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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
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.
Claims 1-9, 12-17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McLoughlin et al (U.S. Pat. 9,867,941 B2, hereinafter “McLoughlin”).
Regarding claim 1, McLoughlin discloses a medicament delivery device apparatus comprising:
a needle 14 (disclosed as a hollow needle on pg. 3, line 4 and shown in Fig. 24H) with a sharp distalmost tip (disclosed as a needle tip on pg. 3, line 4);
a needle hub (where the needle connects to a standard syringe; see Fig. 24H) connected to a proximal end of the needle; and
an adaptor (e.g., 398; see Fig. 26) surrounding a portion of the needle and extending along a longitudinal axis of the needle, wherein the adaptor includes a cylindrical portion (see annotated Fig. 28, below), a distal surface (see annotated Fig. 28, below), and an outwardly facing contact surface (see annotated Fig. 28, below), wherein the contact surface defines a plane angled relative to the longitudinal axis of the needle (see annotated Fig. 28, below, showing plane angled at angle θ) and the contact surface is adjacent to the cylindrical portion and the distal surface (see annotated Fig. 28, below);
wherein the sharp distalmost tip is configured to move from a retracted position in which the sharp distalmost tip is within the adaptor (see Fig. 24E; before use, the needle is retracted behind the bottom of the adaptor so that the adaptor can be placed onto the skin) to a deployed position in which the sharp distalmost tip protrudes beyond the contact surface (see Fig. 24F; when sufficient user skin contact is detected, the injection proceeds by automatic insertion of the needle into the skin; this needle movement proceeds through the aperture 398a of the adaptor and thus beyond the contact surface illustrated in annotated Fig. 28).
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McLoughlin, annotated Fig. 28.
Regarding claim 2, McLoughlin discloses the apparatus of claim 1, further comprising: a user-actuated mechanism configured to selectively move the sharp distalmost tip between the retracted position and the deployed position (see col. 54, line 59 to col. 55, line 4).
Regarding claim 3, McLoughlin discloses the apparatus of claim 2, further comprising: a biasing member configured to urge the sharp distalmost tip toward the retracted position (see col. 55, lines 40-50; the biasing member could be, for example, the worm drive 82b that moves rearwardly to retract the sharp distalmost tip from the skin; see also col. 19, lines 45-50 disclosing a light return spring to retract the needle back into its housing).
Regarding claim 4, McLoughlin discloses the apparatus of claim 1, further comprising: one or more sensors (such as capacitive skin sensor electrodes 3100a-h; see Fig. 29); and a microprocessor 3230 (see Fig. 34A) configured to receive signals from the one or more sensors and, based on the signals, cause the sharp distalmost tip to move from the retracted position to the deployed position (see col. 57, lines 40-45 and col. 58, line 40 to col. 59, lines 32-47, describing how the sensors register that the adaptor has been placed into proper contact with the user’s skin and then automatically insert the needle when the sufficient user skin contact is detected).
Regarding claim 5, McLoughlin discloses the apparatus of claim 4, wherein the one or more sensors include a capacitance sensor positioned on the adaptor (see col. 57, lines 59-61).
Regarding claim 6, McLoughlin discloses the apparatus of claim 4, wherein the one or more sensors include a pressure sensor positioned on the adaptor (the capacitive sensors disclosed in McLoughlin are a type of pressure sensor, in which changes in capacitance are detected as pressure deforms a diaphragm between two flexible plates).
Regarding claim 7, McLoughlin discloses a medicament delivery device apparatus comprising:
a needle 14 (disclosed as a hollow needle on pg. 3, line 4 and shown in Fig. 24H) with a sharp distalmost tip (disclosed as a needle tip on pg. 3, line 4);
a needle hub (where the needle connects to a standard syringe; see Fig. 24H) connected to a proximal end of the needle; and
an adaptor (e.g., 398; see Fig. 26) surrounding a portion of the needle and extending along a longitudinal axis of the needle, wherein the adaptor includes a cylindrical portion (see annotated Fig. 28, below), a distal surface (see annotated Fig. 28, above), and an outwardly facing contact surface (see annotated Fig. 28, above), wherein the contact surface defines a plane angled relative to the longitudinal axis of the needle (see annotated Fig. 28, above, showing plane angled at angle θ) and the contact surface is adjacent to the cylindrical portion and the distal surface (see annotated Fig. 28, above);
wherein the sharp distalmost tip is configured to move from a retracted position in which the sharp distalmost tip is within the adaptor (see Fig. 24E; before use, the needle is retracted behind the bottom of the adaptor so that the adaptor can be placed onto the skin) to a deployed position in which the sharp distalmost tip protrudes from the adaptor (see Fig. 24F; when sufficient user skin contact is detected, the injection proceeds by automatic insertion of the needle into the skin; this needle movement proceeds through the aperture 398a of the adaptor).
one or more sensors (such as capacitive skin sensor electrodes 3100a-h; see Fig. 29); and
a microprocessor 3230 (see Fig. 34A) configured to receive a signal from the one or more sensors indicative of contact with a sclera of an eye (see col. 57, lines 40-45 and col. 58, line 40 to col. 59, lines 32-47, describing how the sensors register that the adaptor has been placed into proper contact with the user’s skin), and configured to cause, in response to the signal, the sharp distalmost tip to move from a retracted position in which the sharp distalmost tip is within the adaptor to a deployed position in which the sharp distalmost tip protrudes beyond the contact surface (see col. 3, lines 4-8; col. 54, lines 49-58).
Regarding claim 8, McLoughlin discloses the apparatus of claim 7, wherein the one or more sensors include a capacitance sensor positioned on the adaptor (see col. 57, lines 59-61).
Regarding claim 9, McLoughlin discloses the apparatus of claim 7, wherein the one or more sensors include a plurality of pressure sensors positioned on the adaptor (the capacitive sensors disclosed in McLoughlin are a type of pressure sensor, in which changes in capacitance are detected as pressure deforms a diaphragm between two flexible plates).
Regarding claim 12, McLoughlin discloses the apparatus of claim 7, wherein the one or more sensors include a level configured to determine an angular position of the needle and the adaptor (see col. 60, lines 4-32, disclosing a tilt event detection to determine the level of tilt of the adaptor and needle relative to the skin surface).
Regarding claim 13, McLoughlin discloses the apparatus of claim 7, further comprising:
a mechanism configured to move the sharp distalmost tip from a retracted position in which the sharp distalmost tip is positioned within the adaptor to a deployed position (see col. 54, line 59 to col. 55, line 4);
wherein the microprocessor is further configured to cause, in response to determining the position of the sharp distalmost tip or adaptor, the mechanism to move the sharp distalmost tip from the retracted position to the deployed position (see Fig. 24F; when sufficient user skin contact is detected, the injection proceeds by automatic insertion of the needle into the skin; this needle movement proceeds through the aperture 398a of the adaptor).
Regarding claim 14, McLoughlin discloses the apparatus of claim 13, wherein the microprocessor is further configured to:
determine, based on the signals from the one or more sensors, that the sharp distalmost tip or adaptor has been moved out of contact with the human organ (see col. 59, lines 60-63, disclosing determining a “lift-off event”);
and cause, in response to determining that the sharp distalmost tip or adaptor has been moved out of contact with the human organ, the mechanism to move the sharp distalmost tip from the deployed position to the retracted position (see col. 59, lines 63-65, disclosing that the emergency stop procedure is initiated to stop drug delivery, and the needle is withdrawn from the user’s skin; this withdrawal is understood to refer to withdrawing the needle and accompanying syringe back into the drive unit).
Regarding claim 15, McLoughlin discloses the apparatus of claim 7, wherein the one or more sensors includes a sensor configured to detect an angular position of the needle relative to a tangent of the human organ (see col. 60, lines 4-32, disclosing a tilt event detection to determine the level of tilt of the adaptor and needle relative to the skin surface);
wherein the microprocessor is further configured to determine that the angular position of the needle is a predetermined angular position (see col. 60, lines 4-15, disclosing that the tilt events may correspond to predetermined “acceptable/small tilt” or “unacceptable/gross tilt” events).
Regarding claim 16, McLoughlin discloses the apparatus of claim 15, further comprising:
a mechanism configured to move the sharp distalmost tip from a retracted position in which the sharp distalmost tip is positioned within the adaptor to a deployed position (see col. 54, line 59 to col. 55, line 4);
wherein the microprocessor is further configured to cause, in response to determining that the angular position of the needle is a predetermined angular position, the mechanism to move the sharp distalmost tip from the retracted position to the deployed position (see col. 59, line 61 to col. 60, line 3; detecting that the needle is in an unacceptable/gross tilt event causes the needle to be retracted, and then when the apparatus is repositioned so that the sensors sense an acceptable tilt event, the needle can then be deployed again).
Regarding claim 17, McLoughlin discloses the apparatus of claim 15, wherein the microprocessor is further configured to cause, in response to determining that the angular position of the needle is a predetermined angular position, one or more visual, audible, or tactile indications to be emitted (see col. 59, lines 65-67, disclosing a message appearing on a display to alert the user to reposition the device).
Regarding claim 20, McLoughlin discloses a kit, comprising:
a needle 14 (disclosed as a hollow needle on pg. 3, line 4 and shown in Fig. 24H) with a sharp distalmost tip (disclosed as a needle tip on pg. 3, line 4);
a container 10 (see Fig. 24E) enclosing an ophthalmic drug (see col. 64, line 2, disclosing epinephrine); and
an adaptor (e.g., 398; see Fig. 26) configured to be coupled to the needle and extend along a longitudinal axis of the needle, wherein the adaptor includes a cylindrical portion (see annotated Fig. 28, below), a distal surface (see annotated Fig. 28, above), and an outwardly facing contact surface (see annotated Fig. 28, above), wherein the contact surface defines a plane angled relative to the longitudinal axis of the needle (see annotated Fig. 28, above, showing plane angled at angle θ) and the contact surface is adjacent to the cylindrical portion and the distal surface (see annotated Fig. 28, above);
wherein when the adapter is coupled to the needle, he sharp distalmost tip is moveable from a retracted position in which the sharp distalmost tip is positioned within the adaptor (see Fig. 24E; before use, the needle is retracted behind the bottom of the adaptor so that the adaptor can be placed onto the skin) to a deployed position in which the sharp distalmost tip protrudes from the adaptor (see Fig. 24F; when sufficient user skin contact is detected, the injection proceeds by automatic insertion of the needle into the skin; this needle movement proceeds through the aperture 398a of the adaptor).
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.
Claims 10, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over McLoughlin in view of Hubbard (WO 98/22021, hereinafter “Hubbard”).
Regarding claim 10, it is noted that McLoughlin does not appear to disclose that the apparatus comprises a microneedle; wherein the needle and the microneedle are electrically connected via a low voltage circuit.
Hubbard discloses a medicament delivery device, comprising an injection needle 22 with an uninsulated portion 26 at its distal tip that functions as an electrode (see pg. 12, lines 15-17) and a microneedle 38 (see pg. 12, lines 18-20; the microneedle 38 is in the form of a standalone muscle electrode, which is known to be small) that also functions as an electrode, and the two electrodes are electrically connected via a low voltage circuit in the form of an EMG analyzer (see pg. 9, line 15 and pg. 10, line 10 disclosing the microvolt level of voltage within the circuit).
A skilled artisan would have found it obvious at the time of the invention to modify the device of McLoughlin to incorporate a microneedle, such that the microneedle and the needle are electrically connected via a low voltage circuit, as taught in Hubbard, in order to determine trigger point EMG activity for the injection site; this feature would be useful for enabling a user to deliver medication locally at the trigger point to block trigger point activity and reduce or eliminate muscle pain (see Hubbard at Abstract), with a reasonable expectation of success.
Further, as per claim 18, it is noted that McLoughlin does not appear to disclose that the microprocessor is configured to determine that a current of the low voltage circuit exceeds a predetermined current; and cause, in response to determining that the current of the low voltage circuit exceeds the predetermined current, one or more visual, audible, or tactile indications to be emitted.
Hubbard further discloses providing a visual or audible indication when the current from the low voltage circuit exceeds a predetermined current (see pg. 10, lines 12-20, disclosing that above-threshold activity is signaled by a steady high-pitched sound from a speaker).
A skilled artisan would have found it obvious at the time of the invention to modify the device of McLoughlin to provide a visual or audible indication when the current from the low voltage circuit exceeds a predetermined current, in order to inform a clinician that a patient should relax the muscles in order to accurately determine the location of a trigger point (see Hubbard at pg. 19, lines 12-20), with a reasonable expectation of success.
Regarding claim 19, Hubbard does not appear to disclose:
a first electrode positioned adjacent the sharp distalmost tip and a second electrode (see individual sensor electrodes 3100a-h in Fig. 29 and/or electrodes 1 through 7 in Fig. 37A);
wherein the microprocessor is further configured to:
determine, based on a conductivity between the first electrode and second electrode, a position of the sharp distalmost tip; and cause, in response to determining position of the sharp distalmost tip, one or more visual, audible, or tactile indications to be emitted.
Hubbard discloses a medicament delivery device, comprising an injection needle 22 with an uninsulated portion 26 at its distal tip that functions as an electrode (see pg. 12, lines 15-17) and another electrode 38 (see pg. 12, lines 18-20, disclosing a standalone muscle electrode); and
wherein a microprocessor is further configured to determine, based on a conductivity between the first electrode and second electrode, a position of the sharp distalmost tip; and cause, in response to determining position of the sharp distalmost tip, one or more visual, audible, or tactile indications to be emitted (see pg. 18, lines 2-6’ the two electrodes are electrically connected to an EMG analyzer, which uses a processor to determine the conductivity between the two electrodes and issues an alert when the difference between the activity at the trigger point exceeds activity in the adjacent tissue where the needle is located).
A skilled artisan would have found it obvious at the time of the invention to modify the device of McLoughlin to provide a first electrode positioned adjacent the sharp distalmost tip and a second electrode, and to configure the microprocessor to determine, based on a conductivity between the first electrode and second electrode, a position of the sharp distalmost tip; and cause, in response to determining position of the sharp distalmost tip, one or more visual, audible, or tactile indications to be emitted, as taught in Hubbard, in order to determine trigger point EMG activity for the injection site; this feature would be useful for enabling a user to deliver medication locally at the trigger point to block trigger point activity and reduce or eliminate muscle pain (see Hubbard at Abstract), with a reasonable expectation of success.
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments have been considered; where necessary, the rejections and objections have been withdrawn. Where necessary, the rejections have been maintained, and an explanation of the rejections is provided above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 06/12/2026
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