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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 C.F.R. § 1.55, filed in this international application.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities: both claims use two colons, which in the instant case unnecessarily complicates the sentences; and Claim 7, line 2, is missing a word. Appropriate correction is required.
Claim Interpretation
The claims of this application use the term “overmolded,” which is a product-by-process limitation; it has been interpreted as laid out in M.P.E.P. § 2113.
Claim Rejections - 35 USC § 102
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 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 9,311,592, granted to Vitello et al. (“Vitello”).
Vitello describes devices as claimed by Applicant, as follows.
Claim 1: A needle cover for protecting a needle mounted on a tip of a medical injection device, wherein the tip extends from a distal end of the medical injection device, the needle cover, comprising:
an inner shield (30 in Figs. 3-3C), extending along a longitudinal axis (center line of its cylinder), and an outer shield surrounding at least partially the inner shield (22), and operatively connected to said inner shield (col. 14, lines 14-17), the needle cover being characterized in that:
the needle cover further comprises a tamper evidence ring (32) that identifies whether the needle cover has been removed from the tip of the medical injection device (col. 13, line 66 to col. 14, line 13).
Claim 2: (The needle cover of claim 1,) wherein the tamper evidence ring comprises at least one of the following: a Bluetooth tag, a radio frequency identification (RFID) tag (col. 14, line 63 to col. 15, line 19), an ultra-wide-band real-time location system (RTLS), a Wi-Fi RTLS, and an infrared RTLS.
Claim 3: (The needle cover of claim 2,) wherein the RFID tag is overmolded (see treatment above) with the tamper evidence ring (id.).
Claim 4: (The needle cover of Claim 1,) wherein the tamper evidence ring comprises a lower portion and an upper portion (Fig. 16, ring 32 has antenna 204 embedded therein, any two portions of the ring can be the claimed upper and lower portions), wherein each of the lower portion and the upper portion include a portion of an antenna (same).
Claim 5: (The needle cover of claim 4,) wherein a conductive bridge is established between the antenna portions of the lower portion and the upper portion of the tamper evidence ring (any middle portion of the antenna 204 is read on by the conductive bridge).
Claim 6: (The needle cover of Claim 1), wherein the tamper evidence ring further comprises a bridge (frangible members 34 in Fig. 16A) that establishes a breakable connection between the tamper evidence ring and the medical injection device.
Claim 7: A medical injection device, comprising:
a barrel (1 in Fig. 1) extending [sic: “from”] a proximal face (at the larger flange) to a distal face (end of barrel adjacent to Luer fitting 2), wherein a tip is provided on the distal face of the barrel (4); and
a needle cover (20 in Fig. 3-3D) for protecting a needle mounted on the tip of the medical injection device (needle is not claimed; the cover 20 is fully capable of protecting at least a portion of the unclaimed needle, were an appropriate one mounted to the Luer fitting), the needle cover, comprising:
an inner shield (30 in Figs. 3-3C), extending along a longitudinal axis (center line of its cylinder), and an outer shield surrounding at least partially the inner shield (22), and operatively connected to said inner shield (col. 14, lines 14-17), the needle cover being characterized in that:
the needle cover further comprises a tamper evidence ring (32) that identifies whether the needle cover has been removed from the tip of the medical injection device (col. 13, line 66 to col. 14, line 13).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent App. Pub. No. 2021/0220573 describes syringes with antennae.
The balance of the documents cited with this Office Action relate generally to medical devices with radio-based tamper revealing features.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http:// patentcenter.uspto.gov.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866.217.9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800.786.9199 (IN USA OR CANADA) or 571.272.1000.
/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights