DETAILED ACTION
Status of Application
Claims 1-19 are pending
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s species election without traverse of Group I, drawn to a His-tag, as submitted in communication filed on 07/06/2026 is acknowledged.
Claims 1-19 are at issue and will be examined to the extent they encompass the elected invention.
Priority
Acknowledgment is made of applicant’s claim for domestic priority under 35
U.S.C. 119 (e) to provisional Application No. 61/993,696 filed on 05/15/2014.
Information Disclosure Statement
The information disclosure statement filed 09/09/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Drawings
The drawings submitted on 09/09/2024 have been reviewed and are accepted by
the examiner for examination purposes.
Claim Objections
Claim 1 is objected to due to the recitation of “i) at least a portion of apolipoprotein A-I (ApoA1… and i) an affinity tag; and b) a population of HDL molecules”. It should be amended to recite “i) at least a portion of apolipoprotein A-I (ApoA1… and ii) an affinity tag; and b) a population of HDL molecules”. Appropriate correction is required.
Claim 16 is objected to due to the recitation of “apolipoprotein A-I (ApoA1) ApoA1 mimetic”. It should be amended to have a comma between “apolipoprotein A-I (ApoA1)” and “ApoA1 mimetic”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
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 ** 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.
Claims 4, 9, 11 (claims 10, 12, and 13 dependent thereon) are indefinite in the recitation of “non low density lipoprotein (LDL) depleted”, for the following reason: “non LDL” could encompass anything that is not a low density lipoprotein or it could be referring to a high density lipoprotein. Therefore, it is unclear what “non LDL depleted” encompasses in this case. Correction is required.
Claim 18 (claim 19 dependent thereon) is indefinite in the recitation of “the kit of claim 15 further comprising a linker”, for the following reason: it is unclear if the kit is required to comprise a separate peptide that can act as a linker, or if the linker should be part of any of the proteins of the kit (e.g., the affinity tag or the HDL…core binding peptide). Correction is required.
Claims 6, 14, and 17 are indefinite for the following reason: Claims 6, 14, and 17 contain the trademarks/trade names “Avitag”, “FLAG-tag”, “His-tag”, “S-tag”, and “Strep-tag”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a peptide tag and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103 (AIA )
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.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Fiddyment et al. (Protein Expression and Purification 80.1 (2011): 110-116; hereby “Fiddyment”), in view of Parrish et al. (European heart journal 30.17 (2009): 2137-2146; hereby “Parrish”), and in further view of Morrow et al. (Protein expression and purification 16.2 (1999): 224-230; hereby; “Morrow”).
Fiddyment teaches the expression and purification of wildtype and mutant ApoAI (Abstract). Fiddyment teaches that a pET-45 expression system was used to produce N-terminal His-tagged ApoAI (Page 111 [6]) Fiddyment teaches that Reconstituted HDL particles were prepared with the recombinant apolipoproteins (Page 112 [5]). Fiddyment teaches that the native HDL was obtained from plasma via Ultracentrifugation (Fig 5.).
Regarding claim 1, Fiddyment does not teach the composition of claim 1, wherein the HDL tagging molecules and the HDL molecules are in the composition in a ratio of 1:2 - 2:1. Regarding claims 2-3, Fiddyment does not teach that the composition comprises a human plasma sample. Regarding claims 4, 9, and 11, Fiddyment does not expressly teach that that samples are non low density lipoprotein (LDL) depleted.
Parrish teaches that an HDL particle has 2-3 molecules of apoA1 on their surface (Page 2138 [3]). Morrow teaches the expression and purification of apoE (Page 225 [5]). Morrow teaches that the first purification step uses the His tag present in the linker region between ApoE and thioredoxin (Page 225 [6]). Morrow teaches the isolation of ApoE from human plasma (Page 226 [226]). Morrow teaches that LDL receptor binding assays were performed on the human plasma samples (Page 226 [5]).
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 HDL compositions of Fiddyment with the ApoAI to HDL ratios of Parrish, and use human plasma samples that have not undergone LDL depletion as suggested by Marrow. A person of ordinary skill in the art is motivated to make said modifications because Fiddyment teaches the preparation of recombinant His-tagged HDL particles for use in HDL studies, Parrish teaches the known structural relationship between ApoAI and HDL that would have guided the selection of the recited ratio, and Marrow demonstrates that recombinant apolipoproteins may be analyzed in human plasma without removing LDL first. One of ordinary skill in the art has a reasonable expectation of success at arriving to combining the teachings of Fiddyment, Marrow, and Parrish because all that is required is applying known HDL tagging techniques that were well established in the art. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Fiddyment et al. (Protein Expression and Purification 80.1 (2011): 110-116; hereby “Fiddyment”), in view Morrow et al. (Protein expression and purification 16.2 (1999): 224-230; hereby; Morrow), as applied to claims 1-17, in further view of Sauer et al. (Biochemistry 44.6 (2005): 2021-2029; “Sauer”).
The combined teachings of Fiddyment and Morrow are discussed above. Additionally, Marrow teaches ApoE plays a significant role in lipoprotein uptake.
Regarding claim 18-19, Fiddyment and Morrow do not teach a linker wherein the linker is selected from a PEG linker, a peptide linker, an alkyl linker, or a substituted alkyl linker.
Sauer teaches that human ApoE covalently coupled to PEG-derivatized lipids mediates efficient uptake of liposomes (Page 2 [4]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the PEG-linker, as taught by Sauer, into the combined teachings of Fiddyment and Morrow. A person of ordinary skill in the art is motivated to incorporate the PEG-linker into the combined teachings of Fiddyment and Morrow because Sauer teaches that utilizing a PEG linker facilitates efficient uptake which would improve the uptake of the compositions taught by Fiddyment and Morrow. One of ordinary skill in the art has a reasonable expectation of success at arriving to incorporating Sauer’s known PEG linker into the recombinant HDL taught by Fiddyment and Marrow because all that is required is performing PEG conjugation on the HDL molecules to improve HDL uptake. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claim is in condition for allowance.
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/S.L.S./Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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