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 .
Applicant’s response to the Non-final Office Action dated 04/16/2025, filed with the office on 07/15/2025, has been entered and made of record.
Response to Amendment
In light of Applicant’s amendments, the objections of record with respect to claims 10 and 11 are withdrawn.
5. In light of Applicant’s amendment of claim 10, the claim now provides sufficient structure for the recited functions. Accordingly, the claims are no longer interpreted under 35 U.S.C. 112(f).
Status of Claims
Claims 1-15 are pending. Claims 1 and 10-13 are amended. Claims 14 and 15 are new.
Response to Arguments
Applicant’s amendment of independent Claims 1, 12 and 13, which has altered the scope of the claims of the instant application, has necessitated the new ground(s) of rejection presented in this office action with respect to claims of the instant application. Accordingly, in response to Applicant’s arguments that are merely directed to the amended portion of the claims, new analyses have been presented below, which make Applicant’s arguments moot.
Consequently, THIS ACTION IS MADE FINAL.
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.
Claims 1-5, 7, 8, 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chung et al. (US 2020/0034658 A1), in view of Day et al. (US 2013/0221097 A1) and in further view of Davidson et al. (US 2022/0036651 A1).
Regarding claim 1, Chung teaches a type of drug packaging management mechanism (Chung, ¶0006: “pharmaceutical management system and methods implemented by the system for identifying clinical drugs”) involving sheets containing tablets/drugs (Chung, ¶0042: “a product contained between sheets of material”) inside a pocket of the packaging (Chung, ¶0042: “The cavity or pocket is large enough to contain the good which is housed in the blister package”) the packaging disclosed by Chung is a blister packaging where one face has breakable opening and the opposite face has pockets/blisters (Chung, ¶0042: “The primary component of a blister package is a cavity or pocket made from a formable web, usually a thermoformed plastic”; also see fig. 4) the drug is sealed within the sheet by thermal bonding (Chung, ¶0042: “wherein the sheets are adhered or sealed together by methods known to those skilled in the art; for example, the sheets are sealed by heat”) the packaging contains drug information printed on at least one face (Chung, ¶0042: “For pharmaceutical fields, “blister packages” are commonly used as unit-dose packaging for pharmaceutical tablet, and contain drug information printed on the back thereof”) Chung further discloses a memory with instructions and a processor for executing the instructions (Chung, ¶0098: “a non-transitory, tangible processor-readable storage medium having stored thereon processor-readable instructions that, when executed by the processor of a programmable device, control the programmable device to perform”) finally, Chung discloses a capturing device for imaging both sides of the packaging which includes the back side contains the printed drug information (Chung, ¶0052: “the image capturing device may encompass both sides of the blister package”) and (Chung, ¶0042: “contain drug information printed on the back”). Although Chung discloses a heat-sealed blister packaging with a printed information used for identification of a drug, Chung does not explicitly teach identifying individual identification using an extracted feature value depending on an individual-specific local positional relation that occurs spontaneously during a manufacturing process of the PTP sheet between printed information on the cover and a grid pattern formed on the packaging.
In an analogous field of endeavor, Day teaches identifying individual identification using an extracted feature value (Day, ¶0147: “the reservoir-identification system 203 may be further configured to detect the position of the coding feature”; and ¶0161: “the limits of data could be detected by a unique value”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Chung using the teachings of Day to introduce an identifier feature. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of identifying individual information about the drug packaging. Therefore, it would have been obvious to combine the analogous arts Chung and Day to obtain the above-described limitations in claim 1. Although Day teaches identification of a drug packaging based on a feature value, Day does not explicitly teach an individual-specific local positional relation that occurs spontaneously during a manufacturing process of the PTP sheet between printed information on the cover and a grid pattern formed on the packaging.
In an analogous field of endeavor, Davidson discloses an individual-specific local positional relation (Davidson, ¶0028: “The grid letters (unique identifiers) serve as a visual cue which allows for the identification of a regional location”) that occurs spontaneously during a manufacturing process of the PTP sheet between printed information (Davidson, ¶0028: “unique identifiers which are interposed between every fourth or fifth grid dot depending on the dimensions of the grid file”) on the cover and a grid pattern formed on the packaging. (Davidson, ¶0027: “On a surface of each substrate sheet there is printed a grid. The grid consists of a uniform pattern of small circular marks (grid dots) and unique identifiers which are arranged as a two-dimensional grid”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Chung in view of Day using the teachings of Davidson to introduce an identifier printed between the grid pattern of a PTP sheet. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of detecting the relative position of the printed information in the grid pattern. Therefore, it would have been obvious to combine the analogous arts Chung, Day and Davidson to obtain the invention in claim 1.
Regarding claim 2, Chung in view of Day and in further view of Davidson discloses a plurality of feature points on a plane (Chung, ¶0090: “a finite set of points in the plane or other low-dimensional Euclidean spaces”). Day further teaches feature values (Day, ¶0161: “the limits of data could be detected by a unique value at the start and/or end, e.g. 11 then 10 00 01 00 10 . . . , or mechanical features on the container could be detected”) depending on the position of the feature (Day, ¶0161: “the first value would preferably not be the same as the value that would be read if no coding is present, e.g. start with 01 instead of 00”) lastly, Chung teaches analyzing nearby areas of grid cells for feature information (Chung, ¶0111: “Each grid cells and its neighboring grid cells were then analyzed to determine if they contained any feature information”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Chung in view of Day in further view of Davidson using the additional teaching of Day to introduce feature values depending on a feature position. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of identifying the packaging using the feature values detected on the feature code. Therefore, it would have been obvious to combine the analogous arts Chung, Day and Davidson to obtain the invention in claim 2.
Regarding claim 3, Chung in view of Day and in further view of Davidson discloses square shaped grid pattern used for finding features relative to the squares (Chung, ¶0111: “Each grid cells and its neighboring grid cells were then analyzed to determine if they contained any feature information… 13×13 grid”) and features points (Chung, ¶0090: “a finite set of points in the plane or other low-dimensional Euclidean spaces”). Day further teaches detecting nearby coding features and their relative positions (Day, ¶0142: “detect the presence of a portion of any coding feature that is in its proximity… the size and relative position of each coding feature can be detected”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Chung in view of Day in further view of Davidson using the additional teaching of Day to introduce detection of coding features. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of analyzing the square grid for feature points and their relative positions for identification of the packaging. Therefore, it would have been obvious to combine the analogous arts Chung, Day and Davidson to obtain the invention in claim 3.
Regarding claim 4, Chung in view of Day and in further view of Davidson discloses dividing a region into partial regions and analyze the partial regions for features (Chung, ¶0044: “in order to better divide the identified targets and to expose inherent descriptive features”).
Regarding claim 5, Chung in view of Day and in further view of Davidson discloses a displacement vector representing a point in the analyzed region to another point (Chung, ¶0109: “The displacement vector v was then calculated based on the coordinates of the mi-point M and centroid B”) Chung further discloses finding corners of a quadrilateral shape/square (Chung, ¶0094: “the closest quadrilateral shape and the corner coordinates thereof are derived”).
Regarding claim 7, Chung in view of Day and in further view of Davidson discloses a neighborhood analysis to detect features (Chung, ¶0111: “Each grid cells and its neighboring grid cells were then analyzed to determine if they contained any feature information”). Day further teaches feature values (Day, ¶0161: “the limits of data could be detected by a unique value at the start and/or end, e.g. 11 then 10 00 01 00 10 . . . , or mechanical features on the container could be detected”) depending on the position of the feature (Day, ¶0161: “the first value would preferably not be the same as the value that would be read if no coding is present, e.g. start with 01 instead of 00”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Chung in view of Day in further view of Davidson using the additional teachings of Day to introduce feature values depending on a feature position. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of applying neighborhood analysis to identify feature values detected near feature points of the feature code. Therefore, it would have been obvious to combine the analogous arts Chung, Day and Davidson to obtain the invention in claim 7.
Regarding claim 8, Chung in view of Day and in further view of Davidson discloses a displacement vector from one coordinate point to another coordinate point, (Chung, ¶0109: “The displacement vector v was then calculated based on the coordinates of the mi-point M and centroid B”) where the coordinate points are used for measuring a distance feature (Chung, ¶0109: “Finally, the coordinates of P.sub.2 and P.sub.3 were determined to be the locations that are respectively two times of the distance v from P.sub.1 and P.sub.4”).
Regarding claim 12, it recites a method with steps corresponding to the elements of the apparatus recited in claim 1. Therefore, the recited steps of method claim 12 are mapped to the proposed combination in the same manner as the corresponding elements in apparatus claim 1. Additionally, the rationale and motivation to combine Chung, Day and Davidson presented in rejection of claim 1, apply to this claim. Additionally, Chung further teaches, a method for drug packaging management (Chung, ¶0004: “method and system for medication management (e.g., sorting and identifying medications via their labels and/or package”).
Regarding claim 13, it recites a computer-readable recording medium including computer executable instructions corresponding to the elements of the apparatus recited in claim 1. Therefore, the recited instructions of the computer readable medium of claim 13 are mapped to the proposed combination in the same manner as the corresponding elements of the apparatus claim 1. Additionally, the rationale and motivation to combine Chung, Day and Davidson presented in rejection of claim 1, apply to this claim. Additionally, Chung further teaches, a non-transitory storage containing instructions and a processor for executing the instructions (Chung, ¶0098: “a non-transitory, tangible processor-readable storage medium having stored thereon processor-readable instructions that, when executed by the processor of a programmable device, control the programmable device to perform”) to implement the steps of the method (Chung, ¶0006: “pharmaceutical management system and methods implemented by the system for identifying clinical drugs”).
Regarding claim 14, Chung in view of Day and in further view of Davidson discloses combining feature values extracted from each of the feature points to generate the individual identification information. (Day, ¶0161: “data would be logged continuously during insertion so that each bit of the drug code and position code is read… each bit of the drug code can be identified”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Chung in view of Day in further view of Davidson using the additional teaching of Day to introduce extracting and combining a continuous feature using feature values. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of identifying the packaging based on the combined feature. Therefore, it would have been obvious to combine the analogous arts Chung, Day and Davidson to obtain the invention in claim 14.
Regarding claim 15, Chung in view of Day and in further view of Davidson discloses connecting the feature values of each of the feature points in numerical order based on feature point number. (Day, ¶0161: “start with 01 instead of 00. Still further, preferably, data would be logged continuously during insertion so that each bit of the drug code and position code is read”). The proposed combination as well as the motivation for combining Chung, Day and Davidson references presented in the rejection of claim 14, apply to claim 15 and are incorporated herein by reference. Thus, the apparatus recited in claim 15 is met by Chung, Day and Davidson.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Chung et al. (US 2020/0034658 A1), in view of Day et al. (US 2013/0221097 A1) in further view of Davidson et al. (US 2022/0036651 A1) and still in further view of Ishiyama et al. (US 2016/0055398 A1).
Regarding claim 6, although Chung in view of Day and in further view of Davidson discloses light sources that illuminates the print feature (Chung, ¶0119: “Light sources were disposed around the transparent board for illumination”) the combination of references does not explicitly teach extraction of feature values from feature points based on a color or luminance value.
In an analogous field of endeavor, Ishiyama (common inventor) discloses extracting of feature values from feature points from an image based on a luminance value (Ishiyama, ¶0034: “extraction technology for extracting image feature of a finger print which can extract, for example, a luminance value and a feature point of an image”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Chung in view of Day, in further view of Davidson using the teachings of Ishiyama to introduce luminance value. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of identifying a print information based on the luminance values of the feature points in the print. Therefore, it would have been obvious to combine the analogous arts Chung, Day, Davidson and Ishiyama to obtain the invention in claim 6.
Regarding claim 9, although Chung in view of Day and in further view of Davidson discloses light sources that illuminates one side of the packaging (Chung, ¶0119: “Light sources were disposed around the transparent board for illumination”) where the side of the packaging sheet contains a grid pattern (Davidson, ¶0027: “On a surface of each substrate sheet there is printed a grid”) and analyzing features from a neighborhood of grid cells (Chung, ¶0111: “Each grid cells and its neighboring grid cells were then analyzed to determine if they contained any feature information”). However, the combination of Chung, Day and Davidson references does not explicitly teach extraction of feature values from feature points based on a color or luminance value.
In an analogous field of endeavor, Ishiyama (common inventor) discloses extracting of feature values from feature points from an image based on a luminance value (Ishiyama, ¶0034: “extraction technology for extracting image feature of a finger print which can extract, for example, a luminance value and a feature point of an image”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Chung in view of Day, in further view of Davidson using the teachings of Ishiyama to introduce luminance value. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of identifying a print information based on the luminance values of the feature points in the print. Therefore, it would have been obvious to combine the analogous arts Chung, Day, Davidson and Ishiyama to obtain the invention in claim 9.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Chung et al. (US 2020/0034658 A1) in view of Day et al. (US 2013/0221097 A1) in further view of Davidson et al. (US 2022/0036651 A1) and still in further view of Taguchi et al. (US 2021/0047066 A1).
Regarding claim 10, Chung in view of Day and in further view of Davidson discloses an imaging device for acquiring images (Chung, ¶0310: “a pharmaceutical management system is provided. Referring to FIG. 3, a system 300 is depicted, which comprises an image capturing device 310”) a drug packaging machine (Chung, ¶0042: “a continuous web sheet on roll stock (for machine packaging”) the packaging sheets containing tablets/drugs (Chung, ¶0042: “a product contained between sheets of material”) inside a pocket of the packaging (Chung, ¶0042: “The cavity or pocket is large enough to contain the good which is housed in the blister package”) the packaging disclosed by Chung is a blister packaging where one face has breakable opening and the opposite face has pockets/blisters (Chung, ¶0042: “The primary component of a blister package is a cavity or pocket made from a formable web, usually a thermoformed plastic”; also see fig. 4) the drug is sealed within the sheet by thermal bonding (Chung, ¶0042: “wherein the sheets are adhered or sealed together by methods known to those skilled in the art; for example, the sheets are sealed by heat”) the packaging contains drug information printed on at least one face (Chung, ¶0042: “For pharmaceutical fields, “blister packages” are commonly used as unit-dose packaging for pharmaceutical tablet, and contain drug information printed on the back thereof”). Although the combination of Chung, Day and Davidson discloses a drug packaging with a blister pockets on one face and a printed feature on the other face, the combination of Chung, Day and Davidson does not explicitly teach, punching out the sheet units and only capturing the images of the sheet units once they are punched out.
In an analogous field of endeavor, Taguchi discloses, capturing pictures of the sheet units after they are punched out. (Taguchi, ¶0199: “take images of the tablets 5 across the pocket portions 2… after the PTP sheet 1 is punched out from the PTP film 6”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Chung in view of Day, in further view of Davidson using the teachings of Taguchi to introduce imaging at specific stages of production. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of verifying individual information printed on the packaging sheet. Therefore, it would have been obvious to combine the analogous arts Chung, Day, Davidson and Taguchi to obtain the invention in claim 10.
Regarding claim 11, Chung in view of Day and in further view of Davidson discloses an imaging device for acquiring images (Chung, ¶0310: “a pharmaceutical management system is provided. Referring to FIG. 3, a system 300 is depicted, which comprises an image capturing device 310”) a drug packaging machine (Chung, ¶0042: “a continuous web sheet on roll stock (for machine packaging”) the packaging sheets containing tablets/drugs (Chung, ¶0042: “a product contained between sheets of material”) inside a pocket of the packaging (Chung, ¶0042: “The cavity or pocket is large enough to contain the good which is housed in the blister package”) the packaging disclosed by Chung is a blister packaging where one face has breakable opening and the opposite face has pockets/blisters (Chung, ¶0042: “The primary component of a blister package is a cavity or pocket made from a formable web, usually a thermoformed plastic”; also see fig. 4) the drug is sealed within the sheet by thermal bonding (Chung, ¶0042: “wherein the sheets are adhered or sealed together by methods known to those skilled in the art; for example, the sheets are sealed by heat”) the packaging contains drug information printed on at least one face (Chung, ¶0042: “For pharmaceutical fields, “blister packages” are commonly used as unit-dose packaging for pharmaceutical tablet, and contain drug information printed on the back thereof”). Although the combination of Chung, Day and Davidson discloses a drug packaging with a blister pockets on one face and a printed feature on the other face, the combination of Chung, Day and Davidson does not explicitly teach, punching out the sheet units and capturing the images of the sheet units before they are punched out.
In an analogous field of endeavor, Taguchi discloses, capturing pictures of the sheet units before they are punched out. (Taguchi, ¶0193: “take images of the tablets 5 across the pocket portions 2… before the PTP sheet 1 is punched out from the PTP film 6”). The proposed combination as well as the motivation for combining Chung, Day, Davidson and Taguchi references presented in the rejection of claim 10, apply to claim 11 and are incorporated herein by reference. Thus, the apparatus recited in claim 11 is met by Chung, Day, Davidson and Taguchi.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/MEHRAZUL ISLAM/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662