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 request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
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.
Claims 29 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5718859 to Frederiksen.
Regarding claim 29, Frederiksen teaches method for applying a label (10) onto a vial with cap (26 and 27), comprising: pressing an end label portion (12) of a label against an end face of a the vial (26) or the cap (27); deforming the label at neck portion ((14) to move a main label portion (13) toward a side surface of the vial (26) and/or the cap; and pressing the main label portion (13) of the label against the side surface of the vial (26) and/or the cap, the main label portion having a tamper-evident feature.
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 1, 4-7, 9-15, 19, 21, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over US 5601314 to Burns in view of US 5718859 to Frederiksen.
Regarding claim 1, Burns teaches a pharmacy label comprising: a facestock (12) configured to have data (preprinted variable and/or non-variable information; column 5, lines 12-37) on a first surface thereof, and an adhesive layer (pressure-sensitive adhesive 14; column 4, line 56-60) on a second surface of the facestock (12) wherein the facestock defines an end label portion (first part 49), a main label portion (bottom face 24) and a neck portion (reduce portion 42 and second part 51) between the end label portion and the main label portion, the neck portion being narrower than the end label portion and the main label portion.
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Burns does not teach the main label portion is adhered to a side surface of the vial and/or of the cap or the main label portion having a tamper-evident feature.
Frederiksen teaches a tamper-evident closure seal for containers such as syringes comprising: a facestock (upper layer 18 joined to a bottom layer 19 by an adhesive intermediate layer 20) configured to have data on a first surface thereof (seal configured to have an inscription for marking the type and quantity of material within the container, column 2, lines 48-56), and an adhesive layer (extremely aggressive adhesive 21) on a second surface of the facestock, wherein the facestock defines an end label portion (central circular section 12), a main label portion (enlarged contact sections 13) and a neck portion (thin strip sections 14) between the end label portion (12) and the main label portion (13), the neck portion (14) being narrower than the end label portion (12) and the main label portion (13) and wherein the label (seal 10) is sized such that when the end label portion (12) is against an end surface of the vial or the cap (27), the main label portion (13) is adhered to a side surface of the vial (syringe 26) and/or of the cap, the main label portion (13) having a tamper-evident feature (slit 11, column 4, line 48-53).
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It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to construct pharmacy label taught by Burns with tamper-evident feature such as slits as taught by Frederiksen with a reasonable expectation of success to provide to cause the label to be destroyed to indicated an attempt has been made to remove the label.
Regarding claim 4, Burns teaches the neck portion is narrower than the end label portion by having a minimum width being between 10% to 80% of a width of the end label portion.
Regarding claim 5, Burns teaches the neck portion has a constant width from the end label portion to the main label portion.
Regarding claim 6, Burns teaches the neck portion flares from the end label portion to the main label portion.
Regarding claim 7, Burns teaches the main label portion has a generally rectangular or square shape.
Regarding claims 9, 11, 12, and 13, Burns does not teach the claimed dimensions regarding the length, width, and/or diameter of the end label portion, the neck portion and/or the main label portion. However, it would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to construct label taught by Burns with any suitable dimensions with a reasonable expectation of success to provide a label to conform or fit the bottle/container to which the label is attached as a matter of design.
Regarding claim 10, Frederiksen teaches the main label portion (13) is wider than the end label portion (12).
Regarding claim 14, Burns teaches the main label portion (24) has a tear line (perforations 39) transverse to a length thereof.
Regarding claim 15, Burns teaches the end label portion (49) and/or the main label portion (24) has a barcode, data and/or ink (printed indicia) thereon.
Regarding claim 19, Burns teaches a support liner (release paper 16), the adhesive layer (14) being between the facestock (12) and the support liner (16), for releasable connection of the facestock (12) to the support liner (16).
Regarding claim 21, Burns teaches the support liner (16) has a first liner portion and a second liner portion separated by at least one slit (39). (Column 5, line 34-37).
Regarding claim 28, Frederiksen teaches a tamper-evident closure seal for containers such as syringes comprising: at least one of the label (seal 10), vial with cap (a container and cap, such as the syringe 26 and cap 27); wherein the label (10) is sized such that when the end label portion (12) is against an end surface of the vial or the cap (26), the main label portion (13) is adhered to a side surface of the vial and/or of the cap, the main label portion (13) having a tamper-evident feature (slits 11).
Claims 1, 2, 4-7, 10, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 4865352 to Gollon in view of US 5718859 to Frederiksen.
Regarding claim 1, Gollon teaches a tag comprising: a facestock configured to have data (information 26, name 28; column 5, lines 36-46 or bar code column 6, line 67-column 7, line 11) on a first surface thereof, and an adhesive layer (30) on a second surface of the facestock wherein the facestock defines an end label portion (16 or 16a), a main label portion (20 and 18a/20a) and a neck portion (18 and 22a) between the end label portion and the main label portion, the neck portion being narrower than the end label portion and the main label portion.
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Gollon does not teach the main label portion is adhered to a side surface of the vial and/or of the cap, the main label portion having a tamper-evident feature.
Frederiksen teaches a tamper-evident closure seal for containers such as syringes comprising: a facestock (upper layer 18 joined to a bottom layer 19 by an adhesive intermediate layer 20) configured to have data on a first surface thereof, and an adhesive layer (extremely aggressive adhesive 21) on a second surface of the facestock, wherein the facestock defines an end label portion (central circular section 12), a main label portion (enlarged contact sections 13) and a neck portion (thin strip sections 14) between the end label portion (12) and the main label portion (13), the neck portion (14) being narrower than the end label portion (12) and the main label portion (13) and wherein the label (seal 10) is sized such that when the end label portion (12) is against an end surface of the vial or the cap (27), the main label portion (13) is adhered to a side surface of the vial (syringe 26) and/or of the cap, the main label portion (13) having a tamper-evident feature (slit 11, column 4, line 48-53).
It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to tag taught by Gollon with tamper-evident feature such as slits as taught by Frederiksen with a reasonable expectation of success to provide to cause the label to be destroyed to indicated an attempt has been made to remove the label.
Regarding claim 2, Gollon teaches the end label portion (16) has a generally circular shape (figure 1).
Regarding claim 4, Gollon teaches the neck portion (18 and 22a) is narrower than the end label portion by having a minimum width being between 10% to 80% of a width of the end label portion.
Regarding claim 5, Gollon teaches the neck portion (18 and 22a) has a constant width from the end label portion (16 and 16a) to the main label portion (20 and 18a/20a).
Regarding claim 6, Gollon teaches the neck portion flares (49) from the end label portion(10a) to the main label portion (18a/20a).
Regarding claim 7, Gollon teaches the main label portion (16a) has a generally rectangular or square shape (figure 4).
Regarding claim 10, Frederiksen teaches the main label portion (13) is wider than the end label portion (12). It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to construct main label portion of the tab taught by Gollon wider that the end label portion as taught by Frederiksen with a reasonable expectation of success to provide a larger surface area to printing indicia. A change in the size of a prior art device is a design consideration within the skill of the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).
Regarding claim 14, Frederiksen teaches the main label portion has a tear line (11) being the tamper-evident feature.
Regarding claim 15, Gollon teaches the end label portion and/or the main label portion has a barcode, data and/or ink thereon (information 26, name 28; column 5, lines 36-46 or bar code column 6, line 67-column 7, line 11).
Claims 1, 5, 7, 18, 19 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190291101 A1 to Ambartsoumian in view of US 5718859 to Frederiksen.
Regarding claim 1, Ambartsoumian teaches a tag (tube holder 20) comprising: a facestock configured to have data (bar code 25) on a first surface thereof, and an adhesive layer (¶0058, figure 27-28) on a second surface of the facestock wherein the facestock defines an end label portion (not labeled), a main label portion (foldable tab 34) and a neck portion (not labeled) between the end label portion and the main label portion, the neck portion being narrower than the end label portion and the main label portion. Ambartsoumian also teaches the support liner (63) is in adhered to another support liner (60) by another layer of adhesive (62) in a piggy-back configuration.
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Ambartsoumian does not teach the main label portion is adhered to a side surface of the vial and/or of the cap, the main label portion having a tamper-evident feature.
It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to tag (tube holder) taught by Ambartsoumian with tamper-evident feature such as slits as taught by Frederiksen with a reasonable expectation of success to provide to cause the label to be destroyed to indicated an attempt has been made to remove the label.
Regarding claim 5, Ambartsoumian teaches the neck portion has a constant width from the end label portion to the main label portion.
Regarding claim 7, Ambartsoumian teaches the main label portion (34) has a generally rectangular or square shape (figure 17).
Regarding claim 18, Ambartsoumian teaches a wireless communication tag or related component (a radio-frequency identification (RFID) chip or a near-field communication (NFC) chip 27) in the label.
Regarding claim 19, Ambartsoumian teaches a support liner (63), the adhesive layer (61) being between the facestock (20A) and the support liner (63), for releasable connection of the facestock to the support liner.
Regarding claim 35, Ambartsoumian teaches a wireless communication tag or related component (a radio-frequency identification (RFID) chip or a near-field communication (NFC) chip 27) in the label. Frederiksen teaches applying the label (10) onto the vial (26) with cap (27) includes applying the label. with a wireless communication tag therein to the vial with cap.
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Claims 1-3, 5, 7, 9-13, 19, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over US 20140167401 to Flynn in view of US 5718859 to Frederiksen.
Regarding claim 1, Flynn teaches a security device/label comprising: a facestock configured to have data on a first surface thereof, and an adhesive layer (¶0008) on a second surface of the facestock wherein the facestock defines an end label portion (130), a main label portion (110) and a neck portion (120) between the end label portion and the main label portion, the neck portion being narrower than the end label portion and the main label portion.
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Flynn does not teach the main label portion is adhered to a side surface of the vial and/or of the cap, the main label portion having a tamper-evident feature.
It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to security device/label taught by Flynn with tamper-evident feature such as slits as taught by Frederiksen with a reasonable expectation of success to provide to cause the label to be destroyed to indicated an attempt has been made to remove the label.
Regarding claim 2, Flynn teaches the end label portion (130) has a generally circular shape (figure 1).
Regarding claim 3, Since the applicant does not disclose that the end label portion having a diameter of at most 6.5mm solves any stated problem or is for any particular purpose, it appears that constructing the diameter of the end label of any suitable dimension to coincide with the diameter of the cap of the vial would perform equally well.
Regarding claim 5, Flynn teaches the neck portion has a constant width from the end label portion to the main label portion.
Regarding claim 7, Flynn teaches the main label portion (110) has a generally rectangular or square shape (figure 1).
Regarding claim 9, Flynn does not teach the main label portion has a maximum width a ranging from 3.0 mm to 40.0 mm. However, since Flynn teaches the label can be attached to various types of containers, it would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to construct main label portion of the security label taught by Flynn with any suitable dimensions with a reasonable expectation of success to provide a label to conform or fit the bottle/container to which the label is attached as a matter of design.
Regarding claim 10, Flynn teaches the main label (110) portion is wider than the end label portion (130).
Regarding claims 3, 9, 11, 12, and 13, Flynn does not teach the claimed dimensions regarding the length, width, and/or diameter of the end label portion, the neck portion and/or the main label portion. However, it would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to construct label taught by Flynn with any suitable dimensions with a reasonable expectation of success to provide a label to conform or fit the bottle/container to which the label is attached as a matter of design.
Regarding claim 19, Flynn teaches a support liner (thin plastic or paper cover), the adhesive layer being between the facestock and the support liner, for releasable connection of the facestock to the support liner (¶0008).
Regarding claim 28, Flynn teaches the label can be attached to various types of containers (¶0008).
It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to substitute alcoholic or pharmaceutical containers taught by Flynn with matrix tube with a reasonable expectation of success to provide means to label a matrix tube. Such a modification would have involved a simple substitution of one known container for another to obtain predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ 2D 1385 (2007).
Regarding claim 28, Frederiksen teaches a tamper-evident closure seal for containers such as syringes comprising: at least one of the label (seal 10), vial with cap (a container and cap, such as the syringe 26 and cap 27); wherein the label (10) is sized such that when the end label portion (12) is against an end surface of the vial or the cap (26), the main label portion (13) is adhered to a side surface of the vial and/or of the cap, the main label portion (13) having a tamper-evident feature (slits 11).
Response to Arguments
Applicant's arguments filed March 27, 2026 have been fully considered but they are not persuasive.
Regarding the rejection of claim 29 as being anticipated by US 5718859 to Frederiksen, the applicant argues Frederiksen teaches a seal and not a label as claimed. The applicant argues “not once-does Frederiksen use the word "label' to describe its invention”. The applicant further argues “[a] label is a structure configured to bear data- information, text, barcodes, or other identifying indicia-on its surface. That is its fundamental purpose”. The applicant contends “[t]here is no teaching, suggestion, or even passing mention of the seal bearing data of any kind”.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a label configured to bear data- information, text, barcodes, or other identifying indicia-on its surface) are not recited in the rejected claim 29. Although the claim is interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The examiner also contends the limitations implied by the applicant, but not actually claimed, are taught by Frederiksen. As pointed out the applicant, Frederiksen teaches the seal comprises an inscription for marking the type and quantity of material within the container.
The applicant also argues “Frederiksen's seal is structurally incompatible with the concept of a label configured to bear data. The seal is formed with slits 11 covering "substantially the entire surface" of the seal (Frederiksen, column 2, lines 37-38). Critically, the formation of slits 11 in the seal 10 produces elevated areas 24 and 25 directly adjacent the side surfaces 22 and 23 of each slit, caused by displacement of seal material during the opening of the slits”.
The examiner disagrees.
The claim does not recite limitations precluding slits.
The rejection is maintained.
Regarding the rejection claims 1-7, 9-15, 18-21, 28, and 35 under 35 U.S.C. 102(a)(1) as being anticipated is herein withdrawn. These claims are now rejection under 35 U.S.C. 103.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASSANDRA DAVIS whose telephone number is (571)272-6642. The examiner can normally be reached Monday-Friday 8:00 AM-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Liu can be reached at 571-272-8227. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CASSANDRA DAVIS/Primary Examiner, Art Unit 3631
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