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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-12 and new claims 40-46) in the reply filed on April 21, 2026 is acknowledged. The traversal is on the ground(s) that the previous unity of invention analysis in evaluating the claims was improper since this application was filed under 35 USC 111(a) as a continuation of application 15/757,642. Therefore, a restriction of the claims should have been made under 37 CFR 1.141-1.146 showing that the claims are independent and distinct, rather than a unity of invention analysis. This argument is persuasive, and all of the remaining pending claims 1-12 and 40-46 are examined in this Office action. Claims 13-39 are canceled.
The requirement is still deemed proper and is therefore made FINAL.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the inclusion of legal phraseology such as “comprise” on line 1 of the abstract. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: In paragraph 0001 on page 1 of the specification, the phrase –now abandoned—should be inserted after the phrase “This application is a continuation of 15/757,642, filed on March 5, 2018” so as to update the status of this parent application.
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 1-12 and 40-46 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 is indefinite since it is not clear how the unsealed portion of the first elastomeric membrane receives fluid from the opening in the chassis. Does the unsealed portion of the first elastomeric membrane contain an opening aligned with the opening in the chassis to receive fluid from the opening in the chassis? Claim 1 is also indefinite since it is not clear how the first elastomeric membrane can have an unsealed portion and a sealed portion circumscribing the unsealed portion because this membrane comprises a single piece of elastomeric material. It is not clear how this single piece of elastomeric material can have an unsealed portion and a sealed portion since an unsealed portion and a sealed portion would require another component in the cartridge to seal to and unseal from. It is not clear what the first elastomeric material seals to and unseals from in order to form the sealed portion and the unsealed portion. In addition, on line 6 of claim 1, the phrase “a sealed portion circumscribing the unsealed portion” is indefinite since in order for such a configuration to occur, more than one elastomeric membrane or other structure would have to be present for forming the unsealed portion circumscribed by the sealed portion.
Claim 3 is indefinite since it is not clear how the groove is “configured to facilitate formation of a channel”. How does the grove “facilitate” the formation of a channel? Does the groove in the chassis comprise the channel, and is the channel in this phrase the same as the channel defined by the unsealed portion of the first elastomeric membrane recited in claim 1?
Claim 7 is indefinite since it is not clear where the fluid is located in the cartridge so as to be positioned adjacent the first elastomeric membrane. Is the fluid located in the opening of the chassis?
Claim 11 is indefinite since it is not clear where the barrier membrane and the holding chamber are located in the cartridge in relation to the chassis and the first elastomeric membrane. Does the barrier membrane separate the holding chamber located in the chassis from the unsealed portion of the first elastomeric membrane so that when the barrier membrane is broken, the fluid flows from the holding chamber into the unsealed portion of the membrane? In addition, claim 11 is indefinite since it is not clear how the fluid released from the holding chamber when the barrier membrane breaks serves to initiate formation of the channel in the unsealed portion of the first elastomeric membrane. Does the fluid released from the holding chamber serve to separate the sealed portion of the first elastomeric membrane to open it up and form the unsealed portion as the fluid pushes through the unsealed portion?
Claim 40 is indefinite since it is not clear where the first mixing chamber and the second mixing chamber are located in the cartridge in relation to the chassis and the first elastomeric membrane. Structural cooperation between the recited physical components of the cartridge is missing. Are the first and second mixing chambers located in the chassis, or are they formed by a combination of the first elastomeric membrane and some other component of the cartridge?
Claim 42 is indefinite since it is not clear where the second elastomeric membrane and the first foil layer are located in relation to the other physical components of the cartridge. Structural cooperation between the recited physical components of the cartridge is missing. Specifically, where are the second elastomeric membrane and the first foil layer located in the cartridge in relation to the chassis and the first elastomeric membrane?
Claim 43 is indefinite since it is not clear whether the second elastomeric membrane is attached or sealed to the first elastomeric membrane at some points so as to form the first and second mixing chambers.
On line 2 of claim 44, the phrase “the reagents” lacks antecedent basis.
Claim 45 is indefinite since it is not clear whether the barrier membrane is located in the channel so as to restrict the downstream flow of reagents. Where are the reagents flowing in the cartridge?
Claim 46 is indefinite since it is not clear where the first and second pistons are located in the cartridge. Structural cooperation between the recited physical components of the cartridge is missing. Are the first and second pistons located in the chassis of the cartridge?
Inventorship
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 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) 1-7 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Asogawa et al (US 2014/0079605, submitted in the IDS filed on April 21, 2026).
With regards to claim 1, Asogawa et al teach of a cartridge 50 having a laminated structure formed of elastic members and comprising a sample reservoir for introducing a sample, a reaction reservoir in which mixing and reaction of a sample are performed, and a channel formed in a middle layer of the laminated structure for bringing the sample reservoir and the reaction reservoir into communication with each other (see abstract in Asogawa et al). The cartridge 50 comprises a chassis 51a defining openings into chambers 52a, 52b and 52c located at the top surface of the chassis 51a where a sample is introduced to the cartridge, wherein the openings are covered by a cover 20, and a first elastomeric membrane 51b comprising an unsealed portion defining at least a portion of channels 72a, 72b and 72c through which a sample flows from the chambers 52a, 52b and 52c to a reaction reservoir 52d, and a sealed portion circumscribing the unsealed portion. See the sealed portion of the laminated structure depicted in Figure 4B of Asogawa et al where elastomeric layers 51b and 51c are sealed together at the edges and which sealed area circumscribes an unsealed portion between the layers 51b and 51c, wherein the unsealed portion comprises the channels 72a, 72b and 72c that allow a sample to flow from the chambers 52a, 52b and 52c in the cartridge to the reaction reservoir 52d when a pressurized medium such as air is introduced through pressurizing ports 22a, 22b and 22c into the body of the chassis 51a. The pressurized air serves to push on a film 91 located over the opening in the chassis 51a, and this pushing action causes the samples in the sample reservoirs 52a, 52b and 52c to flow out from the sample reservoirs in a direction E (see Figure 3B) while expanding the area located between the elastomeric layers 51b and 51c to form an unsealed portion comprising the channels 72a, 72b and 72c. See Figures 3A, 4A and 4B, and paragraphs 00540056 and 0061-0062 in Asogawa et al.
With regards to claim 2, the chassis 51a taught by Asogawa et al comprises a pot defining an upper passage, wherein the upper passage is vertically aligned with the opening of the chassis. See Figures 3A, 3B and 4A-4C in Asogawa et al that depict a pot located between the vertical walls of the chassis 51a, and an opening at the top of the vertical walls.
With regards to claims 3-4, the chassis 51a of the cartridge 50 taught by Asogawa et al comprises a groove 51d that facilitates the formation of the channels 72a, 72b and 72c formed by the elastomeric layers 51b and 51c when the layers are caused to become unsealed from one another, wherein the groove 51d has a square or rounded shape. See Figure 4B in Asogawa et al which depicts a groove 51d that accommodates the unsealed portions of the elastomeric layers 51 b and 51c forming the channels 72a, 72b and 72c.
With regards to claims 5-6, Asogawa et al teach that the cartridge 50 also comprises a second elastomeric membrane 51c fixedly attached to at least a portion of the first elastomeric membrane 51b. The second elastomeric membrane 51c comprises a sealed portion fixedly connected to the sealed portion of the first elastomeric membrane 51b, and the sealed portion of the first elastomeric membrane 51b and the sealed portion of the second elastomeric membrane 51c define at least a portion of the perimeter of the channels 72a, 72b and 72c. See Figures 4A and 4B in Asogawa et al.
With regards to claim 7, Asogawa et al teach that a fluid is positioned adjacent to the first elastomeric membrane 51b and that the fluid is movable into and through the channels 72a, 72b and 72c when pressurized air causes the samples in the sample reservoirs 52a, 52b and 52c to flow out from the sample reservoirs in a direction E (see Figure 3B) while expanding the area located between the elastomeric layers 51b and 51c to form an unsealed portion comprising the channels 72a, 72b and 72c.
With regards to claim 11, Asogawa et al teach that a barrier membrane 91 seals a sample fluid into a holding chamber comprising the chambers 52a, 52b and 52c in the cartridge, wherein the barrier membrane 91 stretches or breaks in response to pressure from air introduced into the pressurizing ports 22a, 22b and 22c to allow the sample fluid to flow from the chambers 52a, 52b and 52c into the space between the elastomeric layers 51b and 51c and form the channels 72a, 72b and 72c.
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.
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) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asogawa et al (US 2014/0079605, submitted in the IDS filed on April 21, 2026) in view of Pierik et al (US 2016/0074858, also submitted in the IDS filed on April 21, 2026). For a teaching of Aosgawa et al, see previous paragraphs in this Office action.
With regards to claims 8-10, Asogawa et al fail to teach that encapsulated reagents can be positioned inside the openings of the chassis 51a, wherein the chassis 51a is configured to direct the encapsulated reagents into the channels 72a, 72b and 72c or provide access to the encapsulated reagents from the channels 72a, 72b and 72c, and fail to teach that a foil layer is positioned between the chassis 51a and the first elastomeric membrane 51b, wherein the foil layer seals encapsulated reagents in a pot formed by the chassis 51a.
Pierik et al is in the analogous art of fluidic systems (see the abstract), and discloses a cartridge 1100 comprising a flexible layer (FW) having a bead chamber 1111 which encapsulates a reagent in the form of a lyophilized bead (LB). The bead chamber 1111 may be sealed by a foil, which controls access to the reagent and allows for control of exposing the lyophilized reagent bead to a fluid for dissolution of the lyophilized reagent bead. See Figure 6 and paragraphs 0103-0105 in Pierik et al.
Based upon a combination of Asogawa et al and Pierik et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to position encapsulated reagents in the openings of the chassis 51a taught by Asogawa et al, wherein the chassis 51a is configured to direct the encapsulated reagents into the channels 72a, 72b and 72c or provide access to the encapsulated reagents from the channels 72a, 72b and 72c, and to encapsulate the reagents in the openings using a foil layer that is positioned between the chassis 51a and the first elastomeric membrane 51b so as to allow the samples added to the cartridge taught by Asogawa et al to react with reagents to detect different analytes in the sample, and because Pierik et al teach that it is advantageous to include encapsulated and lyophilized reagents in a chamber enclosed by a foil in a fluidic cartridge so as to not have to separately introduce reagents to the cartridge for reaction with a sample, and encapsulation of the reagents by a foil layer allows controlled access to the reagents in the cartridge when desired.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asogawa et al (US 2014/0079605, submitted in the IDS filed on April 21, 2026) in view of Hongo et al (US 2009/0023201, also submitted in the IDS filed on April 21, 2026). For a teaching of Aosgawa et al, see previous paragraphs in this Office action.
With regards to claim 12, Asogawa et al fail to teach that the pot formed in the chassis 51a comprises a plunger inside the upper passage of the pot that is configured to move downward in response to pressure and direct sample fluid into the channels 72a, 72b and 72c.
Hongo et al is in the analogous art of fluidic systems (see the abstract), and discloses a cartridge 1 comprising multiple fluid chambers or pots 12a, 12b and 12c that are enclosed by a flexible membrane 3. Plungers 201b, 201e and 201f are present in the cartridge 1 to exert pressure on the flexible membrane 3 to force fluid located in the pots 12a, 12b and 12c to a channel 208. See Figures 7A-7C, and paragraph 0274 in Hongo et al.
Based upon the combination of Asogawa et al and Hongo et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a plunger inside the upper passage of the pot in the chassis 51A of the cartridge taught by Asogawa et al that is configured to move downward in response to pressure and direct sample fluid into the channels 72a, 72b and 72c because the pot in the chassis 51a taught by Asogawa et al is closed on one side by a flexible barrier 91 that is pushed by pressurized air to move a sample fluid from the pot to the channels 72a, 72b and 72c, and Hongo et al teach that an alternative and equivalent way to move fluids held within pots of a fluidic cartridge by a flexible barrier or membrane is to push on the flexible barrier or membrane with a plunger.
Claim(s) 40-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asogawa et al (US 2014/0079605, submitted in the IDS filed on April 21, 2026) in view of Asogawa et al (EP 2,829,882). For a teaching of Aosgawa et al, see previous paragraphs in this Office action.
With regards to claims 40-45, Asogawa et al fail to teach that the cartridge 50 further comprises first and second mixing chambers and a fluidic channel connecting the first and second mixing chambers, wherein the first and second mixing chambers are formed by a combination of the elastomeric membranes 51b and 51c and/or a foil layer, wherein the first and second mixing chambers are deformable to cause mixing of reagents, and wherein a barrier membrane is located downstream of the mixing chambers to restrict the downstream flow of reagents.
Asogawa et al (EP 2,829,882) is in the analogous art of fluidic systems (see the abstract), and discloses a chip for the analysis of a target substance in a sample comprising a first flexible substrate 1, a second flexible substrate 2, and a third substrate 3. A flow channel-forming non-bonded area 11 is formed on a bonding surface of the first flexible substrate 1 and the second flexible substrate 2 in a band-like manner. Two mixing chambers 9a and 9b connected by a fluidic channel are formed in the non-bonded area of the flexible substrates, wherein the substrates are deformable in the areas of the mixing chambers 9a and 9b to cause mixing of reagents therein. See the abstract, Figures 4D and 4E, and paragraph 0058 in Asogawa et al (EP 2,829,882).
Based upon the combination of Asogawa et al and Asogawa et al (EP 2,829,882), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in the cartridge taught by Asogawa et al (US 2014/0079605) first and second mixing chambers and a fluidic channel connecting the first and second mixing chambers, wherein the first and second mixing chambers are formed by a combination of the elastomeric membranes 51b and 51c and/or a foil layer, wherein the first and second mixing chambers are deformable to cause mixing of reagents, because the cartridge taught by Asogawa et al (US 2014/0079605) is intended to mix a sample fluid with reagents in a reaction reservoir 52d, and Asogawa et al (EP 2,829,882) teach that the inclusion of first and second mixing chambers in a cartridge connected by a fluidic channel and formed in a non-bonded area between two flexible substrates allows the effective mixing of a sample with reagents in the chambers by deforming the flexible substrates multiple times to facilitate the movement of the sample and reagents between the mixing chambers.
With regards to claim 45, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a barrier membrane located downstream of the mixing chambers in the cartridge taught by the combination of Asogawa et al (US 2014/0079605) and Asogawa et al (EP 2,829,882 ) because such a barrier membrane would confine the mixing of the sample with the reagents in the mixing chambers and ensure that the reagents in the mixing chambers do not flow to the extraction reservoir 52e of the cartridge taught by Asogawa et al (US 2014/0079605).
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asogawa et al (US 2014/0079605, submitted in the IDS filed on April 21, 2026) in view of Asogawa et al (EP 2,829,882) as applied to claims 40-45 above, and further in view of Hongo et al (US 2009/0023201, also submitted in the IDS filed on April 21, 2026). For a teaching of Aosgawa et al (US 2014/0079605), Asogawa et al (EP 2,829,882) and Hongo et al (US 2009/0023201), see previous paragraphs in this Office action.
With regards to claim 46, the combination of Asogawa et al (US 2014/0079605) and Asogawa et al (EP 2,829,882) fails to teach that first and second pistons interact with the first and second mixing chambers formed by a combination of the elastomeric membranes 51b and 51c in the cartridge. However, based upon the combination of Asogawa et al (US 2014/0079605), Asogawa et al (EP 2,829,882) and Hongo et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in the cartridge taught by Asogawa et al (US 2014/0079605) first and second mixing chambers and a fluidic channel connecting the first and second mixing chambers between the elastomeric membranes 51b and 51c of the cartridge for the reasons set forth above, and to further include first and second pistons which interact with the first and second mixing chambers because Hongo et al teach that an effective way to move fluids held within chambers of a fluidic cartridge by a flexible barrier or membrane is to push on the flexible barrier or membrane with a plunger or piston.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Weekamp (US 7,892,493) who teach of a fluid transport device with reduced dead volume; Eberhart et al (US 2017/0002399) who teach of a fluidic cartridge with a valve mechanism; and Kimura et al (US 9,415,391) who teach of a cartridge for biochemical use comprising a membrane located adjacent to a liquid transport channel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 May 19, 2026
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