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 .
DETAILED ACTION
Responsive to communications entered 24OCT2025
Claims pending 1,4,7,10-13,16-18,20-23,25-26,28-32
Claims currently under consideration 1,4,7,10-13,16-18,20-23,25-26,28-32
Priority
This application has a filing date of 03/14/2022 and is a 371 of
PCT/IB2020/059171 filed 09/30/2020
PCT/IB2020/059171 has PRO 62/970,977 filed 02/06/2020
PCT/IB2020/059171 has PRO 62/909,101 filed 10/01/2019
Withdrawn Objection(s) and/or Rejection(s)
The following rejection(s) are hereby withdrawn in view of applicant's amendments::
claims 1,20-22,30 under 35 U.S.C. 102(a)(1 & 2) as being anticipated by Fang et al (US AppPub 20050009204);
claims 4,7,10,31,32 under 35 U.S.C. 102(a)(1 & 2) as being anticipated by Heerding (US AppPub 20010014737); and
claims 1,20-22,30 & 4,7,10,31,32; 11-13,16,18,23,25,26 under 35 U.S.C. 103 as being unpatentable over either of Fang et al (US AppPub 20050009204) or Heerding (US AppPub 20010014737) each taken separately in view of Zhou et al (US AppPub 20040248323).
Maintained Claim Rejection(s) - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1,20,21,22,30 and 17,28,29 are rejected under 35 U.S.C. 103 as being unpatentable over either of Fang et al (US AppPub 20050009204) in view of Barrio et al (US 6274119).
Fang et al teach throughout the document and especially the abstract, microarray and methods therewith, for multiplexed drug target (pathological) protein binding assays using a cocktail solution of labeled ligands. More particularly, in figures 2,8,9 and paragraph 0026 taken with document claims 1-9, Fang et al performs a saturation binding assay (Scatchard analysis) that, as evidenced by Motulsky et al (2010 Current Protocols in Neuroscience 52 unit 7.5; of record) in sections 7.5.3-7.5.9, inherently: contacts at least 1 aliquot of an enriched biological sample protein on a microarray bearing at least 5 chambers with a cold test ligand at saturating fixed concentration; contacts the protein with a radiolabeled test ligand at multiple concentrations to form a radiolabeled complex between the radiolabeled test ligand and the protein in each aliquot; elutes unbound radiolabeled test ligand from the aliquots; detects a signal from the radiolabeled test ligand in the radiolabeled complex in each aliquot; and finally calculates Kd from such detected signals in each aliquot, thereby reading on present claim 1 (in part),20,21,22 and 30.
Fang et al do not teach immobilization of a dried pathological protein such as Abeta (beta amyloid) or Tau per claims 17,28 and 29; nor an enriched human brain sample thereof from a patient suffering from or a deceased patient who suffered from a neurodegenerative disease and a pathological protein being associated with a neurodegenerative disease of claim 1.
Barrio et al disclose throughout the document and especially the abstract figures 1 and 5 (including legends) 2-(1,1-dicyanopropen-2-yl)-6-dimethylaminonaphthalene (DDNP) analogs as labels for beta amyloid plaques that are present in the brains of Alzheimer’s (neurodegenerative) disease patients. More particularly, in column 19 lines 6-11, Barrio et al teach drying beta amyloid on a slide like claims 17, 28 and 29 or else rehydration of a (necessarily dry) amyloid beta and Tau enriched brain tissue section from such a patient. See also column 1.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have analyzed beta amyloid plaque binding of DDNP as advocated by Barrio et al using Scatchard analysis of Fang et al.
One of ordinary skill in the art would have been motivated to have analyzed beta amyloid plaque binding of DDNP as advocated by Barrio et al using Scatchard analysis of Fang et al in an effort to better characterize such binding regarding, for instance, stoichiometry and/or being specific or not: as interpreted in MPEP 2141 section III (C) the Supreme Court held under KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385, 1396 (2007) the use of a known technique to improve similar methods in the same way is obvious.
One of ordinary skill in the art would have had a reasonable expectation of success in applying the technique of Scatchard analysis employed by Fang et al toward characterizing DDNP binding to beta amyloid since such technique is exceedingly well recognized in the art as robust, having been used for almost a century.
***
Please note that the above rejection has been updated from the original version to more clearly address applicants’ newly amended and/or added claims and/or arguments.
Response to Arguments
The remarks accompanying the present response argue not all elements are taught.
Applicant’s arguments have been fully considered but they are not deemed persuasive for the following reasons.
More specifically, in the pertinent section at p 13 the current remarks assert Barrio does not suggest an enriched human brain sample derived from a patient suffering from or a deceased patient who suffered from a neurodegenerative disease and a pathological protein is associated with a neurodegenerative disease, alleging the Barrio reference only discloses experiments with amyloid beta injected into rat brains.
In this vein, as noted in the above updated rejection, while the rat brain experiment is shown in figure 2, Applicant’s attention is again respectfully invited to figure 1, particularly panels A-C as well as figure 5 and the figures’ respective legends at column 5 lines 7-62 Barrio column 19 line 9, especially with column 1 that indeed disclose suggest rehydrated amyloid beta (and Tau) positive brain tissue sections from a human patient that suffered from Alzheimer’s, a neurodegenerative disease. Such human brain sections are depicted in said figures and plainly at least suggesting the enriched brain sample set forth in claim 1 as now amended.
New 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 1,4,7,10-13,16-18,20-23,25-26,28-32 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, each of claims 1,4 and 7 recite the broad recitation “wherein the enriched biological sample is derived from a human biological sample from a patient suffering from or a deceased patient who suffered from a neurodegenerative disease” and the claims also recite “wherein the human biological sample is a brain sample” which is the narrower statement of the limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In other words, concerning claims 1,4 and 7, paragraph 0007 of the present published application specifies “The... assays described herein allow for characterization of binding of ligands to low-abundance proteins such as those derived from brain or other patient tissues or fluids”. Consequently, it is unclear if claims 1, 4 and 7 encompass proteins derived only from a human patient brain or whether other tissues or fluids are included as well, thereby rendering the metes and bounds of the claimed subject matter uncertain.
In accordance with MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
In so far as the metes and bounds of the offending claim(s) may not be interpreted properly for the reasons above, all dependent claims therefrom claim 1,4 and 7 are rejected as being indefinite as well.
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 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTOPHER M GROSS/
Primary Examiner, Art Unit 1684
6FEB2026