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 .
Claim Status
Claims 1-10 are cancelled.
Claims 11-19 are new. Applicant’s amendment has necessitated new ground of rejection. Accordingly, this Action is FINAL.
Specification
The Examiner acknowledges the amendment to the specification.
Withdrawn rejections
Applicant's amendments and arguments filed 8/8/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 1-8 were rejected under 35 U.S.C. 103(a) as being unpatentable over Bauman, E. (Coronavirus Update + Best Practices for Natural Protection March 13, 2020; NPL reference #2 on IDS filed 4/10/23) and Higher Health (What is Pharmaceutical Grade? [online] retrieved on 5/3/25 from: https://www.higherhealthspineandsport.com/blog/what-is-pharmaceutical-grade; 2019: 5 pages). Claims 1-8 were rejected under 35 U.S.C. 103(a) as being unpatentable over Barrett et al. (WO2017077528) and Knibbs (Express March 11, 2020; NPL reference #7 on the IDS filed 4/10/23) and Calder, PC. (Nutrients 2010;2:355-374) and Tan et al. (Prostaglandins, Leukotrienes and Essential Fatty Acids 132 (2018) 23–29) and Yi et al. (Int. J. Biol. Sci. 2020 March 15;(16):1753-1766) and Higher Health (What is Pharmaceutical Grade? [online] retrieved on 5/3/25 from: https://www.higherhealthspineandsport.com/blog/what-is-pharmaceutical-grade; 2019: 5 pages). Applicant has cancelled these claims to render the rejections moot.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation “at least 95%” and the claim also recites “preferably 99%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 of this title, 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 negatived by the manner in which the invention was made.
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(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 11-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bauman, E. (Coronavirus Update + Best Practices for Natural Protection March 13, 2020; NPL reference #2 on IDS filed 4/10/23) and Peet et al. (US20110065793) and Belluzzi (WO2018146545).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from infectious disease etiology and treatment protocols, including viral infections such as COVID-19, pharmaceutically active compounds and their biological activity, pharmaceutical formulation techniques and administration— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 11, 14 and 15, Bauman recommends to the ordinary artisan that in order to significantly decrease the frequency and severity of viral illness including COVID-19, then 2-3 grams of EPA/DHA should be taken per day (Page 3 of 7), where EPA is the essential free fatty acid eicosapentaenoic acid.
Regarding claim 17, the method of Bauman implicitly modulates an immune response caused by increase in the expression of interleukins and the release of arachidonic acid (AA) to reduce the level of interleukins and release of AA. The Examiner's finding is based on the principle that products of identical chemical compositions cannot have mutually exclusive properties. This is a well settled principle in patent law. See In re Papesch, 315 F.2d 381,391 (CCPA 1963) ("From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing."). Where patentability rests upon a property of the claimed material not disclosed within the art, the USPTO has no reasonable method of determining whether there is, in fact, a patentable difference between the prior art materials and the claimed material. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Therefore, where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the USPTO can require an applicant to prove that the prior art products do not necessarily possess the characteristics of his claimed product. Id.
Regarding claim 18, the method of Bauman implicitly reduces a late complication event of COVID-19 and variants thereof wherein the late complication is lung fibrosis in a subject by reducing IL-6 and VEGF production and the secondary neoangiogenesis that ultimately generates pulmonary fibrosis. See the Examiner’s reasoning above.
Regarding claims 11-19, Peet et al. teach that EPA can be in the free acid form [0009, 0079] and that “it was important for clinical efficacy to administer EPA in a highly purified form for maximum clinical effectiveness. Surprisingly, the same daily dose of EPA in a purified form seems considerably more effective” [0030]. Peet et al. also teach: “that highly purified EPA is therapeutically more effective” [0033]; and “it is likely that any form of highly purified EPA which is able to raise EPA levels in the blood” [0073]. Peet et al. teach dosage forms include soft and hard capsules, powder, tablets and parenteral formulations in oils or emulsions or dispersions [0075]. Peet et al. also teach a useful daily dose of 0.5g to 5 g per day [0077-0078]. Therefore, the art of Peet et al. teaches the desirability of having high purity EPA free fatty acid.
Regarding claims 11-19, Beluzzi teaches highly purified eicosapentaenoic acid free fatty acid which has a purity of at least 95% and more preferably at least 99% (Abstract; claim 15) with a therapeutic amount from 500 mg to about 2 g daily (Claim 18) or from about 250 mg to about 4 g per day administered daily, or every other day or weekly or for about 1-8 months (Page 7, lines 30-34). Beluzzi teaches that (Examiner added emphasis): “EPA free fatty acid is commercially available under the tradename ALFA™ (S.L.A. Pharma, UK). This PUFA is 99% pure EPA, in a free fatty acid form” (Page 7, lines 22-23).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Bauman is that Bauman do not expressly teach eicosapentaenoic acid in the free fatty acid (EPA-FFA) form having purity of at least 95%, or at least 90%, 95% or 99% in solid or in liquid form or for parenteral administration as a sterile solution, emulsion or suspension used in the method. This deficiency in Bauman is cured by the teachings of Peet et al. and Beluzzi.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to perform the method of Bauman, with at least 95%, or at least 90%, 95% or at least 99% pure EPA, as suggested by Beluzzi, in solid or in liquid form or for parenteral administration as a sterile solution, emulsion or suspension, as suggested by Peet, and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because the art of Peet et al. teaches and suggests that the more purified form of EPA has better therapeutic effectiveness and it is then merely a matter of obtaining the commercial product ALFA™ containing 99% pure EPA free fatty acid for use in the method of Bauman with a reasonable expectation of success. Accordingly, the ordinary artisan would use at least 99% pure eicosapentaenoic acid in the method of Bauman to treat, reduce and alleviate the effects of COVID-19, including any cytopathic destructive effects, with a reasonable expectation of success. Selection of a dosage form, such as in a solid or in a liquid form or for parenteral administration as a sterile solution, emulsion or suspension is well within the skill of the ordinary pharmaceutical artisan in this art and also suggested by Peet et al. One would do so with a reasonable expectation of success.
The difference between the instant application and Bauman is that Bauman do not expressly teach wherein the amount is delivered for a period of one month to six months to normalize the AA:EPA ratio between 1:1 to about 5:1. However, it is at the discretion of the ordinary artisan to determine the treatment duration for the patient’s benefit and a treatment period of 1-6 months is within the skill level of the ordinary artisan. Especially when Beluzzi teach and suggest administration for about 1-8 months. The AA:EP ratio is implicitly normalized between 1:1 to about 5:1 because the same amount of EPA is administered to the same patient population.
The difference between the instant application and Bauman is that Bauman do not expressly teach reducing the level of interleukins and release of AA reducing IL-6 and VEGF production and the secondary neoangiogenesis that ultimately generates pulmonary fibrosis. However, these are latent benefits of the method of Bauman that naturally flow from performing the method of Bauman. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). See MPEP 2145(II).
Response to Arguments
Applicant’s arguments filed 8/8/25 have been carefully considered but are not persuasive. On page 9 of remarks, Applicant asserts that Bauman does not teach free fatty acid form of EPA. Respectfully, the Examiner has a different perspective. Bauman writes “Essential Fatty Acids” and names EPA, which stands for eicosapentaenoic acid and is the free fatty acid. No conjugates or esters are described. Thus, the disclosure of Bauman is directed to the free fatty acid. Applicant has presented no evidence to the contrary. The Examiner has also cited Beluzzi for teaching commercial sources of 99% pure free fatty acid form of EPA. Thus, highly purified EPA free fatty acid is readily available for use by the ordinary artisan in the method of Bauman.
On pages 9-11 of remarks, Applicant asserts that Bauman does not disclose any information about the purity of the EPA or as a pharmaceutical grade compound. The Examiner responds by pointing out that Bauman is not relied upon for teaching the purity of the EPA. It is impermissible to attack references singly when the Examiner relies upon the combined teachings of the references, nor may they attack a reference for not teaching a limitation of the claim when the Examiner has explicitly relied upon another reference as teaching that limitation. See In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). As explained previously, one of ordinary skill in the art would have been motivated to do this because the artisan desires the highest purity pharmaceutical product, which ensures that impurities and/or contaminants are minimized, for treatment in people as required by the USP and FDA as taught by Higher Health. Applicant’s arguments are not persuasive. Furthermore, newly cited Peet et al. teach that the purified form of EPA is therapeutically more effective and Beluzzi teaches that highly purified EPA in the free fatty acid form is commercially available.
On page 10 of remarks, Applicant argues that Bauman does not disclose the use of EPA as a medicament or pharmaceutical but only as a supplement or a remedy. In response, it is the Examiner’s position that it is merely semantics as to whether one considers the composition of Bauman a medicament or pharmaceutical or supplement or remedy. The terms do not add any structure to the composition used in the method. Moreover, a remedy would infer medicament or pharmaceutical. Applicant’s arguments are not persuasive.
On page 10 of remarks, Applicant argues that Bauman does not disclose any method including the reduction of an overactive immune response. Respectfully, the Examiner has a different perspective because the same EPA administered to the same patient population will have the same effects including the reduction of an overactive immune response even if Bauman did not recognize it at the time. See MPEP 2112 II: “II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).” All Applicant is claiming is a latent benefit of the method of Bauman. See MPEP 2145(II): Prima Facie Obviousness Is Not Rebutted by Merely Recognizing Additional Advantages or Latent Properties Present But Not Recognized in the Prior Art
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Applicant’s arguments are not persuasive.
None of Applicant’s arguments are persuasive.
Claims 11-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Barrett et al. (WO2017077528) and Knibbs (Express March 11, 2020; NPL reference #7 on the IDS filed 4/10/23) and Calder, PC. (Nutrients 2010;2:355-374) and Tan et al. (Prostaglandins, Leukotrienes and Essential Fatty Acids 132 (2018) 23–29) and Yi et al. (Int. J. Biol. Sci. 2020 March 15;(16):1753-1766) and Peet et al. (US20110065793) and Belluzzi (WO2018146545).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 11-19, Barret et al. teach methods of treating lung inflammation due to viral infection by administering a resolvin molecule derived from eicosapentaenoic acid (Claims 1 and 18) where the infection is SARS coronavirus (Claim 19). Barret et al. teach that the “pharmaceutical composition of the present invention may be in a form suitable for oral use, e.g., as tablets, troches, lozenges, aqueous, or oily suspensions, dispersible powders or granules, emulsions, hard or soft capsules, syrups or elixirs, or oral semi-solids such as gels” [0076]. Sterile injectable aqueous or oleaginous suspensions are also taught [0078].
Regarding claims 11-19, Knibbs suggests bolstering your immune system to fight off COVID-19 with high-quality sustainable MSC certified fish oil such as Wiley’s finest peak EPA, taking 2000 mg per day for optimal health (Pages 2-3).
Regarding claims 11-19, Calder teaches that resolvins are derived from orally administered eicosapentaenoic acid, the free fatty acid form, and are anti-inflammatory and inflammation resolving by decreasing production of eicosanoid mediators from arachidonic acid (Abstract; page 361, 4.3. and Figure 3; page 364, 8.; page 366, 1st paragraph). Calder teaches inhibition of IL-6 and IL-8 (Page 363, 7.2.). Calder teaches administration of 2.1 g EPA over 12 weeks (Page 357, Figure 1).
Regarding claims 11-19, Tan et al. teach: “The current study found that EPA+DHA supplementation of 2.5 g/d resulted in significantly reduced n-6:n-3 PUFA ratios, AA:EPA ratios and levels of select proinflammatory cytokines in the circulation of aging adults with CVLUs after 4 and 8 weeks of therapy.” (Page 26, Figure 1D; page 28, 5. Conclusion). Tan reports that the recommended amount of EPA and DHA varies from 250 to 500 mg/day but “the general consensus is that higher combined EPA+DHA intake levels are needed for anti-inflammatory effects to occur.” (Page 28, 5. Conclusion). Tan et al. also teach that it is known that: “the n-6 PUFA arachidonic acid (AA) is metabolized to eicosanoids (e.g., prostaglandin E2 [PGE2]) that induce proinflammatory cytokine production. Conversely, increasing intake of n-3 EPA and DHA has been found to reduce the amount of AA available for eicosanoid synthesis because the n-6 and n-3 PUFA families are competitively metabolized.” (Page 24, left column 2nd paragraph). Tan et al. teach administration of 1.5 grams of EPA (Page 24, 2.3.) for 4 and 8 weeks (Page 25, 2.6.) Tan et al. report that they: “found that EPA+DHA therapy had a significant lowering effect on levels of all inflammatory factors quantified after 4 weeks of therapy and an even greater lowering effect after 8 weeks of therapy.” (Page 27, left column 4. Discussion).
Regarding claims 11-19, Yi et al. teach that “It has been known that a cytokine storm results from an overreaction of the immune system in SARS and MERS patients. Cytokine storm is a form of systemic inflammatory response featured by the release of a series of cytokines including TNFα, IL-1β, IL-2, IL-6, IFNα, IFNβ, IFNγ, and MCP-1.” (Page 1759, left column Tackling cytokine storms). Steroids treatment of COVID-19 is to reduce the severity of inflammatory damage (Table 2, page 1759).
Regarding claims 11-19, Peet et al. teach that EPA can be in the free acid form [0009, 0079] and that “it was important for clinical efficacy to administer EPA in a highly purified form for maximum clinical effectiveness. Surprisingly, the same daily dose of EPA in a purified form seems considerably more effective” [0030]. Peet et al. also teach: “that highly purified EPA is therapeutically more effective” [0033]; and “it is likely that any form of highly purified EPA which is able to raise EPA levels in the blood” [0073]. Peet et al. teach dosage forms include soft and hard capsules, powder, tablets and parenteral formulations in oils or emulsions or dispersions [0075]. Peet et al. also teach a useful daily dose of 0.5g to 5 g per day [0077-0078]. Therefore, the art of Peet et al. teaches the desirability of having high purity EPA free fatty acid.
Regarding claims 11-19, Beluzzi teaches highly purified eicosapentaenoic acid free fatty acid which has a purity of at least 95% and more preferably at least 99% (Abstract; claim 15) with a therapeutic amount from 500 mg to about 2 g daily (Claim 18) or from about 250 mg to about 4 g per day administered daily, or every other day or weekly or for about 1-8 months (Page 7, lines 30-34). Beluzzi teaches that (Examiner added emphasis): “EPA free fatty acid is commercially available under the tradename ALFA™ (S.L.A. Pharma, UK). This PUFA is 99% pure EPA, in a free fatty acid form” (Page 7, lines 22-23).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Barrett et al. do not expressly teach eicosapentaenoic acid in the free fatty acid (EPA-FFA) form in an amount of from 500 mg to about 4 g per day or about 1 g to 3 g per day having purity of at least 95%, or at least 90%, 95% or 99% used in the method for treating and reducing the effects of COVID-19 and variants thereof in a subject thereby alleviating the cytopathic destructive effects of COVlD-19 and variants thereof in a human patient infected with such a virus and reducing a late complication event of COVID-19 and variants thereof wherein the late complication is lung fibrosis in a subject, wherein EPA-FF A is administered in an amount to reduce IL-6 and VEGF production and the secondary neoangiogenesis that ultimately generates pulmonary fibrosis as well as modulating an immune response caused by increase in the expression of interleukins and the release of arachidonic acid (AA), the method comprising the administration to a subject a therapeutically effective amount of EPA-FF A having a purity of 99%) to reduce the level of interleukins and release of AA to provide an AA:EPA ratio between 1:1 and about 5:1. This deficiency in Barrett et al. is cured by the teachings of Tan et al., Calder, Knibbs, Yi et al., Peet et al. and Beluzzi.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to perform the method of Barrett, with at least 95%, or at least 90%, 95% or at least 99% pure EPA, as suggested by Knibbs, Calder, Peet et al. and Beluzzi, and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because the artisan knows that EPA is the substrate the body utilizes to make the desirable resolvins of Barratt et al. It is then obvious to administer EPA in the method of Barrett et al., in solid or in liquid form or for parenteral administration as a sterile solution, emulsion or suspension, to produce the resolvins endogenously with a reasonable expectation of success. With regard to the purity, the ordinary artisan desires the highest purity pharmaceutical product, which ensures that impurities and/or contaminants are minimized, for treatment in people. One of ordinary skill in the art would have been motivated to do employ the highest purity EPA because the art of Peet et al. teaches and suggests that the more purified form of EPA has better therapeutic effectiveness and it is then merely a matter of obtaining the commercial product ALFA™ containing 99% pure EPA free fatty acid for use in the method of Barrett with a reasonable expectation of success. Accordingly, the ordinary artisan would use at least 99% pure eicosapentaenoic acid in the method of Barrett to treat, reduce and alleviate the effects of COVID-19, including any cytopathic destructive effects, with a reasonable expectation of success. Furthermore, the ordinary artisan is aware that COVID-19 is a SARS coronavirus through the teachings of Yi et al. characterized as an inflammatory condition and is within the scope of the method of Barrett et al. The ordinary artisan would perform the method of Barrett et al., as modified by Calder and Higher Health on human patients with COVID-19 to treat any lung inflammation caused by COVID-19 with a reasonable expectation of success. Especially when the artisan is aware from the combined references that COVID-19 is characterized by a cytokine storm and EPA reduces inflammation and those cytokines. Regarding the amount to administer, Tan et al. report using 1.5 grams per day for 4 and 8 weeks and suggest that higher amounts might be required. Calder reported administering 2.1 grams over 12 weeks and Knibbs suggest 2 grams per day for optimal health and Beluzzi teaches a therapeutic amount from 500 mg to about 2 g daily (Claim 18) or from about 250 mg to about 4 g per day administered daily, or every other day or weekly or for about 1-8 months. Consequently, it is merely routine optimization of the dosage amount and time period of administration by the ordinary artisan to obtain the desired outcome of healing the patient with a reasonable expectation of success. Therefore, alleviating the cytopathic destructive effects of COVID-19 in a patient infected with such a virus and modulating an immune response caused by increase in the expression of interleukins and the release of arachidonic acid (AA) to reduce the level of interleukins and release of AA and reduce a late complication event of COVID- 19 and variants thereof wherein the late complication is lung fibrosis in a subject by reducing reduce IL-6 and VEGF production and the secondary neoangiogenesis that ultimately generates pulmonary fibrosis and a period of one month to six months to normalize the AA:EP A ratio between 1:1 to about 5:1 are implicit outcomes from using high purity EPA in the amounts taught in the prior art to treat the same patient population.
The test for obviousness is "what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 4I3, 425 (CCPA I98I) (MPEP 2145(III)). In the present case, the combined references render obvious the claimed methods with a reasonable expectation of success. (See MPEP 2143.02: The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).) All that is required to show obviousness is that the applicant "make his claimed invention merely by applying knowledge clearly present in the prior art. Section 103 requires us to presume full knowledge by the inventor of the prior art in the field of his endeavor." In re Winslow, 365 F.2d 1017, 1020, 53 C.C.P.A. 1574, 1578 (1966). Application of Sheckler, 438 F.2d 999, 1001 (C.C.P.A. 1971). Thus, does Applicant make their claimed invention merely by applying knowledge clearly present in the prior art.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments filed 8/8/25 have been carefully considered but are not persuasive.
On page 11 of remarks, Applicant notes that resolvin and EPA free fatty acid are chemically different. The Examiner is aware of that. That is the reason for application of Calder that teaches that resolvins are derived from orally administered eicosapentaenoic acid, the free fatty acid form. It is then obvious to administer the highly pure free fatty acid eicosapentaenoic acid, as suggested by Peet et al. and Beluzzi, to naturally produce resolvins. Applicant argues that Barret does not disclose any method including reduction of an overactive immune response and only teaches treating SARS coronavirus and not COVID-19. However, the ordinary artisan is well-aware that COVID-19 is due to a coronavirus and that, as stated above, the artisan is aware from the combined references that COVID-19 is characterized by a cytokine storm and EPA reduces inflammation and those cytokines. Thus, the combination of references teach and suggest each and every claimed limitation.
On pages 12-14, Applicant discusses the secondary reference of Knibbs, Calder, Yi and Tan. The Examiner is relying upon Knibbs, Calder, Yi and Tan as characterized by the Examiner in the rejection and not as characterized by Applicant.
In summary, it remains obvious in view of the preponderance of evidence to treat and reduce the effects of COVID-19 by administering the free fatty acid eicosapentaenoic acid in the highest purity to reduce the overactive immune response with a reasonable expectation of success. No commercial success is claimed, nor is any other factor indicating non-obviousness shown to exist. The claims remain rejected.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after review of all the facts, Applicant’s arguments are not persuasive. The Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts, which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claims are allowed.
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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613 /
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