DETAILED ACTION
Applicants’ arguments, filed 5 November 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “adoxorubicin derivative.” This claim appears to lack a space between “a” and “doxorubicin.” Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-7 and 17-20 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.
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(d).
In this case, claims 6 and 7 recites the following, wherein text has been reproduced below and annotated by the examiner.
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The claim language “even more preferably” is a preference which renders the claim indefinite when recited in the claim.
For the purposes of examination under prior art, the examiner will proceed in examination with the assumption that the preferable limitations are optional.
Response to Arguments Regarding Indefiniteness Issues
In applicant’s response on 5 November 2025 (hereafter referred to as applicant’s response), applicant argued that the claims have been amended to remove the preferred embodiments, as of applicant’s response, page 8. This is not persuasive because claim 7 still recites various preferred embodiments.
Claim Rejections - 35 USC § 103 – Obviousness
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 6, and 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossann et al. (Journal of Controlled Release, Vol. 162, 2012, pages 400-406 and supplemental pages 1-5).
Hossann et al. (hereafter referred to as Hossann ’12) is drawn to thermosensitive liposomes with the following chemical structures, as of Hossann ’12, page 400, title and abstract, wherein relevant text from the abstract has been reproduced below.
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The formulation known as “DPPG2/PEG-TSL” appears to comprise 30 mol% of the lipid known as DPPG2, which exceeds the required 15 mol%.
Elsewhere in the reference, Hossann ’12 teaches the following, as of page 402, right column, Table 1, reproduced below with annotation by the examiner.
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As to claim 1, the claim requires a thermosensitive liposome. Hossann ’12 teaches this as of page 400, title.
As to claim 1, the claim requires an intraliposomal buffer. Hossann ’12 appears to teach Tris/NaCl buffer for this purpose as of at least page 401, right column, section 2.3.
As to claim 1, the claim requires an active pharmaceutical ingredient which is doxorubicin or a derivative thereof. Hossann ’12 teaches doxorubicin as of at least page 401, right column, section 3.1.
As to claim 1, the claim recited a molar ratio of doxorubicin to lipids comprised in the bilayer of from 0.06 up to 0.10. Hossann ’12 teaches an embodiment comprising an 0.10 ratio of carboxyfluorescein to lipids, as of the above-indicated example drawn to “DPPG2/PEG-TSL”. Hossann ’12 does not anticipate the claimed invention because the carboxyfluorescein is not the same as doxorubicin. Nevertheless, the carboxyfluorescein of Hossann ’12 is being used as a fluorescent marker, as of Hossann ’12, page 402, left column, section 3.2. The skilled artisan would therefore have been motivated to have substituted doxorubicin in place of carboxyfluorescein because doxorubicin is an actual therapeutic drug, whereas carboxyfluorescein is a fluorescent dye used to study the composition of Hossann ’12 but would not have been used in actual pharmaceutical therapy.
As to claim 2, the skilled artisan would have understood the doxorubicin of Hossann ’12 to have been hydrophilic, especially at a neutral or acidic pH value wherein the amine group of doxorubicin is protonated and the doxorubicin can therefore interact with water via ion-dipole intermolecular bonding. As such, the skilled artisan would have expected said carboxyfluorescein to have been in the interior aqueous space rather than the lipid bilayer.
As to claim 6, this is an independent claim. This claim appears to require a thermosensitive liposome comprising DPPG2 at an amount of at least 15% in the bilayer, as well as a doxorubicin in the same amount as required by claim 1. Claim 6 appears to differ from claim 1 only in that claim 6 recites an intraliposomal buffer with a pH of from 5 to 8. Hossann ’12 teaches buffers with pH values of 8.0 or 7.4 as of page 401, right column, section 2.3. As such, for this reason as well as the reasons set forth above regarding claim 1, the teachings of Hossann ’12 are understood to render the composition of claim 6 prima facie obvious.
As to claim 8, Hossann ’12 teaches 30 mol% of the lipid known as DPPG2, as of Hossann ’12, page 400, title and abstract. This is within the claimed range of 15 mol% to 35 mol%.
As to claim 9, Hossann ’12 teaches a particle size of about 139 nm, as of page 402, left column, last paragraph.
As to claim 10, the formulation of Hossann ’12 known as DPPG2-TSL does not appear to comprise cholesterol or a derivative of cholesterol; see Hossann ’12, page 400, abstract.
As to claim 11, the DPPG2 of Hossann ’12 appears to be the same as the DPPG2 recited by the instant claims. As such, the skilled artisan would have expected that the DPPG2 of Hossann ’12 would have had the same chemical structure as the claimed DPPG2. See MPEP 2112.
As to claim 12, Hossann ’12 teaches DPPC and DSPC in addition to DPPG2, as of Hossann ’12, abstract, relevant text reproduced above.
As to claim 13, Hossann ’12 teaches 50 mol% DPPC, 15 mol% DSPC, 30 mol% DSPG2, and 5 mol% DSPE-PEG2000 as of Hossann ’12, page 400, abstract, fourth and fifth lines of abstract in reference to the formulation known by Hossann ’12 as “DPPG2/PEG-TSL.” All of these values are within the claim scope.
As to claim 14, the doxorubicin of Hossann ’12 is useful for treating cancer.
Claim(s) 7 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossann et al. (Journal of Controlled Release, Vol. 162, 2012, pages 400-406 and supplemental pages 1-5) in view of Epstein et al. (US 2018/0122003 A1).
Hossann ’12 is drawn to thermosensitive liposomes comprising DPPG2 among other lipids. Hossann ’12 teaches doxorubicin as an active agent, as of at least page 401 of Hossann ’12. See the rejection above over Hossann ’12 by itself.
Hossann ‘12 does not teach a storage buffer.
Epstein et al. (hereafter referred to as Epstein) is drawn to anti-cancer therapy, as of Epstein, title and abstract. Epstein teaches storing a composition for later use in a buffer comprising PBS (i.e. phosphate buffered saline) further comprising 7% trehalose and 1% bovine serum albumin, as of Epstein, paragraph 0302.
Epstein does not teach a thermosensitive liposome.
It would have been prima facie obvious for one of ordinary skill in the art to have used the storage buffer of Epstein to have stored the composition of Hossann ‘12. Hossann ‘12 is drawn to a liposomal composition. However, Hossann ’12 is silent as to how the composition can be stored for an extended period of time without degrading. Epstein teaches that a buffer comprising PBS, trehalose, and BSA is useful as a storage buffer. As such, the skilled artisan would have been motivated to have used the buffer of Epstein to have predictably stored the composition of Hossann ’12 such that the composition of Hossann ’12 could have been stored without degradation with a reasonable expectation of success.
As to claim 7, the claim requires a storage buffer which has a saline concentration of less than 100 mM, an osmolarity of higher than 300 mOsm/kg. As best understood by the examiner, the buffer of Epstein meets these requirements. First, the buffer of Hossann ’12 does not include sodium chloride; as such, it would have lower than 100 mM sodium chloride. Regarding the osmolarity, the examiner understands the term “PBS” to refer to phosphate buffered saline which has the salt concentration found in blood, and therefore an osmolarity of between about 260-300 mOsm/kg. However, the inclusion of 7% trehalose would have increased the osmolarity to have been greater than 300 mOsm/kg. Claim 7 also requires a bilayer and an intraliposomal buffer. The skilled artisan would have understood that liposomes such as that of Hossann ’12 form a lipid bilayer and an aqueous interior space inside the bilayer. This aqueous interior space would appear to comprise citrate ions, as of Hossann ’12, page 401, right column, paragraph 2.2; this would have formed a buffer. Claim 7 also requires at least 15% DPPG2; this appears to have been taught as of Hossann ’12, page 400, title and abstract, which teaches compositions as high as 30 mol% DPPG2 in the abstract. Hossann ’12 also teaches doxorubicin, which is a pharmaceutically active ingredient.
As to claim 17, Hossann ’12 teaches 30 mol% DPPG2 as of page 400, abstract.
As to claim 18, Hossann ’12 teaches a particle size of about 139 nm, as of page 402, left column, last paragraph.
As to claim 19, Hossann ’12 does not appear to include cholesterol in the lipid bilayer.
As to claim 20, the DPPG2 of Hossann ’12 appears to be the same as the DPPG2 recited by the instant claims. As such, the skilled artisan would have expected that the DPPG2 of Hossann ’12 would have had the same chemical structure as the claimed DPPG2. See MPEP 2112.
Response to Arguments Regarding Prior Art Rejections
In applicant’s response on 5 November 2025 (hereafter referred to as applicant’s response), applicant has provided various arguments regarding the previously applied prior art rejections. These arguments have been addressed below.
In applicant’s response, page 10, applicant makes the following argument, as of the second to last paragraph, which is reproduced below.
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The examiner does not dispute that the only liposome taught by Hossann ’12 that comprises doxorubicin has a ratio of 0.14 mole of doxorubicin per mole of lipid. This exceeds the maximum value of 0.10 mole of doxorubicin per mole of lipid. As such, the instant claims are no longer considered anticipated by Hossann ’12 in view of the claim amendments, and the previously applied anticipation rejection has been withdrawn.
Nevertheless, Hossann ’12 does teach an embodiment wherein carboxyfluorescein is used as a model active agent, and the carboxyfluorescein to lipid molar ratio is 0.1 mole of carboxyfluorescein per mole of lipid. See Hossann ’12, page 402, right column, Table 1, reproduced below with annotation by the examiner pointing to the relevant embodiment.
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The above-indicated embodiment differs from the claimed subject matter because it teaches carboxyfluorescein, which is not the same as the doxorubicin or doxorubicin derivative or salt required by the instant claims. As such, the instant claims are not anticipated by Hossann ’12. Nevertheless, the skilled artisan would have understood that carboxyfluorescein is a model active agent used for testing purposes because of its fluorescence capabilities. The skilled artisan would not have been motivated to have used fluorescein to have provided therapeutic properties; in contrast, the skilled artisan would have been motivated to have substituted doxorubicin in place of fluorescein when the composition of Hossann ’12 is to be used in the clinic because doxorubicin is a therapeutic agent whereas carboxyfluorescein is not a therapeutic agent.
Applicant then discusses comparative testing present in the instant application, a of applicant’s response on page 11. This comparative testing details desirable results at doxorubicin/lipid mole ratios of 0.06, 0.07, 0.08, 0.09, and 0.10, but poor results at a doxorubicin/lipid mole ratio of 0.13. The examiner does not dispute that the results obtained by applicant at a mole ratio of 0.13 are significantly worse than those obtained at other ratios tested. This appears to be due to the fact that there is apparent particle aggregation and active agent leakage at a mole ratio of 0.13 that is not present at other mole ratios tested.
Nevertheless, this is insufficient to overcome the applied rejection over Hossann ’12 because Hossann ’12 teaches a mole ratio of 0.10 mole active agent to 1 mole of lipid. Although the active agent taught by Hossann ’12 is carboxyfluorescein, which is a fluorescent marker rather than a pharmaceutical active agent, the skilled artisan would have reasonably expected that the results obtained by Hossann ’12 regarding carboxyfluorescein would have been applicable to other active agents such as doxorubicin. Expected beneficial results are evidence of obviousness. See MPEP 716.02(c)(II). In this case, the skilled artisan would have expected that the beneficial results obtained by applicant at a mole ratio of 0.10:1 of doxorubicin to lipids would have been expected to have occurred in the embodiment of Hossann ’12 comprising an 0.1:1 mole ratio of carboxyfluorescein to lipids.
Applicant also argues that the term “stability” has a different definition in the Hossann ’12 as compared with the claimed invention, as of applicant’s response on page 12. This argument is not persuasive with respect to instant claim 1 because instant claim 1 does not recite the term “stable” or “stability.”
Regarding the secondary reference of Epstein et al. (US 2018/0122003 A1), applicant makes the argument that Hossann ’12 does not appear to teach or render obvious the required composition. Applicant does not appear to have presented additional arguments regarding the secondary reference. As such, the applied rejection over Hossann ’12 in view of Epstein has been maintained.
The examiner has included proposed amendments to overcome the applied rejection at the end of the office action.
Non-Statutory 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, 6 and 8-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-32 of copending Application No. 18/294,183 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a thermosensitive liposome. The liposome comprises DPPG2 at a molar ratio of at least 15%, an active ingredient which is doxorubicin, and a particular molar ratio between the active ingredient and the bilayer lipids.
The copending claims are drawn to a method of treating cancer, entailing administering a liposome comprising doxorubicin, as of copending claim 17. The liposome has DPPG2 at an amount of 15 mol% to 55 mol%, as of copending claim 32.
The instant and copending claims differ because the copending claims are drawn to a method of treating a disease, whereas the instant claims are drawn to a compsition. Nevertheless, the composition administered by the method of the copending claims appears to comprise all of the instantly claimed features except the ratio of active pharmaceutical ingredients to bilayer lipids. The skilled artisan would have been motivated to have optimized the amount of doxorubicin and the amount of bilayer lipids to have achieved the claimed requirements. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a thermosensitive liposome comprising doxorubicin and lipids including DPPG2 has been recited by the copending claims. As such, it would not have been inventive for the skilled artisan to have determined the optimum ratio of active agent to lipid via routine experimentation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 7 and 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-32 of copending Application No. 18/294,183 in view of Epstein et al. (US 2018/0122003 A1).
The instant claims are drawn to a thermosensitive liposome. The liposome comprises DPPG2 at a molar ratio of at least 15%, an active ingredient, and a particular molar ratio between the active ingredient and the bilayer lipids.
The copending claims are drawn to a method of treating cancer, entailing administering a liposome comprising doxorubicin, as of copending claim 17. The liposome has DPPG2 at an amount of 15 mol% to 55 mol%, as of copending claim 32.
The copending claims do not recite the required storage buffer.
Epstein et al. (hereafter referred to as Epstein) is drawn to anti-cancer therapy, as of Epstein, title and abstract. Epstein teaches storing a composition for later use in a buffer comprising PBS (i.e. phosphate buffered saline) further comprising 7% trehalose and 1% bovine serum albumin, as of Epstein, paragraph 0302.
Epstein does not teach a thermosensitive liposome.
It would have been prima facie obvious for one of ordinary skill in the art to have used the storage buffer of Epstein to have stored the composition used in the method of the copending claims. The copending claims are drawn to a method utilizing a liposomal composition. However, the copending claims are silent as to how the composition can be stored for an extended period of time without degrading. Epstein teaches that a buffer comprising PBS, trehalose, and BSA is useful as a storage buffer. As such, the skilled artisan would have been motivated to have used the buffer of Epstein to have predictably stored the composition used in the method of the copending claims such that the composition used in the method of the copending claims could have been stored without degradation with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments Regarding Double Patenting Rejections
In applicant’s response, pages 13-14, applicant requested to hold the double patenting rejections in abeyance. As such, no substantive arguments have been presented regarding the double patenting rejections. Therefore, the double patenting rejections have been maintained by the examiner.
Proposed Claim Amendments to Overcome Prior Art Rejections
The examiner proposes amending the claims in the following manner in order to overcome the applied prior art rejections.
X) Claim 1 is proposed to be amended in the following manner:
Claim 1 (Proposed Amendment): A thermosensitive liposome comprising a lipid bilayer and an intraliposomal buffer, wherein the lipids in the lipid bilayer consist of 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC), 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and 1,2-dipalmitoyl-sn-glycero-3-phosphodiglycerol (DPPG2), wherein the molar concentration of [[ ]] DPPG2 in [[ ]] the lipid bilayer is at least 15 percent,
wherein said thermosensitive liposome comprises an active pharmaceutical ingredient, wherein said active pharmaceutical ingredient is doxorubicin, [[ ]] a doxorubicin derivative or a pharmaceutically acceptable salt thereof and wherein the molar ratio between said active pharmaceutical ingredient and the lipids comprised in said bilayer is from 0.06 up to 0.10.
X) Claim 2 is proposed to be allowed without further amendment.
X) Claims 3-7 have been or are proposed to be cancelled without prejudice or disclaimer. The examiner has proposed new claim 21 which depends upon claim 1 but is drawn to the subject matter recited by claim 6.
X) Claim 8 is proposed to be allowed without further amendment.
X) Claim 9 is proposed to be allowed without further amendment.
X) Claim 10 is proposed to be cancelled without prejudice or disclaimer, as it is no longer limiting in view of the proposed changes to claim 1.
X) Claim 11 is proposed to be allowed without further amendment.
X) Claim 12 is proposed to be cancelled without prejudice or disclaimer as it is no longer limiting in view of the proposed amendment to claim 1.
X) Claim 13 is proposed to be amended in the following manner:
Claim 13 (Proposed Amendment): A thermosensitive liposome according to claim [[ ]] 1,
wherein the molar concentration of 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC) in said bilayer is from 0.45 up to 0.65; [[ ]]
wherein the molar concentration of 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) in said bilayer is from 0.15 up to 0.25; and [[ ]]
wherein the molar concentration of 1,2-dipalmitoyl-sn-glycero-3-phosphodiglycerol (DPPG2) in said bilayer is from 0.15 up to 0.35.
X) Claim 14 is proposed to be allowed without further amendment.
X) Claims 15-16: The examiner reviewed these claims but was unsure about how to amend these claims to be in condition for rejoinder. As such, the examiner proposes cancelling claims 15-16.
X) Claims 17-20 are proposed to be cancelled without prejudice or disclaimer because these claims depend upon claim 7, which is proposed to be cancelled.
X) The examiner proposes adding the following new claims:
Claim 21 (Proposed New): The thermosensitive liposome of claim 1, wherein the intraliposomal buffer has a pH of from 5 up to 8.
Reasons for Requesting Proposed Amendments
The examiner presents the following reasons for proposing the above-indicated claim amendments.
In the above-applied rejection over Hossann ’12, the examiner relied upon an embodiment of Hossann ’12 that had an 0.1:1 molar ratio of active agent to lipid. However, this embodiment comprises DPPC/DSPC/DPPG2/DSPE-PEG2000 and was referred to as DPPG2/PEG-TSL, as of the abstract of Hossann ’12 and page 402, right column, Table 1 of Hossann ’12.
With the proposed amendments, the “consisting of” language is understood to exclude DSPE-PEG2000. See the definition of the phrase “consisting of” set forth in MPEP 2111.03(II). As such, Hossann ’12 does not teach an embodiment wherein the liposome both lacks DSPE-PEG2000 and comprises a ratio of pharmaceutical active ingredient to lipids in the required range. There would have been no expectation that, had the liposome of Hossann ’12 been optimized to have these features, that the resultant liposome would have had unexpectedly and significantly greater stability as compared with a liposome lacking a PEGylated lipid and having a molar ratio of active agent to lipids that is in the slightly higher range of 0.13-0.16.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick F Krass can be reached at (571)272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612