DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Amendment
1- The amendment filed on 02/03/2026 has been entered and fully considered. Claims 1-7 and 11-16 remain pending in the application, where the independent claims have been amended. New claims 17-23 have been added.
Response to Arguments
2- Examiner has considered Applicants’ proposed amendments and acknowledges they moot/overcome the 35 USC 112(b) rejection of the pending claim 7 and the double patenting rejections of claim 1 as set forth in the non-final office action mailed on 9/04/2025. The above rejections are therefore withdrawn.
3- Applicants’ amendments and their corresponding arguments with respect to the rejections of the pending claims under 35 USC § 102 and 103 have been fully considered but are found not persuasive to overcome the prior art used in the previous office action, despite the fact that the amendments have changed the scope of the invention and overcome the rejection as written in the previous office action.
4- Therefore, the amendments necessitated, upon further consideration, new grounds of rejection using additional teachings from the same references used in the previous office action. The new limitations are addressed in the rejections here under in more details.
5- Here is a brief response to the Arguments presented by the Applicants to explain further the rationale behind the new rejections and the Examiner’s interpretations.
Applicants argue in their response (pp. 6-8) that prior art Ymeti does not teach the all the limitations of the amended claim 1 and claim 11, and the dimensions claimed therein under the anticipation rationale.
The Examiner respectfully agrees with the Applicants about using an anticipation-based rejection. However, the Examiner reiterates the obviousness rationale used in the rejection of the previous claim 8, and complements it here; The Examiner notes that Ymeti discloses it can adapt the dimensions of the structure according to the measurement applications and needs (¶ 84, 141). In addition, Ymeti insists on the use of such portable miniature measurement chip in microfluidic systems (¶ 60, 85, 138-144 for ex.), which are known for their millimeter to sub-micron dimensions (See references incorporated in ¶ 102 as evidence). This would suggest to one PHOSITA to adapt those dimensions, to match or overlap with the claimed dimension ranges, as a mere obvious practice since no specificities are presented with this claimed ranges, and since it has been held that where the general condition of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 23.
As to claims 13-16, and the arguments about the unrelated art Paul, the Examiner also respectfully disagrees and points to the fact that Paul pertains to fabricating metal oxide films for biology and medicine applications, which relates to the biological applications of Ymeti’s microfluidics, Paul teaches methods of producing porous metal oxide films using spray deposition (Abstract, ¶ 2 and Figs. 1-6) with the claimed techniques. Regardless of the specific intended use, one PHOSITA would find it necessary to consider Paul’s teachings film deposition techniques for products destinated for the bio-medical applications.
Also, the examiner submits the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). See also In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983). It is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.”; and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973). Combining the teachings of references does not involve an ability to combine their specific structures. Thus, 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). Therefore, prior arts must be considered in entirely, including discloses that teach away from the claims, MPEP § 2143.01-02.
Claim Rejections - 35 USC § 103
6- 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
7- Claims 1-7, 11-12, 17-23 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Ymeti et al. (PGPUB No. 2012/0214707, cited by Applicants)
As to claims 1, 11, Ymeti teaches an interferometric chip and its method of making (Abstract and Figs. 1-12) comprising: a substrate (Fig. 1 for ex; substrate SUB) having one or more waveguide channels having a sensing layer thereon (¶ 84-89;WGS consists of the substrate, a core layer and cover layer having a measuring region MRG and a reference region RRG), the sensing layer adapted to bind or otherwise be selectively disturbed by one or more analytes, and to form an interferometer (¶ 84-89, 95-97; a reception REC is used to bind respective analytes for detection); (Claim 11) introducing a marker to the chip (¶ 142, 149).
Ymeti does not teach expressly wherein the one or more waveguide flow channels exhibiting a length of from about 1.0 mm to about 20 mm; a width of from about 0.1 mm to about 0.3 mm; and a depth of from about 0.0001 mm to about 0.0010 mm.
However, Ymeti does disclose adapting the dimensions of the structure according to the measurement applications and needs (¶ 84, 141). In addition, Ymeti insists on the use of such portable miniature measurement chip in microfluidic systems (¶ 60, 85, 138-144 for ex.), known for their millimeter to sub-micron dimensions (See references incorporated in ¶ 102 as evidence), which would suggest to one PHOSITA to adapt those dimensions, to match or overlap with the claimed dimension ranges, as a mere obvious practice since no specificities are presented with this claimed ranges, and since it has been held that where the general condition of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 23.
Therefore, it would have been obvious to one with ordinary skills in the art before the effective filing date of the instant application to use the apparatus of Ymeti so that wherein the one or more waveguide flow channels exhibiting a length of from about 1.0 mm to about 20 mm; a width of from about 0.1 mm to about 0.3 mm; and a depth of from about 0.0001 mm to about 0.0010 mm, with the advantage of effectively optimizing the optical measurements of the targeted analytes.
Moreover, Ymeti appears to teach/suggest:
(claims 2, 7) comprising at least two waveguide channels coated with the sensing layer and at least two waveguide channels not coated with the sensing layer; wherein the one or more waveguide channels each comprises a different sensing layer to allow the interferometric system comprising the chip to detect different analytes on each waveguide flow channel (¶ 59, 85-88, 102 for ex.)
(claim 3) further comprising a blocking coating (Figs. 1-2; 85-89 for ex.).
(claim 4/12) further comprising a marker physically positioned at an end portion of the substrate to provide orientation during assembly or analysis, the marker selected from the group consisting of a colorant, a cut edge, an etching, an affixed label, and any combination thereof (¶ 142, 149).
(Claim 5) wherein the substrate comprises at least one optical material (¶ 84 for ex.; substrate optical cladding).
(Claim 6) wherein the sensing layer comprises one or more proteins, enzymes, aptamers, peptides, nucleic acids, carbohydrates, lipids, or monomers and polymers, or whole cell microorganisms suitable for binding one or more analytes (¶ 49, 85-87 for ex.)
(Claim 17) wherein the blocking coating comprises at least one blocking protein or protein-based blocking reagent (¶ 105 for ex).
(Claim 18) wherein a blocking coating is applied to at least one external surface of the substrate and to at least one reference waveguide channel (Abstract,¶ 13, 18-21, 98-100, 105 for ex.).
(Claim 19) wherein each waveguide channel comprises a different sensing layer, and the chip is configured to be used in an interferometric system adapted to independently detect different analytes in parallel (fig. 2, ¶ 11, 34, 102, 106, 110 for ex.).
(Claim 20) wherein the chip comprises at least one measurement waveguide channel and at least two reference waveguide channels arranged to enable correction of drift during interferometric detection (¶ 97, 110 for ex.)
(Claim 21) further comprising a flow cell wafer positioned above the chip, wherein the flow cell comprises at least two detection microchannels, each adapted to communicate a test sample composition to one or more waveguide channels (Fig. 2, ¶ 97-101, 138-140 for ex).
(Claim 22) wherein each detection microchannel is formed by etching or molding a concave path into a surface of the flow cell wafer (Fig. 10, ¶ 59, 142).
(Claim 23) wherein each detection microchannel is arranged in a serpentine flow pattern positioned above parallel waveguide channels (Fig. 10 A-B).
8- Claims 13-16 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Ymeti in view of Paul et al. (PGPUB 20120263938)
As to claims 13-16, Ymeti teaches the interferometric chip method of claim 11.
Ymeti does not teach expressly wherein the step of coating the chip with a sensing layer is performed via a technique selected from the group consisting of micro-dripping, wick threading, inkjet printing, additive manufacturing, gravure printing, aerosol jet printing, spin-coating, dip- coating, silk screen application, felt marker application, and micro paintbrush application; (claim 14) wherein the micro-dripping utilizes one or more micro-pumps and, optionally, one or more nozzles in liquid communication with the one or more micro-pumps; (claim 15) further comprising the step of applying a waveguide channel coating to the one or more waveguide channels; (claim 16) wherein the waveguide channel coating comprises at least one metal oxide or metal dioxide.
However, in a similar field of endeavor of fabricating metal oxide films for biology and medicine applications, Paul teaches methods of producing porous metal oxide films using spray deposition (Abstract, ¶ 2 and Figs. 1-6) wherein the step of coating the chip with a sensing layer is performed via a technique selected from the group consisting of micro-dripping, wick threading, inkjet printing, additive manufacturing, gravure printing, aerosol jet printing, spin-coating, dip- coating, silk screen application, felt marker application, and micro paintbrush application; (claim 14) wherein the micro-dripping utilizes one or more micro-pumps and, optionally, one or more nozzles in liquid communication with the one or more micro-pumps; (claim 15) further comprising the step of applying a waveguide channel coating to the one or more waveguide channels; (claim 16) wherein the waveguide channel coating comprises at least one metal oxide or metal dioxide (¶3, 8-11, 26-27, 38-40).
Therefore, it would have been obvious to one with ordinary skills in the art before the effective filing date of the instant application to use the apparatus of Ymeti so that wherein the step of coating the chip with a sensing layer is performed via a technique selected from the group consisting of micro-dripping, wick threading, inkjet printing, additive manufacturing, gravure printing, aerosol jet printing, spin-coating, dip- coating, silk screen application, felt marker application, and micro paintbrush application; wherein the micro-dripping utilizes one or more micro-pumps and, optionally, one or more nozzles in liquid communication with the one or more micro-pumps; further comprising the step of applying a waveguide channel coating to the one or more waveguide channels; wherein the waveguide channel coating comprises at least one metal oxide or metal dioxide, with the advantage of effectively optimizing the manufacturing of the measuring system.
Conclusion
Helmers et al. “Performance of a compact, hybrid optical evanescent-wave sensor for chemical and biological applications”, APPLIED OPTICS @ Vol. 35, No. 4 @ 1 February 1996.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
The examiner has pointed out particular references contained in the prior art of record in the body of this action for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. Applicant should consider the entire prior art as applicable as to the limitations of the claims. It is respectfully requested from the applicant, in preparing the response, to consider fully the entire references as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED AMARA whose telephone number is (571)272-7847. The examiner can normally be reached on Monday-Friday: 9:00-17:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur Chowdhury can be reached on (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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/Mohamed K AMARA/
Primary Examiner, Art Unit 2877