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 .
Claim Status
Claims 1-2, 5-6, 10-14, and 21-26 are pending.
Claims 1 and 5-6 are currently amended. Claims 21-26 are new.
Claim 3-4, 7-9, and 15-20 are cancelled.
Claims 10-13 and 21 are withdrawn as being directed to a non-elected invention, the election having been made on 6/26/2025 without traverse.
Claims 1-2, 5-6, 14, and 22-26 have been examined.
Priority
This application is a CON of 17/543,213 12/06/2021 ABN
17/543,213 is a CON of 16/072,454 07/24/2018 PAT 11220530
16/072,454 is a 371 of PCT/EP2017/051409 01/24/2017
FOREIGN APPLICATION EP 16152579.5 filed on 01/25/2016
Withdrawn Rejection
The rejection of Improper Markush Group is withdrawn because claim 3claim 3 is cancelled.
The rejection of claims 1-6, 9, and 14 under 35 U.S.C. 101 is withdrawn because the amendment s to the claims overcome the rejection.
New Ground of Rejection
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 1-2, 5, 6, 14, 22-26 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “a human SEC 14-like protein” and “a cognate ligand”, and the claim also recites “α-tocopherol transfer protein” and “a tocopherol” which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2, 5, 6, 14, and 22-26 are further rejected as depending on claim 1.
The rejection may be overcome by amending claim 1 as follows
A nanosphere comprising an equal number of:
(i) a human SEC14-like protein, and
(ii) a cognate ligand
wherein said SEC14-like protein is α-tocopherol transfer protein (α-TTP) and wherein said cognate ligand
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitation of “wherein said cognate ligand of said α-tocopherol transfer protein (α-TTP) is α-tocopherol” in claim 6 failing to further limit the same limitation of wherein clause in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Modified Rejection
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 1-2, 5-6, 14, and 22-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Min et al. (Proc Natl Acad Sci U S A. 2003 Dec 9;100(25):14713-8, previously cited 9/2/2025) and as evidenced by Aeschimann et al. (Sci Rep. 2017 Jul 10;7(1):4970, previously cited 9/2/2025).
The broadest interpretation of claim 1 is drawn to a ligand complexed with a protein in a composition comprising an equal number of (i) a human SEC14-like protein, and (ii) a cognate ligand of said SEC 14-like protein in a nanosphere comprising trimers formed by the a human SEC14-like protein complexed with its cognate ligand at equa1 number of 3 to 60. The nanosphere is defined in the specification as “a composition” in the specification. (p9, line 29-31).
Min et al. teach “Crystal structure of human α-tocopherol transfer protein (the elected protein species) bound to its ligand: Implications for ataxia with vitamin E deficiency” (Title). Min et al. teach the crystal structure of the complex comprising multiple monomers of an α-tocopherol transfer protein (ATTP) bound to a ligand (2R,4'R,8'R)-α-T (p14714, col 1. Results) at equimolar amount, 1:1 ratio, (p14713, col 2, last para to p14714, col 1, para 1). Min et al. show a monomer of α-tocopherol transfer protein (ATTP) bound to a single α-tocopherol as follows (p14715, Fig 1A), reading on an equal number of α-tocopherol transfer protein and α-
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tocopherol. It is understood Min’s crystal comprising multiple monomers and each monomer comprises a human α-tocopherol transfer protein bound to an α-tocopherol at 1:1 molar ratio. Aeschimann et al. is cited as evidence to show inherent properties of Min crystal. Aeschimann et al. teach a physical phenomenon “ upon binding to its substrate, α-TTP acquires tendency to aggregation (reading on crystalize of monomers of α-tocopherol transfer protein (ATTP) bound to a ligand (2R,4'R,8'R)-α-T at 1:1 molar ratio) into thermodynamically stable high molecular weight oligomers. Determination of the structure of such aggregates by X-ray crystallography revealed a spheroidal particle formed by 24 protein monomers (p2, para 1; Fig 1A). Aeschimann et al. further show a trimer unit aggregating to the spheroidal particle (p4, para 1-2 and Fig 2A). Thus, Min’s crystal comprises trimers formed by a monomer of human α-tocopherol transfer protein and α -tocopherol (α-T) to form a spheroidal particle with equal number 24 protein monomers, reading on the limitations (i) and (ii) in claims 1-2, 5-6, and 22-26. See MPEP 2112.01 (I). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
With respect to claim 14, Min et al. teach a composition comprising crystals of α-tocopherol transfer protein (ATTP) bound to α-tocopherol nanosphere (evidenced by Aeschimann et al. p2, para 1; Fig 1A) in a pharmaceutically acceptable Tris-HCl buffer (p14714, col 1, Crystallography).
Response to Arguments
Applicant's arguments (Remarks, p8, para 2-3) filed 2/2/2026 have been fully considered but they are not persuasive because Aeschimann et al. is cited as evidence to show inherent properties of Min’s crystal structure. Aeschimann et al. teach a physical phenomenon “ upon binding to its substrate, α-TTP acquires tendency to aggregation (reading on crystalize of monomers) into thermodynamically stable high molecular weight oligomers. Determination of the structure of such aggregates by X-ray crystallography revealed a spheroidal particle formed by 24 protein monomers (p2, para 1; Fig 1A). Aeschimann et al. further show a trimer unit aggregating to the spheroidal particle (p4, para 1-2 and Fig 2A). Applicant failed to provide data to show Min’s crystal (as evidenced by Aeschimann et al.) NOT satisfying the claimed structure. It is noted that argument does not replace evidence where evidence is necessary. The examiner requires an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. See MPEP 2112(V).
Modified Rejection
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.
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.
The factual inquiries 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 1-2, 5-6, 14, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Min et al. evidenced by Aeschimann et al. and further in view of NP_000361.1 (https://www.ncbi.nlm.nih.gov/protein/NP000361.1?report=genbank&log$=protalign&blast_rank=1&RID=AEDYCM4U015, previously cited 9/2/2025).
Claims 1-2, 5-6, 14, and 22-26 are drawn to an elected species of human α-tocopherol transfer protein (SEQ ID NO: 3).
Min et al. and evidenced by Aeschimann et al. teach a human α-tocopherol transfer protein bound to its ligand of (2R,4'R,8'R)-α-T (p14714, col 1. Results).
Min et al. and evidenced by Aeschimann et al. did not specify a protein sequence of a human α-tocopherol transfer protein.
NP_000361.1 is cited to show a human α-tocopherol transfer protein was known in the art. A side-by-side comparison of the elected SEQ ID NO: 3 to NP_000361.1 is shown as
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follows, reading on 1-2, 5-6, 14, and 22-26.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Min et al. and evidenced by Aeschimann et al. with (ii) NP_000361.1 because (a) Min et al. and evidenced by Aeschimann et al. teach a human α-tocopherol transfer protein bound to its ligand of (2R,4'R,8'R)-α-T (p14714, col 1. Results) and (b) NP_000361.1 is cited to show a human α-tocopherol transfer protein sequence was known in the art. The combination would have reasonable expectation of success because all references teach a human α-tocopherol transfer protein.
Response to Arguments
Applicant's arguments filed 2/2/2026 have been fully considered but they are not persuasive. See response to arguments above. NP_000361.1 was cited previously and the examiner makes a separate to clarify the prior rejection in response to claim amendments.
Modified Rejection
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
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Claims 1-2, 5-6, 14, and 22-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 13-14 of U.S. Patent No. 11,220,530 B2 (the ‘530 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘530 patent is obvious to this instant application.
Claim 1 of the ‘530 patent disclosed a nanosphere as follows.
Claims 2-3 of the ‘530 patent disclosed human SEC 14-like protein as α-tocopherol transfer protein (α - TTP).
Claim 4 of the ‘530 patent disclosed said cognate ligand of said α-tocopherol transfer protein is a α-tocopherol, satisfying the instant claim 6.
Claim 5 of the ‘530 patent disclosed said cognate ligand of said α-tocopherol transfer protein (α-TTP) is a α-tocopherol, further satisfying the instant claim 6.
Claim 6 of the ‘530 patent disclosed said equal number is 24, satisfying the instant claim 5.
Claims 7-8 of the ‘530 patent disclosed said cognate ligand is R,R,R-α tocopherol.
Claim 13 of the ‘530 patent disclosed a α-tocopherol transfer protein sequence of the elected species of SEQ ID NO: 3.
Claim 14 of the ‘530 patent disclosed a pharmaceutical composition comprising: (a) the nanosphere of claim 1 any one of the claims 1 to 9 and (b) a pharmaceutically acceptable carrier, satisfying the instant claim 14.
Thus, claims 1-8 and 13-14 are obvious to the instant claims 1-2, 5-6, 14, and 22-26.
Conclusion
No claim is allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.L/Examiner, Art Unit 1658
21-May-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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