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 without traverse of Species I, Figs. 1-10 and subspecies I(a) Fig. 1B in the reply filed on 09/17/2026 is acknowledged. Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/17/2026. Claims 5-9, 12 and 21 are withdrawn from consideration as being drawn to an unelected Species. Claims 5 and 9 are directed towards Species II. Claim 12 is directed to Species III. Claims 6-8 and 21 are included due to their dependencies. Claims 1-4, 11, and 13-14 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 2-4, 11 and 13-14 objected to because of the following informalities:
The claims recite “A labeling shell as in claim” and should instead recite “The labeling shell as in claim”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-4, 11 and 13-14 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.
Claim 1 recites “wherein at least one window is formed in the tubular body”, this is unclear. A window is an opening in the wall or roof of a building or vehicle, fitted with glass in a frame to admit light or air and allow people to see out. Does the applicant mean an opening or aperture in the tubular body as shown in the figures or an opening filled with glass?
Claims not specifically mentioned are included due to their dependencies.
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.
Claim(s) 1-4 and 11 /are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al. US 3,655,985, herein after referred to as Brown.
Regarding claim 1 Brown discloses a labeling shell (Figs. 1-6) for a drug vial having a glass reservoir and an opening sealed by an elastomeric stopper (Fig. 4), the reservoir having a barrel portion (Fig. 4), the labeling shell comprising:
a tubular body (1 cylindric body) formed to accommodate the reservoir of the drug vial (Fig. 4), the tubular body having a first open end defining a first opening (9 centrally disposed opening) having a first diameter smaller than a diameter of the barrel portion of the reservoir of the drug vial so as to prevent passage therethrough of the reservoir (Fig. 4),
wherein the elastomeric stopper is exposed through the first open end with the reservoir being accommodated in the tubular body (Fig. 4); and,
a cap (17 lid or cover) mountable to the tubular body to selectively cover the elastomeric stopper of the drug vial with the reservoir being accommodated in the tubular body (Figs. 1, 4 and 6);and
wherein at least one window (13 window insert) is formed in the tubular body to permit viewing of the reservoir with the reservoir being accommodated in the tubular body (Fig. 6).
Brown discloses substantially all the limitations of the claim(s) except for the body and cap being made from a polymeric material. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the body and cap being made from a polymeric material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 2 Brown discloses the labeling shell as in claim 1 and further discloses wherein the tubular body (1) includes a second open end, axially spaced from the first open end (lower end of 1 that is closed by the first end closure 5, Figs. 1, 4 and 6).
Regarding claim 3 Brown discloses the labeling shell as in claim 2 and further discloses wherein the second open end defines a second opening having a second diameter larger than a diameter of the barrel portion of the reservoir of the drug vial so as to allow passage therethrough of the reservoir (Fig. 4).
Regarding claim 4 Brown discloses the labeling shell as in claim 2 and further comprising a closure (5 first end closure) formed to at least partially cover the second open end, wherein the second open end defines a second opening, the closure being formed to be received in the second opening (Fig. 4).
Regarding claim 11 Brown discloses the labeling shell as in claim 1 and further discloses wherein the polymeric cap (17) is removably mountable to the tubular body (Figs. 1 and 4).
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.
Claim(s) 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Brown in view of Freedman et al. US 2020/0255206 A1.
Regarding claim 13 Brown discloses the labeling shell as in claim 1. Brown discloses substantially all the limitations of the claim(s) except for the tubular body comprising a polymeric material and the polymeric material comprising a thermoplastic elastomer. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the material used to be a polymeric material comprising a thermoplastic elastomer, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Further, Freedman discloses a container for holding an insert (Fig. 12) that is made from a polymeric material that further comprises a thermoplastic elastomer (paragraph [0060]).
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 materials used for the labelling shell to include polypropylene with a thermoplastic elastomer as this material will provide a protective environment (sealed, container is moisture tight, with low vapor transmission, paragraph [0055], lines 3-4) for the reservoir and are readily available to be safely manufactured.
Regarding claim 14 Brown as modified discloses the labeling shell as in claim 13 and further discloses wherein the polymeric material further comprises a thermoplastic elastomer (paragraph [0060], Freedman).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lauren Kmet whose telephone number is (313)446-4834. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L KMET/ Examiner, Art Unit 3735
/Anthony D Stashick/ Supervisory Patent Examiner, Art Unit 3735
