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 .
Status of the Application
Claims 1-3, 6-14, and 16-27 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 01/09/2026 are acknowledged. Claims under consideration in the instant office action are claims 1-3, 6-14, and 16-27.
Applicants' arguments, filed 01/09/2026, have been fully considered but they are not deemed to be persuasive. The rejection of claims 1-3, 6-8, 10-12, 14, 18-23, and 26-27 under 35 U.S.C. 102(a)(2) has been withdrawn due to Applicant’s amendments. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
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.
Claims 1-3, 6-8, 10-12, 14, 18-23, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Gralinski et al. (Mechanisms of Severe Acute Respiratory Syndrome Coronavirus-Induced Acute Lung Injury, American Society for Microbiology, 2013, 4(4), pp. 1-12). in view of Martin et al. (WO 2017/140430, as disclosed in IDS).
Gralinski et al. is drawn towards mechanisms of severe acute respiratory syndrome coronavirus-induced acute lung injury (see abstract). Gralinski et al. teaches “Severe acute respiratory syndrome coronavirus (SARS-CoV) emerged in 2002 and 2003 in China after evolving from related virus species circulating in bats. This novel group II coronavirus infected over 8,000 people worldwide, with a mortality rate of ~10%. In 2012, a novel human betacoronavirus from group 2c named Middle East respiratory syndrome coronavirus (MERSCoV) emerged in the Middle East.” (pg. 1, left column, first paragraph). Gralinski et al. teaches “Acute SARS-CoV infection resulted in denudation of airway epithelial cells, often accompanied by the accumulation of debris, which obstructed airway functions. Progression to acute lung injury (ALI) and the more severe form, acute respiratory distress syndrome (ARDS), often involved an acute-phase diffuse alveolar damage (DAD), which is characterized by exudates and hyaline membranes in the lung alveoli.” (pg. 1, right column, first paragraph).
Martin et al. does not teach treating an acute lung injury caused by a coronoviral infection by administering luminol.
Martin et al. teaches “A new crystalline form of 5-amino-2,3-dihydro-l,4-phthalazinedione (luminol) is provided. Advantageous uses for this crystalline form as a detecting agent or as an agent for forensic purposes are disclosed, as well a pharmaceutical composition containing said crystalline form.” (see abstract). Martin et al. teaches such compositions for use in lung diseases (pg. 22, lines 15-28). Martin et al. teaches “Alkaline salts of luminol have been structurally characterized only recently (Guzei et al., J. 15 Coord. Chem. 2013, 66, 3722-3739), as the sodium salt of luminol has regained interest for its pharmaceutical activity.” (pg. 1, lines 14-16). Martin et al. teaches a method of producing a crystalline Form II of luminol (pg. 4, lines 26-27; pg. 5, lines 10-21). Martin et al. teaches a composition comprising luminol and a pharmaceutically acceptable excipient including solubilizing agents such as cyclodextrin, thereby forming a cyclodextrin complex (pg. 8, lines 5-11, pg. 13, lines 5-14). Martin et al. teaches such compositions further comprising steroidal and non-steroidal anti-inflammatory agents (pg. 16, 22-27). Martin et al. teaches luminol compositions preferably used for the treatment of respiratory diseases including acute respiratory distress syndrome, which is well known in the art as a severe form of acute lung injury (pg. 20, lines 13-15; pg. 22, lines 15-27). Martin et al. teaches luminol compositions suitable for oral administration or intravenous administration (pp. 7-8, bridging paragraph). Martin et al. teaches such compositions in an oral dosage form of tablets (pg. 8, lines 24-27). Martin et al. teaches “Yet another preferred embodiment is the formulation of luminol as an aerosol (aerosol spray)…. Aerosols are usually administered to the patient by means of a nebulizer, a metered-dose inhaler (MDI) or a dry powder inhaler (DPI).” (pp. 21-22, bridging paragraph).
It would have been obvious to one of ordinary skill in the art to treat an acute lung injury caused by a coronoviral infection by administering luminol, as suggested by Martin et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since an acute lung injury can be treated by compositions comprising luminol as taught by Martin et al. (pg. 20, lines 13-15; pg. 22, lines 15-27), which can be caused by SARS-CoV infections as taught by Gralinski et al. (pg. 1, paragraphs 1-2). Given that luminol is administered to patients with an acute lung injury which may arise from SARS-CoV infections, such a method would read on the active steps of the claimed invention, and when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met, with a reasonable expectation of success absent evidence of criticality of the particular steps.
Regarding the recited crystalline form of luminol, when the composition recitations are met, the desired properties are met, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope (i.e. claim 1). Additionally, when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Regarding the recited crystalline form of luminol, when the composition recitations are met, the desired properties are met, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope (i.e. claim 1). Additionally, when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Claims 9, 13, 16-17, 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gralinski et al. (Mechanisms of Severe Acute Respiratory Syndrome Coronavirus-Induced Acute Lung Injury, American Society for Microbiology, 2013, 4(4), pp. 1-12) and Martin et al. (WO 2017/140430, as disclosed in IDS) as applied to claims 1-3, 6-8, 10-12, 14, 18-23, and 26-27 above, and further in view of Stephens et al. (Lung Injury and Acute Respiratory Distress Syndrome After Cardiac Surgery, 2016, 8(10), pp. 1122-1129).
The teachings of Gralinksi et al. and Martin et al. are presented above.
Gralinksi et al. and Martin et al. do not teach wherein a previous treatment with at least one other pharmaceutically active agent was refractory. Martin et al. does not teach the addition of a luminol composition to the ventilation air of a cardiopulmonary bypass device.
Stephens et al. is drawn towards lung injury and ARDS following cardiac surgery (see abstract). Stephens et al. teaches that “In cases of refractory hypoxemia, rescue therapies such as recruitment maneuvers, high-frequency oscillatory ventilation, and extracorporeal membrane oxygenation may preserve life.” (see abstract). Stephens et al. teaches refractory ARDS associated with physical medicine and rehabilitation (pg. 1125, right column, third paragraph). Stephens et al. teaches “Cardiac surgical patients routinely become significantly volume overloaded as a consequence of cardiopulmonary bypass and intraoperative and postoperative fluid resuscitation.” (pg. 1125, left column, third paragraph). Stephens et al. teaches rescue therapies of ventilation involving the inhalation of an active agent (pg. 1126), and as a consequence it would follow that one of ordinary skill in the art administer a therapeutic agent to the ventilation air of a pulmonary bypass device.
It would have been obvious to one of ordinary skill in the art to add a luminol composition to the ventilation air of a cardiopulmonary bypass device for patients with refractory ARDS, as suggested by Stephens et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since luminol is an effective therapeutic agent for the treatment of ARDS as taught by Martin et al. (pg. 20, lines 13-15; pg. 22, lines 15-27), which can be added to the ventilation of a pulmonary bypass device as a rescue therapy for patients with refractory hypoxemia as taught by Stephens et al. (pg. 1125, left column, third paragraph; pg. 1126), with a reasonable expectation of success absent evidence of criticality of the particular steps.
Regarding the recited crystalline form of luminol, when the composition recitations are met, the desired properties are met, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope (i.e. claim 1). Additionally, when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Response to Arguments
Applicant argues that “the Martin reference does not teach or suggest reducing or inhibiting the replication of SARS-CoV-2 in an individual who has acute lung injury, by using a pharmaceutically effective amount of 5-amino-2, 3-dihydro-l, 4-phthalazinedi one or one of its pharmaceutically acceptable salts. The addition of Stephens et al. does not cure the deficiencies of Martin. Stephens suggests a therapy with a medication alongside the ventilation of a patient in the ICU, but does not teach or suggest the claim elements that are missing in Martin.” The Examiner respectfully disagrees since Martin does teach methods of treating lung diseases, including acute lung injury by administering the recited compound. Although Marin does not teach or suggest reducing or inhibiting the replication of SARS-CoV-2 in an individual, Stephens et al. teaches that acute lung injury can be caused by coronaviral infections including MERS (pg. 1, paragraphs 1-2), and one of ordinary skill in the art would thus be motivated to treat a patient population suffering from an acute lung injury caused by coronaviral infections. Additionally, when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Claims 1-3, 6-14, and 16-27 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 ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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, Renee Claytor can be reached at (571)272-8394. 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.
/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
Prosecution Insights