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 .
The Art Unit location of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Art Unit 1656 and Examiner Erica Jones-Foster.
Applicants’ amendment to the claims filed on 9/2/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-17 are pending.
Priority
Acknowledgement is made of applicants’ claimed domestic priority to U.S. provisional application 63/487,962, filed on 3/2/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/4/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The Drawings filed on 3/4/2024 are acknowledged and accepted by the Examiner.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 14-17) in the reply filed on 9/2/2026 is acknowledged.
Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 14-17 are pending and examined on the merits.
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 14-17 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 term “about” in claims 14 (claims 16-17 dependent thereof), 15 is a relative term which renders the claim indefinite. The term “about” is not defined by the specification. There is no one for one to ascertain what the recitation ‘a KD of less than about 15 µM’ (instant application claim 14) and ‘a KD of between about 0.1 µM and about 15 µM’ encompasses. Appropriate correction is suggested.
Claim 14 (claims 15-17 dependent thereof) recite the phrase ‘‘a KD of less than about 15 µM’.” The phrase " less than about " is a relative phrase which renders the claim indefinite. The phrase " less than about " is a term of degree, and there is no indication what the percentage is being compared. Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from the claims. It is suggested that applicant clarify the meaning of the claims. See Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. §112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162 (Feb. 9, 2011), page 7165.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 14-15, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Moya et al (WO2022189801A1, Date of Publication: 15 September 2022, Examiner cited) {herein Moya}, in view of Maliki et al (2017, The FEBS Journal, Examiner cited) {herein Maliki) and Kojima et al (Date of Publication: 14 October 2004, The EMBO Journal, Examiner cited) {herein Kojima}.
Claims 14-15, 17 are drawn to a method for identifying a candidate therapeutic for treating Alzheimer's disease, the method comprising: determining an equilibrium dissociation constant (KD) between an analyte and an isolated protein, wherein the isolated protein comprises a sequence having at least 95% identity to SEQ ID NO: 1; wherein a KD of less than about 15 µM identifies the analyte as a candidate therapeutic.
With respect to claims 14-15, Moya teaches a method wherein an affinity peptide sequence that is 100% identical to the instant application SEQ ID NO: 1 (BIN1 SH3) is attached to a capsid protein for the amplified detection of corresponding analyte from a biological sample (page 19, lines 7-8; page 19, lines 14-15; page 20, lines 8-10; page 21, line 1; page 21, lines 18-25; page 23, line 7; appendix A). A second capsid, upon which the first capsid is configured to bind, is capable of wicking across a lateral flow device comprising a solid support and a lateral flow assay test strip (page 22, lines 20-25), thereby allowing the analyte specific to the capsid to bind to the first capsid (page 23, lines 9-11). Said method allows for the detection and monitoring of analytes related to the human physiological condition (page 2, line 25). As such, it would be obvious to one of ordinary skill that Moya could identify ‘candidate therapeutics’ for treating Alzheimer’s as Moya explicitly teaches the well-known peptide BIN1 SH3 (instant application SEQ ID NO: 1, which is 100% identical to SEQ ID NO: 31 (taught by Moya), appendix A) is attached to a capsid protein for the detection of analytes related to human physiological condition (page 19, lines 7-8; page 19, lines 14-15; page 20, lines 8-10; page 21, line 1; page 21, lines 18-25; page 23, line 7; appendix A). Since Alzheimer’s is a physical, neurodegenerative brain disorder that damages and destroys brain cells over time, It is the Examiner’s position that the teaching of the detection of analytes related to human physiological conditions by Moya include Alzheimer’s.
However, Moya does not teach a method wherein a KD of less than about 15 µM identifies the analyte as a candidate therapeutic (claim 14). Moya does not teach the method of claim 14, wherein the analyte is a chemical compound (claim 17).
With respect to claims 14-15, 17, Malki teaches a method wherein Tau is a well-known analyte of BIN1 SH3 (instant application SEQ ID NO: 1, abstract). Furthermore, Kojima teaches phosphoinositides are chemical analytes and have a high affinity for B1N1 SH3 (abstract), as recited in the instant application claim 17. Therefore, it would be obvious to one of ordinary skill in that art that Tau and/or phosphoinositides would be a ‘candidate therapeutic’ for treating Alzheimer’s as it is a well-known analyte of the instant application SEQ ID NO: 1, B1N1 SH3, and is taught by Moya et al. Nevertheless, Maliki further teaches that the SH3 domain of BIN1 readily interact with Tau, forming a complex (abstract). The KD of the Tau and BIN1-SH3 is between 12µM to 15µM (page 3223, column 1, para 1). As such, it is the Examiner’s position that Tau is a ‘candidate’ therapeutic for treating Alzheimer’s disease as one of ordinary skill in the art would have a reasonable expectation of success that a capsid protein with an affinity peptide of BIN1 SH3 (instant application SEQ ID NO: 1; Moya SEQ ID NO: 31) would bind an Alzheimer’s analyte such as Tau as Maliki teaches the binding of BIN1 SH3 and Tau is well-known in the art and has a high affinity with a KD between 12µM to 15µM. Since Maliki teaches the binding of BIN1 SH3 and Tau has a KD between 12µM to 15µM, it is the Examiner’s position that said binding would necessarily identify Tau as a candidate therapeutic as recited in the instant application claim 15 as targeting Tau in the body could slow the cognitive decline in Alzheimer’s as Maliki teaches BIN1 might modulate the pathophysiological process involving Tau which is the leading cause of neurodegeneration (page 3219, column 2, para 1). Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Moya et al (WO2022189801A1, Date of Publication: 15 September 2022, Examiner cited) {herein Moya}, in view of Maliki et al (2017, The FEBS Journal, Examiner cited) {herein Maliki) and Kojima et al (Date of Publication: 14 October 2004, The EMBO Journal, Examiner cited) {herein Kojima} as applied to claims 14-15, 17, in further view of Myszka et al (Date of Publication: 2003, Drug Discovery, Examiner cited) {herein Myszka}.
Claim 16 is drawn to the method of claim 14, wherein the step of determining the KD is done by surface plasmon resonance.
However, Moya in view of Maliki do not teach wherein the step of determining the KD is done by surface plasmon resonance (claim 16).
With respect to claim 16, Myszka teaches a method wherein surface plasmon resonance (SPR) is used to measure the binding using label-fee, real-time measurements (page 2, para 1).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Moya et al of a method wherein an affinity peptide sequence that is 100% identical to the instant application SEQ ID NO: 1 is attached to a capsid protein for the amplified detection of corresponding analyte from a biological sample (page 19, lines 7-8; page 19, lines 14-15; page 20, lines 8-10; page 21, line 1; page 21, lines 18-25; page 23, line 7; appendix A) or combine the teaching of Myszka and Kojima because Kojima teaches phosphoinositides are chemical analytes that have a high affinity for B1N1 SH3 (abstract), a peptide associated with Alzheimer’s disease. Whereas, Maliki teaches a method wherein Tau is also a well-known analyte of BIN1 SH3 (abstract).
One of ordinary skill in the art would be motivated to either use the teachings of Moya et al. by itself or combine the teachings of Maliki and Kojima because Maliki provides the motivation for Moya in view of Malaki to substitute the method of using NMR (Malaki: page 3219, column 1 para 2) to measure the equilibrium constant between Tau (Alzheimer’s analyte) and B1N1 SH3 (instant application SEQ ID NO: 1 and Moya: SEQ ID NO: 31, appendix A) for SPR as Myszka teaches SPR measures KD in real time and provides full kinetic rates, whereas NMR is well-known in the industry to require complex titration experiments and is better suited for qualitative screening (Myszka: page 2, para 1; page 3, para 2). Therefore, one of ordinary skill in the art would have a reasonable expectation of success that substituting NMR for SPR would result in a more accurate, significantly lower (stronger), and fully resolved KD value when dealing with a tight-binding interaction as what is taught by Moya in view of Maliki.
One of skill in the art would have a reasonable expectation of success to make and use the claimed method for identifying a candidate therapeutic for treating Alzheimer's disease because Moya provides the basic method and its uses. Malki teaches a method wherein Tau is a well-known analyte of BIN1 SH3 (abstract). Whereas Kojima teaches phosphoinositides (chemical analyte) have a high affinity for B1N1 SH3 (abstract). Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Status of Claims
Claims 14-17 are pending
Claims 1-13 stand withdrawn pursuant to 37 CFR 1.142(b).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Appendix A
Instant application SEQ ID NO: 1 vs Moya et al SEQ ID NO: 31 (STIC search result No. 1 .rag)
Query Match 100.0%; Score 443; Length 81;
Best Local Similarity 100.0%;
Matches 81; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GRLDLPPGFMFKVQAQHDYTATDTDELQLKAGDVVLVIPFQNPEEQDEGWLMGVKESDWN 60
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Db 1 GRLDLPPGFMFKVQAQHDYTATDTDELQLKAGDVVLVIPFQNPEEQDEGWLMGVKESDWN 60
Qy 61 QHKELEKCRGVFPENFTERVP 81
|||||||||||||||||||||
Db 61 QHKELEKCRGVFPENFTERVP 81
Prosecution Insights