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 § 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, 4-6, 8, 11, 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perriere (US 2010/0121271).
Regarding claim 1, Perriere discloses an injector 1/51 comprising:
a base 2/52;
a housing 3/53 movable relative to the base 2/52;
a needle unit (including base 16/516, cone 16/516 & needle 14/514) disposed within the base 2/52, the needle unit comprising at least one piercing needle 16/516 configured to pierce a pierceable membrane 17/517 of a drug product container 12/512, and at least one microneedle 14/514 disposed on an opposite side of the at least one piercing needle 16/516; and
a driving mechanism (spring 18 & pump 13 in Figs. 1-4; or spring 518, rotary drive system 528, pump 513 in Figs. 5-8) configured and arranged to drive at least one of the drug product container and the needle unit toward another of the drug product container and the needle unit, paras [0042-0046, 0058, 0083-0086, 0095-0097, 0101-0102].
Regarding claim 4, wherein the at least one piercing needle 16/516 comprises a plurality of piercing needles.
Regarding claim 5, wherein at least one microneedle 14/514 comprises a plurality of microneedles.
Regarding claim 6, wherein the needle unit comprises at least one channel providing fluid communication between the at least one piercing needle and the at least one microneedle (e.g., the pump 13 operates to drawn substance from the reservoir and deliver it to the needles 14, para [0046]; the percussion cones 16 come into contains with the capsules 17 so as to pierce them and create a leak tight passage so that the medicinal substance contained in the reservoir 12 is transmitted to the pump13, para [0053]; the percussion cones 516 and the capsules 517 are designed to co-operates with one another when the are moved together so as to create a passage between the reservoir 512 and the pump 513, para [0076])
Regarding claim 8, wherein the base (element 5/55 is a part of the base 2/52) defines an open 19/519 bottom through which the needle unit (e.g., microneedle 14/514 is a part of the needle unit) may pass.
Regarding claims 11, 14-15, this claim is rejected using the same analysis as noted above with regard to claims 1, 4-5.
Regarding claims 16-20 , they encompass(es) the same scope of the invention as to that of claims 1 & 11 except they are drafted in method format instead of apparatus format. The claims 16-19 are therefore rejected for the same reason as set forth above. With aspect to claim 20, a driving mechanism that includes a spring18/518 & 523.
It is noted that Examiner believes that device and method claims are not patentable distinguish from each other. In other words, if the device/apparatus claim (or method claim) is unpatentable and rejected over the prior art, the evidence or admission may be used in a rejection under method claim (or device/apparatus claim) as well. Therefore, claims 1-20 are examined together. However, if Applicant believes that the device and method claims are patentable distinguishable, then the claims would be subject to further Election/Restriction.
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.
Claims 2, 7 & 12 are rejected under 35 U.S.C. 103 as being unpatentable over Perriere (US 2010/0121271) in view of Leroy et al. (US 2006/0207912).
Regarding claims 2 & 12, Perriere discloses all the claimed subject matter as required except for the limitations that a thermoformed cover in the drug container and wherein the pierceable membrane includes a frangible foil seal.
Leroy discloses a plastic package for pharmaceutical product including a thermoformed cover (lower portion 2 of package is thermoformed, para [0025], Fig. 1); and wherein a pierceable membrane include a frangible foil seal (cover member is a polypropylene foil which can be readily stripped to access the pharmaceutical product, Fig. 1, para [0024])
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the injector device of Perriere with obtaining thermoformed cover in the drug container and a frangible foil seal, as taught by Leroy, in order to keep the package in sterile condition.
Regarding claim 7, Perriere in view of Leroy discloses all the claimed subject matter as required. Perriere further teaches that the driving mechanism comprises a driving spring 523 disposed above the drug product container 512 and a counter spring 518 disposed below the drug product container 512.
Claims 3, 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Perriere (US 2010/0121271).
Regarding claims 3 & 13, Perriere discloses the claimed invention as required; wherein the drug container 12/512 includes a cylindrical or circular shaped compartment for storing a drug product. Meanwhile, the claimed invention requires that the drug container includes a halo-shape compartment. It would have been an obvious matter of design choice to obtain a halo-shaped, since applicant has not disclosed that the halo-shaped of the compartment solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with a cylindrical/circular shaped compartment in Perriere.
Regarding claim 10, it appears to Examiner that the needle unit comprises a rigid material for holding the needle 14/514. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain a rigid material in the needle unit, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Perriere (US 2010/0121271) in view of Yang et al. (US 12,569,167).
Regarding claims 3 & 13, Perriere discloses the claimed invention as required except for the limitation that the needle unit comprises absorbable patch.
Yang discloses an injector comprising: a needle unit 1000 includes a microneedle unit 1500; wherein the needle unit comprises an absorbable patch 1000, col. 7, lines 13-16.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device ofPerriere with providing an absorbable patch in the needle unit, as taught by Yang, in order to allow a fluid being absorbed into the absorbable patch.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
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