicant’s characterization of the reference.
Nonetheless, it is noted Fujieda discloses that the disclosed multi-layered tube can form a catheter (col.10, lines 53-57) and is suitable for use as a component for medical devices that are inserted into the body such as an infusion tube, catheter and balloon catheter “in addition” to its extracorporeal uses (col. 10, line 58 - col. 11, line 3).
Fujieda is considered to be from the same field of endeavor because the device of Fujieda is a flexible multi-layered medical tube and the device of the application is similarly a flexible multi-layered medical tube.
Applicant further argues that Fujieda is not reasonably pertinent to the problem faced by the inventor because there is no overlap in the problem faced by Fujieda and the inventor of the claimed invention.
The Examiner disagrees. As stated by Applicant, the problem faced by the inventor of the instant application is to provide a dilator (i.e., medical tube) that is flexible and able to visibly marked (see [0005] of the Specification). Fujieda discloses a specific arrangement of a multi-layered medical tube that provides enhanced flexibility, transparency and anti-kinking properties (see col. 1, lines 15-23).
Fujieda’s discloses other problems solved by the multi-layered tubing that are not disclosed by Applicant. However, this does not mean that Fujieda’s invention is not pertinent to the problem faced by Applicant, which is to enhance the flexibility of a dilator (i.e., a medical tube).
The rejections of the claims under 35 U.S.C. 103 are therefore maintained.
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.
Claims 1-6 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Walters et al. (US 2014/0180332), in view of McNamara et al. (US 2010/0249910), and further in view of Fujieda et al. (US 6,977,105).
Regarding claim 1, Walters discloses a puncture location device (110, see Fig. 3A-3B) configured to determine a location of a puncture in an artery relative to a skin surface of a patient (see Abstract), the puncture location device comprising: a flexible elongated body (134) that extends along a central longitudinal axis, the flexible elongated body having: a proximal end (P2), a distal end (D2) spaced from the proximal end along the central longitudinal axis, an inner channel (138) that extends from the proximal end toward the distal end along the central longitudinal axis, an inner core that defines the inner channel (the body 134 can be considered an inner core, the inner surface of which defines the inner channel, see Fig. 3B); the flexible elongated body further having at least one distal port (142) that is open to the inner channel, and a proximal port (146) open to the inner channel and positioned between the proximal end and the at least one distal port (see Fig. 3A), wherein the at least one distal port is configured to receive blood therethrough such that blood travels through the inner channel and through the proximal port when the at least one distal port is placed in a path of blood flow (distal port 142 is in fluid communication with proximal port 146 and is configured to receive blood, see [0048]).
Walters fails to teach the inner core including a first polymeric material and an outer layer surrounding the inner core and including a second polymeric material that is different from the first polymeric material.
McNamara, in the same field of art, teaches a flexible elongated body (112, see Fig. 12) which can be formed of two layers (i.e., an inner and an outer layer) including different polymeric materials for combining the desirable properties of each material (see [0196]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Walters so that the elongated body is comprised of two layers made of different polymeric materials, as taught by McNamara, since doing so would produce an elongated flexible body having a combination of desired properties from each material.
The distal port would extend through the outer layer and inner core since Walters teaches the distal port being extending through the outer surface of the elongated body and being open to the inner channel (see Walters [0048] and Fig. 3A).
The combination of Walters and McNamara teaches wherein the outer layer comprises a first portion of a radius of the flexible elongated body, the inner core comprises a second portion of the radius of the flexible elongated body, but fails to expressly teach the first portion is less than the second portion. In other words, Walters and McNamara fail to expressly the teach the outer layer is thinner than the inner core.
Fujieda, in the same field of art, teaches a multilayered catheter (see Fig. 1A) where the outer layer thinner than the inner later depending on the desired flexibility and anti-kinking properties (see col. 10, lines 28-42).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the outer layer of Walters and McNamara so that it is thinner than the inner core, in view of the teachings of Fujieda, since doing so would enhance flexibility and kink resistance.
Regarding claim 2, Walters, McNamara and Fujieda teach the puncture location device of claim 1, wherein the first polymeric material comprises low-density polyethylene and the second polymeric material comprises high-density polyethylene (McNamara teaches that suitable polymeric materials for the construction of the multi-layered elongate member include HDPE and LDPE, see [0196]).
Regarding claim 3, Walters, McNamara and Fujieda teach the puncture location device of claim 1, wherein the first polymeric material is predominantly low-density polyethylene and the second polymeric material is predominantly high-density polyethylene (McNamara teaches that suitable polymeric materials for the construction of the multi-layered elongate member include HDPE and LDPE, see [0196]).
Regarding claim 4, Walters, McNamara and Fujieda teach the puncture location device of claim 1. Walters further discloses the flexible elongated body includes a plurality of markings (154, see Fig. 3A) spaced apart along a longitudinal direction that is parallel to the central longitudinal axis.
Regarding claim 5, Walters, McNamara and Fujieda teach the puncture location device of claim 4, wherein the plurality of markings are etched into the outer surface of the outer layer.
The claimed phrase “wherein the plurality of markings are etched into the outer surface of the outer layer” is being treated as a product by process limitation; that is, that markings are formed by etching. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. Thus, even though the combination of Walters, McNamara and Fujieda is silent as to the process used form the markings on the outer surface of the outer layer, it appears that the product taught by Walters, McNamara and Fujieda would be the same or similar as that claimed; especially since both applicant’s product and the prior art product are markings on the outer surface of a flexible elongated body.
Regarding claim 6, Walters, McNamara and Fujieda teach the puncture location device of claim 4, wherein the plurality of markings are not etched into the inner core (Walters does not teach that the markings are etched into the inner core).
Regarding claim 19, Walters, McNamara and Fujieda teach the puncture location device of claim 1, wherein the flexible elongated body has a tapered portion that defines the distal end (there is a taper towards the distal end D2, see Fig. 3A) and a linear portion that extends from the tapered portion to the proximal end (there is a liner portion proximal of the tapered portion that extends from the tapered portion to the proximal end P2, see 3A), wherein the tapered portion tapers toward the central longitudinal axis (the tapered portion tapers towards the central longitudinal axis in the distal direction, see Fig. 3A).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Walters, McNamara, and Fujieda, as applied to claim 1 above, and further in view of Strickland (US 5,218,957).
Regarding claim 7, Walters, McNamara, and Fujieda teach the puncture location device of claim 1, but fail to expressly teach wherein the inner core has a greater flexibility than the outer layer.
Strickland, in the same field of art, teaches a related device (10, see Fig. 4-5) comprising a flexible elongated body having an inner core (56) and an outer layer (58), where the inner core has greater flexibility than the outer layer (see col. 3, lines 36-51).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Walters, McNamara, and Fujieda so that the inner core has greater flexibility than the outer layer, as taught by Strickland, since doing so was a known way to provide a multi-layered catheter having sufficient flexibility and rigidity to navigate body lumens.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Walters, McNamara, and Fujieda, as applied to claim 1 above, and further in view of Smith et al. (US 2019/0015644).
Regarding claim 8, Walters, McNamara, and Fujieda teach the puncture location device of claim 1, wherein the flexible elongated body has an outer cross-sectional dimension that is perpendicular to the central longitudinal axis, but fail to teach expressly teach wherein the outer cross-sectional dimension is at least 0.18 inches.
Smith, in the same field of art, discloses a related device (100, see Fig. 1) comprising a flexible elongated body (121) having an outer cross-sectional dimension that is perpendicular to the central longitudinal axis that is at least 0.18 inches (the outer diameter of the shaft 121 can be 0.193 inches which is at least 0.18 inches, see [0035]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Walters, McNamara, and Fujieda so that the flexible elongated body has an outer cross-sectional dimension that is at least 0.18 inches, as taught by Smith, since Smith teaches that this is a satisfactory for a shaft having the desired pushability for navigating tortuous vasculature.
Claims 9-18 are rejected under 35 U.S.C. 103 as being unpatentable over Walters, McNamara, and Fujieda, as applied to claim 1 above, and further in view of Garrison et al. (US 2015/0173782).
Regarding claims 9 and 10, Walters, McNamara, and Fujieda fail to expressly teach the outer layer comprises about 0.01 inches of a radius of the flexible elongated body.
Garrison, in the same field of art, teaches a related device (105, see Fig. 24A) having an elongated body including an inner core and an outer layer (see [0099]) where the thickness of the layers is selected in order to construct an elongated body having “the desired flexibility and kink resistance requirement” (see [0107]). Therefore, the thickness of the outer layer is disclosed as a result effective variable in that changing the thickness of the outer layer would change the flexibility and kink resistance of the device. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Walters, McNamara, and Fujieda by making the outer layer comprises about 0.01 inches of a radius of the flexible elongated body 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 11 and 12, Walters, McNamara, and Fujieda fail to expressly teach the inner core is about 0.052 of the radius of the flexible elongated body.
Garrison, in the same field of art, teaches a related device (105, see Fig. 24A) having an elongated body including an inner core and an outer layer (see [0099]) where the thickness of the layers is selected in order to construct an elongated body having “the desired flexibility and kink resistance requirement” (see [0107]). Therefore, the thickness of the inner core is disclosed as a result effective variable in that changing the thickness of the inner core would change the flexibility and kink resistance of the device. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Walters, McNamara, and Fujieda by making the inner core about 0.052 of the radius of the flexible elongated body 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 13, Walters, McNamara, and Fujieda fail to expressly teach the inner core and the outer layer comprise between 65% and 80% of an outer diameter of the flexible elongated body.
Garrison, in the same field of art, teaches a related device (105, see Fig. 24A) having an elongated body including an inner core and an outer layer (see [0099]) where the thickness of the layers is selected in order to construct an elongated body having “the desired flexibility and kink resistance requirement” (see [0107]). Therefore, the thicknesses of the inner core and outer layer are disclosed as a result effective variables in that changing the thicknesses of the inner core and out layer would change the flexibility and kink resistance of the device. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Walters, McNamara, and Fujieda by making the inner core and the outer layer comprise between 65% and 80% of an outer diameter of the flexible elongated body 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, Walters, McNamara, and Fujieda fail to expressly teach the inner core and the outer layer comprise about 75% of an outer diameter of the flexible elongated body.
Garrison, in the same field of art, teaches a related device (105, see Fig. 24A) having an elongated body including an inner core and an outer layer (see [0099]) where the thickness of the layers is selected in order to construct an elongated body having “the desired flexibility and kink resistance requirement” (see [0107]). Therefore, the thicknesses of the inner core and outer layer are disclosed as a result effective variables in that changing the thicknesses of the inner core and out layer would change the flexibility and kink resistance of the device. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Walters, McNamara, and Fujieda by making the inner core and the outer layer comprise between 75% of an outer diameter of the flexible elongated body 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 15, Walters, McNamara, and Fujieda fail to expressly teach the outer layer comprises up to about 10% of an outer diameter of the flexible elongated body.
Garrison, in the same field of art, teaches a related device (105, see Fig. 24A) having an elongated body including an inner core and an outer layer (see [0099]) where the thickness of the layers is selected in order to construct an elongated body having “the desired flexibility and kink resistance requirement” (see [0107]). Therefore, the thickness of the outer layer is disclosed as a result effective variable in that changing the thickness of the outer layer would changes the flexibility and kink resistance of the device. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Walters, McNamara, and Fujieda by making the outer layer comprises up to about 10% of an outer diameter of the flexible elongated body 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 16, Walters, McNamara, and Fujieda fail to expressly teach the outer layer comprises between about 3% and 8% of an outer diameter of the flexible elongated body.
Garrison, in the same field of art, teaches a related device (105, see Fig. 24A) having an elongated body including an inner core and an outer layer (see [0099]) where the thickness of the layers is selected in order to construct an elongated body having “the desired flexibility and kink resistance requirement” (see [0107]). Therefore, the thickness of the outer layer is disclosed as a result effective variable in that changing the thickness of the outer layer would changes the flexibility and kink resistance of the device. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Walters, McNamara, and Fujieda by making the outer layer comprises up to about 3% and 8% of an outer diameter of the flexible elongated body 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 17, Walters, McNamara, and Fujieda fail to expressly teach the inner core comprises between about 20% and 35% of an outer diameter of the flexible elongated body.
Garrison, in the same field of art, teaches a related device (105, see Fig. 24A) having an elongated body including an inner core and an outer layer (see [0099]) where the thickness of the layers is selected in order to construct an elongated body having “the desired flexibility and kink resistance requirement” (see [0107]). Therefore, the thickness of the inner core is disclosed as a result effective variable in that changing the thickness of the inner core would changes the flexibility and kink resistance of the device. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Walters, McNamara, and Fujieda by making the inner core comprises between about 20% and 35% of an outer diameter of the flexible elongated body 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 18, Walters, McNamara, and Fujieda fail to expressly teach the inner core comprises between about 25% and 30% of an outer diameter of the flexible elongated body.
Garrison, in the same field of art, teaches a related device (105, see Fig. 24A) having an elongated body including an inner core and an outer layer (see [0099]) where the thickness of the layers is selected in order to construct an elongated body having “the desired flexibility and kink resistance requirement” (see [0107]). Therefore, the thickness of the inner core is disclosed as a result effective variable in that changing the thickness of the inner core would changes the flexibility and kink resistance of the device. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Walters, McNamara, and Fujieda by making the inner core comprises between about 25% and 30% of an outer diameter of the flexible elongated body 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
THIS ACTION IS MADE FINAL. 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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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771