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 .
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.
Election/Restrictions
Applicant’s election in the reply filed on 16 September 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants provided a compliant species drug: fenretinide.
The Examiner found prior art on Applicants’ elected species. Therefore, the Markush search was not extended to other species.
The Elected species reads on 139-178
Claims 139-178 are examined in this office action.
Current Status of 17/913,118
This Office Action is in response to the amended claims of 09/20/2022.
Claims 139-178 are original and are examined in this office action.
Priority
Effective filing date is 03/26/2020.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 12/07/2022. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objection to Specification
The Specification is objected to because it contains numerous occurrence of embedded hyperlink and/or other form of browser-executable code. For example, on page 2, 3, 21, 30, 31-39, 44-45 and 49 of the specification has the hyperlinks.
Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 102
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.
Claims 150 and 155-156 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Newswire (https://firstwordpharma.com/story/4549757 (published March 14, 2018) retrieved January 23, 2026).
Newswire disclose use of LAU-7b (fenretinide) in oral therapy for anti-inflammatory drug in adult patients to prevent lung damage (lung damage can be caused by pneumonia, overactive lung inflammatory response, and acute respiratory distress syndrome), since prior art is silent about the cause of lung damage, examiner interpret this as overactive lung inflammation and acute respiratory distress syndrome (ARDS) thus anticipating claims 150 and 155-156.
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.
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 139-142 and 147-159 are rejected under 35 U.S.C. 103 as being unpatentable over
Wu et.al. (Virologica Sinica (2020) 35:266–271, published March 3rd 2020).
In view of
Newswire (https://firstwordpharma.com/story/4549757 (published March 14, 2018) retrieved January 23, 2026)
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Wu et.al teaches SAR-coronavirus causes cytokine chemokine release (figure1) that result in uncontrollable pulmonary inflammation (over active lung inflammation, claim 155 and 159) and acute respiratory diseases partially teaching claims 139, 147 150 and 154.
Newswire disclose use of LAU-7b (fenretinide) oral therapy for anti-inflammatory drug to prevent lung damage (lung damage can be caused by pneumonia, overactive lung inflammatory response, and acute respiratory distress syndrome), since prior art is silent about the cause of lung damage, examiner interpret this overactive lung inflammation, acute respiratory distress syndrome (ARDS) (Newswire,paragraph [2]) and pneumonia thus teaching claims 150 and 155-156 and partially teaching claims 141-142, 149, 152-153, and 157-158.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Wu et.al. does not teach fenretinide for treating SARs-coronavirus or the use of LAU-7B as form of fenretinide; or the dosage of fenretinide.
Newswire does not teach treating SARs-coronavirus with fenretinide or the dosage of fenretinide.
Anisel et.al. does not teach dosage of LAU-7B or fenretinide for treating SAR-Covid-19.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment for respiratory infection.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Wu teaches SARs-Covid 19 causes cytokine chemokine release (Wu figure1) that causes overreactive lung inflammation results in acute respiratory diseases (Wu page 266). Therefore, a person skilled in the art would be motivated to use fenretinide in the form of LAU-7b to prevent/ prophylaxis lung damage caused by overreactive lung inflammation results in acute respiratory diseases from SARS-coronavirus infections. If would be expected LAU-7b would be able to treat SARS coronavirus infection that result in overactive lung inflammations and acute respiratory disease, since LAU-7b is known to prevent lung damage in the prior art (Newswire,paragraph [2]), thus teaching all the elements of claims 139, 141, 147, 149, 150, 152, 154-155, 157 and 159.
Claims 140, 142, 148, 151,153, 156, and 158 are directed to dosage and frequency of the dosage of compound of fenretinide. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be 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) (“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). See MPEP 2144.05(II)(A).
Claims 143-146 are rejected under 35 U.S.C. 103 as being unpatentable over
Shi et. al. Lancet Infect Dis 2020; 20: 425–34 Published Online February 24, 2020 https://doi.org/10.1016/ S1473-3099(20)30086-4
In view of
Newswire (https://firstwordpharma.com/story/4549757 (published March 14, 2018) retrieved January 23, 2026)
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Shi et.al teaches pneumonia can be induces by SAR-coronavirus (summary)
Newswire disclose use of LAU-7b (fenretinide) in oral therapy for anti-inflammatory drug to prevent lung damage (lung damage can be caused by pneumonia, overactive lung inflammatory response, and acute respiratory distress syndrome), since prior art is silent about the cause of lung damage, examiner interpret this overactive lung inflammation, acute respiratory distress syndrome (ARDS) (Newswire,paragraph [2]) and pneumonia thus partially teaching claims 143, 145-146 and 174 .
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Shi et.al. does not teach fenretinide for treating SARs-coronavirus related pneumonia the use of LAU-7B as form of fenretinide; or the dosage of fenretinide.
Newswire does not teach treating SARs-coronavirus related pneumonia with fenretinide or the dosage of fenretinide.
Anisel et.al. does not teach dosage of LAU-7B or fenretinide for treating SAR-Covid-19.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment for respiratory infection.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Wu teaches SARs-Covid 19 causes cytokine chemokine release (Wu figure1) that causes overreactive lung inflammation results in acute respiratory diseases (Wu page 266). Therefore, a person skilled in the art would be motivated to use fenretinide in the form of LAU-7b to prevent/ prophylaxis lung damage caused by overreactive lung inflammation results in acute respiratory diseases from SARS-coronavirus infections. If would be expected LAU-7b would be able to treat SARS coronavirus infection that result in overactive lung inflammations and acute respiratory disease, since LAU-7b is known to prevent lung damage in the prior art (Newswire,paragraph [2]), thus teaching all the elements of claims 143,145,172 and 174.
Claims 144,146 and 173 are directed to dosage and frequency of the dosage of compound of fenretinide. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be 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) (“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). See MPEP 2144.05(II)(A).
Claims 164-171 and 175-178 are rejected under 35 U.S.C. 103 as being unpatentable over
Yang et.al Cancer Chemother Pharmacol (2006) 58: 540–546
In view of
Newswire (https://firstwordpharma.com/story/4549757 (published March 14, 2018) retrieved January 23, 2026)
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Yang teaches fenretinide induces apoptosis of lymphoblastic leukemia (causes for reticulocytopenia, independent claim 175) cells with 20% oxygen level (hypoxemia) (abstract) thus partially teaching claims 164, 168 and 175
Newswire disclose use of LAU-7b (fenretinide) in oral therapy partially teaching claims 166, 170 and 177.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Yang et.al. does not teach the use of LAU-7B as form of fenretinide in humans; or the dosage of fenretinide.
Newswire does not teach treating hypoxemia or reticulocytopenia with fenretinide or the dosage of fenretinide.
Anisel et.al. does not teach dosage of LAU-7B or fenretinide for treating hypoxemia or reticulocytopenia.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment for respiratory infection.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to use fenretinide in the form of LAU-7b (Newswire) to prevent/ treating hypoxemia and reticulocytopenia since fenretinide is used in the prior art to treat/prevent hypoxemia and reticulocytopenia (Yang, abstract). If would be expected LAU-7b which is used in human would be able to prevent/ treating hypoxemia and reticulocytopenia same as any form of Fenretinide thus teaching of claims 164-171 and 175-178
Claims 165, 167, 169, 171, 176 and 178 are directed to dosage and frequency of the dosage of compound of fenretinide. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be 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) (“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). See MPEP 2144.05(II)(A).
Claims 160-163 are rejected under 35 U.S.C. 103 as being unpatentable over
Zheng J. SARS-CoV-2: an Emerging Coronavirus that Causes a Global Threat. Int J Biol Sci. 2020 March 15;16(10):1678-1685.
In view
Wu et.al. (Virologica Sinica (2020) 35:266–271, published March 3rd 2020).
In further view of
Newswire (https://firstwordpharma.com/story/4549757 (published March 14, 2018) retrieved January 23, 2026)
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Zheng et.al teaches use of remdesivir (a delayed chain terminator antiviral compound) for treating SAR-coronavirus (page 1682) partially teaching claims 160-161.
Wu et.al teaches SAR-coronavirus causes cytokine chemokine release (figure1) that result in uncontrollable pulmonary inflammation (over active lung inflammation, claims and acute respiratory diseases) partially teaching claims.
Newswire disclose use of LAU-7b (fenretinide) oral therapy for anti-inflammatory drug to prevent lung damage (lung damage can be caused by pneumonia, overactive lung inflammatory response, and acute respiratory distress syndrome), since prior art is silent about the cause of lung damage, examiner interpret this overactive lung inflammation, acute respiratory distress syndrome (ARDS) (Newswire,paragraph [2]) and pneumonia thus teaching claims.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Zheng et.al does not teach reducing SAR-coronavirus with combination of fenretinide and a delayed chain terminator antiviral compound. or the dosage of fenretinide.
Wu et.al. does not teach reducing SAR-coronavirus with combination of fenretinide and a delayed chain terminator antiviral compound; or the dosage of fenretinide.
Newswire does not teach treating SARs-coronavirus with fenretinide or the dosage of fenretinide.
Anisel et.al. does not teach dosage of LAU-7B or fenretinide for treating SAR-Covid-19.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment for respiratory infection.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Wu teaches SARs-Covid 19 causes cytokine chemokine release (Wu figure1) that causes overreactive lung inflammation results in acute respiratory diseases (Wu page 266). Zheng teaches use of remdesivir (a delayed chain terminator antiviral compound) for treating SAR-coronavirus (page 1682) partially teaching claims 160-161. Therefore, a person skilled in the art would be motivated to use fenretinide in the form of LAU-7b (newswire)to prevent/ prophylaxis lung damage caused by overreactive lung inflammation results in acute respiratory diseases from SARS-coronavirus infections with antiviral such as remdesivir. Combination of fenretinide and remdesivir would be reduces viral load and at the same time treat the symptoms of SARS-coronavirus such as lung damage. Since would be expected LAU-7b would be able to treat SARS coronavirus infection that result in overactive lung inflammations and acute respiratory disease, since LAU-7b is known to prevent lung damage in the prior art (Newswire,paragraph [2]), thus teaching claims 160-163.
Claims 162 are directed to dosage of fenretinide. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be 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) (“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). See MPEP 2144.05(II)(A).
Conclusion
No Claims are allowable as written.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625