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 Application
Applicants' arguments/remarks filed 09/11/2025 are acknowledged. Claim 1 is currently amended. Claims 3 and 5 are canceled. Claims 1, 2, 4 and 6-14 are examined on the merits within and are currently pending.
Withdrawn Rejections
With applicants' amendment, filed 09/11/2025 and with respect to the applicant’s arguments/remarks, the 35 U.S.C. § 103 rejection of Claims 3 and 5 has been withdrawn in view of the cancellation of the claims.
Maintained Rejections
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4 and 6-11 and 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Essler et al. (US 8192753 B2).
Claims 1-2, 4 and 6,
Essler et al. teach liposomes including optionally cationic lipids (Abs). A pH-sensitive cationic lipid with the general formula (I):
Cation-spacer2-Y-spacer1-amphiphilic Substance (I),
wherein
(a) the cation is selected from the group comprising, piperazine or derivatives thereof,
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(b) spacer 1 and/or spacer 2 are lower alkyl residues with up to 8C atoms with linear structure (Col. 2, lines 46-58).
(c) Y comprises a deletion. (Col. 2, line 61). The Y group can be omitted in those cases where the cation can be coupled directly to the amphiphilic substance, e.g. in the esterification of imidazole 4,5-dicarboxylic acid with dipalmitoylglycerol. (Col. 4, lines 26-29).
(d) the amphiphilic Substance comprises a structure according to general formula (III) below (Col 2, lines 66-67):
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Formula III, wherein R1 and R2 independently are C8-C30 acyl chains (C=O) with 0, 1 or 2 ethylenically unsaturated bonds, and X is —O—. (Col 3, lines 18-29).
With these, the structure is the applicant structure (1) below.
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With regard to Claims 7 and 14
The invention also relates to a method of loading liposomes with active substances, wherein one defined pH value is used for encapsulation, and a second pH value is adjusted to
remove unbound active substance. (Col. 14, lines 64-67). The liposomes according to the invention can be used to protect and transport active substances, drugs or pharmaceutical compositions intended to cure, alleviate or avoid diseases, illness, physical defects or pathological affection by application on or in the human body. (Col. 13, lines 38-47).
With regard to Claim 8,
DNA above average can be enclosed in liposomes. (Col. 15, line 15). Preparation of Liposomes Loaded with DNA Plasmids. (Example 6, Col. 18, lines 31-34).
With regard to Claim 9,
The liposome comprises the additional lipid compound cholesterol. (Claim 7, Col. 20).
With regard to Claims 10-11,
Formula III, wherein R1 and R2 independently are C8-C30 acyl chains (C=O) with 0, 1 or 2 ethylenically unsaturated bonds. (Col 3, lines 18-29).
The liposome comprises additional lipid compound is phosphatidylcholine, phosphatidyl ethanolamine, ceramide, sphingolipid, tetraether lipid, cholesterol or diacylglycerol, phosphatidyl serine, phosphatidic acid or CHEMS. (Claim 7, Col. 20).
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.
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 non-obviousness.
Claim(s) 1, 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Essler et al. (US 8192753 B2), as applied in claim 1 above, in view of Ugwu et al. (US 20200138717 A1).
The teachings of Essler et al. are described in claims 1 and 11 above.
Claim(s) 12
Essler et al. teach chloroform is to dissolve phospholipid and other lipids. (Example 6, Col. 18, lines 36-38).
Essler et al. do not teach alcohol solution is to dissolve phospholipid.
Ugwu et al. teach preparing a lipid phase by dissolving aprepitant, phospholipid, and tocopherol in ethanol or a mixture of ethanol-methylene chloride. (0054).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to prepare lipid particles with phospholipids taught by Essler et al. and with ethanol solvent, taught by Ugwu et al. since ethanol is one of many common solvents used to prepare lipid particles.
With regard to Claim 13
Essler et al. teach preparation of liposome loaded with DNA plasmids in an acidic buffer NaAc, pH 4. (Col. 18, Example 6).
Response to Arguments
Regarding Claims Rejections Under 35 U.S.C. § 102/103
Applicant argues that Essler is too broad to anticipate the claimed invention. Allegedly, Essler meets the limitations of claim 1, however the reference is very broad encompassing a plethora of options. For a rejection under 102, the claimed subject matter must be directed at a narrow range, and the reference teaches a broad range, it is reasonable to conclude that the narrow range is not disclosed with sufficient specificity to constitute anticipation of the claims.
Applicant's arguments have been fully considered but they are not persuasive because Essler teaches applicant’s compound (1), with many options of R1, R2 and m as applicant does. Essler add more options of the cation, which is selected from imidazole, morpholine, piperazine, purine, pyridine and/or pyrimidine or derivatives thereof, while applicant specifies the cation is piperazine. Applicant is not persuasive to compare broader (Essler) vs. broad (applicant) to be too broad. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed."). See also MPEP § 2131.05 and § 2145, subsection X.D., which discuss prior art that teaches away from the claimed invention in the context of anticipation and obviousness, respectively.
Applicant argues that Essler clearly lacks an anticipatory example of the claimed invention. In Net Moneyin Inc., the Federal Circuit emphasized that more than mere disclosure of all claim limitations within the four corners of a document is required to anticipate a claim. And applicant argues that Regarding the 103 rejection, since there are too copious a number of choices described in Essler, the reference is too broad to render obvious the claimed invention. "In determining obviousness, the inquiry is not whether each element existed in the prior art, but whether the prior art made obvious the invention as a whole for which patentability is claimed.
Applicant's arguments have been fully considered but they are not persuasive because the express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. "The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness." In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP § 716.07. See also In re Antor Media Corp., 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012). Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102." In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims. The response above to the applicant’s argument is based on applicant’s amended claim 1 that wherein R 1 and R2 are the same or different and each represent a chain hydrocarbon group having 11 to 23 carbon atoms, R3 represents a hydrogen atom and m represents an integer of 1 to 3.
Conclusion
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.
Correspondence
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGOC-ANH THI NGUYEN whose telephone number is (571)270-0867. The examiner can normally be reached Monday - Friday 8:00 am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NGOC-ANH THI NGUYENExaminer, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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