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 .
The preliminary amendment filed 28 November 2023 has been entered. Claims 1-2, 5, 9, 12-13, 16, 22, 26-27, 33, 36, 39, 44-45, 55, 57, and 64-66 are pending and under examination.
Claim Interpretation
Claims 2, 13, and 27 recite “i.e.,”. This is being interpreted as “that is,”. Claim 2 lines 3-4 recites “a severe disease as defined by the WHO Ordinal Scale (i.e., 5-7)”, which is being interpreted as “a severe disease as defined by the WHO Ordinal Scale (that is, 5-7)”.
Claims 16 and 39 recite “e.g.”, which is being interpreted as “for example”.
See Merriam-Webster online dictionary, “The Difference Between ‘i.e.’ and ‘e.g.’’”, Last Updated 16 May 2025; accessed 16 November 16, 2025.
Claim Objections
Claim 16 is objected to because of the following informalities:
The claim says “(c) both (a) an d(b)”. There is an extra space after “an”, and a missing space between d and (b).. 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 16, 39, 55, and 57 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 claims 16 and 39, the phrase “e.g.”, which means "for example", renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 55 recites “comprises an oligopeptide consisting of 1 to 10 amino acids”. Claim 57 describes that the oligopeptide can be as small as a single amino acid, particularly methionine or glycine. The plain meaning of the term “oligo” is a plurality, i.e. more than one. See for example Reddy et al. Experimental Dermatology 21:563-568 (2012), abstract. Thus claims 55 and 57 are indefinite because it is unclear whether they allow for inclusion of a structure which is just a single amino acid, or whether the structure to be included must be an oligopeptide, which is necessarily more than one amino acid.
Claim 57 contains the trademark/trade name XTEN. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe long unstructured hydrophilic sequences of amino acids and, accordingly, the identification/description is indefinite.
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.
Claim(s) 1, 12, 26, 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahn J. Microbiol. Biotechnol 30(3):313-324 (2020).
Ahn teaches that Genexine “is developing a COVID-19 vaccine using Hyleukin-7 platform technology” and that Hyleukin-7 platform consists of a fusion between IL7 and an Fc fragment “designed to hybridize IgD and IgG4 for long-acting effects of Fc fusion proteins” (p. 320, first complete paragraph). While Ahn does not use the word “administering” the reference clearly indicates that this product is to be given to subjects with COVID-19, anticipating claims 1, 12, 26, and 44. Claims 5, 9, 22, 33 are included in this rejection as they recite effects that will occur following administration of the modified IL7.
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, 5, 9, 12, 22, 26, 33, 36, 38, 44-45, 55, 57, and 64-66 are rejected under 35 U.S.C. 103 as being obvious over Sung (U.S. 2021/0324027; published 21 October 2021, filed 16 April 2021, claiming benefit of foreign priority documents filed 16 April 2020).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Sung teaches IL7 polypeptides linked to either oligopeptides having 1-10 amino acids or to an Fc region, and that these extend the half-life of the IL7. See for example abstract, p. 4 paragraphs 0082 – 0083. Specific oligopeptides recited paragraphs 0097-0121 are oligopeptides comprising methionine, as in present claims 55 and 57. The half-life extending moieties recited in claim 57, including the Fc region of antibodies as well as others, are taught in Sung paragraph 0125. Sung teaches that the IL7 polypeptides disclosed therein can be used to treat several diseases, including coronavirus diseases such as SAR-CoV and SARS-CoV2, as in present claims 1, 12, 26, and 44. While Sung teaches the particular components required by the claims, the reference does not explicitly teach arranging them as set forth in the presently-rejected claims, as required by 35 USC 102.
Nevertheless, it would have been obvious to a person of ordinary skill in the art to use the IL7 polypeptides disclosed by Sung in treatment of coronavirus infections, as directed by paragraph 0181 of Sung.
Claims 5, 9, 22, 33 are included in this rejection as they recite effects that will occur following administration of the modified IL7.
Claim 45 is included in this rejection as Sung teaches the doses to be used including administer 720 mg/kg, which is within the range recited in claim 45. See Sung, paragraph 0175.
Claims 36 and 38 are included as Sung teaches administering other drugs, including antigens and adjuvants, which can be considered to meet the broad “standard of care” recited in claim 36.
Claims 64-66 are included as Sung teaches administering the same types of IL7; note the IL7s recited at Sung paragraph 0089 align with those recited in the present specification p. 59 paragraph 0151. Sung also teaches the signal sequence can be removed (Sung, paragraph 0086), as in present claim 65.
Claim(s) 1-2, 5, 9, 12-13, 16, 22, 26-27, 33, 36, 39, 44-45, 55, 57, and 64-66 are rejected under 35 U.S.C. 103 as being unpatentable over Muller Eur J Clin Microbiol Infect Dis (2006) 25:230-237 in view of Lu Clinical Immunology 114:30-41 (2005), cited on IDS and Yang WO 2016/200219, cited on IDS.
Muller teaches that SARS (now known as SARS-CoV-1, encompassed by claims 1, 12, and 26 and recited in claim 44) is characterized by lymphopenia, which is pertinent to claims 1 and 12 in particular. See Muller, p. 232 last complete paragraph. Muller indicates that this is a common symptom in SARS; see paragraph spanning pp. 235-236. Many patients have respiratory symptoms, but the reference does not suggest that any had hypoxia, as in claims 2, 13, and 27. It appears that while lymphopenia exists upon initial presentation, this is before severe hypoxia. However Muller does not teach treating with IL7 proteins as claimed.
Lu teaches that IL7 can counteract lymphopenia. Administering IL7 results in a higher CD4+ T cell count (abstract). This is pertinent to claims 1, 12, and 22 in particular. Prior to treatment the subjects had 3 CD4+ T cells / ml blood (p. 33, Results), which is at least 5% below normal as in claim 16. Administering IL7 restored the number of CD4+ T cells (Results). Lu concludes that IL7 can be useful to increase antiviral T cells, which suggests to the person of ordinary skill in the art that it could be used to treat viral infections. However Lu does not teach treating with modified IL7 proteins as claimed.
Yang teaches modified IL7 proteins. In particular Yang teaches peptides of the structure A-IL-7, wherein A is an oligopeptide consisting of 1-10 amino acids, in particular it can be methionine-methionine as in claims 1, 55, and 57. The IL7 peptide also has a half-life extending moiety such as Fc, albumin, XTEN, or others. See in particular Yang, p. 26 claims 1, 4, 5, and 7. This is encompassed by claim 1, 12, 55, and 57. Yang also indicates that the modified IL7 proteins can be used to treat viral infections; see claim 27 and Example 12 on pp. 23-24. Therefore it would have been obvious to a person of ordinary skill in the art to administer the modified IL7 proteins encompassed by the claims to SARS subjects, thereby arriving at the claimed invention. In particular, since many SARS patients have lymphopenia and IL7 increases immune cells, the person of ordinary skill in the art would expect a similar effect with the modified IL7s of Yang.
Claims 5, 9, 22, 26, 33, are included as Lu indicates IL7 increases immune cells, particularly CD4+ cells.
Claim 36 is included as Yang teaches that other drugs may also be administered; see p. 15 paragraph 124. Claim 39 is included as Yang teaches immunostimulants, antigens, and adjuvants can be administered, which fit within the very broad “standard of care”; see paragraph 123.
Claim 45 is included as Yang indicates that 2 mg/kg can be administered; see paragraph 122.
Claims 64 and 66 are included as Yang teaches that SEQ ID NO:1, which refers to the same accession number as present SEQ ID NO:1, can be used. See Yang p. 5 paragraph 46.
Claim 65 is included as Yang indicates that signal sequences are optional, and are cut off during protein translation; see p. 10 paragraph 93 – p. 11 paragraph 94. Since signal sequences are taught by Yang to be well-characterized and not needed for functioning of the final protein, removing it would have been 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 1-2, 5, 9, 12-13, 16, 22, 26-27, 33, 36, 39, 44-45, 55, 57, and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11548927 in view of Muller, Lu, and Yang.
The claims of the ‘927 patent are drawn to modified IL7 proteins, including with oligopeptides and Fc regions. However the ‘927 patent does not claim methods of treating diseases, as in the present claims.
The teachings of Muller, Lu, and Yang, including the particular places where each reference discloses or makes obvious the limitations of all claims, are set forth in the rejection under 35 USC 103 above. The rejection under 35 USC 103 also discloses why the person of ordinary skill in the art would have found it obvious to use modified IL7s, such as those claimed in ‘927, in the present methods.
Claims 1-2, 5, 9, 12-13, 16, 22, 26-27, 33, 36, 39, 44-45, 55, 57, and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10208099 in view of Muller, Lu, and Yang.
The claims of the ‘099 patent are drawn to modified IL7 proteins, including with oligopeptides. However the ‘099 patent does not claim methods of treating diseases, as in the present claims.
The teachings of Muller, Lu, and Yang, including the particular places where each reference discloses or makes obvious the limitations of all claims, are set forth in the rejection under 35 USC 103 above. The rejection under 35 USC 103 also discloses why the person of ordinary skill in the art would have found it obvious to use modified IL7s, such as those claimed in ‘099, in the present methods.
Claims 1-2, 5, 9, 12-13, 16, 22, 26-27, 33, 36, 39, 44-45, 55, 57, and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11041007 in view of Muller, Lu, and Yang.
The claims of the ‘007 patent are drawn to modified IL7 proteins, including with oligopeptides. However the ‘007 patent does not claim methods of treating diseases, as in the present claims.
The teachings of Muller, Lu, and Yang, including the particular places where each reference discloses or makes obvious the limitations of all claims, are set forth in the rejection under 35 USC 103 above. The rejection under 35 USC 103 also discloses why the person of ordinary skill in the art would have found it obvious to use modified IL7s, such as those claimed in ‘007, in the present methods.
Claims 1-2, 5, 9, 12-13, 16, 22, 26-27, 33, 36, 39, 44-45, 55, 57, and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11357827 in view of Muller, Lu, and Yang.
The claims of the ‘827 patent are drawn to methods of treating influenza with modified IL7 proteins, including with oligopeptides and Fc regions. However the ‘827 patent does not claim methods of treating coronavirus diseases, as in the present claims.
The teachings of Muller, Lu, and Yang, including the particular places where each reference discloses or makes obvious the limitations of all claims, are set forth in the rejection under 35 USC 103 above. The rejection under 35 USC 103 also discloses why the person of ordinary skill in the art would have found it obvious to use modified IL7s, such as those claimed in ‘827, in the present methods.
Claims 1-2, 5, 9, 12-13, 16, 22, 26-27, 33, 36, 39, 44-45, 55, 57, and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10844104 in view of Muller, Lu, and Yang.
The claims of the ‘104 patent are drawn to modified IL7 proteins, including with oligopeptides and Fc regions. However the ‘104 patent does not claim methods of treating diseases, as in the present claims.
The teachings of Muller, Lu, and Yang, including the particular places where each reference discloses or makes obvious the limitations of all claims, are set forth in the rejection under 35 USC 103 above. The rejection under 35 USC 103 also discloses why the person of ordinary skill in the art would have found it obvious to use modified IL7s, such as those claimed in ‘104, in the present methods.
Claims 1-2, 5, 9, 12-13, 16, 22, 26-27, 33, 36, 39, 44-45, 55, 57, and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12357677 in view of Muller, Lu, and Yang.
The claims of the ‘677 patent are drawn to methods of treating influenza with modified IL7 proteins, including with oligopeptides and Fc regions. However the ‘677 patent does not claim methods of treating coronavirus diseases, as in the present claims.
The teachings of Muller, Lu, and Yang, including the particular places where each reference discloses or makes obvious the limitations of all claims, are set forth in the rejection under 35 USC 103 above. The rejection under 35 USC 103 also discloses why the person of ordinary skill in the art would have found it obvious to use modified IL7s, such as those claimed in ‘677, in the present methods.
Claims 1-2, 5, 9, 12-13, 16, 22, 26-27, 33, 36, 39, 44-45, 55, 57, and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12344647 in view of Muller, Lu, and Yang.
The claims of the ‘647 patent are drawn to modified IL7 proteins, including with oligopeptides. However the ‘647 patent does not claim methods of treating diseases, as in the present claims.
The teachings of Muller, Lu, and Yang, including the particular places where each reference discloses or makes obvious the limitations of all claims, are set forth in the rejection under 35 USC 103 above. The rejection under 35 USC 103 also discloses why the person of ordinary skill in the art would have found it obvious to use modified IL7s, such as those claimed in ‘647, in the present methods.
Claims 1-2, 5, 9, 12-13, 16, 22, 26-27, 33, 36, 39, 44-45, 55, 57, and 64-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 16-17, 19, 22-23, 27-37 of copending Application No. 18327423 in view of Muller, Lu, and Yang.
The claims of the ‘423 application are drawn to modified IL7 proteins, including with oligopeptides and Fc regions. However the ‘423 application does not claim methods of treating diseases, as in the present claims.
The teachings of Muller, Lu, and Yang, including the particular places where each reference discloses or makes obvious the limitations of all claims, are set forth in the rejection under 35 USC 103 above. The rejection under 35 USC 103 also discloses why the person of ordinary skill in the art would have found it obvious to use modified IL7s, such as those claimed in ‘647, in the present methods.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Monneret Cell & Molecular Immunology 17(9):1001-1003. Published online 29 July 2020. The reference teaches administering IL7 to a patient with COVID-19. However it does not teach modified IL7 proteins as claimed.
Laterre JAMA Network Open 3(7):e2016485. Published 22 July 2020. The reference teaches administering IL7 to a patient with COVID-19. However it does not teach modified IL7 proteins as claimed.
Lee Clin Transl Sci 13:1161-1169 (2020; cited on IDS). The reference provides evidence that IL7 fused to Fc increases lymphocyte count.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL E KOLKER whose telephone number is (571)272-3181. The examiner can normally be reached Monday-Friday, 8:00am - 4:30pm.
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/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644