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 Amendment
Applicant’s amendment filed 9/7/2026 has been entered.
Claims 1-25 are cancelled.
Claims 26-45 remain pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 28-29 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding Claim 28, the claim recites “receiving, from the human operator, feedback”. This limitation positively claims a human operator within the step and therefore is nonstatutory subject matter. Claim 29 depends from Claim 28.
Note Claim 27 is not rejected under 35 U.S.C. 101 as the inspection being “performed by a human operator” is not being carried out it is merely being recommended by the control unit in claim 26.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 26-27, 30-42, and 44 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Luciano Jr. (US PGPUB 2017/0275035).
Regarding Claim 26, Luciano Jr. discloses a method of determining compliance of a plurality of medicament packages (254-262; Figures 4B) for containing discrete medicaments (tablets; Para. 0123-0124) dispensed and packaged by an automated dispensing device (automated filling station 12 including inspection station 20 and control modules 22, 24; Figure 1A; note Para. 0081 outlines the dual inspection filling station) comprising a control unit (22, 24) and one or more sensors (“a measurement device” of “first inspection station 14” (Para. 0064) and “one or more camera or video sensors” of “second inspection station 20” (Para. 0071)) for providing feedback (Para. 0065, 0075) on a production process, wherein the method comprises the steps of:
- for each medicament package of the plurality of medicament packages (254-262), associating with the respective medicament package one or more process values (“the measured medication value from the first inspection station 14” and “the measured medication value from the second inspection station 20”) indicative of the production process of the automated dispensing device (12, 20-24) affecting at least one of the respective medicament packages (254-262) or the discrete medicaments contained in said respective medicament package (254-262), wherein the one or more process values (measured medication values of stations 14, 20) are indicative of feedback signals generated by the one or more sensors (“a measurement device” of “first inspection station 14” (Para. 0064) and “one or more camera or video sensors” of “second inspection station 20” (Para. 0071));
- comparing the process values (“measured medication value”) for a respective one of the medicament packages (254-262) and expected process values (“expected medication value” R1; Figure 1B; Para. 0067) which have been previously stored in a memory (“a collection of training data”; Para. 0072) to find deviations (i.e. R2, R3; Figure 1B) from the expected values (R1; Para. 0067; see also Paras. 0071-0073 which outline comparison of values from station 20);
- identifying the deviations (R2, R3 associated with “negative inspection result state” and “an inconclusive inspection result state”) as irregularities in the one or more process values (measured medication values; Para. 0067, 0078);
- issuing, by the control unit (via analytical module 27, process control module 24 to signal to movement control module 28), a recommendation (instructions to movement control 28) for further compliance inspection (“post inspection state” via 30, 32, 36 associated with determined “a manual inspection station state, a correction station state, and an assembly station state”) of at least one medicament package of the plurality of medicament packages (254-262) based on an identified irregularity in the one or more process values (based on the “two or more automated inspection results”; Para. 0085) associated with said at least one medicament package (254-262; Para. 0085-0088);
- performing an automatic compliance check (via 22 and analytical module 27 based on feedback from inspection stations 14, 20, 26) on the respective medicament package prior to issuing the recommendation (“post inspection state” via 30, 32, 36 associated with determined “a manual inspection station state, a correction station state, and an assembly station state”; Para. 0085-0088);
-wherein the recommendation (via 27, 24 to signal to movement control module 28; Para. 0088) is a recommendation for a first type (“an assembly station state”; Para. 0088) of the further compliance inspection when the outcome of the automatic compliance check (via 22 and analytical module 27) is that the at least one medicament package is compliant (Para. 0088, 0092, 0110), and the recommendation (via signal to movement control module 28; Para. 0088) is a recommendation for a second type (“a manual inspection station state” or “correction station state”) of the further compliance inspection (“post inspection state”) when the outcome of the automatic compliance check is that the at least one medicament package is non-compliant (based on at least one “negative inspection result”; Paras. 0108-0109; note Para. 0142 and Figure 10 outlines that any inspection result being “negative” or “no” as shown in Figure 10 leads to a signal to send the package to either manual inspection or correction station).
Regarding Claim 27, Luciano Jr. discloses wherein at least one of the first type of the further compliance inspection (“post inspection state”) and the second type of the further compliance inspection is performed by a human operator (at 30; Para. 0088, 0091, 0108).
Regarding Claim 30, Luciano Jr. discloses at least one of the first type of the further compliance inspection (“post inspection state”) and the second type of the further compliance inspection is at least partially automated (at 36 Para. 0105, 0113).
Regarding Claim 31, Luciano Jr. discloses the steps of:
- providing an inspection station (14, 20, 26, 30, 36) for compliance inspection (i.e. Para. 0063, 0071, 0081, 0091, 0105) and a correction station (32, 34) for compliance inspection and correction (Para. 0091);
wherein the first type (“an assembly station state”) of further compliance inspection is carried out at the inspection station (36; Para. 0110) and the second type of further compliance inspection (“a manual inspection station state” or “correction station state”) is carried out at the correction station (32; Para. 0108, 0109).
Regarding Claim 32, Luciano Jr. discloses the plurality of medicament packages are discharged from and collected outside of the automated dispensing device (12, 20-24; Para. 0115), wherein the automatic compliance check (i.e. at 26) is performed outside of the automated dispensing device (12, 20-24) prior to or during collection of the plurality of medicament packages (Para. 0105; prior to discharge from system 10).
Regarding Claim 33, Luciano Jr. discloses the steps of automatically flagging one or more medicament packages of the plurality of medicament packages for re-production (Para. 0152).
Regarding Claim 34, Luciano Jr. discloses the step of skipping at least a part of the production process for the one or more medicament packages which have been flagged for re-production (Para. 0152 outlines marking and routing improperly filled packages to a correction station which readily bypasses production processes upstream (i.e. the unwinding of the material, the initial filling station)).
Regarding Claim 35, Luciano Jr. discloses the step of recommending that the one or more medicament packages (254-262) which have been flagged for re-production are removed without inspection (Para. 0128 outlines removing a defective pouch at the correction station which is upstream of the final inspection station).
Regarding Claim 36, Luciano Jr. discloses the plurality of medicament packages (254-262) forms a string (Figure 4B; see also Figure 5A; Paras. 0125, 0128).
Regarding Claim 37, Luciano Jr. discloses the plurality of medicament packages are pouches (Paras. 0055, 0068, 0127-0128).
Regarding Claim 38, Luciano Jr. discloses the production process comprises one or more processes of the group comprising:
storing of discrete medicaments (Figure 3; i.e. 210a-210c in modules 208a-208c; Para. 0117; note filling station 200 is interpreted as just a detailed view of filling station 12),
preparation (within hopper 204) of the discrete medicaments (210a-210c) for dispensing (Para. 0117),
dispensing (from hopper 204) of the discrete medicaments (210a-210c; Para. 0117),
packaging of the discrete medicaments (210a-210c) in the plurality of packages and discharging of said plurality of packages from the automated dispensing device (Para. 0115).
Regarding Claim 39, Luciano Jr. discloses the process of dispensing comprises one or more of the following subprocesses:
singulating the discrete medicaments (210a-210c) prior to dispensing (Para. 0117), dispensing of the discrete medicaments (out of 208a-208c; Para. 0117), intermediate collection (via hopper 204) of the dispensed discrete medicaments (Para. 0117) and discharging of the collected dispensed discrete medicaments (via opening hopper 204; Para. 0116-0117).
Regarding Claim 40, Luciano Jr. discloses the process of packaging comprises the following subprocesses:
feeding of packaging material (212; Figure 3) used to form the medicament packages (254-262; shown in Figure 3),
sealing the medicament packages (Para. 0119, 0123),
discharging the medicament packages (254-262) from the automated dispensing device (12, 20).
Regarding Claim 41, Luciano Jr. discloses the one or more process values are indicative of one or more causes for non-compliance including several of the options claimed such as incorrect filling prior to dispensing, an overdispense, an underdispense (which would all be indicated by a discrepancy between the total weight measured at station 14 and the expected weight; Para. 0064-0067; note that measured weight would readily indicate such causes) and dispensing of an incorrect discrete medicament, dispensing of a damaged discrete medicament, an error in the collection of a dispensed discrete medicament (which would be indicated in the comparison from imaging feedback of station 20; Paras. 0070-0075).
Regarding Claim 42, Luciano Jr. discloses an automated dispensing device (10; Figure 1) for dispensing and packaging discrete medicaments (i.e. 210a-210c; Figure 3) into a plurality of medicament packages (254-262), the automated dispensing device (10) comprising:
a system (inspection stations 14, 20, 26 and controls 22, 24) for determining compliance of a plurality of medicament packages (254-262) containing discrete medicaments (210a-210c) dispensed and packaged by the automated dispensing device (10; refer to the rejection of Claim 26 above),
wherein the device (10) further comprising a control unit (22, 24) and one or more sensors (“a measurement device” of “first inspection station 14” (Para. 0064) and “one or more camera or video sensors” of “second inspection station 20” (Para. 0071)) for providing feedback on a production process; and
wherein the control unit (22, 24) that is configured to perform the steps of the method according to claim 26 (refer to the rejection of Claim 26 above).
Regarding Claim 44, Luciano Jr. discloses the control unit (22, 24) is operationally connected to said one or more sensors (“a measurement device” of “first inspection station 14” (Para. 0064) and “one or more camera or video sensors” of “second inspection station 20” (Para. 0071)) for receiving feedback signals generated by the one or more sensors, wherein the one or more process values (measured values) are indicative of the feedback signals generated by the one or more sensors (of 14, 20; Para. 0065, 0075).
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.
Claims 28-29, 43 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Luciano Jr. (US PGPUB 2017/0275035).
Regarding Claims 28 and 29, Luciano Jr. discloses several features of the claimed invention but does not readily disclose the embodiment of Figures 1A includes a method including displaying the recommendation for further compliance inspection (“post inspection”) to the human operator and receiving, from the human operator, feedback on the further compliance inspection from the human operator. And further Luciano Jr. does not disclose displaying a reason for the recommendation together with the recommendation, wherein the reason comprises one or more elements of information of the group comprising: the identified irregularity, a possible root cause associated with said irregularity and an inspection area containing said irregularity.
Attention can be brought to a further embodiment of Luciano Jr. depicted in Figure 8 which includes a control process system (550) which includes a control process module (556) that gathers and compares values similar to that of Figure 1A (see Paras. 0145-0151) and wherein the process thereof includes displaying the recommendation for further compliance inspection (“post inspection”) and a reason for the recommendation (i.e. each inspection results indicating an identified irregularity) to the human operator and receiving, from the human operator, feedback on the further compliance inspection from the human operator (“The personal computer displays the results of all inspections and analysis available to a technician”; Para. 0153).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have displayed the inspection results/recommendations as taught by the embodiment of Figure 8 of Luciano Jr. By displaying such results, feedback can be readily fed to the user to ensure the packages are fed to the proper post inspection processing stations.
Regarding Claim 43, the embodiment of Figure 1A of Luciano Jr. discloses the system (10) further comprises a human machine interface (42) but does not readily disclose the human machine interface (42) is operationally connected to the control unit (22, 24), wherein the control unit is configured for causing the human machine interface to display the recommendation for further compliance inspection.
Attention can be brought to a further embodiment of Luciano Jr. depicted in Figure 8 which includes a control process system (550) which includes a control process module (556) that gathers and compares values similar to that of Figure 1A (see Paras. 0145-0151) and wherein system includes a human machine interface (568) connected to the control unit (556), wherein the control unit (556) is configured for causing the human machine interface (568) to display the recommendation for further compliance inspection (“The personal computer 568 displays the results of all inspections and analysis available to a technician”; Para. 0153).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have connected the control unit of Figure 1A of Luciano Jr. with the human machine interface and configure the control unit to cause the human machine interface to display the recommendation for further compliance inspection as taught by the embodiment of Figure 8 of Luciano Jr. By utilizing such a human machine interface, feedback can be readily communicated to correction and assembly personnel as taught by Luciano Jr. (Para. 0153) which readily ensures the improper packages are corrected accordingly.
Regarding Claim 45, Luciano Jr. discloses several features of the claimed invention including an analytical module (27; Figure 1A) which when operated with control modules (22, 24), causes an automated dispensing device (12, 20) to perform the steps according to Claim 26 (see rejection of Claim 26 above), however, the embodiment of Figure 1A of Luciano Jr. does not readily disclose that the analytical module (27) is a computer program product comprising a non-transitory computer-readable medium holding instructions that, when executed by a processor, carries out the method as claimed.
Attention can be brought to the teachings of embodiment of Figure 6 of Luciano Jr. which includes another automated dispensing device (400; Figure 6) which comprises an analytical module (418) in the form of a computer program product comprising a non-transitory computer-readable medium holding instructions that, when executed by a processor (CPU 420), carries out a method for determining compliance of packages formed by the device (400; Para. 0141).
While it can be readily implied that the analytical module (27) of Figure 1A is formed by a computer program product comprising instructions as claimed, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have embodied such a module as a computer program product as taught by the embodiment of Figure 6 of Luciano Jr. By utilizing a computer program product comprising such instructions, the method for determining compliance can be effectively and reliably repeated.
Response to Arguments
Applicant's arguments filed 9/7/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments on Pages 9-11 that:
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Examiner respectfully asserts that as outlined above, the instructions to the movement module (28) is viewed as issuing a recommendation for further inspection as no further details pertaining to what a “recommendation” encompasses are being claimed and therefore an instruction to move the package to a further inspection station is viewed as a recommendation for further inspection. As outlined in Para. 0088 of Luciano Jr., “the assembly station state results in an instruction to the movement control module 28 to transfer the preliminary package to an assembly station 34, that includes a final inspection component 36”, therefore the instruction to move to the assembly station 34 can be reasonably viewed as instruction/recommendation for further inspection as “a final inspection component 36” is part of the assembly station.
Para. 0088 of Luciano Jr. outlines the inspection states are used to send corresponding instructions/recommendations to the movement control module 28. These inspection states are determined based on the identification or irregularity or lack thereof which is elaborated on in Paras. 0067, 0078. Such inspection states are then used in the analytical module to determine “post inspection states include a manual inspection station state, a correction station state, and an assembly station state” (Para. 0086) which are used to send corresponding further inspection recommendations to the movement control module. And again it must be reiterated that the “assembly station state” readily leads to instruction to an assembly station which includes a further inspection station 36.
Further with respect to the argument that claim 26 requires a separate automatic compliance check, Examiner respectfully asserts that the claim does not preclude the automatic compliance check leading to such recommendations. And further as outlined in the rejection above, measured process values are compared to expected values (R1; Para. 0067; see also Paras. 0071-0073 which outline comparison of values from station 20).
In response to Applicant’s arguments on Pages 11-12 that:
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Examiner respectfully asserts that (1) the manner in which the claim is constructed does not readily preclude one from interpreting the automatic compliance check as being part of the value comparisons and (2) any of the inspection stations 14, 20, and 26 can be readily viewed as the automatic compliance check as the combination of results from the inspection station leads to determination of the post inspection state which results in corresponding recommendations/instructions to the movement control module.
In response to Applicant’s arguments on Pages 12-13 pertaining to the 103 rejection that:
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Examiner respectfully asserts that mere display of inspection results readily provides reasoning for recommendation/instructions for further inspection corresponding to the post inspection states as outlined. Further as outlined in Para. 0153 all inspection results and analysis are displayed which at least implies display of data associated with the recommendation/instructions of further inspection. Note reference to “Figure 6” was merely a typo and is instead “Figure 8”.
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 JOSHUA G KOTIS whose telephone number is (571)270-0165. The examiner can normally be reached Monday - Thursday 6am-430pm.
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/JOSHUA G KOTIS/Examiner, Art Unit 3731 10/1/2026
