DETAILED ACTION
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 .
Status of the Claims
Claims 1-47 were originally filed January 23, 2023.
The preliminary amendment received January 23, 2023 amended claims 3-6, 8-16, 18, 21-30, 33, and 36-46.
The amendment received August 14, 2023 canceled claims 2-15, 17-30, and 32-46 and added new claims 48-62.
Claims 1, 16, 31, and 47-62 are currently pending.
Claims 48-50, 52, 57, and 62 are currently under consideration.
Please note: claims 51, 53, 54, and 58 have indefinite “such as” language. See MPEP § 2173.05(d).
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 16, 31, and 48-62) in the reply filed on November 26, 2025 is acknowledged.
Claim 47 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 26, 2025.
Applicant’s election without traverse of claim 48, human, LG3, tPA, intravenous, and once at the same time as the species in the reply filed on November 26, 2025 is acknowledged.
Claims 1, 16, 31, 51, 53-56, and 58-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 26, 2025.
Please note: the species of human, administration of tPA, and once at the same time are not part of the present claims. Therefore, any art rejection of record does not require the elected species of human, administration of tPA, and once at the same time.
Priority
The present application is a 371 (National Stage) of PCT/US2021/070948 filed July 26, 2021 which claims the benefit of 63/061,308 filed August 5, 2020 and 63/056,059 filed July 24, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 23, 2025 is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 48 is objected to because of the following informalities: “(a)” should read “a”. Appropriate correction is required.
Claim 62 is objected to because of the following informalities: all method steps should be recited as active, positive steps (i.e. “administered” should read “administering”). 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.
Claims 48-50, 52, 57, and 62 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if a second administration step is required or not (e.g. administering a thrombolytic therapy). The thrombolytic therapy could limit the patient population or require a second administration step. Please see claim 49 which limits the thrombolytic therapy to tPA.
Claim 52 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how the limitation of “wherein the subject is suffering from a stroke” limits the recitation of “a stroke patient” in independent claim 48.
Claim 52 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.
Claim 52 recites the limitation "the subject" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 52 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. Claim 52 depends on independent claim 48. Independent claim 48 requires “a stroke patient”. Dependent claim 52 requires “the subject is suffering from a stroke”. Therefore, dependent claim 52 does not appear to further limit the scope of the stroke patient of independent claim 48. 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 48-50, 52, 57, and 62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bix WO 2019/118689 published June 20, 2019.
For present claims 48-50, 52, 57, and 62, Bix teaches a method of intravenously administering perlecan domain V (DV; comprising LG3) to a human suffering from a stroke wherein t-PA may also be administered (please refer to the entire specification particularly the abstract; paragraphs 3, 6, 9, 12-16, 18, 20-26, 42-47, 51, 52, 79; claims).
Therefore, the teachings of Bix anticipate the presently claimed method.
Claims 48-50, 52, 57, and 62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bix U.S. Patent Application Publication 2012/0003180 published January 5, 2012.
For present claims 48-50, 52, 57, and 62, Bix teaches a method of intravenously administering perlecan domain V (DV; SEQ ID NO: 1) or LG3 (SEQ ID NO: 2) to a human suffering from a stroke wherein t-PA may also be administered (please refer to the entire specification particularly the abstract; paragraphs 3-7, 26, 31-37, 39-44, 49-51, 76, 77, 74, 75; claims).
Therefore, the teachings of Bix anticipate the presently claimed method.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658