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 .
Claims 1-3 and 15 are examined in this office action
Claims 1 is currently amended
Election/Restrictions
Applicant's election with traverse of Group I, Species I Claims 1-13 and 15 in the reply filed on 6/22/2026 is acknowledged. The traversal is on the ground(s) that Kessler et al. does not disclose or suggest a configuration of a labeling arrangement as recited in Applicant's amended independent claim 1. Label sections 18 and 19 of label 5 of Kessler et al. consist only of sections and not of tabs extending from an edge. Moreover, Kessler et al. fails to disclose or teach a needle catcher. Additionally, any search for the invention embodied in Group I, Species I would necessarily include a search for the invention embodied in the remaining groups and species.
This is not found persuasive because Examiner interprets Kessler to teach that "the first and second flaps extend away from a main portion or an edge of the label" as recited in the rejection above. The two flaps or tabs (body portion 18 and cap portion 19) extend away from the middle of the tamper evident label 5 as shown in annotated Fig. 3 below. Additionally, the needle catcher limitation is read upon by the needle cap 4 of Kessler. Thus, the technical features required by Group I and Group II do not make a contribution over the prior art in view of Kessler et al. Additionally, the L-shaped tab as shown in Fig. 3 would require a different set of search terms than the rectangular tabs of Fig. 2. Thus the search burden on the examiner exists and the election restriction is upheld.
The requirement is still deemed proper and is therefore made FINAL.
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)(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.
Claim(s) 1-3, 5-6, 8-9, 13, and 15 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Kessler et al. (US Patent No. 7141286).
Regarding claim 1, Kessler discloses a labelling arrangement (tamper evident syringe assembly 1, Fig. 1) for attachment to a syringe (syringe body 2, Fig. 2) comprising a syringe body (syringe body 2, Fig. 2), a syringe needle ("… the needle preferably is sealed with an appropriate design of needle cap 4." – Col. 4 Line 28) and a needle protection cap surrounding the syringe needle (needle cap 4, Fig. 2), the labelling arrangement comprising:
a label (tamper evident label 5, Fig. 1) adapted to be attached to the syringe body (3) of the syringe ("… a tamper evident label 5 bonded to the syringe body and the needle cap is shown." – Col. 4 Line 14),
a needle trap (needle cap 4, Fig. 2) adapted to receive and secure the syringe needle of the syringe after use ("… the needle preferably is sealed with an appropriate design of needle cap 4." - Col. 4 Line 28),
a first label flap (cap portion 19, Fig. 3) coupled to the needle trap ("… a cap portion 19 which is bonded to the reduced diameter portion 13 of the needle cap 4." – Col. 5 Line 9), and
a second label flap (body portion 18, Fig. 3)
separate from the first label flap ("… the tamper evident label 5 is divided into two portions." – Col. 5 Line 5), which is configured to be predeterminedly severable ("The body portion 18 and the cap portion 19 are separated from each other by a crease line or perforation 20 …" – Col. 5 Line 11) and is set up to be attached to the needle protection cap of the syringe ("… a cap portion 19 which is bonded to the reduced diameter portion 13 of the needle cap 4." - Col. 5 Line 9) and to form an opening detection element on the syringe (tamper evident label 5, Fig. 1), wherein the first and second label flaps extend away from a main portion or an edge (perforation 20, Fig. 3) of the label (See annotated Fig. 3) and are connected to one another by means of the label (Fig. 3), so that, with reference to an applied state in which the labeling arrangement is attached to the syringe in accordance with operation (Fig. 1), when the syringe is opened by removing the needle protection cap ("Once the needle cap 4 is removed, the plunger assembly 3 can be engaged by pushing on the thumb rest 11.” – Col. 5 Line 31), the second label flap (label 5, Fig. 3) can be severed and a section of the second label flap together with the needle protection cap can be removed from the label and the syringe body ("… the needle cap 4 is rotated about the axis of the syringe assembly 1 and the label 5 twists and breaks at the perforation 20." – Col. 5 Line 26).
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Regarding claim 2, Kessler discloses the labeling arrangement (tamper evident syringe assembly 1, Fig. 1) as recited above, wherein
the first (cap portion 19, Fig. 3) and second label flaps (body portion 18, Fig. 3)
and the label (tamper evident label 5, Fig. 1) are formed in one piece from a common web of material ("… the tamper evident label 5 is divided into two portions." - Col. 5 Line 5, as shown in Fig. 3).
Regarding claim 3, Kessler discloses the labeling arrangement (tamper evident syringe assembly 1, Fig. 1) as recited above, wherein
the label (tamper evident label 5, Fig. 1), the first label flap (cap portion 19, Fig. 3) and/or the second label flap (body portion 18, Fig. 3) have an adhesive surface (“The rear side of the tamper evident label is covered with a permanent adhesive …” – Col. 5 Line 1) by means of which they can be adhesively attached to the element provided for them (“The cap portion is bonded by the permanent adhesive to the needle cap and the body portion is bonded to the outer surface of the syringe body …” – Col. 5 Line 19) comprising the syringe body (syringe body 2, Fig. 2), needle trap (needle cap 4, Fig. 2), and needle protection cap (needle cap 4, Fig. 2).
Regarding claim 5, Kessler discloses the labeling arrangement (tamper evident syringe assembly 1, Fig. 1) as recited above, wherein
the second label flap (body portion 18, Fig. 3) has a predetermined severing area (perforation 20, Fig. 3) with a severing element (perforation 20, Fig. 3) which is formed in coordination with a geometry of the syringe (as shown in Figs. 1-3).
Regarding claim 6, Kessler discloses the labeling arrangement (tamper evident syringe assembly 1, Fig. 1) as recited above, wherein
the severing element (perforation 20, Fig. 3) of the second label flap (body portion 18, Fig. 3) comprise a perforation (perforation 20, Fig. 3) and/or punching.
Regarding claim 8, Kessler discloses the labeling arrangement (tamper evident syringe assembly 1, Fig. 1) as recited above, wherein
the severing area (perforation 20, Fig. 3) is designed in a predetermined manner in coordination with syringe (syringe body 2, Fig. 2), so that, with respect to an applied state in which the labeling arrangement is attached to the syringe during operation (Fig. 1), the severing area (perforation 20, Fig. 3) is arranged in a transition region (reference number 7 in Fig. 2) between the syringe body (perforation 20, Fig. 3) and the needle protection cap (needle cap 4, Fig. 2).
Regarding claim 9, Kessler discloses the labeling arrangement (tamper evident syringe assembly 1, Fig. 1) as recited above, wherein
the severing area (perforation 20, Fig. 3) has an adhesive-neutral or adhesive-free surface in the region of the severing element (“… it is not necessary to provide the rear side of the cap portion of the label with an adhesive …” – Col. 5 Line 66).
Regarding claim 13, Kessler discloses the labeling arrangement (tamper evident syringe assembly 1, Fig. 1) as recited above, wherein
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with respect to a longitudinal axis (See annotated Fig. 1) of the labeling arrangement (tamper evident syringe assembly 1, Fig. 1), the second label flap has a length (See annotated Fig. 1) which is designed in a predetermined manner in coordination (“… a cap portion which is bonded to the reduced diameter portion of the needle cap.” – Col. 5 Line 6) with a geometry of the needle protection cap (needle cap 4, Fig. 1).
Regarding claim 15, Kessler discloses a syringe system (tamper evident syringe assembly 1, Fig. 1), comprising:
a syringe (syringe body 2, Fig. 2) with a syringe body (syringe body 2, Fig. 2), a syringe needle ("… the needle preferably is sealed with an appropriate design of needle cap 4." – Col. 4 Line 28) and a needle protection cap (needle cap 4, Fig. 1) surrounding the syringe needle ("… the needle preferably is sealed with an appropriate design of needle cap 4." – Col. 4 Line 28), and
the labeling arrangement (tamper evident syringe assembly 1, Fig. 1) according to claim 1, which is attached to a syringe (syringe body 2, Fig. 2) so that the label is arranged on the syringe body (syringe body 2, Fig. 2) and the second label flap is arranged on the needle protection cap (needle cap 4, Fig. 1) (“On the left side there is the body portion which is bonded to the syringe body and which may show written information of the syringe contents, and on the right side there is a cap portion which is bonded to the reduced diameter portion of the needle cap.” – Col. 5 Line 5).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kessler et al. (US Patent No. 7141286) in view of Ambartsoumian et al. (WO 2024174019 A1).
Regarding claim 4, Kessler in view of Ambartsoumian discloses the labeling arrangement (Kessler, tamper evident syringe assembly 1, Fig. 1) as recited above, wherein
the adhesive surface of the label (Kessler, tamper evident label 5, Fig. 1) and the adhesive surface of the second label flap (Kessler, body portion 18, Fig. 3) which are designed in a predetermined manner in coordination with the syringe body (Kessler, syringe body 2, Fig. 2) and the needle protection cap (Kessler, needle cap 4, Fig. 2) (Kessler, “On the left side there is the body portion which is bonded to the syringe body and which may show written information of the syringe contents, and on the right side there is a cap portion which is bonded to the reduced diameter portion of the needle cap.” – Col. 5 Line 5).
Kessler does not expressly disclose that the adhesive surface of the label and the adhesive surface of the second label flap have different adhesives.
Ambartsoumian teaches that the adhesive surface of the label (adhesive 12) and the adhesive surface of the second label flap (adhesive 12) have different adhesives (“The use of combinations of adhesives in the same area or in different areas of the label.” – Para [0095]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention, to modify the labeling arrangement of Kessler to include that the adhesive surface of the label and the adhesive surface of the second label flap have different adhesives as taught by Ambarsoumian to be adhered to a body (Ambartsoumian, Abstract).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kessler et al. (US Patent No. 7141286) in view of Stafeil (US Pub No. 20180303712 A1).
Regarding claim 7, Kessler in view of Stafeil discloses the labeling arrangement (Kessler, tamper evident syringe assembly 1, Fig. 1) as recited above, wherein
the second label flap (Kessler, body portion 18, Fig. 3) has a severing area (Kessler, perforation 20 and reference number 7, Fig. 2) which is exposed when the syringe (Kessler, syringe body 2, Fig. 2) is opened and the second label flap is severed (Kessler, “the needle cap is rotated about the axis of the syringe assembly and the label twists and breaks at the perforation.” – Col. 5 Line 27).
Stafeil teaches that the second label flap (IV port 82, Figs. 11A-11C) has a predetermined colored area (graphic 90, Figs. 11A-11C) (“…the color of the graphic 90 can vary by preference …” – Para [0140]) in the severing area (label 100, Fig. 10C), which is exposed when the syringe is opened (“… form a graphic 90 on the IV port 82 when the label 100, or portions of the label 100 are removed.” – Para [0138]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention, to modify the labeling arrangement of Kessler to include that the second label flap has a predetermined colored area in the severing area which is exposed when the syringe is opened as taught by Stafeil to serve as a further visual indicator (Stafeil, Para [0142]).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kessler et al. (US Patent No. 7141286) in view of Erfinder (DE 102021122087 A1).
Regarding claim 10, Kessler in view of Erfinder discloses the labeling arrangement (Kessler, tamper evident syringe assembly 1, Fig. 1) as recited above, comprising
Kessler does not expressly disclose a carrier element which is coupled to the label, to the first label flap and to the second label flap, wherein the carrier element has a straight contour at one edge and a curved contour at an opposite edge, and wherein the curved contour comprises a recess, which is designed in a predetermined manner in coordination with the first label flap and/or the needle trap, so that the first label flap is arranged in the region of the recess and the carrier element does not cover the first label flap or only cover it in sections on one side.
Erfinder teaches a carrier element (central support 12, Fig. 1) which is coupled to the label (plates 14, Fig. 1), to the first label flap (See annotated Fig. 1) and to the second label flap (See annotated Fig. 1), wherein the carrier element (central support 12, Fig. 1) has a straight contour at one edge (See annotated Fig. 1) and a curved contour (See annotated Fig. 1) at an opposite edge, and wherein the curved contour comprises a recess (See annotated Fig. 1), which is designed in a predetermined manner in coordination with the first label flap and/or the needle trap, so that the first label flap is arranged in the region of the recess (See annotated Fig. 1) and the carrier element does not cover the first label flap or only cover it in sections on one side (See annotated Fig. 1).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention, to modify the labeling arrangement of Kessler to include a carrier element which is coupled to the label, to the first label flap and to the second label flap, wherein the carrier element has a straight contour at one edge and a curved contour at an opposite edge, and wherein the curved contour comprises a recess, which is designed in a predetermined manner in coordination with the first label flap and/or the needle trap, so that the first label flap is arranged in the region of the recess and the carrier element does not cover the first label flap or only cover it in sections on one side as taught by Erfinder so the identification plates can be detached from the central carrier (Erfinder, Para [0010]).
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Regarding claim 11, Kessler in view of Erfinder discloses the labeling arrangement (Kessler, tamper evident syringe assembly 1, Fig. 1) as recited above, wherein
Kessler does not expressly disclose that the recess is further configured in a predetermined manner in coordination with the second label flap, so that the second label flap is arranged adjacent to the recess and the carrier element covers the second label flap on one side.
Erfinder teaches that the recess (See annotated Fig. 1) is further configured in a predetermined manner in coordination with the second label flap (See annotated Fig. 1), so that the second label flap is arranged adjacent to the recess (See annotated Fig. 1) and the carrier element covers the second label flap on one side.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention, to modify the labeling arrangement of Kessler to include that the recess is further configured in a predetermined manner in coordination with the second label flap, so that the second label flap is arranged adjacent to the recess and the carrier element covers the second label flap on one side as taught by Erfinder so the identification plates can be detached from the central carrier (Erfinder, Para [0010]).
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Regarding claim 12, Kessler in view of Erfinder discloses the labeling arrangement (Kessler, tamper evident syringe assembly 1, Fig. 1) as recited above, wherein
Kessler does not expressly disclose that with respect to a longitudinal axis of the labeling arrangement, the first and the second label flap are formed in a strip-like manner on a common side of the label at a predetermined distance from each other.
Erfinder teaches that with respect to a longitudinal axis of the labeling arrangement (See annotated Fig. 1), the first (See annotated Fig. 1)and the second label flap (See annotated Fig. 1) are formed in a strip-like manner (as shown in Fig. 1) on a common side of the label at a predetermined distance from each other (See annotated Fig. 1).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention, to modify the labeling arrangement of Kessler to include that with respect to a longitudinal axis of the labeling arrangement, the first and the second label flap are formed in a strip-like manner on a common side of the label at a predetermined distance from each other as taught by Erfinder so the identification plates can be detached from the central carrier (Erfinder, Para [0010]).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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