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 .
DETAILED ACTION
The amendment after non-final office action filed January 29, 2026 is acknowledged. Claims 2-4, 7-9, 16 were cancelled, claims 1, 5-6, 10, 14-15, 18 and 20 was amended, claims 21-27 were newly added and claims 1, 5-6, 10-15, 17-27 are pending.
*After further review, a new rejection under obvious type Double patenting is presented below due to amendment and thus, a second Non-final follows.
Election/Restrictions
The election of species requirement was previously withdrawn.
Claims 1, 5-6, 10-15, 17-27 are examined on the merits of this office action.
Withdrawn Objections/Rejections
The objection to claims 1, 5, 15 is withdrawn in view of amendment of the claims filed January 29, 2026.
The rejection of claims 1-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of amendment of the claims filed January 29, 2026.
The rejection of claims 1-20 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of amendment of the claims filed January 29, 2026.
Maintained/Revised Rejections
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.
Claim 6 is 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.
Claim 6 claims “the lipoprotein of claim 1, wherein 20 mol% of the one or more amphiphiles included in the surfactant composition have at least one single negative charge”. The phrase “at least one single negative charge” is ambiguous, as it is uncertain whether each compound must have exactly one negative charge or at least one (with the possibility of more). The term “single negative charge” suggests exactly one negative charge, whereas “at least one” encompasses one or more charges. Accordingly, the metes and bounds of the claim are not certain.
Response to Applicant’s Arguments
Applicants do not address the specific rejection, in particular the phrase “at least one single negative charge” and thus, the rejection is maintained.
New Rejections
Claim Rejections - 35 USC § 112
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.
Claims 10 and 18 are 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.
Claims 10 and 18 are dependent on claim 1. Claim 1 was amended to recite “wherein the hydrophobic group comprises at least one hydrocarbon moiety, wherein said hydrocarbon moiety is selected from the group consisting of branched or linear alkyl, branched or linear alkenyl or cycloalkyl, each of C5-C30”. However, claims 10 and 18 further recite that the hydrocarbon moiety may be linear alkyl-ether, which is not included among the hydrocarbon moieties recited in instant claim 1. Thus, rather than further limitation claim 1, claims 10 and 18 introduce alternative subject matter outside the scope of claim 1 and thereby broaden the scope of the base claim.
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.
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.
Claims 1, 5-6, 10-15, 17-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No.12410213 in view of Cao (Languimir, 2017) and Shakiba (Bioengineering, 2017). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A lipoprotein cage for intracellular delivery of cargo, said lipoprotein cage comprises:(i) an assembled protein cage comprising at least one polypeptide comprising an amino acid sequence I, wherein said amino acid sequence I is an amino acid sequence selected from the group consisting of SEQ ID NOs: 2, 4, 12 to 16, and 20 to 27 wherein said assembled protein cage possesses a positively charged interior; and(ii) a surfactant composition comprising one or more amphiphiles, wherein the one or more amphiphiles are selected such that the net charge of the composition is negative; each of said amphiphiles comprises a hydrophilic group and a hydrophobic group, wherein said hydrophilic group is an anionic hydrophilic group selected from the group consisting of a carboxylate, sulfate, sulfonate, phosphonate, boronate, phosphate and amino acid moiety, and wherein the hydrophobic group comprises at least one hydrocarbon moiety, wherein said hydrocarbon moiety is selected from the group consisting of branched or linear alkyl, branched or linear alkenyl or cycloalkyl, each of C5-C30” (see claim 1). The instant application further claims 20 mol% of said one or more amphiphiles in the surfactant composition C(alim 6); wherein at least one of said one or more amphiphiles is an ammonium salt, alkaline salt or alkaline earth salt of dodecyl sulfate (claim 11); wherein at least one of said one or more amphiphiles is an anionic steroid (claim 12); one or more cargo molecules (claim 13).
US Patent No. ‘213 claims “ A polypeptide comprising an amino acid sequence I, wherein said amino acid sequence I is an amino acid sequence selected from the group consisting of SEQ ID NO: 2 to 5 and SEQ ID NO: 10 to 16, 37 and 38” (which over lap with the instant SEQ ID Nos). US Patent No. ‘213 claims “A complex comprising the nanoparticle of claim 15 and one or more cargo molecules, wherein said one or more cargo molecules are encapsulated in said nanoparticle” (claim 16).
However, Cao teaches surfactants, including anionic SDS (see abstract, pages 5448-5453), interact with peptide self assemblies through electrostatic and hydrophobic interactions to modify morphology, promote hybrid assemblies, and tune nanostructure formation (pages 5448-5452, conclusion paragraph 5453). Shakiba teaches surfactant coated nanoparticles for intracellular drug delivery (Abstract, section 3, intracellular uptake), wherein surfactants improve cargo encapsulation, cellular uptake, endocytosis, endosomal escape and controlled release (section 3; figure 8, section 4).
It would have been obvious before the effective filing date of the claimed invention to modify the protein cage system of the US Patent ‘213 to include a surfactant, such as SDS. One of ordinary skill in the art would do so to improve assembly, stabilized cargo complexes and enhance delivery. Furthermore, such addition constitutes only a routine and predictable optimization and does not render the instant claims patentably distinct. There is a reasonable expectation of success give the art teaches including anionics surfactants to improve properties of self assembling nanoparticles for therapeutic use.
Regarding specific surfactants, such as cholesterol sulfate, it would have been obvious to select cholesterol sulfate as the surfactant because it is known anionic amphiphile having a hydrophobic sterol group and hydrophilic sulfate head group useful for membrane interaction and stabilization. Its selection from known suitable amphiphiles would have a routine optimization.
Claims 1, 5-6, 10-15, 17-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/291236 (reference application) in view of Cao (Languimir, 2017) and Shakiba (Bioengineering, 2017). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A lipoprotein cage for intracellular delivery of cargo, said lipoprotein cage comprises:(i) an assembled protein cage comprising at least one polypeptide comprising an amino acid sequence I, wherein said amino acid sequence I is an amino acid sequence selected from the group consisting of SEQ ID NOs: 2, 4, 12 to 16, and 20 to 27 wherein said assembled protein cage possesses a positively charged interior; and(ii) a surfactant composition comprising one or more amphiphiles, wherein the one or more amphiphiles are selected such that the net charge of the composition is negative; each of said amphiphiles comprises a hydrophilic group and a hydrophobic group, wherein said hydrophilic group is an anionic hydrophilic group selected from the group consisting of a carboxylate, sulfate, sulfonate, phosphonate, boronate, phosphate and amino acid moiety, and wherein the hydrophobic group comprises at least one hydrocarbon moiety, wherein said hydrocarbon moiety is selected from the group consisting of branched or linear alkyl, branched or linear alkenyl or cycloalkyl, each of C5-C30” (see claim 1). The instant application further claims 20 mol% of said one or more amphiphiles in the surfactant composition C(alim 6); wherein at least one of said one or more amphiphiles is an ammonium salt, alkaline salt or alkaline earth salt of dodecyl sulfate (claim 11); wherein at least one of said one or more amphiphiles is an anionic steroid (claim 12); one or more cargo molecules (claim 13).
Co-pending 19/291236 claims “A polypeptide comprising an amino acid sequence I consisting of:MX13QAIGILELX1 SIAAGMELGDAMLKSAX14VX15LLVSKTISX2GKFLLMLG GDIX8AIX9X12AIX1oTGTX11QAGX3LLVDSLVLAXi6IHPSVLPAIX17GX18NX19V X20X7X21 QAVGIVETX4SVAACISAADX22AVX23GSX24VTLVRVHMAX5GIGGK CYMVVAGDVSDVALAVTVAS S SAGAYGX6LVYASLIPX2PHX26AMWX27QM VX28GX29E (SEQ ID NO: 1),wherein any of X1to X29 are independently of each other an amino acid, provided that at least 3 of X1 to X6 are independently of each other a positively charged amino acid, and wherein optionally up to 5 amino acids in positions other than denoted by X1 to X29 in SEQ ID NO: 1 are exchanged by any amino acid” (Claim 1). Co-pending 19/291236 further claims wherein said amino acid sequence I is an amino acid sequence selected from the group consisting of SEQ ID NO: 2 to 5 and SEQ ID NO: 10 to 16, 37 and 38 (instant claim 8) which are identical to the instant respective SEQ ID Nos;; A complex comprising the nanoparticle of claim 11 and one or more cargo molecules, wherein said one or more cargo molecules are encapsulated in said nanoparticle (claim 12). Co-pending 19/291236 is silent to including a surfactant such as SDS within the nanoparticle.
However, Cao teaches surfactants, including anionic SDS (see abstract, pages 5448-5453), interact with peptide self assemblies through electrostatic and hydrophobic interactions to modify morphology, promote hybrid assemblies, and tune nanostructure formation (pages 5448-5452, conclusion paragraph 5453). Shakiba teaches surfactant coated nanoparticles for intracellular drug delivery (Abstract, section 3, intracellular uptake), wherein surfactants improve cargo encapsulation, cellular uptake, endocytosis, endosomal escape and controlled release (section 3; figure 8, section 4).
It would have been obvious before the effective filing date of the claimed invention to modify the protein cage system of the co-pending Application 19/291236 to include a surfactant, such as SDS. One of ordinary skill in the art would do so to improve assembly, stabilized cargo complexes and enhance delivery. Furthermore, such addition constitutes only a routine and predictable optimization and does not render the instant claims patentably distinct. There is a reasonable expectation of success give the art teaches including anionics surfactants to improve properties of self assembling nanoparticles for therapeutic use.
Regarding specific surfactants, such as cholesterol sulfate, it would have been obvious to select cholesterol sulfate as the surfactant because it is known anionic amphiphile having a hydrophobic sterol group and hydrophilic sulfate head group useful for membrane interaction and stabilization. Its selection from known suitable amphiphiles would have a routine optimization.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 23-27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/Examiner, Art Unit 1654
Prosecution Insights