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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 23 March 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 8, and dependents thereof, is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 8, Applicant recites the limitation “an axis of symmetry of the valve is parallel to a central axis of the introducer needle…” However, the instant specification lacks antecedent basis for this particular limitation and Applicant has failed to offer any further explanation of its intended scope and meaning in the context of the specification. Applicant offers a general explanation as to why the Liu reference does not meet this limitation, but for the reasons cited below this explanation is not found persuasive given Examiner’s understanding of the broadest reasonable interpretation of the phrase (particularly absent any direction from the specification of any particular interpretation of the phrase). Presumably, this limitation is understood to reference that which is generally illustrated in Fig. 5, which is to say that the valve (146) possesses left/right symmetry about an axis parallel to the central axis when viewed in this direction.
However, given that Liu would also possess such left/right symmetry along an axis when viewed from a similar angle (see generally Fig. 1A) wherein it is understood that an axis that runs parallel to the central axis of the needle (7), in this view, creates left/right symmetry such that the valve with have symmetrical shaped left and right halves. Specifically, the port arm (4) is understood to be provided at the midline of the hub body (2) with the valve (5) disposed centrally within this port line. In the view shown in Fig. 1A, this port arm and valve is understood to be projected into the plane of the page and wherein an axis parallel to the central axis will create left/right symmetry by bisecting the port arm and valve in half.
Examiner offers the illustrated view of Fig. 46A of U.S. Publication No. 2004/0167478 (“Mooney”) as providing an equivalent view which can be annotated (see below) to demonstrate the valve to exhibit this symmetry in the apparent same sense that Applicant’s invention exhibits symmetry (see below). Applicant’s attention is also directed toward Fig. 19 and 20 of Mooney which illustrates an isometric view of the hub construction. As shown in Fig. 20 when the side port and valve construction is bisected along a plane on which the above indicated axis of symmetry lies the valve with be bisected into two mirrored, identical halves demonstrating the necessary “symmetry” of the instant claim limitation. The side arm of Liu will be understood to exhibit equivalent symmetry. As such, it must be understood that Examiner and Applicant have two different understandings of the plain meaning of the instant claim text in light of the instant specification. When such confusion exits without the accompanying specification providing any additional understanding of the instant claim language it must be understood that the associated claim limitations are indefinite as the scope is unclear and were the claim to issue the ordinary artisan would not effectively understand what invention(s) could or could not be made without infringing upon the issued patent.
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Supplemental Figure: Exemplar Axis of Symmetry Showing Left/Right Symmetry for an Angled Side Port/Valve and the Instant Application Along the Same Standard
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 99/59651 (“Liu”).
Regarding Claim 8, Liu discloses an introducer needle (Fig. 1B), comprising:
a needle shaft (7); and
a needle hub (2) over a proximal portion of the needle shaft (see Fig. 1B), the needle hub including:
an opening (9) directly in a side of the needle hub proximal of a proximal end of the needle shaft (see Fig. 1B); and
a valve (5) disposed in the opening and configured to form a fluid-tight seal around an elongate medical device (18) when passed through the port and into a needle- hub lumen of the needle hub, wherein an axis of symmetry of the valve is parallel to a central axis of the introducer needle (see generally Fig. 1A). Specifically, in the view shown in Fig. 1A with the port opening/valve arrangement being shown projecting into the plane of the page (or the reverse of Fig. 1A with the port opening/valve arrangement projecting out of the plane of the page) a left/right axis of symmetry exists for the valve which is parallel to a central axis of the introducer needle (i.e. the valve will be bisected along an axis which lies central along the midline thereby creating two mirrored left/right haves, thereby demonstrating symmetry – see below).
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Supplemental Figure: Rendering of Liu illustrating the reverse shown in Fig. 1A, wherein an axis of symmetry exists for the valve/port opening arrangement that creates left/right symmetry along an axis parallel to the central axis of the needle shaft. The left and right hand halves are mirrored, symmetrical halves of one another.
Regarding Claim 9, Liu discloses the valve includes a split (6) septum (5) compressed in the opening (see Fig. 1B, 1C).
Regarding Claim 10, Liu discloses the needle hub further includes a needle-hub connector (3) including a needle-hub bore proximal of the port (see Fig. 1B), a syringe tip of the syringe disposed in the needle-hub bore, thereby fluidly connecting the needle to the syringe (see Fig. 1B).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP H07303704 (“Okada”).
Regarding Claim 8, Okada discloses an introducer needle (A) comprising:
A needle shaft (2); and
A needle hub (1) over a proximal portion of the needle shaft, the hub including:
An opening (22) in a side of the hub proximal of a proximal end of the needle shaft (see Fig. 5); and
A valve (23) disposed in the opening such that an axis of symmetry of the valve is parallel to a central axis of the introducer needle (see Fig. 5), the valve configured to form a fluid-tight seal about an elongate medical device (via opening 23a) when passed through the opening and into a needle hub lumen of the needle hub (see i.e. the interior of 1 – Fig. 5).
Regarding Claim 9, Okada discloses the valve includes a split-septum (23, 23a) compressed in the opening (see Fig. 5).
Regarding Claim 10, Okada discloses the needle hub further includes a needle hub connector (i.e. the slip-type fitting forming the proximal end of 1 – see generally Fig. 1 or Fig. 7) including a needle-hub bore (i.e. the proximal end of the hub) proximal of the opening configured to accept a syringe tip (e.g. 3a) inserted therein for fluidly connecting the needle to the syringe.
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.
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.
Claim(s) 1, 2, 6, 7, 8, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0221968 (“Ransbury”) in view of JP H07303704 (“Okada”).
Regarding Claims 1 and 8, Ransbury discloses an introducer assembly (see generally Fig. 4C - see also guidewire 204), comprising:
a syringe (140);
a needle (300) fluidly connected to the syringe (see Fig. 4D), the needle including:
a needle shaft (200); and
a needle hub (320) over a proximal portion of the needle shaft (see Fig. 4C), the needle hub including:
a needle-hub connector (103);
a port (130) in a side of the needle hub proximal of a proximal end of the needle shaft (see Fig. 5),
a valve (330) disposed in the port configured to form a fluid-tight seal around an elongate medical device (e.g. 204) when passed through the port and into a needle-hub lumen of the needle hub (see generally Fig. 5D – Par. 79), and
an access guidewire (204) slidably disposed in the introducer assembly in a ready-to-deploy state of the introducer assembly (see generally Fig. 5D), a bare-wire portion of the access guidewire distally extending through the valve such that the valve forms a fluid-tight seal around the bare-wire portion of the access guidewire (see generally Fig. 5D – Par. 79).
Ransbury discloses the invention substantially as claimed except that that the entirety of port is distal to the needle-hub connector without any portion of the port radially extending beyond the needle-hub connector. However, Okada discloses a related introducer assembly (see generally Fig. 1 or 7 – see more particularly Fig. 5) wherein the needle (A) can be provided with a hub (1) having a low-profile port (22 – see Fig. 5) with a valve (23) disposed therein as an alternative to a conspicuously disposed port arm (4).
While Okada does not disclose any particular reason why this particular configuration (see Fig. 5) is utilized over the conspicuous side-arm configuration(s) (see Fig. 1 or 7), the ordinary artisan would reasonably recognize and appreciate that such a configuration creates a low-profile arrangement wherein elimination of the side-arm removes a bulky construction which might impede positioning of the needle or otherwise create a potential hazard upon which clothing or other medical implements might snag during use. Furthermore, Okada clearly establishes the two shape arrangements to be suitable alternatives to one another for the purpose of providing a guidewire entry side-port for a needle hub. It would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the conspicuous side-port arm of the invention of Ransbury with a low profile port arrangement, as disclosed by Okada, in order to reduce the profile the hub and create a smaller, more streamlined hub arrangement which will be understood by the ordinary artisan to improve the ease of positioning the device as well as reducing the snag potential associated with the side-port. It has been held that mere changes in shape of an invention are obvious, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), and that simple substitution of known equivalents to obtain only a predictable and expected outcome is also obvious, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Examiner submits that in affecting such a modification to the invention of Ransbury the resultant construction will be such that the entirety of the port is distal of the needle-hub connector (see generally Fig. 5 – Okada) without any portion of the port radially extending beyond the needle-hub connector (see generally Fig. 5 – Okada and see generally Fig. 4C of Ransbury with consideration of the luer lugs (103) which extends conspicuously from the circumference of the needle hub and that the valve disposed within the port opening in the side of the needle hub will have an access of symmetry which is parallel to a central axis of the introducer needle (see generally Fig. 5, Okada).
Regarding Claim 2, Ransbury discloses the access guidewire passing through the needle-hub lumen (see generally Fig. 5D), through the proximal end of the needle shaft (see generally Fig. 5D), and into a needle-shaft lumen of the needle shaft such that a guidewire tip in a distal portion of the access guidewire is disposed just proximal of a needle tip in a distal portion of the needle shaft (see generally Fig. 5D – particularly during insertion or removal of the guidewire altering the extent to which the guidewire extends through the needle shaft lumen).
Regarding Claims 6 and 9, Ransbury, as modified, discloses the valve includes a split septum compressed in the port (see 330 – Par. 79; see also 23, 23a Okada).
Regarding Claims 7 and 10, Ransbury discloses the needle-hub connector includes a needle-hub bore proximal to the port (see Fig. 4C – i.e. the opening through 103 through which the nose of the syringe is to be received), a syringe tip/nose (see Fig. 4C, i.e. the male luer nose provided generally at 102 – see Par. 15) disposed in the needle-hub bore (see generally Fig. 5D), thereby fluidly connecting the needle to the syringe.
Claim(s) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0221968 (“Ransbury”) in view of JP H07303704 (“Okada”) as applied above, and further in view of U.S. Patent No. 4,781,695 (“Dalton”)
Regarding Claims 21 and 22, Ransbury, as modified, discloses the invention substantially as claimed except that that the port and valve are shaped like an elliptical cylinder with the axis of symmetry of the valve coincident with a major axis of a transverse cross-section of the valve such that the port has a major width and a minor width, and the minor width of the port is commensurate with a width of the needle hub from which the port radially extends. However, Examiner submits that such a shape constitutes a mere obvious design choice whereby without any exposition in the instant specification as to the shape of the port/valve of the instant invention being of any particular importance or solving any particularly stated problem or performing any particular function such a mere change in shape must be understood to be a mere obvious design choice, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Furthermore, Dalton discloses that oval shape septums/ports may be considered beneficial over circular shaped septums/ports inasmuch as an oval shape allows for the major axis of the septum/port to be increased without affecting a corresponding increase in the minor axis (see Col. 2, Ln. 59 – Col.3, Ln. 15) allowing the septum/port to be increased to permit easier access without requiring an increase in the bulk of the hub. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the septum/port of the invention of modified Ransbury to be of an oval construction, the major axis of the septum and port corresponding with the longitudinal axis of the needle hub with the minor axis lying transverse to the longitudinal axis and corresponding to the width of the hub in order to allow for a maximally sized septum/port without requiring any further increases in size/width of the hub which would be necessitated in a circular septum/port configuration.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0221968 (“Ransbury”) in view of JP H07303704 (“Okada”) as applied above, and further in view of JP 2009232917 (“Matsuzawa”).
Regarding Claims 4 and 5, Ransbury discloses the invention substantially as claimed except that the access guidewire includes a wound-wire portion proximal of the bare-wire portion. However, Matsuzawa discloses an access guidewire (20) comprising a distal bare wire portion (see Figs. 7-12 – i.e. the portion extending distally from the introducer tool (12) and a wound-wire portion (i.e. the proximal portion received within the introducer tool) proximal of the bare-wire portion, the wound-wire portion creating, in a read-to-deploy state, a sterile barrier configured to maintain sterility of the access
guidewire received proximally to the needle hub (see “Best-Mode”). It would have been
obvious for one having ordinary skill in the art at the time the invention was made to
provide the device of Ransbury with a proximal, wound-wire portion received within a sterile insertion tool barrier, as disclosed by Matsuzawa, in order to help manage the extra length of the guidewire during insertion while maintaining the sterility of the guidewire during storage and immediately before insertion.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0221968 (“Ransbury”) in view of JP H07303704 (“Okada”) as applied above, and further in view of U.S. Publication No. 2020/0100896 (“Jimenez”).
Regarding Claim 23, Ransbury discloses the invention substantially as claimed except that the needle hub further includes a push- button bleed valve configured for bleeding air into the port while withdrawing the needle from a needle tract of a patient. However, Jimenez discloses a related hub/septum construction (140) which includes a push-button bleed valve (184) which is configured to permit bleeding of air into the port when needed (Par. 78). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the invention of Ransbury with a push-button bleed valve, as disclosed by Jimenez, in order to permit the hub to be vented when desired to break a vacuum when needed including while withdrawing the needle from a needle tract of patient.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument or are not persuasive (see specifically above the provided alternative interpretation of Liu in light of the claims as generally understood in view of Examiner’s concerns of indefiniteness.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 07/31/2026
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