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 1-5, 7-8, 10-11, 13-14 are under examination on the merits.
Claims 6, 9, 12 have been canceled.
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.
Claim 3 is 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. In claim 3, the phrase “ a factor of not less than 2 or not more than 0.5” does not make sense. It is unclear what factor is referred to and if applicant is referring to range in said phrase or not.
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.
Claim(s) 1-5, 7-8, 10-11, 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over JP 4796967 B2, 10/2011, see also its English translation thereof (attached), which will be used to cite relevant text.
Said Japanese patent teaches biomarkers in cerebrospinal fluid (CSF) for Alzheimer’s disease. In paragraph 10 of said translation document it is disclosed that Cystatin C, a cysteine protease inhibitor, is considered to be involved in neurodegeneration and the repair process of the nervous system, and in the different types of dementia, the deposition of the protein along with β-amyloid peptide is found as cerebral amyloid angiopathy (CAA).
In section IX. Paragraph 13, said patent discloses full-length cystatin C is believed to bind to human lysosomal proteases (eg, cathepsins B and L) and inhibit its activity.
In example 3, said patent discloses the following:
M12583.4 peptide has been identified as a truncated cystatin C peptide and has the sequence underlined in SEQ ID NO: 4. This truncated Cys-C, lacking the first 8 N-terminal residues, has a 20-fold lower affinity for cathepsin B, but not for other cathepsins. Cathepsin B plays a key role in AD. Cathepsin B is identified in many early Alzheimer's disease endosomes, but can also be detected in a small percentage of normal brain endosomes, (wherein said endosomes are extracellular vesicles). Said patent also mentions that it has been found that this truncated Cys-C is a biomarker for AD in both CSF and blood. This is the first time this 8aa N-terminal truncated version has been described in CSF or blood (which inherently has plasma therein).
Under Mode of invention, Example 1, discloses that Tau is also a marker for diagnosis of AD patients.
Therefore, given the above teachings, said patent clearly establishes the role of cathepsin B in detection and Alzheimer’s disease and its Tau pathogenic phase.
Therefore, when confronting a candidate AD patient, it would have been obvious to one ordinary skill in the art to take a blood (or plasma) sample of said patient and look for abnormal levels (lower/higher than normal levels) of cathpesin B therein relative to control. One of ordinary skill in the art will be motivated to measure and compare cathepsin B levels of patient’s sample relative to control because the above shown Japanese patent teaches that in AD patients (including those who are at Tau-pathogenic phase or neurodegenerative phase, truncated Cystatin C hardly allows the binding of Cathepsin B and result in its abnormal levels in blood/plasma endosomes relative to control, rendering this invention obvious.
Finally, one of ordinary skill in the art has a reasonable expectation of success in measuring the amount of cathepsin B accumulation in the endosomes of candidate AD patient and comparing said amount to control because such methods were fully established in the prior art before the effective filing of this application.
With respect to claims 8 and 11, it should be noted that one of ordinary skill in the art reasonably expects that the endosomes of said AD patients will have at least one of said proteins by inherency.
Regarding claim 14, considering the utility of Cathepsin B as a potential biomarker in diagnosis of AD, it is readily motivating to tone of ordinary skill to place said protease in a kit together with its assay reagents, rendering said claim also obvious.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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, Melenie L Gordon can be reached at 571-272-8037. 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.
/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651