DETAILED ACTIONStatus of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 2-4, 6-17, 19-21, 24-27, 31-36, 39-43, 45, 47-49, 51, 55-58, 60-62, 64-66, and 68-80 are cancelled.
Claims 1, 5, 18, 22, 23, 28-30, 37, 38, 44, 46, 50, 52-54, 59, 63, 67, and 81 are pending.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 8, recites “betain” which should read as “betaine”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 54, 59, 63, and 67 are 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 pre-AIA the applicant regards as the invention.
Claims 54, 59, 63, and 67 are indefinite for reciting the phrase “nano-in-microparticles” which is unclear because examiner is unable to determine if the formulation is a mixture of different sized nanoparticles, or if the formulation comprises nanoparticles within microparticles, or if the formulation is a mixture of nanoparticles and microparticles. Instant specification [0075]: “the nano-in-microparticles are reconstituted having a mixture of small nanoparticles and large nanoparticles, wherein the small nanoparticles are from about 10 nm to about 100 nm or from about 28 nm to about 44 nm and the large nanoparticles are from about 200 nm to about 600 nm from about 300 nm to about 330 nm”. The instant specification does not objectively provide clarity or guidance for this phrase.
Appropriate correction is required.
Claim Rejections - 35 USC §103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use,
on sale or otherwise available to the public before the effective filing date of the claimed
invention.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 18, 22, 23, 28-30, 37, 38, 44, 46, 50, 52-54, 59, 63, 67, and 81 are rejected under 35 U.S.C. 103 as being unpatentable over Putnam et al. (WO 2014078470 A1) hereinafter Putnam in view of Uchegbu et al. (US2016279189A1) hereinafter Uchegbu.
Regarding claims 1, 5, 18, 22, 23, 28-30, 37, 38, 44, 46, 50, 52-54, 59, 63, 67, and 81, Putnam is drawn to a composition wherein the drug-loaded carrier comprises a biocompatible framework carrying at least one drug, as well as methods for using these compositions for targeted delivery of a drug to cells expressing higher levels of P-glycoprotein compared to other cells in a mammal, for the treatment of various diseases or conditions, such as neurological conditions (abstract).
Putnam discloses the biocompatible framework may also be or include a polysaccharide. The polysaccharide may be based on, for example, a chitosan (glycol chitosan, N-trimethyl chitosan, N-triethyl chitosan). Such polymers and their use in drug delivery are well known in the art, as evidenced by, for example, Z. Liu, et al., "Polysaccharides-based nanoparticles as drug delivery systems", Advanced Drug Delivery Reviews, vol. 60, no. 15, 2008, pp. 1650-1662; and Saravanakumar G. et al., "Polysaccharide-based nanoparticles: a versatile platform for drug delivery and biomedical imaging", Curr. Med. Chem., 19(19), 2012, pp. 3212-3229, all of which are herein incorporated by reference in their entirety [0039].
Putnam discloses the biocompatible framework is in the form of a nanoparticle or microparticle, which may be hollow. As used herein, the term "nanoparticle" generally refers to a particle having a size of at least 1 nm and less than 1 micron, e.g., a particle having a size of precisely, about, at least, greater than, up to, or less than, for example, 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 250, 300, 350, 400 nm [0056].
Putnam discloses the neuroactive drug can be any drug that treats, prevents, or diagnoses a neurological disease or condition. The neuroactive drug may be, for example, a drug to treat a neurological condition, such as Parkinson's disease [0074].
Putnam discloses the pharmaceutical composition may be administered in a number of ways. Administration may be intranasal [0101].
Putnam does not explicitly disclose wherein the glycol chitosan carbohydrate polymer is Quaternary ammonium palmitoyl glycol chitosan (GCPQ).
However, Uchegbu is drawn to a composition comprising a hydrophilic drug and an amphiphilic carbohydrate compound for use in therapy wherein the composition is intranasally administered to the human body. The composition can be used to treat a variety of neurodegenerative conditions (abstract).
Uchegbu discloses although chitosan and its derivatives are well documented for the delivery of drugs via the nasal route, nasal delivery with self-assembling amphiphilic carbohydrates such as GCPQ has not been reported. Unlike chitosan, which is soluble at acidic pH, GCPQ is capable of self-assembly at neutral pH, and this confers an advantage over its parent compound for nasal delivery. We believe that the addition of the palmitoyl chain to chitosan enables this chitosan derivative to self-assemble and confers greater association with drug compounds and therefore enhanced delivery [0014]. Uchegbu discloses the amphiphilic carbohydrate compound forms nanoparticles which can be loaded with hydrophilic drug [0055].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Putnam, wherein the glycol chitosan is GCPQ, as previously disclosed by Uchegbu, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Putnam and Uchegbu disclose chitosan for drug delivery and Uchegbu discloses although chitosan and its derivatives are well documented for the delivery of drugs via the nasal route, nasal delivery with self-assembling amphiphilic carbohydrates such as GCPQ has not been reported. Unlike chitosan, which is soluble at acidic pH, GCPQ is capable of self-assembly at neutral pH, and this confers an advantage over its parent compound for nasal delivery. We believe that the addition of the palmitoyl chain to chitosan enables this chitosan derivative to self-assemble and confers greater association with drug compounds and therefore enhanced delivery [0014]. Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615