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 .
Election/Restrictions
Claims 23-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups 2-3, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/22/2026.
Applicant’s election without traverse of Group 1, claims 1-22, in the reply filed on 01/22/2026 is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “spring clamp” of claim 14 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 19 is objected to because of the following informalities:
Regarding claim 19, the phrase “and the needle is configured to extend from the distal end of the catheter tube, as the piston is moved axially…“ in lines 2-3 should read “and the needle is configured to extend form the distal end of the catheter tube[[,]] as the piston is moved axially” to remove the comma for proper grammar.
Appropriate correction is required.
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.
Claims 12-13 and 21-22 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 12, the phrase “wherein another electrode is disposed on a part of the subject’s body” in lines 1-2 renders the claim indefinite because it is unclear. Claim 12 is dependent upon claim 1 which is directed towards an injection catheter. Thus, it is unclear if this other electrode is a component of the injection catheter or a separate component of an unintroduced system. Examiner is interpreting this limitation as the injection catheter is a part of a system with another electrode configured to be disposed on a part of the patient’s body.
Regarding claim 21, the phrase “wherein inserting the needle into the myocardial tissue increases the impedance” in lines 1-2 renders the claim indefinite because it is unclear. It is unclear because the claim is drawn to the result of a method step while the claims are drawn to a device. Thus, it is unclear how the result of claim 21 impacts the structure of the claimed device. Examiner is interpreting this limitation as the structure of the injection catheter must be capable of being configured to insert the needle into the myocardial tissue.
Regarding claim 22, the phrase “wherein a fluid is injected via the injection catheter into the myocardial tissue when the impedance begins to decrease” in lines 1-2 renders the claim indefinite because it is unclear. It is unclear because the claim is drawn to the result of a method step while the claims are drawn to a device. Thus, it is unclear how the result of claim 22 impacts the structure of the claimed device. Examiner is interpreting this limitation as the structure of the injection catheter must be capable of being configured to injection a fluid when the impedance begins to decrease.
Regarding claim 13, this claim is rejected due to its dependency upon claim 12.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 12-13 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 12 recites “wherein another electrode is disposed on a part of the subject’s body” which positively recites the human body. Examiner is interpreting this limitation as the other electrode is configured to be disposed on a part of the subject’s body.
Regarding claim 13, this claim is rejected due to its dependency upon claim 12.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 and 7-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mickley et al. (U.S Patent Pub. No. 20070225610 A1, "Mickley").
Regarding claim 1, Mickley discloses (Claim 1) an injection catheter (14 in Fig. 1 and 5) comprising:
a catheter tube (18 in Fig. 1 and 5);
a needle (52 in Fig. 5) disposed in the catheter tube (18, see Fig. 1 and 5), wherein the needle (52) is retractable (see Fig. 2A-2C and para. 0022), is configured to extend from a distal end (15) of the catheter tube (18) into a myocardial tissue (46) of a subject (see Fig. 2B-2C and para. 0026), and is electrically conductive (see para. 0022);
an electrode (110) disposed at a distal portion of the catheter tube (14, see Fig. 8D and para. 0050);
a first electrical lead (24) coupled to the needle (52, see Fig. 5 and para. 0022); and
a second electrical lead (114) coupled to the electrode (110, see Fig. 8D and para. 0050),
wherein the first electrical lead (24) and the second electrical lead (114) are configured to measure a change in a bioelectrical parameter (see para. 0019 and 0050),
and wherein a depth of the needle (52) inserted into the myocardial tissue is based on the change in the bioelectrical parameter (see para. 0030,0034 and 0037-0038 – the electrical signals are used to determine whether the distal end of the needle 52 has penetrated the myocardial tissue and whether it has passed through the myocardial tissue and into the pericardial space thus the depth of the needle 52 inserted into the myocardial tissue is based on the electrical signals).
Regarding claim 2, Mickley discloses (Claim 2) the injection catheter (14) of claim 1, wherein the first electrical lead (24 in Fig. 5) traverses a first length of the catheter tube (18) to a first proximal portion of the catheter tube (18, see Fig. 5 and para. 0032– lead 24 is positioned on outer surface of needle 52 within the control assembly 54 of catheter tub 18 such that it traverse a small length of the catheter tube 18 within the proximal control assembly 54).
Regarding claim 7, Mickley discloses (Claim 7) the injection catheter (14) of claim 1, wherein the needle (52) is hollow (see para. 0033).
Regarding claim 8, Mickley discloses (Claim 8) the injection catheter (14) of claim 1, wherein the needle (52) has at least one hole located at a distal portion of the needle (see para. 0033 – needle 20 has at least a distal opening for injection), the at least one hole providing fluid communication between an interior of the needle (52) and an environment external to the needle (52, see para. 0033).
Regarding claim 9, Mickley discloses (Claim 9) the injection catheter (14) of claim 1, wherein the electrode (110 in Fig. 8D) is disposed on an outer surface of the catheter tube (18, see Fig. 8D and para. 0050 – the metal hood electrode 110 is formed on an outer, distal surface of the catheter tube 18).
Regarding claim 10, Mickley discloses (Claim 10) the injection catheter (14) of claim 9, wherein the electrode (110 in Fig. 8D) is a ring electrode (see Fig. 8D and para. 0050 – catheter 18 is a tubular shaft thus making the metal hood electrode 110 a ring extending around the tubular shaft of catheter 18).
Regarding claim 11, Mickley discloses (Claim 11) the injection catheter (14) of claim 9, wherein the change in the bioelectrical parameter is measured with the needle (52) being in a bipolar configuration (see para. 0050).
Regarding claim 12, Mickley discloses (Claim 12) the injection catheter (14) of claim 1, wherein another electrode is disposed on a part of the subject's body (examiner notes this limitation is being interpreted in light of the 112(b) and 101 rejections above as the injection catheter is a part of a system with another electrode configured to be disposed on a part of the patient’s body, see Fig. 7A and para. 0040 – the configuration 74 shown in Fig. 7A illustrates an injection catheter of the same form of catheter 14 that is used with twelve additional electrodes disposed on the subject’s body).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Mickley in view of Yamamoto et al. (U.S Patent Pub. No. 20040260241 A1, “Yamamoto”).
Regarding claim 3, Mickley discloses the injection catheter of claim 2, as discussed above.
While Mickley discloses the second electrical lead (114) traverses a second length of the catheter tube (18, see Fig. 8D and para. 0050), Mickley fails to explicitly disclose (Claim 3) wherein the second electrical lead traverses a second length of the catheter tube to a second proximal portion of the catheter tube.
Yamamoto discloses a catheter (20 in Fig.1) comprising a catheter tube (255 in Fig. 9) and a needle (263 in Fig. 9) each comprising electrodes (275, 270) respectively, wherein the catheter (20) is used to map and infuse therapeutics into cardiac tissue (see para. 0078). Yamamoto teaches (Claim 3) wherein the second electrical lead (285 in Fig. 9) traverses a second length of the catheter tube (255) to a second proximal portion (30 in Fig. 1) of the catheter tube (255, see para. 0122 – the second electrical lead 285 coupling to the catheter tube 255 traverses a length of the catheter tube 255 to the operating unit 30 as seen in Fig. 1).
Since Mickley discloses the second electrical lead (114) coupled to a distal end of the catheter tube (18) and extending proximally within the catheter tube (18, see Fig. 8D), and Yamamoto discloses the second electrical lead (285) coupling to a distal end of the catheter (255) and extending proximally to a proximal portion (30) of the catheter (255, see Fig. 1 and 9), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second electrical lead taught by modified Mickley to traverse a length of the catheter tube to a proximal portion of the catheter tube as taught by Yamamoto according to known methods to yield predictable results. Modifying the location of the coupling of an electrical lead to a conductive element is a known method that would yield results that would function that same in combination as they do separately. Further, such a combination would allow all the electrical leads and wires to be have terminals provided in a singular location at the proximal end of the assembly allowing for simpler connection of the leads to other instruments.
Regarding claim 4, modified Mickley discloses the injection catheter of claim 3, as discussed above. In modified Mickley, Mickley discloses the first proximal portion is the proximal control assembly (54) of the catheter tube (18, see Fig. 5 and para. 0032).
In modified Mickley, Yamamoto discloses the second proximal portion is the proximal operating unit (30) of the catheter tube (255, see para. 0121-0122). Yamamoto further discloses that both electrical leads (280, 285) extend to the proximal operating unit (30, see para. 0121-0122).
Thus, in combination, Mickley in view of Yamamoto discloses that both electrical leads traverse a length of the catheter tube to a proximal portion of the catheter tube.
Regarding claim 5, modified Mickley discloses the injection catheter of claim 3, as discussed above. In modified Mickley, Mickley discloses the first proximal portion is the proximal control assembly (54) which forms a proximal end of the catheter tube (18, see Fig. 5 and para. 0032). In modified Mickley, Yamamoto discloses wherein at least one of the first proximal portion (30) or the second proximal portion (30) is the proximal operating unit (30) which forms a proximal end of the catheter tube (255, see Fig. 1 and para. 0070 – the operating unit 30 forms a proximal end of the catheter 255 as seen in Fig. 1).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mickley in view of Mattmuller (DE Patent Pub. No. 102019216119 A1).
Regarding claim 6, Mickley discloses the injection catheter of claim 1, as discussed above.
However, Mickley fails to disclose (Claim 6) further comprising an electrically conductive post coupled between the first electrical lead and the needle.
Mattmuller discloses an injection and suction cannula assembly (1 in Fig. 1) comprising a catheter tube (5.1 in Fig. 2) and inner cannula tube (5.2 in Fig. 2) both of which may be used as electrodes (see para. 0101-0102 and 0104), wherein Mattmuller teaches (Claim 6) further comprising an electrically conductive post (“connection pins” in para. 0077) coupled between the first electrical lead and the inner cannula tube (5.2, see para. 0077-0078 – conductive connection pins interpreted as the electrically conductive post may be coupled between a cable and the inner cannula tube 5.2 to provide electrical connection to the inner cannula tube 5.2 functioning as an electrode).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first electrical lead by Mickley to be coupled to an electrically conductive post between the first electrical lead the needle as taught by Mattmuller. Mattmuller teaches that providing connection pins makes it possible to electrically connect the catheter instrument to an electrical source in a monopolar or bipolar configuration in a particularly simple and quick manner (see para. 0082).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mickley in view of Sherman et al. (U.S Patent Pub. No. 20120197243 A1, “Sherman”).
Regarding claim 13, Mickley discloses the injection catheter of claim 12, as discussed above.
Mickley discloses the catheter (14) may be used alongside a plurality of skin electrodes (13 in Fig. 1) used to take ECG measurements (see para. 0021), wherein the needle (52) and the plurality of skin electrodes (13) may be used in a unipolar configuration with the plurality of skin electrodes (13) functioning as reference electrodes to measure the change in the bioelectrical parameter (see Fig. 7A and para. 0040). When the electrode (110) is added to the catheter tube (18, see Fig. 8D), then the assembly may also be used in a bipolar configuration to measure the change in the bioelectrical parameter (see para. 0050).
However, Mickley fails to explicitly disclose that the reference electrodes are ground electrodes, and that the catheter system can be used both in unipolar and bipolar configurations.
Sherman discloses an electrical ablation system (12 in Fig. 1) comprising a catheter tube (16 in Fig. 1) comprising a plurality of electrodes (34 in Fig. 1) that may be used to measure impedance characteristics of cardiac tissue (see para. 0032 and 0039), wherein Sherman teaches the plurality of electrodes (34) may be used selectively in a bipolar configuration or a unipolar configuration including a patient return ground electrode (see para. 0037 and 0040 – examiner notes a patient return ground electrode is a ground electrode disposed on the subject’s body at a different location than the surgical site).
Since Mickley discloses a unipolar catheter assembly and a bipolar catheter assembly both for measuring the change in a bioelectrical parameter to determine penetration depth (see para. 0040 and 0050), and Sherman discloses a catheter assembly that may be used in both a unipolar and a bipolar configuration to measure impedance (see para. 0037 and 0040), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the injection catheter of Mickley to have a ground electrode and be operable in both a unipolar and bipolar configuration as taught by Sherman. Mickley explicitly discloses that one may incorporate a ground electrode into the assembly to significantly enhance signal quality (see para. 0049), and Sherman further teaches that measuring impedance values using both bipolar and unipolar configurations allows for a wider breadth of information about the cardiac tissues as measuring impedance with different polarities provides different impedance characteristics which can be used to assess the treatment (see para. 0051-0052). Examiner notes such a modification would allow Mickley to explicitly operate in both unipolar and bipolar configurations to provide a wider breadth of information about tissue penetration using impedance values from different polarity measurements.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Mickley in view of Dycus et al. (U.S Patent Pub. No. 20060129146 A1, “Dycus”).
Regarding claim 14, Mickley discloses the injection catheter of claim 1, as discussed above.
While Mickley discloses the first electrical lead (24) coupling to the outer surface of the needle (52) as seen in Fig. 5 (see para. 0032), Mickley fails to disclose (Claim 14) a spring clamp coupled between an outer surface of the needle and the first electrical lead.
Dycus discloses an endoscopic electrosurgical forceps device (10 in Fig. 1); however, the electromechanical connections between the electrical leads and device structures would have been reasonably pertinent and one in the art would have consulted such art and applied its teaching when faced with solving the problem of coupling an electrical lead to a needle. Dycus teaches that a spring clip may be used as an electromechanical connection between a tube (160) and electrical lead (310c, see Fig. 32 and para. 0117 – Fig. 32 shows connection of lead 310c to outer surface of tube 160).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection between the first electrical lead and the needle of Mickley to have spring clamp as taught by Dycus according to known methods to yield predictable results. In both Mickley and Dycus, the needle or tube is electrically connected to an electrical lead, and thus one of ordinary skill in the art could have combined the elements as claimed by known methods to perform the same function of electrical connection. One of ordinary skill in the art would have recognized that using an electromechanical connection therebetween such as a spring clip would be predictable.
Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Mickley in view of Schwartz (U.S Patent Pub. No. 20030129750 A1).
Regarding claim 15, Mickley discloses the injection catheter of claim 1, as discussed above.
While Mickley discloses that the needle (52) may define an axial passageway for fluid injection (see para. 0033), Mickley fails to disclose (Claim 15) injection tubing disposed in the catheter tube and coupled to a proximal portion of the needle, such that an inner volume of the injection tubing is fluidly coupled to an inner volume of the needle.
Schwartz discloses a catheter (20 in Fig. 1A) for intracardiac drug delivery comprising a needle (24 in Fig. 1A) slidably disposed within the catheter tube (20), wherein the catheter tube (20) comprises electrodes (38 in Fig. 1A) for measuring electrical activity to asses map the heart tissue (see para. 0119 and 0126). Schwartz teaches (Claim 15) injection tubing (46 in Fig. 1A) disposed in the catheter tube (20 in Fig. 1A) and coupled to a proximal portion of the needle (24 in Fig. 1A, see para. 0120), such that an inner volume of the injection tubing (46) is fluidly coupled to an inner volume of the needle (46, see para. 0120).
Since Mickley discloses the needle (52) being used for fluid injection (see para. 0033), and Schwartz discloses the needle (24) being coupled through injection tubing (46) to a fluid dispenser (54, see para. 0120), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the injection catheter of Mickley to incorporate injection tubing coupled to the needle within the catheter tube as taught by Schwartz according to known methods to yield predictable results. In both Mickley and Schwartz, the needle has a fluid pathway for fluid injection, and thus one of ordinary skill in the art could have combined the elements as claimed by known methods to perform the same function of fluid communication. One of ordinary skill in the art would have recognized that using injection tubing for fluid communication with a needle would be predictable.
Regarding claim 16, Mickley discloses the injection catheter of claim 1, as discussed above. However, Mickley fails to disclose (Claim 16) further comprising a pressure sensor configured to monitor intraluminal pressure in the catheter tube.
Schwartz teaches (Claim 16) further comprising a pressure sensor (40 in Fig. 1A) configured to monitor intraluminal pressure in the catheter tube (20, see para. 0123 – sensor 40 may be a pressure transducer for measuring intraluminal pressure within needle 24 and thus within the catheter tube 20).
Since Mickley discloses the needle (52) may be used to fluid injection see para. 0033), and Schwartz discloses an injection needle (24) having a pressure sensor (40) for monitoring intraluminal pressure thereof (see para. 0123), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the injection catheter of Mickley to incorporate a pressure sensor for measuring intraluminal pressure in the catheter tube as taught by Schwartz. Schwartz provides that incorporating a pressure sensor within the device allows for intraluminal pressures of the needle to be monitored for occlusions to ensure proper dosage is delivered through the needle (see para. 0123).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mickley in view of Lum et al. (U.S Patent Pub. No. 20020042594 A1, “Lum”).
Regarding claim 17, Mickley discloses the injection catheter of claim 1, as discussed above.
While Mickley discloses the needle (52) is slidably disposed within the catheter tube, Mickley is silent to the mechanism and thus silent to (Claim 17) wherein the catheter tube comprises a transverse wall that is fixed relative to the distal end of the catheter tube and through which the needle passes.
Lum discloses a plurality of needle drivers which are electrically controlled to advance a needle to a desired depth (see para. 0032), wherein Lum teaches (Claim 17) wherein the catheter tube (180 in Fig. 7B) comprises a transverse wall (178 in Fig. 7B) that is fixed relative to the distal end of the catheter tube (180 in Fig. 7B) and through which the needle (150 in Fig. 7B) passes (see para. 0036 – ledge 178 to the inner surface of catheter tube 180 such that it forms a transverse wall that needle 150 passes through).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the injection catheter of Mickley to spring-driven advancement mechanism comprising a transverse wall through which the needle passes as taught by Lum. Lum provides a variety of drivers such as the spring driver of Fig. 7B that allow for the depth of penetration of the needle to be optimized (see para. 0032). Such a modification would be motivated for Mickley as it would provide an easily and automatically controlled advancement mechanism for the needle of the injection catheter.
Claim(s) 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mickley in view of Lum as applied to claim 17 above, and further in view of Griffin et al. (U.S Patent Pub. No. 20040249406 A1, “Griffin”).
Regarding claim 18, modified Mickley discloses the injection catheter of claim 17, as discussed above.
In modified Mickley, Lum discloses (Claim 18) a hammer (181 in Fig. 7B) coupled to the needle (150 in Fig. 7B, see para. 0036 – hammer which is used to impact disc 177 of the needle 150); and a spring (176B in Fig. 7B) coupled between the hammer (181) and the transverse wall (178) of the catheter tube (180, see Fig. 7B and para. 0036).
While Lum discloses a hammer (181) which is used to impact the end disk (177) of needle (150), Lum fails to explicitly disclose the hammer as a piston.
Griffin discloses a lancet driving mechanism for advancing a needle (32 in Fig. 1) through the distal end of a device (10 in Fig. 2), wherein the lancet driving mechanism comprising a piston (40 in Fig. 2) coupled to the needle (32, see Fig. 2 and para. 0033); and a spring (36 in Fig. 2) coupled between the piston (40) and the transverse wall (distal wall of 20a in Fig. 2) of the catheter (10, see para. 0032).
Since in modified Mickley, Lum discloses a hammer (181) used to advance the needle (150) and a retraction spring (176B), and Griffin discloses a piston (40) used to advance the needle (32) and a retraction spring (36), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the hammer of modified Mickley with the piston of Griffin. Both a hammer and piston are known elements in the art used for applying a force to an object, and one of ordinary skill in the art could have substituted the known hammer of Lum for the known piston of Griffin to achieve a spring-driven needle advancement mechanism that would have been predictable.
Regarding claim 19, modified Mickley discloses the injection catheter of claim 18, as discussed above. In modified Mickley, Lum discloses (Claim 19) wherein the spring (176B in Fig. 7B) is configured to compress and the needle (150) is configured to extend from the distal end of the catheter tube (180, see Fig. 7B and para. 0036), as the hammer (181) is moved axially towards the transverse wall (178) of the catheter tube (180, see para. 0036).
In modified Mickley, Griffin discloses the piston (40 in Fig. 2) which is moved axially towards the transverse wall (distal wall of 20a) of the device (10) to compress the spring (36, see para. 0032).
Claim(s) 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Mickley in view of Carpenter et al. (U.S Patent Pub. No. 20030014010 A1, “Carpenter”).
Regarding claim 20, Mickley discloses the injection catheter of claim 1, as discussed above.
While Mickley discloses electrical signals of the tissue may be used to determine penetration depth of the needle into the myocardium (see para. 0026), Mickley does not explicitly disclose (Claim 20) wherein the bioelectrical parameter comprises impedance.
Carpenter discloses an injection catheter (1 in Fig. 1) comprising a catheter tube (2 in Fig. 1) with electrodes (36 in Fig. 1) and a needle (6 in Fig. 3, see para. 0039), wherein Carpenter teaches (Claim 20) wherein the electrodes (36 in Fig. 1) measure impedance (see para. 0039).
Since Mickley discloses an injection catheter (18) comprising an electrode (110) and a needle (52) formed as an electrode which measure a bioelectrical parameter to determine penetration depth (see 0026), and Carpenter discloses an injection catheter (1) comprising electrodes (36) and a needle (6) wherein the electrodes (36) measure impedance to determine penetration depth (see para. 0039), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified bioelectrical parameter measured by Mickley to explicitly be impedance as taught by Carpenter. Carpenter discloses that impedance values are advantageous for measuring penetration depth as there are differences in electrical impedance caused by air, blood, and heart tissue thus a change in impedance can be used to assure that the catheter is placed in the desired location before injection (see para. 0039).
Regarding claim 21, modified Mickley discloses the injection catheter of claim 20 as discussed above. Examiner notes, in light of the 112(b) rejection above, the limitations of claim 21 are being interpreted as the structure of the injection catheter must be capable of being configured for insertion of the needle into the myocardial tissue to increase impedance.
In modified Mickley, Carpenter discloses the electrodes (36 in Fig. 1) measure impedance (see para. 0039), and that inserting the needle (6) into the myocardial tissue causes a change in impedance (see para. 0064).
Thus, in combination, modified Mickley discloses the structure of the injection catheter (14 in Fig. 1) which comprises the needle (52) configured for insertion into myocardial tissue (see para. 0026), and thus is capable of achieving the desired result of claim 21.
Regarding claim 22, modified Mickley discloses the injection catheter of claim 21 as discussed above. Examiner notes, in light of the 112(b) rejection above, the limitations of claim 22 are being interpreted as the structure of the injection catheter must be capable of being configured for injection into the myocardial tissue when the impedance begins to decrease.
In modified Mickley, Carpenter discloses the electrodes (36 in Fig. 1) measure impedance (see para. 0039), and that inserting the needle (6) into the myocardial tissue causes a change in impedance (see para. 0064), and a fluid is injected via the injection catheter (1 in Fig. 1) into the myocardial tissue after the needle (6) is advanced a controlled distance into the myocardial tissue (see para. 0064).
Thus, in combination, modified Mickley discloses the structure of the injection catheter which is capable of being configured to deliver fluid via injection when the impedance begins to decrease.
Conclusion
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/K.M.T./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783