DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims and Previous Objections/Rejections Status
Claims 1-3 and 5-21 are pending in the application.
Any objections and/or rejections from previous office actions that have not been reiterated in this office action are obviated.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3 and 5-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
New Grounds of Rejection
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1,5,6 and 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Quay (US 6,245,319B1).
Quay (US 6,245,319B1) discloses the method of ultrasound diagnostic imaging via administering ultrasound contrast agents to a subject and application of ultrasound (abstract; column 3, lines 51-58; Example 51; claim 22) that encompasses the method of medical diagnostic imaging via ultrasound of the instant claims.
The ultrasound contrast agents comprise biocompatible colloidal liquid-in-liquid dispersion droplets having a liquid dispersion phase which has a boiling point below between -20 and 37°C (column
3, lines 3-5; column 5, lines 11-13) that encompasses the droplets having a liquid consisting of components having a boiling point that is below room temperature (25°C) of the instant claims.
The liquid dispersed phase comprises fluorine-containing chemicals, such as decafluorobutane, trifluoromethane, etc. and mixtures thereof (column 3, lines 6-16; table found from column 24-32; claim 22). The mixture of fluorine-containing chemicals encompasses the plurality of different perfluorocarbons and each having a different activation energy of the instant claim 9. The decafluorobutane encompasses the decafluorobutane of the instant claim 5.
The droplets further comprises lipids, sucrose, sorbitol, surfactants, protein, etc. (column 3, lines 20-22; column 5, lines 35-41; claims 26,30,35).
The lipids, sucrose, sorbitol, surfactants, protein encompass the lipids, sugars, surfactants and proteins, respectively of the instant claim 6.
The dispersed liquid phase shifts from a state of a liquid to a gas due to changes in temperature and/or pressure (abstract; column 4, lines 14-16).
Quay does not explicitly disclose that the change from a liquid to a gas causes the droplet to increase in size after administration.
Quay further discloses that the examination of the emulsion at 20°C to 37°C caused the particles to suddenly grow in size (Example 17). The particle size of the liquid dispersed phase particles comprises typically below 1000 nm and the gaseous particles have a size typically below 10,000 nm in diameter (abstract).
At the time of the invention it would have been obvious to one of ordinary skill in the art that
the droplets of Quay will increase in size due to a change from a liquid state to gas state via an increase in temperature and/or pressure after administration to a subject that causes the particles to grow in size from below 1000 nm to below 10,000 nm in diameter.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double
patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3,5-14 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-16 of U.S. Patent No. 11,123,302B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the particles of U.S. Patent No. 11,123,302B2 comprise liquid perfluorocarbons, such as DFB and OFP encapsulated in a shell wherein the liquid perfluorocarbons have boiling points below 25°C and atmospheric pressure that encompass the nanodroplets of the instant claims that are used for the methods for medical diagnostic imaging and therapy that comprise liquid perfluorocarbons, such as DFB and OFP encapsulated in a shell wherein the liquid perfluorocarbons have boiling points below 25°C and atmospheric pressure.
The plurality of perfluorocarbons having different activation energies present in particles of U.S. Patent No. 11,123,302B2 encompass the plurality of perfluorocarbons having different activation energies present in the nanodroplets of the instant claims.
The shell of the particles of U.S. Patent No. 11,123,302B2 include a lipid, a protein, a polymer, a gel, a surfactant, a peptide or a sugar that encompasses the shell of the instant claims comprising a lipid, a protein, a polymer, a gel, a surfactant, a peptide or a sugar.
The component of U.S. Patent No. 11,123,302B2 that causes the second substance to attach to
cells of a tissue within a target region, attaches to proteins expressed by the cells of the tissue within the target region, promotes intracellular uptake and is tissue-specific encompasses the shell component that causes the shell to attach to cells of a tissue within a target region, promotes intercellular uptake and targets a component within a cell of the instant claims.
The protein target region of U.S. Patent No. 11,123,302B2 comprises a tumor, cancerous cells or pre-cancerous cells that encompasses the target region of the instant claims that comprise a tumor, cancerous cells or pre-cancerous cells.
The particles of U.S. Patent No. 11,123,302B2 encompass the nanodroplets of the instant claims, have the same properties and are capable of the same functions, such as being used for the methods for medical diagnostic imaging and therapy of the instant claims.
Conclusion
Claims 15 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
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/MELISSA J PERREIRA/Examiner, Art Unit 1618
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