DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendment after Non-final office action filed on 8/19/2026 is acknowledged.
3. Claim filed on 8/19/2026 is acknowledged.
4. Claims 4-6, 10, 11, 16, 17, 20-25, 28-33, 36-39, 41-51 and 54 have been cancelled.
5. Claims 1-3, 7-9, 12-15, 18, 19, 26, 27, 34, 35, 40, 52, 53 and 55-59 are pending in this application.
6. Claims 26, 27, 34, 35 and 57-59 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claims 8, 9 and 12-15 remain withdrawn from consideration as being drawn to non-elected species.
7. Applicant elected without traverse of Group 1 (claims 1-3, 7-9, 12-15, 18, 19, 40, 52, 53, 55 and 56) and elected without traverse of
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as species of conjugate comprising an ανβ6-binding peptide covalently attached to an imaging agent; about 7 days recited in claim 7 as species of imaging scheme from instant claims 7, 13 and 14; and a subject with SARS-CoV-2-related lung damage as species of subject with a specific virus-related lung damage from instant claims 2, 3, 8, 9, 12 and 15 in the reply filed on 4/13/2026.
Restriction requirement was deemed proper and made FINAL in the previous office action. Group 1 is drawn to a method of imaging virus-related lung damage comprising: (a) administering to a subject a conjugate comprising an ανβ6-binding peptide covalently attached to an imaging agent, wherein the subject has been exposed to or infected with a respiratory virus causative of lung damage; and (b) detecting the conjugate in lung tissue of the subject to determine the location and/or concentration of the conjugate in the lung tissue, thereby imaging the lung damage. A search was conducted on the elected species; and prior art was found. Claims 8, 9 and 12-15 remain withdrawn from consideration as being drawn to non-elected species. Claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56 are examined on the merits in this office action.
Non-compliant Amendment
8. The claim filed on 8/19/2026 is a non-complaint amendment. In the claim filed on 8/19/2026, Applicant amended claim 56 to delete the period at the end of claim 56. However, such change is not properly indicated and the status identifier of claim 56 is not updated (see MPEP § 714).
Declaration under 37 C.F.R. § 1.130(a)
9. Declaration of Julie L. Sutcliffe under 37 CFR 1.130(a) has been filed on 8/19/2026. The Declaration is sufficient to disqualify the NCT04376593 document (from https://clinicaltrials.gov/study/NCT04376593?term=NCT04376593&viewType=Card&rank=1&tab=history&a=1#version-content-panel, 2020, pages 1-10) as a prior art reference.
Withdrawn Objections and Rejections
10. Objection to the drawings is hereby withdrawn in view of Applicant’s amendment to the drawings.
11. Objection to claim 3 is hereby withdrawn in view of Applicant’s amendment to the claim.
12. Rejection to claims 1-3, 18, 19, 40, 52, 53, 55 and 56 under 35 U.S.C. 102(a)(1) as being anticipated by Hausner et al (WO 2015/160770 A1, filed with IDS) is hereby withdrawn in view of Applicant’s amendment to the claim.
13. Rejection to claims 3 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Foster et al (J Nucl Med, 2020, 61, pages 1717-1719, filed with IDS) is hereby withdrawn in view of Applicant’s amendment to the claim.
14. Rejection to claims 3 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by the NCT04376593 document (2020, pages 1-10, from https://clinicaltrials.gov/study/NCT04376593?term=NCT04376593&viewType=Card&rank=1&tab=history&a=1#version-content-panel) is hereby withdrawn in view of Applicant’s amendment to the claim and the filed Declaration of Julie L. Sutcliffe under 37 CFR 1.130(a).
15. Rejections to instant claims on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of US patent 10919932 B2, US patent 11185601 B2, US patent 11485758 B2, US patent 11591369 B2, co-pending Application No. 17/945457 and co-pending Application No. 18/038851 are hereby withdrawn in view of Applicant’s amendment to the claim.
Maintained/Revised Objections
16. (Revised due to Applicant’s amendment to the specification) The specification remains objected to for the following minor informality: The specification discloses the conjugate “
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. (SEQ ID NO: 16)” on page 5, paragraph [0021] and many others of instant specification. First, Applicant is suggested to amend this recitation as “
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(SEQ ID NO: 16).”. Second, the quality of this chemical formula/structure is extremely poor. Third, Applicant is suggested to remove the spaces in the amino acid sequence in the conjugate. Fourth, F in the recited conjugate is not clearly defined. Applicant is required to address these issues.
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 (see MPEP § 608.01).
17. (Revised due to Applicant’s amendment to the claim) Claim 7 remains objected to for the following minor informality: Applicant is suggested to amend claim 7 as “The method according to claim 1, wherein the imaging is performed at least about 1 day after infection with SARS-CoV-2”. In the instant case, the scheme recited in instant claim 7 broadly includes any time after about 1 day of SARS-CoV-2 infection. Therefore, the recited long lists of time frame is unnecessary.
18. (Revised due to Applicant’s amendment to the claim) Claim 53 remains objected to for the following minor informality: Claim 53 recites various peptides. However, they are missing the respective sequence identifier. Applicant is required to amend claim 53 to comply with 37 CFR 1.821(d).
19. (Revised due to Applicant’s amendment to the claim) Claim 55 remains objected to for the following minor informality: Claim 55 recites various peptides. However, they are missing the respective sequence identifier. Applicant is required to amend claim 55 to comply with 37 CFR 1.821(d).
Furthermore, Applicant is suggested to amend claim 55 as “…wherein the ανβ6-binding peptide comprises the amino acid sequence selected from…”.
With regards to the term “an amino acid sequence”, the Examiner would like to point out that the term “an amino acid sequence” broadly includes any fragment and full length of the recited amino acid sequence. And in the instant case, based on the disclosure of instant specification, the intended scope of the recited peptide appears to be one comprising the full length of the recited amino acid sequence. Therefore, Applicant is required to amend the recited “an amino acid sequence” to “the amino acid sequence”.
20. (Revised due to Applicant’s amendment to the claim) Claim 56 remains objected to for the following minor informality: Claim 56 recites the conjugate
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. First, this conjugate is missing the sequence identifier. Applicant is required to amend claim 56 to comply with 37 CFR 1.821(d). Second, the quality of this chemical formula/structure is extremely poor. Third, Applicant is suggested to remove the spaces in the amino acid sequence in the conjugate. Fourth, F in the recited conjugate is not clearly defined. Fifth, instant claim 56 needs to end with a period.
Response to Applicant's Arguments
21. Applicant fails to address all the minor issues in the specification and claims 7, 53, 55 and 56. Furthermore, detailed explanations have been added for the objections to instant claims 7 and 55. Taken all these together, these objections are deemed proper and are hereby maintained.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
22. 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.
23. Claims 53 and 56 remain 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 pre-AIA the applicant regards as the invention.
24. Claim 53 recites the limitation “X1 and X2 are independently selected amino acids”. With regards to the term “selected amino acids”, the instant specification fails to define it. Therefore, it is unclear what is encompassed within the recited “X1 and X2 are independently selected amino acids”. Thus, the metes and bounds of instant claim 53 is vague and indefinite.
Furthermore, in view of the filed sequence listing and in the broadest reasonable interpretation, for the purpose of this examination, the Examiner is interpretating the recited “X1 and X2 are independently selected amino acids” as “X1 and X2 are independently any amino acid”.
25. Claim 56 recites the conjugate
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. However, F in the recited conjugate is not clearly defined. It is unclear whether the recited F is 18F, 19F, or either of them. Therefore, the metes and bounds of instant claim 56 is vague and indefinite.
Response to Applicant's Arguments
26. With regards to the rejection to instant claim 53, Applicant argues that based on paragraphs [0047] and [0098]-[0100] of instant specification, the term “selected amino acids” is defined in instant specification.
With regards to the rejection to instant claim 56, Applicant argues that based on paragraphs [0014], [0033], [0042] and [0043] of instant specification and instant claim 19, F in the conjugate is either 18F or 19F.
27. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about the rejection to instant claim 53, the Examiner understands that instant specification defined the term “amino acid”. The Examiner also understands that the instant specification discloses “X1 and X2 are independently selected”. However, none of the paragraphs cited by Applicant defines or discloses the term “selected amino acids”. Furthermore, the interpretation provided by the Examiner is a curtesy for compact prosecution, otherwise, instant claim 53 would not be further examined. It is unclear to the Examiner how and/why such interpretation can be an evidence that instant claim 53 is definite. Further clarification is required. In addition, Applicant is suggested to amend the recited “X1 and X2 are independently selected amino acids” as “X1 and X2 are independently any amino acid” to overcome this ground of rejection.
In response to Applicant arguments about the rejection to instant claim 56, the Examiner understands that paragraphs [0014], [0033], [0042] and [0043] of instant specification and instant claim 19 recites both 18F and 19F. However, such disclosure does not mean F in instant claim 56 is defined as either 18F, 19F or both. Therefore, the metes and bounds of instant claim 56 is vague and indefinite. Furthermore, Applicant is suggested to amend instant claim 56 by adding “and wherein F in the conjugate is 18F or 19F” to overcome this ground of rejection.
Taken all these together, these rejections are deemed proper and are hereby maintained.
Claim Rejections - 35 U.S.C. § 103
28. 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 of this title, 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.
29. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
30. (Revised due to Applicant’s amendment to the claim) Claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56 remain rejected under 35 U.S.C. 103 as being unpatentable over Hausner et al (WO 2015/160770 A1, filed with IDS) in view of Meliopoulos et al (PLoS Pathog, 2016, 12, pages 1-30, cited and enclosed in the previous office action), Liu et al (JCI Insight, 2019, 4, pages 1-19, cited and enclosed in the previous office action) and Okin (Challenges to Therapies for ARDS Related to COVID-19, 2020, pages 1-5, from https://advances.massgeneral.org/research-and-innovation/article.aspx?id=1163, cited and enclosed in the previous office action).
The instant claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56 are drawn to a method of imaging virus-related lung damage comprising: (a) administering to a subject a conjugate comprising an ανβ6-binding peptide covalently attached to an imaging agent, wherein the subject has been exposed to or infected with a respiratory virus causative of lung damage; and (b) detecting the conjugate in lung tissue of the subject to determine the location and/or concentration of the conjugate in the lung tissue, thereby imaging the lung damage.
Hausner et al, throughout the patent, teach bi-terminal PEGylated peptide conjugates that target ανβ6 integrin; and a method of in vivo imaging of a target tissue comprising: (a) administering to a subject in need of such imaging, a bi-terminal PEGylated peptide conjugate, wherein an imaging agent is covalently attached to the peptide, the first PEG moiety, or the second PEG moiety; and (b) detecting the conjugate to determine where the conjugate is concentrated in the subject, wherein the subject suffers ανβ6 integrin-mediated diseases and disorders such as cancer, chronic fibrosis, chronic obstructive pulmonary disease (COPD), lung emphysema and chronic wounding skin disease; and wherein the detection and characterization of such disease relies on in vivo localization and quantification of expression levels of ανβ6, for example, Abstract; page 3, paragraph [0008]; page 7, paragraphs [0022] and [0024]; page 42, paragraph [0149]; and page 48, paragraph [0167]. It meets the limitations of the conjugate recited in instant claims 1 and 40. Hausner et al further teach the imaging agent in the conjugate includes radionuclides, detectable tags, fluorophores, fluorescent proteins, and enzymatic proteins; and the radionuclide can be 18F, 19F and many others, for example, page 44, paragraphs [0154] and [0155]. It meets the limitations of instant claims 18 and 19. Hausner et al also teach the bi-terminal PEGylated peptide conjugate can be [18F]FBA-PEG28-A20FMDV2-PEG28 having the structure
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with C-terminal amide, wherein the A20FMDV2 peptide consists of the amino acid sequence NAVPNLRGDLQVLAQK VART; or [18F]FBA-PEG28-A20FMDV2 K16R-PEG28, wherein the A20FMDV2 peptide in the [18F]FBA-PEG28-A20FMDV2-PEG28 conjugate is replaced with A20FMDV2 K16R consisting of the amino acid sequence NAVPNLRGDLQVLAQRVART, and wherein [18F]FBA-PEG28-A20FMDV2 K16R-PEG28 provides unexpectedly high ανβ6-affinity/-retention/-selectively in vitro and yields improved in vivo results, displays good clearing from the kidney, and exhibits high radiotracer stability, for example, Abstract; pages 3-4, paragraph [0010]; page 8, paragraph [0028]; and pages 59-60, paragraph [0201]. The conjugate [18F]FBA-PEG28-A20FMDV2 K16R-PEG28 with C-terminal amide in Hausner et al reads on
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as the elected species of conjugate comprising an ανβ6-binding peptide covalently attached to an imaging agent; and it meets the limitations of instant claims 52, 53, 55 and 56.
The difference between the reference and instant claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56 is that the reference does not explicitly teach about 7 days recited in claim 7 as the elected species of imaging scheme; a subject with SARS-CoV-2-related lung damage as the elected species of subject with a specific virus-related lung damage; the subject recited in instant claimed method; and the limitation of instant claim 7.
However, Meliopoulos et al, throughout the literature, teach the epithelial-restricted ανβ6 integrin is upregulated during injury; upregulated of ανβ6 during influenza infection is involved in disease pathogenesis; and the central role ανβ6 integrin in balancing the pulmonary environment during injury, for example, Abstract; page 2, Author Summary, and the 1st and 2nd paragraph in Section “Introduction”; and page 3, the 2nd paragraph. Meliopoulos et al further teach that in addition to influenza infection, severe respiratory infections are often associated with acute lung injury (ALI), such as patients with SARS and MERS-CoV infection, for example, the paragraph bridging pages 2-3.
Furthermore, Liu et al teach that SARS-CoV, MERS-CoV and H7N9 infection cause fatal acute lung injury, for example, Abstract; and page 1, the 1st paragraph in Section “Introduction”. Liu et al further teach comparison of the pathological changes in the lungs of SARS-CoV infected Chinese macaques at 7 and 35 days after infection with SARS-CoV, for example, the paragraph bridging pages 2-3.
In addition, Okin, throughout the literature, teaches that similar to SARS-CoV, MERS-CoV and influenza infection, COVID-19 (synonym of SARS-CoV-2) infection causes acute lung injury, for example, page 3, the 1st paragraph in Section “Targeting Host Immune Response”.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Hausner et al, Meliopoulos et al, Liu et al and Okin to develop a method of imaging acute lung injury (ALI) in a subject infected with SARS-CoV, MERS-CoV, influenza or COVID-19 (synonym of SARS-CoV-2), wherein the method comprises: (a) administering to the subject the conjugate [18F]FBA-PEG28-A20FMDV2-PEG28 or [18F]FBA-PEG28-A20FMDV2 K16R-PEG28, and detecting the conjugate in the lung tissue of the subject to determine the location and/or concentration of the conjugate in the lung tissue, thereby imaging the lung damage. It reads on a subject with SARS-CoV-2-related lung damage as the elected species of subject with a specific virus-related lung damage.
Furthermore, one of ordinary skill in the art would have been motivated to optimize the time/scheme to perform the imaging to obtain a better determination of the lung damage, including the imaging is performed about at least 1 day, such as about 7 days after the infection. It reads on about 7 days recited in claim 7 as the elected species of imaging scheme. In the instant case, Liu et al teach comparison of the pathological changes in the lungs of SARS-CoV infected Chinese macaques at 7 and 35 days after infection with SARS-CoV. And the MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (see MPEP § 2144.05 II A).
One of ordinary skilled in the art would have been motivated to combine the teachings of Hausner et al, Meliopoulos et al, Liu et al and Okin with routine optimization to develop a method of imaging acute lung injury (ALI) in a subject infected with SARS-CoV, MERS-CoV, influenza or COVID-19 (synonym of SARS-CoV-2), wherein the method comprises: (a) administering to the subject the conjugate [18F]FBA-PEG28-A20FMDV2-PEG28 or [18F]FBA-PEG28-A20FMDV2 K16R-PEG28, and detecting the conjugate in the lung tissue of the subject to determine the location and/or concentration of the conjugate in the lung tissue, thereby imaging the lung damage, and wherein the imaging is performed about at least 1 day, such as about 7 days after the infection, because Meliopoulos et al, throughout the literature, teach the epithelial-restricted ανβ6 integrin is upregulated during injury; upregulated of ανβ6 during influenza infection is involved in disease pathogenesis; and the central role ανβ6 integrin in balancing the pulmonary environment during injury. Meliopoulos et al further teach that in addition to influenza infection, severe respiratory infections are often associated with acute lung injury (ALI), such as patients with SARS and MERS-CoV infection. Liu et al teach that SARS-CoV, MERS-CoV and H7N9 infection cause fatal acute lung injury. Liu et al further teach comparison of the pathological changes in the lungs of SARS-CoV infected Chinese macaques at 7 and 35 days after infection with SARS-CoV. Okin, throughout the literature, teaches that similar to SARS-CoV, MERS-CoV and influenza infection, COVID-19 (synonym of SARS-CoV-2) infection cause acute lung injury. Furthermore, one of ordinary skill in the art would have been motivated to optimize the time/scheme to perform the imaging to obtain a better determination of the lung damage, including the imaging is performed about at least 1 day, such as about 7 days after the infection. And the MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (see MPEP § 2144.05 II A).
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Hausner et al, Meliopoulos et al, Liu et al and Okin with routine optimization to develop a method of imaging acute lung injury (ALI) in a subject infected with SARS-CoV, MERS-CoV, influenza or COVID-19 (synonym of SARS-CoV-2), wherein the method comprises: (a) administering to the subject the conjugate [18F]FBA-PEG28-A20FMDV2-PEG28 or [18F]FBA-PEG28-A20FMDV2 K16R-PEG28, and detecting the conjugate in the lung tissue of the subject to determine the location and/or concentration of the conjugate in the lung tissue, thereby imaging the lung damage, and wherein the imaging is performed about at least 1 day, such as about 7 days after the infection.
Response to Applicant's Arguments
31. Applicant argues that “A. The references do not teach the ordered imaging use as a whole” by arguing about each of the cited prior art references individually. Applicant further argues that “B. The rejection does not adequately support a reasonable expectation of useful viral-lung imaging”. Applicant also argues that “C. Claim 7 is not supported by routine optimization of an identified result-effective variable”.
32. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments that “A. The references do not teach the ordered imaging use as a whole” by arguing about each of the cited prior art references individually:
First, the Examiner agrees that none of the cited references individually teaches or suggests the method recited in instant claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56; and none of the cited references anticipates the method recited in instant claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56. However, the Examiner would like to point out that instant claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56 are rejected under 35 U.S.C. 103 (obviousness type), and the rejection is based on the combined teachings of Hausner et al, Meliopoulos et al, Liu et al and Okin with routine optimization. Therefore, it is not necessary for each of the cited references to teach all the limitations of instant claims.
Second, the Examiner would like to point out that the MPEP states "One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references…" (see MPEP § 2145 IV).
Third, in the instant case, the rejection set forth in Section 30 above teaches each and every limitation recited in instant claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56.
In response to Applicant’s arguments that “B. The rejection does not adequately support a reasonable expectation of useful viral-lung imaging”, in the instant case, in view of the teachings of Hausner et al as stated in Section 30 above, one of ordinary skilled in the art would understand and reasonably expect the conjugate and the method of in vivo imaging of a target tissue disclosed in Hausner et al can be used to detect ανβ6 integrin-mediated condition via relaying on in vivo localization and quantification of expression levels of ανβ6. And in view of the combined teachings of Meliopoulos et al, Liu et al and Okin, one of ordinary skilled in the art would understand and reasonably expect acute lung injury caused by influenza, SARS-CoV, MERS-CoV or COVID-19 (synonym of SARS-CoV-2) infection is a condition with upregulated of ανβ6 (a ανβ6 integrin-mediated condition taught in the method in Hausner et al). Therefore, in view of the combined teachings of Hausner et al, Meliopoulos et al, Liu et al and Okin with routine optimization as set forth in Section 30 above, a person of ordinary skilled in the art would have reasonable expectation of success in developing the method recited in instant claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56.
Furthermore, with regards to the expectation of success, the MPEP states: “Absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. The Federal Circuit concluded that “[g]ood science and useful contributions do not necessarily result in patentability.” Id. at 1364, 83 USPQ2d at 1304.” (see MPEP § 2145).
In response to Applicant’s arguments that “C. Claim 7 is not supported by routine optimization of an identified result-effective variable”:
First, as stated in Section 30 above, in the instant case, Liu et al explicitly teach comparison of the pathological changes in the lungs of SARS-CoV infected Chinese macaques at 7 and 35 days after infection with SARS-CoV.
Second, one of ordinary skill in the art would have been motivated to optimize the time/scheme to perform the imaging to obtain a better determination of the lung damage, including the imaging is performed about at least 1 day, such as about 7 days after the infection. And the MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (see MPEP § 2144.05 II A). In the instant case, other than statements/arguments, Applicant fails to provide any evidence and/or data to indicate the scheme recited in instant claim 7 is critical.
Third, the Examiner would like to point out that the scheme recited instant claim 7 broadly includes any time after about 1 day of SARS-CoV-2 infection.
Taken all these together, the rejection is deemed proper and is hereby maintained.
Obviousness Double Patenting
33. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
34. Claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16, 25-27 and 29-46 of US patent 10919932 B2 and in view of Hausner et al (WO 2015/160770 A1, filed with IDS), Meliopoulos et al (PLoS Pathog, 2016, 12, pages 1-30, cited and enclosed in the previous office action), Liu et al (JCI Insight, 2019, 4, pages 1-19, cited and enclosed in the previous office action) and Okin (Challenges to Therapies for ARDS Related to COVID-19, cited and enclosed in the previous office action, from https://advances.massgeneral.org/research-and-innovation/article.aspx?id=1163, 2020, pages 1-5).
35. Instant claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56 are drawn to a method of imaging virus-related lung damage comprising: (a) administering to a subject a conjugate comprising an ανβ6-binding peptide covalently attached to an imaging agent, wherein the subject has been exposed to or infected with a respiratory virus causative of lung damage; and (b) detecting the conjugate in lung tissue of the subject to determine the location and/or concentration of the conjugate in the lung tissue, thereby imaging the lung damage.
36. Claims 1-16, 25-27 and 29-46 of US patent 10919932 B2 are drawn to various conjugates that bind to ανβ6; composition and kit comprising such conjugate, and a method for the in vivo imaging of a target tissue with such conjugate.
37. The difference between instant claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56 and claims 1-16, 25-27 and 29-46 of US patent 10919932 B2 is that claims 1-16, 25-27 and 29-46 of US patent 10919932 B2 do not teach apply the conjugate for imaging virus-related lung damage, and the limitations of instant claims 7 and 56.
However, in view of the combined teachings of Hausner et al, Meliopoulos et al, Liu et al and Okin with routine optimization as set forth in Section 30 above, it would have been obvious to one of ordinary skilled in the art to apply the conjugate and/or modify the method recited in claims 1-16, 25-27 and 29-46 of US patent 10919932 B2 and develop the method recited in instant claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56.
38. For the same and/or similar reasoning/rational as the rejection set forth in Sections 34-37 above, instant claims 1-3, 7, 18, 19 and 40 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19, 21-28 and 31-35 of US patent 11185601 B2, and claims 1-15, 24-26 and 28 of US patent 11485758 B2; and in view of the combined teachings of Hausner et al (WO 2015/160770 A1, filed with IDS), Meliopoulos et al (PLoS Pathog, 2016, 12, pages 1-30, cited and enclosed in the previous office action), Liu et al (JCI Insight, 2019, 4, pages 1-19, cited and enclosed in the previous office action) and Okin (Challenges to Therapies for ARDS Related to COVID-19, 2020, pages 1-5, from https://advances.massgeneral.org/research-and-innovation/article.aspx?id=1163, cited and enclosed in the previous office action) with routine optimization as set forth in Section 30 above.
39. For the same and/or similar reasoning/rational as the rejection set forth in Sections 34-37 above, instant claims 1-3, 7, 18, 19, 40, 52 and 53 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-22 of US patent 11591369 B2; and in view of the combined teachings of Hausner et al (WO 2015/160770 A1, filed with IDS), Meliopoulos et al (PLoS Pathog, 2016, 12, pages 1-30, cited and enclosed in the previous office action), Liu et al (JCI Insight, 2019, 4, pages 1-19, cited and enclosed in the previous office action) and Okin (Challenges to Therapies for ARDS Related to COVID-19, 2020, pages 1-5, from https://advances.massgeneral.org/research-and-innovation/article.aspx?id=1163, cited and enclosed in the previous office action) with routine optimization as set forth in Section 30 above.
40. For the same and/or similar reasoning/rational as the rejection set forth in Sections 34-37 above, instant claims 1-3, 7, 18, 19, 40, 52, 53 and 55 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 and 20 of US patent 12649008 B2 (issued patent of Application No. 18/038851); and in view of the combined teachings of Hausner et al (WO 2015/160770 A1, filed with IDS), Meliopoulos et al (PLoS Pathog, 2016, 12, pages 1-30, cited and enclosed in the previous office action), Liu et al (JCI Insight, 2019, 4, pages 1-19, cited and enclosed in the previous office action) and Okin (Challenges to Therapies for ARDS Related to COVID-19, 2020, pages 1-5, cited and enclosed in the previous office action, from https://advances.massgeneral.org/research-and-innovation/article.aspx?id=1163) with routine optimization as set forth in Section 30 above.
41. For the same and/or similar reasoning/rational as the rejection set forth in Sections 34-37 above, instant claims 1-3, 7, 18, 19, 40, 52, 53, 55 and 56 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 53-57 and 59-64 of co-pending Application No. 17/945457 (Notice of Allowance mailed on 7/20/2026); and in view of the combined teachings of Hausner et al (WO 2015/160770 A1, filed with IDS), Meliopoulos et al (PLoS Pathog, 2016, 12, pages 1-30, cited and enclosed in the previous office action), Liu et al (JCI Insight, 2019, 4, pages 1-19, cited and enclosed in the previous office action) and Okin (Challenges to Therapies for ARDS Related to COVID-19, 2020, pages 1-5, cited and enclosed in the previous office action. from https://advances.massgeneral.org/research-and-innovation/article.aspx?id=1163) with routine optimization as set forth in Section 30 above.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Applicant's Arguments
42. Applicant argues about the cited prior art references as presented in Section 31 above. Applicant further argues that the rejections set forth in Sections 38-41 lack claim-to-claim analysis. Applicant also requests withdrawal of the provisional rejection.
43. Applicant's arguments have been fully considered but have not been found persuasive.
With regards to Applicant’s arguments about the cited prior art references, these have been addressed in Section 32 above.
With regards to Applicant’s arguments that the rejections set forth in Sections 38-41 lack claim-to-claim analysis, as stated in these sections, such rejections are based on the same and/or similar reasoning/rational as the rejection set forth in Sections 34-37 above. And it is the Examiner’s position that Applicant has the ability to understand such reasoning/rational. Furthermore, it is not necessary for the Examiner to repeatedly write the rejection under the same and/or similar reasoning/rational.
With regards to Applicant’s arguments about the provisional rejection, the fact that claim might be amended is not a reason for withdrawal of provisional ODP rejection.
Taken all these together, until a proper terminal disclaimer is filed and approved by the Office, these double patenting rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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