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 § 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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pub. No. 2019/0201615 to You et al (“You”).
Regarding claims 1-4, You discloses a medical injection apparatus (Fig. 2a), comprising a first reservoir (Liquid Reservoir 1) configured to contain a medical solution; a second reservoir (Liquid Reservoir 2) configured to contain liquid medicine; the first reservoir is coupled in parallel with the second reservoir (see fig. 2a);.a static mixer (Mixing Chamber) configured to receive the solution from the first reservoir; receive the liquid medicine from the second reservoir; and obtain a medical solution by mixing the medicine with the solution (para. [0031] stating, “This design is especially advantageous in a situation that requires mixing two different liquids immediately prior to injection or pre-mixing of liquids are not preferred.”); a valve (Outlet Valve) connected between the first reservoir, the second reservoir, and the static mixer (see Fig. 2a), the valve configured to seal each of the first reservoir, the second reservoir, and the static mixer with respect to one another responsive to the valve being closed (the valve is closed before the bubble expands, see para. [0031] stating, “When bubble expands under external acoustic waves, the two inlet valves close and the two outlet valves open, pushing liquid into the one common outlet chamber connected to a micro-needle or other means for injecting.”); and pass the saline solution from the first reservoir and pass the medicine from the second reservoir to the static mixer responsive to the valve being opened (see para. [0031] above); and an injection unit (Micro-Needle) configured to receive the medical solution from the static mixer; and inject the medical solution into a skin of a subject (see para. [0031]).
Regarding claim 5, You is inherently configured to contain a liquid medicine of botulinum toxin. The instant specification does not set forth any particular requirements for the reservoir configuration specific to containing botulinum other than being configured to contain a liquid. You specifically discloses that both reservoirs 1 and 2 are for containing liquid; therefore, they are configured to contain liquid botulinum toxin.
Claim(s) 1, 2, 4, 5, 10, 11 and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat. No. 10,744,311 to Onozuka et al (“Onozuka”).
Regarding claims 1, 2, 4, 10, 11 and 13-14, Onozuka discloses a medical injection apparatus (161), comprising a first reservoir (113) configured to contain a medical solution (117); a second reservoir (115) configured to contain liquid medicine (119); the first reservoir is coupled in parallel with the second reservoir (see fig. 13);.a static mixer (153) configured to receive the solution from the first reservoir; receive the liquid medicine from the second reservoir; and obtain a medical solution by mixing the medicine with the solution; and an injection unit (1) configured to receive the medical solution from the static mixer; and inject the medical solution into a skin of a subject; wherein the injection unit comprises one or more chambers (19); a primary pipe (66) connected to the static mixer (153); one or more secondary pipes (21, 23a, 23b) connecting the primary pipe to the one or more chambers, cach respective secondary pipe of the one or more sccondary pipes configured to receive the medical solution from the static mixer through the primary pipe; and pass the medical solution to a respective chamber of the one or more chambers; and a plurality of hollow microneedle arrays (5) attached to the one or more chambers, a tip (27) of each respective microneedle in each respective microneedle array of the plurality of microneedle arrays extruding from a surface of each respective chamber of the one or more chambers (protruding from surface 31), further comprising a plurality of cartridges (15), each respective cartridge of the plurality of cartridges connected between a respective chamber (19) of the one or more chambers and a respective microneedle (27) in a respective microneedle array of the plurality of microneedle arrays. Onozuka also discloses one or more elastic membranes (121/123), each respective elastic membrane of the one or more elastic membranes mounted on a respective chamber (fig. 10) and configured to push the medical solution from the respective chamber into each microneedle in a respective microneedle array of the plurality of microneedle arrays (5) responsive to the respective elastic membrane being pushed.
Regarding claim 5, Onozuka is inherently configured to contain a liquid medicine of botulinum toxin. The instant specification does not set forth any particular requirements for the reservoir configuration specific to containing botulinum other than being configured to contain a liquid. Onozuka specifically discloses that both reservoirs 1 and 2 are for containing liquid; therefore, they are configured to contain liquid botulinum toxin.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat. No. 4,191,183 to Mendelson (“Mendelson”).
Regarding claims 1-4, Mendelson discloses a medical injection apparatus (fig. 1), comprising a first reservoir (12, 14, 16, 18) configured to contain a saline solution (col. 1, In. 22); a second reservoir (12, 14, 16, 18) configured to contain medicine (liquids A-D); the first reservoir is coupled in parallel with the second reservoir (see fig. 1; a static mixer (50) configured to receive the solution from the first reservoir; receive the medicine from the second reservoir; and obtain a medical solution by mixing the medicine with the solution; a valve (52, 54, 56, 58) connected between the first reservoir, the second reservoir, and the static mixer, the valve configured to seal each of the first reservoir, the second reservoir, and the static mixer with respect to one another responsive to the valve being closed; and pass the saline solution from the first reservoir and pass the medicine from the second reservoir to the static mixer responsive to the valve being opened (col. 4, In. 10-32); and an injection unit (60) configured to receive the medical solution from the static mixer; and inject the medical solution into a skin of a subject (para. 1).
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pub. No. 2011/0196308 to Kodgule et al. (“Kodgule”).
Regarding claims 1-4, Kodgule also discloses a medical injection apparatus, comprising a first reservoir (1) configured to contain a solution; a second reservoir (2) configured to contain liquid medicine (biological material: para. 35-37); the first reservoir is coupled in parallel with the second reservoir (see fig. 2);.a static mixer (7) configured to receive the saline solution from the first reservoir; receive the medicine from the second reservoir; and obtain a medical solution by mixing the medicine with the solution; a valve (5, 6) connected between the first reservoir, the second reservoir, and the static mixer, the valve configured to seal each of the first reservoir, the second reservoir, and the static mixer with respect to one another responsive to the valve being closed; and pass the saline solution from the first reservoir and pass the medicine from the second reservoir to the static mixer responsive to the valve being opened (para. 80); and an injection unit (8) configured to receive the medical solution from the static mixer; and inject the medical solution into a skin of a subject.
Claim(s) 1, 2 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pub. No. 2004/0260234 to Srinivasan et al. (“Srinivasan”).
Regarding claims 1, 2 and 4, Srinivasan also discloses a medical injection apparatus (100) comprising a first reservoir (324) configured to contain a solution; a second reservoir (306 or 326) configured to contain liquid medicine (108); the first reservoir being coupled in parallel with the second reservoir (fig. 5); a static mixer (102 and tube leading to 112); a valve (112) and an injection unit (104).
Claim(s) 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pub. No. 2020/0188648 to Klemm et al. (“Klemm”).
Regarding claim 15, Klemm discloses method for medical injection (see the embodiment of Fig. 7, method steps are considered inherently necessary in order for the device to work as disclosed), comprising: containing a saline solution (see para. [0078]) in a first reservoir (236); containing medicine in a second reservoir (12); receiving the saline solution from the first reservoir at a static mixer (19); receiving the medicine from the second reservoir at the static mixer (19); obtaining, utilizing the static mixer, a medical solution by mixing the medicine with the saline solution (see para [0077] stating, “As shown in FIG. 7, the system 230 comprises a mechanism for mixing the chemical penetration enhancer to the medicament prior to the medicament delivery into the skin of the patient.”); receiving the medical solution from the static mixer at an injection unit (15 and 16); and injecting, utilizing the injection unit, the medical solution into a skin of a subject (via injection needles 16).
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) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over You in view of US Pat. No. 6,611,707 to Prausnitz et al (“Prausnitz”).
Regarding claim 6, You teaches the first and second reservoirs being mounted on the static mixer (fig. 2a). You fails to teach the first reservoir being mounted on the second reservoir. However, Prausnitz discloses a medical injection apparatus comprising a first reservoir (56) configured to contain a saline solution (col. 7, In. 33); a second reservoir (58) configured to contain medicine (54), the second reservoir configured to receive the saline solution from the first reservoir and obtain a medical solution by mixing the medicine with the solution (col. 7, In. 35); and an injection unit (14) configured to receive the medical solution from the second reservoir; and inject the medical solution into a skin of a subject; wherein the first reservoir is mounted on the second reservoir (fig. 4B). It is considered that it would have been obvious for a person skilled in the art to modify You's apparatus by mounting the first reservoir on the second reservoir, as taught by Prausnitz, rather than in parallel to allow a more compact apparatus.
Regarding claim 7, Prausnitz further discloses the first reservoir comprises an elastic balloon (col. 6, In. 51-52); and the medical injection apparatus further comprises one of a barrier or a semipermeable membrane (52) placed between the elastic balloon and the second reservoir, each of the barrier and the semipermeable membrane configured to pass the saline solution from the elastic balloon to the second reservoir responsive to pressing the elastic balloon (col. 6, In. 46-64).
Regarding claim 8, You discloses the medical injection apparatus comprising a valve (Inlet Valves, Bubble, Outlet Valves) connected between the first reservoir and the second reservoir, the valve configured to seal the first reservoir with respect to the second reservoir responsive to the valve being closed. The modified apparatus of You and Prausnitz would have been configured to push the medicine from the second reservoir to the static mixer by passing the saline solution from the first reservoir to the second reservoir responsive to the valve being opened.
Regarding claim 9, You in view of Prausnitz fail to teach that the medicine comprises a botulinum toxin powder. However, the medicine itself is never positively recited. Claim 9 ultimately depends from claim 1 which only recites that the second reservoir is configured to contain medicine. Therefore, claim 9 only requires that the second reservoir is configured to contain botulinum toxin powder. Since the instant specification does not set forth any particular requirements for the reservoir configuration specific to containing botulinum toxin powder other than being configured to contain a powder, the combination of You and Prausnitz meets the claim limitation since the reservoir of Prausnitz is disclosed as containing a powder. See the combination set forth applied to claim 6 above.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Onozuka in view of You.
Regarding claim 12, Onozuka discloses a spring (83) mounted on the reservoirs configured to push the medical solution from the static mixer into the primary pipe. Onozuka fails to disclose a valve connected between the static mixer (153) and the primary pipe (66). However, You discloses using micro valves to control the intake and discharge of liquids (para. 32-34). It is considered that it would have been obvious to a person skilled in the art to incorporate a valve between the static mixer and the primary pipe since You discloses that the valve provides flow control to the device which would enhance overall medicine dispensing.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klemm in view of Prausnitz.
Klemm meets the claim limitations as described above for claim 15 but fails to disclose that the first reservoir is mounted on the second reservoir.
However, Prausnitz discloses a medical injection apparatus comprising a first reservoir (56) configured to contain a saline solution (col. 7, In. 33); a second reservoir (58) configured to contain a powdered medicine (54), the second reservoir configured to receive the saline solution from the first reservoir and obtain a medical solution by mixing the medicine with the solution (col. 7, In. 35); and an injection unit (14) configured to receive the medical solution from the second reservoir; and inject the medical solution into a skin of a subject; wherein the first reservoir is mounted on the second reservoir (fig. 4B). As shown by Prausnitz the first reservoir is mounted on the second reservoir.
At the time of the invention, it would have been obvious to use the first and second reservoir construction of Prausnitz as the two reservoir configuration as taught by Klemm in Fig. 7. The motivation to make the incorporation would have been in order to provide complete mixing through the reservoir.
Regarding claim 17, the combination of You in view of Prausnitz teaches wherein receiving the saline solution from the first reservoir at the static mixer and receiving the medicine from the second reservoir at the static mixer comprise: pushing the medicine from the second reservoir to the static mixer, comprising: passing the saline solution from the first reservoir to the second reservoir by opening a first valve (52) connected between the first reservoir and the second reservoir.
Regarding claim 18, the combination of You in view of Prausnitz teaches the method of claim 16 and also teaches wherein receiving the medical solution from the static mixer at the injection unit comprises: passing the medical solution from the static mixer to a primary pipe (see annotated Fig. 7 below) connected to the static mixer; passing the medical solution from the primary pipe to a respective chamber (19b) of one or more chambers through a respective pipe (see annotated Fig. 7 below) of one or more pipes connecting the primary pipe to the one or more chambers; and passing the medical solution from the respective chamber to each respective hollow microneedle in a respective hollow microneedle array of a plurality of hollow microneedle arrays attached to the one or more chambers, a tip of the each respective microneedle extruding from a surface of the respective chamber (see Fig. 7 and para. [0054]).
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Regarding claim 19, the combination of You in view of Prausnitz teaches the method of claim 17 and Prausnitz further teaches wherein injecting the medical solution comprises: mounting a compressed spring (34) on the first reservoir; connecting a second valve (52) between the static mixer and the primary pipe; and pushing, utilizing the compressed spring, the medical solution from the static mixer into and the primary pipe by opening the second valve (see col. 7, ll. 28-35).
Regarding claim 20, the combination of You in view of Prausnitz teaches the method of claim 17, wherein injecting the medical solution comprises: mounting each respective elastic membrane (see col. 4, ll. 65-67) of one or more elastic membranes on a respective chamber (56) of the one or more chambers; and pushing the medical solution from the respective chamber into each microneedle in a respective microneedle array of the plurality of microneedle arrays by pushing a respective elastic membrane of the one or more elastic membranes (see col. 6, ll, 46-64).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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/CATHERINE S WILLIAMS/ Primary Examiner, Art Unit 3993
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