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 .
Preliminary Amendments were 12/20/2023 and 03/08/2024.
Information Disclosure Statement
Information disclosure statements were filed 12/20/2023, 06/05/2024, 10/22/204, 03/27/2026, and 08/21/2026.
Election/Restrictions
Applicant elected claims 1-4, 6-18, 22-24 and 31 with traverse. After a review of the election/restriction, it is agreed that claim 25 should be included in the search and examination with the other elected claims.
Therefore, claims 1-4, 6-18, 22-25, and 31 will be searched and examined in this office action.
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 1-4, 6-18, 22-25 and 31 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.
While it is noted that applicant is claiming a treatment method, it was also noted that “treatment” is defined at [00150] as including prevention of the disease. The following rejection is based on that broad definition.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner's position that one skilled in the art could not practice the invention without undue experimentation.
(1) The nature of the invention:
The invention is directed towards treatment of proliferative retinopathy (PVR) through intravitreal administration of a solution of methotrexate, sucrose, and phosphate buffers.
(2) The state of the prior art
Methotrexate is currently used to treat various ophthalmic conditions including retinitis pigmentosa.
(3) The relative skill of those in the art
The relative skill of the those in the art is high and is usually that of a Ph.D. or medical specialist in ophthalmology.
(4) The predictability or unpredictability of the art
The unpredictability of the treatment of PVR art is very high. The significance of a particular medication for different therapeutic uses cannot be predicted a priori but must be determined from the case to case by painstaking experimental study.
(5) The breadth of the claims
The claims are directed towards specific conditions.
(6) The amount of direction or guidance presented
The disclosure defines the various intravitreal compositions and methods used in the treatment of PVR. However, there is no guidance which makes prevention predictable. A disclosure should contain representative examples which provide reasonable assurance to one skilled in the art that the compounds fall within the scope of a claim will possess the alleged activity. See In re Riat et al. (CCPA 1964) 327 F2d 685, 140 USPQ 471; In re Barr et al. (CCPA 1971) 444 F 2d 349, 151 USPQ 724.
(7) The presence or absence of working examples
There are no examples which show prevention of PVR indefinitely.
(8) The quantity of experimentation necessary
Since the significance of the particular therapeutic effect of the claimed method cannot be predicted a priori but must be determined from the case to case by painstaking experimental study , one of ordinary skill in the art would be burdened with undue "painstaking experimentation study" to determine whether the claimed method does indeed “prevent” PVR.
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.
Claim(s) 1, 6-18, and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 202101003A1 (Aldeyra Therapeutics).
Aldeyra Therapeutics teaches intravitreal administration of methotrexate for treatment of various ocular conditions including inflammatory conditions [0004], [0029]. Treatment of PVR is set out in claims 38 to 63, which also depend on claims 1-37 , Sucrose is added as a density enhancing agent [0006]. A phosphate buffer is used at [0008]. Volume of administration is from 20 ul to 300 ul [00124]. The transit rate of the composition is less than 10 mins in 1mL of silicone oil having a viscosity of at least 1000 centistoke and depth of 1 cm (claim 1). Polydimethyl siloxane having viscosities of 1000 centistoke oil and 5,000 centistoke oil is set out at [0042] and [0043], respectively. Transit time can be less than mins (claim 2). The concentration of methotrexate is between 2 m/ML to about 20 m/ML [0072]. The density of the methotrexate is about 1.0 to about 1.2 g/cm3 [0045]. The concentration of sucrose is 0.5% w/v to 18% w/v [0055]. The buffering agent may be phosphate and dibasic [0067], with a pH between 5.5 to 8.5 [0056]. The subject being treated may have a prior history of other ocular conditions [0016]. The dosage of methotrexate is about 50 ug to 600 ug [0014]. Aldeyra Therapeutics states the composition may be used or various ophthalmic diseases [0004] and [0135]- [0136]. The claims are anticipated by Aldeyra Therapeutics.
Conclusion
No claims are allowed.
It is noted that US Patent No. 11,911,385 discloses treatment of both PVR and associated punctate keratitis. However, the claim were restricted out and ultimately canceled. Therefore a rejection under the judicially created doctrine of obviousness-type double patenting is not possible.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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