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 .
Status of Application, Amendments and/or Claims
1. Claims 1-21 are pending and under examination in the present application.
Information Disclosure Statement
2. The information disclosure statements (IDSs) filed 04/12/2021 have been considered and the references therein are of record.
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.
3. Claims 1, 4-14 and 17-21 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 1 and 14 each recite an anti-Tau antibody in which “the amino acid sequence of HCDR3 is given by SEQ ID NO: 75”. However, according to the sequence listing, SEQ ID NO: 75 is a light chain variable region (LCVR) sequence that is 112 amino acids in length. See also claims 2 and 15, which recite that the LCVR of the anti-tau antibody is given by SEQ ID NO: 75. Within this HCVR sequence of SEQ ID NO: 76, it would appear that SEQ ID NO: 74 is the HCDR3. However, given the currently recited sequence, it is unclear how an HCDR sequence can comprise a LCVR sequence. The metes and bounds of the claims are thus indefinite.
Dependent claims 4-13 and 17-21 are included in this rejection as they contain all of the limitations of independent claims 1 and 14, yet nothing in addition that would aid in clarifying the issue. combined
Claim Rejections - 35 USC § 103
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. Claims 1-21 is/are rejected under 35 U.S.C. 103 as being obvious over Adolfsson et al. (WO 2016/196726 A1) in view of Holtzman et al. (US 7,195,761 B2) and Hayashi et al. (US 2016/0251420 A1; filed 02/18/2016 with benefit to earlier priority).
The applied reference (US 2016/0251420 A1) has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claim interpretation: For the purpose of applying prior art, the HCDR3 of claims 1 and 14 will be interpreted as being SEQ ID NO: 74 instead of the recited SEQ ID NO: 75. See rejection at section 3 above.
Adolfsson et al. teach anti-Tau antibodies, and pharmaceutical formulations thereof, and the use of the antibodies in the treatment of a tauopathy, such as Alzheimer’s disease (AD), comprising administering an anti-tau antibody (see [0027]-[0030]). Adolfsson teaches that the therapeutic method may comprise administering the anti-tau antibody in combination with at least one additional therapy, such as other anti-Tau antibodies or antibodies against amyloid-beta (Abeta or Ab) ([0035]). Such a method is on point to the patient of present claim 1, because AD is a disease characterized by the both the formation of amyloid plaques and aberrant tau aggregation, as well as the therapeutic method of claim 1, which comprises treatment with a combination of an anti-Tau antibody and an anti-Ab antibody.
Adolfsson discloses that in the combined administration of two or more therapeutic agents, administration of the anti-Tau antibody can occur prior to, simultaneously, and/or following administration of the additional therapeutic agent or agents ([00356]), which addresses limitations of present claim 12 (the anti-Ab antibody and the anti-Tau antibody are administered simultaneously) and claim 13 (the anti-Ab antibody is administered prior to the administration of the anti-Tau antibody).
Regarding claim 11, Adolfsson teaches that treatment of AD includes treatment of patients having mild AD, moderate AD, mild to moderate AD ([00104]-[00106]) or prodromal AD ([00333]).
Regarding claim 14, a pharmaceutical formulation comprising an anti-Tau antibody is taught to include pharmaceutically acceptable carriers, diluents, and/or excipients ([00326]).
Finally, Adolfsson discloses that an anti-Abeta antibody that may be administered with the anti-Tau antibody can be solanezumab ([00352]), which is the humanized version of the anti-Abeta antibody 266 (hu266).
Thus, while Adolfsson teaches a method for treating a patient having AD comprising administering a combination of an anti-Tau antibody and an anti-Abeta antibody, the prior art reference does not explicitly teach the CDR, LCVR, HCVR, LC and HC amino acid sequences of anti-Abeta antibody of present claims 4-8 and 17-21, nor does the reference teach the anti-Tau antibody of claims 1-3 and 14-16.
Holtzman et al. teach humanized anti-Ab antibody 266 (hu266) and its therapeutic use in the treatment of AD (col. 1 lines 18-27; paragraph spanning cols. 3-4). The hu266 antibody of Holtzman comprises the identical LCVR, HCVR, HC and LC sequences of the present claims, as described below with their corresponding sequence identification numbers (SEQ ID NOs):
Antibody
LCVR
HCVR
Light chain (LC)
Heavy chain (HC)
Instant application anti-Ab Ab
47
48
49
50
Holtzman’s hu266
9
10
11
12
Because Holtzman teaches the identical LCVR, HCVR, LC and HC amino acid sequences of instant claims 6-8 and 19-21, the CDR amino acid sequences of instant SEQ ID NOs: 39-44 as in claims 4 and 17 would also be identical because they are comprised by the longer LCVR, HCVR, LC and HC sequences. See also column 10 of Holtzman, which teaches the hu266 CDR sequences (SEQ ID NOs: 1-6), which are identical to the instant sequences of SEQ ID NOs: 39-44.
Holtzman further teaches the identical potential Xaa substitutions to the LCVR and HCVR framework regions as recited in present claims 5 and 18, for example at col. 11 lines 1-11, col. 12 lines 3-11, and col. 13 line 1.
Finally, Holtzman discloses that the humanized anti-Abeta antibodies may be used in the treatment of clinical or pre-clinical AD (col. 3 lines 55-56), which addresses present claim 10.
In summary, although not explicitly called by its commercial name, the humanized anti-Abeta antibody disclosed by Holtzman is solanezumab.
Hayashi et al. teach anti-Tau antibodies and their use in the treatment of AD (see abstract). In particular, Hayashi teaches an anti-Tau antibody that comprises identical CDR, LCVR, HCVR, LC and HC amino acid sequences as the present claims, as shown with their sequence identification numbers (SEQ ID NOs) here:
Antibody
LCVR
HCVR
Light chain (LC)
Heavy chain (HC)
Instant application anti-Tau Ab
75
76
67
68
Hayashi’s anti-Tau Ab
9
10
1
2
Hayashi also teaches pharmaceutical compositions comprising the anti-Tau antibody, which composition comprises one or more pharmaceutically acceptable carriers, diluents or excipients ([0007]), which is on point to the pharmaceutical composition of present claim 14.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have used a combination of one or more anti-Tau antibodies and an anti-Abeta antibody such as solanezumab (the antibody of Holtzman) for the treatment of a patient having Alzheimer’s disease, as taught by Adolfsson, and thereby arrive at the presently claimed invention. In particular, Adolfsson expresses teaches that a combination of one or more anti-Tau antibodies could be used in combination with an anti-Abeta antibody. Thus the anti-Tau antibody of Adolfsson, the anti-Tau antibody of Hayashi, and the anti-Abeta antibody of Holtzman could all be used in combination for the treatment of a patient having AD. MPEP § 2144.06, section I, states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). In the instant case, all of the antibodies are taught to be useful for the treatment of AD, and thus their combined therapeutic use would have been obvious.
Alternatively, it would have been obvious to have substituted the anti-Tau antibody of Adolfsson for the anti-Tau antibody of Hayashi, in combination with the anti-Abeta antibody Holtzman, according to the express suggestion of Adolfsson, and thereby arrive at the presently claimed invention. This is because the artisan has good reason to pursue the known options within his or her technical grasp to obtain predictable results. Such would amount to the simple substitution of one known functional equivalent for another (i.e., one anti-Tau antibody for another) to yield a predictable outcome.
Conclusion
5. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly A. Ballard whose telephone number is (571)272-2150. The examiner can normally be reached Mon-Fri 8AM - 5PM EST.
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, Jeffrey Stucker can be reached at 571-272-0911. 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.
/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675