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 .
Response to Arguments
Applicant’s amendment filed 07/14/2026 is accepted and entered.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Davidowitz/Thilly/Meyer is now cited to disclose the limitations of Claim 1, with Thilly only being relied upon for the thermoplastic material of the container.
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.
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) 1, 6-8, 10, 12-14, 18, and 20-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidowitz et al (US 2021/0061541) in view of Thilly et al (US 2009/0306620) further in view of Meyer (US 2008/0068178).
Regarding Claim 1, Davidowitz discloses a vessel (vial 330, Fig. 3C) having an electronic component (307, Fig. 3C) attached to the vessel (330, Fig. 3C);
wherein the vessel (330, Fig. 3C) is a vial (330, Fig. 3C; ¶ [0031, 0035]) having a plastic wall (container 300, Fig. 3C; ¶ [0027]),
wherein the electronic component (307, Fig. 3C) is configured to provide both the vessel (330, Fig. 3C) in an unfilled state and a pharmaceutical package that results from filling a lumen of the vessel (330, Fig. 3C) with a pharmaceutical solution and then sealing the lumen with the ability to be traced (¶ [0036]); and
wherein the vessel (330, Fig. 3C) is a vial (330, Fig. 3C; ¶ [0031, 0035]) with a thickened flange region (lip 306, Fig. 3A, unlabeled in Fig. 3C) and a stopper (301, Fig. 3A; stopper is unlabeled in Fig. 3C) and crimp closure (cap with crimpable skirt 302, Fig. 3A; cap and skirt unlabeled in Fig. 3C; ¶ [0026-0027]).
Davidowitz is silent whether the plastic wall is a thermoplastic wall, and whether the electronic component is embedded in the thickened flange region of the vial and configured to be visually concealed by the stopper and crimp closure.
Thilly teaches a medicinal vial, thus being in the same field of endeavor, where the vial is made of COC (¶ [0014, 0067]), a polymer disclosed as a thermoplastic material in Applicant’s specification (see Applicant’s published specification, ¶ [0011]). COC is a hard plastic material that is accepted for use in the pharmaceutical industry and is capable of being injection molded (¶ [0014]).
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 generic plastic material of Davidowitz to be the thermoplastic material COC, as taught by Thilly, as Thilly indicates that COC is a well known and accepted plastic for manufacturing pharmaceutical vials via injection molding (¶ [0014]). Since the vial of Davidowitz is also made by injection molding (¶ [0037]), the COC of Thilly is an acceptable material to use to construct the vial of Davidowitz. Further, it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Davidowitz/Thilly is silent whether the electronic component is embedded in the thickened flange region of the vial and configured to be visually concealed by the stopper and crimp closure.
Meyer teaches a container, thus being in the same field of endeavor, with an RFID antenna molded into the neck of the container (¶ [0012]).
Therefore, it would have been obvious to modify the vessel of Davidowitz/Thilly to have the electronic component embedded in the thickened flange region of the vial, as taught by Meyer, who indicates that electronic components can be molded into the neck of a container (¶ [0012]). This is further motivated by Davidowitz, who indicates that those of ordinary skill in the art would understand that there are other ways and locations for configuring the electronics component within the vial (¶ [0035]). One of ordinary skill in the art would find it obvious to place the electronics component in the thickened flange region of the vial of Davidowitz/Thilly based on both the teachings of Meyer and the knowledge of one of ordinary skill in the art, who would find it obvious to place the electronics component in the thickened portion of the neck to ensure the electronics would be fully embedded within the neck, as the thickened portion would more likely fully embed the electronics components than the non-thickened portion. The combination of Davidowitz/Thilly/Meyer would have the electronic component embedded in the thickened flange region of the vial, and the electronic component would be configured to be visually concealed by the stopper and crimp closure.
Regarding Claim 6, Davidowitz further discloses the electronic component (307, Fig. 3C) is an RFID tag (¶ [0036, 0042-0046, 0061-0062]; the electronics can utilize RFID communication methods and therefore can be considered an RFID tag).
Regarding Claim 7, Davidowitz further discloses the electronic component (307, Fig. 3C) comprises an integrated circuit (¶ [0039]; a microprocessor is a type of integrated circuit).
Regarding Claim 8, Davidowitz further discloses the electronic component (307, Fig. 3C) comprises data storage (memory 409, Fig. 4A; ¶ [0039]).
Regarding Claim 10, Davidowitz/Thilly/Meyer discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Davidowitz/Thilly/Meyer further discloses the thermoplastic wall of the vessel comprises COC (Thilly ¶ [0014, 0067]).
Regarding Claim 12, Davidowitz further discloses the electronics component (307, Fig. 3C) is overmolded into the wall (300, Fig. 3C) of the vessel (330, Fig. 3C; ¶ [0031, 0037]; the electronic component is embedded within the wall via injection molding and therefore is overmolded).
Regarding Claim 13, Davidowitz further discloses the material that mades up at least a portion of the vessel wall (300, Fig. 3C) completely or substantially completely surrounds the electronic component (307, Fig. 3C; ¶ [0031, 0037], since the electronic component is embedded within the wall the wall completely surrounds the electronic component).
Regarding Claim 14, Davidowitz further discloses no part of the electronic component (307, Fig. 3C) is present on an outer surface of the vessel wall (300, Fig. 3C; ¶ [0031], since the electronic component is embedded within the wall, no part of the electronic component would be present on an outer surface).
Regarding Claim 18, Davidowitz further discloses the electronic component (307, Fig. 3C) is configured to be written to using an external writer (¶ [0057, 0064, 0072]).
Regarding Claim 20, Davidowitz further discloses the electronic component (307, Fig. 3C) comprises a temperature sensor (408, Fig. 4A; ¶ [0036, 0040]).
Regarding Claim 21, Davidowitz further discloses the electronic component (307, Fig. 3C) comprises a pressure sensor (408, Fig. 4A; ¶ [0036, 0040]).
Regarding Claim 22, Davidowitz further discloses the electronic component (307, Fig. 3C) is configured to register an interrogation event into a database (¶ [0041, 0054]).
Regarding Claim 23, Davidowitz further discloses an inner surface, an outer surface, or both, of the wall (300, Fig. 3C) in which the electronic component (307, fig. 3C) is embedded are identical or substantially identical to those of the wall of the same vessel prepared without the electronic component (¶ [0031, 0037]; the vials would be prepared by injection molding with or without embedding the electronic component, so the surfaces of the vessel walls are substantially identical in a vessel with and without the electronic component).
Regarding Claim 24, Davidowitz further discloses the electronic component (307, Fig. 3C) comprises identification information (410, Fig. 4A) stored direction on the component (307, Fig. 4A; ¶ [0039-0041]).
Regarding Claims 25 and 26, Davidowitz further discloses the electronic component (307, Fig. 3C) is readable and writable without connection to a computing network such as a cloud-computing network (¶ [0036, 0042-0046, 0056-0058, 0062]; since the information can be stored directly on the component, the chip can be read and written by a scanner without connecting to a cloud network; this is substantially similar to that discussed by Applicant in ¶ [0178] of the published specification).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidowitz et al (US 2021/0061541) in view of Thilly et al (US 2009/0306620) further in view of Meyer (US 2008/0068178), and further evidenced by Helmer (US 2022/0296814).
Regarding Claim 19, Davidowitz/Thilly/Meyer discloses the claimed invention substantially as claimed as set forth above for Claim 1.
Davidowitz/Thilly/Meyer further discloses the vessel is configured such that the electronic component can withstand sterilization by ethylene oxide, since Davidowitz/Thilly/Meyer utilizes COC, a thermoplastic polymer (Thilly ¶ [0014, 0067]), and Helmer indicates that pharmaceutical containers made of COC can withstand sterilization by ethylene oxide (Helmer ¶ [0067]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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