DETAILED ACTION
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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1, 2, 11, 13, 15, 16, 19, 20, 23, 24, 31, 32, 35, and 41, drawn to a composition comprising: synthetic nanocarriers comprising a hydrophobic polyester carrier material and rapamycin; wherein the rapamycin is present in the synthetic nanocarriers in a stable, super-saturated amount that is less than 50 weight % rapamycin/hydrophobic polyester carrier material; and wherein the synthetic nanocarriers are initially sterile filterable, classified in A61K40/22.
II. Claim 46, drawn to a method for producing synthetic nanocarriers comprising a hydrophobic polyester carrier material and rapamycin, comprising: obtaining or providing the hydrophobic polyester carrier material, obtaining or providing rapamycin in an amount that exceeds the saturation limit of the rapamycin, combining the hydrophobic polyester carrier material and rapamycin, and stabilizing the rapamycin, classified in A61K2121/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the process as claimed can be used to make another and materially different product. The steps recited in the method could be used to make bulk liquid comprising rapamycin such as for forming a device coating.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) separate classification which shows that each invention has attained recognition in the art as a separate subject for inventive effort, and also a separate field of search;
(b) separate status in the art even though the inventions are classified together, each invention forming a separate subject for inventive effort as recognized by inventors;
(c) search for one of the inventions is not likely to result in finding art pertinent to the other invention(s) (e.g., searching different classes/subclasses or electronic resources, or employing different search queries), a different field of search is shown, even though the two are classified together; and
(d) the inventions are likely to raise serious examination issues including non-prior art issues under 35 U.S.C. 101, pre-AIA 35 U.S.C. 112, first paragraph and/or 35 U.S.C. 112(a) that are relevant to one invention and not relevant to the other invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Jessica A. von Reyn on June 23, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1, 2, 11, 13, 15, 16, 19, 20, 23, 24, 31, 32, 35, and 41. Affirmation of this election must be made by applicant in replying to this Office action. Claim 46 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Rejections - 35 USC § 112
The following rejection is maintained with wording modified to reflect amendment to claim 2
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, 13, and 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 pre-AIA the applicant regards as the invention.
Claim 1 recites “the rapamycin is present in the synthetic nanocarriers …amount that is less than 50 weight% rapamycin/hydrophobic polyester carrier material…”. The combination of “%” and “/” renders this phrase vague. It could mean that (i) the weight of rapamycin is less than half of the weight of the hydrophobic polyester carrier material, (ii) the rapamycin is present bound to the hydrophobic polyester carrier material, at less than 50 weight% of the synthetic nanocarrier, or (iii) something else. Reciting “relative to the weight of …” in lieu of the slash would avoid this issue.
For the purposes of examination now, this claim term is interpreted as either of (i) or (ii).
Claim 2 does not recite whether “…45 weight%” is relative to the composition, the synthetic nanocarriers, or the hydrophobic polyester carrier material.
Claim 13 also recites “…is 5-95% weight% hydrophobic polyester carrier material/total solids” which raises the same issue as claim 1.
Claim 20 also recites “…to 10/weight hydrophobic polyester…” appears to be missing a percent sign. The “/” also raises the same issue as in claim 1.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 2, 11, 13, 15, 16, 19, 20, 23, 24, 31, 32, 35, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Fraser (US 2012/0276109) as evidenced by Zhou (US 2013/0171223).
Regarding claims 1, 2, 11, 19, 23, 24, 31, 32, 35, and 41, Fraser teaches composition comprising synthetic nanocarriers comprising a hydrophobic polyester such as those in instant claim 11, and rapamycin (title; abstract; ¶¶0005, 0128, 0136-38, 0141-43, 0170-72, 0207-09, 220-31, 0239-51, 0264-71, 0288-97, 0322-26, 0355-71; claims 39, 40). Example 4 (¶¶0239-45) discloses “[p]reparation of PLGA-rapamycin conjugate” (¶0239), and “preparation of a nanocarrier containing PLGA-rapamycin conjugate and ovalbumin peptide” (¶0241), comprising PLA-PEG (¶0244). Example 12 (¶¶0264-71) discloses PLGA-rapamycin nanocarrier wherein rapamycin content is 9.5% (w/w) (¶0271). The nanocarrier effective diameters are sufficiently small, e.g., 227 nm (¶0297), for sterile filtration. Fraser teaches surfactants including those in claims 15 and 16 (¶0128) and coupling antigens (¶0131).
Fraser does not specifically disclose that in any of its example nanocarriers the rapamycin is present in a super-saturated amount as required in claim 1 and this rejection is made under an obviousness rationale. However, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to prepare Fraser’s nanocarriers wherein rapamycin is present in a super-saturated amount. One having ordinary skill in the art at the time of the invention would have been suggested to do so since the skilled person would have recognized that the loading level of rapamycin could be at, below, or above the saturation level. As Zhou evidences “supersaturating drug delivery systems is a promising concept to obtain adequate oral bioavailability and improve overall pharmacokinetic properties” (¶0002; see title; abstract; ¶¶0054-56) for poorly water-soluble drugs such as rapamycin. Thus, choosing from but three alternatives would not have required an inventive step.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 11, 13, 15, 16, 19, 20, 23, 24, 31, 32, 35, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 12, 13, 20, 22, 25, 27, and 37 of copending Application No. 14/934,132 in view of Fraser (US 20120276109).
Although the claims at issue are not identical, they are not patentably distinct from each other. Both claim sets are drawn to synthetic nanocarriers comprising a hydrophobic carrier material, a non-ionic surfactant having HLB balance under 10, and a rapamycin or rapalog. The primary difference is that the instant claims recite rapamycin while the ‘132 application’s claims recite rapalog. However Fraser teaches that rapalogs as well as rapamycin could be loaded onto the nanocarriers (¶0005). Thus the claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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