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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5-18-2026 has been entered.
The amendment filed on 5-18-2026 is acknowledged. Claims 1, 5, 11 and 14 have been amended. Claims 3-4, 6-7, 13 and 15 have been canceled. Claims 1-2, 5, 9-12, 14, 17-18, 20 and 22-24 are pending. Claims 11-12, 14, 17, 20 and 22-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-2, 5, 9-10 and 18 are currently under examination.
Claim Rejections Withdrawn
The rejection of claims 1-5, 9-10 and 18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of the amendment thereto.
The rejection of claims 1-6, 9-10 and 18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for nucleic acids encoding the DMab 319-44mod1 (with the amino acid sequence of SEQ ID NO:2 or with the nucleic acid sequence of SEQ ID NO:1), does not reasonably provide enablement for nucleic acids encoding variants of said antibody that bind to an undefined OspA is withdrawn in light of the amendment thereto.
New Grounds of Rejection
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 1-2, 5, 9-10 and 18 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 1 is rendered vague and indefinite by the use of the phrase “…wherein the nucleic acid molecule encodes the amino acid sequence as set forth in SEQ ID NO:2…”. It is unclear what is meant to be engendered by said phrase as nucleic acids encode proteins not sequences. Sequences constitute an abstraction and do not constitute patentable matter. As written, it is impossible to determine the metes and bounds of the claimed invention. It is suggested that the phrase “…wherein the nucleic acid molecule encodes a polypeptide with the amino acid sequence as set forth in SEQ ID NO:2…” be used instead.
Claim 1 is rendered vague and indefinite by the use of the phrase “…wherein the nucleic acid molecule encodes the amino acid sequence as set forth in SEQ ID NO:2 or the nucleic acid as set forth in SEQ ID NO:1…”. It is unclear what is meant to be engendered by said phrase as nucleic acids encode proteins not sequences. Moreover, nucleic acids do not encode other nucleic acids. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 9 is rendered vague and indefinite by the use of the phrase “…wherein the nucleotide sequence encodes a leader sequence.”. It is unclear what is meant to be engendered by said phrase as the only nucleic acid sequence recited in the independent claim encodes a synthetic antibody. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 11 is rendered vague and indefinite by the use of the phrase “…wherein the nucleic acid molecule comprises an expression vector.”. It is unclear what is meant to be engendered by said phrase as expression vectors contain nucleic acids not vice versa.
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 5 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. Said claim merely describes portions of the sequence recited in the independent claim (i.e. said claim recites the sequences of the light and heavy chains of the antibody recited in the independent claim). 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 claim is allowed.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 June 23, 2026
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