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.
The amendment received July 27, 2026 amended claims 48, 54, and 56-59 and canceled claims 49-52 and 60-62.
Claims 1, 16, 31, 48, and 53-59 are currently pending.
Claims 48 and 57 are currently under consideration.
Please note: claims 53, 54, and 58 have indefinite “such as” language. See MPEP § 2173.05(d).
Election/Restrictions
Applicants elected, without traverse, Group I (claims 1, 16, 31, and 48-62) in the reply filed on November 26, 2025.
Applicants elected, without traverse, claim 48, human, LG3, tPA, intravenous, and once at the same time as the species in the reply filed on November 26, 2025. Claims 1, 16, 31, 51, 53-56, and 58-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
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 June 11, 2026 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.
Withdrawn Objections
The objection to claim 48 regarding “(a)” should read “a” is withdrawn in view of the amendment received July 27, 2026.
The objection to claim 62 regarding all method steps should be recited as active, positive steps (i.e. “administered” should read “administering”) is withdrawn in view of the amendment received July 27, 2026 which canceled the claim.
New Objections Necessitated by Amendment
Claim Objections
Claim 48 is objected to because of the following informalities: the acronym should be utilized with the first appearance in the claim (i.e. line 2). Appropriate correction is required.
Claim 48 is objected to because of the following informalities: there is a disconnect between “human stroke patient” (preamble) and “a subject” (body of the claim). Appropriate correction is required.
Claim 48 is objected to because of the following informalities: “coadministering to a subject with LG3” should read “coadministering to a subject LG3”. Appropriate correction is required. Please note: “a subject” should also be changed – see the above objection.
Claim 48 is objected to because of the following informalities: “administered” should read “administering” (i.e. all method steps should be recited as active, positive steps). Appropriate correction is required.
Withdrawn Rejections
The rejection of claim 52 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 is withdrawn in view of the amendment received July 27, 2026 which canceled the claim.
The rejection of claim 52 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 is withdrawn in view of the amendment received July 27, 2026 which canceled the claim.
The rejection of claim 52 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 is withdrawn in view of the amendment received July 27, 2026 which canceled the claim.
The rejection of claims 48-50, 52, 57, and 62 under 35 U.S.C. 102(a)(1) as being anticipated by Bix WO 2019/118689 published June 20, 2019 is withdrawn in view of the amendment received July 27, 2026 regarding the coadministration of LG3 and t-PA. The rejection of record was not withdrawn due to LG3 not being disclosed. LG3 is an art recognized subdomain of perlecan (i.e. within domain V; see Bix U.S. Patent Application Publication 2012/0003180) which Bix WO 2019/118689 teaches.
Maintained and/or Modified* Rejection
*wherein the modification is due to amendment
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 and 57 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. receiving tissue plasminogen activator). The “receiving tissue plasminogen activator” could limit the patient/subject population or require a second administration step.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) (indefinite) for claims 48 and 57 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment regarding “coadministration” clarifies the claim.
Applicants’ arguments are not convincing since independent claim 48 still refers to receiving tPA in a human stroke patient. Therefore, it is unclear if the human stroke patient/subject received tPA then was coadministered LG3 and tPA or if the human stroke patient is only coadministered LG3 and tPA. This is particularly relevant since the body of the claim requires both coadministration (e.g. formulation comprising both LG3 and tPA; administration of LG3 and tPA at the same time) and tPA administered more than three hours after the stroke occurring.
New Rejections Necessitated by Amendment
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 48 and 57 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Support in the originally filed specification for coadministration of LG3 and t-PA to a human stroke patient receiving t-PA was not found. The only coadministration in the originally filed specification is in Example 1, page 20 wherein tPA (10 mg/kg, IV) and LG3 (6 mg/kg, IP) were coadministered to mice. It is also respectfully noted that t-PA was not administered more than three hours after the stroke occurring.
Claims 48 and 57 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 how tPA can be coadministered with LG3 (e.g. formulation comprising both LG3 and tPA; administration of LG3 and tPA at the same time) while also being administered alone more than three hours after the stroke occurring.
Maintained and/or Modified* Rejection
*wherein the modification is due to amendment
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 and 57 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 and 57, Bix teaches a method of intravenously administering perlecan domain V (DV; SEQ ID NO: 1) or LG3 (SEQ ID NO: 2) in combination with t-PA to a human suffering from a stroke wherein administration of t-PA alone is preferably within 3 hours of stroke and combination administration of perlecan domain V (DV; SEQ ID NO: 1) or LG3 (SEQ ID NO: 2) with t-PA is within 168, 144, 120, 96, 72, 48, 24, 12, 6, or 3 hours of a stroke (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.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) as being anticipated by Bix for claims 48 and 57 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment received July 27, 2026 negates the rejection and that the “wherein t-PA is administered more than three hours after the stroke occurring” negates the rejection. Applicants provided paragraphs 50 and 51 (improperly labeled as paragraph 50) of Bix.
Applicants’ arguments are not convincing since the teachings of Bix anticipate the method of the instant claims. Bix teaches in paragraph 50 that t-PA alone should be administered within 3 hours for best results, DV (i.e. LG3) can be utilized in combination with t-PA, and that DV (i.e. LG3) in combination with t-PA can be administered within 168, 144, 120, 96, 72, 48, 24, 12, or 6 hours of stroke (i.e. t-PA administered more than three hours after the stroke occurring). Bix teaches in paragraph 51 that t-PA can be administered in combination with DV (i.e. LG3). Bix also teaches at paragraph 76 that the composition can be administered within 48 hours, between about 10 minutes and 24 hours, or within 3 hours after the onset of stroke.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 48 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Bix WO 2019/118689 published June 20, 2019 and Bix U.S. Patent Application Publication 2012/0003180 published January 5, 2012.
For present claims 48 and 57, Bix teaches a method of intravenously administering perlecan domain V (DV; comprising LG3) to a human suffering from a stroke wherein DV (i.e. LG3) is administered 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 days, 3-72 hours, or about 4 hours to about 20 days after stroke and wherein t-PA may also be administered and if t-PA is administered alone, t-PA should be provide within 4.5 hours of stroke (please refer to the entire specification particularly the abstract; paragraphs 3, 6, 9, 12-16, 18, 20-26, 42-47, 51, 52, 55, 57, 75, 79, 84; claims).
Bix (WO 2019/118689) does not specifically teach coadministration of LG3 and t-PA.
For present claims 48 and 57, Bix teaches a method of intravenously administering perlecan domain V (DV; SEQ ID NO: 1) or LG3 (SEQ ID NO: 2) in combination with t-PA to a human suffering from a stroke wherein administration of t-PA alone is preferably within 3 hours of stroke and combination administration of perlecan domain V (DV; SEQ ID NO: 1) or LG3 (SEQ ID NO: 2) with t-PA is within 168, 144, 120, 96, 72, 48, 24, 12, 6, or 3 hours of a stroke (please refer to the entire specification particularly the abstract; paragraphs 3-7, 26, 31-37, 39-44, 49-51, 76, 77, 74, 75; claims).
All the claimed elements (i.e. LG3 subdomain of DV and t-PA coadministration) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. treating symptoms of stroke) and the combination would have yielded predictable results (i.e. treating symptoms of stroke) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. individual treatment of LG3 and t-PA) for another (i.e. combination therapy with LG3 and t-PA) would have yielded predictable results (i.e. treating symptoms of stroke) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. combination therapy with LG3 and t-PA) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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