DETAILED ACTION
This office action is in response to applicant’s filing dated May 13, 2026.
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on May 13, 2026 has been entered.
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.
Acknowledgment is made of Applicant’s amendments filed May 13, 2026. Claims 1, 2, 4, 5, 9, 11, 13-16, 23, 25, and 27-30 are withdrawn from consideration, as being drawn to an unelected invention or specie. Acknowledgment is made of Applicant’s cancelation of claims 19, 20, and 35.
Claims 17, 36 and 37 are under consideration in the present office action.
Priority
The present application is a 371 of PCT/US2020/023366, filed March 18, 2020 which claims priority benefit to U.S. Provisional Application No. 62/820,842, filed on March 19, 2019 and U.S. Provisional Application No. 62/820,838, filed on March 19, 2019.
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 36 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites multiple open ended numerical ranges: “at least about 5 mg/ml or at least about 50 mg/ml”, which is a confusion over the intended scope of the claim. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the interest of compact prosecution, for the purposes of applying art, the lower concentration “at least about 5 mg/ml” is considered, as the concentration “at least 5 mg/ml includes “50 mg/ml”.
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, 36 and 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 alginate, a starch, pullulan, hyaluronic acid, chitosan, glucose, galactose, mannose, N- acetylglucosamine or N-acetyl-D-galactosamine, and wherein the concentration of mTOR inhibitor in the pharmaceutical composition is at least about 5 mg/ml.
Desai teaches pharmaceutical composition that includes nanoparticles comprising rapamycin or a derivative thereof and a carrier protein ( e.g., albumin) (column 64, lines 44 – 46), wherein the composition is administered via subcutaneous route (column 50, line17, claim 21). The compositions, taught by Desai, further includes a sugar (column 63, lines 38 - 39), where "sugar" is defined as monosaccharides, disaccharides and polysaccharides and derivatives or modifications thereof. The examples of sugars are: sucrose, fructose or trehalose (column 14, lines 6 – 10). Fructose is a monosaccharide, ketohexose, and a structural isomer of aldohexoses (glucose, galactose and mannose) recited in the instant claim 17. Thus, since fructose is a close structural (positional) isomer of claimed sugars, it presumably possess similar properties, and therefore an obvious variant of claimed sugars glucose, galactose and mannose. MPEP 2144.09 states: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious).
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 identical or very similar to 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:
- Desai does not teach or suggest the claimed pharmaceutical composition suitable for subcutaneous administration to an individual comprising the specifically recited saccharide. Desai does not disclose the saccharides alginate, pullulan, hyaluronic acid, chitosan, glucose, galactose, mannose, N-acetylglucosamine, and N- acetyl-D-galactosamine. Thus, one of ordinary skill in the art reading Desai would not have been led to the subject matter of the amended claims.
Examiner’s response:
Applicant's arguments have been fully considered but they are not persuasive because: as set forth above, Desai teaches pharmaceutical composition suitable for the same route of administration, where the composition includes all the identical or similar components in the same amounts as recited by instant claims. Thus, the instant invention is considered obvious in view of teachings of prior art.
Therefore, applicant’s arguments are not persuasive and the rejection of claims 17, 36 and 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, wherein the saccharide is alginate, a starch, pullulan, hyaluronic acid, chitosan, glucose, galactose, mannose, N- acetylglucosamine or N-acetyl-D-galactosamine.
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 saccharide is alginate, a starch, pullulan, hyaluronic acid, chitosan, glucose, galactose, mannose, N- acetylglucosamine or N-acetyl-D-galactosamine, 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 specific saccharides recited in claim 17. 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, 36 and 37 are rejected. No claim is allowed.
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/E.V.V./
Examiner, Art Unit 1691
/SAVITHA M RAO/ Primary Examiner, Art Unit 1691
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