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 Claims
Claims 2-11 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed May 3, 2024. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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 2-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating an ocular surface blinding disorder, does not reasonably provide enablement for preventing an ocular surface blinding disorder. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized in Ex parte Forman, 230 USPQ 546 (BPAI 1986) and reiterated by the Court of Appeals in In re Wands, 8 USPQ2nd 1400 at 1404 (CAFC 1988). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The Board also stated that although the level of skill in molecular biology is high, the results of experiments in genetic engineering are unpredictable. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
Claims 2-11 require a method of preventing an ocular surface blinding disorder. However, the phrase "preventing a disorder", given its broadest reasonable interpretation in light of the teachings in the specification, requires that absolutely no cell, nor tissue, or individual would present any symptom of a disorder after treatment with the administering an extracellular vesicle. There is no evidence, either in the specification or in the prior art, that any method to date can accomplish this goal. The specification presents the results of experiments demonstrating that administering an extracellular vesicle. These data fails to show that administering an extracellular vesicle prevents However, there is no support for the prevention of any disorder or disease, as is required by the claims, and neither can such support be obtained through reasonable extrapolation of the data or teachings in the art.
Even if the patient has genetic predisposition to the selected identified disease states, you are still treating the individual patient and not preventing. It has not been shown in the specification that the "prevention" of such disease is accepted in the art as being predictive of the utility alleged, especially when absent of pharmacological data.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: When the 35 USC 112 issue stated above is resolved. The instant claims are deemed allowable even though Rodriguez-Borlado WO 2017/160884 teaches treating eye injury/ocular eye condition administering extracellular vesicles from human cardiospheres (see abstract, pg 6, lines 4-12 pg 7 lines 9-13 and claims 1-4), wherein the conditions are limbal stem cell difficiency (see pg 1, lines 5+, as required by instant claims 3-4 and the lesion is a burn of the cornea (see pg 1, lines 30+, as required by instant claim 5) and limbal stem cell is a chronic inflammation, see pg 3, lines 21+). With regards to instant claim 6, Rodriguez-Borlado teaches treating keratitis. Therefore it is reasonable that one of ordinary skill in the art would have been motivated to treat any eye disease associated with keratitis. MPEP 2143 states "when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." Therefore that the skilled artisan would have had reason to try these methods with the reasonable expectation that at least one would be successful. With regards to instant claim 7, it is reasonable that administration of the EV would treat the cornea when applied to the eye as required by instant claim 11. However Rodriguez-Borlado fail to teach per-se that the disorder is ocular surface blinding nonetheless teaches that these conditions leads to potentially blinding injuries (see pg 2, lines 13+). Rodriguez-Borlado also fails to teach that the EVs are produced by a genetically modified cell comprising one or more recombinant nucleic acid sequence(s) expressing recombinant Paired Box 6 (rPAX6) and/or recombinant type VII Collagen (rCOL7A1); and wherein said EVs contain (i) rPAX6 proteins and/or rPAX6 mRNAs; and/or (ii) rCOL7A1 proteins and/or rCOL7A1 mRNAs.
None of the searches teach the production of EV as recited by the instant claim 2. The closest prior art is stated above with recitation of how it relates.
No claims are allowed.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 2/23/26