DETAILED ACTION
This office action is in response to the communication received February 23, 2026 concerning application number 18/147,271.
The amendments of claims 1 and 11 are acknowledged.
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 Arguments
Applicant’s arguments regarding teachings of Donschietz not disclosing a fundamentally different locking mechanism are not persuasive. Applicant argues that in Donschietz, “the locking member is secured by circumferential rotation about the longitudinal axis of the sleeve” and “[r]adially extending lugs travel within annular recess channels and are retained in the locking recesses through a bayonet-style locking engagement.” (see February 23, 2026 filed Remarks, page 6). Applicant does not point to any section of Donschietz to support their argument. Furthermore, no support of their interpretation of the required rotation for locking could be found, especially as Donschietz discloses in Figure 3 a snap-fit mechanism in which ridge 54 is snap-fit into recess 42 (see par. 96 for explanation of snap-fit). Therefore, there is no required circumferential rotation of a ring with annular channels, as the ridges would have to be pushed into the recesses for locking. Furthermore, as sometimes the pushing is not evenly along such a snap fit configuration, one side can be pushed into place first and the other side being then pivotally pushed into place in order to get the full snap-fit.
Applicant’s arguments that Donschietz does not disclose the required first and second locking channels and first and second locking tabs are persuasive, as Donschietz only discloses one recess and one ridge. Consequently, rejections of claims 1-5 are modified below in being rejected under 35 USC 103 as unpatentable in view of Donschietz and Johnson.
Applicant’s arguments regarding Donschietz and Johnson are not persuasive. Applicant argues that Donschietz relies on circumferential rotation of a ring having radial lugs and that a person of ordinary skill in the art would not be motivated to abandon the rotational bayonet locking for the pivotable tab-and-channel engagement. As explained above, Donschietz does not disclose such required rotation and discloses a pivotable tab-and-channel engagement.
Applicant’s arguments that ridges and recesses of Donschietz form a circumferential bayonet-style coupling system and do not function in a manner that permits retention of a first tab while pivoting to insert a second tab as the geometry and motion are fundamentally different are not persuasive. As the shape of Donschietz would be modified to be rectangular, there would be four sides and therefore four recesses, with four ridges, where these four recesses can act as locking channels and these four ridges can act as locking tabs.
Claim Objections
Claim 11 is objected to because of the following informalities: “tab int second” in line 5 should be “tab into the second”. Appropriate correction is required.
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 11-16 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 claim 11, the limitations “a first locking channel,” “a second locking channel,” “a first locking tab,” and “a second locking tab” render the claim indefinite as it is unclear whether these are the same or different than those claimed in claim 1. For examination purposes, these are interpreted as the same.
Claims 12-13 are rejected as dependents of claim 11.
Regarding claim 12, the limitations “a first side of the locking member” and “a second side of the locking member” render the claim indefinite as it is unclear whether these are the same or different than those already claimed in claim 1. For examination purposes, these are interpreted as the same.
Claim 13 is rejected as a dependent of claim 12.
Regarding claim 14, the limitations “a first locking tab” and “a second locking tab” render the claim indefinite as it is unclear whether these are the same or different than those already claimed in claim 1. For examination purposes, these are interpreted as the same.
Regarding claim 15, the limitations “a first locking channel,” “a second locking channel,” “a first locking tab,” and “a second locking tab” render the claim indefinite as it is unclear whether these are the same or different than those already claimed in claim 1. For examination purposes, these are interpreted as the same.
Claim 16 is rejected as a dependent of claim 15.
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.
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.
Claim(s) 1-5 and 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Donschietz (US 2021/0094743) in view of Johnson (US 2010/0038273).
Regarding claim 1, Donschietz discloses a lockable vial sleeve assembly (see Fig. 3), comprising: a sleeve 14 configured to house a vial 12, the sleeve defining: a body (see Fig. 3, body making up sleeve); a first opening 28 provided at one end of the body, the first opening configured to receive the vial therethrough (see Figs. 3, 6); a second opening 32 provided at another end of the body (see Fig. 3), the second opening positioned opposite the first opening (see Fig. 3); and a locking member 16 configured to pivotably lock to the sleeve adjacent the one end (see Figs. 3, 6, par. 93, 96, half of locking member can be placed in recess and then pivotally pushed into place with the other half), wherein the vial is insertable into the body through the first opening (see Fig. 6), and wherein in response to the locking member being pivotably locked to the sleeve, the locking member at least partially closes the first opening to restrict withdrawal of the vial through the first opening (see Fig. 6, par. 97).
Donschietz discloses the sleeve defines the first opening (see Fig. 3) and the locking member defines a complimentary shape to the first opening, with the locking member configured to be received by the first opening (see Figs. 2-3, 6) but does not specifically teach the sleeve defines a first locking channel on a first side of the first opening and a second locking channel on a second side of the first opening opposite the first side, wherein the locking member includes a first locking tab and a second locking tab, wherein the first locking tab is configured to be received within the first locking channel, and the locking member is configured to pivot about the first locking tab to insert the second locking tab into the second locking channel.
Johnson discloses a sleeve with a rectangular shape that is able to accommodate a vial of a rectangular shape as an alternative to a cylindrical shape (see Figs. 5-6, par. 69). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the sleeve be a rectangular shape as such a container and associated sleeve shape is an alternative to a cylindrical shape, as disclosed by Johnson, and would predictably result in a vial and sleeve that can house material within the vial. Furthermore, as Johnson discloses the sleeve shape and first opening sized to accommodate the vial (see Figs. 3, 6), one of ordinary skill in the art would modify Donschietz to have an opening in the same shape of the rectangular vial, and the complimentary locking member would also have the rectangular shape in order to cover the rectangular opening.
Consequently, there would be a ridge on each rectangular edge of the locking member similar to ridge 54 (see Donschietz, Fig. 3) and the rectangular sleeve would have a recesses on the inside on a first side of the first opening similar to annular recess 42 to accommodate the rectangular locking member (see Donschietz, Fig. 3). The recesses are interpreted as locking channels and there would be one on each side of the inside on a first side of the first opening of the rectangular sleeve and the ridges are interpreted as tabs, and there would be one on each side of the locking member. Consequently, the sleeve would define a first locking channel and a second locking channel, the locking member including a first locking tab and a second locking tab, the first locking tab configured to engage the first locking channel, and the second locking tab configure to engage the second locking channel. Due to the snap-fit configuration, the first locking tab would be able to be received within the first locking channel and then the locking member could pivot about the first locking tab to insert the second locking tab in to the second channel.
Regarding claim 2, Donschietz and Johnson disclose the limitations of claim 1 and Donschietz further discloses the second opening 32 has a cross-sectional diameter that is less than a cross-sectional diameter of the first opening 28 (see Fig. 3).
Regarding claim 3, Donschietz and Johnson disclose the limitations of claim 2 and Donschietz further discloses the second opening 32 is configured to receive a portion of the vial (see Fig. 2, top portion of vial within second opening).
Regarding claim 4, Donschietz and Johnson disclose the limitations of claim 3 and Donschietz further discloses the second opening 32 is configured to receive a cap 62, 64 of the vial 12 (see Fig. 6).
Regarding claim 5, Donschietz and Johnson disclose the limitations of claim 1 and Donschietz further discloses the sleeve further defining a base (see Fig. 6, bottom of the body), the base is defined by the body (see Fig. 6, being part of the body, it is defined by the body).
Regarding claim 9, Donschietz and Johnson disclose the limitations of claim 1 and as explained above, as Johnson discloses the sleeve shape and first opening sized to accommodate the vial (see Figs. 3, 6), one of ordinary skill in the art would modify Donschietz to have an opening in the same shape of the rectangular vial, and the complimentary locking member would also have the rectangular shape in order to cover the rectangular opening.
Additionally, official notice is taken that a square is a well-known type of rectangle. Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the rectangular shape or the vial, sleeve first opening, and locking member be a square, as it is a well-known type or rectangle and would result in a rectangular shape of the lockable vial sleeve shown as obvious above in light of Donschietz and Johnson.
Regarding claim 10, Donschietz and Johnson disclose the limitations of claim 1 and as explained above, as Johnson discloses the sleeve shape and first opening sized to accommodate the vial (see Figs. 3, 6), one of ordinary skill in the art would modify Donschietz to have an opening in the same shape of the rectangular vial, and the complimentary locking member would also have the rectangular shape in order to cover the rectangular opening and therefore be received by the first opening.
Regarding claim 11, Donschietz and Johnson disclose the limitations of claim 1 and as explained above, together disclose the sleeve defining a first locking channel and a second locking channel, the locking member including a first locking tab and a second locking tab, wherein the first locking tab is configured to be received within the first locking channel, and the locking member is configured to pivot about the first locking tab to insert the second locking tab into the second locking channel (see rejection of claim 1 above).
The limitations “the locking tab is received and retained in the first locking channel, while the locking member is pivoted to insert the second locking tab into the second locking channel” is considered a product-by-process claim. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). While Donschietz do not disclose the specific act of pivoting, the capability and end result of the first locking tab being received and retained in the first locking channel and the second locking tab being inserted into the second locking channel results in the same product, and therefore as the product is the same as or obvious form a product of the prior art, the claim is unpatentable, similar to as in In re Thorpe.
Regarding claim 12, Donschietz and Johnson disclose the limitations of claim 11 and as there would be tabs on each rectangular side of the locking member, there would the first locking tab on the first side and the second locking tab on the second side (see rejection of claims 1 and 11 above).
Regarding claim 13, Donschietz and Johnson disclose the limitations of claim 12 and as the rectangular locking member has four sides, each with a tab, these references disclose the first side of the locking member is opposite the second side of the locking member (see rejection of claim 12 above, first tab on the opposite side of the rectangle from the side of the rectangle with the second tab).
Regarding claim 14, Donschietz and Johnson disclose the limitations of claim 1, and as explained above in the rejection of claim 1, these references disclose the locking member including the first locking tab and the second locking tab (see rejection of claim 1 above). The first locking tab can be placed in the first locking channel and then the locking member pivotally pushed to have the second locking tab placed in the second locking channel, therefor having the second locking tab configured to engage the sleeve while the first locking tab is in engagement with the sleeve (see rejection of claim 1 above).
Regarding claim 15, Donschietz and Johnson disclose the limitations of claim 1 and together disclose the sleeve defines the first locking channel spaced form the second locking channel (see rejection of claim 1, the rectangular shape with locking channels on four sides, and these sides would be spaced apart), and the locking member includes the first locking tab and the second locking tab, the second locking tab configured to be inserted into the second locking channel while the first locking channel receives and retains the first locking tab (see rejection of claim 1).
Regarding claim 16, Donschietz and Johnson disclose the limitations of claim 15 and as explained above in reference to the pivotally pushed, the first locking tab and related locking channel would be opposite the second locking tab and related channel (see rejections of claim and 15 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Herlin et al. (US 2019/0127107), disclosing a ridge pushed into a channel by securing one half of the ridge into the channel and then pivoting the other half.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781