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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/26/2025 has been entered.
Specification
The amendment filed 09/26/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “[...] the fully enclosed flow chamber 12 being composed of biocompatible material to prevent coagulation and contamination of the aqueous clinical specimen 22.” P10/L1-2; “The biocompatible material can be chosen to minimize interaction with whole blood or similar biological materials, thereby preserving the original sample compositions and prevent coagulation and similar conditions that can affect the analysis.” P18/L18-20; “[...] the fully enclosed flow chamber being composed of biocompatible material to prevent coagulation and contamination of the aqueous biological specimen;” P37/L11-13.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 10 is objected to because of the following informalities: “The” in L35.
Claims 11-20 are objected because the claims depend to the canceled claim 1. Accordingly, the claims 11-20 have not been further treated on the merits.
Claim 20 is objected to because of the following informalities: the claim appears incomplete. Appropriate correction is required.
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.
Claim 10 is 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. This rejection concerns new matter.
Claim 10 recites in part “the fully enclosed flow chamber being composed of biocompatible material to prevent coagulation and contamination of the aqueous biological specimen” The current remarks urges support therefor may be found in “page 8 lines 6-17”. The examiner cannot find support in the specification as originally filed, whereas it is noted the specification as originally filed describes, at best, “The design of the flow chamber 14 and microtubes 32 can vary depending on the specific application and the type of sensors 36 being used and can me made of biocompatible materials to ensure that the materials do not alter the composition of the biological materials 38. Common materials might include medical-grade plastics or polymers. The flow chamber 14 and microtubes 32 can be designed to be disposable and single-use to prevent cross-contamination and ensure the accuracy of subsequent measurements.” (¶ 0036). Accordingly, the disclosure as originally filed provided no implicit or explicit support for this limitation. Applicants are reminded that it is their burden to show where the specification and priority document as appropriate supports any amendments to the disclosure.
Claim Rejections - 35 USC § 112
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 10-20 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.
Claims 10-20 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. Claim 10 is unclear reciting “[...] designed for quantitative measurements of aqueous biological specimen inserted in the flow channels of the fully enclosed chamber using a clinical specimen collection equipment, [...] for the quantitative measurements and a remote access device in wireless communication [...] for rapid measuring and recording of data from a host using artificial intelligence processing units, [...] to prevent coagulation and contamination of the aqueous biological specimen; [...] is removably connected to the clinical specimen collection equipment at an injection point of a passageway that is attached to the bottom surface thereof for the rapid transmission of the aqueous biological material through plurality of flow channels being fixedly attached to the bottom surface thereof; the passageway having a substantially circular hollow tube provided on a substantially vertical axis for a pump force insertion of the aqueous biological material therein using a pump attached to the clinical specimen collection equipment and wherein the pump force moves the biological material rapidly through the passageway into a 5-way divergent point attached to the flow channels and rapidly through the flow channels being attached to the 5-way divergent point, the flow channels having outer ends and being provided in an interconnected branched arrangement from the 5-way divergent point and with respect to the passageway and being connected to a plurality of microtubes at the outer ends thereof from the 5-way divergent point; The plurality of microtubes being positioned below the vertical planes of the 5-way divergent point and beneath the top surface of the fully enclosed flow chamber thereby preventing flow reversal of the aqueous biological material and individual analysis of the aqueous biological specimen within the plurality of microtubes and wherein the plurality of flow channels radially extend away from the passageway and being connected to a plurality of microtubes at the outer ends thereof; wherein the plurality of microtubes having interior compartments for housing the medical diagnostic sensors and the aqueous biological material once the aqueous biological material is pumped into the passageway and flows through the 5-way divergent point thereof by capillary action upon attaching the clinical specimen collection equipment and the aqueous biological material is pumped into the injection point of the passageway and is directed to flow into the plurality of microtubes and wherein the aqueous biological material remains in a stationary position therein; the clinical specimen collection equipment thereby distributing the aqueous biological material into the 5-way divergent point and thereby into the plurality of microtubes for rapid and direct sensor analyses, and wherein the enclosed passageway prevents the release of the aqueous biological material and ensures reliable measurements; wherein at least one medical diagnostic sensor is provided at the injection point of the passageway for measuring at least one physical parameter and at least one chemical parameter; wherein the medical diagnostic sensors track the in vivo and in vitro, measuring, and monitoring of the aqueous biological material of the host using standard electrochemical principles for measuring and recording the data once the aqueous biological material is pumped into the plurality of flow channels; wherein the artificial intelligence processing units incorporating machine learning algorithms to analyze the data in real time are integrated into the memory cartridges and medical diagnostic sensors of the system through interfaces allow for the exchange of the data between the memory cartridges, medical diagnostic sensors, and artificial intelligence processing units and wherein the artificial intelligence processing units utilize predictive analytics to enhance the accuracy of measurements from the aqueous biological material; wherein at least one of the medical diagnostic sensors being adapted for connection to the host; wherein the system measures and records additional data from the host; and at least one of the medical diagnostic sensors being placed in the fully enclosed flow chamber and being interconnected for wireless communication with the remote access device, and wherein the remote access device executes artificial intelligence verification of the in vivo and in vitro tracking, measuring, and monitoring of the aqueous biological material.” because it is unclear which structures the integrated analysis system comprises. It is unclear if the applicant is claiming an integrated analysis system comprising a fully enclosed flow chamber, aqueous biological specimen, flow channels, a clinical specimen collection equipment, a remote access device, a host, a plurality of artificial intelligence processing units having machine learning algorithms, an injection point, a passageway, aqueous biological material, plurality of flow channels, a passageway having a substantially circular hollow tube provided on a substantially vertical axis, the passageway includes a 5-way divergent point, a pump, an interconnected branched arrangement, a plurality of microtubes, each of the plurality of microtubes having interior compartments, each of the interior compartments comprises a plurality of medical diagnostic sensors, interfaces, and artificial intelligence verification.. In addition, the claim is unclear reciting terms such as a 5-way divergent point, a pump force insertion, artificial intelligence verification. These terms are indefinite because the specification does not clearly define the terms. Further, the claim is unclear reciting “[...] and being connected to a plurality of microtubes at the outer ends thereof from the 5-way divergent point; The plurality of microtubes being positioned [...] and being connected to a plurality of microtubes at the outer ends thereof; wherein the plurality of microtubes [...]”, etc. because it is unclear which of the plurality of microtubes are being referred. For the reasons above, dependent claims are similarly unclear.
Claim 10 recites the limitation "the flow channels" in L3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the fully enclosed chamber" in L4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the bottom surface" in L19. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the aqueous biological material" in L20. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "plurality of flow channels" in L20. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the vertical planes" in L34. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the system" in L70. There is insufficient antecedent basis for this limitation in the claim.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 10 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Shachar et al. (US 2022/0097064).
Regarding claim 10, Shachar et al. teach:
10. An integrated analysis system (e.g., 10) comprising
a fully enclosed flow chamber (e.g., disk 13) with a top surface and with an interior space (see Figs. 2-3 for example) capable for quantitative measurements (¶ 0017+) of aqueous biological specimen (¶ 0014+) inserted in flow channels of the fully enclosed chamber using a clinical specimen collection equipment (e.g., syringe ¶ 0098), the fully enclosed flow chamber capable of housing medical diagnostic sensors (¶ 0057, 0098) and a remote access device (e.g., smart device ¶ 0112, microcontroller 43 ¶ 0103; wireless/Wi-Fi module 68 Fig. 1, ¶ 0105; GUI ¶ 0176) capable of in wireless communication with the fully enclosed flow chamber (see Fig. 1 & ¶ 0057, 0103-0112, 0176-0181 for example), the integrated analysis system further comprising:
the fully enclosed flow chamber being composed of biocompatible material (this limitation is sufficiently broad to have read on a disk composed of polymer composition ¶ 0100);
memory cartridges (e.g., 60) attached to the fully enclosed flow chamber (see Fig. 1 for example);
wherein the fully enclosed flow chamber is capable of being removably connected to the clinical specimen collection equipment at an injection point of a passageway (see ¶ 0098 & Figs. 2-3, 11-13 for example) that is capable of being attached to a bottom surface, a plurality of flow channels being fixedly attached to the bottom surface thereof (see i.e., channels formed from 202, 203, and 204 in Fig. 13);
the passageway having a substantially circular hollow tube provided on a substantially vertical axis (see i.e., substantially circular through-holes (202, 203, 204, ¶ 0099) formed through the disk 13 (a substantially vertical axis)) capable for insertion of the aqueous biological material therein (¶ 0098-0099+), a 5-way divergent point (see i.e., connecting points 202, 203, 204 that diverge vertically and horizontally) attached to the flow channels (see Figs. 11-13 for example), the flow channels having outer ends and being provided in an interconnected branched arrangement from the 5-way divergent point and with respect to the passageway and being connected to a plurality of microtubes (e.g., 26, 28, 32, 38) at the outer ends thereof from the 5-way divergent point (see Figs. 3, 11-13 for example);
wherein the plurality of microtubes having interior compartments (i.e., interior of 26, 28, 32, 38) capable for receiving the medical diagnostic sensors and the aqueous biological material (¶ 0098-0099+);
wherein the medical diagnostic sensors capable of tracking the in vivo and in vitro, measuring, and monitoring of the aqueous biological material (¶ 0114-0144+);
wherein artificial intelligence processing units capable of incorporating algorithms (¶ 0016, 0058);
wherein at least one of the medical diagnostic sensors being capable for connection to the host (see Fig. 1 & ¶ 0057 for example);
wherein the system is capable of measuring and recording additional data (e.g., analyzed data, see ¶ 0057, 0079 for example); and
at least one of the medical diagnostic sensors being placed in the fully enclosed flow chamber (e.g., sensors 38, ¶ 0057+) and capable of being interconnected for wireless communication with the remote access device (see Fig. 1 & ¶ 0057, 0079 for example).
Regarding claim 10, Shachar et al. meet all the structural limitations recited by the instant invention. Applicants’ preamble recites “for the rapid measuring and recording of data from a host”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
With regard to limitations in claim 10 (e.g., [...] designed for quantitative measurements of aqueous biological specimen inserted in the flow channels of the fully enclosed chamber using a clinical specimen collection equipment, [...] for the quantitative measurements and a remote access device in wireless communication [...] for rapid measuring and recording of data from a host using artificial intelligence processing units, [...] to prevent coagulation and contamination of the aqueous biological specimen; [...] is removably connected to the clinical specimen collection equipment at an injection point of a passageway that is attached to the bottom surface thereof for the rapid transmission of the aqueous biological material through plurality of flow channels being fixedly attached to the bottom surface thereof, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
Claim(s) 10 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Guzman (US 2022/0170885).
Regarding claim 10, Guzman teaches:
10. An integrated analysis system (¶ 0036+) comprising
a fully enclosed flow chamber (see e.g., 10 & ¶ 0050) with a top surface and with an interior space capable for quantitative measurements (¶ 0080+) of aqueous biological specimen inserted in flow channels of the fully enclosed chamber (¶ 0073-0076+) using a clinical specimen collection equipment (e.g., needle ¶ 0124 & Fig. 8), the fully enclosed flow chamber capable of housing medical diagnostic sensors (e.g., analyte concentrator-microreactor (ACM) device 42, 418, 438) and a remote access device capable of in wireless communication (see ¶ 0047, 0052, 0061+) with the fully enclosed flow chamber (see e.g., computer controlled system, ¶ 0050, 0126; see also portable miniaturized point-of-care instrument or device ¶ 0107 for example), the integrated analysis system further comprising:
the fully enclosed flow chamber being composed of biocompatible material (this limitation is sufficiently broad to have read on plastic or other polymeric materials ¶ 0074);
memory cartridges (e.g., computer memory, supercomputers) attached to the fully enclosed flow chamber (¶ 0126+);
wherein the fully enclosed flow chamber is capable of being removably connected to the clinical specimen collection equipment at an injection point of a passageway (see ¶ 0124 & Fig. 8 for example) that is capable of being attached to a bottom surface (i.e., bottom surface of 12), a plurality of flow channels being fixedly attached to the bottom surface thereof (see e.g., 20, 52, 53 in Figs. 1-3 for example);
the passageway having a substantially circular hollow tube provided on a substantially vertical axis (see Figs. 1-3 & incorporated reference US 10408789 Fig. 10 for example) capable for insertion of the aqueous biological material therein, a 5-way divergent point (see incorporated reference US 10408789 Figs. 2, 3, 9, 14 for example) attached to the flow channels, the flow channels having outer ends and being provided in an interconnected branched arrangement from the 5-way divergent point and with respect to the passageway and being connected to a plurality of microtubes (see incorporated reference US 10408789 transport channel 24A, and separation channels 28A, 30A, 32A for example) at the outer ends thereof from the 5-way divergent point (see incorporated reference US 10408789 Fig. 14 for example);
wherein the plurality of microtubes having interior compartments () capable for receiving the medical diagnostic sensors and the aqueous biological material (see Fig. 7 & ¶ 0116 for example);
wherein artificial intelligence processing units capable of incorporating algorithms (¶ 0131);
wherein at least one of the medical diagnostic sensors being capable for connection to the host (see ¶ 0047, 0050, 0052, 0061, 0107, 0126 for example);
wherein the system is capable of measuring and recording additional data (see ¶ 0087, 0128 for example); and
at least one of the medical diagnostic sensors being placed in the fully enclosed flow chamber (see Fig. 7, ¶ 0126-0148, 0157+) and capable of being interconnected with the remote access device (see ¶ 0047, 0050, 0052, 0061, 0107, 0126-0148, 0157+).
Regarding claim 10, Guzman meets all the structural limitations recited by the instant invention. Applicants’ preamble recites “for the rapid measuring and recording of data from a host”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
With regard to limitations in claim 10 (e.g., [...] designed for quantitative measurements of aqueous biological specimen inserted in the flow channels of the fully enclosed chamber using a clinical specimen collection equipment, [...] for the quantitative measurements and a remote access device in wireless communication [...] for rapid measuring and recording of data from a host using artificial intelligence processing units, [...] to prevent coagulation and contamination of the aqueous biological specimen; [...] is removably connected to the clinical specimen collection equipment at an injection point of a passageway that is attached to the bottom surface thereof for the rapid transmission of the aqueous biological material through plurality of flow channels being fixedly attached to the bottom surface thereof, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
Response to Arguments
Applicant's arguments filed 09/26/2025 have been fully considered but they are not persuasive.
Applicant’s amendments have been considered and have been addressed within the above new rejections and amended art rejection.
In response to the Applicant's arguments to the process or intended use limitations, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The Courts have held that limitations regarding the contents, intended use or manner of operating an apparatus do not further limit the patentability of apparatus claims. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488,492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
It is encouraged that the claim be amended to affirmatively recite specific structural elements of the system, and to include additional structural limitations where appropriate, to positively define the invention in structural terms. Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798