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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 29th, 2026 has been entered.
Claim Status
Claims 1-13 are currently pending in the application and under consideration. Claims 1 has been amended.
Response to Arguments
Applicant’s arguments submitted on June 29th, 2026 have been considered and while the rejection is seen to overcome the previously presented rejection of claim 1 with Bauss in view of Konrad, the disclosure of Flippe et al. (U.S. Publication 2018/0161524) as seen in the rejection below is seen to render the amended claim limitation obvious in the combination of Bauss in view of Konrad and further in view of Flippe.
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.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauss et al. (U.S. Publication 2019/0217018) in view of Konrad (U.S. Publication 2001/0021356) and further in view of Flippe et al. (U.S. Publication 2018/0161524).
Regarding claim 1, Bauss discloses an adaptor 330b for a medical container 400 having a distal tip 420, the adaptor comprising: a proximal part 360 configured to be secured onto the distal tip of the medical container (¶0084 securely connected to container 400 through connection 360), a distal part 340 configured to receive a connector (¶0084 internal threaded portion for example, a Luer Lok connector, receives mail threaded portion 345 of top 330a), and a remotely readable (¶0083 electronic component 202 configured to allow remote identification of the medical container when the adaptor is secured to the medical container, the remotely readable electronic component extends around an outer surface of the distal tip of the medical container (Fig. 15B shows the element 202 located around an outer surface of 420 of container and since the element 202 is a 3D object it would at least partially extend around the outer surface) and being at least partially embedded (¶0083 imbedded into hub 330b) into a body of the adaptor, the distal tip of the medical container extending distally past the remotely readable electronic component (Fig. 15B shows extension of distal tip past component 202 through the adaptor 330b), wherein an inner surface of the remotely readable electronic component is flush with an outer surface of the adaptor (Fig. 15B shows element 202 flush with surface of 330b), and an inner surface of the adaptor contacting the distal tip of the medical container (inner surface of 360 contacts distal tip).
Bauss does not expressly disclose the remotely readable electronic component being flush with the inner surface of the adaptor that is contacting the distal tip of the medical container, or a plurality of ribs along the inner surface of the adapter and the remotely readable electronic component between the plurality of ribs.
Regarding the remotely readable electronic component being flush with the inner surface of the adaptor that is contacting the distal tip of the medical container, Konrad, in the same field of endeavor of RFID tagged medical containers (Fig. 3), teaches a remotely readable electronic component 16 being embedded between two elements that are secured onto one another through insertion of one element into the other (¶0074 containers are arranged...so that it fits inside the container…the container can be inserted in the container, preferably with virtually no clearance), wherein the remotely readable electronic component is flush with both of the surfaces of the exterior and interior elements such that it is sandwiched between the elements and held internally therein, for the purpose of protecting the remotely readable electronic component from environmental influences as far as possible (¶0076).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the positioning of remotely readable electronic component of Bauss to have been flush with an interior surface of the adaptor that is contacting the distal tip of the medical container, as taught by Konrad, for the purpose of protecting the remotely readable electronic component from environmental influences by placing it between the two elements and since this rearrangement of the positioning of the remotely readable electronic component would not have changed the remotely readable electronic components ability to be read.
Furthermore, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Bauss in view of Konrad do not expressly disclose a plurality of ribs along the inner surface of the adapter and the remotely readable electronic component between the plurality of ribs.
However, Flippe, in the same field of endeavor of adaptors for drug delivery devices, teaches a plurality of ribs along the inner surface of the adapter for the purpose of homogenously distributing adhesive into an annular space to form a uniform adhesive layer segmented by the plurality of ribs ¶0054 and dividing adhesive into three portions which allow resisting the important torque applied when a connector is connected to the drug delivery device with the longitudinal ribs reducing the shear stress between the adhesive and either the outer surface of the longitudinal tip or the inner surface of the mounting ring of the adaptor…and blocking any potential rotational movement of the adaptor against the adhesive layer which contributes to increase the torque resistance of an adaptor bonded to the longitudinal tip of a drug delivery device by an adhesive layer ¶0058.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the adaptor of Bauss to have included a plurality of ribs along the inner surface of the adapter as taught by Flippe for the purpose of homogenously distributing adhesive into an annular space to form a uniform adhesive layer segmented by the plurality of ribs (¶0054 of Flippe) and dividing adhesive into three portions which allow resisting the important torque applied when a connector is connected to the drug delivery device with the longitudinal ribs reducing the shear stress between the adhesive and either the outer surface of the longitudinal tip or the inner surface of the mounting ring of the adaptor…and blocking any potential rotational movement of the adaptor against the adhesive layer which contributes to increase the torque resistance of an adaptor bonded to the longitudinal tip of a drug delivery device by an adhesive layer (¶0058 of Flippe).
The placement of the remotely readable electronic component between the plurality of ribs would have amounted to a mere rearrangement of the positioning of the remotely readable electronic component and since the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved a rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). The position of the remotely readable electronic component between the plurality of ribs would not have changed component’s ability to be remotely readable, and since applicant has not given any criticality to why the position of the part disclosed has any importance to the function of the claimed device this limitation would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Furthermore, Bauss in view of Konrad suggest the RFID chip being placed between the point of connection between the adaptor and the distal tip and this placement would have resulted in at least a portion of the RFID chip being between two of the protrusions taught by Flippe.
Regarding claim 2, Bauss in view of Konrad and Flippe suggest the adaptor according to claim 1. Bauss further discloses the remotely readable electronic component being an RFID tag including an RFID chip (¶0003 RFID tags (chips)).
Bauss does not expressly disclose the RFID tag including an RFID antenna, however, in a separate embodiment (Fig. 10 and 11) Bauss, in the same field of endeavor of medical containers with remotely readable components, teaches providing an RFID antenna 208 with the tag for the purpose of improving both the writing and reading of the RFID tag (¶0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the RFID tag of Bauss to have included an RFID antenna, as taught by Bauss, for the purpose of improving the writing and reading of the RFID tag (¶0059 of Bauss).
Regarding claim 3, Bauss in view of Konrad and Flippe suggest the adaptor according to claim 1. Bauss further discloses the proximal part 360 having at least one annular space (space in which distal tip is positioned through as seen in Fig. 15B) configured to accommodate a glue material (¶0084 connected to container through connection 360 which can be an adhesive connection). The positioning of the remotely readable material flush with the inner surface as suggested by Bauss in view of Konrad in the rejection of claim 1 above would have resulted in the electronic component being arranged so as to be covered by the glue material.
Regarding claim 4, Bauss in view of Konrad and Flippe suggest the adaptor according to claim 1. Bauss further discloses the adaptor being configured to be secured to the medical container by glueing (¶0084 adhesive connection).
Regarding claim 5, Bauss in view of Konrad and Flippe suggest the adaptor according to claim 1. Bauss further discloses the remotely readable electronic component being completely located within the proximal part of the adaptor (¶0083 imbedded into hub 330b).
Regarding claim 6, Bauss in view of Konrad and Flippe suggest the adaptor according to claim 1. Bauss in view of Konrad and Flippe further suggest the inner surface of the proximal part being provided with protrusion (ribs as taught by Flippe above protrude from the inner surface), and the RFID chip being located between two of the protrusions (above rejection of claim 1 details the positioning of the RFID chip between the ribs as a mere rearrangement of parts).
Regarding claim 7, Bauss in view of Konrad and Flippe suggest the adaptor according to claim 2. Bauss further discloses the proximal part comprising an annular ring (element 360 shown to annularly surround distal tip in Fig. 15B and thus is an annular ring). Bauss does not expressly disclose the RFID antenna being located in the annular ring.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the RFID antenna to be in the annular ring since this claimed position of the RFID antenna being in the annular ring does not change the antenna’s ability to improve the transmission of reading and writing signals to the RFID chip. Since applicant has not given any criticality to why the position of the antenna disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 8, Bauss in view of Konrad and Flippe suggest the adaptor according to claim 1. Bauss further discloses the adaptor being mounted onto the distal tip of the medical container (¶0084 securely connected to container; Fig. 15b shows connection around distal tip and to surface of distal tip thus mounted onto the distal tip).
Regarding claim 9, Bauss in view of Konrad and Flippe suggest the adaptor according to claim 1. Bauss further discloses the adaptor being secured to the distal tip by means of a glue material (¶0084 connected to container through connection 360 which can be an adhesive connection). The positioning of the remotely readable material flush with the inner surface as suggested by Bauss in view of Konrad in the rejection of claim 1 above would have resulted in the electronic component being arranged so as to be covered by the glue material and thus embedded between the adaptor and the glue material.
Regarding claim 10, Bauss in view of Konrad and Flippe suggest the adaptor according to claim 1. Bauss further discloses a method for manufacturing the medical container, the method comprising the steps of: providing the adaptor (¶0006 provides shield assembly), providing a distal tip of the medical container (¶0006 fixedly attached to medicament container and thus provided with shield assembly), connecting the adaptor to the distal tip by means of the proximal part of the adaptor (¶0084 330b securely connected to container through connection 360).
Regarding claim 11, Bauss in view of Konrad and Flippe suggest the adaptor according to claim 1. Bauss further discloses the remotely readable electronic component being an RFID tag including an RFID chip (¶0003 RFID tags (chips)) and a through opening (opening of 360 in which distal tip extends through).
Bauss does not expressly disclose the RFID tag including an RFID antenna, however, in a separate embodiment (Fig. 10 and 11) Bauss, in the same field of endeavor of medical containers with remotely readable components, teaches providing an RFID antenna 208 extending around an opening ( ¶0059 extends around outside surface, through opening can be seen in Fig. 11 to internal to the outside surface) of an adaptor 203 with the tag 202 for the purpose of improving both the writing and reading of the RFID tag (¶0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the RFID tag of Bauss to have included an RFID antenna extending around an outer surface and thus around the through opening, as taught by Bauss, for the purpose of improving the writing and reading of the RFID tag (¶0059 of Bauss).
Regarding claim 12, Bauss in view of Konrad and Flippe suggest the adaptor according to claim 1. Bauss in view of Konrad further suggest the remotely readable component being flush with the inner surface of the proximal part of the adaptor (see above rejection of claim 1).
Regarding claim 13, Bauss in view of Konrad and Flippe suggest the adaptor according to claim 1. Bauss further discloses the remotely readable electronic component being external to the distal tip of the medical container (embedded in element 330b which is external to distal tip of the medical container and thus component is external as well).
Conclusion
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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