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
This Office Action is a response to Applicant’s Election filed May 22, 2026.
Claims 1-31 are pending in the present application.
Election/Restrictions
Applicant’s election of Group II in the reply filed on May 22, 2026 is acknowledged. Applicant’s further election of nucleic acid from claim 9; siRNA from claim 10; SEQ ID NO:6 from claim 14; and compound 22 from claims 7, 14 and 22 are also acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Accordingly, claims 9 and 21-31 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-8 and 10-20 have been examined on the merits as detailed below:
Information Disclosure Statement
It is noted that Applicants have not filed an information disclosure statement under § 1.97(c). Applicant is reminded of 37 CFR § 1.56, which details Applicants duty to disclose all information known to be material to patentability.
Drawings
The Drawings filed on November 6, 2023 are acknowledged and have been accepted by the Examiner.
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, 8, 10, 11 and 15-20 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 pre-AIA the applicant regards as the invention.
Claim 1 discloses the cationic lipid of Formula (I). From the description in the present description, it is disclosed, "a novel and safe cationic lipid for effectively delivering a therapeutic agent into a cell". In this example, the cationic lipid is generally an amphiphilic lipid having a hydrophilic group having a structure very similar to that of a natural phospholipid and a hydrophobic group due to an aliphatic hydrocarbon, and is a compound having a cationic charge on a molecule. However, Formula (I) also includes the case where at least one of X and Y is -(C=O) CH2NH2 and the other X, Y, and Z are selected from the group consisting of -(C=O) CH2NH2 and H, that is, the case of monoglycerol, diglycerol and triglycerol. Since these compounds are polar and do not have a hydrophobic group due to an aliphatic hydrocarbon, they are contrary to the structure of the cationic lipid claimed. In addition, when considering the description of the present application, there is no description or example in which monoglycerol, diglycerol, and triglycerol (i.e. polar compounds) are used as cationic lipids. Further, considering the common technical knowledge before the effective filing date, it is recognized that a cationic lipid for effectively delivering a therapeutic agent into a cell needs to be an amphiphilic compound. Since a compound such as monoglycerol is polar and does not have a hydrophobic group and is not amphiphilic, the metes and bounds of the present application cannot be determined.
MPEP § 2173.02 (II) states that one of the purposes of examination under 35 USC § 112, second paragraph is to determine whether the claim apprises one of ordinary skill in the art of its scope and, therefore, serves the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent. See, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). See also In re Larsen, No. 01-1092 (Fed. Cir. May 9, 2001) (unpublished). If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993). In this case, there is no “bright line” by which to reasonably apprise the scope of the invention. As presented, the claims are not clear or precise and therefore indefinite.
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
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.
Claims 1-8 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 91/16880 A1 to Eibl Hansjörg.
The claims are drawn to a cationic lipid of formula (I),
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wherein at least one of X and Y is –(C=O)CH2NH2, and the other X, Y, and Z are independently selected from the group consisting of –(C=O)CH2NH2, –[(C=O)CH2NH](C=O)R1, –(C=O)R1, and H, wherein R1 is C9-25 alkyl, or C13-21 alkenyl.
Hansjörg teaches and discloses liposomes with an excess positive charge which can be used as carriers of active substances and drug carriers when treating liver diseases. Hansjörg teaches a compound and generic formulae which fall under formula (I) of claim 1 of the present invention, liposomes containing them, the use of the liposomes for delivery of an active pharmaceutical ingredient (API) for treating malignant and inflammatory liver diseases (cf. 01, page 8, lines 15-23; page 9, lines 4-10; page 18, lines 13-23; page 19; compound 9; page 24, line 5 - page 25, line 10; page 9, lines 25-31; page 3, lines 3-16; and claims 1-11).
Hansjörg teach a subformula of diacylglycerides with glycine attached to the remaining position of the glycerine (cf. 01, page 8, lines 15-23) which is exemplified by the specific compound 1,2-dipalmitoyl-sn-glycero-3-glycinester, HCI (cf. 01, page 19). See compound 9 of Hansjörg. NOTE: Hansjörg teaches that more than one glycine moiety may be present.
The 1,2-dipalmitoyl-sn-glycero-3-glycinester, HCI disclosed in Hansjörg corresponds to a compound in which X is –(C=O)CH2NH2, Y and Z are independently (C=O)R1, and R1 is C15 alkyl among the compounds represented by Formula (I) of Claim 1 of the present application.
Hansjörg teach the compounds of their invention are converted into a lipid suspension together with other liposome components to form a liposome and as liposome components, DPPC and cholesterol are comprised therein. Hansjörg further teach different molar ratios of the cationic lipid and the non-cationic lipid. See Tables 1 and 2, for example.
Hansjörg also teach a drug preparation containing one or more agents in a liposome and identify interferon as an example of one or several API.
Staring from compound 9 of Hansjörg, it would have been obvious to modify the substituents of the exemplified compounds (e.g. compound 9) of Hansjörg by replacing two glycine molecules in order to arrive at the cationic lipid formula of the claimed invention. KSR forecloses an obvious to try rationale may be proper when the possible options for solving a problem are known, finite, and predictable, with a reasonable expectation of success. KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Also, see MPEP § 2143. Furthermore, the modification amounts to the combination of prior art elements according to known methods to yield predictable results. See KSR Int’l Co. v. Teleflex Inc. 550 U.S. 398, 416-417 (2007).
A person of ordinary skill in the art would have been motivated to make this modification since Hansjörg teach liposomes comprising an excess positive charge which can be used as carriers of active substances when treating liver diseases.
One of ordinary skill in the art would have had a reasonable expectation of success since Hansjörg taught teaches that more than one glycine moiety may be present concerning the liposomes of two-chain lipophilic structures which contain a compound of the general formula (I) which has a positive excess charge can be used to treat liver diseases.
Therefore, the subject matter of claims 1-8 and 15-20 is obvious over Hansjörg.
******
Claims 1, 8 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over WO 91/16880 A1 to Eibl Hansjörg and further in view of U.S. Patent Publication 20200318110 A1 to Lin, Shi-Lung.
The claims are as described above.
Hansjörg is relevant and relied upon in its entirety supra.
Hansjörg do not teach an active pharmaceutical ingredient comprising SEQ ID NOs: 1-7 of the present invention.
Shi-Lung teach a synthetic miRNA-302, which can be encapsulated in a cationic liposomal reagent a delivered to cells for the treatment of disease. The synthetic miRNA-302a of Shi-Lung comprises SEQ ID NO:1 of the present invention.
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See Shi-Lung, SEQ. ID. NO. 3.
Shi-Lung also teach a natural pre-miR-302a sequence which comprises SEQ ID NO:2 of the present inventio. See Shi-Lung, SEQ. ID. NO. 4. Shi-Lung further teach an antisense strand of siRNA-302a mimic which comprises SEQ ID NO:7 of the present invention. See Shi-Lung, SEQ. ID. NO. 1.
Hansjörg teach liposomes with an excess positive charge which can be used as carriers of active substances and drug carriers when treating liver diseases. Before the effective filing date of the claimed invention, it would have been prima facie obvious to modify the teachings of Hansjörg to include the miRNA of Shi-Lung for delivery of API to cells.
A person of ordinary skill in the art would have been motivated to make this modification since Hansjörg teach liposomes comprising an excess positive charge which can be used as carriers of active substances when treating diseases.
One of ordinary skill in the art would have had a reasonable expectation of success since Hansjörg taught liposomes of two-chain lipophilic structures which contain a compound of the general formula (I) which has a positive excess charge can be used to treat diseases.
Therefore, the subject matter of claims 1, 8 and 10-14 is obvious over Hansjörg in view of Shi-Lung.
Conclusion
No claims are allowable at this time.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/Primary Examiner, Art Unit 1635
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