DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The first preliminary amendment of 6/2/23 has been entered in full. Claims 13-18, 20-21, 25, 27 and 29 are amended. Claim 28 is canceled.
The second preliminary amendment of 12/26/23 has also been entered in full. Claims 2 and 15 are amended.
Claims 1-27 and 29-33 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities:
The title of the invention is not descriptive because it is directed in part generally to any “Application Thereof”, but the claimed methods are limited to treatment of cancer with the antibody. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Anti-Human B7-H3 and Application Thereof in Treatment of Cancer”.
Appropriate correction is required.
Claim Objections
Claims 1-27 and 29-33 are objected to because of the following informalities:
In claim 1, line 8 should end in “and” to join the two variable regions that are comprised by the antibody.
In each of claim 9 and 12, line 2 of each claim, “are” should be “is”; i.e., “the anti-human B7-H3 antibody or fragment thereof is”.
In claim 9, line 3, “binding to human B7-H3 extracellular domain” should be “binding to the human B7-H3 extracellular domain”.
In each of claims 13-15, lines 3-4 of each claim, the recitation “of heavy chain variable region” and/or “of light chain variable region” should be “of the heavy chain variable region” and/or “of the light chain variable region”.
In claim 24, the names of the small molecules should each start with a lower case letter in the same manner as “auristatin”, as they are not proper nouns.
In claim 24, the recited group of elements (1)-(3) is missing the conjunction “and”.
In claim 24, the acronym “PBD” should be accompanied by the full terminology; e.g., “pyrrolobenzodiazepine (PBD)”.
In claims 30 and 33, line 4, “ewing” and “wilms’” should be “Ewing” and “Wilms’”.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
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 13-20, 25-27 and 29-33 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 pre-AIA the applicant regards as the invention.
Claim 13 is indefinite because the preamble indicates that it is intended “for preparing an anti-human B7-H3 humanized antibody or fragment thereof”, but the concluding clause of the claim indicates that it is performed “in order to obtain the anti-human B7-H3 antibody or fragment thereof according to claim 1”, which does not include the term “humanized”. Furthermore, parent claim 1 does not require the antibody to be “humanized”. Thus, it is unclear whether claim 13 requires the antibody that the resultant antibody is humanized or not.
In each of claims 14 and 15, method steps (1)-(3) are lacking a conjunction joining the group, and thus it is unclear the method requires all of the steps (“and”) or only one of the steps (“or”).
In claim 17, line 8, in the recitation; “and the one or more second active elements may be the same or different”, it is unclear whether this means that the second active element can be the same or different from the first active element, or whether the “one or more second active elements” are the same or different as each other; i.e., if there are more than one second element, these are the same or different from each other.
Claim 18 recites the limitation “the anti-human B7-H3 antibody or fragment thereof or the fusion molecule according to claim 17” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Specifically, parent claim 17 only refers to a fusion molecule, and thus the recitation of “the anti-human B7-H3 antibody or fragment thereof” in claim 18 lacks antecedent basis in the parent claim.
Claim 20 recites “the polynucleotide or the nucleic acid construct according to claim 19” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Specifically, parent claim 19 is only directed to a construct, and thus the recitation of “the polynucleotide” in claim 20 lacks antecedent basis in the parent claim.
Claim 25 recites the limitation “the anti-human B7-H3 antibody or fragment thereof, the fusion molecule, the polynucleotide the nucleic acid construct, the host cell, or the conjugate according to claim 21” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Specifically, parent claim 19 is directed only to a conjugate, and thus the recitation of “the anti-human B7-H3 antibody or fragment thereof, the fusion molecule, the polynucleotide the nucleic acid construct, the host cell” that is “according to claim 25” lacks antecedent basis in the parent claim.
Claim 27 is directed to a “Use” of the claimed antibody or composition “…in the preparation of an agent … or in preparation of a medicament …”, which is a recitation of a "use" without setting forth any steps of how this use is actually practiced. Dependent claims 29 and 30 further limit the type of disease to which this “use” is directed. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q), which states:
"Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986)."
MPEP 2173.05(q) further states, “It is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b) if the facts support both rejections”. As such, claims 27, 29 and 30 are indefinite for reciting a use without any active, positive steps. See also the rejection of claims 27, 29 and 30 below in the section titled "Claim Rejections - 35 USC § 101".
Claim 30 and 33 are indefinite because each further limits the “solid tumor cancer” to types of solid cancer that are joined by the conjunction “and”, which on face appears to limit the “solid tumor cancer” to all of the recited types of cancer, but it is unclear how one cancer can include all of listed types. This rejection could be overcome, for example, by amending these claims to change “and” to “or”.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 27, 29 and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter.
Claims 27, 29 and 30 are each directed to the “use” of an antibody in the preparation of an agent for diagnostics or treatment. These claims do not fall within at least one of the four categories of patent eligible subject matter because, per MPEP 217.05(q): ““Use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)(“one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101”).”
Notes on Patentability
(1) No prior art has been identified that teaches or suggests an anti-human B7-H3 antibody or fragment thereof that comprises a HCVR and LCVR comprising the specific sets of CDRs recited in the claims; specifically, a HCVR with VH CDRs of SEQ ID NO: 40, 41 and 42 and a LCVR with LH CDRs of SEQ ID NO: 43, 44, and 45; or a HCVR with VH CDRs of SEQ ID NO: 46, 47 and 48 and a LCVR with LH CDRs of SEQ ID NO: 49, 50 and 51; or a HCVR with VH CDRs of SEQ ID NO: 52, 53, and 54 and a LCVR with LH CDRs of SEQ ID NO: 55, 56 and 57.
(2) The relevant prior art recognized that B7-H3 was overexpressed in a variety of solid tumors. For example, Du et al (2019. Cancer Cell 35, 221-237) teaches that “B7-H3 is overexpressed in solid tumors but rarely in normal tissues” (page 221), further explaining that “it is aberrantly expressed in a high proportion of human malignancies” and that “[o]verexpression of B7-H3 in tumor cells frequently correlates with fewer tumor-infiltrating lymphocytes, faster cancer progression, and poor clinical outcome in several malignancies, such as pancreatic ductal adenocarcinoma (PDAC), prostate cancer, ovarian cancer (OC), lung cancer, and clear cell renal carcinoma” (page 223). Du further explains that “[d]ue to its broad expression across multiple tumor types, B7-H3 is an attractive target for cancer immunotherapy” and that “B7-H3-specific monoclonal antibodies (mAbs) and antibody-drug conjugates showed antitumor activity against B7-H3+ tumor cells in xenograft mouse models, and phase I clinical trials showed a good safety profile” (page 223).
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674