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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submissions filed on 20 April 2026 has been entered.
The Examiner acknowledges the amendments to claims 1 and 15. Claims 1-20 are pending.
Previously Presented Drawing Objections
The Examiner notes that the drawings filed 20 April 2026 would not be accepted, as the particular indication of the position and orientation of the septum 126 as depicted in amended Fig. 1 would be considered new matter not supported by the Applicant’s disclosure [which merely discloses a septum in the fluid port, as opposed to any particular position or orientation]. Upon further consideration, the Examiner has chosen to not maintain the previously presented drawing objections presented in the Final Rejection for reference characters 122 and 126 being used to designate fluid port 120. The drawings filed 17 April 2023 are considered acceptable.
Specification
The amendment filed 10 November 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The amendments to the specification filed 10 November 2025 is considered to recite new matter [“The fluid port 122 includes a septum 126 configured to define a fluid tight seal across the fluid port 122 when the stylet 150 is removed from the needle 110” (Applicant’s Specification ¶0030)], as the Examiner notes that the disclosure as originally filed is only considered to provide support for the stylet port including a septum configured to define a fluid tight seal across the stylet port when the stylet is removed from the needle [see ¶0007 of Specification filed 17 April 2023 and original claim 11] as opposed to the recited “fluid port”, which as depicted in at least Fig. 1 of the Drawings filed 17 April 2023 and as described in at least ¶0030 of the originally filed Specification is coupled to tube 123 as opposed to defining a port for the stylet 150 to extend therethrough.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 101
Examiner’s Note Regarding § 101 Analysis: The Examiner notes that claim(s) 15 recites a judicial exception [“identifying the first location based on the first value of the electrical property” (line 18)] at Step 2A Prong 1, which is considered to be an abstract idea that can be performed in the mind or by hand by merely observing at least a limited amount of known or previously collected data and drawing mental conclusions therefrom based on known or previously derived relationships [Applicant’s Specification ¶¶0037-0040]. However, the Examiner further notes that claim(s) 15 recites limitations directed towards sufficiently particular structure of a provided needle assembly and use thereof [lines 2-17 of claim 15] that is considered to integrate the judicial exception into a practical application at Step 2A Prong 2 and allow the invention to amount to significantly more than the judicial exception at Step 2B.
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) 1-9 and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goyal (US-10791990-B2, previously presented) in view of Ooi (US-20210001042-A1, cited by Applicant, previously presented).
Regarding claim 1, Goyal teaches
A medical needle assembly, comprising:
a needle [elongate sleeve 104A (Goyal Fig. 2)] configured for vascular access of a patient, the needle defining a needle lumen extending between a proximal end and a distal end of the needle [an inner bore 108 of an elongate sleeve 104A. The elongate sleeve can include a first end 112A and a second end 114 (Goyal Col 4:47-49, Figs. 1-2)];
a stylet disposed within the needle lumen [The device 200B can include a stylet 218. The stylet 218 can be located within the needle lumen 116. In an example, the stylet 218 can include a proximal stylet end 226 and a distal stylet end 220 (Goyal Col 8:58-61, Fig. 2)], the stylet including:
a solid core [In a further example, the stylet 218 can include a stylet lumen 222 located between the distal stylet end 220 and the proximal stylet end 226 (Goyal Col 8:66-9:1), wherein the stylet lumen being disclosed as being exemplary and not required (“can include…”) is considered to read on a stylet that includes a solid core (no lumen therethrough)],
wherein:
the needle defines a needle electrode [the stylet 218 can be the first electrode and the elongate sleeve 104A can be the second electrode. In the example of FIG. 2, the elongate sleeve 104A can be the first electrode and the stylet 218 can be the second electrode (Goyal Col 9:24-27)],
the stylet includes a stylet electrode adjacent a distal end of the stylet [Goyal Col 9:24-27], and
the needle and stylet electrodes are configured to enable ascertainment of an electrical property of a body substance adjacent the distal end of the needle [the circuit 124 can provide a unique signal for ligament, fat, and CSF respectively. Accordingly, the indicator 126A can provide a unique output for each signal based on the ligament, fat, and CSF respectively. In other examples, the circuit 124 can also provide a unique signal for blood, bone, or other tissues. The plurality of indicators 126A can provide respective output corresponding to the unique signal for blood, bone, or other tissues (Goyal Col 6:43-50); In the example of FIG. 5, the stylet 218 is the first electrode and the elongate sleeve 104A is the second electrode. The circuit 124 can also be electrically coupled to the at least one indicator 126B. At least one of the indicators 126B can provide an output based on the signal. In the example of FIG. 5, the signal can correspond to the electrical characteristic between the stylet 218 and the elongate sleeve 104A (Goyal Col 10:63-11:3)].
However, while Goyal fails to explicitly disclose that the stylet includes a non-circular cross-sectional shape, Goyal does disclose that an electrically insulative coating extending along a length of the stylet may include a non-circular cross-sectional shape [The polymer needle 102B can be an electrical isolator between the stylet 218 and the elongate sleeve 104A. The polymer needle 102B can be constructed from a dielectric material, for instance, the material of the polymer needle 102A can include, but is not limited to the materials of the polymer needle 102B previously discussed herein (Goyal Col 9:27-33, Fig. 2); An outer surface of the polymer needle 102B can include, but is not limited to, a circular, rectangular, triangular, oval, or other cross sectional shape along the longitudinal axis 201 of the polymer needle 102B (Goyal Col 7:13-16)], and wherein in a separate embodiment, the coating extending along the length of the stylet may act as an electrode [The device 200A can include a first electrode coupled to the polymer needle 102A (Goyal Col 4:54-55)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assembly of Goyal to employ wherein the stylet includes a non-circular cross-sectional shape, as this modification is considered to amount to mere simple substitution of one known element [stylet 218 having a circular cross-sectional shape] for another [electrode element having a non-circular/oval cross-sectional shape] with similar expected results [function as an electrode] [MPEP § 2143(I)(B)]; and may further amount to mere change in shape [In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (MPEP § 2144.04 (IV)(B)].
However, while Goyal discloses that the stylet is removably coupled to the needle [the polymer needle 102B can be removably coupled to the elongate sleeve 104A. For instance, the polymer needle 102B can be removed from the elongate sleeve 104A for sterilization (Goyal Col 8:3-7)], Goyal is silent regarding the entire length of the assembly [Accordingly, the entire length of the device 200B is not illustrated or drawn to scale (Goyal Col 7:10-11)] and fails to explicitly disclose wherein the stylet extends proximally beyond a proximal end of the needle.
Ooi discloses a medical needle assembly, comprising: a catheter defining a catheter electrode and a stylet, disposed within a lumen of the catheter, defining a stylet electrode [The catheter system 300 may also include a first electrode 341 and a second electrode 342. In the embodiment shown in FIG. 3, the catheter lumen 322 may include the first electrode 341, and the introducer needle 330 may include the second electrode 342 (Ooi ¶0057, Fig. 3), wherein the introducer needle 330 is considered to be an equivalent stylet], wherein the stylet extends proximally beyond a proximal end of the catheter [In some embodiments, the needle assembly 12 may include a needle hub 28, which may be removably coupled to the catheter adapter 16. In some embodiments, the needle assembly 12 may include an introducer needle 30. In some embodiments, a proximal end of the introducer needle 30 may be secured within the needle hub 28. In some embodiments, the introducer needle 30 may extend through the catheter 22 when the catheter system 10 is in an insertion position ready for insertion into the vein of a patient, as illustrated, for example, in FIGS. 1A and 1B (Ooi ¶0043, Figs. 1A-B); It is to be understood that any of the embodiments of the present disclosure may be combined together in any number of different ways… As another non-limiting example, the embodiment of FIG. 3 may be combined with any one of (or any combination of) the embodiments of FIGS. 1A-2 and 4-8, and so forth (Ooi ¶0094)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assembly of Goyal to employ wherein the stylet extends proximally beyond a proximal end of the needle, as this modification would amount to mere simple substitution of one known element [stylet of Goyal that is silent as to the length relative to the needle, which the stylet is removably inserted into] for another [stylet as disclosed by Ooi, which extends proximally beyond a proximal end of the catheter, which the stylet is removably inserted into] with similar expected results [providing a stylet defining a stylet electrode that is removably insertable into a tubular instrument] [MPEP § 2143(I)(B)].
Regarding claim 2, Goyal in view of Ooi teaches
The assembly according to claim 1, wherein the stylet is formed of a stainless steel [The first electrode and the second electrode can be constructed from an electrically conductive and biocompatible material including, but not limited to, stainless steel, titanium, or other electrically conductive and biocompatible material (Goyal Col 4:60-64)].
Regarding claim 3, Goyal in view of Ooi teaches
The assembly according to claim 1, wherein the stylet includes an electrically insulative coating extending along a length of the stylet [Goyal Col 9:27-33, Fig. 2].
Regarding claim 4, Goyal in view of Ooi teaches
The assembly according to claim 3, wherein the coating defines a uniform thickness [Goyal Col 9:27-33, Fig. 2, wherein the coating being defined by the needle is considered to read on having a uniform thickness].
Regarding claim 5, Goyal in view of Ooi teaches
The assembly according to claim 1, wherein the non-circular cross-sectional shape extends along an entire length of the stylet [see § 103 modification of claim 1 above; Goyal Col 7:13-16].
Regarding claim 6, Goyal in view of Ooi teaches
The assembly according to claim 1, wherein a major diameter of the non-circular cross-sectional shape extends across the needle lumen [see § 103 modification of claim 1 above; Goyal Col 7:13-16].
Regarding claim 7, Goyal in view of Ooi teaches
The assembly according to claim 6, wherein the needle lumen defines:
a first flow path extending along a first side of the non-circular cross-sectional shape [see § 103 modification of claim 1 above; Goyal Col 7:13-16, wherein it is understood that the modified oval cross-section of the stylet is considered to define a minor diameter axis that may define a first flow path on one side of the stylet and a second flow path on an opposite side of the stylet, as the coating for the stylet (102B, see Goyal Col 9:27-33) is understood to be positioned within an inner bore of the needle (elongate sleeve 104A) (see Goyal Col 7:64-65)], and
a second flow path extending along a second side of the non-circular cross-sectional shape, the second side opposite the first side [see § 103 modification of claim 1 above; Goyal Col 7:13-16, wherein it is understood that the modified oval cross-section of the stylet is considered to define a minor diameter axis that may define a first flow path on one side of the stylet and a second flow path on an opposite side of the stylet, as the coating for the stylet (102B, see Goyal Col 9:27-33) is understood to be positioned within an inner bore of the needle (elongate sleeve 104A) (see Goyal Col 7:64-65)].
Regarding claim 8, Goyal in view of Ooi teaches
The assembly according to claim 6, wherein the non-circular cross-sectional shape includes an oval [see § 103 modification of claim 1 above; Goyal Col 7:13-16].
Regarding claim 9, Goyal in view of Ooi teaches
The assembly according to claim 1, wherein:
the needle includes a needle lead configured to electrically couple the needle electrode to a measurement module [The circuit 124 can be electrically coupled to the first electrode and the second electrode. For instance, the circuit 124 can be connected to the first electrode or the second electrode by at least one wire 142 (Goyal Col 5:11-14)], and
the stylet includes a stylet lead configured to electrically couple the stylet electrode to the measurement module [Goyal Col 5:11-14].
Regarding claim 15, Goyal teaches
A method of accessing a vasculature of a patient, comprising:
providing a needle assembly, comprising:
a needle [elongate sleeve 104A (Goyal Fig. 2)] configured for vascular access of a patient, the needle defining a needle lumen extending between a proximal end and a distal end of the needle [an inner bore 108 of an elongate sleeve 104A. The elongate sleeve can include a first end 112A and a second end 114 (Goyal Col 4:47-49, Figs. 1-2)];
a solid core stylet disposed within the needle lumen, the stylet including a cross-sectional shape extending proximally along a length of the stylet [The device 200B can include a stylet 218. The stylet 218 can be located within the needle lumen 116. In an example, the stylet 218 can include a proximal stylet end 226 and a distal stylet end 220 (Goyal Col 8:58-61, Fig. 2); In a further example, the stylet 218 can include a stylet lumen 222 located between the distal stylet end 220 and the proximal stylet end 226 (Goyal Col 8:66-9:1), wherein the stylet lumen being disclosed as being exemplary and not required (“can include…”) is considered to read on a stylet that includes a solid core (no lumen therethrough)],
wherein:
the needle defines a needle electrode [the stylet 218 can be the first electrode and the elongate sleeve 104A can be the second electrode. In the example of FIG. 2, the elongate sleeve 104A can be the first electrode and the stylet 218 can be the second electrode (Goyal Col 9:24-27)],
the stylet includes a stylet electrode adjacent a distal end of the stylet [Goyal Col 9:24-27], and
the needle and stylet electrodes are configured to enable ascertainment of an electrical property of a body substance adjacent the distal end of the needle [the circuit 124 can provide a unique signal for ligament, fat, and CSF respectively. Accordingly, the indicator 126A can provide a unique output for each signal based on the ligament, fat, and CSF respectively. In other examples, the circuit 124 can also provide a unique signal for blood, bone, or other tissues. The plurality of indicators 126A can provide respective output corresponding to the unique signal for blood, bone, or other tissues (Goyal Col 6:43-50); In the example of FIG. 5, the stylet 218 is the first electrode and the elongate sleeve 104A is the second electrode. The circuit 124 can also be electrically coupled to the at least one indicator 126B. At least one of the indicators 126B can provide an output based on the signal. In the example of FIG. 5, the signal can correspond to the electrical characteristic between the stylet 218 and the elongate sleeve 104A (Goyal Col 10:63-11:3)];
inserting the needle into a first location within the patient [the device 200B can be suitable for insertion into a patient, into tissue samples, or the like (Goyal Col 8:36-37)];
obtaining a first value of an electrical property between the needle and stylet electrodes, the first value defined by a first body substance located at the first location [As previously discussed the circuit 124 can be configured to provide a signal based on the electrical characteristic of the tissue or fluid. Accordingly, the detection system 100A can be adapted to identify the location of the device 200A or 200B within the patient, for example, the location of a portion of the device 200A located between the first electrode and the second electrode (Goyal Col 10:2-8), wherein any first instance of using the assembly of Goyal may read on inserting the needle into a first location]; and
identifying the first location based on the first value of the electrical property [Goyal Col 10:2-8].
However, while Goyal fails to explicitly disclose that the stylet includes a non-circular cross-sectional shape, Goyal does disclose that an electrically insulative coating extending along a length of the stylet may include a non-circular cross-section [The polymer needle 102B can be an electrical isolator between the stylet 218 and the elongate sleeve 104A. The polymer needle 102B can be constructed from a dielectric material, for instance, the material of the polymer needle 102A can include, but is not limited to the materials of the polymer needle 102B previously discussed herein (Goyal Col 9:27-33, Fig. 2); An outer surface of the polymer needle 102B can include, but is not limited to, a circular, rectangular, triangular, oval, or other cross sectional shape along the longitudinal axis 201 of the polymer needle 102B (Goyal Col 7:13-16)], and wherein in a separate embodiment, the coating extending along the length of the stylet may act as an electrode [The device 200A can include a first electrode coupled to the polymer needle 102A (Goyal Col 4:54-55)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Goyal to employ a stylet that includes a non-circular cross-sectional shape, as this modification is considered to amount to mere simple substitution of one known element [stylet 218 having a circular cross-section] for another [electrode element having an oval cross-section] with similar expected results [function as an electrode] [MPEP § 2143(I)(B)]; and may further amount to mere change in shape [In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (MPEP § 2144.04 (IV)(B)].
However, while Goyal discloses that the stylet is removably coupled to the needle [the polymer needle 102B can be removably coupled to the elongate sleeve 104A. For instance, the polymer needle 102B can be removed from the elongate sleeve 104A for sterilization (Goyal Col 8:3-7)], Goyal is silent regarding the entire length of the assembly [Accordingly, the entire length of the device 200B is not illustrated or drawn to scale (Goyal Col 7:10-11)] and fails to explicitly disclose the stylet extending proximally beyond a proximal end of the needle.
Ooi discloses a medical needle assembly, comprising: a catheter defining a catheter electrode and a stylet, disposed within a lumen of the catheter, defining a stylet electrode [The catheter system 300 may also include a first electrode 341 and a second electrode 342. In the embodiment shown in FIG. 3, the catheter lumen 322 may include the first electrode 341, and the introducer needle 330 may include the second electrode 342 (Ooi ¶0057, Fig. 3), wherein the introducer needle 330 is considered to be an equivalent stylet], wherein the stylet extends proximally beyond a proximal end of the catheter [In some embodiments, the needle assembly 12 may include a needle hub 28, which may be removably coupled to the catheter adapter 16. In some embodiments, the needle assembly 12 may include an introducer needle 30. In some embodiments, a proximal end of the introducer needle 30 may be secured within the needle hub 28. In some embodiments, the introducer needle 30 may extend through the catheter 22 when the catheter system 10 is in an insertion position ready for insertion into the vein of a patient, as illustrated, for example, in FIGS. 1A and 1B (Ooi ¶0043, Figs. 1A-B); It is to be understood that any of the embodiments of the present disclosure may be combined together in any number of different ways… As another non-limiting example, the embodiment of FIG. 3 may be combined with any one of (or any combination of) the embodiments of FIGS. 1A-2 and 4-8, and so forth (Ooi ¶0094)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Goyal to employ a the stylet extending proximally beyond a proximal end of the needle, as this modification would amount to mere simple substitution of one known element [stylet of Goyal that is silent as to the length relative to the needle, which the stylet is removably inserted into] for another [stylet as disclosed by Ooi, which extends proximally beyond a proximal end of the catheter, which the stylet is removably inserted into] with similar expected results [providing a stylet defining a stylet electrode that is removably insertable into a tubular instrument] [MPEP § 2143(I)(B)].
Regarding claim 16, Goyal in view of Ooi teaches
The method according to claim 15, wherein:
the stylet is formed of a stainless steel [Goyal Col 4:60-64],
the stylet includes an electrically insulative coating extending along a length of the stylet [Goyal Col 9:27-33, Fig. 2], and
the coating defines a uniform thickness [Goyal Col 9:27-33, Fig. 2, wherein the coating being defined by the needle is considered to read on having a uniform thickness].
Regarding claim 17, Goyal in view of Ooi teaches
The method according to claim 16, further comprising:
inserting the needle into a second location within the patient, the second location different from the first location [Goyal Col 10:2-8, wherein any second instance of using the assembly of Goyal may read on inserting the needle into a second location, wherein the charts 300 and 326 of Figs. 3A-B indicating different electrical characteristics of different locations further indicates that the assembly of Goyal may be inserted into different locations];
obtaining a second value of the electrical property between the needle and stylet electrodes, the second value defined by a second body substance located at the second location [Goyal Col 10:2-8]; and
identifying the second location based on the second value of the electrical property [Goyal Col 10:2-8].
Regarding claim 18, Goyal in view of Ooi teaches
The method according to claim 15, wherein the non-circular cross-sectional shape defines a flow path extending along the needle lumen [see § 103 modification of claim 1 above; Goyal Col 7:13-16, wherein it is understood that the modified oval cross-section of the stylet is considered to define a minor diameter axis that may define a flow path about the stylet, as the coating for the stylet (102B, see Goyal Col 9:27-33) is understood to be positioned within an inner bore of the needle (elongate sleeve 104A) (see Goyal Col 7:64-65)].
Claim(s) 10-11 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goyal in view of Ooi, as applied to claims 7 and 18 above, in further view of Burkholz (US-11097083-B2, previously presented).
Regarding claim 10, Goyal in view of Ooi teaches
The assembly according to claim 7, wherein the needle includes a hub [In the example of FIG. 5, the detection system 100B includes a plurality of indicators 126B located within a housing 502. The device 200B can also be coupled to the housing 502 (Goyal Col 10:57-60, Fig. 5)].
However, while Goyal discloses in a separate embodiment: a fluid port operatively connected to fluid flow paths defined by elements within the needle to allow for fluid withdrawal through the needle [the polymer needle 102A can be fluidly coupled to an apparatus 144 for administering a therapeutic treatment or extracting a fluid or a tissue sample from the patient for diagnostic purposes. The apparatus 144 can include a syringe, a catheter, or the like (Goyal Col 6:51-55, Fig. 1)], Goyal fails to explicitly disclose wherein the hub comprises a fluid port in fluid communication with at least one of the first or second flow paths, and a stylet port configured to receive the stylet therethrough,
Ooi discloses a catheter hub [catheter adapter 16 (Ooi Figs. 1A-B)] comprising: a fluid port in fluid communication with at a flow path defined by a lumen of the catheter while the stylet is disposed therein [the catheter system 10 may include an extension tube 34. In some embodiments, a distal end of the extension tube 34 may be coupled the catheter adapter 16 and a proximal end of the extension tube 34 may be coupled to an adapter 36 (Ooi ¶0044, Figs. 1A-B)], and a stylet port configured to receive the stylet therethrough [a catheter adapter 16, which may include a distal end 18, a proximal end 20 (Ooi ¶0042, Figs. 1A-B), wherein as depicted in Ooi Figs. 1A-B, the proximal end 20 is configured to receive the needle 30 therethrough].
Burkholz discloses systems for facilitating intravenous instrument delivery, wherein Burkholz discloses a catheter hub [catheter adapter 14 (Burkholz Figs. 1A-C)] comprising a fluid port in fluid communication with a flow path defined by a lumen of a catheter [second or side port 24 (Figs. 1A-C, 3A-C); the extension tube 28 extending from the second or side port 24 of the catheter adapter 14 (Burkholz Col 14:1-3)], wherein the catheter is configured to removably receive a stylet within the catheter lumen [an introducer needle 26 may be withdrawn through the catheter adapter 14 after insertion of the catheter 12 into the vasculature of a patient. In the integrated or closed IV catheter system, when the introducer needle 26 is withdrawn through the catheter adapter 14, the first lumen 20a, which may correspond to a “needle channel,” may be closed off by the septum 18 from an external environment surrounding the catheter adapter 14. Thus, the septum 18 may prevent fluid from exiting the catheter adapter 14 through the first port 20a (Burkholz Col 7:13-23, Figs. 1A-2C)]; and a stylet port configured to receive the stylet therethrough, the stylet port defining a fluid tight seal with a cross-sectional shape of the stylet [the first port 22 may form the first lumen 20a… the septum 18 and/or the septum housing 16 may be disposed in the first lumen 20a (Burkholz Col 7:2-3, 9-10); Burkholz Col 7:13-23, Figs. 1A-2C].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assembly of Goyal in view of Ooi to employ a fluid port in fluid communication with at least one of the first or second flow paths, and a stylet port configured to receive the stylet therethrough, the stylet port defining a fluid tight seal with the non-circular shape, so as to allow for bodily fluid collection [a blood collection device (not shown) may be coupled to the adapter 36 to withdraw blood from the patient via the catheter 22 inserted in the vein (Ooi ¶0045); a fluid pathway of the catheter assembly 10 during fluid infusion and/or blood withdrawal may extend through the second port 20b (Burkholz Col 7:23-25)], as Goyal suggests positioning the assembly in a location of a body to allow for bodily fluid collection [Goyal Col 6:51-55]; and to prevent accidental leakage [Burkholz Col 7:13-23].
Regarding claim 11, Goyal in view of Ooi and Burkholz teaches
The assembly according to claim 10, wherein:
the stylet is configured for removal from the needle [the polymer needle 102B can be removably coupled to the elongate sleeve 104A. For instance, the polymer needle 102B can be removed from the elongate sleeve 104A for sterilization (Goyal Col 8:3-7), wherein the coating 102B for the stylet 218 being removable from the needle (elongate sleeve 104A) is considered to read on the stylet 218 also being removable from the needle], and
the stylet port includes a septum configured to define a fluid tight seal across the stylet port when the stylet is removed from the needle [see § 103 modification to claim 10 above; Burkholz Col 7:13-23, Figs. 1A-2C].
Regarding claim 19, Goyal in view of Ooi teaches
The method according to claim 18, wherein the needle includes a hub [In the example of FIG. 5, the detection system 100B includes a plurality of indicators 126B located within a housing 502. The device 200B can also be coupled to the housing 502 (Goyal Col 10:57-60, Fig. 5)].
However, while Goyal discloses in a separate embodiment: a fluid port operatively connected to fluid flow paths defined by elements within the needle to allow for fluid withdrawal through the needle [the polymer needle 102A can be fluidly coupled to an apparatus 144 for administering a therapeutic treatment or extracting a fluid or a tissue sample from the patient for diagnostic purposes. The apparatus 144 can include a syringe, a catheter, or the like (Goyal Col 6:51-55, Fig. 1)], Goyal fails to explicitly disclose wherein the hub comprises a fluid port in fluid communication with at least one of the first or second flow paths, and a stylet port configured to receive the stylet therethrough,
Ooi discloses a catheter hub [catheter adapter 16 (Ooi Figs. 1A-B)] comprising: a fluid port in fluid communication with at a flow path defined by a lumen of the catheter while the stylet is disposed therein [the catheter system 10 may include an extension tube 34. In some embodiments, a distal end of the extension tube 34 may be coupled the catheter adapter 16 and a proximal end of the extension tube 34 may be coupled to an adapter 36 (Ooi ¶0044, Figs. 1A-B)], and a stylet port configured to receive the stylet therethrough [a catheter adapter 16, which may include a distal end 18, a proximal end 20 (Ooi ¶0042, Figs. 1A-B), wherein as depicted in Ooi Figs. 1A-B, the proximal end 20 is configured to receive the needle 30 therethrough].
Burkholz discloses systems for facilitating intravenous instrument delivery, wherein Burkholz discloses a catheter hub [catheter adapter 14 (Burkholz Figs. 1A-C)] comprising a fluid port in fluid communication with a flow path defined by a lumen of a catheter [second or side port 24 (Figs. 1A-C, 3A-C); the extension tube 28 extending from the second or side port 24 of the catheter adapter 14 (Burkholz Col 14:1-3)], wherein the catheter is configured to removably receive a stylet within the catheter lumen [an introducer needle 26 may be withdrawn through the catheter adapter 14 after insertion of the catheter 12 into the vasculature of a patient. In the integrated or closed IV catheter system, when the introducer needle 26 is withdrawn through the catheter adapter 14, the first lumen 20a, which may correspond to a “needle channel,” may be closed off by the septum 18 from an external environment surrounding the catheter adapter 14. Thus, the septum 18 may prevent fluid from exiting the catheter adapter 14 through the first port 20a (Burkholz Col 7:13-23, Figs. 1A-2C)]; and a stylet port configured to receive the stylet therethrough, the stylet port defining a fluid tight seal with a cross-sectional shape of the stylet [the first port 22 may form the first lumen 20a… the septum 18 and/or the septum housing 16 may be disposed in the first lumen 20a (Burkholz Col 7:2-3, 9-10); Burkholz Col 7:13-23, Figs. 1A-2C].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Goyal in view of Ooi to employ a fluid port in fluid communication with at least one of the first or second flow paths, and a stylet port configured to receive the stylet therethrough, the stylet port defining a fluid tight seal with the non-circular shape to comprise the hub, so as to allow for bodily fluid collection [a blood collection device (not shown) may be coupled to the adapter 36 to withdraw blood from the patient via the catheter 22 inserted in the vein (Ooi ¶0045); a fluid pathway of the catheter assembly 10 during fluid infusion and/or blood withdrawal may extend through the second port 20b (Burkholz Col 7:23-25)], as Goyal suggests positioning the assembly in a location of a body to allow for bodily fluid collection [Goyal Col 6:51-55]; and to prevent accidental leakage [Burkholz Col 7:13-23].
Regarding claim 20, Goyal in view of Ooi and Burkholz teaches
The method according to claim 19.
However, Goyal in view of Ooi and Burkholz as presently modified fails to explicitly disclose wherein the fluid port is coupled with a syringe via a tube, the method further comprising: drawing blood through the flow path and into the tube; and observing blood within the tube to confirm placement of the needle within the vasculature.
Goyal discloses the use of a syringe to draw blood [extracting a fluid or a tissue sample from the patient for diagnostic purposes. The apparatus 144 can include a syringe, a catheter, or the like (Goyal Col 6:53-55, Fig. 1)]. Ooi and Burkholz each respectively disclose wherein the fluid port of the hub is coupled with a blood collection device via a tube, wherein blood is drawn through the flow path and into the tube and blood is observed within the tube to confirm placement of the needle within the vasculature [a blood collection device (not shown) may be coupled to the adapter 36 to withdraw blood from the patient via the catheter 22 inserted in the vein (Ooi ¶0045, Figs. 1A-B); a fluid pathway of the catheter assembly 10 during fluid infusion and/or blood withdrawal may extend through the second port 20b… the second lumen 20b of the catheter adapter 14 may be connectable to blood withdrawal or infusion means via an extension tube 28 that may extend from the second port 20b of the catheter adapter 14 (Burkholz Col 7:23-25, 27-30), wherein collecting blood within a blood collection device coupled via a tube after placement of the catheter within vasculature for blood collection is considered to read on blood being observable within the tube].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Goyal in view of Ooi and Burkholz to employ wherein the fluid port is coupled with a syringe via a tube, the method further comprising: drawing blood through the flow path and into the tube; and observing blood within the tube to confirm placement of the needle within the vasculature, so as to allow for bodily fluid collection [Ooi ¶0045; Burkholz Col 7:23-25, 27-30], as Goyal suggests positioning the assembly in a location of a body to allow for bodily fluid collection [Goyal Col 6:51-55].
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goyal (US-10791990-B2, previously presented).
Regarding claim 12, Goyal teaches
A medical stylet, comprising:
a cross-sectional shape extending along the stylet from a proximal end to a distal end of the stylet [The device 200B can include a stylet 218. The stylet 218 can be located within the needle lumen 116. In an example, the stylet 218 can include a proximal stylet end 226 and a distal stylet end 220 (Goyal Col 8:58-61, Fig. 2)];
an electrode extending across a distal end face of the stylet, the electrode configured to electronically couple with a substance of a patient [the stylet 218 can be the first electrode and the elongate sleeve 104A can be the second electrode. In the example of FIG. 2, the elongate sleeve 104A can be the first electrode and the stylet 218 can be the second electrode (Goyal Col 9:24-27); In a further example, the stylet 218 can include a stylet lumen 222 located between the distal stylet end 220 and the proximal stylet end 226 (Goyal Col 8:66-9:1), wherein the stylet lumen being disclosed as being exemplary and not required (“can include…”) is considered to read on a stylet that includes a distal end face (no lumen therethrough); the circuit 124 can provide a unique signal for ligament, fat, and CSF respectively. Accordingly, the indicator 126A can provide a unique output for each signal based on the ligament, fat, and CSF respectively. In other examples, the circuit 124 can also provide a unique signal for blood, bone, or other tissues. The plurality of indicators 126A can provide respective output corresponding to the unique signal for blood, bone, or other tissues (Goyal Col 6:43-50); In the example of FIG. 5, the stylet 218 is the first electrode and the elongate sleeve 104A is the second electrode. The circuit 124 can also be electrically coupled to the at least one indicator 126B. At least one of the indicators 126B can provide an output based on the signal. In the example of FIG. 5, the signal can correspond to the electrical characteristic between the stylet 218 and the elongate sleeve 104A (Goyal Col 10:63-11:3)];
an electrically insulative coating extending along a length of the stylet so that the electrode is limited to the distal end face [In one example, an adhesive can be disposed between the lumen 116 and the stylet 218 to fixedly couple the stylet 218 within the lumen 116. In a further example, the stylet 218 can be ultrasonically welded or press fit into the lumen 116 (Goyal Col 9:1-5); The polymer needle 102B can be an electrical isolator between the stylet 218 and the elongate sleeve 104A. The polymer needle 102B can be constructed from a dielectric material, for instance, the material of the polymer needle 102A can include, but is not limited to the materials of the polymer needle 102B previously discussed herein… For instance, the distal stylet end 220 and the first end 112A can be aligned so a length of the electrical path 230 is reduced (Goyal Col 9:27-33, 37-39, Fig. 2), wherein as depicted in Goyal Fig. 2, the polymer needle 102B insulates the stylet 218 such that only distal stylet end 220 is exposed to function as the electrode]; and
a stylet lead configured to electrically couple the stylet electrode to a measurement module [The circuit 124 can be electrically coupled to the first electrode and the second electrode. For instance, the circuit 124 can be connected to the first electrode or the second electrode by at least one wire 142 (Goyal Col 5:11-14)].
However, while Goyal fails to explicitly disclose wherein the cross-section shape is non-circular, Goyal does disclose that the electrically insulative coating extending along the length of the stylet may include a non-circular cross-section [Goyal Col 9:27-33, Fig. 2; An outer surface of the polymer needle 102B can include, but is not limited to, a circular, rectangular, triangular, oval, or other cross sectional shape along the longitudinal axis 201 of the polymer needle 102B (Goyal Col 7:13-16)], and wherein in a separate embodiment, the coating extending along the length of the stylet may act as an electrode [The device 200A can include a first electrode coupled to the polymer needle 102A (Goyal Col 4:54-55)], which is considered to disclose electrode functionality of non-circular cross-section shapes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stylet of Goyal to employ a stylet that includes a non-circular cross-sectional shape, as this modification is considered to amount to mere simple substitution of one known element [stylet 218 having a circular cross-section] for another [electrode element having an oval cross-section] with similar expected results [function as an electrode] [MPEP § 2143(I)(B)]; and may further amount to mere change in shape [In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (MPEP § 2144.04 (IV)(B)].
Regarding claim 13, Goyal teaches
The stylet according to claim 12, wherein:
the stylet is formed of a stainless steel [Goyal Col 4:60-64], and
the coating defines a uniform thickness [Goyal Col 9:27-33, Fig. 2, wherein the coating being defined by the needle is considered to read on having a uniform thickness].
Regarding claim 14, Goyal teaches
The stylet according to claim 12, wherein:
the stylet is configured for insertion within a lumen of a vascular access needle [Goyal Col 8:58-61, Fig. 2],
a major diameter of the non-circular shape extends across the lumen [see § 103 modification of claim 12 above; Goyal Col 7:13-16], and
the lumen defines:
a first flow path extending along a first side of the non-circular shape [see § 103 modification of claim 1 above; Goyal Col 7:13-16, wherein it is understood that the modified oval cross-section of the stylet is considered to define a minor diameter axis that may define a first flow path on one side of the stylet and a second flow path on an opposite side of the stylet, as the coating for the stylet (102B, see Goyal Col 9:27-33) is understood to be positioned within an inner bore of the needle (elongate sleeve 104A) (see Goyal Col 7:64-65)], and
a second flow path extending along a second side of the non-circular shape, the second side opposite the first side [see § 103 modification of claim 1 above; Goyal Col 7:13-16, wherein it is understood that the modified oval cross-section of the stylet is considered to define a minor diameter axis that may define a first flow path on one side of the stylet and a second flow path on an opposite side of the stylet, as the coating for the stylet (102B, see Goyal Col 9:27-33) is understood to be positioned within an inner bore of the needle (elongate sleeve 104A) (see Goyal Col 7:64-65)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 8, filed 20 April 2026, with respect to previously presented Drawing Objections have been fully considered but are moot. See corresponding Previously Presented Drawing Objections section above, wherein the Examiner notes that the previously presented drawing objections are not maintained and the Drawings filed 17 April 2023 are considered acceptable.
Applicant’s arguments, see Applicant’s Remarks p. 8, with respect to the previously presented Claim Objections have been fully considered and are persuasive. The objection to claim 15 has been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 8-11, with respect to the previously applied rejections of claims 1, 12, 15, and those dependent therefrom under § 103 have been fully considered but they are not persuasive.
Regarding independent claims 1 and 15, the Applicant asserts that Goyal and Ooi fail to teach, individually or in combination, the amended subject matter of claim 1 of “the stylet including […] a solid core”, wherein the Applicant notes that Goyal teaches that the stylet 218 includes a lumen 222 as opposed to a solid core. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that Goyal discloses that the lumen 222 of stylet 218 is considered to be exemplary and not required [In a further example, the stylet 218 can include a stylet lumen 222 located between the distal stylet end 220 and the proximal stylet end 226 (Goyal Col 8:66-9:1), wherein the stylet lumen being disclosed as being exemplary and not required (“can include…”) is considered to read on a stylet that includes a solid core (no lumen therethrough)], such that Goyal teaches a solid core stylet.
Regarding independent claims 1 and 15, the Applicant asserts that Goyal is silent regarding the outside diameter of the stylet 218 in relation to the inside diameter of lumen 116, and further notes that Fig. 2 of Goyal illustrates the outside diameter of the stylet 218 and inside diameter of lumen 116 as a single line, and therefore, absent any description otherwise, one of ordinary skill would understand that stylet 218 completely fills the lumen 116 and that lumen 222 of the stylet 218 in Fig. 2 replaces the lumen 116 of polymer needle 102A of Fig. 1 to define the flowpath to apparatus 144. The Applicant further notes that any modification to the assembly of Goyal that removes lumen 222 of stylet 218 would eliminate the flow path and destroy the intended purpose of Goyal. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that while Goyal depicts several embodiments of the elongate sleeve having a circular cross section [Goyal Fig. 4-7], Goyal only explicitly discloses the polymer needle 102B as having an ovular cross-sectional shape, among other non-circular shapes [An outer surface of the polymer needle 102B can include, but is not limited to, a circular, rectangular, triangular, oval, or other cross sectional shape along the longitudinal axis 201 of the polymer needle 102B (Goyal Col 7:13-16)], such that the Applicant’s interpretation that the stylet 218 as modified would completely fill lumen 216 would be improper [based on the understanding that a non-circular cross-sectional shape cannot entirely fill a circular cross-sectional shape that the non-circular cross-sectional shape resides within].
Regarding independent claim 12, the Applicant notes that in the previously presented Response to Arguments, the Examiner alleges that Goyal teaches the “electrically insulative coating” by citing Goyal Col 9:1-5, which states that “In one example, an adhesive can be disposed between the lumen 116 and the stylet 218 to fixedly couple the stylet 218 within the lumen 116”, as teaching that the adhesive is disposed along the length of lumen 116, which the Applicant disagrees with. The Applicant further notes that Goyal is silent regarding any position of the adhesive along the length of lumen 116, and therefore does not explicitly teach that the adhesive is disposed along the length of lumen 116 and moreover does not provide any description of what it means to fixedly couple the stylet 218 within lumen 116. As such, the Applicant asserts that one of ordinary skill in the art would interpret fixedly coupling the stylet 218 within lumen 116 to meant that longitudinal displacement of the stylet 218 within lumen 116 is prevented, and that preventing longitudinal displacement of stylet 218 within lumen 116 does not require the adhesive to be disposed along the entire length of lumen 116, such that the adhesive cannot be interpreted as reading on the “electrically insulative coating” of claim 12 and that Goyal does not teach “an electrically insulative coating extending along a length of the stylet so that the electrode is limited to the distal end face” as required by claim 12. However, the Examiner notes that the Applicant’s argument does not appear to have acknowledged the additional citations and Examiner’s analysis of Goyal as previously presented on p. 22 of the Final Rejection dated 23 February 2026, wherein the Examiner further cites Goyal Col 9:27-33, 37-39, and Fig. 2, wherein the “electrically insulate coating” is not considered to be read on by the adhesive of Goyal, but instead by the polymer needle 102B, which is explicitly cited as being an electrical insulator and is depicted as being along an entire length of the stylet 218. The portions regarding the fixed coupling between the stylet 218 and the polymer needle 102B was to emphasize that the needle 102B covers the stylet to limit the electrode to the distal end face of the stylet 218. Furthermore, as Goyal discloses that lumen 222 of the stylet 218 is considered to be exemplary and not required [Goyal Col 8:66-9:1, see Examiner’s Response to Arguments with respect to the arguments presented against the § 103 rejections of claims 1 and 15 above], the polymer needle 102B is considered to define an electrically insulative coating extending along a length of stylet 218 so that the electrode defined by stylet 218 is limited to the distal end face of stylet 218 similar to the argued claim language.
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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