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 arguments regarding the rejections of claim 1 and 8 have been fully considered but they are not persuasive. Regarding claim 1, the Applicant argues an interpretation of the term “entirely within said base opening” that is not in accordance with the common meaning of the term. From a top down perspective, the cited art meets the limitation in its entirety. Regarding claim 8, the Examiner has amended the citation to better highlight the cited features.
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 1-3, 6-7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bouthiette, US 20230121169.
Regarding claim 1, Bouthiette discloses: A system for packaging blister labels (Fig. 1, tray system 10), wherein the system comprises:
an insert (Fig. 1, depositing plate 120 ), configured to receive a blister pack array ([0041], “The depositing plate is designed to be placed over the blister pack 80 (not shown in FIG. 1, but illustrated in FIG. 6)”), said insert having a generally planar body and a plurality of openings within an outermost perimeter of said insert (see Fig. 1);
a base (Fig. 1, mounting tray 110) having a base opening (see Figs. 1, 1a-1b); and wherein said base is separate from said insert, and is configured to receive said outermost perimeter of said insert at the perimeter of said base opening to secure said insert entirely within said base opening (see Figs. 1, 1a-1b).
Regarding claim 2, Bouthiette further discloses: said plurality of openings of said insert are positioned in an array of columns and rows (see Figs. 1, 1a-1b).
Regarding claim 3, Bouthiette further discloses: said base is generally rectangular in shape (see Figs. 1, 1a-1b).
Regarding claim 6, Bouthiette further discloses: said plurality of openings are round ([0046], “It should be noted that, although the pill-holes 126, in the illustrated embodiment, are rectangular or square in shape, they are not limited to this configuration and may take on other non-limiting shapes. For example, the pill-holes 126 may be of circular, oval or any other geometrical shape suitable to receive a pill.”).
Regarding claim 7, Bouthiette further discloses: said plurality of openings are square ([0046], “It should be noted that, although the pill-holes 126, in the illustrated embodiment, are rectangular or square in shape, they are not limited to this configuration and may take on other non-limiting shapes. For example, the pill-holes 126 may be of circular, oval or any other geometrical shape suitable to receive a pill.”).
Claims 8, 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by M. Bouthiette, US 5788079.
Regarding claim 8, M. Bouthiette discloses: A label sheet (Fig, 7, container-sealing sheet (9)) for packaging blisters, said label sheet comprising:
a blister portion (Fig. 5, cells surrounding tearing lines 11) comprising:
a plurality of individual labels (Fig. 12, individual lids 12), each of said plurality of individual labels comprising a front surface and a back surface (see Fig. 7), said back surface comprising a central bare portion without adhesive and an adhesive portion (See Fig. 7), and wherein one or more of said plurality of individual labels further comprise at least one tear propagation slit directed inward from a perimeter of the individual label (see Examiner Illustration 1), said at least one tear propagation slit not extending beyond said adhesive portion (see Fig. 7 for location of adhesive, which exists on the outside of the cell portions) ;
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Examiner Illustration 1
a frame portion (Fig. 5 shows external frame for mounting in printer) separate from and defining a perimeter of said blister portion; and
a removable back portion (Fig. 7, peelable skin 19).
Regarding claim 11, M. Bouthiette further discloses: at least one of said plurality of individual labels has a visual indicator on said front surface (see Fig. 6).
Regarding claim 12, M. Bouthiette further discloses: one or more of said plurality of said individual labels further comprise at least one tear propagation slit (see Fig. 5).
Regarding claim 20, M. Bouthiette further discloses: said at least one tear propagation slit flanks a bare corner portion of said back surface (see Fig. 5).
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 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Bouthiette, US 20230121169, in view of M. Bouthiette, US 5788079.
Regarding claim 4, Bouthiette discloses the device of claim 1.
Bouthiette does not explicitly disclose: said base is configured to receive and secure a label sheet proximate to said insert.
M. Bouthiette teaches: said base is configured to receive and secure a label sheet (Fig, 7, container-sealing sheet (9)) proximate to said insert.
Therefore, it would have been obvious to one having ordinary skill in the art at the time before filing to utilize the label sheet as taught by M. Bouthiette in combination with the device as taught by Bouthiette, thereby combining prior art elements to achieve a predictable result. The benefit of this alteration is that it allows for the sealing of the blister pack, so nothing will fall out after placement of the pills, as well as the ability to label the medication as needed by the manufacturer.
Regarding claim 5, the modified Bouthiette further discloses: at least one locator pin at the base (Both Bouthiette and M. Bouthiette have visible lugs, uncited in Bouthiette, and protuberances 5 in M. Bouthiette), said at least one locator pin configured to secure said label sheet proximate to said insert (M. Bouthiette, holes 7 and 15).
Claims 9, 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over M. Bouthiette, US 5788079 in view of Braverman, US 9963265.
Regarding claim 9, M. Bouthiette discloses the device of claim 8.
M. Bouthiette does not explicitly disclose: said back surface of at least one of said plurality of individual labels further comprises a bare corner portion.
Braverman teaches: said back surface of at least one of said plurality of individual labels further comprises a bare corner portion (Braverman, see Fig. 8).
Therefore, it would have been obvious to one having ordinary skill in the art at the time before filing to utilize the visually indicated, bare corner label portion as taught by Braverman in combination with the device as taught by M. Bouthiette, thereby combining prior art elements to achieve a predictable result. The benefit of this alteration is that it allows for the easy opening (“peeling”) of the pill compartment without the need for a sharp object or tool to access the contents.
Regarding claim 13, the modified M. Bouthiette further discloses: said at least one of said plurality of individual labels further has a visual indicator on said front surface, and the location of said visual indicator corresponds to said bare corner portion (Braverman, see Fig. 8).
Regarding claim 14, M. Bouthiette discloses the device of claim 8.
M. Bouthiette does not explicitly disclose: said label sheet is comprised of a paper-foil face layer.
Braverman teaches: said label sheet is comprised of a paper-foil face layer (Col. 4, line 59, “the cover sheet 22 is preferably formed as a multi-layer construction or lamination having an outside layer 22A, which may be composed of paper or a plastic, e.g., vinyl. A metal foil layer 22B is disposed under the outside layer. The undersurface of the foil layer 22B includes a layer of the heretofore identified releasably securable adhesive 44. Lastly, the outer surface of the adhesive layer 44 is covered by the liner patch 46.”).
Therefore, it would have been obvious to one having ordinary skill in the art at the time before filing to utilize the paper foil label sheet composition as taught by Braverman in combination with the device as taught by M. Bouthiette, thereby combining prior art elements to achieve a predictable result. This alteration represents a simple substitution of one label material design for another, The benefit of this alteration is that multiple material properties can be selected based upon the needs of the user. The Examiner would further note that a paper/foil label composition is not only common, but appears to be the industry standard. Upon observing several individually wrapped dosage units around his house (Benadryl and Zofran ODT), the Examiner noted that both had a paper/foil construction.
Regarding claim 15, M. Bouthiette discloses the device of claim 8.
M. Bouthiette does not explicitly disclose: said central bare portion is circular in shape.
Braverman teaches: said central bare portion is circular in shape (Col. 8, line 15, “the chambers 30 may be other than square shape, e.g., they may be of circular, oval, triangular, or any other shape, providing that the flange surrounding the chamber is square.”).
Therefore, it would have been obvious to one having ordinary skill in the art at the time before filing to utilize the pill holder shape design as taught by Braverman in combination with the device as taught by M. Bouthiette, thereby combining prior art elements to achieve a predictable result. This alteration represents a simple substitution of one shape design for another. The Examiner further notes that this limitation holds no criticality, as the current application indicates that many shapes are potentially used ([0099] “Referring to Figures37-39, exemplary embodiments of label sheets for round blisters 242, square blisters 244, and oblong blisters 246 are shown”).
Regarding claim 16, M. Bouthiette discloses the device of claim 8.
M. Bouthiette does not explicitly disclose: said central bare portion is square in shape.
Braverman teaches: said central bare portion is square in shape (Col. 8, line 15, “the chambers 30 may be other than square shape, e.g., they may be of circular, oval, triangular, or any other shape, providing that the flange surrounding the chamber is square.”).
Therefore, it would have been obvious to one having ordinary skill in the art at the time before filing to utilize the pill holder shape design as taught by Braverman in combination with the device as taught by M. Bouthiette, thereby combining prior art elements to achieve a predictable result. This alteration represents a simple substitution of one shape design for another. The Examiner further notes that this limitation holds no criticality, as the current application indicates that many shapes are potentially used ([0099] “Referring to Figures37-39, exemplary embodiments of label sheets for round blisters 242, square blisters 244, and oblong blisters 246 are shown”).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over M. Bouthiette, US 5788079 in view of Micell, 9962318.
Regarding claim 10, M. Bouthiette discloses the device of claim 8.
M. Bouthiette does not explicitly disclose: said label sheet further comprises one or more appendix labels.
Micell teaches: said label sheet further comprises one or more appendix labels (Col. 13, line 47 – Col. 14, line 61 describes the use of printed labels with removable sublabels that can be stuck to prescription products as needed by the user - While dosage tables 42 may be provided on prescription labels 40 in any number of manners and positions, the dosage tables 42 are preferably connected to each label 40 using perforations 48 such that dosage table 42 may be printed and applied to a container with the with the standard prescription information or removed as desired by the user … It should be understood that this embodiment also allows a pharmacist to remove the dosage table 42 and apply it elsewhere on the container separately from the label 40 … the perforations 48 permit the pharmacist to remove the dosage table 42 and apply it to the container where available space is provided. It should also be understood that label 40 could include multiple dosage tables 42 with one of the dosage tables 42 intended to be applied to the container with label 40 and another table 42 operable to be removed via perforations 48 for application on another substrate ... Referring to FIGS. 8-9, dosage tables 42 may also be provided to a pharmacy for application to a prescription container as a separate sticker distinct from the prescription label 40. … The sticker embodiment is particularly useful when a pharmacy's labeling software does not have the capability, or the pharmacy chooses not to modify its pharmacy labeling software to give it the capability, of printing appropriate dosage numbers 46 in the dosage tables 42 based on the dosage instructions of the prescription entered into the pharmacy computer. Thus, in this situation, the pharmacy could stock a plurality of stickers having pre-printed dosage tables 42 with blank sequence sections 44 (i.e., sequence sections with no dosage numbers 46) such that the dispensing entity can handwrite the appropriate dosage numbers 46 at the time of dispensing the prescribed medication.”).
Therefore, it would have been obvious to one having ordinary skill in the art at the time before filing to utilize the appendix label design as taught by Micell in combination with the device as taught by M. Bouthiette, thereby combining prior art elements to achieve a predictable result. The benefit of this alteration is that it allows the user more flexibility in the labeling of the medication. This benefit is discussed in the cited language of Micell above, and includes increasing the ability of the pharmacist to properly label medications in possibly limited space situations as well as reducing the stocking requirements of the pharmacy.
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 DANIEL JEREMY LEEDS whose telephone number is (571)272-2095. The examiner can normally be reached Mon-Thurs, 0730-1730.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached at 571-270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL JEREMY LEEDS/Primary Examiner, Art Unit 3731
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