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 .
Applicant’s amendment filed on 07/22/2026 has been entered.
Amended claims 1-6, 9-13, 16-17, 20-22, 28, 30, 33 and 35 are pending in the present application.
Applicant’s election without traverse of Group I in the reply filed on 07/22/2026 is acknowledged.
Applicant also elected the species CPMV-based species and particularly CPMV comprising ApoAI-4FN (SEQ ID NO: 9). Be electing this species, Applicant also elected the VNP comprising a maleimide-bearing CPMV-M(PEG)4.
Accordingly, claims 28, 30, 33 and 35 were withdrawn from further considerations because they are directed to non-elected inventions. Additionally, claims 10-13 and 22 (the elected species ApoAI-4FN is a water-soluble peptide) were also withdrawn from further consideration because they are drawn to non-elected species.
Thus, claims 1-6, 9, 16-17 and 20-21 are examined on the merits herein with the above elected species.
Claim Objections
Claims 16-17 are objected to because of the abbreviation “M(PEG)4” which should be spelled out in full at its first occurrence.
Similarly, claim 21 is objected to because of the abbreviation “SM(PEG)4” which should be spelled out in full at its first occurrence.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 9, 16-17 and 20-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163 - 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention ....” This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc). Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111 (Fed. Cir. 1991), clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” Vas-Cath Inc. v. Mahurkar, 19USPQ2d at 1117. The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed. ”Vas-Cath Inc. v. Mahurkar, 19USPQ2d at 1116.
The instant claims encompass a formulation method comprising: a) admixing a viral nanoparticle (VNP) with an effective amount of about 4% (e.g., 3.6 wt% to 4.4 wt%) of a poloxamer such as Pluronic F127 (F12&) or any equivalent thereof to prepare a mixture at a temperature of about 25 0C (e.g., 23.75 0C to 26.25 0C); b) cooling the mixture at a unimerization temperature below about 19.5 0C (e.g., 18.5 0C to 20.5 0C) to promote unimerization of the poloxamer such as F127 or the equivalent thereof and then returning the mixture to a micellization temperature of 250C to promote micellization of the poloxamer such as F127 or the equivalent thereof; and c) mixing the mixture prepared by step b). The term “an equivalent of Pluronic F127” is defined by the instant specification to include poloxamers that are triblock copolymers consisting of a central hydrophobic block of polypropylene glycol flanked by two hydrophilic blocks of polyethylene glycol (PEG) (paragraph [0070]).
Apart from disclosing only the use of Pluronic F127 (PEO101-PPO56-PEO101), wherein PEO is polyethylene oxide and PPO is polypropylene oxide (see at least Experimental section); the instant specification failed to describe sufficiently any Pluronic F127 equivalent to be utilized in the formulation method that specifically requires a unimerization temperature below about 19.5 0C and a micellization temperature of 25 0C as claimed broadly. For example, what is the specific structure of an equivalent of Pluronic F127 (e.g., how many PPO subunits and/or the number of subunits PEO that flank the central PPO subunit(s)) such that the equivalent would meet the requirements of the formulation method as claimed? Since the prior art before the effective filing date of the present application (07/26/2021) also failed to provide sufficient guidance and/or written description for the issue discussed above as evidenced at least by the teachings of Liu et al (Langmuir 28:11957-11961, 2012), Basak et al (Langmuir 29:4350-4356, 2013; IDS), Alexandridis et al (Macromolecules 27:2414-2425, 1994) and Zhang et al (Nature Communications 7:11645;DOI: 10.1038/ncomms11649; 9 pages, 2015); it is incumbent upon the instant specification to do so. Furthermore, the instant specification also fails to provide and describe at least a representative number of species for a broad genus of an equivalent of Pluronic F127 to be utilized in a formulation method as claimed broadly.
The claimed invention as a whole is not adequately described if the claims require essential or critical elements which are not adequately described in the specification and which are not conventional in the art as of Applicants’ filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641, 1646 (1998). The skilled artisan cannot envision at least a representative number of species for a broad genus of an equivalent of Pluronic F127 to be utilized in a formulation method as claimed broadly; and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
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 1-6, 9, 16-17 and 20-21 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-2 and 4-5 contain the trademark/trade name Pluronic F127 (F127). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe poloxamer 407 and, accordingly, the identification/description is indefinite.
Additionally, claims 1-2, 4-5 and 17 are also indefinite because the limitation “a poloxamer such as Pluronic F127 (F127) or an equivalent thereof” and/or “the poloxamer such as F127 or the equivalent thereof”. This because what other poloxamers apart from F127 and an equivalent of F127 do the claims encompass? Clarification is requested because the metes and bounds of the claims are not clearly determined.
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 6 recites the broad recitation “tobacco mosaic virus (TMV), cowpea mosaic virus (CPMV) and tobacco mild green mosaic virus (TMGMV), and a modified equivalent thereof”, and the claim also recites “TMV-lysine, TMV-lysine with a Lys substitution at amino acid position 158, CPMV-lysine, CPMV with a Lys substitution at amino acid position 158, chemically conjugated TMC, chemically conjugated CPMV, chemically conjugated TMGMV, TMV-Cys5.5, ligand-modified TM, ligand-modified CPMV, ligand-modified TMGMV, avermectin-TMGMV and TMGMV-Cys5” which is the narrower statement of the range/limitation. 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.
Additionally, in claims 6 and 17, it is also unclear what is encompassed at least by the limitation “CH401-Rat (SEQ ID NO: 1), Myostatin 1 (SEQ ID NO: 2),……and ApoAI-4FN (SEQ ID NO: 9)”. Are SEQ ID NOs. 1, 2 and 9 representative members of the peptides CH401-Rat, Myostatin 1 and ApoAI-4FN, respectively; or Applicant intends to claim the CH401-Rat peptide of SEQ ID NO: 1, the Myostatin 1 peptide of SEQ ID NO: 2 and the ApoAI-4FN peptide of SEQ ID NO: 9. Once again, clarification is requested because the metes and bounds of the claim are not clearly determined.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This is because dependent claim 2 recites the limitation “the step b) micellization temperature is from 23.75 0C to 26.25 0C”, yet step b) of independent claim 1 recites the limitation “then returning the mixture to a micellization temperature of 25 0C to promote micellization of the poloxamer”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (Langmuir 28:11957-11961, 2012) in view of Basak et al (Langmuir 29:4350-4356, 2013; IDS), Alexandridis et al (Macromolecules 27:2414-2425, 1994) and Zhang et al (Nature Communications 7:11645;DOI: 10.1038/ncomms11649; 9 pages, 2015).
The instant claims encompass a formulation method comprising: a) admixing a viral nanoparticle (VNP) with an effective amount of about 4% (e.g., 3.6 wt% to 4.4 wt%) of a poloxamer such as Pluronic F127 (F12&) or an equivalent thereof to prepare a mixture at a temperature of about 25 0C (e.g., 23.75 0C to 26.25 0C); b) cooling the mixture at a unimerization temperature below about 19.5 0C (e.g., 18.5 0C to 20.5 0C) to promote unimerization of the poloxamer such as F127 or the equivalent thereof and then returning the mixture to a micellization temperature of 250C to promote micellization of the poloxamer such as F127 or the equivalent thereof; and c) mixing the mixture prepared by step b). It is noted that at least ligand-modified CPMV is optional is optional in dependent claims 6 and 9.
Liu et al already disclosed protein bio-nanoparticles coated with nonionic block copolymer Pluronics F127 via noncovalent interaction by mixing 0.1 mg/mL Tobacco mosaic virus (TMV) with 2.5 mg/mL F127 in solution (equivalent to 0.25 wt% of F127) at about 30 0C, which is higher than the CMT of F127 at this concentration; micelles of F127 can adsorb onto the surface of TMV above the critical micelle temperature (CMT) of F127, and the transition from micelle to capsule-like structure can generate a stable polymer coating on the surface of TMV (Abstract; left column, first paragraph at page 11958; Scheme 1 and Figure 1). It is noted that 0.1 mg/mL TMV with 2.5 mg/mL F127 in solution is equivalent to about 34.7 to 35 molar equivalents of F127 per coat protein of TMV.
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Liu et al also stated “No obvious coating was found when TMV and F127 were mixed at 25 0C” (second last sentence of first paragraph on left column at page 11958); and “This study establishes principles for the possible design of clinically useful protein delivery systems” (last sentence in the Abstract). It is also noted that the difference in temperatures for micelles of F127 can adsorb onto the surface of TMV and no obvious coating was found for 0.25 wt% of F127 is about 5 0C (about 30 0C-25 0C).
Liu et al did not teach explicitly a formulation prepared by the method recited in claim 1 of the present application, particularly using about 4 wt% of F127 for admixing with TMV, using a temperature about 19.5 0C to promote F127 unimerization and a temperature of about 25 0C to promote F127 micellization.
Before the effective filing date of the present application (07/26/2021), Basak et al already taught that Pluronic F127 is a triblock copolymer and has a molecular weight of 12,600 g/mol, a critical micellization concentration of 0.725 wt% at 25 0C; and utilized F127 solutions at concentrations 5.26, 2.04, and 1.02 wt%, which are much higher than the CMCs at the temperatures between 40 and 60 0C to encapsulate hydrophobic drugs (Abstract; left column, last two full paragraphs at page 4351).
Additionally, Alexandridis et al also disclosed Critical Micellization Temperatures for Pluronic Copolymer Aqueous Solutions as a Function of a Copolymer, including the CMT of 19.5 0C for F127 solution at the concentration of 5 wt%; as well Critical Micellization Concentrations for Pluronic Copolymer Aqueous Solutions as a Function of Solution Temperature, with the CMT of 20 0C for F127 solution at 4 wt% (Abstract; particularly Tables 2-3 at pages 2418 and 2419, respectively).
Moreover, Zhang et al also showed that Pluronic block copolymers are amenable to low-temperature processing to strip away all free and loosely bound surfactant, leaving behind concentrated, kinetically frozen drug micelles containing minimal solubilizing excipient (Abstract). Zhang et al stated “Pluronic F127 (F127) has a concentration-sensitive critical micellar temperature (CMT)33. The approach of modulating temperatures above and below Pluronic CMT was used to reversibly and thermochromically switch near infrared (NIR) dyes from nanoparticulate to microcrystalline form34…When the temperature was lowered below the CMT, free and loose surfactant (without incorporated ONc) converted to unimeric form and could be removed by membrane filtration, leaving pure and highly concentrated frozen micelles” (right column, third paragraph at page 2).
Accordingly, it would have been obvious for an ordinary skill in the art to modify the teachings of Liu et al by also coating TMV nanoparticles using about 4 wt% of F127 solution and modulating temperature above and below Pluronic CMT such as a temperature of 20 0C (about 19.5 0C) to promote F127 unimerization and a temperature of about 25 0C to promote F127 micellization, including the step of mixing the mixture at step b) to release free or loose F127 in unimeric form from adsorbed F127 micelle coating (see Scheme 1 in the primary Liu reference), as well as repeated steps b) and c) at least twice; in light of teachings of Basak et al, Alexandridis et al and Zhang et al as presented above
An ordinary skill in the art would have been motivated to carry out the above modifications because: (i) Basak et al taught that F127 has a critical micellization concentration of 0.725 wt% at 25 0C, and utilized F127 solutions at concentrations 5.26, 2.04, and 1.02 wt% to form micelles encapsulating hydrophobic drugs; (ii) Alexandridis already established that the CMT of 19.5 0C for F127 solution at the concentration of 5 wt% (Table 2) and the CMT of 20 0C for F127 solution at 4 wt% (Table 3); and (iii) Zhang et al already taught that the approach of modulating temperatures above and below Pluronic CMT (e.g., F127 CMT) was used to reversibly and thermochromically switch near infrared (NIR) dyes from nanoparticulate to microcrystalline form, and when the temperature was lowered below the CMT, free and loose surfactant converted to unimeric form and could be removed. With respect to dependent claims 4-5, it would have been obvious for an ordinary skill in the art to utilize similar molar equivalents of F127 per coat protein of TMV already taught by the primary Liu reference for coating the surface of a protein bionanoparticle.
An ordinary skilled artisan would have a reasonable expectation of success in light of the teachings of Liu et al, Basak et al, Alexandridis et al and Zhang et al; coupled with a high level of skill for an ordinary skilled artisan in the relevant art.
The modified method resulting from the combined teachings of Liu et al, Basak et al, Alexandridis et al and Zhang et al as set forth above is indistinguishable from the engineered system of the present application.
Therefore, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claims 6, 16-17 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (Langmuir 28:11957-11961, 2012) in view of Basak et al (Langmuir 29:4350-4356, 2013; IDS), Alexandridis et al (Macromolecules 27:2414-2425, 1994) and Zhang et al (Nature Communications 7:11645;DOI: 10.1038/ncomms11649; 9 pages, 2015) as applied to claims 1-6 and 9 above, and further in view of Chung et al (Advanced Drug Delivery Reviews 156:214-235; 2020), Steinmetz et al (US 9,925,281), Chackerian et al (WO 2021/016509) and Courage et al (WO 2012/149242).
The combined teachings of Liu et al, Basak et al, Alexandridis et al and Zhang et al were presented above. However, none of the cited references teach specifically that the viral nanoparticle (VNP) is the elected cowpea mosaic virus (CPMV), or maleimide-bearing M(PEG)4 CPMV; or in step a) the VNP comprises a maleimide-bearing CPMV-M(PEG)4 mixed with F127 and a peptide, and/or wherein the peptide comprises a C-terminal GGGC linker and wherein the C-terminal GGGC linker on the peptide reacts with a heterobifunctional maleimide linker SM(PEG)4. It is also noted that in claim 17, the peptide is optionally ApoAI-4FN with SEQ ID NO: 9.
Before the effective filing date of the present application (07/26/2021), Chung et al already reviewed viral nanoparticles for drug delivery, imaging, immunotherapy and therasnostic applications; and they disclosed that the plant virus-like particles (VLP) and viral nanoparticles (VNP)-based platforms include tobacco mosaic virus (TMV) and cowpea mosaic virus (CPMV) (Abstract; right column, last paragraph at page 215; and Fig. 1). Chung et al also taught that VLPs are flexible and versatile tools and amenable for incorporating and delivering a wide range of small or large molecule cargo using different strategies to carry the payloads either inside or outside the capsid; including bioconjugation via powerful chemical reactions mediated by NHS esters, carbodiimides, maleimides and click chemistries (left column at page 216, top of first paragraph; left column at page 217, third paragraph; and Fig. 2).
Additionally, Steinmetz et al already disclosed an imaging nanoparticle comprising a plant virus particle having an imaging agent that is linked to the interior and/or exterior surface, and a layer of biocompatible mineral such as silica coated over the exterior surface (Abstract). Steinmetz et al also taught that the imaging agent can be coupled to a plant virus particle either directly or indirectly (e.g., via a linker group); and suitable linkage chemistries include maleimidyl linkers and a variety of bifunctional or polyfunctional reagents, both homo- and hetero-functional can be utilized as a linker group (col. 9, lines 58-59; and col. 10, lines 14-33). Steinmetz et al further taught that a targeting moiety (e.g., a peptide) can also be attached to the plant virus particle (col. 11, lines 27-45).
Moreover, Chackerian et al constructed a vaccine construct containing an antigenic malaria circumsporozoite protein (CSP) peptide that is conjugated to Qβ bacteriophage VLPs using a bifunctional cross-linker (SMPH), wherein the peptide is modified to include a linker peptide to the C-terminus (e.g., a GGGC linker) or the N-terminus (e.g., a CGGG linker sequence) to the N-terminus; and wherein the SMPH cross-linker conjugates free amines on the surface of the Qβ VLPs to the cysteine residue of the linker peptide (Abstract; and particularly page 18, lines 8-15).
Furthermore, Courage et al already disclosed SM(PEG)4 among others including SMPH as suitable amino-thio linkers for conjugating a peptide to a polymer foam material (Abstract; and particularly paragraph [0134]).
Accordingly, it would have been obvious for an ordinary skill in the art to further modify the combined teachings of Liu et al, Basak et al, Alexandridis et al and Zhang et al by also at least selecting cowpea mosaic virus (CPMV) as a viral nanoparticle for coating with Pluronic F127, including utilizing the maleimide-bearing M(PEG)4 CPMV to be mixed with F127 and a peptide for bioconjugation via the heterobifunctional maleimide linker SM(PEG)4, and wherein the peptide comprises a C-terminal GGGC linker; in light of teachings of Chung et al, Steinmetz et al, Chackerian et al and Courage et al as presented above
An ordinary skill in the art would have been motivated to carry out the above modifications because: (i) Chung et al already disclosed that the plant virus-like particles (VLP) and viral nanoparticles (VNP)-based platforms that include tobacco mosaic virus (TMV) and cowpea mosaic virus (CPMV) have been used for drug delivery, imaging, immunotherapy and therasnostic applications; and that VLPs are flexible and versatile tools and amenable for incorporating and delivering a wide range of small or large molecule cargo using different strategies to carry the payloads either inside or outside the capsid; including bioconjugation via powerful chemical reactions mediated by NHS esters, carbodiimides, maleimides and click chemistries; (ii) Steinmetz et al already successfully disclosed an imaging nanoparticle comprising a plant virus particle having an imaging agent that is linked to the interior and/or exterior surface, and a layer of biocompatible mineral such as silica coated over the exterior surface; wherein an imaging agent is coupled to a plant virus particle either directly or indirectly (e.g., via a linker group) using suitable linkage chemistries that include maleimidyl linkers and a variety of bifunctional or polyfunctional reagents, both homo- and hetero-functional can be utilized as a linker group; (iii) Chackerian et al constructed successfully a vaccine construct containing an antigenic malaria circumsporozoite protein (CSP) peptide that is conjugated to Qβ bacteriophage VLPs using a bifunctional cross-linker (SMPH), wherein the peptide is modified to include a linker peptide to the C-terminus (e.g., a GGGC linker) or the N-terminus (e.g., a CGGG linker sequence) to the N-terminus; and wherein the SMPH cross-linker conjugates free amines on the surface of the Qβ VLPs to the cysteine residue of the linker peptide; and (iv) Courage et al already disclosed SM(PEG)4 among others including SMPH as suitable amino-thio linkers for conjugating a peptide to a polymer foam material.
An ordinary skilled artisan would have a reasonable expectation of success in light of the teachings of Liu et al, Basak et al, Alexandridis et al, Zhang et al, Chung et al, Steinmetz et al, Chackerian et al and Courage et al; coupled with a high level of skill for an ordinary skilled artisan in the relevant art.
The modified method resulting from the combined teachings of Liu et al, Basak et al, Alexandridis et al, Zhang et al, Chung et al, Steinmetz et al, Chackerian et al and Courage et al as set forth above is indistinguishable from the engineered system of the present application.
Therefore, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sharma et al (Circulation 130:776-785, 2014) disclosed apolipoprotein A-I Mimetic peptide 4F rescues pulmonary hypertension by inducing MicroRNA-193-3p (Abstract).
Conclusions
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Quang Nguyen, Ph.D., at (571) 272-0776.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s SPE, James Douglas (Doug) Schultz, Ph.D., may be reached at (571) 272-0763.
To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Group Art Unit 1631; Central Fax No. (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/QUANG NGUYEN/
Primary Examiner, Art Unit 1631
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