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 .
Applicant’s preliminary amendment filed on November 17, 2022 is acknowledged. Claims 1-4, 7-9, 13, 14, 17, 20, 21, 29-36, and 39 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 17, 2022 has been considered by the examiner.
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.
Claim 32 is 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.
Claim 32 is drawn to the claimed method wherein the antigen sample is a zika virus antigen and antibody 1 binds to amino acid E370 of SEQ ID NO: 1 and antibody 2 binds to amino acids T397 and H398 of SEQ ID NO: 1.
The claim is rejected because there is a lack of structure and function correlation between the antigen and the antibodies binding an amino acid E370 or T397 of SEQ ID NO: 1.
The antibodies required in the presently claimed method are not sufficiently described by requiring only one amino acid within SEQ ID NO: 1.
Applicant Specification and claims 33-36 describe the antibodies used in the claimed method, wherein the antibodies comprise the entire antigen binding region. However, present claim 32 describes the antibodies solely by the antigen to which the antibodies should bind. Amending claim 32 to recite either the heavy or light variable chain of the of each of the antibodies required in the claimed method would help overcome the present rejection.
The present claims are rejected for lack of written description support for the reasons discussed above.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7-9, 13, 14, and 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Liu et al. (Clinica Chimica Acta, 2013, p. 139-144).
Liu et al. disclose a method for detecting a signal indicative of the potency in the sample such as the hepatitis B virus vaccine sample comprising providing a kit comprising an acceptor kit and a donor kit, the acceptor kit comprising an amount of an acceptor microsphere and an amount of an acceptor antibody and the donor kit comprising an amount of a donor microsphere and an amount of a donor antibody, wherein the acceptor microsphere is capable to accept energy which is transferred in a proximity reaction to produce a signal and is capable of binding or is bound to the constant region of the acceptor antibody and is not capable of binding to the donor antibody, the acceptor antibody has a variable region which is capable of binding to one of the at least two epitopes of the antigen and a constant region which is capable of binding or is bound to said acceptor microsphere, wherein the acceptor antibody is not capable of binding to the donor microsphere, the donor microsphere is capable to donate energy which is transferred in a proximity reaction to produce a signal by the acceptor microsphere and is capable of binding or is bound to the constant region of the donor antibody and is not capable of binding to the acceptor antibody, and the donor antibody has a variable region which is capable of binding to the other of the at least two epitopes of the antigen and a constant region which is capable of binding to said donor microsphere, wherein the donor antibody is not capable of binding to the acceptor microsphere, and Step 2: contacting the amount of said donor microsphere, the amount of said acceptor microsphere, the amount of said donor antibody and the amount of said acceptor antibody of step 1 with the sample to allow forming a complex of the antigen in the sample with the donor antibody bound to the donor microsphere and the acceptor antibody bound to the acceptor microsphere and the acceptor antibody bound to one of the at least two epitopes of the antigen and the donor antibody bound to the other of the at least two epitopes of the antigen, Step 3: conducting a proximity reaction to produce a signal indicative for the potency of the antigen sample, and Step 4: detecting the signal indicative for the potency of the antigen sample (see Materials and Methods, Results, and Figure 1).
Thus, by this disclosure Liu anticipate the present claims.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-4, 7-9, 13, 14, 17, 20, 21, 29-32, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (Clinica Chimica Acta, 2013, p. 139-144) in view of Yu e al. (US Patent 10,967,057).
Liu teaches the claimed invention as discussed above. They do not teach the antigen being a zika virus antigen and the donor and acceptor antibodies providing an EC50 value towards the zika virus antigen of less than 100 ng/mL, or less than 80 ng/mL, or less than 60 ng/mL, or less than 40 ng/mL, or less than 30 ng/mL.
Regarding present claims 29 and 30, Yu teaches methods of inducing and immune response and detecting Zika virus and teaches a Zika virus sequence identical with present SEQ ID NO: 1 (see SEQ ID NO: 62 in Yu) and the sequence alignment below).
Present SEQ ID NO: 1 and SEQ ID NO: 62 in Yu.
Query Match 100.0%; Score 2667; Length 505;
Best Local Similarity 100.0%;
Matches 504; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 IRCIGVSNRDFVEGMSGGTWVDVVLEHGGCVTVMAQDKPTVDIELVTTTVSNMAEVRSYC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 IRCIGVSNRDFVEGMSGGTWVDVVLEHGGCVTVMAQDKPTVDIELVTTTVSNMAEVRSYC 60
Qy 61 YEASISDMASDSRCPTQGEAYLDKQSDTQYVCKRTLVDRGWGNGCGLFGKGSLVTCAKFA
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YEASISDMASDSRCPTQGEAYLDKQSDTQYVCKRTLVDRGWGNGCGLFGKGSLVTCAKFA 120
Qy 121 CSKKMTGKSIQPENLEYRIMLSVHGSQHSGMIVNDTGHETDENRAKVEITPNSPRAEATL
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 CSKKMTGKSIQPENLEYRIMLSVHGSQHSGMIVNDTGHETDENRAKVEITPNSPRAEATL 180
Qy 181 GGFGSLGLDCEPRTGLDFSDLYYLTMNNKHWLVHKEWFHDIPLPWHAGADTGTPHWNNKE
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GGFGSLGLDCEPRTGLDFSDLYYLTMNNKHWLVHKEWFHDIPLPWHAGADTGTPHWNNKE 240
Qy 241 ALVEFKDAHAKRQTVVVLGSQEGAVHTALAGALEAEMDGAKGRLSSGHLKCRLKMDKLRL
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ALVEFKDAHAKRQTVVVLGSQEGAVHTALAGALEAEMDGAKGRLSSGHLKCRLKMDKLRL 300
Qy 301 KGVSYSLCTAAFTFTKIPAETLHGTVTVEVQYAGTDGPCKVPAQMAVDMQTLTPVGRLIT
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 KGVSYSLCTAAFTFTKIPAETLHGTVTVEVQYAGTDGPCKVPAQMAVDMQTLTPVGRLIT 360
Qy 361 ANPVITESTENSKMMLELDPPFGDSYIVIGVGEKKITHHWHRSGSTIGKAFEATVRGAKR
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 ANPVITESTENSKMMLELDPPFGDSYIVIGVGEKKITHHWHRSGSTIGKAFEATVRGAKR 420
Qy 421 MAVLGDTAWDFGSVGGALNSLGKGIHQIFGAAFKSLFGGMSWFSQILIGTLLMWLGLNTK
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 MAVLGDTAWDFGSVGGALNSLGKGIHQIFGAAFKSLFGGMSWFSQILIGTLLMWLGLNTK 480
Qy 481 NGSISLMCLALGGVLIFLSTAVSA 504
||||||||||||||||||||||||
Db 481 NGSISLMCLALGGVLIFLSTAVSA 504
It would have been prima facie obvious to provide use the method of Liu in order to detect the Zika virus antigen of Yu because Liu teaches that his method uses a shorter incubation time and an easier protocol than the ELISA protocol and Yu teaches that the Alphalisa technology using a bead-based method has multiple advantages over the standard ELISA method (see page 139 and Discussion).
It would have been prima facie obvious to optimize the EC50 value of the zika virus antigen to less than 100 ng/mL, or less than 80 ng/mL, or less than 60 ng/mL, or less than 40 ng/mL, or less than 30 ng/mL, as this would have been a routine optimization.
Thus, the present invention would have been prima facie obvious.
Conclusion
Claims 33-36 are free of prior art.
Claim Objection
Claims 33-36 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648