DETAILED ACTION
Examiner acknowledges receipt of the reply filed 2/11/2026, in response to the non-final office action mailed 10/22/2025.
Claims 1, 13, 15, and 19-23 are pending. Claims 2-8, 11, 12, 17, 18 and 24-26 have been cancelled. Claims 22 and 23 remain withdrawn for the reasons made of record.
Claims 1, 13, 15, and 19-21 are being examined on the merits in this office 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 .
Specification- withdrawn
The objection to the abstract and specification is withdrawn in view of the amendment filed 2/11/2026.
Claim Objections- withdrawn, in part
The objection of claims 2, 5, 12, 15, 19, 20, and 26 is withdrawn in view of the amendment filed 2/11/2026.
Claim Rejections - 35 USC § 112- withdrawn
The rejection of claims 1, 2, 4, 5, 8, 12, 13, 15, 19-21, and 24-26 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 2/11/2026.
The rejection of claims 1, 2, 4, 5, 8, 12, 13, 15, 19-21, and 24-26 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description), is withdrawn in view of the amendment filed 2/11/2026.
The rejection of claims 1, 2, 4, 5, 8, 12, 13, 15, 19-21, and 24-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (scope of enablement), is withdrawn in view of the amendment filed 2/11/2026.
Claim Rejections - 35 USC § 102- withdrawn
The rejection of claims 1, 19-21, 24 and 26 under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Lezdey et al (U.S. Pat. NO. 5532215), is withdrawn in view of the amendment filed 2/11/2026.
Response to Arguments
Applicant’s amendment and arguments, filed 2/11/2026 with respect to the above objections and rejections have been fully considered and are persuasive. The objections and rejections have been withdrawn.
Applicant's arguments filed 2/11/2026 have been fully considered but they are not persuasive with respect to the maintained objections and rejections.
Upon further consideration, a new ground(s) of objection is made in view of the amendment filed 2/11/2026.
An action on the merits is set forth herein.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
New Objection
Claim Objections
Claim 15 is remains objected to because of the following informalities:
Claim 15 should be amended to recite “antitrypsin protein is[[:]] as set forth”. Line 3 should be moved up to line 2 for continuous text.
Appropriate correction is required.
Maintained Objections and Rejections
Drawings- maintained
-- The drawings filed 2/11/2026 have been reviewed and entered --
The drawings filed 10/28/2022 remain objected to for the following reasons. At least Figs 2, 3, 5-9, and 26 are not identified with the figure number on the drawing itself. Compare Fig 1 which recites “Figure 1”. The drawings that would be Figure 2, etc. don’t recite any figure numbering.
The objection to the drawings is maintained. The following figures were not amended to reflect the figure identifiers/numbering consistent with the figure legends.
Figs 11-14, 15a, 15d, [15b, 15c, 15e are labelled], 16a, 16d, 16g, 16j [16b, 16c, 16e, 16f, 16h, 16i are labelled], 17a [17b is labelled], 18a [18b is labelled], 19a [19b is labeled], 21a-c, 22a-c, 23a [23b is labeled], 24, 25a, 25c, 25e and 25g [25b, 25d, and 25f are labeled] require labels identifying the respective figures.
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.
Response to Arguments
Applicant traversed the rejection at p.8 of the reply filed 2/11/2026.
Examiner acknowledges that Figs 2, 3, 5-9, and 26 were updated to reflect figure numbers. However, this was not a comprehensive listing. The office action mailed 10/22/2025 indicated at least Figs 2, 3, 5-9, and 26 did not have a figure number on the respective drawing.
Examiner requests that Applicant review ALL drawings to ensure that each figure is accurately identified, consistent with the specification and figure legends.
Claim Objections-maintained, in part
Claim 21 remains objected to because of the following informalities:
Claim 21 should be amended to recite “ex vivo cell therapy”. The first recitation of the term “ex vivo” is italicized.
The second recitation should also be italicized.
Appropriate correction is required.
Response to arguments
The objection of claim 21 was not addressed in the reply filed 2/11/2026.
Claim Rejections - 35 USC § 103- maintained
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1, 13, and 19-21 remain/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lezdey et al (U.S. Pat. NO. 5532215- previously cited), as evidenced by Hu et al. (Nature Rev Microbiol. 19:141-154 (2021)- previously cited). This rejection is maintained from the office action mailed 10/22/2026, but has been amended to reflect claims filed 2/11/2026.
Lezdey et al teach a method for the inhibition of viral proliferation which comprises treating a patient with a composition containing an antiviral effective amount of a human-type serine protease inhibitor selected from the group consisting of alpha 1-antitrypsin, secretory leucocyte protease inhibitor and alpha 1-antichymotrypsin (e.g., col. 1, ll. 60-67; col. 4, ll. 16-17 and 48-59; claim 1). Lezdey et al teach that the inhibitor can interfere with replication and prevent entry into a cell host (e.g., abstract, cols. 3-6). The serine protease inhibitor is alpha 1-antitrypsin (e.g., cols. 5, 7, 12; Ex VI-VII; claim 2). Lezdey et al teach that the composition can include a pharmaceutically acceptable carrier or excipient can be administered by intravenous injection, infusion, or topical application(e.g., col. 6, Examples I-IV). Lezdey et al teach that the composition can further comprise a protease inhibitor (combination of protease inhibitors) (e.g., col.3, ll. 60- 67; Ex II). Regarding claim 21, the composition may be administered by intravenous injection, infusion (cols. 4, 6, 7, Ex I-III). Lezdey et al teach that the virus can be a coronavirus (col. 6). The composition can be administered for treatment of pulmonary viral infections [reads on respiratory syndrome] (col 7).
Although Lezdey et al do not explicitly disclose the name “SARS-Cov-2”, Lezdey et al do expressly teach administering an antiviral effective amount [reads on therapeutically effective amount] of alpha 1-antitrypsin protein to a subject with a coronavirus viral infection in order to treat the coronavirus viral infection. As evidenced by Hu et al., SARS-CoV-2 is a coronavirus (p. 141).
Thus, administering alpha 1-antitrypsin protein to a subject with a SARS-CoV-2
(coronavirus) viral infection in order to treat the SARS-CoV-2 (coronavirus) viral infection is rendered obvious in view of the teachings of Lezdey et al.
Regarding claim 13, that the protein (alpha-1 antitrypsin) can be a natural or prepared by recombinant means (col. 5, ll. 17-25).
Regarding claim 19, Lezdey et al teach that the composition can include a pharmaceutically acceptable carrier or excipient (e.g., col. 6, Examples I-IV). Regarding claim 20, Lezdey et al teach that the composition mean can further comprise a protease inhibitor (combination of protease inhibitors) (e.g., col.3, ll. 60- 67; Ex II). Regarding claim 21, the composition may be administered by intravenous injection, infusion (cols. 4 and 6). The compositions can further be administered for topical application (col. 7, Ex I-III).
Claims 1, 13, and 19-21 are obvious in view the teachings of Lezdey et al., as evidenced by Hu et al.
Pursuant to MPEP 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969).
Response to Arguments
Applicant traverses the rejection at pp.11-12 of the reply filed 2/11/2026. Applicant alleges that Lezdey fails to teach or suggest a method for treating a SARS-Cov-2 infection comprising administering a therapeutically effective amount of an alpha1-antitrypsin protein (pp. 11). Applicant asserts Lezdey “only discloses a long list of viruses including the term ‘coronavirus’ and generally mentions that these viruses can be treated with serine protease inhibitors having anti-chymotryptic characteristics”. Applicant asserts that “neither the feature ‘SARS-cov-2’ is mentioned in Lezdey nor is AAT specifically linked to the generic feature ‘coronavirus’”. Applicant asserts that the data relating to the serine protease inhibitors for treating an infection caused by a coronavirus is “ostensibly lacking in Lezdey”. Id. Applicant asserts that Lezdey does not create a link between SARS-Cov-2 infection and AAT is an effective treatment thereof.
Applicant asserts that Hu does not remedy the alleged deficiencies of Lezdey. Id.
Applicant further states “the present invention clearly demonstrates-based on experimental data included in the application- that AAT is capable of treating SARS-CoV-2 infection (reply at p. 12). Applicant refers to examples 4-5, Figs 11, 12, 21, and 22, for the assertion that AAT effectively inhibits viral entry of SARS-CoV-2. Examples 8-17 and 16a-I for the indication that AAT is capable of inhibiting pro-inflammatory proteases by inhibiting the activity of cathepsin B and L, TMPRSS2, matriptase, furin, trypsin, PC2, elastase and neutrophil elastase, which propagates acute inflammation upon viral infection. Id.
Examiner has reviewed and considered applicants arguments, but is not persuaded.
Examiner first notes that the term “SARS-CoV-2” was first coined on February 11, 2020 by the World Health Organization (WHO) (Hu et al at p.142). As evidenced by novel coronavirus (2019-nCoV) WHO situation report 22 (Feb 11, 2020), WHO disclosed that “SARS-CoV-2” was a coronavirus (pp. 1-2, 6-7).
Examiner reminds applicant that patents are relevant as prior art for all they contain. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art. MPEP §2123.
Contrary to applicant’s assertions, the “generic feature” coronavirus is a family of viruses of which the “feature” SARS-Cov-2 is a member, as evidenced by Hu et al. Please also refer to WHO situation report.
Lezdey et al teach a method for the inhibition of viral proliferation which comprises treating a patient with a composition containing an antiviral effective amount of a human-type serine protease inhibitor, e.g., alpha 1-antitrypsin, (e.g., col. 1, ll. 60-67; col. 4, ll. 16-17, 5, 7, 12, and 48-59; claims 1-2). Lezdey et al explicitly taught that the inhibitor can interfere with replication and prevent entry into a cell host (e.g., abstract, cols. 3-6). Lezdey et al taught that the serine protease inhibitors (AAT) could be used to treat coronavirus infections.
Thus, contrary to applicant’s assertions, the skilled artisan would have expected applicant results of AAT effectively inhibits viral entry of SARS-CoV-2. Lezdey further taught a method of treating inflammation associated with viral infection in mammals comprising administration of the serine protease inhibitors (AAT) (e.g., col 3).
Accordingly, the rejection is maintained for the reasons set forth herein, and those previously made of record.
Claims 1, 13, 15, and 19-21 remain/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lezdey et al (U.S. Pat. NO. 5532215- previously cited), as evidenced by Hu et al. (Nature Rev Microbiol. 19:141-154 (2021)- previously cited), as applied to claims 1, 13, and 19-21 above, and further in view of Long et al (Biochemistry 23:4828-4837 (1984)- previously cited), as evidenced by UniProt Accession No P01009, human Alpha-1-antitrypsin (accessed 10/18/2025, pp. 1-16- previously cited). This rejection is maintained from the office action mailed 10/22/2026, but has been amended to reflect claims filed 2/11/2026.
The teachings of Lezdey et al are set forth above. The reference teaches that the human-type serum serine protease inhibitors (col. 1, ll.12-14). The reference further teaches that the human-type alpha 1-antitrypsin is naturally occurring, recombinant, glycosylated or non-glycosylated or mutagenized site-specific mutagenesis) (e.g., col. 4, ll. 53-59; col. 5, ll. 17-25).
The reference does not explicitly teach the amino acid sequence of alpha1-antitrypsin (AAT).
Long et al taught the cDNA coding sequence and protein sequence of alpha1-antitrypsin (AAT). See Fig 1. The protein is 418 amino acids in length, containing a 24 amino acid signal peptide and 394 amino acids in the mature polypeptide chain (abstract; p. 4829).
It would have been obvious to one of ordinary skill the art to prepare a recombinant alpha1-antitrypsin protein for use in a method of treating a coronavirus SARS-CoV-2 infection in a subject in need thereof, comprising administering a therapeutically effective amount of alpha1-antitrypsin, as taught by Lezdey et al., as evidenced by Hu et al teaching that SARS-CoV-2 was a coronavirus. The reference explicitly taught use of recombinant human alpha1-antitrypsin in treating a coronavirus infection. The skilled artisan would have recognized that Long et al taught the alpha1-antitrypsin (AAT) cDNA coding sequence that could be used to prepare a recombinant protein. Long et al teach the same amino acid sequence as instant SEQ ID NO:1, as evidenced by UniProt Accession No P01009, human Alpha-1-antitrypsin (accessed 10/18/2025, pp. 1-16). Thus, Long et al teach a protein that has 100% identity with instant SEQ ID NO:1. Accordingly, claim 15 is rendered obvious.
Claims 1, 13, 15, and 19-21 are obvious in view the teachings of the cited references.
Response to Arguments
Applicants refer to the rebuttal arguments as set forth above for the instant rejection. The Office’s rebuttal of these arguments remains the same and is incorporated herein by reference. After full consideration of applicants arguments, the rejection is maintained.
Relevant Art not relied upon
Zhou et al (BMC microbiology 16(1):12 pages (2016)- previously cited) teach that alpha1-antitrypsin (AAT) is related to AIDS progression and is inhibiting HIV-1 replication in infected host cells (abstract). AAT inhibits HIV-1 entry by directly interacting with gp41 and thereby inhibits HIV-1 infection. Id.
Conclusion
No claims are allowed.
Claims 1, 13, 15, and 19-23 are pending. Claims 22 and 23 are withdrawn.
Claims 1, 13, 15, and 19-21 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KRISTINA M HELLMAN/Examiner, Art Unit 1654
/JULIE HA/Primary Examiner, Art Unit 1654