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 .
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 18 is 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.
Claim 18 states: “The method of claim 11, further comprising the outer portion having the left side and the right side, wherein when the left side and the right side are connected to form a circle that provides protection from the subdermal needle.”. However, claim 11 states: ‘…the outer portion capable of compressing into the inner portion, wherein the outer portion is open on one end to allow movement of the subdermal needle…’. It is unclear if the left and right sides are connected to create a circle or comprise an open end. Therefore claim 18 is rejected under 112(b)
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) 1, 2, 5, 11-14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haak (US20120041377 A1) herein referred to as “Haak” in view of Edwards et. al. (US 20170100047 A1) herein referred to as “Edwards” further in view of Boudreaux (US 20040116864 A1) herein referred to as “Boudreaux” further in view of Charlez (US 20120220944 A1) herein referred to as “Charlez”.
Regarding claim 1 A squeeze and stick subdermal needle electrode, comprising: (a) an electrode housing, comprising: (i) an inner portion comprising a semi-rigid ([0057];Haak discloses the material being a flexible polymer which is seen as semi rigid) projection with a top surface sloped downward from a medial line, ([Figure 3]; Haak discloses inner portion that slopes downward from a median line as disclosed by figure 3 below with a square) the semi-rigid projection with an opening to receive a subdermal needle on a proximal side, ([0060]; Haak discloses retaining member 80 that is configured to receive catheter which is seen as a subdermal needle) and(ii) an outer portion comprising a left side and a right side of semi- rigid material for protecting the inner portion ([Figure 1]; Haak discloses side member (20) and side member (40) which are on the left and right side of the inner portion), and wherein the outer portion is open on one end to allow movement of the subdermal needle to enter into subdermal tissue of the patient. ([Figure 1]; Haak discloses the outer portion being open ended allowing for a needle to enter a patient) Haak does not explicitly disclose: and a lead wire on a distal side, wherein the subdermal needle and the lead wire are mated together to transfer electrical signals; the outer portion capable of compressing into the inner portion wherein the compressing drives the left side and the right side of the outer portion into the top surface of the semi-rigid projection which drives the subdermal needle toward a patient
However, Edwards discloses: and a lead wire on a distal side ([Figure 1A]; Edwards discloses wires 14a and 14b on a distal side), wherein the subdermal needle and the lead wire are mated together to transfer electrical signals; ([0017]; “The needle electrodes 12a, 12b may be attached to electrode leads 14a, 14b that connect to a control system 60 that receives signals from the needle electrodes and displays parameters based on those signals that represent physiological aspects of the patient.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the subdermal needle as disclosed by Haak with the wires as disclosed by Edwards. The motivation being to record and transmit physiological data. ([0017])
However, Boudreaux discloses: the outer portion capable of compressing into the inner portion ([Figures 12 and 13]; Boudreaux discloses wings 106 and 86 that compress over an inner portion), wherein the compressing drives the left side and the right side of the outer portion into the top surface of the semi-rigid projection ([Figures 12 and 13]; Wings 106 and 86 over the inner portion).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the subdermal needle as discloses by Haak with the outer portion compressible members. The motivation being to retract a blunt within the needle. ([0043])
However, Charlez discloses: Compression which drives the subdermal needle toward a patient. ([0013]; Charlez discloses pressing outer arms together deploying the puncture needle, [0029]; the puncture needle being inserted into a blood vessel, which is seen as toward a patient)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the subdermal needle as disclosed by Haak with the compressive force driving a needle toward a patient as disclosed by Charlez. The motivation being to aid in the deploying a canula needle ([0013])
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Regarding claim 2, Haak in view of Edwards further in view of Boudreaux further in view of Charlez disclose: The subdermal needle electrode of claim 1. Haak further discloses: wherein the electrode housing is comprised of a polymeric material. ([0057]; Haak discloses the housing being constructed of a polymer, which is seen as polymeric)
Regarding claim 5, Haak in view of Edwards further in view of Boudreaux further in view of Charlez disclose: The subdermal needle electrode of claim 1. Haak does not discloses: further comprising the outer portion having an angular left side and right side that when acted upon compresses the outer portion into the inner portion at a respective angle that causes the outer portion to slide above the inner portion to drive the subdermal needle toward the patient.
However Boudreaux discloses: further comprising the outer portion having an angular left side and right side ([Figure 12] angular left and right sides (016) and (86)) that when acted upon compresses the outer portion into the inner portion at a respective angle that causes the outer portion to slide above the inner portion ([Figure 13]; When (106) and (86) are acted upon they slide above the inner portion) Boudreaux does not disclose: to drive the subdermal needle toward the patient.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the subdermal needle as discloses by Haak with the outer portion compressible members. The motivation being to retract a blunt within the needle. ([0043]).
However, Charlez discloses: Compression to drive the subdermal needle toward the patient. ([0096]; “In some embodiments, pressure is applied on the first handles 75A, 75B in the direction of the arrows 78. This action can advance the syringe 700A and drive a needle through bodily tissue,”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the subdermal needle as disclosed by Haak with the compressive force driving a needle toward a patient as disclosed by Charlez. The motivation being to aid in the deploying a canula needle ([0013])
Regarding claim 11, A method for deploying a squeeze and stick subdermal needle electrode, comprising: provisioning a squeeze and stick subdermal needle electrode, comprising: (a) an electrode housing, comprising: (i) an inner portion comprising a semi-rigid ([0057];Haak discloses the material being a flexible polymer which is seen as semi rigid) projection with a top surface sloped downward from a medial line, ([Figure 3]; Haak discloses inner portion that slopes downward from a median line as disclosed by figure 3 below with a square) the semi-rigid projection with an opening to receive a subdermal needle on a proximal side, ([0060]; Haak discloses retaining member 80 that is configured to receive catheter which is seen as a subdermal needle) and(ii) an outer portion comprising a left side and a right side of semi- rigid material for protecting the inner portion ([Figure 1]; Haak discloses side member (20) and side member (40) which are on the left and right side of the inner portion), and wherein the outer portion is open on one end to allow movement of the subdermal needle to enter into subdermal tissue of the patient. ([Figure 1]; Haak discloses the outer portion being open ended allowing for a needle to enter a patient) Haak does not explicitly disclose: and a lead wire on a distal side, wherein the subdermal needle and the lead wire are mated together to transfer electrical signals; the outer portion capable of compressing into the inner portion wherein the compressing drives the left side and the right side of the outer portion into the top surface of the semi-rigid projection which drives the subdermal needle toward a patient
However, Edwards discloses: and a lead wire on a distal side ([Figure 1A]; Edwards discloses wires 14a and 14b on a distal side), wherein the subdermal needle and the lead wire are mated together to transfer electrical signals; ([0017]; “The needle electrodes 12a, 12b may be attached to electrode leads 14a, 14b that connect to a control system 60 that receives signals from the needle electrodes and displays parameters based on those signals that represent physiological aspects of the patient.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the subdermal needle as disclosed by Haak with the wires as disclosed by Edwards. The motivation being to record and transmit physiological data. ([0017])
However, Boudreaux discloses: the outer portion capable of compressing into the inner portion ([Figures 12 and 13]; Boudreaux discloses wings 106 and 86 that compress over an inner portion), wherein the compressing drives the left side and the right side of the outer portion into the top surface of the semi-rigid projection ([Figures 12 and 13]; Wings 106 and 86 over the inner portion).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the subdermal needle as discloses by Haak with the outer portion compressible members. The motivation being to retract a blunt within the needle. ([0043])
However, Charlez discloses: Compression which drives the subdermal needle toward a patient. ([0013]; Charlez discloses pressing outer arms together deploying the puncture needle, [0029]; the puncture needle being inserted into a blood vessel, which is seen as toward a patient)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the subdermal needle as disclosed by Haak with the compressive force driving a needle toward a patient as disclosed by Charlez. The motivation being to aid in the deploying a canula needle ([0013])
Regarding claim 12, Haak in view of Edwards further in view of Boudreaux further in view of Charlez disclose: The method of claim 11. Charlez further discloses: further comprising releasing compressing forces from the left side and the right side of the outer portion once the subdermal needle has entered the patient. ([0042]; Charlez discloses releasing the outer arms after the needle has punctured the patient.)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the subdermal needle as disclosed by Haak in view of Edwards further in view of Boudreaux further in view of Charlez with the releasing of the outer arms as further disclosed by Charlez. The motivation being to retract the needle. ([0042])
Regarding claim 13, Haak in view of Edwards further in view of Boudreaux further in view of Charlez disclose: The method of claim 11. Charlez further disclose: further comprising removing the subdermal needle electrode by moving in an opposite direction from insertion, ([0054]; Charlez discloses retracting the needle when releasing the outer arms, which is seen as the arms moving in the opposite direction as when inserting) wherein the removing of the subdermal needle allows the subdermal needle to retract back into the outer portion guarding the subdermal needle from improper needle sticks. ([Figure 1b]; Charlez discloses the retracted needle covered by anchoring organ (101) which cover the tip of the needle, which is seen as guarding the needle against improper needle sticks)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the subdermal needle as disclosed by Haak in view of Edwards further in view of Boudreaux further in view of Charlez with the releasing retracting of the needle as further disclosed by Charlez. The motivation being to protect the needle tip. ([0012])
Regarding claim 14, Haak in view of Edwards further in view of Boudreaux further in view of Charlez disclose: The subdermal needle electrode of claim 11. Haak further discloses: wherein the electrode housing is comprised of a polymeric material. ([0057]; Haak discloses the housing being constructed of a polymer, which is seen as polymeric)
Regarding claim 18, Haak in view of Edwards further in view of Boudreaux further in view of Charlez disclose: The method of claim 11. Charlez further discloses: further comprising the outer portion having the left side and the right side, wherein when the left side and the right side are connected to form a circle that provides protection from the subdermal needle. ([Figure 1B]; Charlez discloses a left and right side of (101) that connect and form a circle and cover the needle tip, which is seen as protecting the needle)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the subdermal needle as disclosed by Haak in view of Edwards further in view of Boudreaux further in view of Charlez with the outer portion as further disclosed by Charlez the motivation being to guide the needle ([0027])
Claim(s) 3 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haak in view of Edwards further in view of Boudreaux further in view of Charlez further in view of Broder (US 20080171948 A1) herein referred to as “Broder”
Regarding claim 3, Haak in view of Edwards further in view of Boudreaux further in view of Charlez disclose: The subdermal needle electrode of claim 1. Haak further discloses: wherein the inner portion is comprised of a polymeric material ([0057]; Haak discloses a needle housing constructed of a polymer which includes the inner portion of the housing.) Haak does not explicitly disclose: and the outer portion is comprised of a metal.
However, Broder discloses: and the outer portion is comprised of a metal. ([0037]; Broder discloses clip (10) constructed of metal which is the outer portion of the needle housing)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the needle housing as disclosed by Haak with the metal outer portion as disclosed by Broder. The motivation being to ensure good electrical conductivity ([0037])
Regarding claim 15, Haak in view of Edwards further in view of Boudreaux further in view of Charlez disclose: The subdermal needle electrode of claim 11. Haak further discloses: wherein the inner portion is comprised of a polymeric material ([0057]; Haak discloses a needle housing constructed of a polymer which includes the inner portion of the housing.) Haak does not explicitly disclose: and the outer portion is comprised of a metal.
However, Broder discloses: and the outer portion is comprised of a metal. ([0037]; Broder discloses clip (10) constructed of metal which is the outer portion of the needle housing)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the needle housing as disclosed by Haak with the metal outer portion as disclosed by Broder. The motivation being to ensure good electrical conductivity ([0037])
Claim(s) 4 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haak in view of Edwards further in view of Boudreaux further in view of Charlez further in view of Cadwell (US 20220409116 A1) herein referred to as “Cadwell”.
Regarding claim 4, Haak in view of Edwards further in view of Boudreaux further in view of Charlez disclose: The subdermal needle electrode of claim 1. Haak does not explicitly disclose: wherein the subdermal needle is comprised of stainless steel and a non-tip portion of the subdermal needle has a protective coating.
However, Boudreaux discloses: wherein the subdermal needle is comprised of stainless steel. ([0036]; Boudreaux discloses the needle made of stainless steel)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify needle holder as disclosed by Haak with the stainless-steel needle as disclosed by Boudreaux. The motivation being obvious to try given a finite number of materials to construct a needle.
Regarding claim 16, Haak in view of Edwards further in view of Boudreaux further in view of Charlez disclose: The subdermal needle electrode of claim 11. Haak does not explicitly disclose: wherein the subdermal needle is comprised of stainless steel and a non-tip portion of the subdermal needle has a protective coating.
However, Boudreaux discloses: wherein the subdermal needle is comprised of stainless steel. ([0036]; Boudreaux discloses the needle made of stainless steel)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify needle holder as disclosed by Haak with the stainless-steel needle as disclosed by Boudreaux. The motivation being obvious to try given a finite number of materials to construct a needle.
However, Cadwell discloses: a non-tip portion of the subdermal needle has a protective coating. ([0015]; Cadwell discloses a coating of diamond doped material, which is seen a protective)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the needle holder as disclosed by Haak with the coating as disclosed by Cadwell. The motivation being to provide insulation ([0009])
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haak in view of Edwards further in view of Boudreaux further in view of Charlez further in view of Nielsen (US 20090131860 A1) herein referred to as “Nielsen”.
Regarding claim 7, Haak in view of Edwards further in view of Boudreaux further in view of Charlez disclose: The subdermal needle electrode of claim 1. Haak does not disclose: wherein the proximal side of the inner portion is configured with an adhesive to secure and support the subdermal needle.
However, Nielsen discloses: wherein the proximal side of the inner portion is configured with an adhesive to secure and support the subdermal needle. ([0100]; Nielsen discloses a needle secured using adhesive)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the needle support as disclosed by Haak in view of Edwards further in view of Boudreaux further in view of Charlez with the adhesive secure needle. The motivation being the mounting of a needle to the housing ([0100])
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haak in view of Edwards further in view of Boudreaux further in view of Charlez further in view of Vaughan et. al. (US 20040260357 A1) herein referred to as “Vaughan”.
Regarding claim 8, Haak in view of Edwards further in view of Boudreaux further in view of Charlez disclose: The subdermal needle electrode of claim 1. Haak does not disclose: wherein the subdermal needle and the lead wire are mated with a solder alloy.
However, Vaughan discloses: wherein the subdermal needle and the lead wire are mated with a solder alloy. ([0029]; Vaughan discloses the electrodes being connected to leads via solder)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the needle support as disclosed by Haak in view of Edwards further in view of Boudreaux further in view of Charlez with the solder connections as disclosed by Vaughan. The motivation being obvious to try given a finite amount of way to connect a needle to a lead.
Regarding claim 9, Haak in view of Edwards further in view of Boudreaux further in view of Charlez further in view of Vaughan disclose: The subdermal needle electrode of claim 8. Vaughan further discloses: further comprising an insulation wrap, wherein the insulation wrap is wrapped around the solder alloy, the subdermal needle, and the lead wire. ([0029]; Vaughan discloses the use of a shrink sleeve over the lead solder and needle electrode.)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the needle support as disclosed by Haak in view of Edwards further in view of Boudreaux further in view of Charlez with the insulation wraps as disclosed by Vaughan. The motivation being applying a known technique, shrink wrap, to a known device, needle electrode, to yield the predictable result of insulating the connection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY GEORGE CHA whose telephone number is (571)272-0749. The examiner can normally be reached Monday-Friday 8:30-5:00.
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/CASEY GEORGE CHA/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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