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
The preliminary amendment filed June 12, 2024, is acknowledged and has been entered. Claims 3-8, 10-11 and 14-15 have been amended.
Claims 1-15 are pending in the application and are under examination.
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.
Claims 1-15 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, claim 1 recites the broad limitation of one or two binding domains, which specifically bind to the extracellular domain of ROR1 and then recites the narrow limitation that said ROR1-BDs comprise independently from each other a set of CDR sequences such that it is unclear if the narrow limitations are meant to further limit the claims to a multispecific antibody with two binding domains or not. Furthermore, the claim recites “and/or” between the Markush group members, so it is unclear how a set of CDRs is selected independently from a single set of CDR sequences. Claims 2-15 are included in the rejection as they do not obviate the rejection.
Accordingly, due to the ambiguity that results from a broad limitation followed by a narrow limitation used in this claim, the claim fails to delineate the metes and bounds of the subject matter regarded as the invention with the clarity and particularity necessary to satisfy the requirement set forth under 35 U.S.C. § 112, second paragraph, so as to permit the skilled artisan to know or determine infringing subject matter.
It is suggested that the “and/or” language be amended to “and” and that the claim be amended to recite, “A multispecific antibody comprising: a) a binding domain which specifically binds to the extracellular domain of ROR1 (ROR1-BD); and b) a binding domain which specifically binds to CD3 (CD3-BD); wherein the multispecific antibody does not comprises an immunoglobulin Fc region; wherein said ROR1-BD comprises a set of CDR sequences selected from the set consisting of a) the HCDR1 sequence of SEQ ID NO: 1, the HCDR2 sequence of SEQ ID NO: 2, the HCDR3 sequence of SEQ ID NO: 3, the LCDR1 sequence of SEQ ID NO: 4,the LCDR2 sequence of SEQ ID NO: 5, and the LCDR3 sequence of SEQ ID NO: 6; and b) the HCDR1 sequence of SEQ ID NO: 13 or 14, the HCDR2 sequence of SEQ ID NO: 15, the HCDR3 sequence of SEQ ID NO: 16, the LCDR1 sequence of SEQ ID NO: 17,the LCDR2 sequence of SEQ ID NO: 18, and the LCDR3 sequence of SEQ ID NO: 19; and wherein said CD3-BD comprises the set of CDR sequences consisting of the HCDR1 sequence of SEQ ID NO: 30, the HCDR2 sequence of SEQ ID NO: 31, the HCDR3 sequence of SEQ ID NO: 32, the LCDR1 sequence of SEQ ID NO: 33,the LCDR2 sequence of SEQ ID NO: 34, and the LCDR3 sequence of SEQ ID NO: 35”. Then a dependent claim reciting the multispecific antibody of claim 1, further comprising an additional binding domain which specifically binds to the extracellular domain of ROR1 comprising a set of CDR sequences s selected from the set consisting of a) the HCDR1 sequence of SEQ ID NO: 1, the HCDR2 sequence of SEQ ID NO: 2, the HCDR3 sequence of SEQ ID NO: 3, the LCDR1 sequence of SEQ ID NO: 4,the LCDR2 sequence of SEQ ID NO: 5, and the LCDR3 sequence of SEQ ID NO: 6; and b) the HCDR1 sequence of SEQ ID NO: 13 or 14, the HCDR2 sequence of SEQ ID NO: 15, the HCDR3 sequence of SEQ ID NO: 16, the LCDR1 sequence of SEQ ID NO: 17,the LCDR2 sequence of SEQ ID NO: 18, and the LCDR3 sequence of SEQ ID NO: 19; and wherein said CD3-BD comprises the set of CDR sequences consisting of the HCDR1 sequence of SEQ ID NO: 30, the HCDR2 sequence of SEQ ID NO: 31, the HCDR3 sequence of SEQ ID NO: 32, the LCDR1 sequence of SEQ ID NO: 33,the LCDR2 sequence of SEQ ID NO: 34, and the LCDR3 sequence of SEQ ID NO: 35 can be presented as a new claim along with appropriate amendments to the other dependent claims..
Claims 4, 7-9 and 15 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, claims recite various broad components or properties of an antibody composition and then recite narrower limitations preceded by the term “in particular” or “particularly”, so it so it is unclear if the narrow limitations are meant to further limit the claims.
Accordingly, due to the ambiguity that results from a broad limitation followed by a narrow limitation used in this claim, the claim fails to delineate the metes and bounds of the subject matter regarded as the invention with the clarity and particularity necessary to satisfy the requirement set forth under 35 U.S.C. § 112, second paragraph, so as to permit the skilled artisan to know or determine infringing subject matter.
It is suggested that the “in particular” or “particularly” language be canceled from these claims.
Claims 4 and 9 are indefinite in the recitation of “said hSA-BD" in claims 4 and 9 because claims 4 and 9 depend from claim 1 which do not recite a hSA-BD. Therefore, the recitation lacks proper antecedent basis and it cannot be determined which (if any) hSA-BD is being referred to.
Accordingly, the metes and bounds of the claim cannot be properly determined and the invention is not set forth with the clarity and particularity necessary to satisfy the requirement set forth 35 U.S.C. 112, second paragraph, so as permit the skilled artisan to know or determine infringing subject matter.
Claim 10 is indefinite in the recitation of “A ROR1-BD as defined of claim 1". Is this supposed to recite “A multispecific antibody as defined in claim 1”, “A ROR1-BD as defined in claim 1” or is something else intended because claim 1 is instead drawn to multispecific antibody and not a ROR1-BD per se.
Accordingly, the metes and bounds of the claim cannot be properly determined and the invention is not set forth with the clarity and particularity necessary to satisfy the requirement set forth 35 U.S.C. 112, second paragraph, so as permit the skilled artisan to know or determine infringing subject matter.
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 10 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. In this case, claim 10 depends from claim 1 and claim 1 recites a multispecific antibody that does not appear to be required by claim 10. As such claim 10 fails to include all the limitations of the claim upon which it depends.
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
No claims are allowed. The prior art does not appear to disclose “A multispecific antibody comprising: a) a binding domain which specifically binds to the extracellular domain of ROR1 (ROR1-BD); and b) a binding domain which specifically binds to CD3 (CD3-BD); wherein the multispecific antibody does not comprises an immunoglobulin Fc region; wherein said ROR1-BD comprises a set of CDR sequences selected from the set consisting of a) the HCDR1 sequence of SEQ ID NO: 1, the HCDR2 sequence of SEQ ID NO: 2, the HCDR3 sequence of SEQ ID NO: 3, the LCDR1 sequence of SEQ ID NO: 4,the LCDR2 sequence of SEQ ID NO: 5, and the LCDR3 sequence of SEQ ID NO: 6; and b) the HCDR1 sequence of SEQ ID NO: 13 or 14, the HCDR2 sequence of SEQ ID NO: 15, the HCDR3 sequence of SEQ ID NO: 16, the LCDR1 sequence of SEQ ID NO: 17,the LCDR2 sequence of SEQ ID NO: 18, and the LCDR3 sequence of SEQ ID NO: 19; and wherein said CD3-BD comprises the set of CDR sequences consisting of the HCDR1 sequence of SEQ ID NO: 30, the HCDR2 sequence of SEQ ID NO: 31, the HCDR3 sequence of SEQ ID NO: 32, the LCDR1 sequence of SEQ ID NO: 33,the LCDR2 sequence of SEQ ID NO: 34, and the LCDR3 sequence of SEQ ID NO: 35”. The closest prior art is US 2020/0157218 A1 (Nathwani et al) which discloses bispecific antibodies that bind to ROR1 and CD3. Neither Nathwani et al nor other prior art appears to disclose or suggest bispecific antibodies that bind to ROR1 and CD3 comprising the specific sequences set forth in claim 1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner can normally be reached on Monday through Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (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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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
January 23, 2026