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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-2 and 4-17 in the reply filed on 05/22/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/22/2026.
Claims 3 and 18 were cancelled by the Applicant.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/03/2026 and 11/13/2025 is considered by the examiner.
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 1-2 and 4-17 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 claims 1 and 14, based on the amended claim language to claim 1, it is unclear whether the assembly of claim 1 requires the label to be on the vial with cap or if the label is separate from the vial and cap. Lines 11-14 recite the relationship between the label and the vial and cap, but its not clear if the label is required to be on the vial and cap in the claimed assembly or if lines 11-14 are directed to the intended use of the claimed assembly.
In claim 14, a releasable support liner is claimed presumably with respect to the claimed label, although the claim does not specify the support liner is a further feature of the label. It appears that the support liner is an additional feature of the label, however, it is unclear whether the label is required to be on the vial and cap in claim 1.
Regarding claim 13, there is insufficient antecedent basis for the phrase “the data” in line 1 of the claim. Independent claim 1, form which claim 13 depends, does not recite or require data printed thereon.
Claims 2, 4-12 and 15-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph based on their dependency from the rejected claims above.
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 –
(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, 2, 4, 7, 9, 10, 11, 12, 13, 14, 15, 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ambartsoumian (US 2023/041069).
Regarding claims 1, 2, 4, 14 and 16, Ambartsoumian teaches a label for a matrix tube, such as a sample tube or sample vial, comprising a cap and tube (vial) (Figure 1; [0005-0028, 0052-0053]).
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The label, as shown in Figure 2D above, comprising a facestock (11) defining a main label (10C; tamper evident label portion), a end label portion (10A) and a neck portion (10B) between the main label (10C; tamper evident label portion) and the end label portion (10A), wherein the neck portion (10B) is narrower than the main label (10C; tamper evident label portion) and the end label portion (10A) (Figure 2D, 3A; [0056-0060]). The label further comprises an adhesive layer on a surface of the facestock (12) and a support liner (13) as a release liner for releasable connection of the facestock (12) to the support liner (13) (Figure 3A; [0060-0065]).
The neck portion (10B) and the main label (10C; tamper evident portion) form a T-shape portion of the label, wherein, Figure 2D shows an embodiment wherein two neck portions (10B) and two main label portions (10C; tamper evident portion) are formed on either side of the end label portion (10A) ([0054-0057]). Ambartsoumian further teaches that the facestock of the label an comprise wireless communication components such as RFID or NFC chips ([0060]).
The limitations reciting “wherein the label is sized such that when the end label portion is against an end surface of the vial or an end surface of the cap, the tamper-evident label portion extends circumferentially along at least part a joint line between the vial and the cap and is adhered to a side surface of the vial and of the cap” recites
the intended use of the invention, and has been considered, but is not given patentable weight as a structural limitation of the invention. The limitation defines the structural component by what it does, rather than what it is. This is a functional limitation, and therefore was not evaluated on its own, but in conjunction with the remainder of claim (see Section §2173.05(g) of the MPEP). Ambartsoumian teaches all the structural features of the claimed invention as required by claim 1, and therefore, would be capable of performing in the manner claimed.
Regarding claim 7, Ambartsoumian teaches all the limitations of claim 1 above, and further teaches, as shown by Figure 2D, that the end label portion (10A) has a generally circular shape ([0054-0055]).
Regarding claim 9, Ambartsoumian teaches all the limitations of claim 1 above, and further teaches, as shown by Figure 2D, that the neck portion (10B) has a constant width from the end label portion (10A) to the main label portion (10C; tamper evident portion) ([0055-0058]).
Regarding claim 10, Ambartsoumian teaches all the limitations of claim 1 above, and further teaches, as shown by Figure 2D, that the main label portion (10C; tamper evident portion) has a generally rectangular or square shape ([0057]).
Regarding claims 11, 12 and 13, Ambartsoumian teaches all the limitations of claim 1 above and further teaches that the end label portion (10A) can have a QR code or 2D barcode printed thereon and the main label portion (10C; tamper-evident portion) can have a barcode, symbols, letters, and/or numbers, such that the information printed on the end label portion (10A) and the main label portion (10C; tamper evident portion) are different (Figure 2D; [0055-0058]).
Regarding claim 15, Ambartsoumian teaches all the limitations of claim 1 above. The limitation reciting “wherein the label is configured to be attached to a frozen container” recites the intended use of the invention, and has been considered, but is not given patentable weight as a structural limitation of the invention. The limitation defines the structural component by what it does, rather than what it is. This is a functional limitation, and therefore was not evaluated on its own, but in conjunction with the remainder of claim (see Section §2173.05(g) of the MPEP). Ambartsoumian teaches all the structural features of the claimed invention as required by claim 1, and therefore, would be capable of performing in the manner claimed.
Regarding claim 17, Ambartsoumian teaches all the limitations of claim 1 above. The limitation reciting “wherein the facestock is configured have data on another surface thereof” recites the intended use of the invention, and has been considered, but is not given patentable weight as a structural limitation of the invention. The limitation defines the structural component by what it does, rather than what it is. This is a functional limitation, and therefore was not evaluated on its own, but in conjunction with the remainder of claim (see Section §2173.05(g) of the MPEP). Ambartsoumian teaches all the structural features of the claimed invention as required by claim 1, and therefore, would be capable of performing in the manner claimed.
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 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ambartsoumian (US 2023/0410691) in view of Frederiksen et al. (US 5,718,859; cited on IDS).
Regarding claims 5 and 6, Ambartsoumian teaches all the limitations of claim 1 above, however, the reference does not expressly teach that tear features such as slits and/or weakening are defined in the neck portion (10B) or the main label portion (10C; tamper evident portion).
Fredericksen et al. teaches a tamper evident closure seal for product containers such as syringes, wherein the seal is comprised of a central circular section (12) and two large sections (13) separated from the central circular section (12) by thin strip sections (14) (Figure 1; col. 3 Ln. 10-col. 4 Ln. 5). Fredericksen et al. further teaches that the two large sections (13) and the thin strip sections (14) comprise slits (11), which increase the likelihood that the seal will be destroyed if removal of the seal from the container is attempted (col. 1 Ln. 50-65, col. 3 Ln. 10-col. 4 Ln. 5).
As both Ambartsoumian and Fredericksen et al. are in the field of tamper evident closures, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the neck portion (10B) and/or the main label portion (10C; tamper evident portion) of the label taught by Ambartsoumian to include slits as taught by Fredericksen et al. to increase the likelihood the label will be destroyed upon attempted removal.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ambartsoumian (US 2023/0410691).
Regarding claim 8, Ambartsoumian teaches all the limitations of claim 1 above, and while the reference teaches that the facestock can include a wireless communication device such as RFID or NFC ([0060]), the reference does not expressly teach that such a device is connected to the end label portion (10A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the label of Ambartsoumian to include the wireless communication device at any portion of the facestock layer, including the end label portion (10A) as an obvious matter of design choice based upon where it was desired for the wireless device to be for tampering detection.
Claims 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gaetano (EP 1455326) in view of Chandra et al. (US 2019/0135501; cited on IDS).
Regarding claims 1, 2, 4, 5, 6, 7, 8, 11 and 16, Gaetano teaches an assembly comprising a vial with cap and a label as shown in the Figure from page 5 of the reference reproduced below.
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The label of Gaetano includes a facestock defining a central circular label portion (end label portion), a neck portion on either side of the central circular portion (end label portion) and a perpendicular label section (tamper-evident label portion), wherein the neck portion and the perpendicular label section (tamper-evident label portion) form a T-shape portion of the label as shown in the Figure above. The central circular portion (end label portion) and the perpendicular label section (tamper-evident label portion) both comprise data printed thereon.
Gaetano teaches that the tape seals are adhered to a glass bottle (vial) as shown in the Figures on page 8, wherein upon attempted removal, the tape seals break down leaving traces of the label on to show an attempt at tampering, wherein the seal breaks into a VOID shape (i.e. tears/weakening/slits).
The limitations reciting “wherein the label is sized such that when the end label portion is against an end surface of the vial or an end surface of the cap, the tamper-evident label portion extends circumferentially along at least part a joint line between the vial and the cap and is adhered to a side surface of the vial and of the cap” recites
the intended use of the invention, and has been considered, but is not given patentable weight as a structural limitation of the invention. The limitation defines the structural component by what it does, rather than what it is. This is a functional limitation, and therefore was not evaluated on its own, but in conjunction with the remainder of claim (see Section §2173.05(g) of the MPEP). Gaetano teaches all the structural features of the claimed invention as required by claim 1, and therefore, would be capable of performing in the manner claimed.
Gaetano does not expressly teach a wireless communication inlay attached to the facestock. Chandra et al. teaches a bottle having a sealing device (label) with a mechanism for detecting an opened or tampered state of the bottle (Figure 4A, 5A, 7; [0005, 0010, 0127, 0172]). The sealing device comprises a facestock, comprising a neck portion connected two different areas of the sealing device, one of which includes a wireless tag or a display tag, including RFID tags ([0010-0026, 0078-0089, 0172]). Chandra et al. teaches that wireless devices in labels are known to enhance the level of security while preserving the ability to verify authenticity in the field, wherein by breaking the antenna in some way, the wireless device is destroyed, and cannot be used after the protected item has been opened ([0005]).
As both Gaetano and Chandra et al. are in the field of tamper evident labels, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the label taught by Gaetano to include a wireless communication device such as an RFID or NFC chip as taught by Chandra et al. to enhance the level of security of the label. Furthermore, one of ordinary skill in the art would be motivated to include the wireless communication device at any position within the label as an obvious matter of design choice, including the central circular portion based upon the desired placement for the enhanced security features.
Regarding claims 9 and 10, Gaetano in view of Chandra et al. teaches all the limitations of claim 1 above, and as shown by the Figure from page 5 of Gaetano above, the neck portions are shown as having constant width from the central circular portion (end label portion) to the perpendicular label sections (tamper-evident label portion). The figure further shows that the perpendicular label sections (tamper-evident label portion) have a generally rectangular or square shape.
Regarding claim 12, Gaetano in view of Chandra et al. teaches all the limitations of claim 11 above, and Gaetano teaches that the central circular portion (end label portion) and the perpendicular label section (tamper-evident label portion) both comprise data printed thereon. While the reference does not expressly teach that the central circular portion (end label portion) and the perpendicular label section (tamper-evident label portion) comprise different data thereon, such a modification would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as an obvious matter of design choice based upon the desired data to be displayed on the label. It has been held that where the only different between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product form the prior art (See MPEP 2111.05 and 2112.01(III)).
Regarding claim 13, Gaetano in view of Chandra et al. teaches all the limitations of claim 1 above. While the references do not expressly teach that the data on the central circular portion (end label portion) is a QR code or 2D bar code, such a modification would have been obvious to one of ordinary skill in the at to enhance the security of the label by incorporating a unique barcode or QR code specific to the container to which the label is attached.
Regarding claim 14, Gaetano in view of Chandra et al. teaches all the limitations of claim 1 above. While the references do not expressly teach a support liner releasably connected to the facestock layer, such a modification would have been obvious to one of ordinary skill in the art. Release liners are known in the label art for protecting the adhesive layer until the label is used. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the label of Gaetano to include a release liner to protect the adhesiveness of the tape seal prior to use.
Regarding claim 15, Gaetano in view of Chandra et al. teaches all the limitations of claim 1 above. The limitation reciting “wherein the label is configured to be attached to a frozen container” recites the intended use of the invention, and has been considered, but is not given patentable weight as a structural limitation of the invention. The limitation defines the structural component by what it does, rather than what it is. This is a functional limitation, and therefore was not evaluated on its own, but in conjunction with the remainder of claim (see Section §2173.05(g) of the MPEP). Gaetano in view of Chandra et al. teaches all the structural features of the claimed invention as required by claim 1, and therefore, would be capable of performing in the manner claimed.
Regarding claim 17, Gaetano in view of Chandra et al. teaches all the limitations of claim 1 above. The limitation reciting “wherein the facestock is configured have data on another surface thereof” recites the intended use of the invention, and has been considered, but is not given patentable weight as a structural limitation of the invention. The limitation defines the structural component by what it does, rather than what it is. This is a functional limitation, and therefore was not evaluated on its own, but in conjunction with the remainder of claim (see Section §2173.05(g) of the MPEP). Gaetano in view of Chandra teaches all the structural features of the claimed invention as required by claim 1, and therefore, would be capable of performing in the manner claimed.
Claims 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Frederiksen et al. (US 5,718,859) in view of Chandra et al. (US 2019/0135501; cited on IDS).
Regarding claims 1, 2, 4, 5, 6, 7, 8, 9, 10, 14 and 16 , Fredericksen et al. teaches a tamper evident closure seal for containers such as syringes comprising a body and a cap, wherein the closure seal is comprised of a central circular section (12; end label portion), two thin strips (14; neck portion) coming from either side of the central circular portion (12; end label portion) and two enlarged content portions (13; tamper evident label portion) with a generally rectangular or square shape as shown in Figure 1 reproduced below (col. 1 ln. 50-col. 2 Ln. 40, col. 3 Ln. 20-col. 4 Ln. 30).
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Fredericksen et al. teaches the label is comprised of a facestock layer (19) having an adhesive layer (21) on a surface thereof, wherein a release liner (17) covers the other adhesive surface and is removed prior to label use (col. 3 Ln. 65-col. 4 Ln. 15). The two thin strips (14; neck portion) with constant width and two enlarged content portions (13; tamper evident label portion) comprise slits (11), which increase the likelihood that the seal will be destroyed if removal is attempted (col;. 1 Ln. 50-65).
Fredericksen et al. does not expressly teach a vial and a cap, however, the reference does teach product containers such as a syringe and cap (col. 1 Ln. 10-15). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the product container to be any product container comprising a body and a cap, including a vial with a cap, based upon the desired use of the product container.
Fredericksen et al. does not expressly teach a wireless communication inlay attached to the facestock. Chandra et al. teaches a bottle having a sealing device (label) with a mechanism for detecting an opened or tampered state of the bottle (Figure 4A, 5A, 7; [0005, 0010, 0127, 0172]). The sealing device comprises a facestock, comprising a neck portion connected two different areas of the sealing device, one of which includes a wireless tag or a display tag, including RFID tags ([0010-0026, 0078-0089, 0172]). Chandra et al. teaches that wireless devices in labels are known to enhance the level of security while preserving the ability to verify authenticity in the field, wherein by breaking the antenna in some way, the wireless device is destroyed, and cannot be used after the protected item has been opened ([0005]).
As both Fredericksen et al. and Chandra et al. are in the field of tamper evident labels, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the label taught by Fredericksen et al. to include a wireless communication device such as an RFID or NFC chip as taught by Chandra et al. to enhance the level of security of the label. Furthermore, one of ordinary skill in the art would be motivated to include the wireless communication device at any position within the label as an obvious matter of design choice, including the central circular portion based upon the desired placement for the enhanced security features.
Regarding claims 11 and 12, Fredericksen et al. in view of Chandra et al. teaches all the limitations of claim 1 above. While the reference does not teach that the two enlarged content portions (13; tamper evident label portion) comprise barcode, data, and/or ink thereon as required by claim 11 or that the two enlarged content portions (13; tamper evident label portion) and the central circular section (12; end label portion) comprise different data thereon, such a modification would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as an obvious matter of design choice to convey information to the user. It has been held that where the only different between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product form the prior art (See MPEP 2111.05 and 2112.01(III)).
Regarding claim 13, Fredericksen et al. in view of Chandra et al. teaches all the limitations of claim 1 above. While the reference does not teach that the central circular section (12; end label portion) comprises a QR code or 2D barcode, such a modification would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as an obvious matter of design choice to convey information to the user. It has been held that where the only different between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product form the prior art (See MPEP 2111.05 and 2112.01(III)). Furthermore such a modification would have been obvious to one of ordinary skill in the art to enhance the security of the label by incorporating a unique barcode or QR code specific to the container to which the label is attached.
Regarding claim 15, Fredericksen et al. in view of Chandra et al. teaches all the limitations of claim 1 above. The limitation reciting “wherein the label is configured to be attached to a frozen container” recites the intended use of the invention, and has been considered, but is not given patentable weight as a structural limitation of the invention. The limitation defines the structural component by what it does, rather than what it is. This is a functional limitation, and therefore was not evaluated on its own, but in conjunction with the remainder of claim (see Section §2173.05(g) of the MPEP). Fredericksen et al. in view of Chandra et al. teaches all the structural features of the claimed invention as required by claim 1, and therefore, would be capable of performing in the manner claimed.
Regarding claim 17, Fredericksen et al. in view of Chandra et al. teaches all the limitations of claim 1 above. The limitation reciting “wherein the facestock is configured have data on another surface thereof” recites the intended use of the invention, and has been considered, but is not given patentable weight as a structural limitation of the invention. The limitation defines the structural component by what it does, rather than what it is. This is a functional limitation, and therefore was not evaluated on its own, but in conjunction with the remainder of claim (see Section §2173.05(g) of the MPEP). Fredericksen et al. in view of Chandra teaches all the structural features of the claimed invention as required by claim 1, and therefore, would be capable of performing in the manner claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Williams (US 2011/0086194) teaches a security inherent wrap label with patterned adhesive as shown by Figures 1 and 4 ([0006-0017, 0025-0026, 0030]).
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LAURA POWERS
Examiner
Art Unit 1785
/LAURA C POWERS/Primary Examiner, Art Unit 1785
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