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 .
Election/Restrictions
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 9, 2026.
Applicant traverses the Restriction Requirement on the grounds that the Restriction Requirement fails to comply with the express language of 35 U.S.C. § 121 (Remarks, pg. 11, par. 3 in section II).
Since the methods of claims 1 and 20 have similar steps of measuring increments in a signal and determining an analyte concentration of a sample based on these increments, they are similar to each other; therefore, the restriction requirement is withdrawn.
Claims 1-20 are pending and examined herein.
Specification
The abstract of the disclosure is objected to because it includes “can” in description of the method. A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. What the method “can” include is not a proper description of the invention.
The sentence “Other embodiments are disclosed” fails to describe the technical disclosure of the patent.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-20 are objected to because of the following:
All claims in the claim set submitted March 9, 2026 are marked with “Original” status. These claims are the same as claims submitted April, 3, 2023. The reason for adding “Original” status without amending, cancelling, or adding new claims is unclear. Claims review is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL. —The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 11 recite methods for determining an analyte concentration of the sample based at least in part on the increments in the response signal.
The claims do not recite any specific method for measuring the response signal. The specification discloses only surface plasmon resonance for measuring the response signal. No practical examples are disclosed for any other methods of measuring.
The methods as claimed are suitable for determining an analyte concentration only by surface plasmon resonance. Other approaches routinely used for analyte quantitation, such as ELISA, flow cytometry, proximity detection, electrochemical, or radioisotope methods are not capable of implementing the steps disclosed in claims 1 and 11.
The specification discloses only surface plasmon resonance, relies on its unique detection principle, and solves problems inherent only to surface plasmon resonance.
The prior art is silent on methods for determining an analyte concentration of the sample based at least in part on the increments in the response signal using surface plasmon resonance or other methods of measuring. Other methods cannot benefit from the claimed invention because only SPR can detect unlabeled analyte molecules without relying on intermediate washing steps.
Claims 2-10 and 12-19 are rejected because they depend from rejected claims 1 and 11.
Based on the above findings, one of ordinary skill in the art would conclude that Applicant did not have possession of the claimed invention at the time the application was originally filed.
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 6 and 16 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.
Claims 6 and 16 are unclear because they do not recite any method steps. The claims are indefinite because it is not apparent what limitations the claim language imposes on the claimed methods.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS. —Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 6 and 16 do not recite any method steps; therefore, they fail to further limit the subject matter of their respective parent claims 5 and 15.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Subject Matter Free of the Prior Art
Claims 1-19 are free of the prior art. Claim 20 is allowable.
The prior art neither teaches nor suggests determining analyte concentration in a sample based on increments in the response signal during multiple sample injection sessions without intermediate regeneration step.
The closest prior art teaches:
Karlsson et al. (PGPub 20140147937) - concentration of an analyte is determined by contacting a laminar flow of a sample with a plurality of solid phase surfaces or surface area supporting a ligand capable of specifically binding the analyte, each surface or surface area having a different ligand density (Abstract and [0092]).
Ly et al. (IDS; PGPub 20190302110) - injection of analyte over multiple sensing areas ([0030]).
Tang et al. (Anal Chem. 2006 Mar 15;78(6):1841-8), Mehand et al. (J Mol Recognit. 2012 Apr;25(4):208-15. 2012), Glanville et al. (US 11053304), and Barouch et al. (PGPub 20200055901) - traditional SPR experiments without multiple sample injections and increments measurements.
All the references above fail to teach measuring increments in the response signal during multiple sample injections without intermediate regeneration steps.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER ALEXANDROVIC VOLKOV/
Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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