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. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. 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 appl icant regards as his invention. Claims 1-17 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. On line 5 of claim 1, the phrase “the region” lacks antecedent basis. Claim 1 is indefinite since it recites that the cover is configured to seal the fluid path. Since claim 1 recites that the fluid path comprises a specimen inlet, a diluent inlet, a reagent inlet, a reaction chamber and an air outlet , it is not clear how a specimen, a diluent and a reagent can be introduced into the cartridge and how air can be allowed to exit from the cartridge if the cover seals each of the inlets and the outlet . Does the cover contain openings where the specimen inlet, the diluent inlet, the reagent inlet, and the air outlet are located in the body of the test cartridge , or are each of the specimen inlet, the diluent inlet, the reagent inlet and the air outlet open on a side of the body opposite to the side where the cover is located ? Claim 1 is also indefinite since it is not clear where the membrane is located in the test cartridge relative to the cover. Is the membrane located on the same side of the body where the cover is located, or is the membrane located on an opposite side or surface of the body from where the cover is located? According to the specification and Figure 3 in the instant application, the cover 128 is located on a top side of the body of the cartridge so as to seal the fluid path comprising the specimen inlet, the diluent inlet, the reagent inlet, the reaction chamber and the air outlet while the membrane (i.e. separate membranes 132) is located on a lower side of the cartridge body opposite to the top side and seal s an opposite side of the diluent inlet, the reagent inlet and the air outlet. Claim 1 lacks necessary structural cooperation among each of the recited components of the test cartridge. On line 2 of claim 8, the phrase “the region” lacks antecedent basis. On line 3 of claim 8, the phrase “the one or more reaction chambers” lacks antecedent basis since claim 8 depends from claim 1, and claim 1 only positively recites a single reaction chamber, not “one or more reaction chambers”. At the end of line 7 in claim 11, the word –and—should be inserted since the plurality of needle tubes is the last component of the fluid connector recited in the claim. On lines 8-9 of claim 11, the phrase “a plurality of needle tubes, wherein each needle tube is coupled to the hypodermic needle” is indefinite since it is not clear which hypodermic needle of the plurality of hypodermic needles recited on line 6 of claim 11 this phrase refers to. It is suggested to change this phrase on lines 8-9 of claim 11 to --a plurality of needle tubes, wherein each needle tube of the plurality of needle tubes is coupled to one of the plurality of hypodermic needles--. On line 1 of claim 17, the phrase “The test system of any one of claim 14” should be changed to –The test system of claim 14—since claim 17 is not a multiply dependent claim. 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, 4 and 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maltezos et al (US 2008/0145286, submitted in the IDS filed on August 15, 2024) . With regards to claim 1 , Maltezos et al teach of a test cartridge 900 (see Figure 1 in Maltezos et al) or 400 (see Figure 9 in Maltezos et al) or 500 (see Figure 10 in Maltezos et al) comprising a body 910, 41 or 51 (see Figures 1, 9 and 10 in Maltezos et al) that defines a fluid path comprising a specimen inlet 96 (see Figure 1 and paragraph 0035 in Maltezos et al where a sample port including a filter 96 is disclosed as a specimen inlet ), a diluent inlet 91 (see Figure 1 and paragraph 0034 in Maltezos et al where a liquid storage compartment 91 is disclosed where a diluent is introduced into the body ), a reagent inlet 92 (see Figure 1 and paragraph 0034 in Maltezos et al where a dry storage compartment 92 containing a reagent is disclosed), a reaction chamber 97 (see Figure 1 and paragraphs 0034-0035 in Maltezos et al where a reaction area 97 is disclosed in the test cartridge ) , and an air outlet 99 (see Figure 1 and paragraph 0035 in Maltezos et al where an air vent 99 is disclosed), a cover configured to cooperate with the body of the test cartridge to seal the fluid path, wherein the cover comprises the bottom of the test cartridge or chip 900 depicted in Figure 1 of Maltezos et al (see paragraph 0039 in Maltezos et al where the bottom of the chip 900 is disclosed as an injection molded plastic card with channels defined in it and the bottom serves to enclose and cover one side of the channels), or the cover comprises either the substrate 43 or the reinforcing layer 44 located on either side of the microfluidic cartridge 4 1 depicted in Figure 9 of Maltezos et al, or the cover comprises either the bottom of the chip 51 or the base plate 54 of the test cartridge depicted in Figure 10 of Maltezos et al, and a membrane coupled to the body and configured to seal the diluent inlet 91, the regent inlet 92 and the air outlet 99, wherein the membrane comprises one of the thin membrane 912 held to the plastic substrate of the test cartridge 900 with a clamp 950 depicted in Figure 5 and described in paragraph 0040 of Maltezos et al , the membrane 46 disposed over a channel 42 in the microfluidic cartridge 41 depicted in Figure 9 o f Maltezos et al (see paragraphs 0053, 0056 and 0058 in Maltezos et al), or the membrane 57 disposed over the channel 52 in the microfluidic cartridge 51 depicted in Figure 10 of Maltezos et al (see paragraphs 0067-0071 in Maltezos et al). Maltezos et al teach that the test cartridge is used for performing cell sorting or protein synthesis, and is intended to be used in combination with a light emitter and a light detector (see paragraphs 0004 and 0026 in Maltezos et al). Specifically, the test cartridge is intended to be placed in a controlling unit 20 that comprises a reading unit 21 for performing an assay such as cell sorting. The reading unit 21 comprises light detectors 22 and light sources or emitters 23 for optically analyzing samples contained in the test cartridge. See Figure 15 and paragraph 0106 in Maltezos et al. Malt ezos et al fail to teach that the cover of the test cartridge is transparent in a region of the reaction chamber 97. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a transparent cover as the cover in the test cartridge taught by Maltezos et al because Maltezos et al teach that the test cartridge is intended to be used in combination with a light emitter and a light detector (see paragraphs 0004 and 0026 in Maltezos et al) for performing assays such as cell sorting, and a transparent cover on the cartridge would help to facilitate these types of optical assays. With regards to claim 4 , Maltezos et al teach that the body of the test cartridge 900 depicted in Figures 1, 5 and 7 has one or more surfaces, and wherein the diluent inlet 91, the reagent inlet 92 and the air outlet 99 are arranged on the same surface of the one or more surfaces of the body 910. See in particular Figure 7 in Maltezos et al. With regards to claim 6 , Maltezos et al teach that a protective film in the form of a filter 96 is configured to seal the sample port or specimen inlet of the test cartridge depicted in Figure 1. See Figure 1 and paragraph 0035 in Maltezos et al. With regards to claim 7 , Maltezos et al fail to teach that the test cartridge can contain multiple reaction chambers therein, wherein a first reaction chamber is located in serial arrangement relative to a second reaction chamber. However, 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 test cartridge taught by Maltezos et al with multiple reaction chambers located in a serial arrangement relative to one another because this configuration would allow the test cartridge disclosed by Maltezos et al to perform multi-step chemical or biological reactions. With regards to claim 8 , Maltezos et al fail to teach that the cover of the test cartridge is transparent in the region of the specimen inlet 96, the diluent inlet 91, the reagent inlet 92, the reaction chamber 97, and the air outlet 99. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a transparent cover as the cover in the test cartridge taught by Maltezos et al that covers each of the specimen inlet 96, the diluent inlet 91, the reagent inlet 92, the reaction chamber 97, and the air outlet 99 because Maltezos et al teach that the test cartridge is intended to be used in combination with a light emitter and a light detector (see paragraphs 0004 and 0026 in Maltezos et al) for performing assays such as cell sorting, and a transparent cover on all regions of the cartridge would help to facilitate these types of optical assays. With regards to claim 9 , Maltezos et al teach that the body of the test cartridge is monolithic. See paragraphs 0064 and 0071 in Maltezos et al. With regards to claim 10 , Maltezos et al fail t teach that the fluid path in the test cartridge comprises a wash chamber. However, 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 wash chamber in the fluid path of the test cartridge taught by Maltezos et al because such a wash chamber would allow for the washing of unwanted or unreacted reagents from a sample analyzed in the test cartridge and the elimination this type of interference from a subsequent optical analysis of the sample. Allowable Subject Matter Claims 2-3, 5 and 11-17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims because the closest prior art to Maltezos et al (US 2008/0145286, described above) fails to teach or fairly suggest each of the additional limitations recited in claims 2-3, 5 and 11-17, particularly that the test cartridge comprises separate, discrete membrane portions for sealing one side of each of the diluent inlet, the reagent inlet and the air outlet and membrane clamps configured to clamp each of the separate, discrete membranes, that the test cartridge is used in combination with a fluid connector comprising a carrier plate that defines a plurality of openings, wherein each opening is configured for alignment with one of the diluent inlet, the reagent inlet, or the air outlet of the test cartridge, a plurality of hypodermic needles, wherein each hypodermic needle is arranged at a corresponding opening of the carrier plate, and a plurality of needle tubes, wherein each needle tube is coupled to a hypodermic needle, and that the test cartridge and associated fluid connector are part of a test system further comprising a plurality of pump drives, wherein each pump drive is configured to drive a respective one of a plurality of pumps , and a cartridge holder configured to receive the test cartridge , wherein the test system is configured to move the fluid connector towards the body of the test cartridge, such that each of the plurality of hypodermic needles pierces the membrane of the test cartridge and fluidly couples a respective needle tube to one of the diluent inlet, the reagent inlet, or the air outlet. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please make note of: Padmanabhan et al (US 2007/0144277) who teach of a fluid cartridge and an instrument for holding and interfacing with the cartridge, wherein the instrument comprises needles for piercing a membrane in the cartridge to deliver fluid thereto; Bransky et al (US 2018/0328821) who teach of a disposable cartridge for preparing a sample fluid for analysis; Kitaguchi et al (US 2005/0148091) who teach of an analyzing cartridge and method of use: and Holl et al (US 6,537,501) who teach of a disposable hematology cartridge. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Value for firstName-middleName-lastName?" \* MERGEFORMAT MAUREEN M WALLENHORST whose telephone number is FILLIN "Insert your individual area code and phone number." \* MERGEFORMAT (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, FILLIN "Insert your SPE’s name." \* MERGEFORMAT Lyle Alexander , can be reached at telephone number FILLIN "Insert your SPE’s area code and phone number." \* MERGEFORMAT 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 March 12, 2026