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 .
Receipt is acknowledged of IDS filed on 06/23/2023,
Claims 1-2, 4-12 and 16-17 are pending.
Claims 3, 13-15 are cancelled.
Claims 16-17 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 04/23/2026 is acknowledged.
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, 2, and 4-12 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 contains the terms "DPPC”, “DSPC”, “DSPG”, “DMPC”, “DBPC”, “DPPE",”DPPE-mPEG5000”, “DMPE-PEG-2000” and “DSPE-PEG2000” which is not defined by the claims. Claims must stand alone to define the invention, and should not rely on the description or the drawings to give them
meaning (see Ex Parte Fressola, 27 USPQ 2d 1608). Thus, claim 1, at the very least, should define "DPPC”, “DSPC”, “DSPG”, “DMPC”, “DBPC”, “DPPE",”DPPE-mPEG5000”, “DMPE-PEG-2000” and “DSPE-PEG2000” by their formal names; once "DPPC”, “DSPC”, “DSPG”, “DMPC”, “DBPC”, “DPPE",”DPPE-mPEG5000”, “DMPE-PEG-2000” and “DSPE-PEG2000” are defined, the terms "DPPC”, “DSPC”, “DSPG”, “DMPC”, “DBPC”, “DPPE",”DPPE-mPEG5000”, “DMPE-PEG-2000” and “DSPE-PEG2000” may be subsequently recited.
The dependent claims fall therewith.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, and 4-12 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 6, 7, 9 and 10 of copending Application No. 18/259,157 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application recites, a hydrated phospholipid solvent mixture prepared by
- dissolving a first phospholipid at a temperature above the phase transition temperature of the phospholipids in an organic solvent to form a dissolved phospholipid solvent mixture;
- dissolving a second phospholipid at a temperature above the phase transition temperature of the phospholipids in the dissolved phospholipid solvent mixture to form a dissolved phospholipids solvent mixture;
- adding an aqueous phosphate buffer to the dissolved phospholipids solvent mixture to form a buffered phospholipids solvent mixture; and
- stirring the buffered phospholipids solvent mixture to form a hydrated phospholipids solvent mixture (claim 4).
wherein the phospholipids area combination of at least one out of the group of DPPC, DSPC, DSPG, DMPC, DBPC, DPPE and at least one out of the group of DPPE-mPEG5000, DMPE-PEG-2000 and DSPE-PEG2000, preferably at least one out of the group of DPPC, DSPC, DPPE and at least one out of the group of DPPE-mPEG5000 and DSPE-PEG2000, more preferably DPPC and DPPE-mPEG5000 (claim 6).
wherein the organic solvent is selected from the group of propylene glycol, ethylene glycol, polyethylene glycol 3000 and / or glycerol, preferably the organic solvent is propylene glycol (claim 7),
Wherein the concentration of phospholipids is in the range oof 15 to 18 mg/ml (claim 9),
And wherein the ratio of the phospholipids is in the range of 85:15 to 80:20 (claim 10).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claims 1, 4-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over UNGER (US 2016/0000943 A1).
Regarding claim 1, UNGER teaches a process for preparing a hydrated phospholipids solvent mixture (abstract). The method comprising a solution of DPPC and DPPE-MPEG-5000 in propylene glycol, which was then heated to dissolve the phospholipids (page 8, paragraph 0070), which reads on dissolving a first phospholipid at a temperature above the phase transition temperature of the phospholipids in an organic solvent to form a dissolved phospholipid solvent mixture; and dissolving a second phospholipid at a temperature above the phase transition temperature of the phospholipids in the dissolved phospholipid solvent mixture to form a dissolved phospholipids solvent mixture. A phosphate buffer was then added to the solution and mixed (page 8, paragraph 0070), which reads on adding an aqueous phosphate buffer to the dissolved phospholipids solvent mixture to form a buffered phospholipids solvent mixture. The mixture was then stirred (page 8, paragraph 0070), which reads on stirring the buffered phospholipids solvent mixture to form a hydrated phospholipids solvent mixture.
The solution does not comprise dipalmitoyl phosphatidic acid, DPPA (page 4, paragraph 0034).
The lipid concentration was modified to adjust the concentration and size of microbubbles (page 8, paragraph 0070). The ratio of lipids is altered to adjust the stability of the formulation (page 8, paragraph 0072) and the concentration and size of microbubbles produced (page 10, paragraph 1 and page 4, paragraph 0038).
Regarding claims 1 and 10-11, The reference does not specifically teach lipid concentration and ratios as claimed by the Applicant. The lipid concentration and ratio is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal lipid concentration and ratio in order to best achieve desired results, such as the optimal size, stability and concentration of microbubbles produced. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the lipid concentration would have been obvious at the time of Applicant's invention.
Regarding claim 4, UNGER teaches the phospholipids are DPPC and DPPE-MPEG-5000 (page 8, paragraph 0070).
Regarding claim 5, UNGER teaches propylene glycol is the solvent (page 8, paragraph 0070).
Regarding claim 6, phosphate buffered saline is used (page 9, paragraph 0077).
Regarding claim 7, The reference does not specifically teach the amount of time the composition is stirred as claimed by the Applicant. The amount of time the composition is stirred is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal amount of time the composition is stirred in order to best achieve desired results, such as stirring until the phospholipids are fully dissolved and the composition is fully mixed (page 8, paragraph 0070). Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of time the composition is stirred would have been obvious at the time of Applicant’s invention.
Regarding claim 12, Selection of any order of process steps is prima facia obvious in the absence of new or unexpected results.” See MPEP § 2144.04, IV. It would be obvious to one of ordinary skill in the art to vary the order of steps because, in such a method, where the order of steps is not critical, one of ordinary skill in the art would have recognized that varying the order of steps would result in an equivalent means of carrying out the method. In the instant case, adding the phospholipids sequentially or all at once would result in an equivalent means of carrying out the method.
Claims 1, 2, 4-8 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over UNGER (US 2016/0000943 A1) in view of ROBINSON (US 10,583,208 B2).
UNGER teaches Applicant’s invention as discussed above.
UNGER does not teach filtering the mixture, specifically with a 2 micrometer filter.
Regarding claims 2 and 9, ROBINSON teaches a method of dissolving phospholipids, specifically DPPC and MPEG5000-DPPE, heating the solution to allow for complete dissolution. Then filtering to remove any undissolved foreign matter (column 22, paragraph 4) using a 0.2 micrometer filter (column 38, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate filtering the mixture. The person of ordinary skill in the art would have been motivated to make those modifications, because it removes any undissolved foreign matter, and reasonably would have expected success because the references are in the same field of endeavor, such as method of dissolving DPPC and MPEG5000-DPPE and heating the solution to allow for complete dissolution.
Claims 1, 2, and 4-11 are rejected under 35 U.S.C. 103 as being unpatentable over UNGER (US 2016/0000943 A1) and ROBINSON (US 10,583,208 B2) in view of STURM (Basic Methods for Preparation of Liposomes and Studying Their Interactions with Different Compounds, with the Emphasis on Polyphenols. International Journal of Molecular Sciences. 2021.).
UNGER and ROBINSON teach Applicant’s invention as discussed above. Note, the heating of UNGER is to have the solution above the phase transition temperature for the dissolving oh the phospholipids.
UNGER and ROBINSON do not teach having all steps above the phase transition temperature.
Regarding claim 9, STURM teaches that it is important the water/buffer solution, are preheated above the lipids transitional temperature (Tm), when necessary, in order to enable a smoother creation (page 3, paragraph 1). This is especially important in the case of lipids with high Tm (e.g., DPPC) (page 3, paragraph 3).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having all steps above the phase transition temperature. The person of ordinary skill in the art would have been motivated to make those modifications, because it allows for a smoother combination of reactants, and reasonably would have expected success because the references are in the same field of endeavor, such as adding a buffer solution to dissolved lipids. Furthermore, it is known in the art that heat can accelerate the reaction rate of solutions and that keeping the solution at the phase transition temperature will ensure the phospholipids are fully dissolved and stay dissolved.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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