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 .
Claim Objections
Claim 29 is objected to because of the following informalities: “PB-PDMS”, recited in line 1 of the claim, is presumably intended to be “PMDS-PEO”, in agreement with the remaining limitations recited in line 2 of the claim, with antecedent basis in claim 1, from which claim 29 depends. Appropriate correction is required.
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.
Claims 1-4, 6, 7, and 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nallani et al. (WO 2014/077781), Discher et al. (USPgPub 2005/0048110), and Mohsen et al. (Journal of Controlled Release. 2017; 251: 92-100). All references of record.
Nallani et al. teach a method of eliciting an immune response to an antigen by injecting a subject with a composition comprising a polymersome comprising an amphiphilic synthetic diblock copolymer, poly(butadiene)-poly(ethyleneoxide) (PB-PEO), with encapsulated antigens within the lumen, corresponding to the first population of polymersomes recited in instant claims 1, 11, 12, 13, and 16. See paragraphs [0022, 0031, 0037-0039, 0042], and Example 2, discussing influenza virus hemagglutinin polymersomes, beginning on page 19, and claims 1 and 6-13. Paragraphs [0008 and 0029] of Nallani et al. discuss the addition of adjuvants and paragraphs [0030 and 0045] of Nallani et al. specifically teach that the adjuvant and the polymersome with immunogen cargo is administered/ boosted separately. These teachings are pertinent against the corresponding limitations recited in instant claim 1.
Claim 2 of Nallani et al. requires that the injecting comprises intradermal, intraperitoneal, subcutaneous, or intravenous administrations, as required by instant claim 2.
In Example 2, beginning on page 19, Nallani et al. discuss inducing an immune response in mice by administering influenza virus hemagglutinin polymersomes, as required by instant claims 3 and 4.
Paragraph [0067] teaches that the influenza hemagglutinin polypeptide antigens within the polymersomes are soluble, as required by instant claims 6, 7, and 9.
Paragraph [0021 and 0026] describes self-assembly of dilute solutions of the amphiphilic block copolymers into vesicles, meeting limitation (ii) of claim 10, requiring that the first population of polymersomes are synthetic. Paragraph [0015], describing Figure 3, states that polymersomes are not immunogenic, meeting limitation (iv) of claim 10.
Claim 10 of Nallani et al. recites that the PB-PEO diblock copolymer comprises 5-50 blocks PB and 5-50 blocks PEO, as required by instant claim 13.
Paragraph [0021] and claim 6 of Nallani et al. require that the first population of polymersomes comprise diblock or triblock (A-B-A or A-B-C) copolymer, as required by instant claim 11.
Self-assembly of the amphiphilic block copolymers, PB-PEO, creates hybrid lipid-polymer membranes in paragraphs [0008-0010, 0021, 0025, 0026, 0043] and claims 1, 19, and 20, as required by instant claim 14.
While paragraphs [0008 and 0029] of Nallani et al. discuss the addition of adjuvants and paragraphs [0030 and 0045] of Nallani et al. specifically teach that the adjuvant and the polymersome with immunogen cargo is administered/ boosted separately, Nallani et al. do not teach or suggest the adjuvant as a CpG ODN, as required by claim 15.
Mohsen et al. discuss CpG adjuvants in the Introduction.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have used the CpG ODN of Mohsen et al. to induce a protective innate and subsequent adaptive immune response to eliminate a pathogen, see the second column on page 92. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have used the CpG ODN of Mohsen et al. as the adjuvant of Nallani et al. because Mohsen et al. teach CpGs are adjuvants in the first column on page 92.
Nallani et al. do not teach encapsulation of an adjuvant within a second population of polymersomes, as required by instant claims 1 and 16.
Discher et al. teach polymersomes encapsulating an adjuvant in paragraphs [0022 and 0131].
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have encapsulated the CpG adjuvant of Nallani et al. and Mohsen et al. within a population of polymersomes, as taught by Discher et al., because Mohsen et al. demonstrate that separate administration of encapsulated antigens and encapsulated CpG ODN adjuvants increase the half-life of the CpG adjuvant, reduce non-specific interactions with cells and proteins in vivo, reach the same draining lymph node, efficiently charge the same antigen-presenting cells, and eliminate the extra steps of physical linkage of the CpG adjuvant to the antigen, see the abstract, the Introduction, and section 2.2. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have encapsulated the CpG adjuvant of Nallani et al. and Mohsen et al. within a population of polymersomes, as taught by Discher et al., because Mohsen et al. encapsulate CpG ODN adjuvants in section 4.4 and Nallani et al. teach polymersome vesicle structures with incorporated large, correctly-folded, membrane protein cargos and/or nucleic acids, are stable in paragraphs [0004, 0021, 0042] and claims 1, 11, and 12.
Claims 5, 8, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Nallani et al., Discher et al., and Mohsen et al. as applied to claims 1-4, 6, 7, and 9-16 above, and further in view of Wagner et al. (USPgPub 2007/0184465) and Rideau et al. (Chemical Society Reviews. Dec 2018; 47 (23): 8572-8610). All references of record.
See the teachings of Nallani et al., Discher et al., and Mohsen et al. above. Nallani et al. mention that the subject administered the antigen-loaded polymersomes and adjuvant are mammalian animals in paragraph [0026], but does not teach or suggest that the mammalian animal is a goat, sheep, cow, or pig, as required by instant claim 5, or that the animal is vaccinated against Foot and Mouth Disease virus, as recited in instant claim 25, or that the encapsulated antigen is a DNA polynucleotide, as recited in instant claim 26.
Wagner et al. claim inducing an antigen-specific immune response by administering an antigen or a nucleic acid encoding an antigen encapsulated within a lipid to a subject, see claim 87. Paragraphs [0026 and 0082] define the subject as a cow, pig, sheep, or goat. In paragraphs [0085 and 0086], Wagner et al. teach that the antigen is derived from the Foot and Mouth Disease virus (FMDV) and describe nucleic acids encoding viral antigens, including DNA.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have replaced the liposome encapsulating the FMDV antigen or the nucleic acid encoding an antigen of Wagner et al. with the polymersome of Nallani et al., Discher et al., and Mohsen et al. with a reasonable expectation of success because Rideau et al. state that liposomes are unstable, sensitive, and have poor modular chemical functionality compared with polymersomes, which additionally retain cargo with greater efficiency, are thermodynamically more inert, possess a longer shelf-life, and have demonstrated stability up to six months, “which is probably not the limit” (quote from the paragraph bridging the columns on page 8577), indicating oxidation stability, required by instant claim 8. See Section II and Figure 3d of Rideau et al.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Nallani et al., Discher et al., and Mohsen et al. as applied to claims 1-4, 6, 7, and 9-16 above, and further in view of Lin et al. (Advanced Functional Materials. 2019 Jul ;29 (28): 1807616). All references of record.
See the teachings of Nallani et al., Discher et al., and Mohsen et al. above. Nallani et al. teach a method of eliciting an immune response to an antigen by injecting a subject with a composition comprising a polymersome comprising an amphiphilic synthetic diblock copolymer, poly(butadiene)-poly(ethyleneoxide) (PB-PEO), with encapsulated antigens within the lumen, corresponding to the first population of polymersomes in in instant claims 1, 11, 12, 13, and 16. See paragraphs [0022, 0031, 0037-0039, 0042]. In paragraph [0008], Nallani et al. mention neutralizing antibodies against virus antigens and in Example 2, beginning on page 19, Nallani et al. discuss inducing an immune response in mice by administering influenza virus hemagglutinin polymersomes.
However, none of the references mention an acute respiratory syndrome coronavirus vaccination, as required by instant claims 23 and 24.
Lin et al. teach a composition for treating a Middle East respiratory syndrome virus (MERS) by administering adjuvant-loaded polymeric nanoparticles decorated with MERS receptor binding domain (RBD) proteins, see Figure 1A.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have been motivated to have incorporated the MERS RBD proteins of Lin et al. in the polymersomes of Nallani et al., Discher et al., and Mohsen et al. to induce an immune response against MERS. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have incorporated the MERS RBD proteins of Lin et al. in the polymersomes of Nallani et al., Discher et al., and Mohsen et al. because Nallani et al. teach stable polymersome vesicle structures incorporate large, correctly-folded, membrane protein cargos and/or nucleic acids in paragraphs [0004, 0021, 0042] and claims 1, 11, and 12.
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Nallani et al., Discher et al., and Mohsen et al. as applied to claims 1-4, 6, 7, and 9-16 above, and further in view of instant SEQ ID NO: 44 alignment with Geneseq db access no: BFL39263 on Aug 2018 by Rauch in WO 2018/115527. All references of record.
See the teachings of Nallani et al., Discher et al., and Mohsen et al. above. Nallani et al. teach stable polymersome vesicle structures incorporate large, correctly-folded, membrane protein cargos and/or nucleic acids in paragraphs [0004, 0021, 0042] and claims 1 and 11-13.
However, none of the references teach or suggest SEQ ID NO: 44, recited in instant claim 27.
Geneseq db access no: BFL39263 on Aug 2018 by Rauch in WO 2018/115527 shares 100% identity with instant SEQ ID NO: 44, see the alignment provided.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have incorporated the mRNA encoding the S1 MERS protein of Rauch into the polymersomes of Nallani et al., Discher et al., and Mohsen et al. above to induce an immune response against MERS. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have incorporated the mRNA encoding the S1 MERS protein of Rauch into the polymersomes of Nallani et al., Discher et al., and Mohsen et al. because Nallani et al. teach stable polymersome vesicle structures incorporate large, correctly-folded, membrane protein cargos and/or nucleic acids in paragraphs [0004, 0021, 0042] and claims 1, 11, and 12.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Nallani et al., Discher et al., and Mohsen et al. as applied to claims 1-4, 6, 7, and 9-16 above, and further in view of Rheingans et al. (Macromolecules. 2000; 33: 4780-4790).
See the teachings of Nallani et al., Discher et al., and Mohsen et al. above. Nallani et al. teach amphiphilic polymers comprising PDMS-PEO blocks (presumed to be recited in instant claim 29), i.e., “(PMOXA-b-PDMS-b-PEO)”, see paragraphs [0036, 0038] and claims 17 and 18. However, Nallani et al. do not teach how many blocks of each of PDMS and PEO are assembled.
Rheingans et al. teach PDMS-PEO diblock copolymers comprising 49, 59, and 65 PDMS blocks and 55, 56, and 64 PEO blocks, see Table 1.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have used the quantity of PDMS and PEO polymer blocks used by Rheingans et al. to firm self-associated micellular nanoparticles, see Figure 1.
MPEP § 2144.05 teach:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
In the instant case, Rheingans et al. teach the range of workable molar ratios of each PDMS-PEO diblock nanoparticle component with sufficient specificity within the claimed range for each component in Table 1: MA-PDMS59-PEO56-H; MA-PDMS65-PEO64-COOK; and MA-PDMS49-PEO55-Bz.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have modified the component ratios of Rheingans et al. to 5-100 blocks of each of PDMS and PEO, as claimed, as applicant appears to have placed no criticality on PDMS-PEO ratio since the quantities of these components may range from 5-100 blocks, recited in claim 29, indicating that any amount of each component may be within the range taught. Rheingans et al. teach the molar ratio of the PDMS-PEO block components within the instant range recited in Table 1. It has been held that “[i]n 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). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have optimized the component ratios, as evidenced by the teachings of Rheingans et al., absent unexpected results to the contrary to arrive at the component ratios recited in instant claim 29.
Response to Arguments
Applicant disagrees with the assertion that Nallani et al. disclose “encapsulated antigens within the lumen” of a polymersome vesicle. Applicant specifically points to paragraphs [0022], [0031], [0038], and [0042] of Nallani et al., disclosing the integration of immunogens into the wall of the polymersome vesicle.
Applicant’s arguments and a review of the teachings of Nallani et al. have been fully considered, but are found unpersuasive. While applicant is correct that Nallani et al. discloses membrane-associated antigens integrated into the wall of the polymersome in paragraphs [0022 and 0026], Nallani et al. specifically teach encapsulation of antigens within the polymersomes:
[0037] In certain embodiments, the polymersome carrier may contain one or more compartments (or otherwise termed "multicompartments"). Compartmentalization of the vesicular structure of polymersome allows for the co-existence of complex reaction pathways in living cell and helps to provide a spatial and temporal separation of many activities inside a cell. Accordingly, more than one type of immunogen may be incorporated in the polymersome carrier. The different immunogens may have the same or different isoforms. Each compartment may also be formed of a same or a different amphiphilic polymer. In various embodiments, two or more different immunogens are integrated into the circumferential membrane of the amphiphilic polymer. Each compartment may encapsulate at least one of peptide, protein, and nucleic acid. The peptide, protein, or nucleic acid may be immunogenic.
[0038] In the case where the polymersome carrier contains more than one compartment, the compartments may comprise an outer block copolymer vesicle and at least one inner block copolymer vesicle, wherein the at least one inner block copolymer vesicle is encapsulated inside the outer block copolymer vesicle.
[0039] By "encapsulated" it is meant that the inner vesicle is completely contained inside the outer vesicle and is surrounded by the vesicular membrane of the outer vesicle. The confined space surrounded by the vesicular membrane of the outer vesicle forms one compartment. The confined space surrounded by the vesicular membrane of the inner vesicle forms another compartment.
[0042] In additional embodiments, a secondary protein that complexes with the membrane protein antigen may be encapsulated or incorporated in the lumen of the polymersome carrier. Advantageously, the secondary protein stabilises the membrane protein antigen in a specific conformation.
Applicant opines that the encapsulated protein discussed in paragraph [0042] is not the antigen itself. However, there is no support in Nallani et al. discussing non-immunogenic or non-antigen proteins, in contrast to non-immunogenic empty polymersomes, discussed in paragraph [0058] and depicted in Figure 3. Paragraph [0003] of Nallani et al. state, “immunogens or antigens (used interchangeably herein)”. Antigens that produce a low level of immune response (also discussed in paragraph [0003]) are nonetheless, still immunogenic/ antigenic.
Nallani et al. claim:
1. A method for eliciting in a subject an immune response to an immunogen, comprising injecting the subject with a composition comprising a polymersome carrier having a circumferential membrane of an amphiphilic polymer and an immunogen integrated into the circumferential membrane of the amphiphilic polymer of the polymersome carrier…
11. The method of any one of claims 1 to 10, wherein the polymersome carrier contains one or more compartments.
12. The method of claim 11, wherein each one of the one or more compartments encapsulates at least one of peptide, protein, and nucleic acid.
13. The method of claim 12, wherein the at least one of peptide, protein, and nucleic acid is immunogenic.
Therefore, Nallani et al. explicitly teach inducing an immune response with a polymersome carrier comprising encapsulated antigens within the lumen of a polymersome vesicle.
Applicant submits that the rejection misinterprets Nallani et al. because the reference never discusses including the adjuvant within a polymersome; rather, the adjuvant is merely administered with the polymersome as part of the composition or separately.
In reply, applicant’s attention is directed to the fourth and last full paragraphs on page 5 of the 8/4/2025 Office action, acknowledging the lack of adjuvant encapsulation within the polymersome of Nallani et al.:
While paragraphs [0008 and 0029] of Nallani et al. discuss the addition of adjuvants and paragraphs [0030 and 0045] of Nallani et al. specifically teach that the adjuvant and the polymersome with immunogen cargo is administered/ boosted separately, Nallani et al. do not teach or suggest the adjuvant as a CpG ODN, as required by claim 15.
Nallani et al. do not teach encapsulation of an adjuvant within a second population of polymersomes, as required by instant claims 1 and 16.
The teachings of Discher et al. supply teachings of an encapsulated adjuvant. Mohsen et al. discuss CpG adjuvants in the Introduction and induce a protective innate and subsequent adaptive immune response to eliminate a pathogen in the second column on page 92.
Applicant argues that the combined teachings of Mohsen et al., teaching CpG adjuvants exist, combined with the teachings of Nallani et al. and Discher et al., would encourage the ordinary artisan to use protein-based particles for delivery and would not result in the invention as claimed. Applicant asserts that there is no suggestion or motivation to combine the necessary modifications in the cited references and the three basic criteria of prima facie obviousness have not been met.
Applicant’s arguments and the teachings of the references have been fully reviewed and considered, but are found unpersuasive. The rejection of record comprises all of the components required to satisfy determining obviousness under 35 U.S.C. § 103, discussed in MPEP §§ 2141-2144, by setting forth (A-D):
the relevant teachings of the prior art relied upon, preferably with reference to the relevant column or page number(s) and line number(s) where appropriate:
Nallani et al. teach a method of eliciting an immune response to an antigen by injecting a subject with a composition comprising a polymersome comprising an amphiphilic synthetic diblock copolymer, poly(butadiene)-poly(ethyleneoxide) (PB-PEO), with encapsulated antigens within the lumen, corresponding to the first population of polymersomes recited in instant claims 1, 11, 12, 13, and 16. See paragraphs [0022, 0031, 0037-0039, 0042], and Example 2, discussing influenza virus hemagglutinin polymersomes, beginning on page 19, and claims 1 and 6-13. Additional teachings and corresponding citations of Nallani et al. discussed above are incorporated herein.
Mohsen et al. discuss CpG adjuvants in the Introduction.
Discher et al. teach polymersomes encapsulating an adjuvant in paragraphs [0022 and 0131].
the difference or differences in the claim over the applied reference(s):
While paragraphs [0008 and 0029] of Nallani et al. discuss the addition of adjuvants and paragraphs [0030 and 0045] of Nallani et al. specifically teach that the adjuvant and the polymersome with immunogen cargo is administered/ boosted separately, Nallani et al. do not teach or suggest the adjuvant as a CpG ODN, as required by claim 15.
Nallani et al. do not teach encapsulation of an adjuvant within a second population of polymersomes, as required by instant claims 1 and 16.
the proposed modification of the applied reference(s) necessary to arrive at the claimed subject matter, and
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have encapsulated the CpG adjuvant of Nallani et al. and Mohsen et al. within a population of polymersomes, as taught by Discher et al., because Mohsen et al. demonstrate that separate administration of encapsulated antigens and encapsulated CpG ODN adjuvants increase the half-life of the CpG adjuvant, reduce non-specific interactions with cells and proteins in vivo, reach the same draining lymph node, efficiently charge the same antigen-presenting cells, and eliminate the extra steps of physical linkage of the CpG adjuvant to the antigen, see the abstract, the Introduction, and section 2.2.
an explanation as to why the claimed invention would have been obvious to one of ordinary skill in the art at the time the invention was made.
One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have encapsulated the CpG adjuvant of Nallani et al. and Mohsen et al. within a population of polymersomes, as taught by Discher et al., because Mohsen et al. encapsulate CpG ODN adjuvants in section 4.4 and Nallani et al. teach polymersome vesicle structures with incorporated large, correctly-folded, membrane protein cargos and/or nucleic acids, are stable in paragraphs [0004, 0021, 0042] and claims 1, 11, and 12.
Therefore, the instant rejection satisfies factual inquiries of Graham v. John Deere Co., 383 US. 1, 148 USPQ 459 (1966) and provides appropriate supporting rationale in view of KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding the teachings of Wagner et al. and Rideau et al., applicant argues that liposomes are substantially different than polymersomes in terms of stability, uptake, persistence, an immunological signaling. Applicant states Rideau et al. teach nothing concerning polymersome equivalence in terms of an antigenic carrier in the claimed invention and does not establish why polymersomes retaining cargo with greater efficiency, remaining thermodynamically more inert, possessing a longer shelf-life, and have demonstrated stability up to six months, attributed by Rideau et al., would be in any way relevant to the liposomes of Wagner et al., much less to the invention as presently claimed.
Applicant’s arguments have been fully considered, but are found unpersuasive. Establishment of polymersomes as carriers for antigens and adjuvants is established in the prima facie combined prior art teachings of Nallani et al., Discher et al., and Mohsen et al. as applied to claims 1-4, 6, 7, and 9-16, which are incorporated under the rejection of claims 5, 8, 25, and 26. The teachings of Wagner et al. supply the requisite limitations of an encapsulated nucleic acid encoding an FMDV antigen in a liposome administered to a cow, pig, sheep, or goat in claim 87 and paragraphs [0026, 0082, 0085, and 0086], required by instant claims 5, 8, 25, and 26. Inspiration to replace the liposome carrier of Wagner et al. with the polymersome of Nallani et al., Discher et al., and Mohsen et al. with a reasonable expectation of success is provided by the teachings in Section II and Figure 3d of Rideau et al., i.e., liposomes are unstable, sensitive, and have poor modular chemical functionality compared with polymersomes, which additionally retain cargo with greater efficiency, are thermodynamically more inert, possess a longer shelf-life, and have demonstrated stability up to six months, “which is probably not the limit” (quote from the paragraph bridging the columns on page 8577), indicating oxidation stability. There are no deficiencies in the underlying rejection based on Nallani et al., Discher et al., and Mohsen et al. for Wagner et al. and Rideau et al. to resolve.
Regarding the teachings of Lin et al., applicant points out that the MERS RBD proteins of Lin et al. are not membrane proteins. Applicant asserts that the attachment of antigens to the exterior of a vesicle, whether by the method of Nallani et al. or Lin et al., is unrelated to the present invention.
Applicant’s arguments have been fully considered, but are found unpersuasive. Nallani et al. teach inducing an immune response with a polymersome carrier comprising encapsulated antigens within the lumen of a polymersome vesicle, see paragraphs [0022, 0031, 0037-0039, 0042] and claims 1 and 11-13. The immunogenic peptides, proteins, and nucleic acids encapsulated by the polymersome of Nallani et al. are not limited to membrane proteins, as suggested by applicant. The teachings of Lin et al. supply the requisite MERS-CoV protein.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have been motivated to have incorporated the MERS RBD proteins of Lin et al. in the polymersomes of Nallani et al., Discher et al., and Mohsen et al. to induce an immune response against MERS. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have incorporated the MERS RBD proteins of Lin et al. in the polymersomes of Nallani et al., Discher et al., and Mohsen et al. because Nallani et al. teach stable polymersome vesicle structures encapsulate large, correctly-folded, membrane protein cargos and/or nucleic acids in paragraphs [0021, 0037-0039, 0042] and claims 1 and 11-13. There are no deficiencies in the underlying rejection based on Nallani et al., Discher et al., and Mohsen et al. for Lin et al. to resolve.
Regarding the teachings of Rauch, applicant points to paragraph [0037] of Nallani et al. and emphasizes that the antigens of Nallani et al. are incorporated into the membrane of the polymersome and are not encapsulated into the interior. Applicant underlines the following from paragraph [0037]:
In various embodiments, two or more different immunogens are integrated into the
circumferential membrane of the amphiphilic polymer. Each compartment may
encapsulate at least one of peptide, protein, and nucleic acid. The peptide, protein,
or nucleic acid may be immunogenic.
Applicant’s arguments and the teachings of Nallani et al. have been fully considered and reviewed. In the teachings of Nallani et al. underlined by applicant, Nallani et al. clearly describe the placement of two or more different immunogens. One location of different immunogens is the membrane perimeter of the amphiphilic polymer. Another location for the immunogen is encapsulation within the polymersome. Paragraph [0039] of Nallani et al. defines encapsulated:
By "encapsulated" it is meant that the inner vesicle is completely contained inside the outer vesicle and is surrounded by the vesicular membrane of the outer vesicle. The confined space surrounded by the vesicular membrane of the outer vesicle forms one compartment. The confined space surrounded by the vesicular membrane of the inner vesicle forms another compartment.
Therefore, when the definition by Nallani et al. of encapsulate is applied in context to the at least one immunogenic peptide, protein, and nucleic acid encapsulated within a compartment of the polymersome in paragraph [0037], it is meant that the at least one immunogenic peptide, protein, and nucleic acid is completely contained inside the compartment, i.e., inner vesicle inside the outer polymersome vesicle. There are no deficiencies in the underlying rejection based on Nallani et al., Discher et al., and Mohsen et al. for Rauch et al. to resolve.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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/Shanon A. Foley/Primary Examiner, Art Unit 1671