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 .
Remarks\
This Office Action fully acknowledges Applicant’s remarks filed on July 2nd, 2026. Claims 6-16, and 20-24 are pending. Claims 1-5 and 17-19 are canceled. Claims 21-24 are newly added. Claims 11-16 and 20 are withdrawn from consideration. Claims 6-10 and 21-24 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 6-10, and 21-24, in the reply filed on July 2nd, 2026 is acknowledged.
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 applicant regards as his invention.
Claims 7 and 8 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.
The sought additional, positive component(s) to the detection system by the recitation “…wherein different to-be-detected biomolecules correspond to different encoded luminescent substance pairs…” are indefinitely defined herein.
As likewise noted in the recitation itself, the “different to be-detected biomolecules” are not positive elements of the detection system but are drawn to prospective workpieces.
The claims system by way of claim 1 is drawn to Component A: Detection particles [comprising 1-microcarrier with encoding and 2-detection microparticles) and Component B: Matching microparticles.
Does Applicant intend to further limit the subject matter of either of these components, or does Applicant intend to introduce a third separate, and distinct component C to the system?
For purposes of Examination, these elements are taken as prospective workpieces for use with the system.
It is also noted that the subsequent recitation that follows the above discussion is unclear given the initial establishment being indefinitely defined, and wherein the recitation “the encoded luminescent substance pair” lacks proper antecedent basis in the claims, wherein the claim previously establishes “different luminescent substance pairs.”
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.
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.
Claim(s) 6, 9, 10, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN-102243165 (in view of the English translation provided by Applicant in the IDS of 08/25/2022), hereafter CN-1022, in view of Ullman et al. (USPN 6,251,581), hereafter Ullman.
With regard to claim 6, CN-1022 discloses a photonic crystal encoded microsphere biochip multiplex detection device, comprising a detection dark room and a light source, wherein a photonic crystal encoded microsphere biochip is provided in the detection dark room, and the biochip comprises a plurality of detection particles each comprising a microcarrier (as in photonic crystal microsphere with an encoding functionality; and being non-magnetic as in cl. 21), and a connected target molecule specific biological molecular probes (constituting detection microparticles as claimed). When the probe binds to a target molecule, the presence of the target molecule can be determined from the fluorescence of the signal molecules (see description, paragraphs [0006] to [0020]; and claims 1-10 of English translation provided). With regard to claim 9, CN-1022 discloses the system further comprises a fluorescence microscope 5 with a camera or photographic function (claim 1 of English translation, for example). With regard to claim 10, CN-1022 discloses the system further comprises an imaging processing device as in control device 3 for controlling the optical imaging system in constitution with a CCD image sensor for converting the image signal into a digital signal (claim 4 of the English translation).
With regard to claim 6, CN-1022 does not specifically disclose that the detection microparticles connected to the microcarrier are suited to detection by light initiated
chemiluminescence assay and CN-1022 does not specifically disclose matching microparticles wherein the matching microparticles are light-initiated chemiluminescence microparticles matched to the detection microparticles as claimed.
This is similarly seen with respect to claim 21, in which CN-1022 does not specifically disclose item b.
Ullman discloses assays utilizing photoactivated chemiluminescent labels (abstract; lines 2-24, col. 7). Ullman discloses that the chemiluminescent compound is associated with a specific binding pair and the suspended particle comprises a photosensitizer and has a specific binding pair bound thereto (line 54, col. 4 – line 30, col. 5). Ullman further discloses that the photosensitizer (i.e. donor as in cl. 21) and chemiluminescent compound (i.e. acceptor as in cl. 21) can be linked with particles such as in latex particles, liposomes, etc… for linking the specific binding partner (and provided as matching to one another for such specific binding; lines 54-64, col. 16, lines 14-24, col. 21; line 6, col. 32 – line 67, col. 34, for example).
It would have been obvious to one of ordinary skill in the art to modify CN-1022 to provide detection microparticles that are suitable for light-initiated chemiluminescence detection, and as in donor or acceptor microparticles as in cl. 21, and matching microparticles that are light-initiated chemiluminescent particles matched with the detection particles such as suggested by the analogous art of Ullman to methods for determining an analyte in a medium utilizing two types of suspended particles with specific binding partners connected thereto in which a provision to light-induced chemiluminescence as a as opposed to biological probes for giving a fluorescence emission concordant to an analyte’s bound presence represents an obvious analogue that would have a reasonable expectation of success therein CN-1022 for a likewise desired purpose of optical analyte detection through specific binding.
With regard to claim 9, CN-1022 discloses an optical imaging system comprising a light source, but does not specifically disclose a second light source for the light-initiated chemiluminescent signal.
However, it would have been obvious to one of ordinary skill in the art to modify CN-1022 and by way of the teachings of Ullman wherein the chemiluminescent compound/sensitizers are selected to interact at particular wavelengths wherein provision to an additional, second light source for the light-initiated chemiluminescence signal represents an obvious engineering modification for the purpose of providing an added, active light source to be tuned to the desired wavelength for the photoactivated chemiluminescent interrogation so as to properly and discretely optically investigate for a bound analyte.
Claim(s) 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN-1022 in view of Ullman as applied to claims 6, 9, 10, and 21 above, and further in view of De Geest et al. (US 2010/0081215), hereafter De Geest.
CN-1022/Ullman does not specifically disclose that a surface of the microcarrier with the encoding function is covered by a polyelectrolyte shell layer as in claims 22-24.
De Geest discloses coatings for microcarriers, wherein the core of the microcarrier is provided with a code (abstract). De Geest discloses that the micocarrier has a core coated with at least one layer of polyelectrolyte material wherein the coating makes the microcarriers suitable for high throughput assays in which the coating ensures the binding of probes to the surface is optimized (pars.[0006,0009,0027], for example).
It would have been obvious to one of ordinary skill in the art to modify CN-1022/Ullman to provide the microcarrier with the encoding function with a surface covered by a polyelectrolyte layer such as suggested by the analogous art of De Geest to a microcarrier with a code and utilizing in binding assays in which the polyelectrolyte layer provides the recognized benefit of realizing microcarriers suitable for high throughput assays in which the coating ensures the binding of probes to the surface is optimized as would be likewise appreciated in CN-1022/Ullman.
Further, with regard to claims 23 and 24, it is noted that the recitation of claim 23 “…is formed by self-assembly…” is drawn to a product-by-process recitation, in which remains drawn to the product/structure itself. . [Further, the added stipulations in claim 24 are further provisions to the components of the product-by-process recitation, in which it remains that the recitation is to the product of the polyelectrolyte shell]
See MPEP 2113.
As discussed above, CN-1022 in view of De Geest discloses such a product in that of a polyelectrolyte shell layer and claims 23 and 24 remain unpatentable for likewise reasons as discussed above in claim 22.
Allowable Subject Matter
Claims 7 and 8 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior of record does not teach or suggest, as best understood herein, the biomolecule multiplex detection system of claim 7, and thus that of claim 8 given its interdependency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Singh et al. (USPN 6,703,248) discloses particles for diagnostic and therapeutic use in specific binding assays that is relevant to Applicant’s field of endeavor.
True (US 2009/0149340) discloses encoded microparticles including the use of fluorescence quantitation in specific binding that is relevant to Applicant’s field of endeavor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/Primary Examiner, Art Unit 1798
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