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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/20/24 has been entered.
Claims Status
Claims 43-69 are pending in the application.
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.
Claim 51 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.
Claim 51 recites the limitation "the calcium concentration of DPPA" and “the calcium
concentration of DPPC” in lines 1-2. There is insufficient antecedent basis for these limitations in the claim.
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.
Claim(s) 43-69 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hui et al. (US 2012/0027688A1).
Hui et al. (US 2012/0027688A1) teaches of a clear phospholipid suspension comprising a lipid blend, a non-aqueous solvent and a further aqueous solvent (abstract; p4, [0100-0101],[0107]).
The lipid blend comprises N-(methoxypolyethylene glycol 500 carbamoyl)-1,2-dipalmitoyl-sn-glycerol-phosphatidylethanolamine (MPEG5000-DPPE), 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC) and 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid (DPPA) (p1, [0016-0019]; p2, [0054-0058]; p3, [0085]).
The lipid blend anticipates the one or more phospholipids comprising MPEG5000-DPPE, DPPA and DPPC of the instant claims.
The non-aqueous solvents comprise a mixture of methanol and toluene (p1, [0014-0015]; p2,
[0058]) that anticipates the methanol and toluene of the instant claims.
The MPEG5000-DPPE is present in the lipid blend in a molar percentage of 8% (Table 1) that
anticipates the molar percentage of 5-15% MPEG5000-DPPE of the instant claims.
The DPPC is present in the lipid blend in a molar percentage of 82% (Table 1) that anticipates the molar percentage of 77-90% DPPC of the instant claims.
The mole percent ratio of DPPA,DPPC and MPEG5000-DPPE is 10:82:8 (Table 1) that anticipates the mole percent ratio of DPPA,DPPC and MPEG5000-DPPE is 10:82:8 of the instant claims.
The lipid solution may further comprise a saline and/or propylene glycol (p3, [0079]; p4, [0109]) that anticipates the saline and/or propylene glycol of the instant claims.
The addition of the saline aqueous solution anticipates forming the phospholipid suspension with an aqueous solution of the instant claims
The lipid suspension is contacted with a perfluoropropane gas (PFP) (p6, [0126]) that anticipates contacting the phospholipid suspension with a perfluoropropane gas of the instant claims.
The DPPA,DPPC and MPEG5000-DPPE may be present in a range of about 0.75-1.0 mg/mL or 5,6,7, etc. mg/mL (p2, [0028-0029]; p3, [0080]) that anticipates the one or more phospholipids is present in a concentration of about 0.9 to about 7.5 mg/mL of the instant claims.
The ratio of lipid blend to non-aqueous solvent, such as propylene glycol comprises from about 1 mg/mL of lipid blend to solvent to about 100 mg/mL (p4, [0106]) that anticipates the ratio of lipid to propylene glycol of 1:100 of the instant claims.
The phospholipid solution and suspension of Hui et al. anticipates the phospholipid solution and suspension of the instant claims as they both include DPPA,DPPC and MPEG5000-DPPE, methanol/toluene solvent mixture, and saline and/or propylene glycol. Therefore, the phospholipid solution and suspension of Hui et al. have the same properties and are capable of the same functions,
such as a phospholipid solution having a concentration of less than 0.7 ppm of divalent metal ions,
MPEG5000-DPPE having a calcium and/or magnesium concentration of less than 115 ppm, calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm.
The specification states that the low calcium lipid blend solution is clear as contrasted to the
cloudy solution having a high calcium concentration in the lipid blend and/or when a high calcium and magnesium containing MPEG5000-DPPE was added.
Therefore, it would have been predictable to one of ordinary skill in the art that the MPEG5000-DPPE of Hui et al. comprises low calcium and magnesium concentrations and/or a low calcium concentration lipid blend to have a clear resulting phospholipid solution in the non-aqueous solvent. The low lipid blend calcium concentration and/or the low calcium and magnesium concentrations of MPEG5000-DPPE of Hui et al. further yields low calcium and magnesium concentrations in the resulting phospholipid suspension, such as less than 0.7 ppm.
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)
It is respectfully pointed out that instant claims 43-69 are product-by-process limitations. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed Cir. 1985). See MPEP 2113.
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 43-52,54,55,57-66,68 and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9,913,919B2 in view of Hui et al. (US 2012/0027688A1). The lipid-encapsulated gas microspheres made by the method of U.S. Patent No. 9,913,919B2 comprise DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution to form a phospholipid suspension that encompasses the phospholipid suspension comprising DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution of the instant claims.
The ratio of the DPPA,DPPC and MPEP5000-DPPE of U.S. Patent No. 9,913,919B2 comprises 10:82:8 that encompasses the ratio of the DPPA,DPPC and MPEP5000-DPPE of 10:82:8 of the instant claims.
The calcium concentration of MPEG5000-DPPE is less than 115 ppm of U.S. Patent No. 9,913,919B2 that encompasses the calcium concentration of MPEG5000-DPPE is less than 115 ppm of the instant claims.
The calcium concentration of the phospholipid solution is less than 0.7 ppm of U.S. Patent No.
9,913,919B2 that encompasses the calcium concentration of the phospholipid solution is less than 0.7
ppm of the instant claims.
The phospholipid suspension of U.S. Patent No. 9,913,919B2 comprises a perfluorocarbon gas that encompasses the perfluoropropane gas of the instant claims.
The calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of U.S. Patent No. 9,913,919B2 that encompasses the calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of the instant claims.
U.S. Patent No. 9,913,919B2 does not disclose the non-aqueous solvents methanol or toluene of
the instant claims.
Hui et al. (US 2012/0027688A1) teaches that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to include a mixture of the non-aqueous solvents methanol and toluene in the phospholipid blend of U.S. Patent No. 9,913,919B2 to evenly disperse the lipid blend into the liquid and for the advantage of avoiding aggregate forming clumps that are very difficult to disperse.
Claims 43-52,54,55,57-66,68 and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 9,789,210B1 in view of Hui et al. (US 2012/0027688A1). The phospholipid suspension used for the method of ultrasound imaging of U.S. Patent No. 9,789,210B1 comprises DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution to form a phospholipid suspension that encompasses the phospholipid suspension comprising DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution of the instant claims.
The ratio of the DPPA,DPPC and MPEP5000-DPPE of U.S. Patent No. 9,789,210B1 comprises 10:82:8 that encompasses the ratio of the DPPA,DPPC and MPEP5000-DPPE of 10:82:8 of the instant claims.
The calcium concentration of MPEG5000-DPPE is less than 115 ppm of U.S. Patent No. 9,789,210B1 that encompasses the calcium concentration of MPEG5000-DPPE is less than 115 ppm of the instant claims.
The calcium concentration of the phospholipid solution is less than 0.7 ppm of U.S. Patent No.
9,789,210B1 that encompasses the calcium concentration of the phospholipid solution is less than 0.7
ppm of the instant claims.
The phospholipid suspension of U.S. Patent No. 9,789,210B1 comprises a perfluorocarbon gas that encompasses the perfluoropropane gas of the instant claims.
The calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of U.S. Patent No. 9,789,210B1 that encompasses the calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of the instant claims.
U.S. Patent No. 9,789,210B1 does not disclose the non-aqueous solvents methanol or toluene of
the instant claims.
Hui et al. (US 2012/0027688A1) teaches that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to include a mixture of the non-aqueous solvents methanol and toluene in the phospholipid blend of U.S. Patent No. 9,789,210B1 to evenly disperse the lipid blend into the liquid and for the advantage of avoiding aggregate forming clumps that are very difficult to disperse.
Claims 43-52,54,55,57-66,68 and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,220,104B2 in view of Hui et al. (US 2012/0027688A1). The phospholipid suspension made by the method of U.S. Patent No. 10,220,104B2 comprises DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution that encompasses the DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further
Aqueous solution of the instant claims.
The ratio of the DPPA,DPPC and MPEP5000-DPPE of U.S. Patent No. 10,220,104B2 comprises 10:82:8 that encompasses the ratio of the DPPA,DPPC and MPEP5000-DPPE of 10:82:8 of the instant claims.
The calcium concentration of MPEG5000-DPPE is less than 115 ppm of U.S. Patent No. 10,220,104B2 encompasses the calcium concentration of MPEG5000-DPPE is less than 115 ppm of the
instant claims.
The calcium concentration of the phospholipid solution is less than 0.7 ppm of U.S. Patent No. 10,220,104B2 encompasses the calcium concentration of the phospholipid solution is less than 0.7 ppm of the instant claims.
The phospholipid suspension of U.S. Patent No. 10,220,104B2 comprises a perfluorocarbon gas that encompasses the perfluoropropane gas of the instant claims.
The calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of U.S. Patent No. of U.S. Patent No. 10,220,104B2 that encompasses the calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of the instant claims.
U.S. Patent No. 10,220,104B2 does not disclose the non-aqueous solvents methanol or toluene of the instant claims.
Hui et al. (US 2012/0027688A1) teaches that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to include a mixture of the non-aqueous solvents methanol and toluene in the phospholipid blend of U.S. Patent No. 10,220,104B2 to evenly disperse the lipid blend into the liquid and for the advantage of avoiding aggregate forming clumps that are very difficult to disperse.
Claims 43-52,54,55,57-66,68 and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,583,208B2 in view of Hui et al. (US 2012/0027688A1). The phospholipid suspension used in the method of ultrasound imaging of U.S. Patent No. 10,583,208B2 comprises DPPA,DPPC and MPEP5000-DPPE in propylene glycol and an aqueous solution that encompasses the DPPA,DPPC and MPEP5000-DPPE in propylene glycol and an aqueous solution of the instant claims.
The ratio of the DPPA,DPPC and MPEP5000-DPPE of U.S. Patent No. 10,583,208B2 comprises 10:82:8 that encompasses the ratio of the DPPA,DPPC and MPEP5000-DPPE of 10:82:8 of the instant claims.
The calcium concentration of MPEG5000-DPPE is less than 115 ppm of U.S. Patent No. 10,583,208B2 encompasses the calcium concentration of MPEG5000-DPPE is less than 115 ppm of the instant claims.
The calcium concentration of the phospholipid solution is less than 0.7 ppm of U.S. Patent No. 10,583,208B2 encompasses the calcium concentration of the phospholipid solution is less than 0.7 ppm of the instant claims.
The phospholipid suspension of U.S. Patent No. 10,583,208B2 comprises a perfluoropropane gas that encompasses the perfluoropropane gas of the instant claims.
The calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of U.S. Patent No. of U.S. Patent No. 10,583,208B2 that encompasses the calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of the instant claims.
U.S. Patent No. 10,583,208B2 does not disclose the non-aqueous solvents methanol or toluene of the instant claims.
Hui et al. (US 2012/0027688A1) teaches that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to include a mixture of the non-aqueous solvents methanol and toluene in the phospholipid blend of U.S. Patent No. 10,583,208B2 to evenly disperse the lipid blend into the liquid and for the advantage of avoiding aggregate forming clumps that are very difficult to disperse.
Claims 43-52,54,55,57-66,68 and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,266,750B2 in view of Hui et al. (US 2012/0027688A1). The phospholipid suspension used in the method of ultrasound imaging of U.S. Patent No. 11,266,750B2 comprises DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution that encompasses the DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution of the instant claims.
The ratio of the DPPA,DPPC and MPEP5000-DPPE of U.S. Patent No. 11,266,750B2 comprises
10:82:8 that encompasses the ratio of the DPPA,DPPC and MPEP5000-DPPE of 10:82:8 of the instant claims.
The calcium concentration of MPEG5000-DPPE is less than 115 ppm of U.S. Patent No. 11,266,750B2 encompasses the calcium concentration of MPEG5000-DPPE is less than 115 ppm of the instant claims.
The calcium concentration of the phospholipid solution is less than 0.7 ppm of U.S. Patent No. 11,266,750B2 encompasses the calcium concentration of the phospholipid solution is less than 0.7 ppm of the instant claims.
The phospholipid suspension of U.S. Patent No. 11,266,750B2 comprises a perfluoropropane gas that encompasses the perfluoropropane gas of the instant claims.
The calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of U.S. Patent No. of U.S. Patent No. 11,266,750B2 that encompasses the calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of the instant claims.
U.S. Patent No. 11,266,750B2 does not disclose the non-aqueous solvents methanol or toluene of the instant claims.
Hui et al. (US 2012/0027688A1) teaches that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to include a mixture of the non-aqueous solvents methanol and toluene in the phospholipid blend of U.S. Patent No. 11,266,750B2 to evenly disperse the lipid blend into the liquid and for the advantage of avoiding aggregate forming clumps that are very difficult to disperse.
Claims 43-52,54,55,57-66,68 and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,266,749B2 in view of Hui et al. (US 2012/0027688A1). The phospholipid suspension made by the method of U.S. Patent No. 11,266,749B2 comprises DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution that encompasses the DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution of the instant claims.
The ratio of the DPPA,DPPC and MPEP5000-DPPE of U.S. Patent No. 11,266,749B2 comprises 10:82:8 that encompasses the ratio of the DPPA,DPPC and MPEP5000-DPPE of 10:82:8 of the instant claims.
The calcium concentration of MPEG5000-DPPE is less than 115 ppm of U.S. Patent No. 11,266,749B2 encompasses the calcium concentration of MPEG5000-DPPE is less than 115 ppm of the instant claims.
The calcium concentration of the phospholipid solution is less than 0.7 ppm of U.S. Patent No. 11,266,749B2 encompasses the calcium concentration of the phospholipid solution is less than 0.7 ppm
of the instant claims.
The phospholipid suspension of U.S. Patent No. 11,266,749B2 comprises a perfluorocarbon gas that encompasses the perfluoropropane gas of the instant claims.
The calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of U.S. Patent No. of U.S. Patent No. 11,266,749B2 that encompasses the calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of the instant claims.
U.S. Patent No. 11,266,749B2 does not disclose the non-aqueous solvents methanol or toluene of the instant claims.
Hui et al. (US 2012/0027688A1) teaches that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to include a mixture of the non-aqueous solvents methanol and toluene in the
phospholipid blend of U.S. Patent No. 11,266,749B2 to evenly disperse the lipid blend into the liquid and for the advantage of avoiding aggregate forming clumps that are very difficult to disperse.
Claims 43-52,54,55,57-66,68 and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,857,646B2. Although the claims at issue are not identical, they are not patentably distinct from each other because phospholipid suspension made by the method of U.S. Patent No. 11,857,646B2 comprises DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution that encompasses the DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution of the instant claims.
The phospholipid suspension of U.S. Patent No. 11,857,646B2 further comprises the presence of one or two but not all three of methanol, toluene and MTBE that encompasses the presence of one or two but not all three of methanol, toluene and MTBE of the instant claims.
The ratio of the DPPA,DPPC and MPEP5000-DPPE of U.S. Patent No. 11,857,646B2 comprises 10:82:8 that encompasses the ratio of the DPPA,DPPC and MPEP5000-DPPE of 10:82:8 of the instant claims.
The calcium concentration of MPEG5000-DPPE is less than 115 ppm of U.S. Patent No.
11,857,646B2 encompasses the calcium concentration of MPEG5000-DPPE is less than 115 ppm of the
instant claims.
The calcium concentration of the phospholipid solution is less than 0.7 ppm of U.S. Patent No. 11,857,646B2 encompasses the calcium concentration of the phospholipid solution is less than 0.7 ppm of the instant claims.
The phospholipid suspension of U.S. Patent No. 11,857,646B2 comprises a perfluoropropane gas that encompasses the perfluoropropane gas of the instant claims.
The calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC
is less than 90 ppm of U.S. Patent No. of U.S. Patent No. 11,857,646B2 that encompasses the calcium concentration of DPPA is less than 780 ppm and the calcium concentration of DPPC is less than 90 ppm of the instant claims.
Claims 43-46,48-50,52,54,55,57-63,65,66,68 and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 12 of U.S. Patent No. 11,925,695B2 in view of Hui et al. (US 2012/0027688A1). The phospholipid suspension used for the method of ultrasound imaging of U.S. Patent No. 11,925,695B2 comprises DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution that encompasses the DPPA,DPPC and MPEP5000-DPPE in propylene glycol and a further aqueous solution of the instant claims.
The ratio of the DPPA,DPPC and MPEP5000-DPPE of U.S. Patent No. 11,925,695B2 comprises 10:82:8 that encompasses the ratio of the DPPA,DPPC and MPEP5000-DPPE of 10:82:8 of the instant
claims.
The calcium concentration of the phospholipid solution is less than 0.7 ppm of U.S. Patent No. 11,925,695B2 encompasses the calcium concentration of the phospholipid solution is less than 0.7 ppm of the instant claims.
The phospholipid suspension of U.S. Patent No. 11,925,695B2 comprises a perfluoropropane gas
that encompasses the perfluoropropane gas of the instant claims.
U.S. Patent No. 11,925,695B2 does not disclose the non-aqueous solvents methanol or toluene of the instant claims.
Hui et al. (US 2012/0027688A1) teaches that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to include a mixture of the non-aqueous solvents methanol and toluene in the
phospholipid blend of U.S. Patent No. 11,925,695B2 to evenly disperse the lipid blend into the liquid and
for the advantage of avoiding aggregate forming clumps that are very difficult to disperse.
Claims 43-46,48-50,52,54,55,57-63,65,66,68 and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 14-27 of U.S. Patent No. 12,161,730B2. Although the claims at issue are not identical, they are not patentably distinct from each other because phospholipid suspension used for the method ultrasound imaging of U.S. Patent No. 12,161,730B2 comprises DPPA,DPPC and MPEP5000-DPPE in an aqueous solution that encompasses the DPPA,DPPC and MPEP5000-DPPE in an aqueous solution of the instant claims.
The phospholipid suspension of U.S. Patent No. 12,161,730B2 further comprises the presence of one or two but not all three of methanol, toluene and MTBE that encompasses the presence of one or two but not all three of methanol, toluene and MTBE of the instant claims.
The phospholipid suspension of U.S. Patent No. 12,161,730B2 further comprises propylene
glycol and glycerol solvents that encompasses the propylene glycol and glycerol solvents of the instant claims.
The ratio of the DPPA,DPPC and MPEP5000-DPPE of U.S. Patent No. 12,161,730B2 comprises 10:82:8 that encompasses the ratio of the DPPA,DPPC and MPEP5000-DPPE of 10:82:8 of the instant claims.
The calcium concentration of MPEG5000-DPPE is less than 115 ppm of U.S. Patent No. 12,161,730B2 encompasses the calcium concentration of MPEG5000-DPPE is less than 115 ppm of the instant claims.
The calcium concentration of the phospholipid solution is less than 0.7 ppm of U.S. Patent No. 12,161,730B2 encompasses the calcium concentration of the phospholipid solution is less than 0.7 ppm of the instant claims.
The phospholipid suspension of U.S. Patent No. 12,161,730B2 comprises a perfluoropropane gas that encompasses the perfluoropropane gas of the instant claims.
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this
application or proceeding is assigned is 571-273-8300.
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/MELISSA J PERREIRA/Examiner, Art Unit 1618