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 .
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.
Claims 47-49 are 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.
Claim 47 recites “wherein the salmonid oil further comprises”… “columbinic acid” and this component is not found in salmon oil and so it is unclear as to how to find art wherein salmon oil comprises of columbinic acid or how one would find salmon oil containing this component which is usually found in plants.
Claim 48 recites “wherein the salmonid oil further comprises ligustilide, germacrene, thymol, eugenol, carvacrol, linalool, citronellol, terpineol, bisbalol, santalol, thujone, pinacamphone, italidone, linalyl acetate, geranyl acetate, citronellyl formate, helenalin, elecampane, furocoumarin, chavicol, sitosterol, stigmasterol” and none of these components are found in salmon oil and so it is unclear as to how to find art wherein salmon oil comprises of these components or how one would find salmon oil containing these components usually found in plants.
Claim 49 recites “wherein the salmonid oil further comprises iturin A, hoiamides, heronamides, laxaphycin, apramides, dragonamides, gageotetrins, lyngbyabellins, cyclodycidins, parguerine, pumilacidin, sulforeido lipopeptides, fengycins, mebamamides, penicimutamides, sulfoglycolipids, halovir, kahalalide, or tuftsin” and none of these components are found in salmon oil and so it is unclear as to how to find art wherein salmon oil comprises of these components or how one would find salmon oil containing these components usually found in certain species of bacteria or algae.
Examiner’s note: It is advised to show evidence that the salmon oil of the present invention indeed contains any of the components listed in the rejections as these do not appear to be typically found components of salmon oil. This would help overcome the rejection.
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 (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.
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 28-34, 38-50 are rejected under 35 U.S.C. 103 as being unpatentable over Miyata et. al. (Role of omega-3 fatty acids and their metabolites in asthma and allergic diseases, Allergology International 64 (2015) 27-34) and Derya et. al. (WO2012087153A1).
Regarding claims 28-34, Miyata teaches that “Omega-3 fatty acids, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), are found naturally in fish oil and are commonly thought to be anti-inflammatory nutrients, with protective effects in inflammatory diseases including asthma and allergies. The mechanisms of these effects remain mostly unknown but are of great interest for their potential therapeutic applications. Large numbers of epidemiological and observational studies investigating the effect of fish intake or omega-3 fatty acid supplementation during pregnancy, lactation, infancy, childhood, and adulthood on asthmatic and allergic outcomes have been conducted. They mostly indicate protective effects and suggest a causal relationship between decreased intake of fish oil in modernized diets and an increasing number of individuals with asthma or other allergic diseases. Specialized pro-resolving mediators (SPM: protectins, resolvins, and maresins) are generated from omega-3 fatty acids such as EPA and DHA via several enzymatic reactions. These mediators counter-regulate airway eosinophilic inflammation and promote the resolution of inflammation in vivo.” (see abstract).
Miyata also teaches that there is growing evidence that that omega-3 fatty acids have beneficial effects in chronic inflammatory diseases including chronic obstructive pulmonary disease (COPD) and asthma (see first Introduction 1st para.).
Miyata teaches that “reports demonstrated the beneficial and suppressive effects of omega-3-rich supplementation on exhaled NO levels before and after allergen challenge, serum eosinophil counts, eosinophilic cationic protein levels, and in vitro cysteinyl leukotriene release,72 or daytime wheeze, exhaled H2O2 levels, and morning PEF, respectively” (see page 28, right column 1st para.). Miyata continues to teach that “DHA inhalation during the allergen challenge phase in mice suppressed airway eosinophilic inflammation, and this was accompanied by reduced numbers of inflammatory cells in bronchoalveolar lavage fluid (BALF) and decreased airway hyperresponsiveness, and mucus production” (see page 28, right column at bottom). Miyata teaches intravenous administration and inhalation (see page 30, above table 1, left column and page 28, right column 2nd to final para.).
Miyata does not specifically teach that the fish oils are from salmonids or that they are obtained through mild enzymatic hydrolysis of off-cuts of salmonid fish. Miyata does not also specifically teach wherein the eosinophilic respiratory condition is sever acute respiratory syndrome or caused by a coronavirus.
Derya’s general disclosure is to the enzymatic method for enrichment of the omega-3 PUFA content in the acylglycerol fraction of marine oils (see abstract).
Derya teaches “Oils comprising omega-3 PUFA are frequently extracted from wild caught marine resources such as from fish and krill. However, marine oils can also be obtained from farmed marine organisms such as farmed fish. In the recent years, the use of plant oils of terrestrial origin substantially not comprising any omega-3 fatty acids have increased in feed for aquaculture production, especially for Salmonids such as the Atlantic salmon. Since salmon is dependent on receiving these fatty acids with their diet, fish fed a low amount of omega-3 fatty acids will also store a reduced content of these fatty acids in their lipids” (see page 2, 3rd para.).
Derya also teaches “Enzymatic processes for concentrating omega-3 fatty acids were previously recognized as particularly advantageous when handling PUFA, since these fatty acids are highly sensitive to oxidation. Enzymatic methods allow the application of mild reaction conditions, meaning lower temperature and pressure, which is important when dealing with omega-3 fatty acids. Low temperature also improves the feasibility of the process. Furthermore, enzymatic processes are considered as more environmentally friendly compared to chemical ones.
Derya teaches for the purpose of improvement and enrichment of the omega-3 concentration of fish oil “salmon oil from by-products of farmed salmon was produced according to the enzymatic process by Sorensen et al. (2004) involving hydrolysis of by-products by a protease enzyme” (see materials and methods, experiment 1-4 pages 12, 17, 29 and 34). With the broadest reasonable interpretation, the salmon by-products would also be considered an off-cut of salmon since an off-cut of salmon is the unused pieces or part of the fish.
Derya also teaches that “The enzymatic process is commonly followed by a separation process such as membrane filtration or molecular complexation whereby the hydrolyzed free fatty acids are removed and an oil is obtained which has an acylglycerols fraction with an increased/enriched content of omega-3 fatty acids” (see page 3, lines 24-28).
Derya also teaches adding lipases in amounts at about 3% by weight based on the amount of oil (see page 7, 2nd para.).
Derya also teaches “preferably the free fatty acid is separated from the acylglycerol fraction after the hydrolysis, and the lipase-catalyzed hydrolysis of the separated acylglycerol fraction is repeated” (see page 6, para. 3), meaning that there would be no free fatty acid, which would be lower than the claimed 0.5%.
Therefore, it would have been obvious to a person having ordinary skill in the art at the effective filing date to use enzymatically hydrolyzed salmonid oils from the off-cuts of salmonid fish for the method of reducing eosinophil effector function in a human and treating an eosinophilic inflammatory condition which could also be asthma and/or a chronic inflammatory disorder of the airways, because Miyata teaches that the omega-3 fatty acids in fish oils has anti-inflammatory properties which are known to reduce eosinophilic inflammation and eosinophil counts. Derya also teaches that it is common to use salmonid oils and to hydrolyze those oils with proteases and lipases in mild amounts to avoid using higher temperatures and pressures for improving the feasibility of the process and to increase the concentration of the actively important polyunsaturated fatty acids.
It would have further been obvious to optimize the lipase concentration to less than 1% lipase activity because Derya teaches using amounts which are about 3% and also teaches that the key property of the lipase-catalyzed process lies in the fatty acid selectivity of lipases (see page 3, 2nd para.), meaning that all lipases are not created equal thus one would want to optimize the amounts in order to find the most effective concentration for its mechanism of action. It would have also been obvious to optimize the amount of the fish oil to the instantly claimed effective amount because the activity is already known and finding the most effective dose would be an optimization well within the purview of an artisan.
Regarding the limitations which require the salmon oil to comprise of myristoleic acid, heptadecenoic acid, elaidic acid, dihomo gamma linolenic acid, nervonic acid, stearidonic acid, and microcolin A; These components would also be expected in the salmon oil of the prior art as they appear to be the same/similar in nature, unless the applicant can show some evidence to the contrary. For example, when looking to the instant specifications for clarification there does not appear to be any process that would add these components into the oil or fraction them out from the salmon oil. Thus, if these components are naturally found in the salmon oil as claimed by the applicant, then it would be expected to be in the salmon oil of the prior art as they have both been treated in the same manner (using proteases for enzymatic hydrolysis). The same can be said for claims 47-50, unless shown evidence that this indeed is not the case.
There would have been a reasonable expectation of success in arriving at the instant invention given the prior art because the use of hydrolyzed fish oils from salmonids for treating eosinophil inflammatory diseases such as asthma have already been described in the art. It would have been obvious to administer to patients that may be resistant to other forms of treatments as one would want to administer a natural composition with the anticipation of treating the respiratory diseases as just discussed. When one from of treatment is not effective it is obvious to look to other effective respiratory treatments such as the one just described. Furthermore, administering the composition as a capsule as an oral or as intravenous administration would have been obvious as Miyata teaches of different administration routes which are effective and formulating chewables, capsules, etc. are formulation types well within the purview of any skilled artisan.
Claims 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Miyata et. al. (Role of omega-3 fatty acids and their metabolites in asthma and allergic diseases, Allergology International 64 (2015) 27-34), Derya et. al. (WO2012087153A1) as applied to claims 28-34 and 38-50 above, and further in view of Clay et. al. (Primary severe acute respiratory syndrome coronavirus infection limits replication but not lung inflammation upon homologous rechallenge. Journal of Virology. 2012 Apr;86(8):4234-4244).
Miyata and Derya teach the method for reducing eosinophil effector function/disease in a human through the administration of a composition comprising salmonid oil obtained from mild enzymatic hydrolysis of off-cuts of salmonid fish, however do not teach wherein the disease is a viral respiratory disease, coronavirus or severe acute respiratory virus.
Clay’s general disclosure is a scientific report on SARS and its effects on lung inflammation (see abstract).
Clay teaches that lung inflammation stayed persistent following SARS-CoV infection and that leukocyte numbers peaked at 14 days postinfection (dpi) and remained elevated at 28 dpi compared to those of mock-infected control (see abstract). Clay also teaches that eosinophils are increased after a SARS-CoV infection in total lung leukocytes as determined by flow cytometry (see table 4).
Therefore, it would have been obvious to a person having ordinary skill in the art at the effective filing date to use the method of reducing eosinophils and for reducing inflammation caused from eosinophils in other known respiratory diseases such as SARS and coronavirus because these conditions are known to exacerbate both eosinophil and inflammation caused by eosinophils as discussed by Clay. Thus, the administration of the same components known for treating the same issues would have been obvious to administer to a patient population suffering from the same ailments. The same can be said for administering the method of treatments to patients resistant to medical and surgical interventions for treating the disorder or disease, or wherein the human exhibits or has resistance to steroid treatments and wherein the human has steroid treatment resistant asthma. If one form of treatment was not successful then it would have been obvious to use the currently described treatment that is known to be effective, especially after there was little success with steroids or other medical interventions.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655