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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, in the reply filed on 10/13/2025, is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/13/2025.
Claim Rejections - 35 USC § 112 –
Indefiniteness, Lack of Antecedent Basis and Broad to Narrow Limitations
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 6, 12 and 13-15 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 6 recites the broad recitation “docetaxel”, and the claim also recites “(DTX)” which is the narrower statement of the range/limitation.
In the present instance, claim 12 recites the broad recitations “docetaxel” and “doxorubicin”, and the claim also recites “(DTX)” and “(DOX)” which are the narrower statements of the range/limitations.
In the present instance, claim 14 recites the broad recitations “phosphatidylcholine and polyethylene glycol”, and the claim also recites “(PC and PEG)” which are the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The Applicant is encouraged to remove the parentheses from the claims.
Regarding lack of antecedent basis, claim 13 recites the limitation "or salt thereof" in line one. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102 - Anticipation
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)(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) 1-10 and 12-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Halbherr et al (US 2022/0265556 A1).
Halbherr taught a liposomal formulation comprising doxorubicin or crystals thereof, in the aqueous inner compartment, and docetaxel in the lipid bilayer [0073, claim 24]. The liposomal formulation comprised phosphatidylcholine, cholesterol and polyethylene glycol [claim 18].
Halbherr anticipates claims 1-10 and 12-14.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Halbherr et al (US 2022/0265556 A1).
Halbherr et al is believed to be anticipatory as described above, but in the interest of completeness of prosecution, purely arguendo, and for the purposes of this ground of rejection only, Halbherr will be interpreted as if it is not anticipatory.
In that case, claims 1-10 and 12-14 are rendered prima facie obvious over the teachings of Halbherr, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., nanoparticle, first layer surrounding core, particle modifier, therapeutics present within core) were known in the prior art (e.g., Halbherr) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would yield nothing more than predictable results (e.g., a liposomal formulation comprising doxorubicin or crystals thereof, in the aqueous inner compartment, and docetaxel in the lipid bilayer) to one of ordinary skill in the art. MPEP 2143.A.
Halbherr reads on claims 1-10 and 12-14.
Claim 11 is rendered prima facie obvious because Halbherr taught nucleic acids [0069].
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Halbherr et al (US 2022/0265556 A1), in view of Briuglia et al (Drug Deliv and Transl Res, 2015, 5, 231-242).
The 35 U.S.C. 103 rejection over Halbherr was previously described.
Additionally, at ¶ [0050] Halbherr taught at least 3 mol % PEG (reads on the claim 15 limitation of the amount of PEG).
At Example 1, Halbherr taught a 60:40 weight ratio of DSPC to cholesterol, which is a molar ratio of 42:58, as calculated below:
1. Molar Masses
DSPC = 790.15 g/mol
Cholesterol = 386.65 g/mol
2. Assume a Total Mass of 100 g (for simplicity, based on the 60:40 weight ratio)
Mass of DSPC = 60 g
Mass of Cholesterol = 40 g
3. Moles of Each Component
Moles of DSPC: 60 g ÷ 790.15 g/mol = 0.0759 mol
Moles of Cholesterol: 40 g ÷ 386.65 g/mol = 0.1034 mol
4. Molar Ratio
DSPC mol %: 0.0759 ÷ 0.1793 x 100 = 42.3 %
Cholesterol mol % : 0.1034 ÷ 0.1793 x 100 = 57.7 %
At a weight ratio of 60:40, the molar ratio of DSPC to cholesterol is approximately 42:58.
As such, Halbherr was not specific the 77:20 molar ratio of PC to cholesterol, as instantly recited in claim 15.
Nevertheless, Briuglia taught the formulation of liposomes comprised of variable molar ratios of phospholipids (e.g., DSPC) and cholesterol, including at ratios of DSPC:cholesterol at 80-20 [abstract].
Regarding the amounts of phospholipid and cholesterol, the differences in the claimed subject matter and the prior art are 42.3 mol % phospholipid and 57.7 mol % cholesterol, as taught by Halbherr; versus a molar ratio of PC:cholesterol at about 77:20, as instantly claimed.
Halbherr is not silent as the amounts of the phospholipid and cholesterol. As discussed, Halbherr taught the phospholipid to cholesterol molar ratio at 42.3:57.7. However, Halbherr did not teach the claimed ratio of 77:20. Nevertheless, Briuglia, taught that these ingredients are useful in a molar ratio of PC:cholesterol of 80:20, which overlaps that which is instantly recited. These ingredients, and their amounts, are recognized to have different effects (greater or less formulation of liposomes, as taught by Briuglia at the abstract) with changing amounts used. Thus, the general condition (the molar ratio) is known and the amounts of these ingredients are recognized to be result effective. As such, result effective variables can be optimized by routine experimentation, and it would have been prima facie obvious to have optimized the amounts of the phosphatidylcholine and cholesterol present in the composition of Halbherr, as taught by Briuglia et al. See MPEP 2144.05.
Further regarding the instant claim 15, the claim requires 77 mol % phosphatidylcholine. Bruiglia taught 80 mol % phosphatidylcholine. The ordinarily skilled artisan would have been motivated to have modified this to have been 77 mol % phosphatidylcholine. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of combining PC and cholesterol to manufacture liposomes have been taught by the prior art [e.g., Bruiglia et al at the abstract; see also Halbherr at claim 18]; as such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of phosphatidylcholine via routine experimentation.
With the combined teachings of Halbherr and Bruiglia, the ordinarily skilled artisan would have had a reasonable expectation of success in arriving at the claimed molar ratio of PC:cholesterol.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612