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
Acknowledgement is hereby made of receipt and entry of the communication filed on Aug.22, 2023. Claims 1-20 are pending and are currently examined.
Claim Objection
The base claim 12 is objected to because of the following informalities:
The sentence of “The polypeptide according to claim 1 prevention of diseases or disorders caused by HIV-1 virus” in claim 12 need to be rewrote.
Appropriate correction is required.
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 18 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.
Claim 18 recites the limitation “The conjugate” in reference to claim 1. There is insufficient antecedent basis for this limitation in the claim 1.
Claim Rejections - 35 USC § 112 (Enablement) (New)
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.
Claims 12-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
These claims contain subject matter which were not described in the specification in such a way as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Enablement is considered in view of the Wands factors (MPEP 2164.01(a)) (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Claims 12 -13 are directed to a polypeptide as claimed and a vaccine comprising the polypeptide for prevention of diseases or disorders caused by HIV-1 virus or for prevention of HIV 1 virus infection.
The instant specification discloses the neutralization activity of MLA-immunized mice sera in Table 3 (See page 8) and the neutralization activity of MLB- and MLD-immunized mice sera in Table 4 (See page 9), however, the instant specification does not provide steps and experimental to support for how the immunization can prevent HIV-1 infection or prevent the disorders caused by HIV-1 virus, for example, an animal challenge experiment.
Claim 14 is directed to a vaccine, comprising a conjugate of the polypeptide according to claim 11 as an active ingredient or as an auxiliary ingredient for prevention of HIV 1 virus infection.
Accordingly, when all the aforementioned factors are considered in total, it would require undue experimentation for one skilled in the art to practice the full scope of claimed invention as defined by instant claims 12-14.
Allowable Subject Matter
Seq ID NOs: 2-16 are free of prior art.
No prior art reference has been identified teaching or suggesting a polypeptide having a length of up to 180 amino acids and containing a sequence selected from sequences identical to the claimed sequences or differing at most at 5 amino acid positions from the claimed sequence, where the different 5 amino acid positions are located outside of the three variable regions defined by Xs in SEQ ID NO: 2. No prior art reference has been identified teaching or suggesting a polypeptide for induction of HIV-1 virus-neutralizing antibodies targeting the epitope targeted by broadly neutralizing antibody PGT126 in a subject in claim 10, and for induction of HIV-1 virus-neutralizing antibodies targeting the epitope targeted by broadly neutralizing antibody PGT121 in a subject in claim 11, respectively.
Accordingly, claims 1-11, 15-17 and 19-20 are allowable.
Conclusion
Claims 1-11, 15-17 and 19-20 are allowed. Claims 12-14 and 18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am to 4:00 pm.
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/RUIXUE WANG/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/ Primary Examiner, Art Unit 1672