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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/08/2026 has been entered.
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, 6-11, 14-16 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ymeti et al. (U.S. PGPub No. 2012/0214707 A1) in view of Redmond et al. (U.S. PGPub No. 2011/0171754 A1) further in view of Shastry et al. (U.S. PGPub No. 2019/0187162 A1).
As to claim 1, Ymeti discloses and shows in figures 3, 9 and 10, a portable interferometric system for detection and quantification of analyte within an animal health test sample composition, the system comprising ([0070]; [0073]):
an optical assembly unit, the optical assembly unit comprising a light unit (LSO) and a detector unit (PHD) each adapted to fit within a portable housing unit (POD) ([0084], ll. 1-5; [0103]; [0139], where in performing the measurement in the POD, inherently the POD has the source/detector required to perform the disclosed measurement);
a removable cartridge system (CPH, OPC, FCV (i.e. LOC system)) adapted to be inserted in and removed from a cartridge recess within the portable housing unit after one or more uses, the cartridge system comprising ([0139], ll. 1-3; [0141]; [0145], ll. 1-5):
an interferometric chip (OPC) disposed within the cartridge housing (explicitly shown in figure 10) and including one or more waveguide channels (MCH and RCH) having a sensing layer thereon (proteins shown in figure 2), the sensing layer adapted to selectively bind or otherwise be selectively disturbed by one or more analytes (body fluid sample) within the animal health test sample composition ([0088], ll. 1-25; [0103], ll. 1-11);
a flow cell wafer (FCV) disposed adjacent to (as explicitly shown in figure 10, the FCV chip is directly above the waveguide interferometric chip OPC) and in fluidic communication with the interferometric chip (explicitly shown in figure 10, further as disclosed the entire point of the cartridge is to couple samples from the FCV to a binding receptor layer present on the sensing window of the OPC chip) ([0104], ll. 1-11; [0138], ll. 1-9); and
a cartridge housing (CPH) enclosing the interferometric chip and flow cell wafer (explicitly shown in figure 10) ([0141], ll. 1-10):
wherein insertion of the cartridge system in to the portable housing unit provides functional optical and microfluidic coupling between the cartridge system and the optical assembly unit ([0142]; ll. 1-20; where insertion of LOC (cartridge system) into the portable housing unit (POD) clearly provides some level of “functional” coupling between the cartridge system and the optical assembly unit, as the entire purpose of the system in Ymeti is to insert the cartridge into the analysis system that contains the light source LSO and detector PHD, and analyze each LOC cartridge relative to a particular sample contained within).
Ymeti does not explicitly disclose an alignment means for aligning the cartridge system within a cartridge recess in the optical assembly unit upon insertion thereby providing optical and microfluidic alignment of the interferometric chip and flow cell wafer, the alignment means comprising at least one male key portion on an exterior surface of the cartridge housing for engaging and securing the cartridge within a corresponding female rail of the optical assembly unit.
However, Redmond does disclose and show in figure 3, 6b and in ([0062], ll. 30-36) the basic concept of including in the cartridge that gets inserted into an optical assembly a mating system for alignment. Specifically a male key portion (39) more clearly shown in figure 6b, designed to interface with a female rail of the optical assembly unit. The examiner further takes Office Notice that a male/female based interlocking system to align objects is well-known to one having ordinary skill in the art. The basic concept of tongue and groove systems is over a hundred years old and as such extremely well known as a simple way to interlock two parts together. Further as evidenced by Shastry, Figures 27 and 28, and in ([0237]; [0244]) the use of again a common and well-known alignment system in optical cartridge based analysis that aligns the sample cartridge via male key portion (2705) that interfaces with a female rail structure (2803) of the optical assembly unit. Again this yields the predictable result of allowing simple, efficient alignment of one structure inserted into another.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ymeti with an alignment means for aligning the cartridge system within a cartridge recess in the optical assembly unit upon insertion thereby providing optical and microfluidic alignment of the interferometric chip and flow cell wafer, the alignment means comprising at least one male key portion on an exterior surface of the cartridge housing for engaging and securing the cartridge within a corresponding female rail of the optical assembly unit in order to provide the advantage of expected results and increased efficiency as explicitly disclosed in Redmond such a well-known concept provides a “reproducible and robust registration with the internal mechanics of the optical detection reader 13 by direct engagement”.
As to claim 6, Ymeti discloses a portable interferometric system, wherein the sensing layer comprises one or more antigens, antibodies (explicitly shown in figure 1), DNA microarrays, polypeptides, nucleic acids, carbohydrates, lipids, or molecularly imprinted polymers, or immunoglobulins suitable for binding one or more analytes within an animal health test sample composition ([0086], ll. 1-14)
As to claim 7, Ymeti discloses a portable interferometric system, configured to analyze the light signals from two or more waveguide channels (MCH, RCH1-3) to detect the presence of an analyte that individual waveguide channels could not have detected alone (in showing the same claimed use, the examiner is interpreting the prior art as capable of the same intended result) ([0106]).
As to claim 8, Ymeti discloses a portable interferometric system, wherein the one or more waveguide channels each comprises a different sensing layer to allow the system to detect different analytes on each waveguide channel ([0058], ll. 15-16; [0087], ll. 1-15).
As to claim 9, Ymeti discloses a portable interferometric system, wherein the sensitive layer is configured to bind one or more chemical, antibody, virus antigen, virus protein, bacteria, fungi, pathogen, RNA, mRNA, plant growth regulator, metal or any combination thereof ([0112], ll. 10-14).
As to claim 10, Ymeti discloses a portable interferometric system of claim 1, having an analyte detection limit down to about 1.0 picogram/L (Abstract, where the examiner is interpreting Ymeti as capable of the intended result as the prior art has shown the same structure as claimed).
As to claim 11, Ymeti discloses a portable interferometric system, having an analyte detection limit down to about 1000 pfu/ml (Abstract, where the examiner is interpreting Ymeti as capable of the intended result as the prior art has shown the same structure as claimed).
As to claim 14, Ymeti disclose a portable interferometric system, wherein the analyte is one or more of a fungicide, herbicide, insecticide, fungus, bacterium, or microbe ([0086], ll. 15-21).
As to claim 15, Ymeti discloses A method of detecting and quantifying the level of analyte in an animal health test sample composition, the method comprising the steps of: collecting an animal health target sample containing one or more analytes (inherently the sample has to be collected to be measured); optionally entering an identification associated with the target sample; introducing the animal health target sample to the portable interferometric system of claim 1 (again inherently this has to be done to take any measurement); optionally, mixing the target sample with a buffer solution to form an animal health test sample composition; initiating waveguide interferometry on the test sample composition; processing any data resulting from the waveguide interferometry; and optionally, transmitting any data resulting from the waveguide interferometry (Abstract; [0021], ll. 1-4).
As to claim 16, Ymeti fails to disclose a method, wherein the step of transmitting data includes wirelessly transmitting analyte detection and quantification data to a mobile device or server.
However, the examiner takes Office Notice that wirelessly transmitting the data to a server or mobile device is well-known and predictable in the optical art.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ymeti with a method, wherein the step of transmitting data includes wirelessly transmitting analyte detection and quantification data to a mobile device or server in order to provide the advantage of expected result in wirelessly transmitting the data to a server obviously one can relay the information among many computers so for example in medical analysis many doctors can review the detection result.
As to claim 18, Ymeti discloses a method, wherein the animal health target sample is taken from feed, water, soil, air, exhaled breath, skin, hair tissue, or bodily fluid within or surrounding an animal health environment ([0070]).
As to claim 19, Ymeti discloses a method, wherein the animal health target sample is in the form of, dissolved in, or suspended in a liquid or a gas ([0070]).
As to claim 20, Ymeti discloses a method, wherein the data resulting from the waveguide interferometry is provided at or under 30 minutes (i.e. very first minutes) ([0157], ll. 8-12, where first minutes is being interpreted as less than 30, alternatively obviously the first few minutes can be less than 30 to yield a rapid result of the sample under test).
As to claim 21, Ymeti discloses wherein the cartridge housing comprises a vent port (OTL) for allowing air to exit and prevent bubble formation ([0138], ll. 3-9).
Claim(s) 2-3 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ymeti et al in view of Redmond et al. in view of Shastry et al. further in view of Ymeti (NPL: An Ultrasensitive Young Interferometer Handheld Sensor for Rapid Virus Detection, Ymeti2 hereinafter for citations).
As to claim 2, Ymeti in view of Redmond further in view of Shastry does not explicitly disclose wherein the portable housing is sized and shape to fit in a user’s hand.
However, Ymeti2 does disclose in (Title, Abstract) that the similar interferometric sensor design can be handheld.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ymeti in view of Redmond further in view of Shastry wherein the portable housing is sized and shape to fit in a user’s hand in order to provide the advantage of increased versatility in obviously being handheld one can more easily do point-of-care measurement of a user under test as explicitly noted by Ymeti2.
As to claim 3 and 17, Ymeti does seem to show a display for the portable measurement system via the black box shown in figure 9.
Ymeti in view of Redmond further in view of Shastry however does not explicitly disclose a portable interferometric system, further comprising at least one display unit or further comprising the step of display data related to the presence of analyte in the test sample composition on the display unit.
However, Ymeti2 does disclose in figure 5 and corresponding description that the black box can be a readout unit that for example shows that the sample has a H5N1 virus concentration.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ymeti with a portable interferometric system, further comprising at least one display unit or further comprising the step of display data related to the presence of analyte in the test sample composition on the display unit in order to provide the advantage of increased efficiency as obviously if the black box shown in Ymeti were a display it can relay information to the user more rapidly and conveniently than the data be shown somewhere else not on the device doing the noted measurement.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ymeti et al. in view of Redmond et al. in view of Shastry further in view of Ehrenkranz (U.S. PGPub No. 2013/0273528 A1).
As to claim 12, Ymeti in view of Redmond further in view of Shastry does not explicitly disclose a portable interferometric system, further comprising an external camera, the external camera (unit) adapted to capture a photo or video.
However, Ehrenkranz does disclose and show in figure 5A and in ([0006]; [0056]) the use of a basic cellphone (250) to function as an external camera to capture photos or video of the chip under test.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ymeti in view of Redmond further in view of Shastry with a portable interferometric system, further comprising an external camera (unit), the external camera adapted to capture a photo or video in order to provide the advantage of increased accuracy in augmenting the system of Ymeti to also include external image capture of the sample under test, one can further refine the measurement data with the method taught by Ehrenkranz.
Claim(s) 13, is rejected under 35 U.S.C. 103 as being unpatentable over Ymeti et al. in view of Redmond et al. in view of Shastry further in view of Iida (U.S. PGPub No. 2006/0292039 A1).
As to claim 13, Ymeti in view of Redmond further in view of Shastry does not explicitly disclose a portable interferometric system, further comprising a location means adapted to determine the physical location of the system.
However, Iida does disclose in Figure 1 and in ([0145]) the basic concept of using a GPS function in conjunction with a chip based measured device.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ymeti in view of Redmond further in view of Shastry with a portable interferometric system, further comprising a location means adapted to determine the physical location of the system in order to provide the advantage of increased accuracy in tagging a GPS coordinate with a system designed to measured virus potentiality, obviously one could track the spread of disease more accurately.
Response to Arguments
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive.
As to the arguments regarding U.S. Patent No. 11,740,177, the examiner considers the remarks moot as each case is examined on its own merits. As such the evidence provided in the instant case does not currently provide for allowance for the claims as presented.
As to applicant’s argument that there is no motivation to combine, the examiner respectfully disagrees. Firstly, the examiner provided and explicit motivation from Redmond which applicant has not responded to, on this basis alone the rejection is maintained. However, further the additional motivation provided by the examiner regarding tongue and groove, is also maintained. The rejection did not merely state that tongue and groove is known. The motivation provided was that tongue and groove is not merely known, but more so that it is both known as a predictable means by which one can align and maintain one structure relative to another in being present as a known structure for an extended period of time. However for compact prosecution the examiner has provided yet an additional reference (Shastry) simply as evidence to show the exact structure as required by the claim male/female interlocking geometric features of a cartridge/holder. For these reasons the rejection is maintained.
As to applicant’s argument that there is no reasonable expectation of success when using the teachings of Redmond in conjunction with Ymeti, the examiner respectfully disagrees. The details of Redmond’s optical fluorescence system are irrelevant to the motivation and modification as rejected. The examiner merely used Redmond as a means to show a cartridge in an optical system can have male alignment structures that align it with the holder of the cartridge which contains female alignment structures. The expectation of success is clearly and explicitly present as basic geometric structures when implement on any cartridge optical or not would obviously provide a more precise alignment in contrast to merely setting one thing on top of or inside another. This obviously applies not to only optical parts but all alignment of two structures relative to one another.
As to applicant’s argument that the examiner has not explained how one would achieve the “specific alignment recited in claim 1”, the examiner respectfully disagrees. The alignment in general is already explicitly disclosed in Ymeti, as fundamentally if the system of Ymeti did not align the parts relative to each other in the manner claimed Ymeti would be inoperable. The combination and motivation is merely to further refine and stabilize the alignment. This as already previously cited is explicitly taught in Redmond ([0062]) “reproducible and robust registration with the internal mechanics of the optical detection reader 13 by direct engagement”. Applicant appears to be trying to argue criticality of the alignment mechanism of the instant claims. However, the examiner fails to find any evidence that the interferometric alignment is precisely done as a result of the “alignment mechanism” structure as claimed. In other words the examiner fails to find any clear or defined structure in the claim or even argued that would provide some type of nanometer or micron level alignment tolerance between the two parts. In fact applicant’s own alignment male/female structure which is not claimed to precisely require the structures of figure 5B, does not seem to support some critical alignment specification (i.e. some nano or micro based alignment tolerance). As it appears one structure merely wrest on the support rails of the other, shown below.
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The examiner notes for compact prosecution that this structural configuration is known even if it were claimed which is currently is not, in Negami et al which the examiner has provided below.
As to applicant’s argument that Ehrenkranz is fundamentally different than Ymeti and Redmond, the examiner respectfully disagrees. The claim requires merely that “an external camera unit adapted to capture a photo or video”. The claim in no way links this photo or video to anything about the interferometric measurement or any aspect of detection or processing, merely that a photo or video is taken externally. As such the prior art merely discloses doing so via a cell phone. The examiner as previously provided was merely using the prior art camera as an additional means by which you could further refine an understanding of a sample (i.e. colorimetric analysis as noted by applicant). Again if applicant’s argument is that the prior art does not perform an interferometric assessment of the sample via an external camera, then the claim needs to be amended to require that limitation which it currently does not. As such the rejection is maintained.
As to applicant’s argument that Lida does not provide sufficient motivation for teaching the limitation of instant claim 13, the examiner respectfully disagrees. Tracking itself is not specific only to a particular measurement technique as argued by applicant. The claim makes this clear by simply stating “a location means adapted to determine the physical location of the system”. This limitation does not address any particular of any optical technique, it merely provides a limitation that the system’s location is determined at some point. As such the teach of Iida is found to disclose exactly that, using GPS which as also agreed by applicant is known, to derive location of a chip based system. Applicant has not challenged the examiners actual motivation of using said GPS to track disease spread which is in some cases the purpose of the sample measurement devices. As such the rejection is maintained in that the use of measuring location is obvious and predictable if not for disease tracking, obviously merely for knowledge of location to avoid loss/misplacement of the system.
Prior art made of record
Negami et al. (U.S. Patent No. 6,432,364 B1) discloses and shows in figures 30 and 31 a similar alignment means in structure to that of applicant’s alignment means.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P LAPAGE whose telephone number is (571)270-3833. The examiner can normally be reached Monday-Friday 8-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur Chowdhury can be reached at 571-272-2287. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael P LaPage/ Primary Examiner, Art Unit 2877
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