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 .
Notice of Withdrawal of Finality
The finality of the rejection of the last Office action has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 8, the new matter is “wherein the dilator section of the needle being configured to dilate the tissue after it is punctured renders a separate dilator unnecessary”. The specification makes no mention that the dilator section would render a separate dilator unnecessary.
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 1-4, 7-11, 13, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al (U.S. Pub. 2015/0290431 A1, hereinafter “Hall”) in view of Tsyrulnykov et al (U.S. Pat. 9,364,603 B2, hereinafter “Tsyrulnykov”).
Regarding claim 1, Hall discloses an introducer tool, comprising:
a housing 142 (see Fig. 6; the housing may be alternately referred to as 42 in other figures and in this action) including a guidewire actuating mechanism (including a handle 148; see Fig. 6) configured to extend and retract a guidewire 60 (see Fig. 6) fixed to the guidewire actuating mechanism (see para [0042] disclosing “The housing 142 of the needle retraction assembly 140 further includes a handle 148 for selectively advancing the guidewire 60 through the needle 30”);
a sheath 12 (see Fig. 6) including a handle 14 (see Fig. 6), wherein the sheath 12 is detachably coupled to the housing 142 in a first configuration of the introducer tool configured for venous introduction of the sheath (see Fig. 6, showing the sheath 12 coupled to the housing 142 via a hub 22; Fig. 4A also illustrates the first configuration); and
a needle 30 (see Fig. 6) fixed to the housing (via a needle retraction assembly 140 in the housing), wherein a terminal length 30B (see Fig. 6) of the needle 30 extends past an end portion of the sheath 12 in the first configuration of the introducer tool (see Fig. 6, showing the needle portion 30B extending out of the distal end of the sheath 12; see also Fig. 4A).
It is noted that Hall shows a terminal length of the needle includes a beveled section (i.e., a sharp pointed tip at a bevel), but does not appear to disclose that the terminal length of the needle includes a dilator section proximal of the beveled portion.
Tsyrulnykov discloses a vascular access device comprising a cannulation needle 40 (see Fig. 7C), the needle including a beveled section 42 and an internal dilator 45 disposed proximal of the beveled section (see Fig. 7C; see also col. 8, lines 5-7, disclosing that the cannulation needle 40 has an attached internal dilator 45; and see col. 10, lines 28-32, disclosing that the dilator 45 may be attached to or integral with the cannulation needle 40).
A skilled artisan would have found it obvious to modify the device of Hall so that the terminal length of the needle includes a dilator section proximal of the beveled section, as taught by Tsyrulnykov, in order to increase the diameter of the access opening while minimizing trauma to the access point during vascular access (see Tsyrulnykov at col. 10, lines 45-47). Such a modification would also have been expected to provide less traumatic cannulation, less pain, and more gentle distension of tissue during the cannulation process (see Tsyrulnykov at col. 10, lines 55-59 and col. 11, lines 24-30).
Regarding claim 2, Hall discloses a needle-safety mechanism including a needle-safety housing (the distal end of a body 16, shown in Fig. 3C and 4D) configured to enclose the terminal length of the needle in a second configuration of the introducer tool subsequent to the venous introduction of the sheath (see Fig. 4E), wherein a transition from the first configuration to the second configuration of the introducer tool includes withdrawal of the needle from the sheath 12 (see Fig. 4E, showing the needle completely withdrawn from the sheath 12).
Regarding claim 3, Hall discloses that the sheath 12 is a pullable sheath configured to be pulled for removal of the sheath subsequent to the venous introduction of the sheath (although the removal of the sheath subsequent to its venous introduction is not explicitly disclosed, the sheath 12 nonetheless has a handle 14 allowing the sheath 12 to be pulled completely out of the vein at the end of a procedure).
Regarding claim 4, Hall discloses that the sheath 12 is a peelable sheath configured to peel apart from the handle to the terminal length of the sheath (see para [0019], disclosing the sheath 12 as being “splittable”).
Regarding claim 7, Hall discloses that the terminal length of the needle includes a beveled section 140 (see Fig. 7A-7C) which is understood to be able to puncture tissue. The limitation “the dilator section of the needle is configured to dilate the tissue after it is punctured to accommodate an 8-French catheter” recites the intended use of the dilator and does not appear to impart any structural limitation on the dilator itself, for example its diameter or any other dimensional characteristics. A skilled artisan could puncture the skin with the introducer and then perform repeated punctures to dilate the tissue to accommodate an 8-French catheter.
Regarding claim 8, Hall, in view of Tsyrulnykov, discloses that dilator section of the needle being configured to dilate the tissue after it is punctured renders a separate dilator unnecessary (see Tsyrulnykov at col. 10, lines 45-47 and col. 11, lines 24-30, disclosing that the internal dilator enlarges the access opening while gently distending tissue during cannulation. A person of ordinary skill in the art would have understood that incorporating the dilator into the needle eliminates the need for a separate dilating step or separate dilator).
Regarding claim 9, Hall discloses a method for venous access, comprising:
obtaining a venous introducer tool including a housing 142 (see Fig. 6; the housing may be alternately referred to as 42 in other figures and in this action) including a guidewire actuating mechanism (including a handle 148; see Fig. 6) configured to extend and retract a guidewire 60 (see Fig. 6) fixed to the guidewire actuating mechanism (see para [0042] disclosing “The housing 142 of the needle retraction assembly 140 further includes a handle 148 for selectively advancing the guidewire 60 through the needle 30”);
a sheath 12 (see Fig. 6) including a handle 14 (see Fig. 6), wherein the sheath 12 is detachably coupled to the housing 142 in an initial configuration of the introducer tool (see Fig. 6, showing the sheath 12 coupled to the housing 142 via a hub 22; Fig. 4A also illustrates the first configuration); and
a needle 30 (see Fig. 6) fixed to the housing (via a needle retraction assembly 140 in the housing), wherein a terminal length 30B (see Fig. 6) of the needle 30 extends past a terminal length of the sheath 12 in the initial configuration of the introducer tool (see Fig. 6, showing the needle portion 30B extending out of the distal end of the sheath 12; see also Fig. 4A);
puncturing a vein of a patient with the needle of the introducer tool to gain venous access by way of a puncture (see Fig. 4A);
extending the guidewire into the vein past the terminal length of the needle with the guidewire actuating mechanism; and introducing the sheath into the vein by sliding the sheath over the guidewire (see para [0034], disclosing that “[o]nce the vessel 64 has been accessed [by the needle], the guidewire 60 can be manually advanced by the user through the housing 42 of the needle retraction assembly and the needle 30 so as to extend into the vessel lumen; this advancement is understood to occur via the guidewire actuating mechanism described above); and
introducing the sheath into the vein by sliding the sheath 12 over the guidewire (see Fig. 4E and para [0037] disclosing that “the dilator 20 and introducer 12 can be further advanced distally into the vessel 64 until inserted to the desired extent within the vessel”; this movement is understood to occur by sliding the sheath 12 over the guidewire already present within the sheath 12).
It is noted that Hall shows a terminal length of the needle includes a beveled section (i.e., a sharp pointed tip at a bevel), but does not appear to disclose that the terminal length of the needle includes a dilator section proximal of the beveled portion.
Tsyrulnykov discloses a vascular access device comprising a cannulation needle 40 (see Fig. 7C), the needle including a beveled section 42 and an internal dilator 45 disposed proximal of the beveled section (see Fig. 7C; see also col. 8, lines 5-7, disclosing that the cannulation needle 40 has an attached internal dilator 45; and see col. 10, lines 28-32, disclosing that the dilator 45 may be attached to or integral with the cannulation needle 40).
A skilled artisan would have found it obvious to modify the device of Hall so that the terminal length of the needle includes a dilator section proximal of the beveled section, as taught by Tsyrulnykov, in order to increase the diameter of the access opening while minimizing trauma to the access point during vascular access (see Tsyrulnykov at col. 10, lines 45-47). Such a modification would also have been expected to provide less traumatic cannulation, less pain, and more gentle distension of tissue during the cannulation process (see Tsyrulnykov at col. 10, lines 55-59 and col. 11, lines 24-30).
Regarding claim 10, Hall discloses that the terminal length of the needle includes a beveled section 140 (see Fig. 7A-7C) which is understood to be able to puncture tissue. The limitation “the dilator section of the needle is configured to dilate the tissue after it is punctured to accommodate an 8-French catheter” recites the intended use of the dilator and does not appear to impart any structural limitation on the dilator itself, for example its diameter or any other dimensional characteristics. A skilled artisan could puncture the skin with the introducer and then perform repeated punctures to dilate the tissue to accommodate an 8-French catheter.
Regarding claim 11, Hall discloses activating a needle-safety mechanism including of the introducer tool (the distal end of a body 16, shown in Fig. 3C and 4D) and simultaneously withdrawing the needle from the puncture and enclosing at least the beveled section of the needle in a needle-safety housing of the needle-safety mechanism (see Fig. 4D, showing the needle bevel at needle distal end 30B, completely enclosed within the sheath 12).
Regarding claim 13, Hall discloses inserting one or more medical devices into the vein of the patient through the sheath (see para [0038] disclosing that “a catheter may… be inserted into the vessel 64 through the introducer 12”).
Regarding claims 18 and 19, Hall discloses that the needle is fixed to the housing for withdrawal of the needle from the sheath by the housing (needle 30 is fixed to the housing via a needle retraction assembly 140 in the housing).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Tsyrulnykov, further in view of Fisher et al (U.S. Pub. 2009/0234290 A1, hereinafter “Fisher”).
Regarding claim 5, Hall discloses that the sheath 12 is splittable, but Hall, in view of Tsyrulnykov, does not appear to disclose that the sheath has a pair of longitudinal seams or weakened areas enabling the sheath to peel apart from the handle to the terminal length of the sheath.
Fisher discloses a similar type of splittable or peelable sheath, disclosing score lines 130 formed along opposing sides of a tube portion 132 of the sheath (see Fig. 1 and para [0026]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hall, in view of Tsyrulnykov, according to the teaching in Fisher, by providing a pair of longitudinal seams or weakened areas enabling the sheath to peel apart from the handle to the terminal length of the sheath, in order to facilitate peeling or splitting the sheath apart in two pieces along the seams at the time of the sheath removal from a device that has been inserted through the sheath (as taught in Fisher at para [0026]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Tsyrulnykov, further in view of Lee et al (U.S. Pub. 2010/0130926 A1, hereinafter “Lee”).
Regarding claim 6, it is noted that Hall, in view of Tsyrulnykov, does not appear to disclose that the sheath includes a polymer in which polymer chains of the polymer are longitudinally oriented enabling the sheath to peel apart from the handle to the terminal length of the sheath.
Lee discloses a type of catheter tubing which is formed of a polymer having polymer chains longitudinally oriented so that when the tubing is torn, the rupture is designed to propagate along its longitudinal axis when the (see para [0006]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hall, in view of Tsyrulnykov, according to the teaching in Lee, by including in the sheath a polymer in which polymer chains of the polymer are longitudinally oriented, as a well-known way to enable a rupture of the sheath to propagate along its longitudinal axis with a reasonable expectation of success. This modification would have been expected improve the sheath’s ability to peel apart from its handle (the peeling of which occurs longitudinally as well).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Tsyrulnykov, further in view of McGuckin, Jr et al (U.S. Pat. 6,986,752 B2, hereinafter “McGuckin”).
Regarding claim 12, it is noted that Hall, in view of Tsyrulnykov, does not appear to disclose withdrawing the guidewire while leaving the sheath in place.
McGuckin discloses a typical placement of a catheter system in a subcutaneous vessel, comprising inserting a guidewire through an introducer needle into a cavity (see col. 1, line 65 and leaving it in place; inserting a tear-away sheath and dilator over the guidewire and through the first incision site to provide an access port for a catheter (see col. 2, lines 3-7); and then removing the guidewire, leaving the sheath in place (see col. 2, lines 7-9).
A skilled artisan would have found it obvious at the time of the invention to modify the method of Hall, in view of Tsyrulnykov, in order to withdraw the guidewire while leaving the sheath in place, as taught in McGuckin, as desired when the guidewire is no longer useful in the procedure. Performing the guidewire removal step would have expectedly prevented numerous complications including accidental post-procedure guidewire retention.
Regarding claim 14, Hall discloses that the one or more medical devices include at least a catheter (see para [0038] disclosing that “a catheter may… be inserted into the vessel 64 through the introducer 12”) but Hall, in view of Tsyrulnykov, does not appear to disclose that removing the sheath includes withdrawing the sheath from the vein while the catheter is disposed within the sheath and peeling the sheath apart from the handle to the terminal length of the sheath.
McGuckin discloses a typical placement of a catheter system in a subcutaneous vessel, comprising inserting a guidewire through an introducer needle into a cavity (see col. 1, line 65 and leaving it in place; inserting a tear-away sheath and dilator over the guidewire and through the first incision site to provide an access port for a catheter (see col. 2, lines 3-7); removing the guidewire, leaving the sheath in place (see col. 2, lines 7-9); inserting another catheter through the tear-away sheath (see col. 2, lines 10-12); and then splitting or separating the sheath by pulling tabs on the sheath apart, thereby removing the sheath from the body while leaving the catheter in place (see col. 2, lines 12-27).
Based on the teaching in Hall that the sheath is intended to be a peelable sheath (as mentioned above), a skilled artisan would have found it obvious at the time of the invention to modify the method of Hall, in view of Tsyrulnykov,, in order to remove the sheath by withdrawing the sheath from the vein while the catheter is disposed within the sheath and peeling the sheath apart from the handle to the terminal length of the sheath, as taught in McGuckin, with a reasonable expectation of success in completing the introduction of the catheter safely and effectively.
Response to Arguments
For the purpose of compact prosecution, Applicant’s arguments in the Appeal Brief, filed 04/23/2026 (hereinafter "Brief"), have been considered as they relate to the current rejections.
Applicant reiterated traversal of the rejection of claim 8 under 35 U.S.C. 112(a), for failing to provide written support for the limitation "…wherein the dilator section of the needle being configured to dilate the tissue after it is punctured renders a separate dilator unnecessary." Applicant argued that para [0037] of the specification "is more than sufficient" to show that Applicant was in possession of needle 130 having a dilator section 134 that renders a separate dilator unnecessary (see Brief, pg. 11).
Applicant did not dispute that the claim language at issue is not explicitly described in the written description. Applicant appeared to argue that the specification provides implicit or inherent disclosure of the claim limitation1.
Yet, neither para [0037], nor any other part of the disclosure, provides necessary implicit or inherent disclosure of claim 8. Para [0037] discloses that a needle may or may not include a dilator section 134, and suggests that needles with dilator sections can dilate an opening to a diameter of greater than 8 French proximal to the dilator section. But this paragraph makes no mention of a separate dilator at all, much less rendering such a dilator unnecessary.
Regarding Applicant's argument over the claim rejections under 35 U.S.C. § 103, it is noted that a new ground of rejection has been applied that no longer uses Aman as a teaching reference. The new ground of rejection largely renders Applicant's arguments moot over Aman. However, some arguments in the Brief are believed to be relevant to the new ground of rejection; these are answered below in the interest of compact prosecution.
In the Brief, Applicant did not dispute that Hall already teaches an introducer needle with a bevel, and instead attacked the reference of Aman individually for its alleged lack of disclosure of a needle. Applicant also argued that Hall already includes a dilator and, therefore, there would have been no reason to modify Hall in view of Aman (see Brief, pgs. 14-16). Although the reference of Aman is no longer applied in the rejection, the device of Tsyrulnykov is similar to that of Aman vis-à-vis its disclosure of a bevel used to dilate tissue.
It is reiterated that Hall has a dilator for use in dilating tissue after its needle is inserted (see Final action at pg. 13, citing Hall at para [0021] and para [0030]). Tsyrulnykov's needle is used to dilate tissue upon needle insertion (see rejection, above). Because the dilator sections in Hall and Tsyrulnykov perform two different functions, adding a dilator section to the needle of Hall would not have been superfluous.
Regarding claim 2, Applicant asserted that Hall does not disclose the claimed needle-safety mechanism, asserting that the Examiner improperly mapped Hall's introducer 12 onto both the claimed sheath and the claimed needle-safety mechanism at the same time (see Brief, pgs. 16-17). However, the Final action stated that Hall teaches an introducer sheath 12 and a needle safety mechanism including a needle safety housing (the distal end of a body 16). Although the distal end of a body 16 is part of the introducer sheath 12, the two components are not one and the same.
Conclusion
This action has been made NON-FINAL.
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/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
07/20/2026
1 See MPEP 2163(I)(B): "While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure."
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