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 .
Claims 2, 3, 5, 6, 10 have been canceled. Claims 1, 4, 7-9 remain pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7-1-26 has been entered.
Election/Restrictions
Applicants elected Group I, claims 1-6, without traverse in the reply filed on 10-24-25. Claims 7-9 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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, 4 remain under consideration.
Claim Objections
The phrase “consisting essentially of” in claim 1 does not make sense because it excludes any time after the ligating and administering a NO inhibitor where the non-human mammal develops any cerebrovascular disease.
The features of the ligation in claim 1 should all be together.
The features of administering the NO inhibitor in claim 1 should all be together.
The steps in claim 1 should be clear, positive, active steps, e.g. “permanently ligating…”, “administering…”.
The active steps never require clamping the CCA of a non-human mammal.
The active steps never require administering an NO inhibitor to a non-human mammal.
The body of the claim further limits the “cerebrovascular disease” in the preamble without saying the clamping and administering the NO inhibitor results in palsy, stroke, cerebral hemorrhage, or vascular dementia.
“Incising” is a separate step in claim 1.
The phrase “before suturing” in claim 1 is not a clear, positive step that suturing occurs.
Reference to “the anesthetized non-human animal” in step 2 can be simplified.
The NO inhibitors and their dosage should be consolidated.
Claim 1 can be written more clearly and concisely as ---A method of making a non-human mammal that has cerebral ischemia, the method comprising:
a) permanently ligating the common carotid artery of a non-human mammal; and
b) administering 100-400 mg/kg of NG-nitro-L-arginine methyl ester (L-NAME),… …, or aminoguanidine to the mammal obtained in step a) such that cerebral ischemia occurs---.
Claim 4 can be written more clearly as ---wherein the administering is via oral, parenteral,… …, or intranasal delivery---.
Claim Rejections - 35 USC § 112
Enablement
The rejection of claims 1, 4 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, has been withdrawn in view of the amendment.
Written Description
The rejection of claims 1, 4 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description, has been withdrawn in view of the amendment.
Indefiniteness
Claims 1, 4 remain 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.
The term “acute” in the phrase “acute cerebral ischemia” in claim 1 makes the claim indefinite. The specification and the art do not teach the limit of when cerebral ischemia is/is not “acute”. Therefore, those of skill would not be able to determine when they were infringing on the claim.
The phrase “before suturing” in step 2 of claim 1 is indefinite because it is unclear whether or not “suturing” must occur or if it is optional.
Claim Rejections - 35 USC § 102
A) Claims 1, 4 remain rejected under 35 U.S.C. 102a1 as being anticipated by Cooke (WO 0074701).
Cooke taught anesthetizing, incising the neck, permanently ligating the common carotid artery (pg 23, line 15-19), and administering nitric oxide synthase inhibitor (L-NMMA) immediately after ligating (pg 5, lines 33-35; pg 11, line 28; pg 22, line 21; Fig. 7). Compounds are administered at 100 mg/kg (pg 18, lines 28-33). The method of Cooke inherently MUST result in acute cerebral ischemia as claimed because Cooke taught the exact same method in claim 1.
Cooke administered the NNMA intravenously as encompassed by claim 4 (pg 5, lines 33-35; pg 11, line 28; pg 22, line 21; Fig. 7) because it was put into medium that went through the artery.
Response to argument
Applicants discuss Cooke and say it does not teach all the limitations claimed. Applicants’ argue the method of Cooke has a different purpose. Applicants’ discuss “subconfluent cells” that were pre-incubated in medium. Applicants’ arguments are not persuasive for reasons set forth above. The method of Cooke inherently MUST results in acute cerebral ischemia as claimed because it has the exact same method steps as claim 1.
B) Claims 1, 4 remain rejected under 35 U.S.C. 102a1 as being anticipated by Bucala (5700447).
Bucala taught “both common carotid arteries were exposed and the right was ligated”. “Within 5 minutes of severing the artery, the left common carotid artery was temporarily occluded for 30 minutes or 1 hour” (col. 30, lines 30-45). “In some animals, aminoguanidine [ ] was given” (col. 30, lines 60-61). This is equivalent to the active step of claim 1. Bucala removed the brains 24 hours later which is permanent ligation of the common carotid artery as required in claim 1. Bucala inherently MUST result in acute cerebral ischemia as claimed because Bucala taught the exact same method in claim 1.
Bucala administered the aminoguanidine intravenously (col. 30, line 61) as encompassed by claim 4.
Response to arguments
Applicants argue Bucala used different ligation techniques and used aminoguanidine for a different purpose. Applicants’ argument is not persuasive. Bucala taught the exact same method in claim 1.
C) Claims 1 and 4 remain rejected under 35 U.S.C. 102a1 as being anticipated by Mazur (RU2532394).
Mazur taught permanently occluding the common carotid artery in a rat and administering ONMK, L-arginine, or Hypertryl (para 16 and 17). This causes cerebral vascular disease (para 3) which makes it a model of acute cerebral ischemia as required in claim 1. Mazur administered the aminoguanidine immediately before the artery was ligated as required in claim 1 (col. 30, line 59).
The active steps of Mazur are EXACTLY the same as those claimed and described by applicants as being part of the invention. Therefore, the active steps of Mazur inherently MUST result in acute cerebral ischemia as required in claim 1.
Response to arguments
Applicants argue Mazur used different ligation techniques and used aminoguanidine for a different purpose. Applicants’ argument is not persuasive. Mazur taught the exact same method in claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Valazquez (WO 2018204475) taught ligating an artery of a mouse (para 17, 20, 21, 27, 28, 79, 84-87, 95, 96, 110) while administering nitric oxide synthase inhibitor (nitro L-arginine methyl ester (NAME)) (para 79, 83, 84, 95, 110). Valazquez taught ligating an artery while administering nitric oxide synthase inhibitor (para 85)
No claim is allowed.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638
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