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 .
Election/Restrictions
Claims 1-20 are pending and are examined.
Priority
This application is a National entry phase of the PCT/US2022/035677, filed on 06/30/2022, which claims priority to U.S. Provisional Application 63/217,636, filed on 07/01/2021. The priority is recognized for all claim except for claim 2 in which the anti-HPA-1a monoclonal antibody being administered in an amount of about 0.015 mg to about 0.6 mg, is not being disclosed in the priority document. Thus, for claim 2, the priority is considered as the filing date of the PCT Application, 06/30/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/20/2024 was considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim is drawn to the method of claim 1, wherein the subject is HPA-1a negative. The requirement for HPA-1a negative is already present in the independent claim 1 (“A method of administering an anti-human platelet antigen (HPA)-1a monoclonal antibody to a subject that is HPA-1a negative,”). Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102/103
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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) 1-10 and 13-20 are rejected under 35 U.S.C. 102(a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Michaelsen et al. (WO2015150417).
The reference discloses the an anti-HPA-1 antibody 26.4 (p.5), comprising the CDR sequences of the current application to 100% sequence identity (see SEQ ID NOs: 5-7 and 8-10, respectively). The antibody is for use in preventing alloimmunization with HPA-1a in a subject (claim 20) and in a method of treating or preventing FNAIT comprising administering to a patient in need thereof a therapeutically or prophylactically effective amount of an antibody in a pharmaceutical composition (claim 26), and can be administered subcutaneously. The antibody is dosed in such a way to achieve a plasma concentration of 0.08 μg/ml (p. 31). Dosage units containing the antibodies may contain 0.1-10mg, for example 1-5mg of the active agent. Other useful doses include doses which achieve a plasma concentration of 0.1 to 1 IU/ml, for example 0.5 IU/ml (0.08 μg/ml). Such a dose of 0.5 IU/ml (0.08 μg/ml) may be achieved by intravenous administration of 2,000 IU. The antibodies may be administered to a woman who is already pregnant, preferably to a pregnant woman known to be HPA-1a negative, more preferably a woman already pregnant with an incompatible pregnancy (i.e. the mother is HPA-1a negative and the fetus is HPA-1a positive) (p. 32).
The reference is silent regarding a maximum plasma concentration of the anti-HPA-1a monoclonal antibody of about 3 ng/mL to about 40 ng/mL in the subject.
However, the reference indicates that the Dosage units containing the antibodies may contain 0.1-10mg, for example 1-5mg of the active agent. In the instant claims, (claims 2-3) the amount of antibody administered is between 0.015-0.6mg and this amount has to abide by the limitation of the independent claim 1(i.e., to achieve a maximum plasma concentration of the anti-HPA-1 a monoclonal antibody of about 3 ng/mL to about 40 ng/mL in the subject).
With respect to the limitations of claims 19-20 (the pharmaceutical composition further comprises succinate, arginine, polysorbate 80, and water for injection and has a pH of about 6.0-6.5), it is submitted that these were routine composition additive well known in pharmaceutical composition art.
Therefore, it is submitted that the teachings of Michelsen et al. inherently read upon the instant claims 1-10 and 13-20.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Michaelsen et al. (WO2015150417) in view of Kjeldsen-Kragh et al. (Risk of HPA-1a–immunization in HPA-1a–negative women after giving birth to an HPA-1a–positive child. Transfusion59, 1344-1352, 2019 -cited by Applicant).
The claim adds the limitation that the anti-HPA-1a antibody pharmaceutical composition is administered to HPA-1a–negative/HLA-DRB3*01:01–positive women.
The teachings of Michaelsen et al. were presented supra and they were silent with regard to the HLA-DRB3*01:01 status of the patients.
Kjeldsen-Kragh et al. show that in HPA-1a–negative/HLA-DRB3*01:01–positive women, the risk of HPA-1a–immunization is 12.7% after delivery of an HPA-1a–positive child, which is 25 times higher than in HPA-1a–negative/HLADRB3* 01:01–negative women. Thus, the risk of HPA-1a–immunization in high-risk pregnancies is in the same range as the risk of RhD immunization in RhD-negative women after delivery of a RhD-positive child without RhD prophylaxis.
Therefore, it would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have administered the pharmaceutical composition of Michaelsen et al. to HPA-1a–negative/HLA-DRB3*01:01–positive women with a reasonable expectation of success. This is because the patient thus chosen would have had a high risk of alloimmunization and administration of the antibodies would have lowered this risk.
Allowable Subject Matter
Claim 12 is 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.
Conclusion
No claim is allowed. Claims 1-11 and 13-20 are rejected. Claims 12 is objected to as being dependent upon a rejected base claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
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