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.
Claim(s) 1, 6, 8, 10, 12-14, 18, 19, and 23-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thilly et al (US 2009/0306620).
Regarding Claim 1, Thilly discloses a vessel (vial 70, Fig. 3) having an electronic component (RFID 72, Fig. 3) attached to the vessel (70, Fig. 3);
wherein the vessel is a syringe barrel, vial, or cartridge (vial 70, Fig. 3; ¶ [0001-0004, 0067]) having a thermoplastic wall (base wall 73, Fig. 3; ¶ [0014, 0067]);
wherein the electronic component (72, Fig. 3) is embedded (¶ [0067]) in the thermoplastic wall (73, Fig. 3) of the vessel (70, Fig. 3); and
wherein the electronic component (72, Fig. 3) is configured to provide both the vessel (70, Fig. 3) in an unfilled state and a pharmaceutical package that results from filling a lumen of the vessel (70, Fig. 3) with a pharmaceutical solution and then sealing the lumen with the ability to be traced (¶ [0002-0004]).
Regarding Claim 6, Thilly discloses the electronic component (72, Fig. 3) is an RFID tag (¶ [0067]).
Regarding Claim 8, Thilly discloses the electronic component (72, Fig. 3) comprises data storage (¶ [0049]).
Regarding Claim 10, Thilly discloses the thermoplastic wall (73, Fig. 3) of the vessel (70, Fig. 3) comprises COC (¶ [0014, 0067]).
Regarding Claim 12, Thilly discloses the electronic component (72, Fig. 3) is overmolded (¶ [0067]) into the thermoplastic wall (73, Fig. 3) of the vessel (70, Fig. 3).
Regarding Claim 13, Thilly discloses a thermoplastic material that makes up at least a portion of the vessel wall (73, Fig. 3) completely or substantially completely surrounds the electronic component (72, Fig. 3; ¶ [0067]).
Regarding Claim 14, Thilly discloses no part of the electronic component (72, Fig. 3) is present on an outer surface of the vessel wall (73, Fig. 3).
Regarding Claim 18, Thilly discloses the electronic component (72, Fig. 3) is configured to be written using an external writer (¶ [0049-0050]).
Regarding Claim 19, Thilly discloses the vessel (70, Fig. 3) is configured such that the electronic component (72, Fig. 3) can withstand sterilization (¶ [0051]).
Regarding Claim 23, Thilly discloses an inner surface, an outer surface, or both, of the wall (73, Fig. 3) in which the electronic component (72, Fig. 3) is embedded are identical or substantially identical to those of the wall of the same vessel prepared without the electronic component ([¶ [0043, 0067]; compare Figs. 1 and 3, where Fig. 1 does not have the RFID tag within the base wall, but the walls are otherwise the same).
Regarding Claim 24, Thilly discloses the electronic component (72, Fig. 3) comprises identification information stored directly on the component (¶ [0004, 0013, 0049]).
Regarding Claims 25 and 26, Thilly discloses the electronic component (72, Fig. 3) is readable and writeable without connection to a computing network such as a cloud-computing network (¶ [0049-0050]; since the information is stored directly on the RFID chip, the chip can be read and written by an RFID scanner without connecting to a cloud network; this is substantially similar to that discussed by Applicant in ¶ [0178] of the published specification).
Claim(s) 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thilly et al (US 2009/0306620) as evidenced by Hyde et al (US 2016/0114104).
Regarding Claim 7, Thilly discloses the electronic component (72, Fig. 3) comprises an integrated circuit (Thilly indicates the electronic component is an RFID tag, and Hyde teaches that RFID tags include a miniature integrated circuit in ¶ [0058]); therefore, the RFID tag of Thilly inherently comprises an integrated circuit).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thilly et al (US 2009/0306620) in view of Miwata (US 2021/0233433).
Regarding Claims 15 and 16, Thilly is silent whether the vessel further comprises a label, wherein the electronic component is embedded in a portion of the vessel that is visually concealed by the label, and wherein the vessel is configured so that the electronic component is visually concealed by a portion of the pharmaceutical package.
Miwata teaches a pharmaceutical container, thus being in the same field of endeavor, further comprising a label (4, Fig. 4) that visually conceals the bottom surface (13b, Fig. 4) of the container (100, Figs. 3-4). This allows the medication to be protected from light transmission through the container (¶ [0041]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vessel of Thilly to include a label concealing the bottom surface of the container as taught by Miwata, such that the electronic component of Thilly/Miwata is embedded in a portion of the vessel that is visually concealed by the label which can be considered a portion of a pharmaceutical package, as taught by Miwata. This protects the medication within the container from being damaged by light transmission through the bottom of the container (as motivated by Miwata ¶ [0041]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thilly et al (US 2009/0306620) in view of Van Ginneken (US 2020/0390978).
Regarding Claim 17, Thilly is silent whether the electronic component is detectable by automated visual inspection of the vessel in an empty state.
Van Ginneken teaches a pharmaceutical container, thus being in the same field of endeavor, where the container is made of a transparent thermoplastic material (¶ [0135]).
Therefore, it would have been obvious to modify the thermoplastic material of Thilly to be a transparent thermoplastic material, as taught by Van Ginneken, to ensure the medication within the vial can be inspected visually for quality. The combination of Thilly/Van Ginneken would have the electronic component detectable by automated visual inspection of the vessel in an empty state since the wall 73 would be transparent, allowing the RFID chip to be visible through the transparent wall.
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thilly et al (US 2009/0306620) in view of Watt et al (US 2013/0057390).
Regarding Claims 20 and 21, Thilly is silent whether the electronic component comprises a temperature sensor or a pressure sensor.
Watt teaches an RFID tag, thus being in the same field of endeavor, where the RFID tag includes a pressure sensor and a temperature sensor (¶ [0049]). This allows the RFID tag to track the sterilization of associated items and ensure and record that proper sterilization temperatures/pressure have been reached (¶ [0003-0007]).
Therefore, it would have been obvious to modify the RFID tag of Thilly to include a temperature sensor and a pressure sensor, as taught by Watt, to allow the RFID tag to also track the sterilization of the vial and ensure and record that proper sterilization temperatures and pressures have been reached (as motivated by Watt ¶ [0003-0007]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thilly et al (US 2009/0306620) in view of LaBorde (US 9977865).
Regarding Claim 22, Thilly is silent whether the electronic component is configured to register an interrogation event into a database.
LaBorde teaches a system including RFID chips affixed to medical items, thus being in the same field of endeavor, where the electronic component is configured to register an interrogation event into a database (Col. 28 lines 20-41). This allows the locations and history of the RFID tag to be maintained in a database for future reference (as motivated by LaBorde Col. 28 lines 20-41).
Therefore, it would have been obvious to modify the RFID tag of Thilly to be configured to register an interrogation event into a database, as taught by LaBorde, to have the locations and history of the RFID tag be maintained in a database for future reference (as motivated by LaBorde, Col. 28 lines 20-41).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781