DETAILED ACTION
Claims 1-2, 4-8, 10-11, 13-15, 17-19, 28, 31, 35, 37, and 39 are pending in the instant application and being examined on the merit.
The application record does not contain a valid Power of Attorney under 37 CFR 1.32.
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 .
Information Disclosure Statement
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.
Examples of pages requiring such corrections in the instant application include, but are not limited to, the following references:
Zhu et al., J Virol 2006, 80:891-899 (page 40);
Ward et al., (1989) Nature 341:544-546; Bird et al. (1988) Science 242:423-426; Huston et al. (1988) Proc. Natl. Acad. Sci. USA 85:5879-5883 (page 13);
WO 04/037999; GB-A-2 357 768; WO 98/49185; WO 00/46383; WO 01/09300; WO 04/037999; and WO 98/49185 (page 15);
Chou and Fasman, Biochemistry 13: 211, 1974 and Adv. Enzymol., 47: 45-149, 1978; Eisenberg et al., Proc. Nat. Acad Sci. USA 81: 140-144, 1984; Kyte & Doolittle, J Mol. Biol. 157: 105-132, 198 1; and Goldman et al., Ann. Rev. Biophys. Chem. 15: 321-353, 1986 (page 16);
WO 05/061547; Baeuerle et al., 2008, Drugs of the Future 33: 137-147; Bargou, et al., 2008, Science 321:974-977 (page 17); and
PCT/US2018/016524 (page 27).
Specification
The disclosure is objected to because of the following informalities:
“FUNDAMENTALIMMUNOLOGY” should read “FUNDAMENTAL IMMUNOLOGY” (page 13, line 15); and
“V Land” should read “VL and” (page 13, line 22).
Appropriate correction is required.
The use of the term BiTE® and SepharoseTM which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Examples of pages requiring such corrections in the instant specification include, but are not limited to, the following:
BiTE® (page 2, line 9; page 4, line 22; page 16, line 29; page 17, line 3; page 27, line 16; page 32, line 3, etc.); and
SepharoseTM (page 43, line 1; page 48, line 8, etc.).
Claim Rejections - 35 USC § 112(b)
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.
Claims 10-11, 13-15, and 18-19 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.
Claim 10 is indefinite as being incomplete by its dependence on cancelled claim 9. Claim 13 is indefinite as being incomplete by its dependence on cancelled claim 12. Thus, the metes and bounds of the claims are unclear as there is no antecedent basis for the limitations in the cancelled base claims. See MPEP §608.01(n): “If the base claim has been canceled, a claim which is directly or indirectly dependent therein would be rejected as incomplete.” Claims 11, 14-15, and 18-19 are dependent on claim 10 and therefore, also indefinite.
Claim Rejections - 35 USC § 112(d)
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.
Claims 10-11, 13-15, and 17-19 are 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. Because claims 10 and 13 depend from a cancelled claim, the claim fails to incorporate by reference all the limitations of the claim to which is refers. Similarly, because claims 10 and 13 depend upon cancelled claims 9 and 12, respectively, claims 10 and 13 fail to specify further limitations. Claims 11, 14-15, and 17-19 are dependent on claim 10. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 1-2, 4-8, 28, 31, 35, 37, and 39 are directed to an antibody specifically binding to GPC3, or an antigen binding fragment thereof, comprising a light chain variable region (VL) and a heavy chain variable region (VH), wherein
the VL comprises LCDRs 1-3 having the amino acid sequences as set forth in SEQ ID NOs: 1-3 respectively, and the VH comprises HCDRs 1-3 having the amino acid sequences as set forth in SEQ ID NOs: 6-8 respectively; or
the VL comprises LCDRs 1-3 having the amino acid sequences as set forth in SEQ ID NOs: 23-25 respectively, and the VH comprises HCDRs 1-3 having the amino acid sequences as set forth in SEQ ID NOs: 60-62 respectively,
which are free of prior art.
Regarding independent claim 1, the claim recites antibodies or antigen binding portions thereof specifically binding to GPC3 comprising:
a VH with a CDR1-3 of SEQ ID NOs:6-8, respectively; and
a VH with a CDR1-3 of SEQ ID NOs:60-62, respectively.
In regards to the antibody of (a), the closest prior art for the antibody or
antigen binding portion thereof, which specifically binds to GPC3 comprising a VH
with a CDR1-3 of SEQ ID NOs:6-8, respectively, is a human anti-AIP-1 antibody of SEQ ID NO:47 present in U.S. Patent No. 9,394,371B2 (Janda et al), which has a 64% match
to the claimed sequence.
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Importantly, the binding determinant region of the instantly claimed GPC3
antibody does not have an identical match to SEQ ID NO:47 of Janda. Thus, the antibody of Janda is not prior art and the subject matter is allowable.
In regards to the antibody of (b), the closest prior art for the antibody or
antigen binding portion thereof, which specifically binds to GPC3 comprising a VH
with a CDR1-3 of SEQ ID NOs:60-62, respectively, is a 6F4 antibody specific to the JAM-A protein of SEQ ID NO:49 present in U.S. Patent No. 8,071,730B2 (Goetsch et al), which has a 75.7% match to the claimed sequence.
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Importantly, the binding determinant region of the instantly claimed GPC3
Antibody does not have an identical match to SEQ ID NO:49 of Goetsch. Thus, the antibody of Goetsch is not prior art and the subject matter is allowable. Instant claims 2, 4-8, 28, 31, 35, 37, and 39 are dependent on instant claim 1, and also have allowable subject matter.
Conclusion
Claims 1-2, 4-8, 28, 31, 35, 37, and 39 are allowed.
Claims 10-11, 13-15, and 17-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jieun Ham whose telephone number is (571)272-7779. The examiner can normally be reached Monday - Friday 7-2.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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