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 .
Claims 12-22 are pending. Claims 1-11 have been cancelled.
Specification
The disclosure is objected to because of the following informalities:
a.) Paragraph [0001] on page 1 of the specification should be updated to reflect the parent application from which this application claims priority to as a CON.
Appropriate correction is required.
Claim Objections
Claim 14 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 13. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 12-22 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.
Claim 12 is vague. In line 6, the recitation of “wherein two or more of the fluid samples are configured to inject a fluid sample to a sensor surface or detection spot to enable parallel analysis” is confusing because it is not clear as to how a fluid sample can be configured to inject another fluid sample to a sensor surface or detection spot for parallel analysis.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 12-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,255,851. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of patent ‘851 anticipates the instant invention.
Patent ‘851 claims:
1. A method for evaluating an interaction between an analyte and a ligand immobilized on a sensor surface of a biosensor, comprising the steps of
providing a plurality of fluid samples, each containing known concentrations of analyte;
providing a plurality of needles placed above a plate having a plurality of wells arranged in rows and a plurality of sensor surfaces or detection spots, at least some of the sensor surfaces or detection spots having a known amount of ligand immobilized thereon, and each needle being configured to inject a fluid sample to a sensor surface or detection spots;
dividing said plurality of fluid samples into at least two groups, each group having a number of fluid samples corresponding to the number of needles;
injecting the fluid samples of a first of said groups to the sensor surfaces or detection spots by means of the needles to permit association of the analyte to the ligand;
monitoring each sensor surface or detection spot and collecting binding data; and
sequentially repeating the steps of injecting fluid samples to the sensor surfaces or detection spots and monitoring the detection spots and collecting binding data for each group of fluid samples,
wherein the steps above are performed sequentially, without intermediate regeneration or renewal of the immobilized ligand.
2. A method according to claim 1, wherein the plurality of fluid samples form a dilution series where each sample has a concentration of analyte that differs from all other samples.
3. A method according to claim 1, wherein the binding data collected at each sensor surface or detection spot is stored and/or displayed together as a binding curve.
4. A method according to claim 3, wherein a quality of a binding curve is determined based on total response or a predetermined value for the increase in response over the entire curve.
5. A method according to claim 3, wherein some sample binding curves can be removed so that remaining sample binding curves can be displayed together.
6. A method according to claim 1, wherein the amount of ligand immobilized on one sensor surfaces or detection spot differs from the amount of ligand immobilized on another sensor surface or detection spot.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,255,851 in view of Karlsson (US Patent 5,753,518).
Patent ‘851 differ from the instant invention in failing teach binding curve data measured in resonance unit (RU) over time.
Karlsson teaches binding curves generated from a SPR sensor with data measured in resonance units (RU) over time (Fig. 1 and Example 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have data measured in resonance units (RU) over time as taught by Karlsson in the method of patent ‘851 because Karlsson show it to be conventional have data measured in resonance units (RU) over time from SPR sensors which is the type of sensor used in patent ‘851. A person of ordinary skill in the art reasonably would have expected success because both Karlsson and patent ‘851 was using SPR sensors.
Allowable Subject Matter
Claims 20-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 20-22 are free of the prior art because the prior art fails to teach carrying out the steps recited in claim 20 with the method of claim 12.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
12/27/2025