DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3-4, 6-8, 13-15, 17, 19-23, 26-28, and 30 are canceled. Claims 9, 11, 12, 24, 25, 29, 31, 34, 35 have been withdrawn from consideration as being directed to a non-elected Species or Invention. Claims 1-2, 5, 10, 16, 18, 32, 33, and 36 are examined herein.
Claim Rejections - 35 USC § 112
Claims 1, 2, 5, 10, 16, 18, 32, 33, and 36 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 the limitation "the outlet" in line 12. There is insufficient antecedent basis for this limitation in the claim.
The claims not addressed above are rejected since they depend from a rejected claim.
Claim Rejections - 35 USC § 103
Claim(s) 1, 2, 10, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Weber in view of in view of Amorese et al. (US 11099202).
Regarding claim 1, Weber discloses a blister pack, fig. 6 and 7, comprising a blister with a base 1, a top layer 2, and a foil laminate 7 between the top layer and the base, a liquid reagent [0049] in a space between the top layer and the foil laminate, the blister of Weber is for processing or testing [0004] of a medical nature or specimens, and
a channel in the base (at 5, fig. 4 and 6) wherein the channel is parallel to a surface of the foil laminate; and
an actuator 13, fig. 7 configured to release the liquid reagent from the space through the channel to an outlet [0054].
Weber does not teach that the blister packs are connected in a chain of blister packs.
Amorese is analogous art in regard to blister packages for containing reagent and teaches, col. 4: 40-50 that specific volumes of various reagents required for certain reactions are pre-packaged into reservoirs and also that plural blister packs can be linearly connected such that adjacent blister packs are connected to one another along a side that is parallel to a direction of each channel, see fig. 6, channels at 611 (nozzles), perforations separating adjacent blisters (reservoirs 601) are parallel to the channels at 611, col. 6: 1-10. The system of Amorese with adjacent blisters and various reagents provides the benefit of minimal set-up time for processes with multiple steps, col. 4: 30-45.
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 blisters of Weber such that several blisters be attached side by side with various reagents for the purpose of processing samples that require multiple steps while having minimal set-up time as per the teaching of Amorese.
Regarding claim 2, Weber discloses that the foil laminate comprises a frangible seal (lock 6), fig. 1, 4, [0042-0043].
Regarding claim 10, Weber discloses that the blister pack comprises a nozzle (vertical portion at 5, fig. 2 and 12(e)) configured to dispense the liquid reagent from the space.
Regarding claim 32, Weber discloses that the channel directs the liquid reagent perpendicular to a direction of actuation by the actuator, fig. 2 and 3.
Claim(s) 5 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Weber and Amorese as applied to claim 1 above, and further in view of Gutsell et al. (GB 2512141 A).
Regarding claim 5, the references applied above teach all of claim 1, as applied above. Weber does not teach a piercing member in addition to an actuator.
Gutsell teaches a blister pack comprising a blister with a base 2, a top layer at 5, fig. 3, a foil laminate at 6, the foil laminate is between the top layer and the base as seen in fig. 3, a liquid reagent (wet reagent at 8 and 9, pages 8 and 9 respectively), in a space between the top layer and the foil laminate, and a piercing member at 11, fig. 3 for the purpose of perforating the enclosure and providing direct communication between the reservoirs and the conduits, page 9: last 2 lines, page 10: 1-10;
an actuator used to apply pressure, page 5, “actuated by mechanisms within the controller,” and page 13: “…these can be actuated, either by manual or automated means,” configured to release the liquid reagent from the space through the channel, page 5, 3rd paragraph.
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 blisters of Weber to include a piercing means in order to provide a direct path between the liquid in the blister and the channel as per the teaching of Gutsell.
Regarding claim 33, the references applied above teach all of claim 1, as applied above. The references applied above do not teach a substrate for holding a tissue sample.
Weber teaches that the device is for analysis of immune or genetic assays or for medical and pharmaceutical purposes [0004]
Gutsell is analogous art in regard to blister packs for liquid reagents.
Gutsell teaches that each blister comprises an associated a substrate 12, fig. 4, that is capable of holding a tissue sample and receives the liquid from the channel upon release from the blister.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a substrate for receiving the dispensed fluid in order to catch the fluid into a substrate that provides a location for the medical, pharmaceutical, genetic or immune analysis tissue sample being studied, a substrate is capable of holding a sample being analyzed as per the teaching of Gutsell.
Claim(s) 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Weber and Amorese as applied to claim 1 above, and further in view of Papp (US 11590468).
Regarding claims 16 and 18, the references applied above teach all of claim 1, as applied above. The references applied above do not teach a reel-to-reel configuration on which the plurality of blisters is disposed.
However, Papp is analogous art in regard to systems with blisters 302 holding liquid reagent and actuators 308 for releasing the reagent, col. 8: 5-15 where the blisters are on a reel to reel, fig. 3A and 3B, col. 8: 25-35 the reel-to-reel mechanism allows the blisters to be used in a machine for faster and easier to use testing or analysis, col. 1: 55-60.
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 reagent holding blisters of Weber as modified above to be on a reel-to-reel for the purpose of automating testing or analysis for ease as per the teaching of Papp.
Claim(s) 36 is rejected under 35 U.S.C. 103 as being unpatentable over Weber and Amorese as applied to claim 1 above, and further in view of Peuker et al. (WO 01/46037 A1).
Regarding claim 36, the references applied above teach all of claim 1, as applied above. The references applied above do not teach that a distal portion widens to an outlet at an edge of the base.
Peuker is analogous art in regard to packages with a blister 14 holding liquid substances and a widened (funnel shape) outlet at 16 at the edge of the packaging, fig. 8, that prevents splashing or spilling, page 2 of translation: “The flow rate of the substance to be dispensed or the risk of it splashing can be further reduced by designing the dispensing area in a funnel shape at least in a partial area.” See page 4 of translation: “According to the device according to the invention, even when liquid substances are discharged into liquid media, such as milk or sweetener, in a cup filled with coffee or tea, it is easy to ensure that they flow out of the chamber without the risk of splashing or spilling.”
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 end of the outlet of Weber to include a funnel shape widened outlet at the edge in order to prevent splashing of the liquid being dispensed as per the teaching of Peuker.
Response to Arguments
Applicant’s amendment overcame the previous indefinite rejection and is withdrawn, however the amendment to claim 1 now introduces a lack of antecedent basis, correction is required.
Applicant's arguments filed 5 May 2026 have been fully considered and are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 MOLLIE L IMPINK whose telephone number is (571)270-1705. The examiner can normally be reached Monday-Friday (7:30-3:30).
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MOLLIE LLEWELLYN IMPINK
Primary Examiner
Art Unit 3799
/MOLLIE IMPINK/Primary Examiner, Art Unit 3799
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