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 .
Election/Restrictions
Applicant’s election without traverse of Group I claims 1,5,7-8,14-16, 18-19, and 26 in the reply filed on 04/02/2026 is acknowledged.
Claims 21-22, 30-35, 37, 40, and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II, III, IV, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/02/2026.
Priority
The instant application claims domestic priority to PRO 63/238,831 filed 08/31/2021, PRO 63/278,123 filed 11/11/2021, and PRO 63/353,657 filed 06/20/2022. The instant application is a 371 of PCT/IL2022/050951 filed 08/30/2022.
Information Disclosure Statement
The information disclosure statements (IDS) dated 04/08/2024, 04/29/2025, 12/09/2025, and 04/23/2026 all comply with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
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, 5, 7-8, 14-16, 18-19 and 26 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.
Claim 1 recites the limitation “wherein a mean diameter and/or a zeta potential of said liposomes changes by no more than 20 % over the course of 300 days” however no conditions are set for the storage of the liposomes, are they stored at 25C or 50 C or 0C. These conditions could greatly impact the longevity of any composition. As such claim 1 is presently indefinite. Claims 5, 7-8, 14-16, 18-19 and 26 depend from claim 1 and are therefore indefinite. The Examiner is presently interpreting the stability of liposome to be an inherent property of the liposome.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1, 5, 7-8, 14-16, 18-19, 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klein et al (WO2017109784A1 provided in the IDS filed 04/08/2024).
Klein recites polymeric compound having the general formula I:
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Formula I wherein:
m is zero or a positive integer;
n is an integer which is at least 1 , wherein when X does not comprise a phosphate group, n is at least 2;
X is a lipid moiety;
Y is a backbone unit which forms a polymeric backbone;
L is absent or is a linking moiety; and
Z has the general formula II:
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Formula II wherein:
A is a substituted or unsubstituted hydrocarbon;
B is an oxygen atom or is absent; and
R1-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl (Klein at claim 1). Klein recites wherein Y is a substituted or unsubstituted alkylene unit (Klein at claim 2). Klein recites wherein Y is a substituted or unsubstituted ethylene unit. (Klein at claim 3). Klein recites wherein Y has the formula -CR4R5-CR6D-, wherein:
when Y is a backbone unit which is not attached to said L or said Z, D is R7; and when Y is a backbone unit which is attached to said L or said Z, D is a covalent bond or a linking group attaching Y to said L or said Z, said linking group being selected from the group consisting of -0-, -S-, alkylene, arylene, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, O-carbamyl, N- carbamyl, O-thiocarbamyl, N-thiocarbamyl, C-amido, N-amido, C-carboxy, O-carboxy, sulfonamido, and amino; and
R R7 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, heteroalicyclic, halo, hydroxy, alkoxy, aryloxy, thiohydroxy, thioalkoxy, thioaryloxy, sulfinyl, sulfonyl, cyano, nitro, azide, azo, phosphate, phosphonyl, phosphinyl, oxo, carbonyl, thiocarbonyl, urea, thiourea, O- carbamyl, N-carbamyl, O-thiocarbamyl, N-thiocarbamyl, C-amido, N-amido, C- carboxy, O-carboxy, sulfonamido, and amino (Klein at claim 4). Klein recites liposome comprising at least one lipid bilayer according to any one of claims 30 to 31 (Klein at claim 32). Klein recites lipid bilayer comprising at least one bilayer-forming lipid and the polymeric compound of any one of claims 1 to 29 (Klein at claim 30). Klein recites a lubricant composition comprising liposomes according to claim 32 and a carrier (Klein at claim 35). Klein recites wherein said carrier comprises an aqueous liquid (Klein at claim 36). Klein recites wherein B is an oxygen atom (Klein at claim 11). Klein recites herein A is a substituted or unsubstituted hydrocarbon from 1 to 4 carbon atoms in length (Klein at claim 12). Klein recites wherein R4-R3 are each independently hydrogen or Ci_4-alkyl (Klein at claim 14). Klein recites wherein X has the general formula III:
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Formula III wherein:
Wi and W2 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl and acyl, wherein at least one of Wi and W2 is not hydrogen; J is -P(=0)(OH)-0- or absent;
K is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length; M is a linking group selected from the group consisting of -0-, -S-, amino, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, carbamyl, thiocarbamyl, amido, carboxy, and sulfonamide, or absent; and Q is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, or absent,
wherein when M is absent, Q is also absent (Klein at claim 22). Klein recites wherein J is -P(=0)(OH)-0- and K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety (Klein at claim 23). Klein recites wherein M is amido (Klein at claim 24). Klein recites wherein Q is dimethylmethylene (-C(CH3)2-) (Klein at claim 25). Klein recites wherein at least one of Wi and W2 is alkyl, alkenyl, alkynyl or acyl, being from 10 to 30 carbon atoms in length (Klein at claim 28). Klein recites an article of manufacture comprising a composition-of-matter, the composition- of-matter comprising a substrate coated, on at least a portion of a surface thereof, by a lipid bilayer according to claim 30 (Klein at claim 50).
Claim Rejections - 35 USC § 103
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.
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.
a) Claims 1,5,7-8,14-16,18-19,26 are rejected under 35 U.S.C. 103 as being unpatentable over Klein et al (WO2017109784A1 provided in the IDS filed 04/08/2024).
Klein recites polymeric compound having the general formula I:
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Formula I wherein:
m is zero or a positive integer;
n is an integer which is at least 1 , wherein when X does not comprise a phosphate group, n is at least 2;
X is a lipid moiety;
Y is a backbone unit which forms a polymeric backbone;
L is absent or is a linking moiety; and
Z has the general formula II:
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Formula II wherein:
A is a substituted or unsubstituted hydrocarbon;
B is an oxygen atom or is absent; and
R1-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl (Klein at claim 1). Klein recites wherein Y is a substituted or unsubstituted alkylene unit (Klein at claim 2). Klein recites wherein Y is a substituted or unsubstituted ethylene unit. (Klein at claim 3). Klein recites wherein Y has the formula -CR4R5-CR6D-, wherein:
when Y is a backbone unit which is not attached to said L or said Z, D is R7; and when Y is a backbone unit which is attached to said L or said Z, D is a covalent bond or a linking group attaching Y to said L or said Z, said linking group being selected from the group consisting of -0-, -S-, alkylene, arylene, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, O-carbamyl, N- carbamyl, O-thiocarbamyl, N-thiocarbamyl, C-amido, N-amido, C-carboxy, O-carboxy, sulfonamido, and amino; and
R R7 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, heteroalicyclic, halo, hydroxy, alkoxy, aryloxy, thiohydroxy, thioalkoxy, thioaryloxy, sulfinyl, sulfonyl, cyano, nitro, azide, azo, phosphate, phosphonyl, phosphinyl, oxo, carbonyl, thiocarbonyl, urea, thiourea, O- carbamyl, N-carbamyl, O-thiocarbamyl, N-thiocarbamyl, C-amido, N-amido, C- carboxy, O-carboxy, sulfonamido, and amino (Klein at claim 4). Klein recites liposome comprising at least one lipid bilayer according to any one of claims 30 to 31 (Klein at claim 32). Klein recites lipid bilayer comprising at least one bilayer-forming lipid and the polymeric compound of any one of claims 1 to 29 (Klein at claim 30). Klein recites a lubricant composition comprising liposomes according to claim 32 and a carrier (Klein at claim 35). Klein recites wherein said carrier comprises an aqueous liquid (Klein at claim 36). Klein recites wherein B is an oxygen atom (Klein at claim 11). Klein recites herein A is a substituted or unsubstituted hydrocarbon from 1 to 4 carbon atoms in length (Klein at claim 12). Klein recites wherein R4-R3 are each independently hydrogen or Ci_4-alkyl (Klein at claim 14). Klein recites wherein X has the general formula III:
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Formula III wherein:
Wi and W2 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl and acyl, wherein at least one of Wi and W2 is not hydrogen; J is -P(=0)(OH)-0- or absent;
K is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length; M is a linking group selected from the group consisting of -0-, -S-, amino, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, carbamyl, thiocarbamyl, amido, carboxy, and sulfonamide, or absent; and Q is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, or absent,
wherein when M is absent, Q is also absent (Klein at claim 22). Klein recites wherein J is -P(=0)(OH)-0- and K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety (Klein at claim 23). Klein recites wherein M is amido (Klein at claim 24). Klein recites wherein Q is dimethylmethylene (-C(CH3)2-) (Klein at claim 25). Klein recites wherein at least one of Wi and W2 is alkyl, alkenyl, alkynyl or acyl, being from 10 to 30 carbon atoms in length (Klein at claim 28). Klein recites an article of manufacture comprising a composition-of-matter, the composition- of-matter comprising a substrate coated, on at least a portion of a surface thereof, by a lipid bilayer according to claim 30 (Klein at claim 50).
Klein is discussed in the Anticipation Rejection supra. Klein differs from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. Klein teaches the components of the instant recited composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment or a preferred composition. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Klein to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 1, Klein recites a lubricant composition comprising liposomes according to claim 32 and a carrier (Klein at claim 35) Klein recites wherein said carrier comprises an aqueous liquid (Klein at claim 36). Klein recites liposome comprising at least one lipid bilayer according to any one of claims 30 to 31 (Klein at claim 32). Klein recites lipid bilayer comprising at least one bilayer-forming lipid and the polymeric compound of any one of claims 1 to 29 (Klein at claim 30). Klein recites polymeric compound having the general formula I:
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Formula I wherein:
m is zero or a positive integer;
n is an integer which is at least 1 , wherein when X does not comprise a phosphate group, n is at least 2;
X is a lipid moiety;
Y is a backbone unit which forms a polymeric backbone;
L is absent or is a linking moiety; and
Z has the general formula II:
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Formula II wherein:
A is a substituted or unsubstituted hydrocarbon;
B is an oxygen atom or is absent; and
R1-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl (Klein at claim 1). The stability of the liposome would be considered an inherent property. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01(I). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01(II). Therefore, the substantially identical composition of Klein would have the same stability. Similarly, the substantially identical composition of Klein would have the same polydispersity index and zeta potential. Klein does teach zeta potentials in Figure 11. With regards to the elected embodiment as DPPE-pMPC the Formulas of Klein are able to form DPPE-pMPC. The use of DPPE and pMPC are taught in Klein in Figures and Examples.
Regarding instant claim 5, Klein recites wherein Y is a substituted or unsubstituted alkylene unit (Klein at claim 2).
Regarding instant claim 7, Klein recites wherein Y has the formula -CR4R5-CR6D-, wherein:
when Y is a backbone unit which is not attached to said L or said Z, D is R7; and when Y is a backbone unit which is attached to said L or said Z, D is a covalent bond or a linking group attaching Y to said L or said Z, said linking group being selected from the group consisting of -0-, -S-, alkylene, arylene, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, O-carbamyl, N- carbamyl, O-thiocarbamyl, N-thiocarbamyl, C-amido, N-amido, C-carboxy, O-carboxy, sulfonamido, and amino; and
R R7 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, heteroalicyclic, halo, hydroxy, alkoxy, aryloxy, thiohydroxy, thioalkoxy, thioaryloxy, sulfinyl, sulfonyl, cyano, nitro, azide, azo, phosphate, phosphonyl, phosphinyl, oxo, carbonyl, thiocarbonyl, urea, thiourea, O- carbamyl, N-carbamyl, O-thiocarbamyl, N-thiocarbamyl, C-amido, N-amido, C- carboxy, O-carboxy, sulfonamido, and amino (Klein at claim 4).
Regarding instant claim 8, Klein recites wherein B is an oxygen atom (Klein at claim 11). Klein recites herein A is a substituted or unsubstituted hydrocarbon from 1 to 4 carbon atoms in length (Klein at claim 12). Klein recites wherein R4-R3 are each independently hydrogen or Ci_4-alkyl (Klein at claim 14).
Regarding instant claim 14, Klein recites wherein X has the general formula III:
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Formula III wherein:
Wi and W2 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl and acyl, wherein at least one of Wi and W2 is not hydrogen; J is -P(=0)(OH)-0- or absent;
K is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length; M is a linking group selected from the group consisting of -0-, -S-, amino, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, carbamyl, thiocarbamyl, amido, carboxy, and sulfonamide, or absent; and Q is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, or absent,
wherein when M is absent, Q is also absent (Klein at claim 22).
Regarding instant claim 15, Klein recites wherein J is -P(=0)(OH)-0- and K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety (Klein at claim 23).
Regarding instant claim 16, Klein recites wherein M is amido (Klein at claim 24).
Regarding instant claim 18, Klein recites wherein Q is dimethylmethylene (-C(CH3)2-) (Klein at claim 25).
Regarding instant claim 19, Klein recites wherein at least one of Wi and W2 is alkyl, alkenyl, alkynyl or acyl, being from 10 to 30 carbon atoms in length (Klein at claim 28).
Regarding instant claim 26, Klein recites an article of manufacture comprising a composition-of-matter, the composition- of-matter comprising a substrate coated, on at least a portion of a surface thereof, by a lipid bilayer according to claim 30 (Klein at claim 50).
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.
I) Claims 1, 5, 7-8, 14-16, 18-19, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,684,578 B2 in view of Klein et al (WO2017109784A1 provided in the IDS filed 04/08/2024). The instant application recites a sterile composition comprising an aqueous carrier and liposomes, wherein a mean diameter and/or a zeta potential of said liposomes changes by no more than 20 % over the course of 300 days, and wherein said liposomes comprise: a) at least one bilayer-forming lipid; and b) a polymeric compound having the general formula I :
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wherein: m is zero or a positive integer; n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2; X is a lipid moiety; Y is a backbone unit which forms a polymeric backbone; L is absent or is a linking moiety; and Z has the general formula II:
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wherein: A is a substituted or unsubstituted hydrocarbon; B is an oxygen atom or is absent; and Ri-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl wherein: a polydispersity index of said liposomes is no more than 0.2; and/or a zeta potential of said liposomes is in a range of from -40 mV to 40 mV or of from -10 mV to 10 mV.
The reference patent 578 recites A method of delivering a therapeutically active agent to a subject in need thereof, the method comprising administering to the subject a liposome comprising:
a) at least one bilayer-forming lipid;
b) a polymeric compound having the general formula I:
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wherein:
m is zero or a positive integer;
n is an integer which is at least 3;
Y is a backbone unit which forms a polymeric backbone;
L is absent or is a linking moiety;
Z has the general formula II:
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wherein:
A is a substituted or unsubstituted hydrocarbon;
B is an oxygen atom or is absent; and
R1-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl; and
X is a lipid moiety having the general formula III:
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wherein:
W1 and W2 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl and acyl, wherein at least one of W1 and W2 is not hydrogen;
J is —P(═O)(OH)—O— or absent;
K is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, or absent;
M is a linking group selected from the group consisting of —O—, —S—, amino, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, carbamyl, thiocarbamyl, amido, carboxy, and sulfonamide, or absent; and
Q is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length,
wherein when M is absent, K is also absent; and
c) a therapeutically active agent, incorporated in the liposome or on a surface of the liposome,
thereby delivering said therapeutically active agent to said subject in need thereof
wherein said administering comprises sustained release of said therapeutically active agent (‘578 at claim 1). The reference patent 578 recites being for use in treating a medical condition treatable by said therapeutically active agent in said subject (‘578 at claim 2). The reference patent 578 recites wherein said therapeutically effective agent is selected from the group consisting of an analgesic, an anti-inflammatory agent, an anti-proliferative agent, an anti-microbial agent, and a vaccine antigen (‘578 at claim 3). The reference patent 578 recites wherein said administering is effected by parenteral systemic administration (‘578 at claim 4). The reference patent 578 recites wherein said administering is effected by intra-articular administration (‘578 at claim 5). The reference patent 578 recites being for treating a synovial joint disorder (‘578 at claim 6). The reference patent 578 recites wherein said synovial joint disorder is selected from the group consisting of arthritis, bursitis, carpal tunnel syndrome, fibromyositis, gout, locked joint, tendinitis, traumatic joint injury, and joint injury inflicted by surgery (‘578 at claim 7). The reference patent 578 recites wherein said therapeutically active agent is an analgesic or anti-inflammatory agent (‘578 at claim 8). The reference patent 578 recites wherein a molar ratio of said bilayer-forming lipid and said polymeric compound is in a range of from 5:1 to 5,000:1 (‘578 at claim 9). The reference patent 578 recites wherein Y is a substituted or unsubstituted alkylene unit (‘578 at claim 10). The reference patent 578 recites wherein B is an oxygen atom (‘578 at claim 11). The reference patent 578 recites wherein A is a substituted or unsubstituted hydrocarbon from 1 to 4 carbon atoms in length (‘578 at claim 12). The reference patent 578 recites wherein R1-R3 are each independently hydrogen or C1-4-alkyl (‘578 at claim 13). The reference patent 578 recites wherein n is at least 5 (‘578 at claim 14). The reference patent 578 recites wherein at least a portion of said Y, said L or said Z comprises at least one targeting moiety (‘578 at claim 15). The reference patent 578 recites wherein said lipid is selected from the group consisting of a fatty acid, a monoglyceride, a diglyceride, a triglyceride, a glycerophospholipid, a sphingolipid, and a sterol (‘578 at claim 16). The reference patent 578 recites wherein said lipid moiety comprises at least one fatty acid moiety selected from the group consisting of lauroyl, myristoyl, palmitoyl, stearoyl, palmitoleoyl, oleoyl, and linoleoyl (‘578 at claim 17). The reference patent 578 recites wherein said liposome is formulated as part of a pharmaceutical composition, which further comprises a pharmaceutically acceptable carrier (‘578 at claim 18). The reference patent 578 recites wherein n is in a range of from 5 to 50, and m is in a range of from 0 to 50 (‘578 at claim 19).
The teaching of Klein are discussed above.
It would have been prima facie obvious to have combined the reference liposomes with the liposomes of Klein for the predictable out come of an aqueous composition comprising liposomes with a lipid and a polymeric compound of Formula I. There would be a reasonable expectation of success because the reference and Klein both teach an aqueous carrier with liposomes comprising lipid and a polymeric compound with general formula I. See MPEP 2144.05(I). Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
II)Claims 1, 5, 7-8, 14-16, 18-19, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,642,770 also known as US Patent Application Publication 20230301915A1 in view of Klein et al (WO2017109784A1 provided in the IDS filed 04/08/2024). The instant application recites a sterile composition comprising an aqueous carrier and liposomes, wherein a mean diameter and/or a zeta potential of said liposomes changes by no more than 20 % over the course of 300 days, and wherein said liposomes comprise: a) at least one bilayer-forming lipid; and b) a polymeric compound having the general formula I :
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177
145
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wherein: m is zero or a positive integer; n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2; X is a lipid moiety; Y is a backbone unit which forms a polymeric backbone; L is absent or is a linking moiety; and Z has the general formula II:
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164
301
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wherein: A is a substituted or unsubstituted hydrocarbon; B is an oxygen atom or is absent; and Ri-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl wherein: a polydispersity index of said liposomes is no more than 0.2; and/or a zeta potential of said liposomes is in a range of from -40 mV to 40 mV or of from -10 mV to 10 mV.
The reference patent 770 recites A method of treating a synovial joint disorder in a subject in need thereof, the method comprising administering to the subject a liposome comprising:
a) at least one bilayer-forming lipid;
b) a polymeric compound having the general formula I:
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208
826
media_image9.png
Greyscale
wherein:
m is zero or a positive integer;
n is an integer which is at least 3;
Y is a backbone unit which forms a polymeric backbone;
L is absent or is a linking moiety; and
Z has the general formula II:
PNG
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195
826
media_image7.png
Greyscale
wherein:
A is a substituted or unsubstituted hydrocarbon;
B is an oxygen atom or is absent;
R1-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl; and
X is a lipid moiety having the general formula III:
PNG
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247
826
media_image8.png
Greyscale
wherein:
W1 and W2 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl and acyl, wherein at least one of W1 and W2 is not hydrogen;
J is —P(═O)(OH)—O— or absent;
K is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, or absent;
M is a linking group selected from the group consisting of —O—, —S—, amino, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, carbamyl, thiocarbamyl, amido, carboxy, and sulfonamide, or absent; and
Q is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, wherein when M is absent, K is also absent; and
c) a therapeutically active agent, incorporated in the liposome and/or on a surface of the liposome, said therapeutically active agent being selected from an analgesic, an anti-inflammatory agent, an anti-proliferative agent, an anti-microbial agent, and a vaccine antigen,
thereby treating the synovial joint disorder (‘770 at claim 1). The reference patent 770 recites wherein said therapeutically effective agent is selected from the group consisting of an analgesic, an anti-inflammatory agent and an anti-microbial agent (‘770 at claim 2). The reference patent 770 recites wherein said administering is by parenteral systemic administration (‘770 at claim 3). The reference patent 770 recites wherein administering is by intra-articular administration (‘770 at claim 4). The reference patent 770 recites wherein said synovial joint disorder is selected from the group consisting of arthritis, bursitis, carpal tunnel syndrome, fibromyositis, gout, locked joint, tendinitis, traumatic joint injury, and joint injury associated with surgery (‘770 at claim 5). The reference patent 770 recites wherein Y is a substituted or unsubstituted alkylene unit (‘770 at claim 6). The reference patent 770 recites wherein Y has the formula —CR4R5—CR6D-, wherein:
when Y is a backbone unit which is not attached to said L or said Z, D is R7; and when Y is a backbone unit which is attached to said L or said Z, D is a covalent bond or a linking group attaching Y to said L or said Z, said linking group being selected from the group consisting of —O—, —S—, alkylene, arylene, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, O-carbamyl, N-carbamyl, O-thiocarbamyl, N-thiocarbamyl, C-amido, N-amido, C-carboxy, O-carboxy, sulfonamido, and amino; and
R4-R7 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, heteroalicyclic, halo, hydroxy, alkoxy, aryloxy, thiohydroxy, thioalkoxy, thioaryloxy, sulfinyl, sulfonyl, cyano, nitro, azide, azo, phosphate, phosphonyl, phosphinyl, oxo, carbonyl, thiocarbonyl, urea, thiourea, O-carbamyl, N-carbamyl, O-thiocarbamyl, N-thiocarbamyl, C-amido, N-amido, C-carboxy, O-carboxy, sulfonamido, and amino (‘770 at claim 7). The reference patent 770 recites wherein said linking group is selected from the group consisting of —O—, —C(═O)O—, —C(═O)NH— and phenylene (‘770 at claim 8). The reference patent 770 recites wherein L is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length (‘770 at claim 9). The reference patent 770 recites wherein B is an oxygen atom (‘770 at claim 10). The reference patent 770 recites wherein A is a substituted or unsubstituted hydrocarbon from 1 to 4 carbon atoms in length (‘770 at claim 11). The reference patent 770 recites wherein at least a portion of said Y, said L and/or said Z comprises at least one targeting moiety (‘770 at claim 12). The reference patent 770 recites wherein said lipid is selected from the group consisting of a fatty acid, a monoglyceride, a diglyceride, a triglyceride, a glycerophospholipid, a sphingolipid, and a sterol (‘770 at claim 13). The reference patent 770 recites wherein J is —P(═O)(OH)—O— and K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety (‘770 at claim 14). The reference patent 770 recites wherein M is amido (‘770 at claim 15). The reference patent 770 recites wherein J and K are absent and M is carbonyl (‘770 at claim 16). The reference patent 770 recites wherein Q is dimethylmethylene (—C(CH3)2—) (‘770 at claim 17). The reference patent 770 recites wherein at least one of W1 and W2 is alkyl, alkenyl, alkynyl or acyl, being from 10 to 30 carbon atoms in length (‘770 at claim 18). The reference patent 770 recites wherein said lipid moiety comprises at least one fatty acid moiety selected from the group consisting of lauroyl, myristoyl, palmitoyl, stearoyl, palmitoleoyl, oleoyl, and linoleoyl (‘770 at claim 19). The reference patent 770 recites wherein said liposome is formulated as part of a pharmaceutical composition, which further comprises a pharmaceutically acceptable carrier (‘770 at claim 20). The reference patent 770 recites wherein said carrier comprises an aqueous liquid (‘770 at claim 21). The reference patent 770 recites wherein said pharmaceutical composition further comprises a water-soluble biopolymer (‘770 at claim 22).
The teaching of Klein are discussed above.
It would have been prima facie obvious to have combined the reference liposomes with the liposomes of Klein for the predictable out come of an aqueous composition comprising liposomes with a lipid and a polymeric compound of Formula I. There would be a reasonable expectation of success because the reference and Klein both teach an aqueous carrier with liposomes comprising lipid and a polymeric compound with general formula I. See MPEP 2144.05(I). Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
III)Claims 1, 5, 7-8, 14-16, 18-19, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,730,976 B2 in view of Klein et al (WO2017109784A1 provided in the IDS filed 04/08/2024). The instant application recites a sterile composition comprising an aqueous carrier and liposomes, wherein a mean diameter and/or a zeta potential of said liposomes changes by no more than 20 % over the course of 300 days, and wherein said liposomes comprise: a) at least one bilayer-forming lipid; and b) a polymeric compound having the general formula I :
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145
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wherein: m is zero or a positive integer; n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2; X is a lipid moiety; Y is a backbone unit which forms a polymeric backbone; L is absent or is a linking moiety; and Z has the general formula II:
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164
301
media_image5.png
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wherein: A is a substituted or unsubstituted hydrocarbon; B is an oxygen atom or is absent; and Ri-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl wherein: a polydispersity index of said liposomes is no more than 0.2; and/or a zeta potential of said liposomes is in a range of from -40 mV to 40 mV or of from -10 mV to 10 mV.
The reference patent 976 recites A polymeric compound having the general formula I:
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209
825
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wherein:
m is zero or a positive integer;
n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2;
X is a lipid moiety;
Y is a backbone unit which forms a polymeric backbone;
L is absent or is a linking moiety; and
Z has the general formula II:
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196
825
media_image11.png
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wherein:
A is a substituted or unsubstituted hydrocarbon;
B is an oxygen atom or is absent; and
R1-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl,
and wherein:
a) said lipid is selected from the group consisting of a fatty acid, a monoglyceride, a glycerophospholipid, and a sphingolipid, and/or
b) X has the general formula III:
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246
825
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wherein:
W1 and W2 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl and acyl, wherein at least one of W1 and W2 is not hydrogen;
J is —P(═O)(OH)—O— or absent;
K is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length;
M is a linking group selected from the group consisting of —O—, —S—, amino, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, carbamyl, thiocarbamyl, amido, carboxy, and sulfonamide, or absent; and
Q is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, or absent,
wherein when M is absent, Q is also absent (‘976 at claim 1). The reference patent 976 recites wherein Y is a substituted or unsubstituted alkylene unit (‘976 at claim 2).. The reference patent 976 recites wherein Y has the formula —CR4R5—CR6D-, wherein:
when Y is a backbone unit which is not attached to said L or said Z, D is R7; and when Y is a backbone unit which is attached to said L or said Z, D is a covalent bond or a linking group attaching Y to said L or said Z, said linking group being selected from the group consisting of —O—, —S—, alkylene, arylene, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, O-carbamyl, N-carbamyl, O-thiocarbamyl, N-thiocarbamyl, C-amido, N-amido, C-carboxy, O-carboxy, sulfonamido, and amino; and
R4-R7 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, heteroalicyclic, halo, hydroxy, alkoxy, aryloxy, thiohydroxy, thioalkoxy, thioaryloxy, sulfinyl, sulfonyl, cyano, nitro, azide, azo, phosphate, phosphonyl, phosphinyl, oxo, carbonyl, thiocarbonyl, urea, thiourea, O-carbamyl, N-carbamyl, O-thiocarbamyl, N-thiocarbamyl, C-amido, N-amido, C-carboxy, O-carboxy, sulfonamido, and amino (‘976 at claim 3). The reference patent 976 recites wherein A is a substituted or unsubstituted hydrocarbon from 1 to 4 carbon atoms in length (‘976 at claim 4). The reference patent 976 recites wherein n is at least 3 (‘976 at claim 5). The reference patent 976 recites wherein at least a portion of said Y, said L and/or said Z comprise at least one targeting moiety (‘976 at claim 6). The reference patent 976 recites wherein said lipid is selected from the group consisting of a fatty acid, a monoglyceride, a glycerophospholipid, and a sphingolipid (‘976 at claim 7). The reference patent 976 recites wherein X has said general formula III (‘976 at claim 8). The reference patent 976 recites wherein at least one of W1 and W2 is alkyl, alkenyl, alkynyl or acyl, being from 10 to 30 carbon atoms in length (‘976 at claim 9). The reference patent 976 recites a lipid bilayer comprising at least one bilayer-forming lipid and the polymeric compound of claim 1 (‘976 at claim 10). The reference patent 976 recites a liposome comprising at least one lipid bilayer according to claim 10 (‘976 at claim 11). The reference patent 976 recites further comprising at least one functional moiety or agent, bound to a surface of the liposome and/or within a lipid bilayer and/or core of the liposome (‘976 at claim 12). The reference patent 976 recites a lubricant composition comprising liposomes according to claim 11 and a carrier (‘976 at claim 13). The reference patent 976 recites being for lubricating a physiological surface, wherein said carrier is a physiologically acceptable carrier (‘976 at claim 14). The reference patent 976 recites a method of reducing a friction coefficient of a surface, the method comprising contacting the surface with liposomes according to claim 11 (‘976 at claim 15). The reference patent 976 recites further comprising contacting the surface with a water-soluble polymer (‘976 at claim 16). The reference patent 976 recites wherein said surface is a physiological surface, the method being effected by contacting the surface with a composition comprising said liposomes and a physiologically acceptable carrier (‘976 at claim 17). The reference patent 976 recites a method of treating a synovial joint disorder associated with an increased friction coefficient of an articular surface in the synovial joint in a subject in need thereof, the method comprising administering to the subject the liposome of claim 11 (‘976 at claim 18). The reference patent 976 recites a method of inhibiting biofilm formation on a surface of a substrate, the method comprising contacting the substrate with a composition which comprises liposomes according to claim 11 (‘976 at claim 19). The reference patent 976 recites an article of manufacture comprising a composition-of-matter, the composition-of-matter comprising a substrate coated, on at least a portion of a surface thereof, by a lipid bilayer according to claim 10 (‘976 at claim 20).
The teaching of Klein are discussed above.
It would have been prima facie obvious to have combined the reference liposomes with the liposomes of Klein for the predictable out come of an aqueous composition comprising liposomes with a lipid and a polymeric compound of Formula I. There would be a reasonable expectation of success because the reference and Klein both teach an aqueous carrier with liposomes comprising lipid and a polymeric compound with general formula I. See MPEP 2144.05(I).Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
IV)Claims 1, 5, 7-8, 14-16, 18-19, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,396563 B2 in view of Klein et al (WO2017109784A1 provided in the IDS filed 04/08/2024). The instant application recites a sterile composition comprising an aqueous carrier and liposomes, wherein a mean diameter and/or a zeta potential of said liposomes changes by no more than 20 % over the course of 300 days, and wherein said liposomes comprise: a) at least one bilayer-forming lipid; and b) a polymeric compound having the general formula I :
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145
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wherein: m is zero or a positive integer; n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2; X is a lipid moiety; Y is a backbone unit which forms a polymeric backbone; L is absent or is a linking moiety; and Z has the general formula II:
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164
301
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wherein: A is a substituted or unsubstituted hydrocarbon; B is an oxygen atom or is absent; and Ri-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl wherein: a polydispersity index of said liposomes is no more than 0.2; and/or a zeta potential of said liposomes is in a range of from -40 mV to 40 mV or of from -10 mV to 10 mV.
The reference patent 563 recites a polymeric compound having the general formula I:
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216
825
media_image13.png
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wherein:
m is zero or a positive integer;
n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2;
X is a lipid moiety;
Y is a backbone unit which forms a polymeric backbone;
L is absent or is a linking moiety; and
Z has the general formula II:
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196
825
media_image14.png
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wherein:
A is a substituted or unsubstituted hydrocarbon;
B is an oxygen atom or is absent; and
R1-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl,
and wherein:
a) said lipid is selected from the group consisting of a fatty acid, a monoglyceride, a glycerophospholipid, a sphingolipid, and a sterol; and/or
b) said lipid moiety comprises at least one fatty acid moiety selected from the group consisting of lauroyl, myristoyl, palmitoyl, and stearoyl (‘563 at claim 1). The reference patent 563 recites wherein n is in a range of from 5 to 50, and m is in a range of from 0 to 50 (‘563 at claim 2). The reference patent 563 recites having the general formula Ib:
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wherein:
T is a unit of said Y which comprises at least one targeting moiety;
X and T are attached to distal termini of the polymeric compound; and
X, Y, L, Z, n and m are as defined for general formula I, with the proviso that m is a positive integer (‘563 at claim 3). The reference patent 563 recites wherein said lipid is selected from the group consisting of a fatty acid, a monoglyceride, a glycerophospholipid, a sphingolipid, and a sterol (‘563 at claim 4). The reference patent 563 recites wherein said glycerophospholipid is selected from the group consisting of a phosphatidyl ethanolamine, a phosphatidyl serine, a phosphatidyl glycerol and a phosphatidyl inositol (‘563 at claim 5). The reference patent 563 recites wherein X has the general formula III:
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825
media_image16.png
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wherein:
W1 and W2 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl and acyl, wherein at least one of W1 and W2 is not hydrogen;
J is —P(═O)(OH)—O— or absent;
K is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length;
M is a linking group selected from the group consisting of —O—, —S—, amino, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, carbamyl, thiocarbamyl, amido, carboxy, and sulfonamide, or absent; and
Q is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, or absent,
wherein when M is absent, Q is also absent (‘563 at claim 6). The reference patent 563 recites wherein J is —P(═O)(OH)—O— and K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety (‘563 at claim 7). The reference patent 563 recites wherein M is amido (‘563 at claim 8). The reference patent 563 recites wherein Q is dimethylmethylene (—C(CH3)2—) (‘563 at claim 9). The reference patent 563 recites wherein J, M and Q are each absent (‘563 at claim 10). The reference patent 563 recites wherein K is —C(═O)—C(CH3)2— (‘563 at claim 11). The reference patent 563 recites wherein said lipid moiety comprises at least one fatty acid moiety selected from the group consisting of lauroyl, myristoyl, palmitoyl, and stearoyl (‘563 at claim 12). The reference patent 563 recites Aa lipid bilayer comprising at least one bilayer-forming lipid and the polymeric compound of claim 1 (‘563 at claim 13). The reference patent 563 recites wherein a molar ratio of said bilayer-forming lipid and said polymeric compound is in a range of from 5:1 to 5,000:1 (‘563 at claim 14). The reference patent 563 recites a liposome comprising at least one lipid bilayer according to claim 13 (‘563 at claim 15). The reference patent 563 recites a method of reducing a friction coefficient of a surface, the method comprising contacting the surface with liposomes according to claim 15 (‘563 at claim 16). The reference patent 563 recites being effected by contacting the surface with a composition comprising said liposomes and a carrier which comprises an aqueous liquid (‘563 at claim 17). The reference patent 563 recites wherein said surface is a hydrogel surface (‘563 at claim 18). The reference patent 563 recites wherein said surface is a contact lens surface (‘563 at claim 19). The reference patent 563 recites wherein said surface is an articular surface of a synovial joint, and said carrier is a physiologically acceptable carrier (‘563 at claim 20).
The teaching of Klein are discussed above.
It would have been prima facie obvious to have combined the reference liposomes with the liposomes of Klein for the predictable out come of an aqueous composition comprising liposomes with a lipid and a polymeric compound of Formula I. There would be a reasonable expectation of success because the reference and Klein both teach an aqueous carrier with liposomes comprising lipid and a polymeric compound with general formula I. See MPEP 2144.05(I).Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
V)Claims 1, 5, 7-8, 14-16, 18-19, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,116,428 B2 in view of Klein et al (WO2017109784A1 provided in the IDS filed 04/08/2024). The instant application recites a sterile composition comprising an aqueous carrier and liposomes, wherein a mean diameter and/or a zeta potential of said liposomes changes by no more than 20 % over the course of 300 days, and wherein said liposomes comprise: a) at least one bilayer-forming lipid; and b) a polymeric compound having the general formula I :
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145
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wherein: m is zero or a positive integer; n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2; X is a lipid moiety; Y is a backbone unit which forms a polymeric backbone; L is absent or is a linking moiety; and Z has the general formula II:
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301
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wherein: A is a substituted or unsubstituted hydrocarbon; B is an oxygen atom or is absent; and Ri-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl wherein: a polydispersity index of said liposomes is no more than 0.2; and/or a zeta potential of said liposomes is in a range of from -40 mV to 40 mV or of from -10 mV to 10 mV.
The reference patent 428 recites a polymeric compound having the general formula I:
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208
598
media_image17.png
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wherein:
m is zero or a positive integer;
n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2;
Y is a backbone unit which forms a polymeric backbone;
L is absent or is a linking moiety; and
Z has the general formula II:
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196
757
media_image18.png
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wherein:
A is a substituted or unsubstituted hydrocarbon;
B is an oxygen atom or is absent;
R1-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl; and
X is a lipid moiety having the general formula III:
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246
833
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wherein:
W1 and W2 are each independently an acyl group of from 10 to 30 carbon atoms in length;
J is —P(═O)(OH)—O— or absent;
K is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length;
M is a linking group selected from the group consisting of —O—, —S—, amino, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, carbamyl, thiocarbamyl, amido, carboxy, and sulfonamide, or absent; and
Q is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, or absent, wherein when M is absent, Q is also absent (‘428 at claim 1). The reference patent 428 recites having the general formula Tb:
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209
634
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wherein:
T is a unit of said Y which comprises at least one targeting moiety;
X and T are attached to distal termini of the polymeric compound; and
X, Y, L, Z, n and m are as defined for general formula I, with the proviso that m is a positive integer
(‘428 at claim 2). The reference patent 428 recites wherein J is —P(═O)(OH)—O— and K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety (‘428 at claim 3). The reference patent 428 recites wherein M is amido (‘428 at claim 4). The reference patent 428 recites wherein Q is dimethylmethylene (—C(CH3)2—) (‘428 at claim 5). The reference patent 428 recites wherein J, M and Q are each absent (‘428 at claim 6). The reference patent 428 recites wherein K is —C(═O)—C(CH3)2— (‘428 at claim 7). The reference patent 428 recites wherein W1 and W2 are each independently selected from the group consisting of lauroyl, myristoyl, palmitoyl, stearoyl, palmitoleoyl, oleoyl, and linoleoyl (‘428 at claim 8). The reference patent 428 recites wherein J is —P(═O)(OH)—O— and K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety (‘428 at claim 9). The reference patent 428 recites wherein M is amido (‘428 at claim 10). The reference patent 428 recites wherein Q is dimethylmethylene (—C(CH3)2—) (‘428 at claim 11). The reference patent 428 recites wherein:
J is —P(═O)(OH)—O—;
K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety;
M is amido; and
Q is dimethylmethylene (—C(CH3)2—) (‘428 at claim 12). The reference patent 428 recites a lipid bilayer comprising at least one bilayer-forming lipid and the polymeric compound of claim 1 (‘428 at claim 13). The reference patent 428 recites wherein a molar ratio of said bilayer-forming lipid and said polymeric compound is in a range of from 5:1 to 5,000:1 (‘428 at claim 14). The reference patent 428 recites a liposome comprising at least one lipid bilayer according to claim 13 (‘428 at claim 15). The reference patent 428 recites a method of reducing a friction coefficient of a surface, the method comprising contacting the surface with liposomes according to claim 13 (‘428 at claim 16). The reference patent 428 recites being effected by contacting the surface with a composition comprising said liposomes and a carrier which comprises an aqueous liquid (‘428 at claim 17). The reference patent 428 recites wherein said surface is a hydrogel surface (‘428 at claim 18). The reference patent 428 recites wherein said surface is a contact lens surface (‘428 at claim 19). The reference patent 428 recites wherein said surface is an articular surface of a synovial joint, and said carrier is a physiologically acceptable carrier (‘428 at claim 20).
The teaching of Klein are discussed above.
It would have been prima facie obvious to have combined the reference liposomes with the liposomes of Klein for the predictable out come of an aqueous composition comprising liposomes with a lipid and a polymeric compound of Formula I. There would be a reasonable expectation of success because the reference and Klein both teach an aqueous carrier with liposomes comprising lipid and a polymeric compound with general formula I. See MPEP 2144.05(I).Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
i)Claims 1, 5, 7-8, 14-16, 18-19, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 6-7, 10-11, 14-15, 17, 21, 23, 28-29, 33-35, 37, 39, 41-43, 45-47, 49, and 51 of copending Application No. 19/107,083 in view of Klein et al (WO2017109784A1 provided in the IDS filed 04/08/2024).
The instant application recites a sterile composition comprising an aqueous carrier and liposomes, wherein a mean diameter and/or a zeta potential of said liposomes changes by no more than 20 % over the course of 300 days, and wherein said liposomes comprise: a) at least one bilayer-forming lipid; and b) a polymeric compound having the general formula I :
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145
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wherein: m is zero or a positive integer; n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2; X is a lipid moiety; Y is a backbone unit which forms a polymeric backbone; L is absent or is a linking moiety; and Z has the general formula II:
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wherein: A is a substituted or unsubstituted hydrocarbon; B is an oxygen atom or is absent; and Ri-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl wherein: a polydispersity index of said liposomes is no more than 0.2; and/or a zeta potential of said liposomes is in a range of from -40 mV to 40 mV or of from -10 mV to 10 mV.
The reference application 083 recites a polymeric compound represented by Formula I:
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wherein: m is zero or a positive integer; n is an integer which is at least 2, at least 5, preferably at least 10 (e.g., of from 10 to 200); Y is a backbone unit which forms a polymeric backbone of the polymeric compound; L is absent or is a linking moiety; and Z has the general Formula II:
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wherein: the dashed (curved) line denotes an attachment point to the respective Y backbone unit or to the linking moiety L, if present; A is a substituted or unsubstituted hydrocarbon; B is an oxygen atom or is absent; R1-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl; X is a lipid moiety represented by Formula IV:
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wherein:the dashed (curved) line denotes an attachment point to said polymeric backbone; F1, F2, F3 and F4 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, acyl, alkoxy, thioalkoxy, carboxy, thiocarboxy, wherein at least one of F1, F2, F3 and F4 is not hydrogen and is of at least 10 carbonatoms in length; J is -O-P(=O)(OH)-O- or absent; K is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length or absent; M is a linking group selected from the group consisting of -0-, -S-, amino, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, carbamyl, thiocarbamyl, amido, carboxy, and sulfonamide, or absent; and Q is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, or absent, wherein when M is absent, Q is also absent, and when J is absent, M is not absent, provided that: when J is -O-P(=O)(OH)-O-, M is other than amido and/or Q comprises an aryl moiety. (‘083 at claim 1). The reference application 083 recites wherein at least one of F1, F2, F3 and F4 is derived from a fatty acid selected from the group consisting of lauroyl, myristoyl, palmitoyl, stearoyl, palmitoleoyl, oleoyl, and linoleoyl (‘083 at claim 3). The reference application 083 recites wherein J is -P(=O)(OH)-O-; M is amido; and Q is a hydrocarbon substituted by at least one aryl (‘083 at claim 6). The reference application 083 recites wherein Q is a methylene substituted by at least one aryl (‘083 at claim 7). The reference application 083 recites wherein J and K are each absent and M is carboxy (‘083 at claim 10). The reference application 083 recites wherein at least one, or at least two, of F1, F2, F3 and F4 is independently said thioalkoxy and/or said carboxy (‘083 at claim 11). The reference application 083 recites wherein Q is -C(CH3)2- (‘083 at claim 14). The reference application 083 recites wherein Y is a substituted or unsubstituted alkylene unit (‘083 at claim 15). The reference application 083 recites wherein; B is an oxygen atom-; and/or A is a substituted or unsubstituted hydrocarbon from 1 to 4 carbon atoms in length; and/or R1-R3 are each independently hydrogen or C14-alkyl (‘083 at claim 17). The reference application 083 recites wherein n is at least 30 (‘083 at claim 21). The reference application 083 recites wherein n is at least 50 (‘083 at claim 23). The reference application 083 recites wherein at least a portion of said backbone units Y, said L and/or said Z comprise at least one targeting moiety (‘083 at claim 28). The reference application 083 recites a lipid bilayer comprising at least one bilayer- forming lipid and the polymeric compound of claim l (‘083 at claim 29). The reference application 083 recites a liposome comprising at least one lipid bilayer according to claim 29 (‘083 at claim 33). The reference application 083 recites a composition comprising liposomes of claim 33 and a carrier, preferably an aqueous carrier (‘083 at claim 34). The reference application 083 recites being a sterile composition and/or a lubricant composition (‘083 at claim 35). The reference application 083 recites further comprising a water-soluble polymer (‘083 at claim 37). The reference application 083 recites a method of reducing a friction coefficient of a surface, the method comprising contacting the surface with a composition that comprises a liposome according to claim 33 and carrier (‘083 at claim 39). The reference application 083 recites further comprising contacting the surface with a water-soluble polymer (‘083 at claim 41). The reference application 083 recites wherein said surface is a physiological surface, and said carrier is a physiologically acceptable carrier (‘083 at claim 42). The reference application 083 recites wherein said surface is an articular surface of a synovial joint (‘083 at claim 43). The reference application 083 recites a method of inhibiting biofilm formation on a surface of a substrate, the method comprising contacting the substrate with a composition which comprises a liposome according to claim 33 (‘083 at claim 45). The reference application 083 recites an article of manufacture comprising a composition-of-matter, the composition-of-matter comprising a substrate coated, on at least a portion of a surface thereof, by a liposome according to claim 33 (‘083 at claim 46). The reference application 083 recites A method of treating a synovial joint disorder, the method comprising administering to a subject in need thereof the a composition comprising the liposome and a carrier (‘083 at claim 47). The reference application 083 recites having a therapeutically active agent associated therewith, the liposome or the composition being foruse-in-delivering the therapeutically active agent to a bodily site of a subject (‘083 at claim 49). The reference application 083 recites a process of preparing the polymeric compound of claim l the process comprising contacting an initiator compound having Formula V:
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wherein:F1, F2, F3, F4, J, K, M and Q are as defined for Formula IV; and Ri is an electron transfer functional group, with a plurality of monomers that form said -[Y-L-Z]n-[Y]m- polymeric backbone, under conditions that promote atom transfer radical polymerization (ATRP) (‘083 at claim 51).
The teaching of Klein are discussed above.
It would have been prima facie obvious to have combined the reference liposomes with the liposomes of Klein for the predictable out come of an aqueous composition comprising liposomes with a lipid and a polymeric compound of Formula I. There would be a reasonable expectation of success because the reference and Klein both teach an aqueous carrier with liposomes comprising lipid and a polymeric compound with general formula I. See MPEP 2144.05(I).Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection.
ii)Claims 1, 5, 7-8, 14-16, 18-19, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 18/792,590 in view of Klein et al (WO2017109784A1 provided in the IDS filed 04/08/2024).
The instant application recites a sterile composition comprising an aqueous carrier and liposomes, wherein a mean diameter and/or a zeta potential of said liposomes changes by no more than 20 % over the course of 300 days, and wherein said liposomes comprise: a) at least one bilayer-forming lipid; and b) a polymeric compound having the general formula I :
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wherein: m is zero or a positive integer; n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2; X is a lipid moiety; Y is a backbone unit which forms a polymeric backbone; L is absent or is a linking moiety; and Z has the general formula II:
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wherein: A is a substituted or unsubstituted hydrocarbon; B is an oxygen atom or is absent; and Ri-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl wherein: a polydispersity index of said liposomes is no more than 0.2; and/or a zeta potential of said liposomes is in a range of from -40 mV to 40 mV or of from -10 mV to 10 mV.
The reference application 590 recites a method for treating biofilm in a subject in need thereof, the method comprising administering to the subject a liposome comprising: (a) at least one bilayer-forming lipid; (b) a polymeric compound having the general formula I:
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wherein: m is zero or a positive integer; n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2; X is a lipid moiety; Y is a backbone unit which forms a polymeric backbone; L is absent or is a linking moiety; and Z has the general formula II:
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wherein: A is a substituted or unsubstituted hydrocarbon; B is an oxygen atom or is absent; and R1-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl; c) a positively-charged lipidic agent, incorporated within a lipid bilayer and/or on a surface of the liposome; and (d) a therapeutically active agent, bound to a surface of the liposome and/or within a lipid bilayer and/or core of the liposome (‘590 at claim 1). The reference application 590 recites further comprising a sterol, bound to a surface of the liposome and/or within a lipid bilayer and/or core of the liposome (‘590 at claim 2). The reference application 590 recites wherein said positively-charged lipidic agent comprises a hydrocarbon chain of from 4 to 30 carbon atoms in length, substituted and/or terminated by at least one substituent that is positively charged at physiological conditions (‘590 at claim 3). The reference application 590 recites wherein said substituent is or comprises an amine (‘590 at claim 4). The reference application 590 recites wherein said positively-charged lipidic agent is stearyl amine (‘590 at claim 5). The reference application 590 recites wherein: a molar ratio of said bilayer-forming lipid and said positively-charged lipidic agent is in a range of from 1:1 to 100:1, or from 1:1 to 50:1; and/or a molar ratio of said bilayer-forming lipid and said polymeric compound is in a range of from 1:1 to 100:1, or from 5:1 to 50:1; and/or a molar ratio of said positively-charged lipidic agent and said polymeric compound is in a range of from 10:1 to 1:10 (‘590 at claim 6). The reference application 590 recites wherein Y is a substituted or unsubstituted alkylene unit having the formula –CR4R5-CR6D-, wherein: when Y is a backbone unit which is not attached to said L or said Z, D is R7; and when Y is a backbone unit which is attached to said L or said Z, D is a covalent bond or a linking group attaching Y to said L or said Z, said linking group being selected from the group consisting of –O, -S-, alkylene, arylene, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, O-carbamyl, N-carbamyl, O-thiocarbamyl, N-thiocarbamyl, C-amido, N-amido, C-carboxy, O-carboxy, sulfonamido, and amino; and R4-R7 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, heteroalicyclic, halo, hydroxy, alkoxy, aryloxy, thiohydroxy, thioalkoxy, thioaryloxy, sulfinyl, sulfonyl, cyano, nitro, azide, azo, phosphate, phosphonyl, phosphinyl, oxo, carbonyl, thiocarbonyl, urea, thiourea, O-carbamyl, N-carbamyl, O-thiocarbamyl, N-thiocarbamyl, C-amido, N-amido, C-carboxy, O-carboxy, sulfonamido, and amino (‘590 at claim 7). The reference application 590 recites wherein L is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length (‘590 at claim 8). The reference application 590 recites wherein: B is an oxygen atom; and/or A is a substituted or unsubstituted hydrocarbon from 1 to 4 carbon atoms in length; and/or R1-R3 are each independently hydrogen or C1-4-alkyl (‘590 at claim 9). The reference application 590 recites wherein X has the general formula III:
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wherein: W1 and W2 are each independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl and acyl, wherein at least one of W1 and W2 is alkyl, alkenyl, alkynyl or acyl, being from 10 to 30 carbon atoms in length; J is –P(=O)(OH)-O- or absent; K is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length; M is a linking group selected from the group consisting of –O-, -S-, amino, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, carbamyl, thiocarbamyl, amido, carboxy, and sulfonamide, or absent; and Q is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, or absent, wherein when M is absent, Q is also absent (‘590 at claim 10). The reference application 590 recites wherein J is –P(=O)(OH)-O- and K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety (‘590 at claim 11). The reference application 590 recites wherein M is amido and/or Q is dimethylmethylene (–C(CH3)2-) (‘590 at claim 12). The reference application 590 recites wherein said therapeutically active agent is an antimicrobial agent effective in treating said biofilm (‘590 at claim 13). The reference application 590 recites wherein said biofilm is a bacterial biofilm (‘590 at claim 14). The reference application 590 recites comprising at least two therapeutically active agents, each independently bound to a surface of the liposome and/or within a lipid bilayer and/or core of the liposome (‘590 at claim 15). The reference application 590 recites wherein said at least two therapeutically active agents act in synergy (‘590 at claim 16). The reference application 590 recites wherein the liposome is formulated as part of a pharmaceutical composition, which further comprises a pharmaceutically acceptable carrier (‘590 at claim 17). The reference application 590 recites wherein the pharmaceutical composition comprises a plurality of said liposome (‘590 at claim 18). The reference application 590 recites wherein in at least one portion of said plurality of liposomes each liposome comprises a first therapeutically active agent bound to a surface of the liposome and/or within a lipid bilayer and/or core of the liposome, and in at least one another portion of said plurality of liposomes, each liposome comprises a second therapeutically active agent bound to a surface of the liposome and/or within a lipid bilayer and/or core of the liposome, said first and second therapeutically active agents being different from one another (‘590 at claim 19). The reference application 590 recites wherein said first and second therapeutically active agents act in synergy (‘590 at claim 20).
The teaching of Klein are discussed above.
It would have been prima facie obvious to have combined the reference liposomes with the liposomes of Klein for the predictable out come of an aqueous composition comprising liposomes with a lipid and a polymeric compound of Formula I. There would be a reasonable expectation of success because the reference and Klein both teach an aqueous carrier with liposomes comprising lipid and a polymeric compound with general formula I. See MPEP 2144.05(I).Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection.
iii)Claims 1, 5, 7-8, 14-16, 18-19, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of copending Application No. 18/912,658 in view of Klein et al (WO2017109784A1 provided in the IDS filed 04/08/2024). The instant application recites a sterile composition comprising an aqueous carrier and liposomes, wherein a mean diameter and/or a zeta potential of said liposomes changes by no more than 20 % over the course of 300 days, and wherein said liposomes comprise: a) at least one bilayer-forming lipid; and b) a polymeric compound having the general formula I :
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wherein: m is zero or a positive integer; n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2; X is a lipid moiety; Y is a backbone unit which forms a polymeric backbone; L is absent or is a linking moiety; and Z has the general formula II:
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wherein: A is a substituted or unsubstituted hydrocarbon; B is an oxygen atom or is absent; and Ri-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl wherein: a polydispersity index of said liposomes is no more than 0.2; and/or a zeta potential of said liposomes is in a range of from -40 mV to 40 mV or of from -10 mV to 10 mV.
Reference application 658 recites a lubricant composition comprising a lipid bilayer, said lipid bilayer comprising at least one bilayer-forming lipid and a polymeric compound having the general formula I:
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wherein: m is zero or a positive integer; n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2; Y is a backbone unit which forms a polymeric backbone; L is absent or is a linking moiety; and Z has the general formula II:
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wherein: A is a substituted or unsubstituted hydrocarbon; B is an oxygen atom or is absent; R1-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl; and X is a lipid moiety having the general formula III:
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wherein: W1 and W2 are each independently an acyl group of from 10 to 30 carbon atoms in length; J is –P(=O)(OH)-O- or absent; K is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length; M is a linking group selected from the group consisting of –O-, -S-, amino, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, carbamyl, thiocarbamyl, amido, carboxy, and sulfonamide, or absent; and Q is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, or absent, wherein when M is absent, Q is also absent (‘658 at claim 1). Reference application 658 recites wherein said polymeric compound having the general formula Ib:
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wherein: T is a unit of said Y which comprises at least one targeting moiety; X and T are attached to distal termini of the polymeric compound; and X, Y, L, Z, n and m are as defined for general formula I, with the proviso that m is a positive integer (‘658 at claim 2). Reference application 658 recites wherein J is –P(=O)(OH)-O- and K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety (‘658 at claim 3). Reference application 658 recites wherein M is amido (‘658 at claim 4). Reference application 658 recites wherein Q is dimethylmethylene (–C(CH3)2-) (‘658 at claim 5). Reference application 658 recites wherein J, M and Q are each absent (‘658 at claim 6). Reference application 658 recites wherein K is –C(=O)-C(CH3)2- (‘658 at claim 7). Reference application 658 recites wherein W1 and W2 are each independently selected from the group consisting of lauroyl, myristoyl, palmitoyl, stearoyl, palmitoleoyl, oleoyl, and linoleoyl (‘658 at claim 8). Reference application 658 recites wherein J is –P(=O)(OH)-O- and K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety (‘658 at claim 9). Reference application 658 recites wherein M is amido (‘658 at claim 10). Reference application 658 recites wherein Q is dimethylmethylene (–C(CH3)2-) (‘658 at claim 11). Reference application 658 recites wherein: J is –P(=O)(OH)-O-; K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety; M is amido; and Q is dimethylmethylene (–C(CH3)2-) (‘658 at claim 12). Reference application 658 recites wherein a molar ratio of said bilayer-forming lipid and said polymeric compound is in a range of from 5:1 to 5,000:1 (‘658 at claim 13). Reference application 658 recites further comprises an aqueous carrier (‘658 at claim 14). Reference application 658 recites wherein the lipid bilayer forms a liposome (‘658 at claim 15). Reference application 658 recites further comprising a water-soluble polymer (‘658 at claim 16). Reference application 658 recites composition-of-matter comprising a substrate coated, on at least a portion of a surface thereof, by at lipid bilayer, said lipid bilayer comprising at least one bilayer-forming lipid and a polymeric compound having the general formula I:
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wherein: m is zero or a positive integer; n is an integer which is at least 1, wherein when X does not comprise a phosphate group, n is at least 2; Y is a backbone unit which forms a polymeric backbone; L is absent or is a linking moiety; and Z has the general formula II: Formula II wherein: A is a substituted or unsubstituted hydrocarbon; B is an oxygen atom or is absent; R1-R3 are each independently selected from the group consisting of hydrogen, alkyl, cycloalkyl, heteroalicyclic, aryl and heteroaryl; and X is a lipid moiety having the general formula III: Formula III wherein: W1 and W2 are each independently an acyl group of from 10 to 30 carbon atoms in length; J is –P(=O)(OH)-O- or absent; K is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length; M is a linking group selected from the group consisting of –O-, -S-, amino, sulfinyl, sulfonyl, phosphate, phosphonyl, phosphinyl, carbonyl, thiocarbonyl, urea, thiourea, carbamyl, thiocarbamyl, amido, carboxy, and sulfonamide, or absent; and Q is a substituted or unsubstituted hydrocarbon from 1 to 10 carbon atoms in length, or absent, wherein when M is absent, Q is also absent (‘658 at claim 17). Reference application 658 recites wherein J is –P(=O)(OH)-O- and K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety (‘658 at claim 18). Reference application 658 recites wherein M is amido (‘658 at claim 19). Reference application 658 recites wherein Q is dimethylmethylene (–C(CH3)2-) (‘658 at claim 20). Reference application 658 recites wherein J, M and Q are each absent (‘658 at claim 21). Reference application 658 recites wherein K is –C(=O)-C(CH3)2- (‘658 at claim 22). Reference application 658 recites wherein W1 and W2 are each independently selected from the group consisting of lauroyl, myristoyl, palmitoyl, stearoyl, palmitoleoyl, oleoyl, and linoleoyl (‘658 at claim 23). Reference application 658 recites wherein J is –P(=O)(OH)-O- and K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety (‘658 at claim 24). Reference application 658 recites wherein M is amido (‘658 at claim 25). Reference application 658 recites wherein Q is dimethylmethylene (–C(CH3)2-) (‘658 at claim 26). Reference application 658 recites wherein: J is –P(=O)(OH)-O-; K is selected from the group consisting of an ethanolamine moiety, a serine moiety, a glycerol moiety and an inositol moiety; M is amido; and Q is dimethylmethylene (–C(CH3)2-) (‘658 at claim 27). Reference application 658 recites an article of manufacturing comprising the composition-of-matter of claim 17 (‘658 at claim 28). Reference application 658 recites wherein said substrate is a medical device (‘658 at claim 29). Reference application 658 recites wherein said medical device is selected from a medical implant, a surgical tool, a wound care decide, a body cavity and personal protection device and a contact lens (‘658 at claim 30). Reference application 658 recites wherein said medical device is selected from catheters, injection ports, intubation equipment, dialysis shunts, dialysis tubing, wound drain tubes, skin sutures, vascular grafts, implantable meshes, intraocular devices, heart valves, general wound dressings, biologic graft materials, tape closures and dressings, surgical incise drapes, needles, drug delivery skin patches, drug delivery mucosal patches, tampons, sponges, surgical and examination gloves, toothbrushes, intrauterine devices (IUDs), diaphragms, condoms, pacemakers, heart valves, replacement joints, catheter access ports, gastric bands, screw plates, artificial spinal disc replacements, internal implantable defibrillators, cardiac resynchronization therapy devices, implantable cardiac monitors, mitral valve ring repair devices, left ventricular assist devices (LVADs), artificial hearts, implantable infusion pumps, implantable insulin pumps, stents, implantable neurostimulators, maxillofacial implants, and dental implants (‘658 at claim 31).
The teaching of Klein are discussed above.
It would have been prima facie obvious to have combined the reference liposomes with the liposomes of Klein for the predictable out come of an aqueous composition comprising liposomes with a lipid and a polymeric compound of Formula I. There would be a reasonable expectation of success because the reference and Klein both teach an aqueous carrier with liposomes comprising lipid and a polymeric compound with general formula I. See MPEP 2144.05(I). Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are presently allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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