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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11, 13-18, 20, and 22-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase "such as" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Further, the phrase “can be fed to the transport system with an infeed” it is not clear if the infeed is required in this claim because of the phrase “can be”. Further, it is not clear if this is intended use of the transport system and thereby not afforded patentable weight since the infeed does not appear to be actively claimed as part of the structure? Clarification is required.
Claim 15 recites the limitation "the housing" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 18, the phrase "for instance" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Any claim dependent upon a rejected claim, inherit the issues of the parent claim, and are, therefore, also rejected under 35 U.S.C. 112(b).
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 –
Claim(s) 1, 3-6, 9-11, 13-14, and 22-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soto (EP 3882611) .
In regards to claim 1, Soto discloses a medication container inspection device (figs. 1-5) for inspecting one or more medication containers (syringe 3), comprising: - an inspection station (fig. 1 and 3, 1) with an inspection system (1) comprising an inspection apparatus (1), configured for inspecting a single medication container for container defects, and a manipulator (fig. 5) to entangle or agitate the single medication container to increase the visibility of container defects while being inspected by the inspection apparatus (7 and 7b, and ⁋23) a transport system (arm 7) for automatically transporting one or more medication containers, such as a single medication container (3), to the inspection station (1), wherein the one or more medication containers (3) can be fed to the transport system (7) with an infeed (auto in-feed 13),wherein the inspection system (1) is configured to perform multiple inspecting steps in the inspection station (as discussed in ⁋ 29, and Table 2 which shows multiple inspection steps).
In regards to claim 3, the manipulator (fig. 5) is configured for engaging the single medication container (3) at a plurality of engagement positions on the single medication container (as can be seen in fig. 5, the arm holds each of the syringes using 7a and the base 7 and multiple engagements positions, such as the sides and bottom of the syringe).
In regards to claim 4, the inspection system (1) is configured to perform all of the multiple inspecting steps in the inspection station (as discussed in ⁋ 29, and Table 2 which shows multiple inspection steps).
In regards to claim 5, the inspection apparatus (1) comprises one or more viewing devices (4) for viewing the single medication container (3) in the inspection station (⁋ 24).
In regards to claim 6, the inspection system (1) comprises one or more illumination devices (8) for illuminating the single medication container (3) in the inspection station (1) when the single medication container is viewed by the one or more viewing devices (⁋ 24).
In regards to claim 9, the manipulator (fig. 5) doubles as the transport system (7) for automatically transporting the one or more medication containers to the inspection station (1) or the transport system (7) doubles as the manipulator (fig. 5) to entangle or agitate the one or more medication containers (the arm and components of the arm 7 act as both the transport system to pick up the syringes from 13 and the manipulator to rotate and move the syringes as discussed in ⁋ 23).
In regards to claim 10, the single medication container (3) is at least partly transparent, such that the contents of the single medication container can be viewed from outside the container (inherent for the camera and illumination to work as intended to determine particulate defects as discussed in ⁋ 21).
In regards to claim 11, the single medication container comprises a fluid and/or the single medication container comprising a syringe, vial or ampoule (syringe as shown in figs. 4-5).
In regards to claim 13, the system comprises multiple inspection stations (as shown in fig. 3) each with an inspection system (1) comprising an inspection apparatus (1), configured for inspecting a single medication container for container defects, and a manipulator (fig. 5) to entangle or agitate the single medication container to increase the visibility of container defects while being inspected by the inspection apparatus, wherein at least one of the inspection stations is configured to perform multiple inspecting steps in the inspection station (as discussed in ⁋ 29, and Table 2 which shows multiple inspection steps), and - a transport system (7) for automatically transporting one or more medication containers to each of the inspection stations (1), wherein the one or more medication containers (3) can be fed to the transport system (7) with an infeed (13; as discussed in ⁋ 53).
In regards to claim 14, Soto discloses a medication container assembly comprising a medication container inspection device (1) according to claim 1 (as discussed above) and an infeed (fig. 3, 20 and fig. 2, 13) for feeding one or more medication containers (3) to the transport system.
In regards to claim 22, the assembly further comprises an outfeed (fig. 2, 19) for transporting a single medication container (3) away from the inspection station.
In regards to claim 23, Soto discloses a method for inspecting a single medication container (3) using a medication container inspection device (using device 1 of fig. 2) according to claim 1, comprising: automatically transporting one or more medication containers to the inspection station (via fig. 5, 7) with the transport system (7), inspecting a single medication container for container defects with the inspection system (as discussed in ⁋ 29, and Table 2 which shows multiple inspection steps) comprising the inspection apparatus (1), wherein the inspection system (1) performs multiple inspecting steps in the inspection station (as discussed in ⁋ 29, and Table 2 which shows multiple inspection steps), and entangling or agitating the single medication container to increase the visibility of container defects while being inspected by the inspection apparatus (via 7 and 7b).
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) 2, 7-8, 15-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soto (EP 3882611).
In regards to claims 2 and 15, Soto discloses the container inspection device of claim 1, as disclosed above. Soto further discloses an infeed (13) arranged at a side of the inspection device (as can be seen in fig. 2), for allowing an infeed (13) to feed one or more medication containers to the inspection device, wherein the transport system (7) is arranged for automatically transporting one or more medication containers to the inspection station (1) from the infeed (13). Soto is silent to a housing, wherein the inspection station is arranged in the housing with an infeed opening. However, the examiner takes official notice that it is very well known in the art of automatic inspection to include a housing to enclose an inspection device, with an opening in order to allow a sample to be fed to the inspection device. This is done for many reasons, such as in order to protect the sensitive measurement equipment, and to help the optical measurement have less noise detected from ambient light, thus allowing a more precise measurement. Therefore, it would be obvious to one of ordinary skill in the art to include into Soto a housing, wherein the inspection station is arranged in the housing with an infeed opening, as this is well-known in the art to do, and in order to protect the sensitive measurement equipment, and to help the optical measurement have less noise detected from ambient light, thus allowing a more precise measurement.
In regards to claims 7 and 8, Soto discloses the container inspection device, as discussed above. Soto is silent to the side of the housing being the top side of the housing, or that the infeed opening is arranged vertically above the inspection station, such that the transport system can transport the one or more medication containers vertically from the infeed opening to the inspection station. However, it is noted that the infeed needs to feed the medication containers to the inspection station, there are only a finite number of choices of where the opening can be to have this done (to the side of the housing, bottom side of the housing or top side of the housing), one of ordinary skill in the art would have been able to select a top side and have the infeed feed to that side for the transport system to move the medications into the inspection system with a reasonable expectation of success, and this would be done in order to allow the system to still inspect the medicine while taking up less room on the production floor. Therefore, it would be obvious to one of ordinary skill in the art to try to have the side of the housing be the top side of the housing, such that the infeed opening is arranged vertically above the inspection station, such that the transport system can transport the one or more medication containers vertically from the infeed opening to the inspection station, with a reasonable expectation of success, in order to yield the predictable result of allowing the system to feed containers to the inspection system while taking up less room on the production floor.
In regards to claim 16, the infeed (13) holds vials, ampoules, syringes or a nest (2a) of syringes (3 and ⁋ 23).
In regards to claim 17, the infeed is configured for feeding the syringes, vials or ampoules to the infeed opening or, if applicable, the syringes to the infeed opening from the nest (⁋ 23 as discussed above, 13 would feed the infeed opening).
In regards to claim 18, the nest (2a) comprises syringes (3) with injection ends (as can be seen in fig. 4), for instance comprising syringe caps (23). Soto is silent to the syringes being arranged in the nest with the injection ends upwards, wherein the syringes are fed to the transport system with the injection ends upwards. However, it is noted that the infeed needs to feed the medication containers to the inspection station, there are only a finite number of choice of how the syringes are arranged in the nest (injection ends up or down or to the side), one of ordinary skill in the art would have been able to choose to have the syringes arranged in the nest with the injection ends upwards, in order to allow the arm to grab the syringes from the bottom to allow for inspection by the inspection system. Therefore, it would be obvious to one of ordinary skill in the art to try to have the syringes be arranged in the nest with the injection ends upwards, wherein the syringes are fed to the transport system with the injection ends upwards, with a reasonable expectation of success, in order to yield the predictable result of allowing the transport arm to grab the syringes from the top side of the housing for inspection in the inspection station.
In regards to claim 20, the transport system (7) is arranged for automatically transporting syringes (3) to the inspection station with the injection ends upwards (as can be seen in fig. 5).
Additional Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art made of record is Milne (CN 109642865) and Fradkin (WO 20200027923). Both references appear to read on or render obvious at least claim 1 as currently written.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA E GEISEL whose telephone number is (571)272-2416. The examiner can normally be reached Monday-Friday 10am-6pm.
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/KARA E. GEISEL/
Art Unit 2877
Prosecution Insights