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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 16, 2026 has been entered.
The amendments of claims 1-2, 4, 6, and 9 as well as the addition of claims 57-66 are acknowledged.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and its dependents have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments that claims 59 and 63 are allowable for the same reasons that claim 1 are allowable are not persuasive, as claim 1 is rejected below and includes different limitations than those required of claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 62 and 65 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 62 and 65, the originally filed specification and claims do not provide support for “the pair of receptacles are sized to position a pair of openings of the pair of vials laterally flush with the pair of proximal openings at the proximal surface when the pair of vials are received within the pair of receptacles. Due to the angle of the assembly in drawing Figure 1, Figure 1 does not clearly show this feature, especially as the openings of the vial are not clearly shown/labeled. Additionally, paragraph 70 of the filed specification discusses where each pair of receptacles may include a corresponding opening 110a, 110b recessed from or flush with the proximal 106 and paragraph 71 discusses that a first opening 110a and 110b of the receptacles are positioned along upper surface 108 to align with openings of the first and second vials 10a, 10b. Consequently, neither of these paragraphs disclose lateral alignment/being flush regarding the pair of vials and proximal openings of the receptacles.
Claim Rejections - 35 USC § 102
Claim(s) 63 and 65 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Whiteacre (US 3,604,410), as evidenced by Coulter et al. (US 5,653,686).
Regarding claim 63, Whiteacre discloses a vial adapter assembly (see Figs. 1-4), comprising: a housing R including a receptacle configured to receive a vial (see Whitacre, Fig. 2 and Coulter, Fig. 1, col. 1, lines 33-35 describing similarly shaped container 12 as vial) and a proximal opening (see Fig. 3, opening 24 at proximal end) configured to facilitate access to the vial received within the receptacle; and a cap H including an interior surface configured to engage the housing (see Figs. 1-2) and a lid 21 or alternatively 42 formed on the interior surface that is configured to cover the proximal opening and fluidly seal the vial (see Figs. 1-2); wherein the cap is configured to move relative to the housing from a closed configuration towards an open configuration (see Figs. 1-4), and inhibited from moving from the open configuration towards the closed configuration (see col. 3, lines 57-70, the cap by itself would be inhibited from moving from the open configuration towards the closed configuration, as slits on the side would have to be pressed to have the lugs 39 go into openings 31 and Fig. 14 with embodiment of hooks 55 connecting to sockets 56, where hooks would have to be moved to enter sockets and therefore if trying to put together without modification of the hooks, would be inhibited).
Regarding claim 65, Whitacre discloses the proximal opening is formed on a proximal surface of the housing, and the receptacle is sized to position an opening of the vial laterally flush with the proximal opening at the proximal surface when the vial is received within the receptacle (see Fig. 2, opening of stopper 21 would be pushed up flush against cover, and therefore proximal opening).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5-10, and 59-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sattler et al. (US 5,862,934) in view of Janson et al. (US 2015/0164743) further in view of Jordan (US 5,005,721).
Regarding claim 1, Sattler discloses a vessel adapter assembly (see Figs. 1-3), comprising: a housing 11, 20 comprising a distal end (see Figs. 1, 3, bottom end) and a proximal end (see Figs. 1, 3, top end); a first receptacle (see Figs. 1, 3, inside of one of the holding area 11) formed within the housing and configured to at least partially receive a first vessel within a body of the housing via a first distal opening at the distal end of the housing (see Fig. 3, col. 5, lines 9-11; col. 6, lines 1-2), wherein a first proximal opening of the first receptacle is in fluid communication with an upper surface at the proximal end of the housing (see Fig. 1, opening on base 12); a second receptacle formed within the housing (see Fig. 3, inside of a different holding area 11), and configured to at least partially receive a second vessel within the body of the housing via a second distal opening at the distal end of the housing (see Fig. 3; col. 5, lines 9-11; col. 6, lines 1-2), wherein a second proximal opening of the second receptacle is in fluid communication with the upper surface at the proximal end of the housing (see Fig. 1, opening on base 12 of the different holding area 11); and a cap 10 coupled to the housing, wherein the cap is movable relative to the housing from a closed configuration to an open configuration (see Fig. 1 for open and Fig. 3 for closed); wherein, in the closed configuration, the cap is configured to cover the first proximal opening of the first receptacle on the upper surface of the housing (see Fig. 3); wherein, in the open configuration, the cap is configured to uncover the first proximal opening of the first receptacle (see Fig. 1), and expose the upper surface of the housing (see Fig. 1), a portion of the first vessel (see Figs. 1, 3).
Sattler does not disclose the vessels being vials.
Janson discloses that a vessel may be a vial (see par. 2). 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 vessel be a vial as Janson discloses such, and this would predictably result in vessels that would be able to contain liquid.
Sattler and Janson do not disclose the cap is configured to cover the first proximal opening of the first receptacle and the second proximal opening of the second receptacle on the upper surface of the housing; in the open configuration, the cap is configured to uncover the first proximal opening of the first receptacle and the second proximal opening of the second receptacle, and expose the upper surface of the housing (see Fig. 1), a portion of the first vial and a portion of the second vial; and wherein the cap includes a first lid and a second lid on a bottom surface of the cap, the first lid is configured to align with and fluidly seal the first proximal opening and the second lid is configured to align with and fluidly seal the second proximal opening when the cap is in the closed configuration.
Jordan discloses multiple vials that are closed with a single cap 12 with multiple lids 14 formed along the interior surface (see Figs. 2 and 4), the interior surface is configured to cover a pair of proximal openings (see col. 2, line 61-col. 3, line 17), the interior surface is configured to uncover the pair of proximal openings (see Figs. 2 and 4), and wherein the pair of lids are configured to fluidly seal the pair of proximal openings, and wherein the pair of lids are configured to fluidly seal the pair of proximal openings when the cap is in the closed configuration (see col. 3, lines 9-17). Therefore, Jordan discloses the cap is configured to cover a first proximal opening and a second proximal opening on the upper surface of a housing; in the open configuration, the cap is configured to cover both first and second proximal openings and expose the upper surface of the housing, a portion of the first vial, and a portion of the second vial; and wherein the cap includes a first lid and a second lid on a bottom surface a of a cap, the first lid configured to align with and fluidly seal the first proximal opening and the second lid configured to align and seal the second proximal opening when the cap is in the closed configuration. It would have been obvious to have there be a single cap comprising lids as disclosed by Jordan, as it is time consuming and inconvenient to individually open and reclose each vial of a pack with a separate closure (see col. 1, lines 40-42), and providing the single cap with multiple lids would provide expedient, economical and safe re-sealing of multiple dose reagent vials (see col. 1, lines 46-48).
Regarding claim 5, Sattler, Janson, and Jordan disclose the limitations of claim 1 and Sattler further discloses the first and second proximal openings of the first and second receptacles are sized smaller relative to the first and second distal openings of the first and second receptacles (see Figs. 1, 2).
Regarding claim 6, Sattler, Janson, and Jordan disclose the limitations of claim 5 and with the vessels being vials, Sattler discloses the first and second distal openings of the first receptacle and the second receptacle are sized to receive the first vial and the second vial, respectively; and wherein the first and second proximal openings of the first receptacle and the second receptacle are positioned to align with first and second vial openings of the first and second vials, respectively, when the first and second vials are received within the first and second receptacles (see Figs. 1, 3; col. 5, lines 9-11; col. 6, lines 1-2).
Regarding claim 7, Sattler, Janson, and Jordan disclose the limitations of claim 1 and Sattler further discloses the first receptacle is positioned adjacent to the second receptacle such that the first vial is maintained alongside the second vial when received within the housing (see Fig. 3).
Regarding claim 8, Sattler, Janson, and Jordan disclose the limitations of claim 1 and Jordan further discloses a single hinge coupling the housing to the cap, wherein the hinge is configured to pivot the cap relative to the housing when moving from the closed configuration to the open configuration (see Figs. 2, 4; col. 2, line 61-col. 3, line 17).
Regarding claim 9, Sattler, Janson, and Jordan disclose the limitations of claim 1 and Jordan further discloses the cap is configured to simultaneously cover the first proximal opening of the first receptacle and the second proximal opening of the second receptacle when in the closed configuration, and simultaneously uncover the first proximal opening of the first receptacle and the second proximal opening of the second receptacle when in the open configuration (see Figs. 2, 4; col. 2, line 61-col. 3, line 17).
Regarding claim 10, Sattler, Janson, and Jordan disclose the limitations of claim 1 and Sattler further discloses the housing is configured to at least partially enclose the first vial and the second vial such that the first vial and the second vial are positioned adjacent to one another (see Fig. 3).
Regarding claim 59, Sattler discloses a vessel adapter assembly (see Figs. 1-3), comprising: a housing 11, 20 including: a pair of proximal openings (see Figs. 1, 3, opening on base 12); a pair of distal openings (see Figs. 1, 3, opening on second base 15); and a pair of receptacles configured to receive a pair of vessels through the pair of distal openings (see Figs. 1, 3, inside of holding area 11 and col. 5, lines 9-11, col. 6, lines 1-2); and a cap movably coupled to the housing (see Fig. 1), the cap including: an interior surface (see Fig. 1); and a lid formed along the interior surface; wherein the cap is configured to engage the housing and the interior surface is configured to cover one of the pair of proximal openings when in a closed configuration (see Fig. 3), and the cap is configured to disengage the housing and the interior surface is configured to uncover one of the pair of proximal openings when in an open configuration (see Fig. 1); and wherein the lid is configured to fluidly seal one of the pair of proximal openings when the cap is in the closed configuration such that fluid within the pair of vials remains sealed within the pair of vials by the pair of lids (see Figs. 1, 3).
Sattler does not disclose the vessels being vials.
Janson discloses that a vessel may be a vial (see par. 2). 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 vessel be a vial as Janson discloses such, and this would predictably result in vessels that would be able to contain liquid.
Sattler and Janson do not disclose a pair of lids formed along the interior surface, the interior surface is configured to cover the pair of proximal openings, the interior surface is configured to uncover the pair of proximal openings, and wherein the pair of lids are configured to fluidly seal the pair of proximal openings when the cap is in the closed configuration.
Jordan discloses multiple vials that are closed with a single cap 12 with multiple lids 14 formed along the interior surface (see Figs. 2 and 4), the interior surface is configured to cover a pair of proximal openings (see col. 2, line 61-col. 3, line 17), the interior surface is configured to uncover the pair of proximal openings (see Figs. 2 and 4), and wherein the pair of lids are configured to fluidly seal the pair of proximal openings, and wherein the pair of lids are configured to fluidly seal the pair of proximal openings when the cap is in the closed configuration (see col. 3, lines 9-17). It would have been obvious to have there be a single cap comprising lids as disclosed by Jordan, as it is time consuming and inconvenient to individually open and reclose each vial of a pack with a separate closure (see col. 1, lines 40-42), and providing the single cap with multiple lids would provide expedient, economical and safe re-sealing of multiple dose reagent vials (see col. 1, lines 46-48).
Regarding claim 60, Sattler, Janson, and Jordan disclose the limitations of claim 59 and Jordan further discloses the pair of lids are configured to inhibit fluid communication with the pair of vials when the cap is in the closed configuration, thereby inhibit contamination of the fluid in the pair of vials (see col. 3, lines 9-17).
Regarding claim 61, Sattler, Janson, and Jordan disclose the limitations of claim 59, and Jordan further discloses each of the pair of lids 14, 40 (with portion in between) includes a cross-sectional profile that corresponds to an opening of each of the pair of vials, such that each of the pair of lids is configured to cover a perimeter of the opening of each of the pair of vials when the cap is in the closed configuration (see Fig. 4, col. 2, line 61-col. 3, line 17).
Regarding claim 62, Settler, Janson, and Jordan disclose the limitations of claim 59 and Sattler further discloses the pair of proximal openings are formed on a proximal surface of the housing (see Figs. 1,3) and the pair of receptacles are sized to position a pair of openings of the pair of vials in alignment with the pair of proximal openings at the proximal surface when the pair of vials are received within the pair of receptacles (see Figs. 1, 3). However, Settler, Janson, and Jordan as explained above do not specifically teach the pair of receptacles are sized to position a pair of openings of the pair of vials laterally flush with the pair of proximal openings when the pair of vials are received within the pair of receptacles.
Jordan discloses proximal openings at a proximal surface where the pair of vials are received that allow a pair of openings of a pair of vials go through the proximal openings and at a point of time be flush with the proximal openings (see Fig. 4), the proximal openings providing flexibility to allow the openings to be fitted over and around the necks of respective vials to help them stay securely in place (see col. 3, lines 33-41). 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 proximal openings configured similarly in relation to the openings of the pair of vials, as disclosed by Jordan, to allow the openings to be fitted over and around the necks of respective vials to help them stay securely in place.
Claim(s) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Settler, Janson, and Jordan as applied to claim 1 above, and further in view of Kieffer et al. (US 2015/0266632).
Regarding claim 2, Settler, Janson, and Jordan disclose the limitations of claim 1 but do not disclose the housing includes at least one slot on the upper surface of the housing, and the cap includes at least one corresponding protrusion extending outwardly from a bottom surface of the cap configured to mate with the upper surface of the housing.
Kieffer discloses a housing 106 with a receptacle for a vessel 102 and a cap 108, the housing including a slot 128 on the upper surface of the housing (see Fig. 3) and the cap including at least one corresponding protrusion 124 extending outwardly from the bottom surface of the cap configured to mate with the upper surface of the housing (see par. 34-37), thereby assisting the cap in the closed position (see par. 36). 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 housing include a slot and the cap include a protrusion as disclosed by Kieffer in order to assist in retaining the cap in the closed position.
Regarding claim 3, Settler, Janson, Jordan, and Kieffer disclose the limitations of claim 2 and Kieffer further discloses in the closed configuration, the at least one slot is configured to receive the at least one corresponding protrusion (see par. 37).
Allowable Subject Matter
Claims 4 and 58 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art found is Settler, Janson, Jordan, and Kieffer, which do not disclose the required protrusion and slot in a way that is configured to inhibit reclosure of the cap. Furthermore, Kieffer, which discloses the required protrusions and slots in a tamper-evident manner, discloses that while they are designed to expand to a profile greater than that of the at least one slot (see Fig. 12), they are not designed to do so in the open configuration but in the transition to the closed configuration, nor are they designed such that the cap is inhibited from transitioning from the open configuration to the closed configuration. Furthermore, causing the projections to be designed in such a manner would deter the projections from acting in the desired manner, as they are intended to compress when going through the aperture and expanding in the closed position such that when the cap is opened, the protrusions are separated from the cap to indicate tampering.
Claim 57 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art found is Settler, Janson, Jordan, which do not disclose the required adhesive configured to deform at least one of the housing or the cap, thereby inhibiting reclosure of the cap from the open configuration towards the closed configuration. Furthermore, while Nishjima et al. (US 2020/0138212) disclose the use of adhesives as fixation mechanisms to fix one part in relation to another, one of ordinary skill in the art would not have used an adhesive in such a matter required by the claim absent glancing into applicant’s specification.
Claim 64 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art found is Whitacre, which does not disclose at least one protrusion configured to expand to a profile greater than that of the at least one slot to inhibit receipt of the at least one protrusion. Kieffer, which discloses the required protrusions and slots in a tamper-evident manner, discloses that while they are designed to expand to a profile greater than that of the at least one slot (see Fig. 12), they are not designed to do so in the open configuration but in the transition to the closed configuration, nor are they designed such that the cap is inhibited from transitioning from the open configuration to the closed configuration. Furthermore, causing the projections to be designed in such a manner would deter the projections from acting in the desired manner, as they are intended to compress when going through the aperture and expanding in the closed position such that when the cap is opened, the protrusions are separated from the cap to indicate tampering.
Claim 66 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art found is Whiteacre, which does not disclose the required adhesive configured to deform at least one of the housing or the cap, thereby inhibiting reclosure of the cap from the open configuration towards the closed configuration. Furthermore, while Nishjima et al. (US 2020/0138212) disclose the use of adhesives as fixation mechanisms to fix one part in relation to another, one of ordinary skill in the art would not have used an adhesive in such a matter required by the claim absent glancing into applicant’s specification.
Conclusion
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