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 .
A preliminary amendment was filed on 07/21/2022.
Information Disclosure Statement
Information Disclosure Statements were filed on 07/21/2023, 03/15/2024, and 04/28/2026.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 23, 25-42 in the reply filed on 04/28/2026 is acknowledged.
Claim 24 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/28/2026.
Specification
The disclosure is objected to because of the following informalities: At page 12, the “Brief Description of the Figure’ should be the “Brief Description of the Drawing’.
Appropriate correction is required.
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 23, 25-42 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.
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 or prevention of osteoarthritis through administration of hydrogel (C1) which may be in oxidized or crosslinked by an aqueous auxiliary composition which either forms an oxidized hydrogel (C3) or crosslinked (C4).
(B) The nature of the invention;
The method is used to cushion synovial joints.
(C) The state of the prior art;
The prior art shows the use of hydrogel for cushioning of joints
(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 treatment, response to treatment not always predictable.
(F) The amount of direction provided by the inventor;
Applicants provide examples of treatment, not data on prevention of osteoarthritis
(G) The existence of working examples;
There are no working examples for prevention of osteoarthritis in any patients. Further it is presumed that the hydrogels are used after the diagnosis of osteoarthritis.
(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 any treatment, prevention of disease prevention must be evaluated by carefully step by step evaluation of the patient’s response to treatment. This involves painstaking, undue experimentation to determine what is efficacious, and what if any side effects .The claim for prevention of osteoarthritis is not enabled by the original specification.
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) 23, 25-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over US PG-PUB 2017/210843 (Peeters et al).
Peeters et al teach injectable hydrogel materials that consist of water gellants comprising linear hydrophyllic polymers that comprise hydrogen bonding units in the background combined with cross-linkable groups, resulting in a dynamic but firm hydrogel materials that are easily processable, highly elastic, self-healing, and adhesive [0002]. The water gellant comprises a hydrophilic polymer backbone P, a cross-linkable group D, a hydrogen bonding 4H-unit 4H, having the structure according to formulas (A) or (B) or (C) [0024]. Paragraphs [0073] – [0136] describe the same structure of the water gellant and the 4H group as claimed for C1. Cross-linkable group D uses an oxidative pathway mediated by auxiliary A as an oxidant [0154]. The liquid aqueous formulations can comprise a biologically active compound, or may be pharmaceutically active [0177]. The liquid aqueous formulation can comprise an auxiliary A that initiates of mediates the cross-linking of the D groups in the water gellant. A can be an oxidant or initiator selected from alkali metal periodates, hydrogen peroxide, horseradish peroxidase, as well as a crosslinker or initiator [0181-[0183]. This corresponds to the C2 aspect of the method, leading to either the oxidized C3 , or the crosslinked C4. The liquid formulations can be in situ mixed with auxiliary A resulting in the formation of a hydrogel [0189], again corresponding to either C3 or C4. The examples of Peeters et al appear to be those of the chemical structure and function set out in the instant application. The hydrogel can be used for various biomedical applications such as an artificial cartilage material [0195]. The hydrogels of Peeters et al are administered to a location in the body by injection, catheter, or double-chamber syringe [0195]. Physical characteristics such as viscosity, compression strength and pH can all be modified for their optimal biomedical applications to synovial joints. Therefore Peeters et al teaches preparation of the claimed invention for the same art recognized purpose of treating osteoarthritis. Those of ordinary skill in the art would have been able to select the instant hydrogel composition for treatment of osteoarthritis with a reasonable expectation of similar therapeutic results given the various uses taught by Peeters et al.
Conclusion
No claims are allowed
Augustine et al is cited as background art on biomedical hydrogels.
Correspondence
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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