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 .
Election/Restrictions
Claims 1-20 are pending.
Applicant’s election without traverse of Group I, claims 1-10 and 19 in the reply filed on 06/25/2025 is acknowledged.
Claims 11-18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/25/2025.
Claims 1-10 and 19 have been examined on their merits.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show details as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specifically, Figs. 2-5, 7-10, 12-16 are objected to because the details are illegible and the details cannot be read.
Specification
The disclosure is objected to because of the following informalities: the specification contains reference to color in the figures (e.g., “green” paragraph [0013]; “red” paragraphs [0014-0016]; “blue” paragraphs [0015, 0019]) while no petition for color drawing has been submitted and accepted. Removing reference to color in the drawings would be ameliorative.
Additionally, disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see paragraph [0177], reference to NCBI website). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Removing reference to https:// would be ameliorative.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to for the following informalities: Claim 1 contains quotation marks around the abbreviated term herpes simplex virus, that it itself within parentheses (i.e., (“HSV”)). While a person of ordinary skill in the art would have recognized that (“HSV”) refers to herpes simplex virus, typically, in claims, parentheses are sufficient to establish an abbreviation and the quotation marks are redundant. Simply removing the quotation marks would be ameliorative (i.e., (HSV)).
Claim Rejections - 35 USC § 112(b)
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 5 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.
In regards to claim 5, the claim recites “a promoter from modified retroviral promoter region (“MND”).” The claim is indefinite for two reasons. First, MND is not the abbreviated term for “modified retroviral promoter region”. Rather, as used in the art, MND is an abbreviation for “Myeloproliferative sarcoma virus, Negative control region deleted, and dl587rev primer-binding site substituted.”
Therefore, while applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). In the instant case, the specification does not adequately define this term, does not refer to “Myeloproliferative sarcoma virus, Negative control region deleted, and dl587rev primer-binding site substituted”, and only generically states as an example, “a modified retroviral promoter region” (paragraph [0125]).
As a result, this appears to refer to an example, and therefore, the claim is also indefinite because it is unclear if “MND” part of the claimed invention or merely exemplary (See MPEP § 2173.05(d)).
For compact prosecution, “a promoter from modified retroviral promoter region” has broadly been interpreted to refer to any promoter from a modified retroviral promoter region and MND as an optional type.
Claim Rejections - 35 USC § 112(a)
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 1-10 and 19 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.
Independent claim 1 encompasses a genus of any “biologically active fragment” of IL-21 polypeptide.
Dependent claims 3-4 likewise are limited to any “biologically active fragment” of IL-21.
The specification does not define “biologically active” or “fragment”, either singly or together, and therefore, this has been interpreted broadly to refer to any fragment of IL-21 (see MPEP 2111, pending claims must be “given their broadest reasonable interpretation consistent with the specification.” The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the “broadest reasonable interpretation” standard).
In regards to a biologically active fragment, this can refer to not only contiguous amino acids, but any recombinant or modified amino acid sequence or even individual amino acids.
In regards to IL-21, as evidenced by Stem Cell Technologies (retrieved from internet 07/08/2026), recombinant IL-21 alone it at least 132 amino acids in length (Product Information, p2). This corresponds to at least 8778 contiguous fragments alone (fragments = L(L + 1)/2; 132(132 + 1)/2 = 8778).
While the instant specification asserts the broad limitation of any biologically active fragment (paragraphs [0004, 0133, 0136, etc.]), the application only discloses full length recombinant IL-21 (see SEQ ID NO: 1, which has 100% identity with the sequence as evidenced by Stem Cell Technologies above (see Product Information, p2, SEQ ID NO: 2 which has a cleaved methionine) and does not describe any biologically active fragments.
Under the written description guidelines (see MPEP 2163) the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
Actual Reduction to Practice
In regards to claims 1 and 3-4, while as above, a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). While the instant specification asserts any biologically active fragment (paragraphs [0004, 0133, 0136, etc.]), the application only discloses full length recombinant IL-21 (see SEQ ID NO: 1, which has 100% identity with the sequence as evidenced by Stem Cell Technologies above (see Product Information, p2, SEQ ID NO: 2 which has a cleaved methionine) and does not describe any biologically active fragments.
Accordingly, Applicant has not demonstrated the full genus of any biologically active fragment of IL-21, nor demonstrated identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that Applicant was in possession of the claimed genus of compositions.
State of the Art
In regards to claim 1 and 3-4, while as evidenced by Pallikkuth et al. (Crit Rev Immunol, 2012), IL-21 was known in the art (Title, Abstract, p1), the art is silent as to fragments of the broad genus as claimed. Additionally, as evidenced by Stem Cell Technologies (retrieved from internet 07/08/2026), recombinant IL-21 alone it at least 132 amino acids in length (Product Information, p2) which corresponds to at least 8778 contiguous fragments alone (fragments = L(L + 1)/2; 132(132 + 1)/2 = 8778), and the claim encompass not only these fragments but also recombinant or modified amino acid sequences or even individual amino acids, without disclosure on how any of these fragments are distinguishable from the fragments of other amino acids.
Therefore, the was not well established with a representative number of the genus of any biologically active fragment of IL-21.
Conclusion
In regards to claim 1 and 3-4, the claim is broadly limited to any biologically active fragment of IL-21, yet the instant specification provides no guidance nor description of the claimed fragments. Indeed, as above, a fragment can be a single amino acid, such as methionine, glycine, etc, and the specification does not disclose identifying these fragments from the fragments of other proteins. While the IL-21 itself was known in the art, the art is not well established as to the genus of possible fragments.
Therefore, the Examiner concludes that there is insufficient written description of the instantly claimed genus of any biologically active fragment of IL-21. Specifically, there no description of biologically active fragments of IL-21, the art does not adequately describe the genus of possible biologically active fragments of IL-21, and a person of ordinary skill in the art would find that the specification inadequately described the claimed genus of compositions.
Claims 2-10 and 19 are rejected under 35 USC 112(a) for their dependency on claim 1.
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)(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, 4, 6-10, and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhao et al. (US20240216533A1, priority to 03/04/2021)
In regards to claim 1, Zhao discloses a genetically modified (thus, unnatural) herpes simplex virus (HSV) vector that encodes an IL-21 cytokine (polypeptide) (claims 2, 7, and 17).
In regards to claim 4, Zhao discloses that the polypeptide is inserted into the ICP34.5 locus (claim 5).
In regards to claim 6, Zhao discloses a host cell comprising the HSV vector (claim 20).
In regards to claim 7, Zhao discloses that the infected (thus host) cell can be human (paragraph [0011]) which are eukaryotic.
In regards to claim 8, Zhao discloses a composition comprising the HSV vector (claim 20).
In regards to claim 9, Li discloses that the composition comprises a pharmaceutically acceptable carrier (paragraph [0182]).
In regards to claim 10, Zhao discloses that the composition is formulated for intratumoral injection (paragraphs [0178, 180, 0185]).
In regards to claim 19, Zhao discloses a kit comprising the HSC vector composition (paragraphs [0182-0183]).
Therefore, Zhao anticipates the invention.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US20240216533A1, priority to 03/04/2021).
Zhao anticipates claim 1 as discussed above.
In regards to claim 3, Zhao is silent as to the species of the IL-21 polypeptide. However, the compositions and methods of Zhao are in the technical field of treating human disease (paragraphs [0011-0012, 0158, 0178]) and therefore, a person of ordinary skill in the art would have been motivated to use human IL-21 because it would have been most applicable to treating human disease. Furthermore, because IL-21 is a known human gene/polypeptide, it could have been done with predictable results and a reasonable expectation of success.
Therefore, the teachings of Zhao render the invention unpatentable as claimed.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US20240216533A1, priority to 03/04/2021) in view of Ghonime et al. (Translational Oncology, 2018).
Zhao anticipates claim 1 as discussed above.
In regards to claim 2, Zhao is silent as to the type of HSV. However, a person of ordinary skill in the art would have been motivated to use a C134 HSV because Ghonime teaches that C134 is a next generation Δγ134.5 oHSV-1 with improved intratumoral replication and which is sage in non-malignant CNS tissues (e.g., gliomas) (Abstract, p86). Furthermore, because C134 is a known HSV for treating tumors and because Zhao teaches that an object of the invention is treating brain gliomas (paragraph [0178, 0180]), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Zhao and Ghonime renders the invention unpatentable as claimed.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US20240216533A1, priority to 03/04/2021) in view of Papadakis et al. (Current Gene Therapy, 2004).
Zhao anticipates claims 1 and 4 as discussed above.
In regards to claim 5, Zhao teaches that a CMV promoter is used to knock-in the exogenous polypeptide (paragraph [0225, 0229]), but is silent as to the specific type.
However, a person of ordinary skill in the art would have been motivated to use a CMV IE promoter because Papadakis teaches that the CMV-IE promoter drives very high levels of transgene expression in many tissue types (Viral promoters, p89). Furthermore, because Papadakis teaches that use the CMV-IE promoter for gene transfer is ubiquitous and well-known (Viral promoters, p89), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Zhao and Papadakis renders the invention unpatentable as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Eissa et al. (WO2021193081A1).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
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