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.
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 following subject matter must be shown or the features canceled from the claims:
“the one or more sensors include a first electrode positioned on the adaptor and the microneedle” (claim 11).
Specifically, the drawings do not show any configuration of an electrode positioned on both the adaptor and the microneedle at the same time.
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“mechanism configured to selectively move the sharp distalmost tip between the retracted position and the deployed position” (claim 2)
“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” (claim 13)
“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” (claim 16)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 10 and 29 of copending Application No. 17/444,897 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is encompassed by the limitations of claims 8, 10 and 29 of the reference application.
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 35 of copending Application No. 17/444,897 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 20 of the instant application is encompassed by the limitations of claim 35 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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;
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).
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;
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 signals from the one or more sensors and, based on the signals, determine a position of the sharp distalmost tip or adaptor relative to a human organ (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).
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 such that the 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 an 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 an 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
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 12/18/2025