DETAILED ACTION
This office action is in response to applicant’s filing dated November 11, 2025.
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 .
Status of claims
Claims 1, 2, 4, 5, 9, 11, 13-17, 19, 20, 23, 25, 27-30, and 35-37 are pending in the instant application. Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on November 11, 2025 are acknowledged. Claims 1, 2, 4, 5, 9, 11, 13-16, 23, 25, and 27-30 remain withdrawn, as being drawn to an unelected invention or specie.
Claims under consideration in the instant office action are claims 17, 19, 20, and 35-37.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/10/2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Objections and/or Rejections and Response to Arguments
Applicants' arguments, filed on November 11, 2025, have been fully considered.
Acknowledgement is made of the Applicant’s argument about rejection of claims 17, 19, 20, and 35-37 under 35 U.S.C. §§ 102(a)(1) and 102(a)(2) as being anticipated by Desai et al (US Pat. No. 8,911,786). Arguments as shown herein: “Examiner states that Desai teaches compositions comprising nanoparticles that comprise a carrier protein such as albumin and rapamycin by citing to column 3, lines 51-53, and column 4, line 20. The Examiner cites to claim 21 to supply that the composition is administered via subcutaneous route. Applicant respectfully submits that Desai does not expressly disclose the claimed pharmaceutical composition suitable for subcutaneous administration”. Applicant’ arguments are found persuasive.
Accordingly, rejection of claims 17, 19, 20, and 35-37 under 35 U.S.C. §§ 102(a)(1) and 102(a)(2) as being anticipated by Desai is withdrawn.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Maintained and New Objections and/or Rejections
Claim Objections
Claim 36 is objected to because of the following informalities: in claim 36 “[…]the concentration of mTQR inhibitor” appears to be a typographical error and should read “[…]the concentration of mTOR inhibitor”. Appropriate correction is required
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 17, 19, 20, and 35 – 37 are rejected under 35 U.S.C. 103 as being unpatentable over Desai et al (US 8,911,786 B2, cited in IDS, filed 01/13/2022, hereinafter Desai ).
Instant claims are drawn to a pharmaceutical composition suitable for subcutaneous administration to an individual comprising: a) nanoparticles comprising an mTOR inhibitor, such as rapamycin and an albumin, and b) a saccharide, wherein the saccharide is sucrose or wherein the saccharide is trehalose and wherein the concentration of mTOR inhibitor in the pharmaceutical composition is at least about 5 mg/ml.
Desai teaches compositions (e.g., unit dosage forms) comprising nanoparticles that comprise a carrier protein such as albumin and rapamycin or a derivative thereof (column 3, lines 51 – 53 and column 4, line 20), wherein the composition is administered via subcutaneous route (column 50, line17, claim 21). The compositions, taught by Desai, further include a sugar (column 63, lines 38 - 39), where "sugar" is defined as monosaccharides, disaccharides and polysaccharides, e.g. sucrose, fructose and trehalose (column 14, lines 6 – 10). Desai further teaches formulation of pharmaceutical compositions where rapamycin concentrations are 8 mg/mL (column 70, example 1-A, lines 40 – 43), 8.3 mg/mL (column 70, example 1-B, line 1), 16.2 mg/mL (column 71, example 1-C, lines 25-26), 8.2 mg/mL (column 71, example 1-D, line 55 and column 72, example 1-H, line 67), 8.5 mg/mL (column 72, example 1-E, line 8), 9.2 mg/mL (column 72, example 1-F, line 27), 8.4 mg/mL (column 72, example 1-G, line 48), 6.6 mg/mL (column 74, example 1-I, line 19) and 5.0 mg/mL (column 74, example 1-L, line 9) Thus, the listed above concentrations of rapamycin in pharmaceutical compositions, taught by Desai, fall within the limitation of instant claims. MPEP 2131.03 (I) states: "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023).
Thus, since Desai teaches a composition where all the components of the composition are the same as instantly claimed, where all the amounts taught by prior art fall within the instantly claimed ranges, and where the composition is designed for the same route of administration as instantly claimed composition, it would have been prima facie obvious to one of ordinary skill in the art before effective filing date of the claimed invention to combine teachings of prior art and arrive at claimed composition with the reasonable expectation of success. The one of ordinary skills would be motivated to do so on purpose to make a composition from known components, useful for subcutaneous administration, where prior art suggests this composition will be useful for subcutaneous administration.
Therefore, taking all together, taught by prior art, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues:
independent claim 17 is directed to a pharmaceutical composition suitable for
subcutaneous administration to an individual comprising: a) nanoparticles comprising an mTOR inhibitor and an albumin, and b) a saccharide; Desai does not expressly disclose the claimed pharmaceutical composition suitable for subcutaneous administration;
- Desai is silent regarding the specific saccharides for the claimed subcutaneous pharmaceutical composition as recited in claim 35.
Examiner’s response:
Applicant's arguments have been fully considered but they are not persuasive because: although Desai does not teach explicitly the claimed composition, Desai still teaches composition, where the composition contain all the components in the same amount as recited by instant claims. Thus, the instant invention is considered obvious in view of teachings of prior art.
Regarding the arguments about specific saccharides, which Desai silent about, this argument is not found persuasive, because Desai teaches specific examples of saccharides such as sucrose, fructose and trehalose (column 14, lines 6 – 10), suitable for composition.
Therefore, applicant’s arguments are not persuasive and the rejection of claims 17, 19, 20, and 35 – 37 as obvious over teachings of Desai is maintained.
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 17 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claim 7 of U.S. Patent No. US 8,911,786 B2;
claim 29 of U.S. Patent No. US 10705070 B1;
claim 33 of U.S. Patent No. US 11320416 B1.
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are directed to a pharmaceutical composition suitable for subcutaneous administration to an individual comprising: a) nanoparticles comprising an mTOR inhibitor, such as rapamycin and an albumin, and b) a saccharide, such as sucrose or trehalose.
Claim 7 of US 8,911,786 B2 is directed to a unit dosage form for treatment of cancer in a human individual comprising (a) nanoparticles that comprise rapamycin or a derivative thereof and albumin, wherein the rapamycin or derivative thereof is coated with albumin.
Claim 29 of US 10705070 B1 is directed to a commercial batch of a pharmaceutical composition, wherein the pharmaceutical composition comprises (a) nanoparticles comprising rapamycin coated with a coating comprising albumin and (b) a non-nanoparticle portion comprising albumin and rapamycin.
Similarly, claim 33 of US 11320416 B1 is directed to a commercial batch of a pharmaceutical composition, wherein the pharmaceutical composition comprises (a) nanoparticles comprising rapamycin coated with a coating comprising albumin and (b) a non-nanoparticle portion comprising albumin and rapamycin.
Although, instant claims do not recite non-nanoparticle portion in composition, or patented claims do not recite saccharide in the composition, the “comprising” claim language does not exclude additional, unrecited elements.
Thus, the compositions and method of preparation said composition of the granted clams would anticipate the instantly claimed compositions and method of preparation said composition.
Claims 17, 36 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13 – 15 and 26 of U.S. Patent No. US 11497737 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are directed to a pharmaceutical composition suitable for subcutaneous administration to an individual comprising: a) nanoparticles comprising an mTOR inhibitor, such as rapamycin and an albumin, and b) a saccharide, wherein the concentration of mTOR inhibitor in the pharmaceutical composition is at least about 5 mg/ml.
Claims of US 11497737 B2 are directed to a commercial batch of a pharmaceutical composition comprising (a) nanoparticles comprising rapamycin and albumin, and (b) a non-nanoparticle portion comprising albumin and rapamycin, wherein the concentration of albumin in the composition is about 1 mg/mL to about 100 mg/mL, about 30 mg/mL to about 100 mg/mL or wherein the concentration of rapamycin in the nanoparticle composition is about 1 mg/mL to about 50 mg/mL.
Although, instant claims do not recite non-nanoparticle portion in composition, or patented claims do not recite saccharide in the composition, the “comprising” claim language does not exclude additional, unrecited elements.
Although, patented claims do not repeat exact concentration ranges of rapamycin in the composition as instant claims read, the amount ranges of instant claims touch or fall within those ranges of patented claims. MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). It would have been prima facie obvious to one of ordinary skill in the art to utilize the concentrations of rapamycin, taught by patented claims as a starting point for optimizing the amounts of rapamycin to arrive at the claimed concentration. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken all, taught by prior art together, would have been prima facie obvious to one of ordinary skill in the art to arrive at the composition of instant claims by modifying compositions taught by prior art with the reasonable expectation of success.
Response to Arguments
Applicant argues:
- claims of listed above patents do not teach the subject matter of the pending claims. For example, patented claims are silent regarding a pharmaceutical composition suitable for subcutaneous administration, much less one comprising a saccharide. One of ordinary skill in the art reading mentioned in the rejection patented claims would have been left to invent the subject matter of the pending claims, and the use of ''comprising'' language does not cure this deficiency.
- Applicant submits that U.S. Pat. No. 11,497,737 is a later filed application having a later patent term filing date, and thus not a proper reference for a non-statutory double patenting rejection in the instant application.
Examiner’s response:
Applicant's arguments have been fully considered but they are not persuasive because: patented claims teach materially the same pharmaceutical composition, with same active agent, hence having the same properties. The said composition suitable for the same purpose (to treat certain types of cancer). Thus, not specified by patented claims route of administration or addition of inactive ingredient sugar to the known composition will not functionally change the composition. Moreover, the “comprising” claim language does not exclude additional, unrecited elements. According to MPEP 2143.I example 1, [T]he claimed invention in Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 163 USPQ 673 (1969) was a paving machine which combined several well-known elements onto a single chassis. Standard prior art paving machines typically combined equipment for spreading and shaping asphalt onto a single chassis. The patent claim included the well-known element of a radiant-heat burner attached to the side of the paver for the purpose of preventing cold joints during continuous strip paving. The prior art used radiant heat for softening the asphalt to make patches, but did not use radiant heat burners to achieve continuous strip paving. All of the component parts were known in the prior art. The only difference was the combination of the "old elements" into a single device by mounting them on a single chassis. The Court found that the operation of the heater was in no way dependent on the operation of the other equipment, and that a separate heater could also be used in conjunction with a standard paving machine to achieve the same results. The Court concluded that "[t]he convenience of putting the burner together with the other elements in one machine, though perhaps a matter of great convenience, did not produce a ‘new’ or ‘different function’" and that to those skilled in the art the use of the old elements in combination would have been obvious. Id. at 60, 163 USPQ at 674.
Regarding argument about later filing date of US U.S. Pat. No. 11,497,737, the argument is not persuasive because according to MPEP 804 […]a potential double patenting reference is a patent or copending application that meets the following criteria:
at least one common joint inventor, or
a common applicant, or
have at least one common assignee,
or are non-commonly assigned/owned but deemed commonly owned based on a joint research agreement as set forth in 35 U.S.C. 102(c) or pre-AIA 35 U.S.C. 103(c)(2).
The US U.S. Pat. No. 11,497,737 meets at least one of the above criteria.
Therefore, applicant’s arguments are not persuasive and the rejection of claims 17 and 37 on the ground of nonstatutory double patenting over:
claim 7 of U.S. Patent No. US 8,911,786 B2;
claim 29 of U.S. Patent No. US 10705070 B1;
claim 33 of U.S. Patent No. US 11320416 B1, as well as rejection of claims 17, 36 and 37 over claims of Patent No. US 11497737 B2 is maintained.
Conclusion
Claims 17, 19, 20, and 35 – 37 are rejected. 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.
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/E.V.V./ Examiner, Art Unit 1691
/SAVITHA M RAO/ Primary Examiner, Art Unit 1691