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 . Claims included in the prosecution are claims 1, 2, 12, 20, 22, 25, 27, 37, 68 and 80-83.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 07/20/2026 has been entered.
Applicants' arguments, filed 07/20/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Rejections - 35 USC § 103
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.
1. Claims 1, 2, 12, 20, 22, 25, 27, 68, and 80-82 are rejected under 35 U.S.C. 103 as being unpatentable over Fraser et al (U.S. Patent Application Pub. No. 2012/0276109 published on 11/01/2012) in view of Lin (US 2014/0099371, Apr. 10, 2014).
Fraser et al teach a composition comprising synthetic nanocarriers admixed with an antigen (Abstract and para [0207]) and further comprising a mix of hydrophobic carrier materials (i.e., PLA and PLA-PEG copolymers) (para [0130], [0133], [0142] and [0143]) and a rapalog (i.e., rapamycin or rapamycin analog) (para [0005], [0021], [0087], and [0170]).
Fraser et al further teach the composition further comprising one or more amphiphilic entities as an additive that can promote the production of synthetic nanocarriers with increased stability, improved uniformity, or increased viscosity (para [0128]).
Fraser et al further teach the composition wherein a component can be encapsulated within, surrounded by, and/or dispersed throughout a polymer matrix (para [0134]).
Fraser et al further teach the composition wherein the amount of hydrophobic carrier material/polymer in the synthetic nanocarriers may be 77% (PLGA 5g/PLGA-rapamycin 6.5g*100% = 77% by weight; Example 4).
Fraser et al further teach the composition wherein, in an exemplary embodiment, rapamycin is contained in the nanocarrier (i.e., encapsulated) and the amount of rapamycin is 42% by weight of rapalog relative to the weight of the hydrophobic carrier material (rapamycin 2.1g/PLGA 5g*100% = 42% by weight; Example 4).
Fraser et al further teach the composition wherein the diameter is equal to or greater than 100 nm, 120 nm, 130 nm, 140 nm, and 150 nm (para [0096]).
Fraser et al further teach the composition wherein the composition further comprises a pharmaceutically acceptable excipient/carrier (para [0013] and [0100]).
Fraser et al differ from the instant claims insofar as not disclosing wherein the composition comprises sorbitan monopalmitate.
However, Lin discloses a fucose-grafted chitosan/heparin nanocarrier encapsulating amoxicillin (¶ [0037]). Suitable surfactants for the medicinal carrier include Span 40 (¶ [0063]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Fraser et al disclose wherein the composition comprises one or more amphiphilic entities. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated Span 40 into the composition of Fraser et al since it is a known and effective amphiphilic entity for medicinal carriers as taught by Lin.
In regards to instant claim 1 reciting wherein the amount of non-ionic surfactant with HLB value less than or equal to 10 is ≥ 1% but ≤ 13% by weight relative to the weight of the hydrophobic carrier material, Fraser et al disclose wherein an amphiphilic entity can promote the production of synthetic nanocarriers with increased stability, improved uniformity, or increased viscosity. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount based on the stability, uniformity, and viscosity desired. 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.
In regards to instant claim 2 reciting wherein the composition is initially sterile filterable through a 0.22 µm filter, the term “filterable” is merely a functional recitation requiring the ability to be filtered. The claim does not require, however, that filtration actually occurs. Accordingly, since the synthetic nanocarrier of Fraser et al. may be 100 nm (0.1 µm), the synthetic nanocarrier of Fraser et al is filterable through a 0.22 µm filter.
Response to Arguments
Applicant argues that the medicinal carriers described in Lin is not present in the pending claims. It is also noted that the active agent of Lin is also different from the active agent of the instant claims. Additionally, it is noted that Lin does not teach or suggest an amount of non-ionic surfactant with a HLB value less than or equal to 10 relative to the weight of the hydrophobic carrier material. Accordingly, there is no reason why one of ordinary skill in the art would look to Lin.
The Examiner does not find Applicant’s argument to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. As discussed in the rejection, Fraser teaches the claimed hydrophobic carrier material and the claimed active agent. Fraser also provided motivation to optimize to the claimed amount of non-ionic surfactant. Lin was used to provide motivation to incorporate the claimed non-ionic surfactant into the composition of Fraser. As discussed in the rejection and previous office action, Fraser discloses wherein the composition comprises one or more amphiphilic entities. Fraser discloses in paragraph [0128] wherein “[s]uch amphiphilic entities include, but are not limited to, phosphoglycerides….” Accordingly, since Fraser specifically discloses wherein the amphiphilic entities are not limited to what is disclosed, it would have been obvious to one of ordinary skill in the art to supplement Fraser’s list with further a compound, such as Span 40 since these are known and effective amphiphilic entities for medicinal carriers as taught by Lin. One ordinary skill in the art would have had a reasonable expectation of success that the surfactants described in Lin would function in the synthetic nanocarriers described by Fraser since Fraser discloses in paragraph [0128] wherein suitable amphiphilic entities include other Span compounds such as Span 20 and Span 85. Applicant has not shown wherein the surfactants of Lin would not function in the synthetic nanocarriers of Fraser. As such, Applicant’s argument is unpersuasive.
Applicant argues that the Examiner stated that it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount based on the stability, uniformity, and viscosity desired. The conclusory statement does not rise to the level of a rational underpinning explaining why a person of ordinary skill in the art would have arrived at the claimed invention.
The Examiner disagrees and does not find Applicant’s argument to be persuasive. As discussed in the rejection and previous office action, Fraser discloses wherein an amphiphilic entity can promote the production of synthetic nanocarriers with increased stability, improved uniformity, or increased viscosity. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount based on the stability, uniformity, and viscosity desired. Applicant has not explained how Fraser disclosing wherein an amphiphilic entity can promote the production of synthetic nanocarriers with increased stability, improved uniformity, or increased viscosity is not a rational underpinning to explain why a person of ordinary skill in the art would have arrived at the claimed invention through routine optimization. If an amphiphilic entity promotes the production of synthetic nanocarriers with increased stability, improved uniformity, or increased viscosity, it is not clear why one would not be able to optimize an amount of amphiphilic entity to arrive at a desired stability, uniformity, or viscosity. As such, Applicant’s argument is unpersuasive.
Applicant argues that the amount of the non-ionic surfactant with a HLB value less than or equal to 10 relative to the weight of the hydrophobic carrier material is not arbitrary.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown wherein the amount is not arbitrary. Applicant has not provided any objective evidence comparing various amounts of non-ionic surfactant within and outside of the claimed range to show that the amount is not arbitrary. Therefore, Applicant’s argument is unpersuasive.
Applicant argues that the compositions of the claims have unexpectedly beneficial properties as demonstrated in at least Example 9, which demonstrates beneficial effects on filterability and rapamycin load.
The Examiner does not find Applicant’s argument to be persuasive. Example 9 shows the amount of various components in a number of synthetic nanocarriers that can result in initial sterile filterable synthetic nanocarriers with an amount of rapamycin that is expected to be efficacious in vivo. The Examiner does not find this showing to be persuasive since Applicant has not shown wherein certain amounts of various components would not result in initial sterile filterable synthetic nanocarriers. Without such showing, Applicant has not shown wherein the specific amount of various components is critical. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. See MPEP 716.02(d). As such, Applicant’s argument is further unpersuasive.
2. Claims 1, 2, 12, 20, 22, 25, 27, 37, 68, and 80-83 are rejected under 35 U.S.C. 103 as being unpatentable over Fraser et al (U.S. Patent Application Pub. No. 2012/0276109 published on 11/01/2012; of record) in view of Lin (US 2014/0099371, Apr. 10, 2014) and Unger et al. (U.S. Patent Application Pub. No. 2004/0038406 published on Feb. 26, 2004)
Fraser et al teach a composition comprising synthetic nanocarriers admixed with an antigen (Abstract and para [0207]) and further comprising a mix of hydrophobic carrier materials (i.e., PLA and PLA-PEG copolymers) (para [0130], [0133], [0142] and [0143]) and a rapalog (i.e., rapamycin or rapamycin analog) (para [0005], [0021], [0087], and [0170]).
Fraser et al further teach the composition further comprising one or more amphiphilic entities as an additive that can promote the production of synthetic nanocarriers with increased stability, improved uniformity, or increased viscosity (para [0128]).
Fraser et al further teach the composition wherein a component can be encapsulated within, surrounded by, and/or dispersed throughout a polymer matrix (para [0134]).
Fraser et al further teach the composition wherein the amount of hydrophobic carrier material/polymer in the synthetic nanocarriers may be 77% (PLGA 5g/PLGA-rapamycin 6.5g*100% = 77% by weight; Example 4).
Fraser et al further teach the composition wherein, in an exemplary embodiment, rapamycin is contained in the nanocarrier (i.e., encapsulated) and the amount of rapamycin is 42% by weight of rapalog relative to the weight of the hydrophobic carrier material (rapamycin 2.1g/PLGA 5g*100% = 42% by weight; Example 4).
Fraser et al further teach the composition wherein the diameter is equal to or greater than 100 nm, 120 nm, 130 nm, 140 nm, and 150 nm (para [0096]).
Fraser et al further teach the composition wherein the composition further comprises a pharmaceutically acceptable excipient/carrier (para [0013] and [0100]).
Fraser et al differ from the instant claims insofar as not disclosing wherein the composition comprises sorbitan monopalmitate.
However, Lin discloses a fucose-grafted chitosan/heparin nanocarrier encapsulating amoxicillin (¶ [0037]). Suitable surfactants for the medicinal carrier include Span 40 (¶ [0063]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Fraser et al disclose wherein the composition comprises one or more amphiphilic entities. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated Span 40 into the composition of Fraser et al since it is a known and effective amphiphilic entity for medicinal carriers as taught by Lin.
The combined teachings of Fraser et al and Lin do not disclose wherein the amount of non-ionic surfactant with HLB value less than or equal to 10 is ≥ 0.01% but ≤ 20% by weight relative to the weight of the hydrophobic carrier material and wherein the composition is in a kit.
However, Unger et al disclose a collection of particles having an agent, a surfactant molecule having an HLB value of less than about 6.0, and a polymer, with the collection of particles having an average diameter of less than about 200 nanometers (¶ [0007]). The polymer may be hydrophobic (¶ [0041]). The amount of surfactant may range up to about 10.0 weight percent (¶ [0037]). Agents include antigens (¶ [0058]). The collection of particles may be included in a kit having instructions for using the collection of particles (¶ [0009])
Fraser et al do not disclose an amount of amphiphilic entities. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated up to about 10.0 weight percent of amphiphilic entities into the synthetic nanocarriers of Fraser et al since this is a known and effective amount of amphiphilic entities (i.e. surfactant) used to formulate nanocarriers that comprise antigens as taught by Unger et al.
It would have been prima facie obvious to one of ordinary skill in the art to have the composition of Fraser et al in a kit motivated by the desire to incorporate instructions for using the composition of Fraser et al as taught by Unger et al.
In regards to instant claim 2 reciting wherein the composition is initially sterile filterable through a 0.22 µm filter, the term “filterable” is merely a functional recitation requiring the ability to be filtered. The claim does not require, however, that filtration actually occurs. Accordingly, since the synthetic nanocarrier of Fraser et al. may be 100 nm (0.1 µm), the synthetic nanocarrier of Fraser et al. is filterable through a 0.22 µm filter.
Response to Arguments
Applicant argues that Unger does not cure the deficiencies of Fraser.
The Examiner submits that arguments with regards to Fraser are discussed above and are unpersuasive. Therefore, the rejection 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 1, 2, 12, 20, 22, 25, 27, 37, 68 and 80-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 11, 13, 15, 16, 19, 20, 23, 24, 31, 32 and 35 of copending Application No. 18/921,868. Although the claims at issue are not identical, they are not patentably distinct from each other because pending claim 1 can be derived from the independent and dependent claims of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1, 2, 12, 20, 22, 25, 27, 37, 68 and 80-83 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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