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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6 November 2025 has been entered.
Status of Claims
The arguments filed 6 November 2025 are acknowledged and have been fully considered. Claims 1, 3-6, 11-13, and 21-26 are currently pending. No claims are amended; claims 2, 7-10, and 14-20 are cancelled; claim 13 is withdrawn; no claims are.
Claims 1, 3-6, 11-12, and 21-26 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, and constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 refers to Tables 2 and 11 and, as such, is not complete in itself and could be practically defined using SEQ IDs (see MPEP 2173.05(s)).
For examination purposes, claim 12 is interpreted as “The method of claim 1, wherein the CPP is polyarginine, poly D-arginine, or a peptide represented by one of SEQ ID NOs: 1-94 or 108-1259.”
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, 3-4, 11-12, 21, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Wiklander et al. (US 2019/0388347; of record) in view of Yang et al. (Biomaterials, 2014, Vol. 35, 4368-4381), Johnsen et al. (Journal of Controlled Release, 2018, Vol. 269, 10-14), and He et al. (Journal of Controlled Release, 2014, Vol. 176, 123-132).
Claim 1 is drawn to a method for loading a pre-formed liposome with a cargo molecule, comprising contacting the pre-formed liposome with a binding complex, wherein the binding complex comprises the cargo molecule and a cell penetrating polypeptide (CPP) covalently coupled to the cargo molecule, wherein the cargo molecule comprises a protein or a polypeptide and wherein the binding complex becomes internalized by, or associated with, the liposome.
Claim 12 is drawn to the method of claim 1, wherein the CPP is polyarginine, poly D-arginine, or a peptide represented by one of SEQ ID NOs: 1-94 or 108-1259.
Wiklander et al. teach in Example 1 (Paragraphs 47-51) a method for loading extracellular vesicles (EVs) with CPP-Doxorubicin conjugates, comprising covalently conjugating the CPP penetratin with doxorubicin, followed by mixing pre-formed EVs with a buffer containing the penetratin-doxorubicin conjugates, and removing non-loaded penetratin-doxorubicin conjugates by filtration.
As such, Wiklander et al. teach a method for loading a pre-formed vesicle with a cargo molecule (doxorubicin) comprising containing the pre-formed vesicle with a binding complex, wherein the binding complex comprises the cargo molecule and a cell penetrating polypeptide represented by SEQ ID NO:2, wherein the cell penetrating peptide is coupled to the cargo molecule prior to contacting the vesicle with the binding complex.
The method of Wiklander et al. differs from the instantly claimed method in the following ways:
Wiklander et al. do not teach the vesicles being liposomes; and
Wiklander et al. do not teach the cargo molecule comprising a protein.
Yet, as to 1: Johnsen et al. teach that extracellular vesicles and liposomes are similar in general composition and design and are both suitable for drug delivery (Pg. 10 left column). Johnsen et al. further teach that liposomes can be formulated to provide specific characteristic, such as controlled release mechanisms (caption of Fig. 1). Additionally, Johnsen et al. teach that additional comparison is required between extracellular vesicles and liposomal drug delivery systems to determine the optimal drug delivery systems (Sec. 4 on pgs. 12-13), indicating a need for more experimentation with drug loaded liposomes.
Yang et al. teach that liposomes are a suitable delivery system for thermo-controlled release of doxorubicin covalently bound to CPPs (Abstract, Fig. 1), further teaching that pre-formed liposomes can be loaded by contacting them with a solution of the cargo molecule (Sec. 2.4 on pg. 4370).
Wiklander et al. teach that the term extracellular vesicle “shall also be understood to relate to extracellular vesicle mimics, cell and/or cell membrane-based vesicles obtained through cell extrusion, membrane extrusion, vesicle extrusion, or other techniques, etc. Essentially, the present invention may relate to any type of lipid-based structure (with vesicular morphology or with any other type of suitable morphology) that can act as a delivery or transport vehicle for pharmacological agents of interest.” (Par. [0024]). One of ordinary skill in the art would understand that liposomes such as taught by Johnsen et al. and Yang et al. would be considered as lipid-based structure with a vesicular morphology, and fall under the broad description of extracellular vesicle taught by Wiklander et al.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wiklander et al. by substituting liposomes as taught by Yang et al. It would have been obvious to substitute one lipid-based nanoparticle suitable for encapsulation of covalent CPP-doxorubicin conjugates for another, to obtain the predictable result of a method for loading pre-formed liposomes, with a reasonable expectation of success. Further, one of ordinary skill in the art would be motivated to obtain a method for loading liposomes as there is a need in the art for additional experimentation with liposomal drug delivery systems as taught by Johnsen et al.
And, as to 2: Wiklander et al. further teach “Furthermore, peptides and polypeptides, and not only peptides and/or proteins obtainable via peptide synthesis but also peptides and proteins obtainable through recombinant protein production, are also comprised within the definition of the pharmacological agents as per the present invention” (Par. [0034]).
He et al. also teach encapsulation of covalent conjugates comprising a CPP and a protein active agent (Abstract). He et al. further teach the encapsulation of these conjugates in red blood cells (i.e., lipid bilayer structures) by contacting the cells with CPP-protein conjugates (Fig. 2C).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wiklander et al. to load a protein as the cargo molecule. It would have been obvious to substitute one known suitable pharmacological agent for another to obtain a method for forming CPP-protein loaded liposomes. Further, one of ordinary skill in the art would have a reasonable expectation for success based on the teachings of He et al.
Based on all of the foregoing, claims 1 and 12 are rejected as prima facie obvious.
Claim 11 is drawn to the method of claim 1, wherein the pre-formed liposome further comprises a targeting agent that targets the liposome to a cell type, organ, or tissue.
Wiklander et al. teach the EV further comprising at least one targeting moiety targeting a tissue, an organ, or a cell type of interest in order to steer the vesicles to tissues, organs, and/or cell types of interest. (Paragraph 36).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to modify the method of Wiklander et al. and Yang et al. to include a targeting agent on the liposome. One would have been motivated to do so ensure the cargo molecule reaches the intended tissue, organ, or cell type, with a reasonable expectation of success.
As such, claim 11 is rejected as prima facie obvious.
Claims 3 and 21 are drawn to the method of claim 1, wherein the CPP is covalently coupled to the cargo molecule by an amide bond.
Claim 4 is drawn to the method of claim 3, wherein the CPP is covalently coupled to the cargo molecule by a cleavable linker.
Wiklander et al. teach that covalent linkage between the pharmacological agent and CPP can be an amide bond (i.e., a cleavable linker, Paragraph 31).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of Wiklander et al. to utilize an amide bond as the covalent linkage between the pharmacological agent and CPP, as it would have been obvious to substitute one known covalent linkage for another with the predictable result of linking the two molecules.
As such, claims 3-4 and 21 are rejected as prima facie obvious.
Claim 26 is drawn to the method of claim 1, wherein two or more CPP are covalently or non-covalently coupled to the cargo molecule.
Wiklander et al. teach that the method for EV loading comprises the step of exposing a population of EVs to at least one pharmacological agent and at least one CPP (Paragraph 6). The range of at least one CPP overlaps with the instantly claimed range of two or more CPP.
As stated in MPEP 2144.05, “[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).
As such, claim 26 is rejected as prima facie obvious.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wiklander et al., Yang et al., Johnsen et al., and He et al. as applied to claims 1, 3-4, 11-12, 14, 21, and 26 above, and further in view of Narasimhaswamy et al. (US 2010/0233084; of record).
The teachings of Wiklander et al., Yang et al., Johnsen et al., and He et al. have been set forth above.
Claim 6 is drawn to the method of claim 4, further comprising uncoupling the cargo molecule and CPP of the binding complex by cleaving the cleavable linker after the binding complex becomes internalized by, or associated with, the pre-formed liposome.
Wiklander et al. further teach “EVs within which the at least one pharmacological agent has been released from the at least one CPP conjugate and/or CPP complex inside the EV” where inside the EV is defined as “the EV in its entirety, including the membrane of the EV, or even onto the external surface of the EV, as long as the pharmacological agent is in some way interacting with the EV” (Paragraph 33).
As such, Wiklander et al. teaches the method of claim 4, further comprising uncoupling the cargo molecule and CPP of the binding complex after the binding complex becomes internalized by, or associated with, the liposome.
Wiklander et al., Yang et al., Johnsen et al., and He et al. do not teach the method comprising cleaving a cleavable linker.
However, Narasimhaswamy et al. teach delivery of an agent across the blood brain barrier (Paragraph 7). Narasimhaswamy et al. further teach “[f]or agents that are inactive when conjugated with a peptide carrier particle, a linker that is cleavable and can be cleaved by a suitable mechanism in a target cell… can be included to promote release of the agent from the peptide carrier particle in the target cell” (Paragraph 19).
Therefore, it would have been prima facie obvious for a person having ordinary skill in the art to have modified the method of Wiklander et al. and Yang et al. to include a step of cleaving a cleavable linkage as taught by Narasimhaswamy et al. One would have been motivated to do so to provide a method that can release the pharmacological agent from the CPP to ensure proper pharmacological activity, with a reasonable expectation of success.
As such, claim 6 is rejected as prima facie obvious.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wiklander et al., Yang et al., Johnsen et al., He et al. and Narasimhaswamy et al. as applied to claim 6 above, and further in view of LeValley et al. (JACS 2020, Vol. 142, 4671-4679; of record).
The teachings of Wiklander et al., Yang et al., Johnsen et al., He et al. and Narasimhaswamy et al. have been set forth above.
Claim 5 is drawn to the method of claim 4, wherein the cleavable linker is a photo-cleavable linker.
Wiklander et al., Yang et al., Johnsen et al., and He et al. do not teach that the cleavable linker is photo-cleavable.
However, Narasimhaswamy et al. teach the use of a photo-cleavable linker for conjugation with a cell penetrating peptide (Paragraph 135).
And as taught by LeValley et al. photolabile linkers such as nitrobenzyl based linkers are able to be tuned to cytocompatible light doses (Abstract).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of Wiklander et al. to include a photo-cleavable linker as taught by Narasimhaswamy et al. One would have been motivated to do so to provide a cleavable linker that can be cleaved without causing any damage to the cellular environment.
As such, claim 5 is rejected as prima facie obvious.
Claims 22 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Wiklander et al., Yang et al., Johnsen et al., and He et al. as applied to claims 1, 3-4, 11-12, 14, 21, and 26 above, and further in view of Ho et al. (Cancer Research 2001, Vol. 61, 474-477; of record).
The teachings of Wiklander et al., Yang et al., Johnsen et al., and He et al. have been set forth above.
Claim 22 is drawn to the method of claim 1, wherein the CPP is YARA.
Claim 24 is drawn to the method of claim 1, wherein the CPP is YARA and the cargo molecule is a protein.
Wiklander et al., Yang et al., Johnsen et al., and He et al. do not teach the CPP being YARA.
However, Ho et al. teach in Figure 4 the delivery of fluorescein into blood cells utilizing the protein transduction domain (aka CPP) PTD-4 (i.e., YARA).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of Wiklander et al. by substituting YARA as the CPP. One would have been motivated to do so as YARA has been shown to be an effective CPP capable of carrying cargo molecules across a cell membrane, with reasonable expectation of success.
As such, claims 22 and 24 are rejected as prima facie obvious.
Claim 25 is drawn to a method of loading a lipid vesicle comprising all of the limitations of claims 21-22. As such, claim 25 is rejected as prima facie obvious for the reasons applied to claims 21-22 above.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Wiklander et al., Yang et al., Johnsen et al., and He et al. as applied to claims 1, 3-4, 11-12, 14, 21, and 26 further in view of Finkelstein et al. (Journal of Lipid Research, 1978, Vol. 19, 289-303; of record).
The teachings of Wiklander et al., Yang et al., Johnsen et al., and He et al. have been set forth above.
Claim 23 is drawn to the method of claim 1, wherein the cargo molecule is an enzyme.
Wiklander et al., Yang et al., Johnsen et al., and He et al.do not teach the cargo molecule comprising an enzyme.
However, Wiklander et al. teach the CPP vesicles as being suitable for delivery of a wide variety of pharmacological agents, including any kind of protein (Paragraph 25).
And as taught by Finkelstein et al., liposomes are a suitable delivery system for the delivery of therapeutic enzymes (Pg. 289 right column last paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wiklander et al. and Yang et al. to encapsulate an enzyme as the cargo molecule. It would have been obvious to substitute a pharmacological protein with a therapeutic enzyme suitable for delivery by liposomes, with a reasonable expectation of success.
As such, claim 23 is rejected as prima facie obvious.
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, 3-4, 11-12, and 21-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5 and 7-8 of copending Application No. 17/646,988 in view of Yang et al. (Biomaterials, 2014, Vol. 35, 4368-4381) and Johnsen et al. (Journal of Controlled Release, 2018, Vol. 269, 10-14).
Claim 1 of copending application ‘988 is drawn to a method for loading an extracellular vesicle (EV) with a cargo molecule, comprising contacting the EV with a binding complex, wherein the binding complex comprises the cargo molecule and a cell penetrating polypeptide (CPP) covalently or non- covalently coupled to the cargo molecule, and wherein the binding complex becomes internalized by, or associated with, the EV. Claim 5 of copending application ‘988 is drawn to the method of claim 1, wherein the cargo molecule is selected from among protein, polypeptide, or glycoprotein.
Application ‘988 does not recite the vesicles being liposomes. However, Johnsen et al. teach that extracellular vesicles and liposomes are similar in general composition and design and are both suitable for drug delivery (Pg. 10 left column). Johnsen et al. further teach that liposomes can be formulated to provide specific characteristic, such as controlled release mechanisms (caption of Fig. 1). Additionally, Johnsen et al. teach that additional comparison is required between extracellular vesicles and liposomal drug delivery systems to determine the optimal drug delivery systems (Sec. 4 on pgs. 12-13), indicating a need for more experimentation with drug loaded liposomes. Yang et al. teach that liposomes are a suitable delivery system for thermo-controlled release of doxorubicin covalently bound to CPPs (Abstract, Fig. 1), further teaching that pre-formed liposomes can be loaded by contacting them with a solution of the cargo molecule (Sec. 2.4 on pg. 4370). Therefor, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Application ‘988 by substituting liposomes as taught by Yang et al. It would have been obvious to substitute one substitute one lipid-based nanoparticle suitable for encapsulation of covalent CPP-protein conjugates for another, to obtain the predictable result of a method for loading pre-formed liposomes, with a reasonable expectation of success. Further, one of ordinary skill in the art would be motivated to obtain a method for loading liposomes as there is a need in the art for additional experimentation with liposomal drug delivery systems as taught by Johnsen et al.
As such, claims 1 and 5 of Application ‘988 in view of Yang et al. and Johnsen et al. render instant claims 1 and 23 obvious.
Claim 2 of copending application ‘988 is drawn to the method of claim 1, wherein the CPP is covalently coupled to the cargo molecule by a disulfide bond, an amide bond, a chemical bond formed between a sulfhydryl group and a maleimide group, a chemical bond formed between a primary amine group and an N-Hydroxysuccinimide (NHS) ester, a chemical bond formed via Click chemistry, or other covalent linkage, rendering instant claims 3 and 21 obvious.
Claim 3 of copending application ‘988 is drawn to the method of claim 2, wherein the CPP is covalently coupled to the cargo molecule by a cleavable linker, rendering instant claim 4 obvious.
Claim 4 of copending application ‘988 is drawn to the method of claim 3, further comprising uncoupling the cargo molecule and CPP of the binding complex by cleaving the cleavable linker after the binding complex becomes internalized by, or associated with, the EV, rendering instant claim 6 obvious.
Claim 7 of copending application ‘988 is drawn to the method of claim 1, wherein the EV further comprises a targeting agent that targets the EV to a cell type, organ, or tissue, rendering instant claim 11 obvious.
Claim 8 of copending application ‘988 is drawn to the method of claim 1, wherein the CPP is one listed in Table 2 or Table 11, rendering instant claims 12 and 22 obvious.
Claims 5 and 8 of copending application ‘988 together render instant claim 24 obvious.
Claims 2, 5, and 8 of copending application ‘988 together ender instant claim 25 obvious.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 6 November 2025 have been fully considered but they are not persuasive.
Applicant argues on pg. 4 of the remarks that there is a substantial difference between extracellular vesicles and liposomes and one would not have motivation to substitute liposomes in the method of Wiklander et al.
This argument is not persuasive. As discussed above, Johnsen et al. teach that extracellular vesicles and liposomes are similar in general composition and design and are both suitable for drug delivery (Pg. 10 left column). Further, while Applicant has argued that Wiklander’s use of the term “morphology” to refer to the cellular components present in the extracellular vesicles, there is no suggestion present that this is the meaning of “morphology” in Wiklander. One of ordinary skill in the art would understand the “vesicular morphology” or “any other type of suitable morphology” to mean vesicular structure or any other type of suitable lipid-based structure, encompassing liposomes. As Wiklander teaches these vesicular structures or any other type of suitable lipid-based structure to be relevant to the disclosed method, one of ordinary skill in the art would understand that Wiklander suggests the loading of liposomes with an active agent bound to a CPP.
Applicant argues on pg. 5 of the remarks that there is no expectation for success in substituting liposomes in the method of Wiklander, further citing Antimisiaris for a demonstration of a lack of clinical success for liposomal compositions.
This argument is not persuasive. The instant claims are drawn to a method for loading liposomes, not a method of treating a condition using the loaded liposomes, as such the lack of clinical success for liposomal compositions does not obviate an expectation for success. Further, Yang et al. teach that pre-formed liposomes can be loaded by contacting them with a solution of the cargo molecule (Sec. 2.4 on pg. 4370), suggesting the applicability of the method of Wiklander to liposomes.
Applicant argues on pg. 11 of the remarks that the substitution of a protein active agent in the method of Wiklander would not have been “obvious to try” and further there is no expectation for success in this substitution.
This argument is not persuasive. Whether or not the substitution of a protein active agent was obvious to try is not relevant to the instant application, as the obvious to try rationale has not been used to support any conclusion of prima facie obviousness. The substitution of one known element for another to obtain predictable results is a suitable rationale for supporting a conclusion of obviousness (see MPEP 2143(I)(B)). And as further discussed in MPEP 2141(I), "[I]n Sakraida v. AG Pro, Inc., the Court derived . . . the conclusion that when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417, 82 USPQ2d at 1395-9” As both doxorubicin and protein active agents are taught to be suitable active agents by Wiklander, the substitution is prima facie obvious. Further, as a similar method of loading CPP-protein conjugates is taught by He et al. as discussed in the rejection of claim 1 above, one of ordinary skill in the art would have a reasonable expectation of success for the substitution of a protein in the place of doxorubicin.
Applicant’s arguments regarding Sardan et al. are moot in view of the new grounds of rejection set forth above.
Conclusion
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611