DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 September 2025 has been entered.
Election/Restrictions
Applicant has indicated that claim 34 is directed to the embodiment shown in fig. 8, see Remarks from 19 September 2025, page 4 under the heading “Rejection under 35 U.S.C. 112.” Applicant has overcome the drawing objection and 35 U.S.C. 112 rejection. However, in overcoming the objection, it is now understood that claim 34 is directed to a non-elected embodiment (Species J- fig.8). In the response filed 5 November 2024, applicant elected Species J that has a separate substrate and no flow cell (see fig. 7 of the instant invention).
In addition, it is now apparent that claim 35 is directed to the embodiment shown in fig. 8, where there is a flow cell on a substrate, since the substrates of the elected embodiment. With this in mind, claims 34 and 35 are withdrawn from examination.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 34 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 1, 2, 5, 10, 16, 18, 32, and 33, 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 1, the limitation “wherein the plurality of blister packs is linearly connected perpendicular to a direction of each channel” is indefinite.
if the connection between blister packs is perpendicular to the direction of each channel, the blister packs would not be connected along the length that is parallel to the channel in a side-by-side orientation as seen in fig. 7A. For the purposes of examination, the limitation is interpreted to mean that the blister packs are connected to one another along a side that is parallel to a direction of each channel such that the chain or web of blisters extends in a direction perpendicular to the direction of the channel.
The claims not addressed above are rejected since they depend from a rejected claim.
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) 1, 2, 10, 16, 18, 32, are rejected under 35 U.S.C. 103 as being unpatentable over Weber in view of in view of Roe et al. (US 7785272).
Regarding claims 1, 16, and 18, 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.
Roe is analogous art in regard to blisters for testing and processing of a liquid/ specimen, col. 1: 15-20.
Roe teaches a continuous strip of linear connected testing blisters at 160, fig. 8, and a device with an actuator at 42 (piercing device), the test blisters of Row are wound reel to reel (at 80 and 82, fig. 13), where 80 is a supply reel and 82 is a take up reel for used tests, col. 6: 34-55. The reels allow automatic indexing, col. 5: 10-20, col. 10: 1-10.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the blisters of Weber in a continuous strip on a reel-to-reel cartridge in order to allow automation as per the teaching of Roe.
In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to orient adjacent blisters such that they be connected along an edge that is parallel to each channel because connecting the blisters at a side perpendicular to each channel would cause and adjacent blister to block the outlet of the channel.
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) 1, 5, 10, 16, 18, 32, 33 are rejected under 35 U.S.C. 103 as being unpatentable over Gutsell et al. (GB 2512141 A) in view of Roe et al. (US 7785272).
Regarding claims 1, 5, 16 and 18, Gutsell discloses 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;
a channel 7 in the base wherein the channel is parallel to a surface of the foil laminate, page 13: “laminated foil of aluminum and a polymer”; and
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.
Gutsell further discloses linking multiple test devices together in a chain-link structure for automated feeding, page 7, last paragraph.
Gutsell does not suggest a particular orientation for how multiple blisters (test devices) would be linked together.
Roe is analogous art in regard to blisters for testing and processing of a liquid/ specimen, col. 1: 15-20.
Roe teaches a continuous strip of linear connected testing blisters at 160, fig. 8, and a device with an actuator at 42 (piercing device), the test blisters of Row are wound reel to reel (at 80 and 82, fig. 13), where 80 is a supply reel and 82 is a take up reel for used tests, col. 6: 34-55. The reels allow automatic indexing, col. 5: 10-20, col. 10: 1-10.
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 individual blisters of Gutsell to be in a continuous strip on a reel-to-reel cartridge in order to allow automation as per the teaching of Roe.
In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to link the blisters such that blisters are connected along their long side (fig 2) in order to maximize the number of tests on a reel while keeping the thickness of the reel at a minimum (in other words, connecting the tests along a short side would make a longer strip for the same number of tests and increase the thickness of the roll).
Gutsell as modified above results channels are linearly connected along an edge that is parallel to each channel in a chain that extends along a length perpendicular to each channel.
Regarding claim 10, Gutsell discloses a nozzle (unnumbered circles at the top of channel) connected to the channel to dispense liquid from the space into the channel, fig. 2.
Regarding claim 32, the channel 7 of Gutsell is perpendicular to a direction of actuation (pushing down on the top of the blister), fig. 3.
Regarding claim 33, Gutsell further discloses 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.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but 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
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