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 .
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) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tcholakian (US 9566380).
Regarding Claim 1
Tcholakian teaches a vial blinding kit (below – Fig. 7 and 8) comprising: a first vial blinding assembly (Fig. 8) comprising: a first blinding shell (1/5/7) having an interior surface that bounds a first cavity and an exterior surface; and a first vial (11) having a chamber with a liquid trial product disposed therein, the first vial being disposed within the first cavity of the first blinding shell; a second vial blinding assembly (Fig. 7) comprising: a second blinding shell (1/5/7) having an interior surface that bounds a second cavity and an exterior surface; and a second vial (10) having a chamber with a liquid trial product disposed therein, the second vial being disposed within the second cavity of the second blinding shell; wherein the first cavity of the first blinding shell has a different configuration than the second cavity of the second blinding shell but the exterior surface of the first blinding shell has the same configuration as the exterior surface of the second blinding shell, as can be seen in the figures below (Col. 4, Ln. 35 – Col. 6, Ln. 40; and Col. 7, Ln. 7-9).
PNG
media_image1.png
406
553
media_image1.png
Greyscale
Regarding Claim 2
Tcholakian teaches the interior surface bounding the first cavity (Fig. 8) of the first blinding shell (1/5/7) and the interior surface bounding the second cavity (Fig. 7) of the second blinding shell (1/5/7) is at least partially formed by a floor (Fig. 7, 12) (Fig. 8, 12 and 9) extending between an inside face and an opposing outside face.
Regarding Claim 3
Tcholakian teaches the different configuration between the first cavity (Fig. 2) of the first blinding shell and the second cavity (Fig. 7) of the second blinding shell comprises the second cavity having a longer length than the first cavity, as can be seen in the figures above.
Regarding Claim 4
Tcholakian teaches the longer length of the second cavity (Fig. 7) comprises the disposition between the inside face and the outside face of the second blinding shell being closer than the disposition between the inside face and the outside face of the first blinding shell.
Regarding Claim 5
Tcholakian teaches the second vial (10) has a longer length than the first vial (11).
Regarding Claim 6
Tcholakian teaches the outside face of the first blinding shell (Fig. 8) is disposed in the same position as the outside face of the second blinding shell (Fig. 7).
Regarding Claim 7
Tcholakian teaches a vial blinding kit comprising: a first vial blinding assembly (Fig. 8) comprising: a first vial (11) comprising a first vial configuration; a first blinding shell (1/5/7) having an interior surface that bounds a first cavity and an exterior surface, the first cavity of the first blinding shell configured to have a complementary size with the first vial configuration of the first vial; a second vial blinding assembly (Fig. 7) comprising: a second vial (10) comprising a second vial configuration that is different than the first vial configuration of the first vial; and a second blinding shell (1/5/7) having an interior surface that bounds a second cavity and an exterior surface having the same configuration as the exterior surface of the first blinding shell, the second cavity of the second blinding shell configured to have a complementary size with the second vial configuration of the second vial, as can be seen in the figure above.
Regarding Claim 8
Tcholakian teaches the second vial configuration (10) comprises a different size than the first vial configuration (11).
Regarding Claim 9
Tcholakian teaches the second vial configuration (10) comprises a different shape than the first vial configuration (11).
Regarding Claim 10
Tcholakian teaches the complementary size between the first vial (11) and the first cavity and the second vial (10) and the second cavity is configured to enable the first vial and the second vial to longitudinally move less than 10 millimeters within the respective first cavity and second cavity, as the top of the vial (14) is in line with the top (15) of the tubular part of the shell and then the top portion (1) of the shell lies on the top of the vial.
Regarding Claim 11
Tcholakian teaches the interior surface bounding the first cavity of the first blinding shell (Fig. 8) and the interior surface bounding the second cavity of the second blinding shell (Fig. 7) is at least partially formed by a floor (Fig. 7, 12) (Fig. 8, 12 and 9) extending between an inside face and an opposing outside face.
Regarding Claim 12
Tcholakian teaches the floor (12) of the second blinding shell (Fig. 7) is disposed closer to the outside face than the floor (12 and 9) of the first blinding shell (Fig. 8).
Regarding Claim 13
Tcholakian teaches the outside face of the first blinding shell (Fig. 8) is disposed in the same position as the outside face of the second blinding shell (Fig. 7).
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) 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moore (US 2022/0118172) in view of Terwilliger et al. (US 2012/0292219) (hereinafter Terwilliger).
Regarding Claim 14
Moore teaches a vial blinding kit (below – Fig. 11 and 12) comprising: a first vial blinding assembly comprising: a first blinding shell (210) having an interior surface that bounds a first cavity (211) and an exterior surface, an access (218) opening passing through the first blinding shell so as to communicate with the first cavity; and a first vial (20) having a chamber with a liquid trial product disposed therein, the chamber being sealed closed by a stopper having a needle penetrable septum (well known in vials), the first vial being disposed within the first cavity of the first blinding shell so that the septum of the first vial is aligned with the access opening of the first blinding shell; a second vial blinding assembly comprising: a second blinding shell (210) having an interior surface that bounds a second cavity (211) and an exterior surface, an access opening (218) passing through the second blinding shell so as to communicate with the second cavity; and a second vial (20) having a chamber with a liquid trial product disposed therein, the chamber being sealed closed by a stopper having a needle penetrable septum (well known in vials), the second vial being disposed within the second cavity of the second blinding shell so that the septum of the second vial is aligned with the access opening of the second blinding shell, and the exterior surface of the first blinding shell has the same configuration as the exterior surface of the second blinding shell (Paragraphs [0078] – [0083], [0147] – [0151], and [0153]).
PNG
media_image2.png
207
298
media_image2.png
Greyscale
PNG
media_image3.png
582
417
media_image3.png
Greyscale
Moore does not teach wherein the first cavity of the first blinding shell has a different configuration than the second cavity of the second blinding shell.
Terwilliger teaches a vial blinding kit (below – Fig. 1, 5, 4, 9) comprising: a first vial blinding assembly (Fig. 9) comprising: a first blinding shell having an interior surface that bounds a first cavity and an exterior surface; and a first vial (220) having a chamber with a liquid trial product disposed therein, the chamber being sealed closed by a stopper having a needle penetrable septum (226), the first vial being disposed within the first cavity of the first blinding shell; a second vial blinding assembly (Fig. 4) comprising: a second blinding shell having an interior surface that bounds a second cavity and an exterior surface; and a second vial (220) having a chamber with a liquid trial product disposed therein, the chamber being sealed closed by a stopper having a needle penetrable septum (226), wherein the first cavity of the first blinding shell (Fig. 9) has a different configuration than the second cavity of the second blinding shell (Fig. 4) but the exterior surface of the first blinding shell has the same configuration as the exterior surface of the second blinding shell, as can be seen in the figures below (Paragraphs [0049]-[0051]).
PNG
media_image4.png
331
375
media_image4.png
Greyscale
PNG
media_image5.png
422
379
media_image5.png
Greyscale
PNG
media_image6.png
451
427
media_image6.png
Greyscale
PNG
media_image7.png
455
348
media_image7.png
Greyscale
Moore and Terwilliger are analogous inventions in the field of containers for holding vials. It would have been obvious to one skilled in the art at the time of filing to modify the vial blinding kit of Moore with the teachings of the first cavity of the first blinding shell has a different configuration than the second cavity of the second blinding shell of Terwilliger in order to provide a cavity that accommodates a different shaped vial (Paragraph [0056]).
Regarding Claim 15
Moore in view of Terwilliger (hereinafter “modified Moore”) teaches all the limitations of claim 14 as stated above. Moore further teaches the first blinding shell and the second blinding shell are opaque (Paragraph [0024]).
Regarding Claims 16 and 17
Modified Moore teaches all the limitations of claim 14 as stated above. Terwilliger further teaches the first vial has a different configuration, including a different shape, than the second vial (Paragraph [0056]).
Regarding Claim 18
Modified Moore teaches all the limitations of claim 16 as stated above. Terwilliger further teaches the first cavity of the first blinding shell and the second cavity of the second blinding shell are each complementarily sized in relation to the first vial and the second vial, respectively (Paragraph [0056]).
Regarding Claim 19
Modified Moore teaches all the limitations of claim 16 as stated above. Terwilliger further teaches the interior surface bounding the first cavity of the first blinding shell has a different contour than the interior surface bounding the second cavity of the second blinding shell, as can be seen in Fig. 4 and 9 above.
Regarding Claim 20
Modified Moore teaches all the limitations of claim 19 as stated above. Terwilliger further teaches the interior surface of both the first blinding shell and the second blinding shell is at least partially formed by a sidewall, and the sidewall of the first blinding shell has a different thickness than the sidewall of the second blinding shell, via (56).
Response to Arguments
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive.
Applicant argues that Tcholakian does not teach the first blinding shell has an exterior surface that has the same configuration as the exterior surface of the second blinding shell. The Examiner respectfully disagrees. The first and second blinding shells of Tcholakian are the exact same shell with the only difference being an insert being used in two different configurations, adjusting the configuration of the interior cavity. The exterior surface configuration of both the first and second blinding shells of Tcholakian include an anti-toppler ring, cylindrical container, and a cap with nibs.
Applicant further argues that neither Moore nor Terwilliger teach the first blinding shell has an exterior surface that has the same configuration as the exterior surface of the second blinding shell. Again, the Examiner respectfully disagrees. The first and second blinding shells of Moore are the exact same shell (a duplication of parts), and as such would have the same exterior surface configuration. The first and second blinding shells of Terwilliger also have the same exterior surface configuration, as both include a top section, sidewall, and lower portion. Also, for the purposes of simplifying manufacturing, it would further appear obvious to one of ordinary skill in the art in order to streamline manufacturing, the shell components would be repeatedly produced in the same configuration.
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 JENNIFER CASTRIOTTA whose telephone number is (571)270-5279. The examiner can normally be reached Monday - Friday 9am-5pm.
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, Nathan Jenness can be reached at (571) 270-5055. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JENNIFER CASTRIOTTA/Examiner, Art Unit 3733
/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 16 June 2026
Prosecution Insights