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 .
DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found
in a prior Office action.
This Action is in response to the papers filed on April 29, 2026. Pursuant to the amendment filed on April 29, 2026, claims 1, 2, 4, 11, 12, 14-17, 19, 20, 22-28, 30-37 and 40-43 are currently pending. Claims 1, 2, 4, 19, 20, 32, 33, 36, 37 and 40 have been amended, and claim 18 has been cancelled in Applicant’s amendment filed on April 29, 2026. No claims have been added.
Applicant’s election without traverse of Group I, claim(s) 1- 4, 11, 12, 14 – 22, 30 – 42 in the reply filed on July 19, 2024 was previously acknowledged. Claims 23 - 28 and 43 were previously withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, claims 1-2, 4, 11-12, 14-17, 19-20, 22, 30-37 and 40-42 are currently under examination to which the following grounds of rejection are applicable.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 29, 2026 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
The present application filed August 14, 2020, claimed the benefit of PCT/US2019/018324, filed February 15, 2019 which claims the benefit of Provisional Application, 62/631,747, filed February 17, 2018. Therefore, the earliest priority date of the instant application is February 17, 2018.
Response to Arguments
Withdrawn Objections/Rejections in response to Applicants’ arguments or amendments:
Claim Objections
In view of Applicants’ amendment to the claims dated April 29, 2026, wherein claims 1, 2, 4, 19, 20, 32, 33, 36, 37 and 40 have been amended, and claim 18 has been cancelled, the objection to claims 19, 20, 32, 33, and 37 have been withdrawn.
Claim Rejection - 35 USC § 112(b)
In view of Applicants’ amendment to the claims dated April 29, 2026, wherein claims 1, 2, 4, 19, 20, 32, 33, 36, 37 and 40 have been amended, and claim 18 has been cancelled, the rejection to claims 2, 4,18, 33, and 36 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, are withdrawn.
Claim Rejections - 35 USC § 103
In view of Applicants’ amendment to the claims dated April 29, 2026, wherein claims 1, 2, 4, 19, 20, 32, 33, 36, 37 and 40 have been amended, and claim 18 has been cancelled, the rejection to claims 1, 4, 11, 14-17, 19-20, 22, 35, 36, 40, and 41 rejected under 35 U.S.C. 103 as being unpatentable over Kaneda in view of Tang et al, are withdrawn.
In view of Applicants’ amendment to the claims dated April 29, 2026, wherein claims 1, 2, 4, 19, 20, 32, 33, 36, 37 and 40 have been amended, and claim 18 has been cancelled, the rejection to claims 1, 2, and 37 rejected under 35 U.S.C. 103 as being unpatentable over Kaneda in view of Tang et al, as applied to claim 1, and further in view of Watanabe et al., are withdrawn.
In view of Applicants’ amendment to the claims dated April 29, 2026, wherein claims 1, 2, 4, 19, 20, 32, 33, 36, 37 and 40 have been amended, and claim 18 has been cancelled, the rejection to claims 1, 17, and 18 rejected under 35 U.S.C. 103 as being unpatentable over Kaneda in view of Tang et al, as applied to claim 1, and further in view of Kaneda et al. (‘Kaneda-2’), are withdrawn.
In view of Applicants’ amendment to the claims dated April 29, 2026, wherein claims 1, 2, 4, 19, 20, 32, 33, 36, 37 and 40 have been amended, and claim 18 has been cancelled, the rejection to claims 1, and 12 rejected under 35 U.S.C. 103 as being unpatentable over Kaneda in view of Tang et al, as applied to claim 1, and further in view of Lamb et al., are withdrawn.
In view of Applicants’ amendment to the claims dated April 29, 2026, wherein claims 1, 2, 4, 19, 20, 32, 33, 36, 37 and 40 have been amended, and claim 18 has been cancelled, the rejection to claims 1, 16, 30-34, and 42 rejected under 35 U.S.C. 103 as being unpatentable over Kaneda in view of Tang et al, as applied to claim 1, and further in view of Sadelain et al., are withdrawn.
The withdrawn rejections are in view of the amendment to claim 1 in which the claim scope has been narrowed to recited “wherein the fusogen comprises a Henipavirus or Morbillivirus fusogen” as opposed to any paramyxoviral fusogen. Kaneda taught the HVJ fusogen which does not belong to these viral groupings as it is directed to Sendai virus. For this reason, the prior art rejections have been withdrawn.
Maintained Objections/Rejections in response to Applicants’ arguments or amendments:
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.
The rejection of claims 1-2, 4, 11-12, 14-17, 19-20, 22, 30-37 and 40-42 on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No. 11,576,872 B2 is maintained. Although the claims at issue are not identical, they are not patentably distinct from each other because both the issued claims and the claimed invention are drawn to a fusosome comprising the following: (a) lipid bilayer; (b) lumen surrounded by the lipid bilayer; (c) an exogenous or overexpressed fusogen disposed in the lipid bilayer, that is more specifically a Henipavirus or Morbillivirus fusogen, and (d) a payload agent (instant claims) or cargo as recited in the issued claims.
The instant claims differ from the issued claims in that the issued claims do not specifically define the term “cargo” as set forth in the instant claims. However, the specification of the of U.S. Patent No. 11,576,872 B2 teaches that the term “cargo” in the following manner: “e.g., a therapeutic agent, e.g., an endogenous therapeutic agent or an exogenous therapeutic agent.” (See col. 96, lines 4-35).In some embodiments, the cargo is a protein cargo. In embodiments, the cargo is an endogenous or synthetic protein cargo. In some embodiments, the fusosomes have (or are identified as having) at least 1, 2, 3, 4, 5, 10, 20, 50, 100, or more protein cargo molecules per fusosome. (See col. 22, lines 5-9).” Additionally, the specification teaches that the disclosed fusosome “delivers to a target cell at least 10, 50, 100, 500, 1,000....1,000,000,000 copies of a therapeutic agent.” (See col. 21, lines 18-22).
The term cargo is also defined in the following manner: (See col. 38, lines 46-60) “[I]n some embodiments, the fusosome comprises a cargo, e.g., a therapeutic agent, e.g., an endogenous therapeutic agent or an exogenous therapeutic agent. In some embodiments, the therapeutic agent is chosen from one or more of a protein, e.g., an enzyme, a transmembrane protein, a receptor, an antibody; a nucleic acid, e.g., DNA, a chromosome (e.g. a human artificial chromosome), RNA, mRNA, siRNA, miRNA, or a small molecule. In some embodiments, the therapeutic agent is an organelle other than a mitochondrion, e.g., an organelle selected from: nucleus, Golgi apparatus, lysosome, endoplasmic reticulum, vacuole, endosome, acrosome, autophagosome, centriole, glycosome, glyoxysome, hydrogenosome, melanosome, mitosome, cnidocyst, peroxisome, proteasome, vesicle, and stress granule. In some embodiments, the organelle is a mitochondrion.”
Additionally, the specification of the issued US Patent defines the fusosomes as: “[c]apable of delivering (e.g., delivers) a protein to a target cell, e.g., to transiently rescue a protein deficiency. Similarly, in some embodiments, a method herein comprises delivering a protein to a target cell. In embodiments, the protein is a membrane protein (e.g., a membrane transporter protein), a cytoplasmic protein (e.g., an enzyme), or a secreted protein (e.g., an immunosuppressive protein).” (Col. 16, lines 50-57).
Thus, the definition of the term “cargo” as defined in the disclosure of the issued US Patent clearly renders obvious the membrane protein payload agents as set forth in the instant claims. Therefore, the instant claims are rendered obvious over the claims of the issued US Patent in view of the definition of the term “cargo” as set forth in the disclosure of the issued US Patent.
As per MPEP 2111.01, “Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application).
The amendment to instant claim 1 narrows the scope of the particular fusogen as belonging to a Henipavirus or Morbillivirus fusogen, yet it does not differentiate the instant fusosome from the ‘872 fusosome based on such composition as comprising fusogens from these viral genera, e.g. “ the fusogen comprises a protein selected from the group consisting of Nipah virus F and G proteins, measles virus F and H proteins, tupaia paramyxovirus F and H proteins, paramyxovirus F and G proteins or F and H proteins or F and HN proteins, Hendra virus F and G proteins, Henipavirus F and G proteins, Morbilivirus F and H proteins, respirovirus F and HN protein, a Sendai virus F and HN protein, rubulavirus F and HN proteins, or avulavirus F and HN proteins, a derivative thereof, and any combination thereof,”.
In reference to ‘872 stating fusosome as having “the amount of viral capsid protein in the fusosome composition is less than 1% of total protein in the fusosome composition;” the instant claim does not recite any limitation to point to being different than this fusosome, wherein it comprises greater than 1% of viral proteins. Therefore, the instant claims are rendered obvious over the claims of the issued US Patent in view of such limitation as it remains unclear that the instant fusosome is not encompassed by the ‘872 fusosome claimed.
Lastly, in reference to ‘872 stating the “plurality of fusosomes, when contacted with a target cell population in the presence of an inhibitor of endocytosis, and when contacted with a reference target cell population not treated with the inhibitor of endocytosis, delivers at least 30% more of the cargo to the target cell population compared to the reference target cell population” this is a functional characteristic of the fusosomes, particularly inherent qualities which remain to be expected with the instant fusosome due to the compositions being similar, and therefore these characteristics described for the ‘872 fusosome are similarly expected.
Response to Applicants’ Arguments as they apply to the Double Patenting Rejection
At page 11 of the remarks filed on April 29, 2026, Applicants state the fusosomes are different in that ‘872 does not teach a membrane payload agent, and more specifically the list of agents recited in the instant claim 1, and additionally the instant claims do not recite that the amount of viral capsid protein in the fusosome composition is less than 1% of total protein in the fusosome composition, nor that the plurality of fusosomes, when contacted with a target cell population in the presence of an inhibitor of endocytosis, and when contacted with a reference target cell population not treated with the inhibitor of endocytosis, delivers at least 30% more of the cargo to the target cell population compared to the reference target cell population, as required by claim 1 of the '872 patent. These rejections are maintained in view of these arguments wherein each are limitations is addressed above, accordingly. In particular, the rejection describes how ‘872 teaching on ‘cargo’ encompasses the ‘membrane payload agents’ recited in the instant claims. In reference to the viral capsid protein percentage recited in ‘872, there are no limitation presented in the instant claims to differentiate it from the ‘872 fusosome, in particular by reciting a viral capsid protein percentage that is higher than 1%. Lastly, the functional language recited in ‘872 has been considered but the instant fusosome remains an obvious variant due to the compositions being similar, and therefore the ‘872 fusosome functional characteristics are expected to be shared with the instant fusosome.
Claims 1-2, 4, 11-12, 14-17, 19-20, 22, 30-37 and 40-42 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21, 22, 24, 36, 45-47, 54, 59-67 filed on June 2, 2026 of copending Application No. 18/154,618. (hereinafter ‘618).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the issued claims and the instantly claimed invention are drawn to a fusosome comprising the following: (a) lipid bilayer; (b) lumen surrounded by the lipid bilayer; (c) an exogenous or overexpressed fusogen disposed in the lipid bilayer, that is more specifically a paramyxoviral fusogen, and (d) a payload agent (instant claims) or cargo as recited in the ‘618 claims.
The instant claims differ from the issued claims in that the ‘618 claims do not specifically define the term “cargo” as set forth in the instant claims. However, the specification of ‘618 teaches that the term “cargo” in the following manner: “e.g., a therapeutic agent, e.g., an endogenous therapeutic agent or an exogenous therapeutic agent.” (See par 0291). In some embodiments, the cargo is a protein cargo. In embodiments, the cargo is an endogenous or synthetic protein cargo. In some embodiments, the fusosomes have (or are identified as having) at least 1, 2, 3, 4, 5, 10, 20, 50, 100, or more protein cargo molecules per fusosome. (See par 0259).” Additionally, the specification teaches that the disclosed fusosome “delivers to a target cell at least 10, 50, 100, 500, 1,000....1,000,000,000 copies of a therapeutic agent.” (See par 0256).
The term cargo is also defined in the following manner: (See par 0291) “[I]n some embodiments, the fusosome comprises a cargo, e.g., a therapeutic agent, e.g., an endogenous therapeutic agent or an exogenous therapeutic agent. In some embodiments, the therapeutic agent is chosen from one or more of a protein, e.g., an enzyme, a transmembrane protein, a receptor, an antibody; a nucleic acid, e.g., DNA, a chromosome (e.g. a human artificial chromosome), RNA, mRNA, siRNA, miRNA, or a small molecule. In some embodiments, the therapeutic agent is an organelle other than a mitochondrion, e.g., an organelle selected from: nucleus, Golgi apparatus, lysosome, endoplasmic reticulum, vacuole, endosome, acrosome, autophagosome, centriole, glycosome, glyoxysome, hydrogenosome, melanosome, mitosome, cnidocyst, peroxisome, proteasome, vesicle, and stress granule. In some embodiments, the organelle is a mitochondrion.”
Additionally, the specification of ‘618 defines the fusosomes as: “[c]apable of delivering (e.g., delivers) a protein to a target cell, e.g., to transiently rescue a protein deficiency. Similarly, in some embodiments, a method herein comprises delivering a protein to a target cell. In embodiments, the protein is a membrane protein (e.g., a membrane transporter protein), a cytoplasmic protein (e.g., an enzyme), or a secreted protein (e.g., an immunosuppressive protein).” (See par 0225).
Thus, the definition of the term “cargo” as defined in the disclosure of ‘618 clearly renders obvious the membrane protein payload agents as set forth in the instant claims. Therefore, the instant claims are rendered obvious over the claims of Application No. 18/154,618 in view of the definition of the term “cargo” as set forth in the disclosure of ‘618.
As per MPEP 2111.01, “Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application).
The amendment to instant claim 1 narrows the scope of the particular fusogen as belonging to a Henipavirus or Morbillivirus fusogen, yet it does not differentiate the instant fusosome from the ‘’612 fusosome based on such composition as comprising fusogens from these viral genera, e.g. “ the fusogen comprises a protein selected from the group consisting of Nipah virus F and G proteins, measles virus F and H proteins, tupaia paramyxovirus F and H proteins, paramyxovirus F and G proteins or F and H proteins or F and HN proteins, Hendra virus F and G proteins, Henipavirus F and G proteins, Morbilivirus F and H proteins, respirovirus F and HN protein, a Sendai virus F and HN protein, rubulavirus F and HN proteins, or avulavirus F and HN proteins, a derivative thereof, and any combination thereof,”.
Lastly, in reference to ‘618 stating the “plurality of fusosomes, when contacted with a target cell population in the presence of an inhibitor of endocytosis, and when contacted with a reference target cell population not treated with the inhibitor of endocytosis, delivers at least 30% more of the cargo to the target cell population compared to the reference target cell population” this is a functional characteristic of the fusosomes, particularly inherent qualities which remain to be expected with the instant fusosome due to the compositions being similar, and therefore these characteristics described for the ‘618 fusosome are similarly expected.
Response to Applicants’ Arguments as they apply to the Double Patenting Rejection
At page 12 of the remarks filed on April 29, 2026, Applicants state the fusosomes are different in that ‘618 does not teach a membrane payload agent, and more specifically the list of agents recited in the instant claim 1, and additionally the instant claims do not recite that the plurality of fusosomes, when contacted with a target cell population in the presence of an inhibitor of endocytosis, and when contacted with a reference target cell population not treated with the inhibitor of endocytosis, delivers at least 30% more of the cargo to the target cell population compared to the reference target cell population, as required by claim 1 of the ‘618 patent. These rejections are maintained in view of these arguments wherein each are limitations is addressed above, accordingly. In particular, the rejection describes how ‘618 teaching on ‘cargo’ encompasses the ‘membrane payload agents’ recited in the instant claims. Lastly, the functional language recited in ‘618 has been considered but the instant fusosome remains an obvious variant due to the compositions being similar, and therefore the ‘618 fusosome functional characteristics are expected to be shared with the instant fusosome.
New Grounds of Rejection
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 1-2, 4, 11-12, 14-17, 19-20, 22, 30-37 and 40-42 are newly 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.
Applicants are claiming a fusosome comprising: (a) a lipid bilayer comprising a plurality of lipids obtained from a source cell; (b) a lumen surrounded by the lipid bilayer; (c) a fusogen that is exogenous or overexpressed relative to the source cell, wherein the fusogen is disposed in the lipid bilayer, and wherein the fusogen comprises a Henipavirus or Morbillivirus fusogen and (d) a membrane protein payload agent that comprises or encodes one or more of: i) a chimeric antigen receptor (CAR); ii) an integrin membrane protein payload; iii) an ion channel protein; iv) a pore forming protein; v) a Toll-Like Receptor; vi) an interleukin receptor payload; vii) a cell adhesion protein; or viii)a transport protein; and wherein the fusosome comprises a targeting domain that interacts with a target cell moiety of a target cell; and wherein the fusosome does not comprise a nucleus. The Applicant has not provided sufficient support for these particular fusogens to be used in combination with the claimed composition.
The Specification states in relation to the fusogen types, “ In some embodiments the fusogen is a paramyxovirus fusogen. In some embodiments the fusogen is a Nipah virus protein F, a measles virus F protein, a tupaia paramyxovirus F protein, a paramyxovirus F protein, a Hendra virus F protein, a Henipavirus F protein, a Morbilivirus F protein, a respirovirus F protein, a Sendai virus F protein, a rubulavirus F protein, or an avulavirus F protein.” (0715). The following members of this list are considered Henipavirus or Morbillivirus fusogens: Nipah virus protein F, a measles virus F protein, a Hendra virus F protein, a Henipavirus F protein, and a Morbilivirus F protein. These fusogens are not further expanded upon in the Specification. The totality of the working examples, Example 1-116, only employ the HVJ-E fusogen (Examples 55, 56, 96, and 99), yet these fusogens belong to the HVJ virus or Sendai virus , which does not belong to the Henipavirus or Morbilivirus genera, but rather Respirovirus. The Specification describes there being different classes of fusogens, particularly classes I-IV that have different structures, e.g. alpha-helices and beta-sheets. Therefore, there is an expectation that not all fusion proteins behave similarly for fusion to occur. In summary, the Specification does not provide adequate support for the claimed fusosome that comprises Henipavirus or Morbilivirus F proteins based on the lack of working examples with such proteins, and moreover information pertaining to the specific structure and function of these fusion proteins.
The prior art contains teachings of these claimed F proteins during viral infection and in the isolation of the F proteins, but there is a lack of prior art in combination with using these specific F proteins. For example Pager et al., focuses on the Hendra virus F protein by testing fusion during infection, and discovered the protease cathepsin L is involved in converting the Hendra virus precursor F protein to the active form necessary for fusion (abstract). The closest prior art was used in the previous 35 USC 103 rejection wherein Kaneda et al. (of record) teaches the HVJ/Sendai virus fusion proteins for use in vectors, yet these fusion proteins are outside the scope of the instant claim.
In conclusion, the Specification does not provide an adequate written description on the claimed fusogens particularly wherein the fusogen comprises a Henipavirus or Morbillivirus fusogen.
Claim Rejections - 35 USC § 112
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 40 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. Claim 40 does not further limit the scope of claim 1 as it currently recites wherein the fusogen comprises a Henipavirus or Morbillivirus F protein (fusion proteins), yet these limitations are present in claim 1 with the same scope based on the presence of the same type and number of alternatives . 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.
Conclusion
Claims 1-2, 4, 11-12, 14-17, 19-20, 22, 30-37 and 40-42 are rejected. No claims are allowed.
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.
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/MICHAEL ANGELO RIGA/Examiner, Art Unit 1634
/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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