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 .
Priority
Acknowledgement is made that the instant application is a National Stage of International application No. PCT/US2021/072142 (filed 10/30/2021), which claims the benefits of US Provisional Application No. 63/108,289 (filed 10/31/2020).
Election/Restrictions
Applicant's election with traverse of Group I (claims 1, 12, 15, 52, 68, 69, 70, 85(a), and 87(a)) drawn to a pseudotyped particle and species a drawn to a pseudotyped virus, in the reply filed on 12/13/2025 is acknowledged. The traversal is on the grounds that Von Maltzahn et al (WO2020102578A1) does not recite a pseudotyped particle. This is not found persuasive because Von Maltzahn discloses a fusosome that is an exosome (See pg. 85 Enumerated embodiment 254 and pg. 188 ¶00054). The fusosome comprises an exogenous fusogen which can comprise a nucleic acid encoding myomaker or myomerger that is expressed on the fusosome’s surface (reads on one or more polypeptides comprising one or more myomaker or myomerger polypeptides) (See ¶000341). The specification of the instant application defines “pseudotyped” as a particle that has one or more polypeptides on the particle’s surface that are not in the corresponding naturally occurring particle in ¶0095. Therefore, the fusosome of Von Maltzahn which can be and exosome and comprises a an exogenous fusogen expressed on its surface reads on pseudotyped particle that is an exosome.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 12, 15, 52, 68, 69, 85, and 87 have been examined on the merits in so far as they read on the elected species. Claims 56, 63, 65, 70, 71, 72, 80, 89, 90, 91, 98, and 100 are directed to unelected groups and/or species and are therefore withdrawn from consideration.
Claim Objections
Claim 69 is objected to because of the following informalities: Claim 69 uses the abbreviation “VSV”. The full term should precede the first use of an abbreviation. Appropriate correction is required.
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.
Claims 68 and 69 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.
Regarding claim 68: Claim 68 uses product-by-process language. Product-by-process claims are considered only in so far as the process of production affects the final product. Therefore, if the product as claimed is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. In the instant case, the process of production involves contacting (a) a composition comprising cells that express at least one myomerger polypeptide, at least one myomaker polypeptide, or a combination thereof with (b) a composition comprising one or more lentivirus production plasmids and (c) a composition comprising a nucleic acid encoding a gene of interest and/or a nucleic acid that modulates gene expression [i.e. the method of claim 56]. The method of claim 56, as recited, is indefinite as it only teaches contacting the compositions of a, b, and c but does not require a step of transducing or transfecting the cells of composition (a) with compositions (b) or (c). Therefore it is unclear whether the myomaker or myomerger of composition (a) and the gene of interest of composition (c) are expressed by the final pseudotyped lentivirus.
Regarding claim 69: Claim 69 uses product-by-process language. Product-by-process claims are considered only in so far as the process of production affects the final product. Therefore, if the product as claimed is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. In the instant case, the process of production involves contacting (a) a composition comprising cells that express at least one myomerger polypeptide, at least one myomaker polypeptide, or a combination thereof with (b) a composition comprising one or more VSV production plasmids and (c) a composition comprising a nucleic acid encoding a gene of interest and/or a nucleic acid that modulates gene expression [i.e. the method of claim 63]. The method of claim 63, as recited, is indefinite as it only teaches contacting the compositions of a, b, and c but does not require a step of transducing or transfecting the cells of composition (a) with compositions (b) or (c). Therefore, it is unclear whether the myomaker or myomerger of composition (a) and the gene of interest of composition (c) are expressed by the final pseudotyped VSV.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 12, 15, 52, 68, 85, and 87 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Emmanuel et al (WO2021046143A1) as evidenced by Von Maltzahn et al (WO2020102578A1).
Emmanuel discloses non-cell particles comprising pseudotyped virus, or viral like particles, including pseudotyped lentivirus or lentiviral-like particles, containing exogenous CD24 (See abstract and ¶0058). In some embodiments the particle comprises a protein fusogen which may include a myomaker or myomixer (See ¶0370-¶0373). A fusogen facilitates binding to target cell population (See ¶0564). Emmanuel further discloses a composition comprising the pseudotyped particle and a pharmaceutically acceptable carrier (See abstract and ¶0059).
Regarding claims 1, 12, and 15: Emmanuel discloses a pseudotyped lentivirus which reads on a pseudotyped virus. The pseudotyped lentivirus of Emmanuel can comprise a protein fusogen such as a myomaker or myomixer which reads on the pseudotyped particle comprise one or more polypeptides comprising one or more myomaker or myomerger polypeptides.
Regarding claim 52: Following the discussion of claim 1 above, Emmanuel discloses a pseudotyped virus comprising a fusogen such as a myomaker.
Emmanuel does not disclose the pseudotyped particle exhibits fusogenic activity with a target cell upon binding of the myomaker polypeptide to a myomaker or myomerger polypeptide on the target cell.
Von Maltzahn further teaches a myomaker expressing fusosome can fuse with a target cell that expresses both myomaker and myomixer.
Given that Emmanuel discloses a pseudotyped virus comprising a fusogen (reads on fusosome) comprising myomaker and Von Maltzahn teaches a myomaker expressing fusosome can fuse with a target cell expressing myomaker and myomixer (reads on exhibits fusogenic activity upon binding a myomaker on a target cell), the pseudotyped virus of Emmanuel inherently exhibits fusogenic activity with a target cell upon binding of the myomaker polypeptide to a myomaker polypeptide on a target cell.
Regarding claim 68: Claim 68 uses product-by-process language. Product-by-process claims are considered only in so far as the process of production affects the final product. Therefore, if the product as claimed is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. In the instant case, the process of production involves contacting (a) a composition comprising cells that express at least one myomerger polypeptide, at least one myomaker polypeptide, or a combination thereof with (b) a composition comprising one or more lentivirus production plasmids and (c) a composition comprising a nucleic acid encoding a gene of interest and/or a nucleic acid that modulates gene expression [i.e. the method of claim 56]. The method of claim 56, as recited, is indefinite as it only teaches contacting the compositions of a, b, and c but does not require a step of transducing or transfecting the cells of composition (a) with compositions (b) or (c). Additionally, the method is silent as to whether the myomaker or myomerger of composition (a) and the gene of interest of composition (c) are expressed by the final pseudotyped lentivirus. The method of claim 56 can be understood to require the [final product of claim 56] to comprise any pseudotyped lentivirus.
Emmanuel discloses a pseudotyped lentivirus which reads on the pseudotyped lentivirus produced by the method of claim 56. This rejection is based on the above interpretation of the product-by-process limitations.
Furthermore, Emmanuel discloses a pseudotyped lentivirus comprising a myomaker or myomerger protein and CD24 (reads on a gene of interest) which reads on the pseudotyped virus of claim 68. This rejection is NOT based on product by process limitations.
Regarding claims 85 and 87: Emmanuel discloses a pseudotyped lentivirus comprising a protein fusogen such as a myomaker or myomixer which reads on the pseudotyped particle of claim 1. Emmanuel further discloses a composition comprising the pseudotyped particle and a pharmaceutically acceptable carrier which reads on a composition comprising the pseudotyped particle of claim 1 and a pharmaceutical composition comprising the pseudotyped particle of claim 1.
Claims 69 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Whitt (J Virol Methods, 2010).
Whitt teaches methods for producing pseudotyped vesicular stomatitis virus (VSV) (See Methods section).
Regarding claim 69: Claim 69 uses product-by-process language. Product-by-process claims are considered only in so far as the process of production affects the final product. Therefore, if the product as claimed is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. In the instant case, the process of production involves contacting (a) a composition comprising cells that express at least one myomerger polypeptide, at least one myomaker polypeptide, or a combination thereof with (b) a composition comprising one or more VSV production plasmids and (c) a composition comprising a nucleic acid encoding a gene of interest and/or a nucleic acid that modulates gene expression [i.e. the method of claim 63]. The method of claim 63, as recited, is indefinite as it only teaches contacting the compositions of a, b, and c but does not require a step of transducing or transfecting the cells of composition (a) with compositions (b) or (c). Additionally, the method is silent as to whether the myomaker or myomerger of composition (a) and the gene of interest of composition (c) are expressed by the final pseudotyped VSV. The method of claim 56 can therefore be understood to require the [final product of claim 63] to comprise any pseudotyped VSV.
Whitt discloses a pseudotyped VSV which reads on the pseudotyped VSV produced by the method of claim 63. This rejection is based on the above interpretation of product-by-process limitations.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 12, 15, 52, 68, 69, 85, and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Emmanuel et al (WO2021046143A1) in view of Whitt (J Virol Methods, 2010).
The teachings of Emmanuel and Whitt are set forth above.
Emmanuel anticipates claims 1, 12, 15, 52, 68, 85, and 87.
Whitt anticipates claim 69.
Further regarding claim 69: For reasons discussed above, the product-by-process limitations do not clearly require the final product to comprise a myomaker or myomerger and a gene of interest (See product-by-process interpretation in 112 and 102 rejections above). However, in the interest of compact prosecution, the claim is being interpreted as requiring a pseudotyped VSV comprising a myomaker or myomerger and a gene of interest.
Emmanuel discloses a pseudotyped virus comprising a myomaker or myomerger protein and CD24 (reads on a gene of interest).
Emmanuel does not disclose the pseudotyped virus is a VSV.
Whitt teaches methods of pseudotyping VSV.
Given that Emmanuel teaches pseudotyped virus and Whitt teaches a pseudotyped VSV, it would have been prima facie obvious to substitute the pseudotyped virus of Emmanuel with the pseudotyped VSV of Whitt. One would have expected the pseudotyped VSV to work equivocally with the pseudotyped virus of Emmanuel because a pseudotyped VSV is a pseudotyped virus. Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable is considered to be obvious. See KSR International Co. V Teleflex Inc 82 USPQ2d 1385 (US2007) at page 1395.
This rejection is based on the above interpretation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARISOL A O'NEILL whose telephone number is (571)272-2490. The examiner can normally be reached Monday - Friday 7:30 - 5:00 EST.
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/MARISOL ANN O'NEILL/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633