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 (IDS) submitted on 6/5/23 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner.
Claim Objections
Claim 11 is objected to because of the following informalities: the dependency was not properly carried over in the amended claim. Appropriate correction is required. Claim 12 is further objected to based on dependency. Examiner interprets claim 11 to depend from claim 1.
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.
6. Claims 1-7, 9, 11-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCullough et al. (US 10,695,492) (“McCullough”).
(claim 1) McCullough discloses: A drug delivery device comprising (Figs. 18a-c): a syringe barrel 1810 comprising a proximal end, a distal end, and a sidewall arranged between the proximal end and the distal end defining an interior configured to hold a composition; a plunger rod 1820 received at least partially within the interior of the syringe, the plunger rod comprising a proximal end 1822, a distal end 1824, and a stopper 1826 arranged at the distal end; and a sensor assembly 1880, comprising: a capacitive element 1892,1894; and a short-range communication device (communication module) 1872 in electrical communication with the capacitive element, wherein the short-range communication device is capable of measuring capacitance at the capacitive element C47L3-50; a displaceable needle shield 1860; and a spring 1882 having a compressed configuration and an expanded configuration, the spring configured to displace the needle shield from a first, proximal position in which the displaceable needle shield does not surround a needle of the syringe to a second, distal position in which the displaceable needle shield at least partially surrounds the needle of the syringe, wherein the capacitive element is configured to detect a change in capacitance based on a change in state of the spring from the compressed configuration to the expanded configuration. C46L49-C47L50
(claims 2, 16; 4, 18) the sensor assembly does not include a power source. (NFC technology as herein found powers the sensor assembly C38L41-51, C63L7-17)
(claims 3, 17) the short-range communication device 1872 is an NFC device (C38L41-51)
(claims 5, 19) the external NFC- enabled device is a mobile device 110.
(claims 6, 20) the capacitive element comprises a pair of capacitor electrodes 1892,1894.
(claims 7, 21) the capacitive element is arranged at the distal end of the syringe barrel. Figs. 18a-c
(claim 9) the short-range communication device is a passive RFID chip. (C38L41-51)
(claim 11) the sensor assembly 1880 is arranged on the displaceable needle shield 1860. C46L49-C47L2
(claim 12) the capacitive element 1892,1884 is arranged on the displaceable needle shield adjacent the spring. C46L49-C47L2
(claim 13) see rejection of claim 1 and 5, above
(claim 14) see rejection of claim 1, 4 and 5, above. And additionally,
transmitting, with the short-range communication device and to the mobile device, the first capacitance data. C47L28-50
(claim 15) further comprising: actuating the drug delivery device; powering, with a mobile device, the sensor assembly to obtain second capacitance data; and transmitting, with the short-range communication device and to the mobile device, the second capacitance data. C47L28-50, C63L7-17)
Claim Rejections - 35 USC § 103
7. 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.
8. 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.
9. 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.
10. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McCullough in view of Ploch et al. (US 2021/0085879) (“Ploch”).
McCullough discloses the invention as substantially claimed (see above). However, McCullough does not directly disclose the sensor assembly comprises a label arranged on an exterior of the syringe sidewall. Ploch, in the analogous art, teaches an RFID device 300 placed on a housing component such as a label [0062]. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the communication module of McCullough as a label as taught by Ploch for portability and ease of the wireless communication.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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