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 .
Drawings
The drawings are objected to because
Figures 4 and 6 have two views and are identified as one figure. Each figure must be identified separately. Correction to the drawings, Brief description of the drawings, and throughout the specification are needed. See MPEP 608.02 (I) (V) under 37 CFR 1.84 (h) (4)-(5).
The lead line in figure 11 for reference numeral “408 extends to the plunger of the ampule rather than to the ampule itself.
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 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 1-3, 7-8, 10-12, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunter et al. (US 20100016827 A1).
Regarding claim 1, Hunter discloses a transdermal injection component 900 (fig 9), comprising:
an injection volume 990 configured to contain an injectable treatment therein,
a plunger at 920,
the injection volume being in fluid communication with at least one orifice at 910 such that the plunger is configured to exert the injectable treatment from the injection volume through the at least one orifice;
the plunger sealably engaged with the injection volume, the plunger configured to exert the injectable treatment from the injection volume through the at least one orifice so as to effect transdermal injection of the injectable treatment to a patient;
the transdermal injection component being configured to engage with an actuator device 242 [0077] configured to effect movement of the plunger to exert the injectable treatment through the at least one orifice, and any one or more of
(a) a one-way valve 940 [0038] in fluid communication with the sealable injection volume, the one-way valve being configured to place the injection volume into fluid communication with a source of the injectable treatment when the component is engaged with a source of the injectable treatment such that fluid movement is permitted only from the source of the injectable treatment to the injection volume; or
(b) a sealer 980 [0038] disposed so as to seal the sealable injection volume against an environment exterior to the transdermal injection component when (1) the plunger exerts a negative pressure on the injection volume, (2) the component is engaged with a source of the injectable treatment, or both (1) and (2); and
(d) at least one optionally adjustable element configured to stop a motion of the plunger or a motion of an element engaged with the plunger so as to limit the volume of fluid exerted from the injection volume with motion of the plunger. [0009, 0054, 0091-0092].
Regarding claim 2, Hunter discloses the component comprises a one-way valve 940 in fluid communication with the sealable injection volume, the one- way valve being configured to place the injection volume into fluid communication with a source of the injectable treatment 950 when the component is engaged with the source of the injectable treatment such that fluid movement is permitted only from the source of the injectable treatment to the injection volume.
Regarding claim 3, Hunter discloses the component comprises a sealer 980,985, disposed so as to seal the sealable injection volume against an environment exterior to the transdermal injection component when (1) the plunger exerts a negative pressure on the injection volume, (2) the component is engaged with a source of the injectable treatment, or both (1) and (2).
Regarding claim 7, Hunter discloses the transdermal injection component (fig 9) comprises a surface configured to contact a subject (nozzle 910), and wherein (a) the at least one orifice stands proud relative to the surface.
Regarding claim 8, Hunter discloses the component comprises at least one element (242,965) [0091,0092] configured to stop a motion of the plunger so as to limit the volume of fluid exerted from the injection volume with motion of the plunger.
Regarding claim 10, Hunter discloses the injection volume configured to contain an injectable treatment therein is comprised in an ampoule installed in the transdermal injection component [0036].
Regarding claims 11 and 15, Hunter discloses a transdermal injection system and method, comprising:
a transdermal injection component 900 according to claim 1;
an actuator device 242 configured to engage with the transdermal injection component, the actuator device comprising a reversibly moveable element configured to effect encouragement of the plunger of the transdermal injection component such that the plunger exerts the injectable treatment through the at least one orifice, the reversibly moveable element being actuated by operation of an electromagnetic field [0032,0042,0043]. Hunter also discloses operating the transdermal injection system so as to effect transdermal injection of the injectable treatment to a patient.
Regarding claim 12, Hunter discloses the system further comprising a resilient member (coil; see abstract, [0005,0032,0033]; coil assembly) configured to exert a force on at least one of the reversibly moveable element and the plunger.
Regarding claim 16, Hunter discloses a method, comprising:
effecting electromagnetically driven motion of a reversibly moveable element so as to drive a plunger engaged with an injection volume that has an amount of an injectable treatment disposed therein, the motion effecting exertion of the injectable treatment through one or more orifices in fluid communication with the injection volume so as to effect transdermal injection of the injectable treatment from the one or more orifices to a patient [0005,0032].
Regarding claim 17, further comprising effecting a series of transdermal injections, the volume of each of the series of transdermal injections optionally being determined by a movable element disposed within the injection volume [0003,0061,0087,0093].
Claims 1-2, 7-12, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunter et al (US 20080009788 A1).
Regarding claim 1, Hunter discloses a transdermal injection component 100 (fig 1), comprising:
an injection volume 110 configured to contain an injectable treatment therein,
a plunger at 130,
the injection volume being in fluid communication with at least one orifice at 144 such that the plunger is configured to exert the injectable treatment from the injection volume through the at least one orifice;
the plunger sealably engaged with the injection volume, the plunger configured to exert the injectable treatment from the injection volume through the at least one orifice so as to effect transdermal injection of the injectable treatment to a patient;
the transdermal injection component being configured to engage with an actuator device 105 configured to effect movement of the plunger to exert the injectable treatment through the at least one orifice, and any one or more of
(a) a one-way valve [0039] in fluid communication with the sealable injection volume, the one-way valve being configured to place the injection volume into fluid communication with a source of the injectable treatment when the component is engaged with a source of the injectable treatment such that fluid movement is permitted only from the source of the injectable treatment to the injection volume; and
(d) at least one optionally adjustable element 105 configured to stop a motion of the plunger or a motion of an element engaged with the plunger so as to limit the volume of fluid exerted from the injection volume with motion of the plunger. [0034,0061].
Regarding claim 2, Hunter discloses the component comprises a one-way valve [0039] in fluid communication with the sealable injection volume, the one- way valve being configured to place the injection volume into fluid communication with a source of the injectable treatment when the component is engaged with the source of the injectable treatment such that fluid movement is permitted only from the source of the injectable treatment to the injection volume.
Regarding claim 7, Hunter discloses the transdermal injection component (figs 1, 5, and 9) comprises a surface configured to contact a subject (nozzle 910), and wherein the at least one orifice stands flush relative to the surface, or (c) wherein the at least one orifice stands recessed relative to the surface.
Regarding claim 8, Hunter discloses the component comprises at least one element [0006,0034] configured to stop a motion of the plunger so as to limit the volume of fluid exerted from the injection volume with motion of the plunger.
Regarding claim 9, Hunter discloses the component comprises a plurality of orifices 145 in fluid communication with the sealable injection volume such that the plunger is configured to exert the injectable treatment from the injection volume through the plurality of orifices.
Regarding claim 10, Hunter discloses the injection volume configured to contain an injectable treatment therein is comprised in an ampoule installed in the transdermal injection component [0039].
Regarding claims 11 and 15, Hunter discloses a transdermal injection system and method, comprising:
a transdermal injection component 100 according to claim 1;
an actuator device 105 configured to engage with the transdermal injection component, the actuator device comprising a reversibly moveable element configured to effect encouragement of the plunger of the transdermal injection component such that the plunger exerts the injectable treatment through the at least one orifice, the reversibly moveable element being actuated by operation of an electromagnetic field [0034](fig 8). Hunter also discloses operating the transdermal injection system so as to effect transdermal injection of the injectable treatment to a patient.
Regarding claim 12, Hunter discloses the system further comprising a resilient member (coil; see abstract, [0006]; coil assembly) configured to exert a force on at least one of the reversibly moveable element and the plunger.
Regarding claim 16, Hunter discloses a method, comprising:
effecting electromagnetically driven motion of a reversibly moveable element so as to drive a plunger engaged with an injection volume that has an amount of an injectable treatment disposed therein, the motion effecting exertion of the injectable treatment through one or more orifices in fluid communication with the injection volume so as to effect transdermal injection of the injectable treatment from the one or more orifices to a patient [0006,0034,0064,0065].
Regarding claim 17, further comprising effecting a series of transdermal injections, the volume of each of the series of transdermal injections optionally being determined by a movable element disposed within the injection volume [0037,0038,0040].
Claims 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anquetil et al (US 20180147351 A1).
Regarding claim 19, Anquetil discloses a method, comprising:
modulating a flow of a transdermally injected material to a patient in response to a signal collected from an imaging train, the signal being indicative of a location a blood vessel of the patient, the patient's epidermis, the patient's dermis, the patient's fat, the patient's muscle, the patient's bone, or any combination thereof [0003-0005, 0037].
Regarding claim 20, Anquetil discloses the step of the modulating further being in response to any one or more of a viscosity of the transdermally injected material, a characteristic of the patient's epidermis, a characteristic of the patient's dermis, a characteristic of the patient's fat, a characteristic of the patient's muscle, and a characteristic of the patient's bone [0033,0037].
Claims 1-2, 4-5, 7-8, 10, 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Slate et al (US 20020055707 A1).
Regarding claim 1, Slate discloses a transdermal injection component 100 (fig 1), comprising:
an injection volume 48,42 configured to contain an injectable treatment therein,
a plunger at 54,76,
the injection volume being in fluid communication with at least one orifice at 20 such that the plunger is configured to exert the injectable treatment from the injection volume through the at least one orifice;
the plunger sealably engaged with the injection volume, the plunger configured to exert the injectable treatment from the injection volume through the at least one orifice so as to effect transdermal injection of the injectable treatment to a patient;
the transdermal injection component being configured to engage with an actuator device 78,54 configured to effect movement of the plunger to exert the injectable treatment through the at least one orifice, and any one or more of
(a) a one-way valve 74 (fig 7) in fluid communication with the sealable injection volume, the one-way valve being configured to place the injection volume into fluid communication with a source of the injectable treatment when the component is engaged with a source of the injectable treatment such that fluid movement is permitted only from the source of the injectable treatment to the injection volume; and
c) the component defining an opening (system 46 in fig 7; [0031,0037]) disposed proximate to the at least one orifice, the opening being dimensioned such that application of a sufficient negative pressure from the opening encourages patient skin toward the opening.
Regarding claim 2, Slate discloses the component comprises a one-way valve 74 (fig 7) in fluid communication with the sealable injection volume, the one- way valve being configured to place the injection volume into fluid communication with a source of the injectable treatment when the component is engaged with the source of the injectable treatment such that fluid movement is permitted only from the source of the injectable treatment to the injection volume.
Regarding claim 4, Slate discloses the component comprises an opening (system 46) disposed proximate to the at least one orifice, the opening being dimensioned such that application of a sufficient negative pressure from the opening encourages patient skin toward the opening.
Regarding claim 5 Slate discloses the opening extends at least partially circumferentially at 22 around the at least one orifice.
Regarding claim 7, Slate discloses the transdermal injection component (fig 7) comprises a surface configured to contact a subject, and wherein the at least one orifice stands proud relative to the surface.
Regarding claim 8, Slate discloses the component comprises at least one element [26; 0010,0012,0020,0030] configured to stop a motion of the plunger so as to limit the volume of fluid exerted from the injection volume with motion of the plunger.
Regarding claim 10, Slate discloses the injection volume configured to contain an injectable treatment 48 therein is comprised in an ampoule installed in the transdermal injection component [0039].
Regarding claim 13, Slate further discloses a source of negative pressure at 46, the source of negative pressure being configured to exert a negative pressure through an opening of the transdermal injection component such that patient skin is exerted generally toward the at least one orifice of the transdermal injection component, optionally such that the patient skin contacts the transdermal injection component.
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al (US 2010/0016827) in view of Anquetil (2US 018/0147351).
Regarding claims 14 and 18, Hunter (‘827) discloses the invention substantially as claimed. However, Hunter (‘827) fails to disclose transdermal injection system further comprising an imaging train, the imaging train being configured to determine one or more features of a patient, a location of the injectable treatment, or both.
Anquetil teaches a transdermal injection system further comprising an imaging train 170, the imaging train being configured to determine one or more features of a patient, a location of the injectable treatment, or both (see abstract); [0003]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Hunter (‘827) by including Anquetil’s imaging train into Hunter (‘827) injection system in order to further determine patient feature(s) or location.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Slate (US 2002/0055707).
Regarding claims 6 and 9, Slate discloses the invention substantially as claimed. However, it fails to disclose the component defining a plurality of openings disposed proximate to at least one of the at least one orifice, the opening being a first opening of the plurality of openings, the plurality of openings being dimensioned such that application of a sufficient negative pressure from the plurality of openings encourages patient skin toward each of the plurality of opening. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Slate with more orifices in order to improve the suction against the skin. Moreover, this modification is also considered duplication of parts. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960); “…the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.”.
Allowable Subject Matter
Claim 18 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 PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Mon-Thur 8am- 2pm..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783