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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 18, 2025, has been entered.
Status of the Claims
Claims 1-15 are cancelled and claims 16-25 were added in the amendment filed December 18, 2025.
Claim Objections
Claim 19 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. Claim 19 depends from claim 18, which is a multiple dependent claim. See MPEP § 608.01(n).
Claim 20-23 are objected to under 37 CFR 1.75(c) because they depend from claim 19.
Accordingly, claims 19-23 have not been further treated on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-18 and 24-25 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure" (see, e.g., MPEP § 2163(I)(B)).
The language of new claims 16-18 and 24-25 does not literally appear in the originally-filed disclosure. Accordingly, the new claims are not supported by express disclosure in the originally-filed disclosure.
In the Reply filed December 18, 2025, Applicant identified paragraphs [0001]-[0002], [0007], [0022], [0026], [0032], and [0056] as providing support for the amended claim scope. However, these sections of the specification fail to provide implicit or inherent support for the new claims.
Regarding the limitation in claim 16, part (a) “an inner HDL-like vesicle containing apoproteins A and a proteophospholipid with a polypeptide, selected from albumins and transthyretin prealbumins,” the specification includes the following description of an inner HDL-like vesicle in the cited sections:
“inner HDL-like vesicles with a composite comprising apoproteins A and polypeptides from the albumin group, the transthyretin-prealbumin group surrounded with at least one layer containing acyl-phosphatidylcholines which are stabilized with at least one thiolgroup” (para [0001]);
“The inner HDL-like vesicles protect cells with the novel polypeptide composite containing apoproteinsA, transthyretin-prealbumin, cysteine groups which are surrounded with certified semisynthetic, synthetic dipalmitoyl-phosphatidylcholines, wherein cofactors such as apoproteinsE2 and the reelin system activate the VLDL-related systems” (para [0001]);
“ The novel composite containing anionic polypeptides bind zwitterionic acyl-phosphatidylcholines in the form of inner HDL-like vesicles, coated by one or more layers containing acyl-phosphatidylcholines, which are stabilized with enriched thiogroups, with cysteine groups as well. Moreover, at least one layer contains albumin enriched with cysteine-residues, ionic micromaterials and vitamins having a broad buffer capacity and those layers are surrounded with one or two exterior lipid bilayers. The inner HDL-like vesicles protect here human cells of the whole body” (para [0002]);
“The sterile preparation of inner HDL-vesicles is especially important for pulmonal, epimeningeal, parenteral and nasopharyngeal application forms reaching the Plexus Pulmonalis and/or the Chorioid Plexus” (para [0032]).
These sections pointed to by Applicant fail to disclose at least the limitation (emphasis added) “an inner HDL-like vesicle containing apoproteins A and a proteophospholipid with a polypeptide”. There does not appear to be any disclosure of the genus of apoproteins and a proteophospholipid with a polypeptide at all, let alone as the component of the inner HDL-like vesicle.
Regarding the limitation in claim 16, part (b) “in an intermediated layer surrounding inner proteophospholipids, the intermediate albumin layer comprising albumins having at least one cysteine group and transthyretin-prealbumins, wherein the transthyretin-prealbumins are associated with retinols,” the specification includes the following description of the intermediate layer in the cited sections:
“The proteophospholiposomes contain by preference an additional intermediate layer comprising albumin with cofactors as reservoir. The cofactors are selected for the skin by preference out of the group comprising glycoproteins, the filaggrins and the natural moistening factors. The pulmonal application forms are by preference enriched with synthetic dipalmitoyl-phosphatidylcholines as surfactant phospholipids and those are by preference synthetic, semisynthetic, purified proteophosphospholipids and are combined with sterile liquids containing human albumin for bronchial installations (para [0001]).
This section fails to support the limitation in part (b) in its entirety. Although not cited by Applicant, para. [0046] describes “At least one intermediate layer contains albumin with cysteines and provides a broad buffering capacity protecting against swelling of the skin” but does no where mentions the transthyretin-prealbumins, wherein the transthyretin-prealbumins are associated with retinols also required by the claim. Likewise para. [0059] describes “an intermediate layer containing peptides, glycoproteins, cofactors such as reelin and vitamins such as retinol” but does not specifically point to or suggest the claimed combination of albumins having at least one cysteine group and transthyretin-prealbumins associated with retinols.
Regarding the limitation in claim 16, part (c) “an outer lipid bilayer surrounding the intermediate albumin layer, the outer lipid bilayer comprising zwitterionic acyl-phosphatidylcholines and at least one thioether-phosphatidylcholine,” the specification includes the following description of the outer lipid bilayer in the cited sections:
“Moreover, at least one layer contains albumin enriched with cysteine-residues, ionic micromaterials and vitamins having a broad buffer capacity and those layers are surrounded with one or two exterior lipid bilayers” (para. [0002]); and
“ The vesicles are then transformed into micelles in a watery medium having then exterior anionic layers (pH6.5) which can then attract again neutrally charged lipids (about pH7.4). By preference neutrally charged lipids form exterior layers and those bind lipophilic cofactors such as retinol (vitamin A), cholecalciferoles (vitamin D), xanthines as cacao butter and/or with Ginkgolides as Ginkgolide butter (para. [0022]).
These sections pointed to by Applicant fail to disclose at least the limitation (emphasis added) zwitterionic acyl-phosphatidylcholines and at least one thioether-phosphatidylcholine.
Regarding the limitation in claim 16, part (d) “at least one cofactor associated with the intermediate albumin layer, the cofactor being selected from retinols and Ginkgoloides,” the specification includes the following description of the cofactor in the cited sections:
“The proteophospholiposomes contain by preference an additional intermediate layer comprising albumin with cofactors as reservoir. (para [0001]).
These sections pointed to by Applicant fail to disclose a retinol and/or Ginkgoloides associated with the intermediate albumin layer.
Therefore, the specification does not provide inherent or implicit support for the newly added claims.
Claim Rejections - 35 USC § 112(b)
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 17 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.
The indefinite language is (emphasis added): “wherein the albumins in the intermediate albumin layer are selected from serum albumin, lactalbumin and vitamin D binding proteins and from tranthyretin prealbumins”.
This claim depends from claim 16 and is related to part (b) “in an intermediated layer surrounding inner proteophospholipids, the intermediate albumin layer comprising albumins having at least one cysteine group and transthyretin-prealbumins, wherein the transthyretin-prealbumins are associated with retinols”.
The language is indefinite because it is not clear how “and from tranthyretin prealbumins” in claim 17 affects “the transthyretin-prealbumins are associated with retinols” in claim 16.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Both documents were cited on the IDS filed April 16, 2021.
WO 2009/036460 A2 (see paragraphs [0016], [0083], [0088], [0100], [0103], [0530] - [0539], and [0585]) is considered to be the closest prior art to the subject-matter of claim 1. It discloses liposomes containing a conjugate of apolipoprotein ApoA1 and albumin. It also indicates that the proteins contain cysteines and that acylphosphatidylcholine can be used as a further binding partner. WO 2009/036460 A2 does not teach an intermediate layer comprising albumins and transthyretin-prealbumins, and wherein the albumins contain cysteines and the transthyretin-prealbumins are with retinols, and a further layer surrounding the intermediate layer comprising zwitterionic acyl-phosphatidylcholines and at least one stable thioether phosphatidylcholine.
US 2015/086611 A1 describes phospholiposomes with internal vesicles containing a mixture of apolipoproteins and albumin and surrounded by at least one layer of acylphosphatidylcholines. See paragraph [0031], Examples 1 to 6, Figures 1 to 7, and Claims 1 to 20. US 2015/086611 A1 does not teach an intermediate layer comprising albumins and transthyretin-prealbumins, and wherein the albumins contain cysteines and the transthyretin-prealbumins are with retinols, and a further layer surrounding the intermediate layer comprising zwitterionic acyl-phosphatidylcholines and at least one stable thioether phosphatidylcholine.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 7 am - 3 pm.
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/CHRISTINA BRADLEY/Primary Examiner, Art Unit 1654