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 .
Status of the Application
In view of the Pre-Brief Conference Decision filed on 8/11/26, PROSECUTION IS HEREBY REOPENED.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
Claims 1-28 pending. Claims 13-28 have been withdrawn. Claims 1-12 are examined herein.
All rejections of the last Office Action are hereby withdrawn. The following new rejections will now apply.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3-4, 7, 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De Wilde et al. (WO 2019/013615, of record).
De Wilde et al. teach a composition for treating a mammal suffering from or recovering from traumatic brain injury by administering a composition comprising a lipid fraction comprising at least one of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), or docosapentaenoic acid (DPA) (claim 1). The composition may further comprise linoleic acid (claim 4). Any conventional carrier material can be utilized, preferably an organic or inorganic inert carrier material suitable for oral administration (page 8, lines 12-17).
It is noted that the limitation regarding “wherein method reduces formation of micro- or nano-sized tears in a plasma membrane of a brain cell of the subject formed during a concussion or TBI primary injury” is inherent since it refers to an in vivo process that will necessarily occur since all the claimed essential steps have been taught by the cited prior art.
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 of this title, 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.
Claims 2, 5-6, 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over De Wilde et al. (WO 2019/013615, of record), as applied to claims 1, 3-4, 7, 10-12, in view of Muchow et al. (“Omega-3 fatty acids-loaded lipid nanoparticles for patient-convenient oral bioavailability enhancement,” Pharmazie, 2009, 64, 499-504, of record), Cheng et al. (“The role of helper lipids in lipid nanoparticles (LNPs) designed for oligonucleotide delivery,” Advanced Drug Delivery Reviews, 2016, 99, 129-137, of record), and Weiss et al. (WO 2014/140268 A1, of record).
The instant claims are directed to a method of reducing brain injury by administering a composition comprising a polyunsaturated fatty acid, wherein the composition does not comprise docosahexaenoic acid.
De Wilde et al. teach as discussed above, however, fail to disclose lipid nanoparticle, cholesterol or sphingomyelin.
Muchow et al. teach a composition comprising omega-3 fatty acids, encapsulated in a lipid nanoparticle delivery system, which reduces unpleasant taste, avoids swallowing problems, and enhances bioavailability (page 499).
Cheng et al. teach that lipid nanoparticles (LNPs) have shown promise as delivery vehicles for therapeutics. In addition to a cationic lipid, LNPs are typically composed of helper lipids that contribute to their stability and delivery efficiency. Cholesterol is often included as a helper that improves intracellular delivery as well as LNP stability in vivo (abstract).
Weiss et al. teach solid lipid nanoparticles having a solid lipid core which is stabilized by emulsifiers (page 1, lines 1-23), such as sphingomyelin (page 4, lines 24-32).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have formulated the composition comprising DPA, as taught by De Wilde et al., in the method for reducing the risk of pathological effects of traumatic brain injury, in a lipid nanoparticle comprising cholesterol and sphingomyelin, as taught by Muchow, Cheng, and Weiss et al.
A person of ordinary skill in the art would have been motivated to formulate De Wilde’s DPA composition into a lipid nanoparticle comprising cholesterol and sphingomyelin because De Wilde et al. teaches that any conventional carrier material can be utilized. Further, Muchow et al. teaches omega-3 fatty acids containing lipid nanoparticles are well-known to be effective delivery systems that possess several advantages. Furthermore, Cheng and Weiss et al. teach that cholesterol and sphingomyelin are well-known and essential components of lipid nanoparticles. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in formulating a lipid nanoparticle comprising DPA, an additional fatty acid, cholesterol, and sphingomyelin in a method for reducing the risk of pathological effects of traumatic brain injury.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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