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 .
Receipt is acknowledged of the amendment filed 10/30/2025.
Information Disclosure Statement
An information disclosure statement was filed on 10/30/2025.
Withdrawn Rejection(s)
The rejection under 35 USC 102(a)(2) over WO 2019/02834 A1 (Jazz Pharmaceuticals) is withdrawn in view of the amendment filed 10/30/2025.
New Rejection(s)
Claim Rejections - 35 USC § 112
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 1, 3, 21, 23-28 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant has amended the claims from an in vivo to an ex vivo treatment. The in vivo treatment is well known and has no enablement issues. However, the ex vivo treatment now claimed has not been enabled through clinical results. In fact {0124] –{0125} set up study groups to test the effectiveness of the treatment, but no further studies or results have been shown .
The following Wands factors are therefore applicable:
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) determined that factors which enable an invention. These are:
(A) The breadth of the claims;
The instant claims set out a treatment for organ injury or rejection which includes prevention.
(B) The nature of the invention;
The method comprises ex vivo immersion of an organ or bolus injection of the organ ex vivo with a defibrotide.
(C) The state of the prior art;
The prior art comprises in vivo treatments for ischemia and/or organ damage..
(D) The level of one of ordinary skill;
The ordinary practitioner is either a PhD or medical practitioner
(E) The level of predictability in the art;
As with any organ injury or organ rejection, patient response to medication is not always predictable. This is especially the case depending on the amount of damage to the organ , or the person receiving the organ.
(F) The amount of direction provided by the inventor;
some direction is given as to treatment protocols, dosage or frequency in [0124] –[0125], however these are proposed treatments that were never run or evaluated.
(G) The existence of working examples;
There are no working examples on the ex vivo treatment of organs in any patients.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Because each patient response is unique to organ rejection or organ repair, each one must be evaluated by carefully step by step as to dosage, frequency, patient reaction, and efficacy. This involves painstaking, undue experimentation to determine what is efficacious, what if any side effects, and frequency of administration.
The claims for treatment of organ damage or organ rejection are not enabled by the original specification.
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 4, 7, 9-11, 13-15, 17, and 19 recites the limitation " in vivo" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 sets out that treatment is ex vivo. Correction is requested, as the claims contradict how the treatment is administered.
Conclusion
No claims are allowed.
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.
Correspondence
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/CARLOS A AZPURU/ Primary Examiner, Art Unit 1617 caz