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 .
Response to Restrictions
Applicant’s election of Group I in the reply filed on December 29, 2025 is 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)).
Claims 23-24, 27, 29, 31-32 and 35-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 December 29, 2025.
Claims
Claim Rejections - 35 USC § 112 - Indefiniteness
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 11 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.
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 11 recites the broad recitation comprises a phospholipid and a sterol, and the claim also recites “optionally wherein said sterol comprises cholesterol, and said phospholipid comprises a zwitterionic lipid, an anionic lipid, a PEG-ylated lipid including any combination thereof”, which is 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.
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.
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 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 1-2, 5-6, 8, 10-11, 14-15, 17-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bianco-Peled (US 2019/0224111).
Bianco-Peled et al. disclose a composition and method for the administration of therapeutic and/or diagnostic agents. The composition is a hybrid system composed of a polymer comprising drug-loaded lipid nanoparticles (instant claim 1b). The composition may comprises non-crosslinked natural or synthetic polymeric chains and the like. The composition may be hydrogel that are freeze dried (instant claim 1d), meeting no more than 5% water. The polymer includes pectin and chitosan (instant claim 1a). The composition comprises 1 to 10% (w/v)% (paragraph 0122), meeting at least 10% polymer.
The composition may be in the form of a paste, which comprises a crosslinking percent of less than 0.1% (paragraph 0107), meeting wherein at least 99.5% of the polymer is not crosslinked (instant claim 2). The paste may comprise regions that protect the liposome region (paragraph 0109). This would meet the composition having layers where the layer in the middle comprises the liposomes (instant claim 2). In one embodiment, the paste comprises a liposome in a ratio (liposome to macromolecule (non-liposomal polymer)) of 800:1, 750:1, 700:1, 650:1, 600:1, 550:1, or 500:1 including any value and range therebetween (paragraph 0122). The paste includes a liquid that may be water (paragraph 0124). The composition may also be a hydrogel, which is freeze-dried.
The nanoparticles are nano-carriers and have a concentration of at least 10% of the volume (paragraph 0181). The nano-carriers are liposomes nanoparticles. Liposomes are artificial vesicles composed of a substantially spherical lipid bilayer which typically, but not exclusively, comprises phospholipids, sterol, e.g., cholesterol, and other lipids (paragraph 0146). The size of the liposomes dispersed throughout the bulk of the hydrogel, is about 50 nm, about 50 nm, about 60 nm, about 70 nm, about 80 nm, about 90 nm, about 100 nm, about 150 nm, about 200 nm, about 250 nm, about 300 nm, about 400 nm, or about 500 nm diameter, including any value and range therebetween. The liposome of the invention comprises hydrogenated soy phosphatidylcholine (HSPC):cholesterol:PEG in a defined ratio. In certain embodiments, the liposome of the invention comprises HSPC:cholesterol:PEG in the ratio of 65:30:5, respectively (paragraph 0191) (instant claim 14). PEG meets the limitation of cytoprotectant because it is a glycol (instant claim 18). The liposomes have an average or median size of at least e.g., 50%, 60%, 70%, 80%, 90%, or 95% of the liposomes, including any value therebetween, ranges from: about 50 nanometers to 500 nanometers, or, in other embodiments, from 100 nm to 300 nm (paragraph 0161). The molar concentration of the nano-carriers in the composition is about 10-200 millimolar (mM). In some embodiments, the concentration of the nano-carriers in the composition is about 50-150 millimolar (mM) (paragraph 0032) (instant claim 17).
The compositions and formulations may further comprise additives such as lactose (a disaccharide, instant claim 1c). These additives other than the polymers are incorporated in an amount of not more than 20% by weight, based on the whole weight of the preparation in order to avoid deterioration of the release sustaining properties of the composition (paragraph 0204).
Bianco-Peled et al. differ from the instant claims insofar as it does not disclose a composition comprising the specific combination of instant claim 1 but does suggests the specific combination.
Bianco-Peled et al. disclose a combination of liposomes in a polymer matrix comprising chitosan or alginate. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added a cryoprotectant, such as a lactose additive, and freeze-dried the composition because it is suggested by Bianco-Peled et al.
In regard to the amount of water, the compositions include freeze-dried compositions and paste that require a liquid but not water. This meets the limitation of no more than 5%.
In regards to claim 5, the cryoprotectant includes disaccharides and lactose, which is a disaccharide may be added as an additive in an amount of no more than 20%. The nano-carrier and polymer of 1:100 to 1:800 (reference claim 18). The amounts overlap that of the instant claims and the nano-carrier may be in an amount less than the additive. It is well-settled, however, that even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05. Accordingly, since an overlap plainly exists here, it would have been obvious to have selected values within the overlap, consistent with this reasoning.
In regards to claim 6, the ratio between bioadhesive polymer and nanoparticles is between 10:1 to 1:10. Both the polymer and nanoparticles may comprises 10% by volume. The amount of nanoparticles are result effective variables because they comprise the therapeutic agent. The polymer is a result effective variable because they control the rate of release. Therefore it would have been obvious to one of ordinary skill in the art to have adjusted each component in order arrive at the desired therapeutic effect of the desired amount of time. See MPEP 2144.05.
In regards with the amount of polymer, when the composition is freeze-dried, the amount would be more than 10% w/w.
In regards to instant claim 15, the liposomes nanoparticles may range from 50 to 500 nm and comprise substantially the same component to form the liposomes. Therefore one of ordinary skill in the art would reasonably conclude that the liposomes of Bianco-Peled et al. would exhibit substantially the same properties as recited in claim 15.
In regards to claim 20, the composition of Bianco-Peled et al. comprises liposome nanoparticles in a matrix comprising chitosan or alginate, which are the substantially the same components recited by the instant claims. Therefore one of ordinary skill in the art would reasonably conclude that the composition of Bianco-Peled et al. would exhibit substantially the same properties as recited in claim 20.
Obvious-Type 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 1-2, 5-6, 8, 10-11, 14-15, 17-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,096,891. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar both sets of claims recite a composition comprising a polymer matrix with nano-carriers comprising a therapeutic agent. The instant claims differ from the patented claims insofar as they recite no more than 5% water and a cryoprotectant. However, the patented claims don’t recite water and the dependent claim 10 of the patented claims recite polyethylene glycol (PEG), which is a glycol and therefore a cryoprotectant.
Therefore the instant claims are obvious over the patented claims.
Claims 1-2, 5-6, 8, 10-11, 14-15, 17-18 and 20 are rejected.
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612