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
This Office Action is in response to applicant’s arguments filed on 12/22/25. Claims 1-28 are pending. Claim 1 has been amended. Claims 13-28 have been withdrawn. Claims 1-12 are examined herein.
The claim amendments have rendered all the rejections of the last Office Action moot, therefore hereby withdrawn. The following new rejection 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, 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hadley et al. (US Patent Application 2019/0046495 A1, of record).
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 1, 3-4, 7, 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hadley et al. (US Patent Application 2019/0046495 A1, of record) in view of De Wilde et al. (WO 2019/013615).
The instant claims are directed to a method of reducing brain injury by administering a polyunsaturated fatty acid, wherein the composition does not comprise docosahexaenoic acid.
Hadley et al. teach a method for reducing the risk of pathological effects of traumatic brain injury comprising administering to a subject who is at risk of traumatic brain injury (TBI) a composition comprising docosahexaenoate (DHA) (claim 1) in combination with an omega-6 fatty acid, such as omega-6 docosapentaenoic acid (DPA) or DPAn-6 (paragraphs 0050 and 0096). Additional fatty acids, such as myristic acid, palmitic acid, stearic acid, palmitoleic acid, oleic acid, linoleic acid, α-linoleic acid, or vaccenic acid, may be added to the composition (paragraphs 0051 and 0101). Oral dosage forms, for example gelatin capsules, are taught (claims 25-26). Parenteral dosage forms, for example particles, microparticles, coated particles, are taught (paragraph 0140).
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 obvious 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.
However, Hadley et al. fail to disclose wherein the composition does not comprise docosahexaenoic acid.
De Wilde et al. teach a composition for treating 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).
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 Hadley et al. and not DHA, as taught by De Wilde et al.
A person of ordinary skill in the art would have been motivated to preclude DHA in the composition taught by Hadley et al. because De Wilde et al. teach that DPA is alone useful in the treatment of TBI. Furthermore, De Wilde et al. teach the functional equivalency of the following polyunsaturated fatty acids: DHA, EPA, and DPA. Therefore, the skilled artisan would have had a reasonable expectation of success in reducing brain injury in a subject at risk of TBI by administering a composition comprising DPA and not DHA.
Claims 2, 5-6, 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hadley et al. (US Patent Application 2019/0046495 A1, of record) in view of De Wilde et al. (WO 2019/013615), as applied to claims 1, 3-4, 7, 11-12, further 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), and Weiss et al. (WO 2014/140268 A1).
The instant claims are directed to a method of reducing brain injury by administering a polyunsaturated fatty acid, wherein the composition does not comprise docosahexaenoic acid.
Hadley and De Wilde et al. teach as discussed above, however, fail to disclose lipid nanoparticle, cholesterol, and 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 Hadley and 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 Hadley and De Wilde’s DPA composition into a lipid nanoparticle comprising cholesterol and sphingomyelin because Hadley et al. teaches that the composition may be in the form of a particle, microparticle, or coated particle, which encompasses lipid nanoparticles. 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.
It is noted that the limitation regarding “the step of continuing to administer to the subject the composition comprising a therapeutically effective amount of a polyunsaturated fatty acid after the subject has suffered a TBI or concussion” is obvious because if the same composition is useful for reducing the risk of pathological effects before a traumatic brain injury, it would be expected to have the same usefulness after a traumatic brain injury, absent a showing of unexpected results.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at (866)-217-9197 (toll-free).
/Yong S. Chong/Primary Examiner, Art Unit 1623