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
Election/Restrictions
Applicant's election with traverse of Group I, claims 1, 4-5,8-12, 14-15, 17, 20, 22, and 25 and species: SEQ ID NOs: 12, 33, 53, 69, 78, 84, 95, 119, 138, 160, M substituted t position 6 of SEQ ID NO: 69, K substituted into position 4 of SEQ ID NO: 84, L substituted into position 5 of SEQ ID NO: 84, T substituted into position 6 of SEQ ID NO: 12, F substituted into position 7 of SEQ ID NO: 12, I substituted into position 5 of SEQ ID NO: 33, S substituted into position 6 of SEQ ID NO: 33, a ROR1-targeted antibody or antigen-binding fragment, a method for diagnosis, preventing, or treating a cancer, lung cancer, and macromolecular drug in the reply filed 11/19/2025 is acknowledged.
Upon further consideration, the restriction requirement filed 09/24/2025 will be withdrawn as the claims have been amended to obviate the reference used to break unity.
Claims 1, 4-5, 8-15, 17-20, and 22-27 are now under consideration in the instant Office Action.
Claim Objections
Claims 4, 18, and 25 are objected to because of the following informalities: instant claims 4 and 25 use the conjunction “or” too frequently. The terminology “or” is only needed between the penultimate and last claim limitations when semicolons are used.
Instant claim 18 recites a method for detecting ROR1 in a sample. The claim contains incorrect grammar that renders the claim difficult to understand and requires revision. 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 27 is 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.
Instant claim 27 recites parentheses for the terminology “anti-tumor” after “additional anti-cancer”. The terminology of “anti-tumor” does not acronymize the term which it follows, additional anti-cancer, and as such is an improper use of parenthetical references in a claim. It is unclear what Applicant means by encompassing the terminology in parentheses.
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 19 and 23-24 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. Instant claims 19 and 23-24 fail to further limit the claim from which they depend because they recite two known utilities of the claimed antibody: a therapeutic and a diagnostic process. The instant claims fail to provide new limitations which narrow the scope of the claim from which it depends. Additionally, the recitation of two methods in one claim does not further limit the uses or the structure of the antibody that is claimed. See MPEP 608.01(n) and Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92, 79 USPQ2d 1583, 1589-90 (Fed. Cir. 2006) for more. 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675