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 .
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)
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.
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. 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 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 ‘ 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 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. further in view of Ehrenkranz (U.S. PGPub No. 2013/0273528 A1).
As to claim 12, Ymeti in view of Redmond 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 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. further in view of Iida (U.S. PGPub No. 2006/0292039 A1).
As to claim 13, Ymeti in view of Redmond 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 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 03/04/2026 have been fully considered but they are not persuasive.
As to applicant’s argument that Ymeti in view of Redmond fails to disclose the cartridge system as amended, the examiner respectfully disagrees. Specifically the examiner is unclear how applicant has come to the conclusion that the interferometric chip of Ymeti is not disposed adjacent and in fluidic communication with the flow cell wafer. Applicant states “Specifically, Ymeti discloses the use of a (micro-) fluidic cuvette on top of the optical chip (see [0142]). That is, the cuvette itself has fluidic channels. The fluidic channels of the cuvette are aligned with respect to the sensing regions/windows that are on the optical chip itself. To achieve this alignment, Ymeti requires a holder that must be etched or otherwise configured in such a way that the (micro-)fluidic cuvette can be positioned in a specific manner (see Fig. 10B).” The examiner finds the bolded sections above as admitted by applicant explicitly teach the claim limitations even as amended. The examiner is unclear how the specifics of the holder used in Ymeti would somehow teach away from the claimed invention. At least relative to the idea of having an interferometric chip OPC in fluidic contact with the flow cell wafer (FCV). As such the rejection has been maintained as the language argued in this section both in the prior art and as admitted by applicant provides a teaching sufficient to meet the instant claim limitations in question.
As to the argument that Ymeti fails to disclose the alignment means as claimed, this argument is moot as the reference Redmond was used to teach the noted limitation.
As to the argument that Redmond fails to disclose the alignment means, the examiner respectfully disagrees. Applicant argues that Redmond that Redmond does not include the critical specific rail and key system as disclosed and therefore does not teach alignment. The examiner is again unclear as to what specific structural detail applicant finds missing from the prior art. The extremely basic concept of having a male key portion that engages with a female rail portion to align one structure relative to another is explicitly taught in Redmond. Redmond explicitly calls this structure an “alignment feature” 39. The concept as claimed is equivalent to a tongue and grove structure that aligns one structure relative to another. As best the examiner can tell this concept was invented in the early 1800s and cannot in and of itself be relied upon for novelty. Lastly applicant argues that “The claimed configuration is particularly important in the context of interferometric sensing, where optical misalignment on the scale of microns can prevent the sensor from functioning properly”. If applicant’s statement is taken as correct it would stand to reason that one having ordinary skill in the art would likewise require alignment in the system of Ymeti which explicitly also has an interferometric based cartridge. As such applicant’s argument provides further evidence of the advantages of using the rail system of Redmon in conjunction with the interferometric cartridge of Ymeti. For compact prosecution it is suggested that if there is some specific structural details regarding the alignment means disclosed that goes beyond a mere tongue and groove configuration. That the examiner then suggests that these structures may be relied upon and claimed to at the very least attempt to overcome the prior art of record. Ideally there would further be an argument linking these new claimed structure to the criticality as argued by applicant.
As to applicant’s argument that the newly amended wherein clause requires that “This aspect requires that insertion itself establishes both optical alignment and microfluidic interfacing”, the examiner respectfully disagrees. The broadest reasonable interpretation of the newly added wherein clause merely requires that the cartridge system that provides optical and microfluidic coupling within it is provides “functional” coupling upon insertion into the optical assembly unit. The examiner is unclear how the prior art could in any way be interpreted to not have functional coupling between the cartridge and the optical assembly unit, as the is the entire purpose of inserting the cartridge into the POD (which contains the optical assembly unit). In other words the entire purpose of the cartridge in Ymeti is to prepare it and insert it into the POD so that light via the source contained in the POD can be sent through the cartridge to measure the sample under test. As such the newly amended limitation is found to be clearly taught by the prior art of record, as a result the rejection has been maintained.
As to applicant’s argument that Ymeti cannot be combined with Redmond to achieve the claimed alignment means, the examiner respectfully disagrees. The basic concept again of using an extremely common and well-known alignment means that includes a male/female rail engagement system is not only well-known in the optical sample holder art but in all of measuring and testing. As commonly when a sample holder is linked up with a measuring device some form of basic alignment is required, one of the most common and basic ways to perform that alignment is to use a male/female rail engagement system. This could obviously be used with the cartridge of Ymeti as taught by Redmond for the same modification and motivation as provided above. Since applicant has failed to actually challenge the motivation itself in any clear manner the rejection is being maintained.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The argument relative to claim 2 argues against the two documents not cited to teach handheld and ignores the NPL actually used to teach the limitation. Since applicant has failed to address how the Ymeti NPL fails to provide sufficient motivation/modification to show an obvious concept of handheld use, the rejection is maintained. The same logic applies to the arguments regarding claims 3, 12, 13 and 17. As applicant seems to ignore the teachings of the NPL Ymeti2, Ehrenkranz, Lida and argues solely against the references not cited to teach the claim limitation of the noted claims. As such the rejection on claims 2, 3 12, 13 and 17 are maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/Michael P LaPage/ Primary Examiner, Art Unit 2877
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