Where is the line between patentable subject matter and non-patentable products of nature?

By Lawrence H. Frank, PhD
September 7, 2018

This case is an ideal vehicle for providing the clarification the patent and investment community require.  At issue is how to determine whether something is a product of nature under 35 U.S.C. § 101.

Urvashi Bhagat, CEO of Asha Nutrition Sciences, Inc., and inventor of of U.S. Patent Application 12/426,034.

Urvashi Bhagat, CEO of Asha Nutrition Sciences, Inc., and inventor of of U.S. Patent Application 12/426,034.

A conflict exists between the incentive to invent, provided for by the U.S. Constitution and patent law, and the breadth of patent-eligible subject matter under 35 U.S.C. § 101. It has become difficult to recognize the line between patentable subject matter and non-patentable products of nature.  The Supreme Court has made conflicting statements regarding that line in its rulings in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) and Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)). It is time for the Court to resolve these inconsistencies.

There is an essential tension between Funk Bros. and Myriad.  Funk Bros. requires, for patent-eligibility, that more than a “simple step” separates the claimed subject matter from a product of nature.  Thus, in Funk Bros., a non-naturally-occurring mixture of naturally-occurring bacteria was found non-patent-eligible.    See Funk Bros., 333 U.S. at 132 (reasoning that “the state of the art made the production of a mixed inoculant a simple step”).  In contrast, Myriad requires no more than that the claimed subject matter is not identical to a product of nature.  In Myriad, non-naturally-occurring cDNA was held patent-eligible simply because it was not found in nature, even though no more than a routine, conventional, and simple step was required to prepare cDNA from naturally-occurring RNA, and even though the genetic information contained in the cDNA did not differ from the genetic information found in nature.  See Myriad, 569 U.S. at 594 (reasoning that “creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring”).  It therefore remains unclear, under Supreme Court precedent, whether more than a simple step must separate claimed subject matter from something that is found in nature.  Funk Bros. answers “yes” to this question; Myriad answers “no.”

I have recently filed a petition for a writ of certiorari that raises this issue on behalf of Urvashi Bhagat, a solo inventor of new and useful lipid compositions that have the potential to improve the health of millions of Americans who suffer from chronic illness. Yet she is being denied a patent that would support her in bringing these beneficial inventions to market, frustrating the purpose of the U.S. patent system. I hope that her story will inspire others similarly frustrated with the current state of patent-eligibility in the United States to file amici briefs to support her petition. Amici briefs are due by September 29, 2018.

In addition to requesting resolution of the conflict between Funk Bros. and Myriad, Ms. Bhagat’s petition asks the Court to hold the federal courts accountable in properly reviewing agency decisions. Specifically, the petition asksthe Supreme Court to consider whether the Federal Circuit failed to apply “meaningful review,” as the Administrative Procedure Act requires, in affirming the USPTO’s decisions under 35 U.S.C. §§ 101 and 102(b).

Some of the facts that underlie the case are set forth below essentially as laid out in the petition. The full petition and appendix are available here.

This case presents an instance in which an inventor has made and disclosed valuable inventions that apply new and useful discoveries to the solving of long-felt and critical public health problems.  Chronic diseases affect millions of Americans. Petitioner, the inventor of U.S. Patent Application 12/426,034 (which claims priority to an April 21, 2008 filing date), has developed formulations that have the potential to ameliorate or alleviate the symptoms of many who suffer from chronic diseases.  Nevertheless, petitioner has been denied the patent reward that this country’s founders enabled to encourage and foster innovation.

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The rejection of the claims pending in the ’034 application, at issue here, appears to be, in part, a consequence of uncertainty in the proper application of 35 U.S.C. § 101. This case merits review to clarify the scope of patentable subject matter under 35 U.S.C. § 101 and of the incentive to innovate and to invest in and disclose innovations.  Review of this case will also resolve some of the substantial doubt that uncertainty surrounding § 101 has cast on the validity and value of such patents.

In this case, Urvashi Bhagat, moti­vated by the illness, suffering and premature death of her own mother, devoted herself to researching the relationship between diet and chronic illness.  She focused on the role of lipids in health and dis­ease.   Lipids are a diverse class of over 100 distinct chemical compounds that are ubiquitous in nature and include, for example, fatty acids, cholesterol, steroids and certain vitamins.  Lipids play many important biological roles, including being crucial cell membrane components, providing a source of energy to the organism, affecting protein function and involvement in gene regulation. Lipids affect the activity of each other and their derivatives function as important hormones and chemical messengers that affect a broad range of physiological functions.

Bhagat’s research focused on two subsets of lipids, the omega-6 and omega-3 families of fatty acids.  Linoleic acid (LA) is the precursor of the omega-6 family, and alpha-linolenic acid (ALA) is the precursor of the omega-3 family.  The bodies of mammals, including humans, cannot synthesize LA and ALA, but can synthesize the other omega-6 and omega-3 fatty acids from dietary LA and ALA. Mammals must obtain LA and ALA from dietary sources.

From about 1930 to about 1960, nutritional studies demonstrated that omega-6 fatty acids were active in growth and maintenance of skin health.  Between 1964 and 1979, researchers developed awareness that arachidonic acid (AA) (an omega-6 fatty acid) metabolizes into prostaglandins and leukotrienes, involved in several disease processes associated with arthritis, asthma, atherosclerosis, thrombosis, tumor proliferation, and a variety of immune-inflammatory disorders.  Therefore, high amounts of omega-6 were believed to promote pathophysiology. Ingestion of about 1% of daily calories as LA was considered to be optimal, and omega-3 fatty acids were believed to be beneficial and inhibit omega-6 activity by competitive metabolism.

Experts believed that, for LA and ALA to be equally competitive, their intake should be in the ratio of 14:1, but that equality of competition may not be the criterion for optimal function. The nutrition field recommended very low levels of omega-6 consumption (e.g. less than 6.67 grams/day for a 2000 kcal diet) and very low omega-6:omega-3 ratio of (e.g. 2:1).  Numerous international scientists ratified the recommendation.

Petitioner recognized, through her research in the early to mid-2000s on people who suffered from certain chronic conditions, that the recommended dosages and ratios were too low and that the prior art had greatly misunderstood the dose-effect of omega-6 fatty acids.  The prior art held that a stepwise increase in omega-6 intake is associated with adverse health, such as an increase in tumorigenesis when the intake is in the range of 0.5-4.4% of calories.  Those skilled in the art therefore were not motivated to practice higher dosages of omega-6.  Petitioner found, however, that higher intake of omega-6 was required to overcome adverse health conditions (for example, at least 11 grams per day or at least 5.82% of calories consumed).

Petitioner also discovered that the deficiency of omega-6 potentiates certain mechanisms, such that sudden increases in omega-6 have an overflow effect, which can lead to myocardial infarction, strokes, infections, and physiological disturbances.

Petitioner also determined that the optimal amounts and ratios of omega-6 and omega-3 intake depend upon a subject’s intake of other lipids such as, for example, antioxidants, phytochemicals, and other fatty acids and on a subject’s demographics.  She devised formulations that embodied these ratios and amounts, and has pursued patents directed to such formulations.  “[T]he ratio between [omega]-6-to-[omega]-3 of 15–17:1 in diets is not the problem, the problem is the other factors that influence the metabolism of [omega]-6 and [omega]-3.”

Petitioner’s claimed formulations, being mixtures of components from different sources, are formulated to provide certain amounts and ratios of certain components.  At the same time, other components that are not desirable in large amounts or high concentrations become diluted as a consequence of mixing lipids from different sources.  The formulations thus provide a dual advantage.

Subsequent to petitioner’s research and patent application filings, several public health organizations advised higher omega-6 intake based on experimental results.  For example, the American Heart Association advised that the consumption of at least 5% to 10% of energy from omega-6 polyunsaturated fatty acids reduces the risk of chronic heart disease relative to lower intakes.

Therefore, prior to petitioner’s invention of the claimed lipid formulations, the person of ordinary skill in the art could not have determinedand practiced the claimed suitable ratios and dosages of total omega-6 and omega-3 fatty acids for a subject.  Those of ordinary skill in the art have testified to this effect.  Additionally, the public cannot solve this problem because lipids are unpredictable in their sources and less than 1% of Americans understand lipids.  Thus, the claimed subject matter is directed to solving a poorly understood problem and meeting a critical and long-felt, unmet need.  It has great potential to protect and improve public health.

Despite this, USPTO and the Federal Circuit have denied Urvashi Bhagat a patent.

This case is an ideal vehicle for providing the clarification the patent and investment community require.  At issue is how to determine whether something is a product of nature under 35 U.S.C. § 101. This case embodies the need for further guidance because this application was rejected while patents that contain claims indistinguishable, on § 101 grounds, from the present case have issued previously. Clarification from the Court will enable the patent and investment communities to allocate their resources more efficiently by pursuing patents only on patent-eligible subject matter, and ensure that similarly situated inventors are treated similarly as required by the law.

 

Image Source: Photo provided by Urvashi Bhagat.

Updated at a 3:02pm EST September 7, 2018 to add the second paragraph, and to fix 

The Author

Lawrence H. Frank, PhD

Lawrence H. Frank, PhD is a founder of Liang, Frank & King LLP. Dr. Frank’s patent practice encompasses patent drafting, prosecution, opinion (freedom-to-operate, invalidity and non-infringement, including with respect to Orange Book-listed patents), due diligence, patentability analysis, patent term extension under 35 U.S.C. s. 156, and USPTO proceedings. For more information, or to contact Dr. Frank, please see his firm profile page.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 18 Comments comments. Join the discussion.

  1. Anon September 7, 2018 2:34 pm

    This case is an ideal vehicle for providing the clarification the patent and investment community require.“:

    This topic is on more than one patent blog. On another blog, the statement above would be directly challenged given that a novelty rejection under 35 USC 102 has also been sustained in the case.

    If so (and also depending on how easily any such novelty rejection may be morphed into an obviousness rejection), how then is this case “an ideal vehicle?”

  2. Anathema September 8, 2018 8:16 am

    It is clear that the courts are mostly protecting the large businesses and the projects of the internationalists. It seems clear at this point that they are not free to make good case law.

  3. Urvashi Bhagat September 9, 2018 12:07 pm

    Response to Anon, September 7, 2018, 2:34 pm post.

    35 USC 102 rejection was also improperly maintained by Federal Circuit by excising limitations from the claims. Federal Circuit failed to give a meaningful review to the case. The cert petition calls for the Supreme Court to require the Federal Circuit to meaningfully review agency decisions as per APA, in addition to the review of § 101 issues.

    Further, novelty rejection cannot be morphed into an obviousness rejection in this case because of overwhelming opposite teachings in the prior art, continuing confusion in the current art, and long-felt critical unmet need.

    Therefore, “This case is an ideal vehicle for providing the clarification the patent and investment community require.“

  4. Anon September 10, 2018 6:52 am

    Thank you, Ms. Bhagat. That was a cogent reply.

    If indeed your case against the 102 rejection is solid (I am presupposing that it is), the double backing of the attack on the lack of proper review of the infirmity of that 102 decision, coupled with why the 102 decision cannot hold (perhaps referencing the arguments below), as well as inoculating against the to-be-expected 103-from-102 position, may well make this a suitable case.

    Suitable is not ideal. Ideal would be one and only one issue; not the complicated must win on APA to have consideration for the 102, which itself must be won, in addition to the 101 issue.

    While I wish you luck otherwise, I lean towards the High Court not sharing your view of “ideal,” and denying cert.

    That is most definitely NOT saying that I agree with the propriety of that outcome.

  5. Enlightened September 10, 2018 10:25 am

    Millions of people are suffering and you lean towards denying. This is why there is no advancement in this art despite that the problem was acknowledged about 100 years ago.

    Federal Circuit failed to do its job at the expense of pro se.

    Your conflicts of interests would have to be examined, to examine propriety of your leaning.

  6. Werner DJ September 10, 2018 10:34 am

    I have read the WO patent application and I must say that I don’t see where is the technical matter in that description. I am mostly EPO centered regarding the patent law but what I have read look like complex culinary receipts that according to isolated cases, described as Case Study on (menopause, diabetes….) which I want to remark, concern one subject each, have beneficial effects, very concrete and well described. It is surely unnecessary to explain how the scientific method of proof works and the importance of having an adequate number of subjects showing similar effects for that proof to be reliable enough. One subject per effect is understandably no proof at all. So, as I see it. Are culinary receipts a matter patentable matter?

  7. Enlightened September 10, 2018 10:40 am

    “The ultimate tragedy is not the oppression and cruelty by the bad people but the silence over that by the good people.”? -Martin Luther King, Jr.

  8. Chris Whewell September 10, 2018 11:37 am

    “[T]he ratio between [omega]-6-to-[omega]-3 of 15–17:1 in diets is not the problem, the problem is the other factors that influence the metabolism of [omega]-6 and [omega]-3.”

    If the “other factors” are the “problem”, then the claimed ratio(s) of omega 3 / omega-6 seemingly seem to be irrelevant to the extent they’re phrased as claim limitations, by inventors admission.

    Merely b/c fewer than 1% of the population understands lipids, also not much weight there, since fewer 1% understand nuclear physics, other fields. What controls is prior art.

    Government used to recommend eggs as being bad, but now they’re ok. Doctors were once featured promoting smoking in trade magazines, now many believe smoking is bad. It is same with fatty acid ratios, what once was believed good is now believed bad, & vice versa.

    The issue is that lipid chem. has been around since Chevreul’s seminal work. P&G and other majors in the industry have extensive libraries, and finding anticipatory prior art to me at least would not seem an insurmountable hurdle.

    The author and I agree, it is “other factors” which control. Example: middle aged people seem to lack delta-6-desaturase enzyme, necessary for production of gamma-linolenic acid. The issue is indeed, enzyme activity, and given the myriad dietary toxins, and unique individual exposure, a given administration of a composition having a defined lipid ratio may not produce the same result in different subjects. Fluoride, mercury, lead, lack of iodine, reticuloendothelial system inhibition by azomethine bonds, the list is long. There are many many enzymes (catalysts) involved with leukotriene and prostaglandin synthesis in the body, each subject to being poisoned or inactivated, even by changes in pH in a given bodily compartment.

    My final read on patentability is that if it does not exist in nature, there should be no sec. 101 bar. For 103, some kind of unexpected benefit should be documented to overcome a prima facie case, even if it only works on 20% of the population, that is ok since few “drugs” work equally on 100% of the ppl and those skilled in the art know and expect this. Given the ubiquity of lipids in nature, and the prolific work of many in this field, I’m inclined to believe theres a good chance anticipatory prior art exists, somewhere, in some plant or seed or animal. Moreover, merely defining a lipid as being omega 3 or omega 6 is not enough either, since there are many materials within each of these classes, and extra precision in language is necessary to achieve patentable distinction, IMO. Patentability seems to be less problematic in this area than is creating a product that can generate cash which cannot also be engineered around.

  9. Enlightened September 10, 2018 12:53 pm

    (1). All embodiments need not be in the independent claims. And independent claims do recite ratio of omega-6 (and omega-3) in relation to total lipids, one of the other factors.

    (2). “fewer than 1% of the population understands lipids” goes towards long-felt unsolved need, and “inventiveness”, which goes towards patentability under §101 (see Mayo) and §103.

    (3) Unexpected benefits are documented in the application and prosecution history.

    (4) No anticipatory prior art has surfaced in 10 years of examination in several jurisdictions. If you examine how history of omega-6 and omega-3 research unraveled, it makes sense. Back in the 70’s they had started vilifying omega-6 because of Arachidonic acid metabolites.

    (5) Nowhere does the applicant “merely defining a lipid as being omega 3 or omega 6” rather claim 65 itself recites, “omega-6 [and omega-3] by weight of total lipids”.

    As it comes through loud and clear, so few people, including scientists, understand all issues. Most people understand just one part of the problem, therefore cannot solve the whole problem. See illustration below.

    Four blind people were asked to feel an elephant and describe what an elephant is like. One felt the tail and said “elephant is like a rope”, the other felt the leg and said “elephant is like a pole,” another felt the side and said, “elephant is like a wall.” So none could accurately describe an elephant.

    This is why this invention was necessary because there are so few people who understand the problem, and there is so much confusion, that public is massively misled and subjected to unnecessary treatments.

  10. Enlightened September 11, 2018 12:03 pm

    @Werner DJ

    Look at the pending claims. They are not directed to recipes.
    One subject per effect, which correlates across 22+ examples is more than sufficient for patent applications. Read the EPO guidelines, even one example is sufficient. Applicants have to disclose new information NOT rebuild the history of the art. The applicant provides sufficient new information, which add to the thousands of publications in prior art. Also remember that once the information is in public domain it is no longer patentable, so patents are taken when data is still limited.

  11. Chris Whewell September 11, 2018 12:37 pm

    I don’t see ignorance of the masses as a strong basis for arguing fulfillment of an un-felt need. If fewer than 1% of the people know the Nernst equation or concepts of the electrical double-layer in electrochemistry, and I invent a new copper plating bath and system, I wouldn’t consider its benefits as solving a need merely b/c people lack knowledge over the nuts and bolts of it. The benefit is better plating efficiency or corrosion resistance, etc., which might fulfill a need in the art, but can’t be predicated on what Joe or Jane Public knows. Argue analogously for most other fields of art involving any tech, i.e., if I invent some composition having obscure ingredients in a particular claimed ratio, which upon transdermal application clears the loop of Henle, or the islets of Langerhan or crypts of Lieberkuhn, the fact that 99% of the people believe this to be a geography lesson doesn’t mean there was a long-felt need. I’d argue that the lack of skill of masses not persons of ordinary skill in the art is irrelevant to patentability. Remember, the spec is written to the person of ordinary skill in the art, so, the spec isn’t directed to 99% of the masses. Maybe the opposite applies, since, how can the masses cognicize a need, when they don’t know the subject matter ? It’d be fulfilling a need that people didn’t know they had. Fulfillment of un-recognized needs seems to hint at marketing. Like, we really don’t need cellphones, but the industry has made many to feel as if they do, via marketing, and convenience due to lowered production costs and synergies which have evolved from their use. But, we really don’t need them, I do fine without one !!

    So it might be argued that you’re alleging invention of new needs, informing others of a need they didn’t know they had. How can a need that is unknown, be long-felt ?

    I wouldn’t predicate a long-felt need on the lack of knowledge of persons not skilled in the art, since the spec is not directed to them. I’d focus on the 1%.

  12. Enlightened September 11, 2018 4:52 pm

    Please read the cert petition it discusses the knowledge or lack thereof of skilled persons.

  13. Enlightened September 11, 2018 5:32 pm

    @Chris Whewell

    Some quotations from the cert petition are copied below to reflect upon prior art:

    “From about 1930 to about 1960, nutritional studies demonstrated that omega-6 fatty acids were active in growth and maintenance of skin health. Between 1964 and 1979, researchers developed awareness that arachidonic acid (AA) (an omega-6 fatty acid) metabolizes into prostaglandins and leukotrienes, involved in several disease processes associated with arthritis, asthma, atherosclerosis, thrombosis, tumor proliferation, and a variety of immune-inflammatory disorders. Therefore, high amounts of omega-6 were believed to promote pathophysiology. Ingestion of about 1% of daily calories as LA was considered to be optimal, and omega-3 fatty acids were believed to be beneficial and inhibit omega-6 activity by competitive metabolism. See Fed. Cir. App. Appx4263-Appx4269.
    Experts believed that, for LA and ALA to be equally competitive, their intake should be in the ratio of 14:1, but that equality of competition may not be the criterion for optimal function. See, e.g., Fed. Cir. App. Appx0231. The nutrition field recommended very low levels of omega-6 consumption. See, e.g., id. Appx4448 (indicating upper limit of omega-6:omega-3 ratio of 2.32:1 and maximum omega-6 intake of 6.67 grams/day for a 2000 kcal diet). Thirty scientists ratified the recommendation. See id. Appx4448-Appx4449.

    Petitioner recognized, through her research in the early to mid-2000s on people who suffered from certain chronic conditions, that the recommended dosages and ratios were too low and that the prior art had greatly misunderstood the dose-effect of omega-6 fatty acids. The prior art held that a stepwise increase in omega-6 intake is associated with adverse health, such as an increase in tumorigenesis when the intake is in the range of 0.5-4.4% of calories. See Clement Ip et al., Requirement of Essential Fatty Acid for Mammary Tumorigenesis in the Rat, 45 Cancer Res. 1997-2001 (1985). Those skilled in the art therefore were not motivated to practice higher dosages of omega-6. See Fed. Cir. App. Appx4263-Appx4269 and Appx4446-Appx4449. Petitioner found, however, that higher intake of omega-6 was required to overcome adverse health conditions (for example, at least 11 grams per day or at least 5.82% of calories consumed). See Fed. Cir. App. Appx0082-Appx0087, Appx0089-Appx0090, Appx0092, Appx0093, Appx0096-Appx0097 and at Appx0083-Appx0085 (Table 20).

    Petitioner also discovered that the deficiency of omega-6 potentiates certain mechanisms, such that sudden increases in omega-6 have an overflow effect, which can lead to myocardial infarction, strokes, infections, and physiological disturbances. See Fed. Cir. App. Appx0082-Appx0097 and Appx1346-Appx1347.
    Petitioner also determined that the optimal amounts and ratios of omega-6 and omega-3 intake depend upon a subject’s intake of other lipids such as, for example, antioxidants, phytochemicals, and other fatty acids and on a subject’s demographics. See, e.g., id. Appx0057-Appx0058, Appx0060-Appx0061. She devised formulations that embodied these ratios and amounts, and has pursued patents directed to such formulations. “[T]he ratio between [omega]-6-to-[omega]-3 of 15–17:1 in diets is not the problem, the problem is the other factors that influence the metabolism of [omega]-6 and [omega]-3.” See id. Appx7367.
    Petitioner’s claimed formulations, being mixtures of components from different sources, are formulated to provide certain amounts and ratios of certain components. At the same time, other components that are not desirable in large amounts or high concentrations become diluted as a consequence of mixing lipids from different sources. The formulations thus provide a dual advantage.
    Subsequent to petitioner’s research and patent application filings, several public health organizations advised higher omega-6 intake based on experimental results. For example, the American Heart Association advised that the consumption of at least 5% to 10% of energy from omega-6 polyunsaturated fatty acids reduces the risk of chronic heart disease relative to lower intakes. See Fed. Cir. App. at Appx0205-Appx0207, Appx4222-Appx4234. Other “results suggested that low concentrations (?200 ?M) of LA promote colorectal cancer cell growth, while high levels (?200 ?M) induce apoptosis of the colorectal cancer cells in vitro.” Id. at Appx4291.”

    Therefore, prior to petitioner’s invention of the claimed lipid formulations, the person of ordinary skill in the art could not have determined and practiced the claimed suitable ratios and dosages of total omega-6 and omega-3 fatty acids for a subject. Those of ordinary skill in the art have testified to this effect. See Fed. Cir. App. Appx3860-3861, Appx3868-3869, Appx3850. Additionally, the public cannot solve this problem because lipids are unpredictable in their sources and less than 1% of Americans understand lipids. See id. Appx5703, Appx5472-5474, Appx6650-6668, Appx6670-6685, Appx7910. Thus the claimed subject matter is directed to solving a poorly understood problem and meeting a critical and long-felt, unmet need. It has great potential to protect and improve public health. See id. Appx6492-Appx6493, Appx6509-Appx6510, Appx6526-Appx6527.”

    Because you do not have the appendix, some citations are given below. You’ll have to do rest of the research on your own.

    Lands WEM. NUTRITION REVIEWSNOL 44. NO WJUNE 1986
    Lands WEM. Ann. N.Y. Acad. Sci. 1055: 179–192 (2005).
    Simopoulos AP. Ann Nutr Metab 1999;43:127–130

  14. Chris Whewell September 11, 2018 6:13 pm

    Thanks, I view the solution of long-felt needs, as typically pertaining to overcoming a prima facie 103. Its established pretty well that the spec is written for those skilled in the art, and using the ignorance of the masses as a basis for supporting any aspect of patentability seems a bit weak. Maybe file some method claims before cert is denied. Sec 101 states clearly that new uses for known materials qualify as patentable subject matter, that might be one angle to file on. The key is in how the claim is stated, always, as even in civil procedure. Stating a claim upon which no relief can be granted, 12 b 6, etc. Usually in these medical composition / use type cases, there’s a way to prevail, owing to the high level of unpredictability in this field. Something to consider are the R groups on the cardiolipin molecule, how they get there, and what if the wrong lipids get on there, what is the effect on mitochondrial function ? This goes to cell proliferative disease, since the mitochondria are heavily inhibited in that scheme. If a composition is being claimed and its new and useful, there should be no problem. If the composition is known, then a new use patent might be obtainable.

  15. Enlightened September 14, 2018 10:41 am

    “Bhagat v. Iancu – Did the Myriad Decision Overrule Funk Bros.?” (http://www.patents4life.com/2018/09/bhagat-v-iancu-myriad-decision-overrule-funk-bros/) by Warren Woessner is well-written.

    Warren writes, “Was the Myriad decision based on an implicit belief that the cDNA is very useful, while the advantages of a packaged mixture of non-inhibitory strains is no big deal? While the Funk Bros. majority gave little credit to the improved utility of the claimed combinations, the dissent argued that the combinations fulfilled a long-felt and important agricultural need. Perhaps the Supreme Court will answer this question in a way that maintains the “delicate balance” between incentivizing innovation and impeding it.”

    With regard to innovation it should be noted that invention of oils took place about 6000, but since then lipid delivery fundamental to health has not materially advanced. Periodically, certain fatty acids (e.g., omega-3) or oils or low-fat teachings have been hailed, only to reverse a few years later. To date random oils are randomly added to foods; no guidance is given that different batches of the oils can have significantly different lipid composition and that minor lipids components present in oils can be potent. Oil making has advanced but delivery of oil for ingestion by subjects is still archaic. Therefore, nurturing of innovation via patent grant in this case is necessary.

    Read Bhagat’s Open Letter To Andrei Iancu, Director, US Patent and Trademark Office, and Sharon Prost, Chief Judge, United States Court Of Appeals For The Federal Circuit (CAFC) Regarding US Application 12/426, 034 and CAFC case #16-2525 (http://asha-nutrition.com/wp-content/uploads/2018/04/Open-letter-to-USPTO-CAFC.pdf)

    Attachments include:

    Appellant’s Combined Petition For Panel Rehearing And Rehearing En Banc

    Annotated Copy Of The Court’s Opinion Sought To Be Reheard

    “Federal Circuit Finds Composition of Matter Ineligible For Patenting,” March 27, 2018. Opinion by Courtenay Brinckerhoff, IP Partner at Foley & Lardner

    “In Re Urvashi Bhagat: One More Decision Denying Patent Eligibility of Nature-Based Product Claims,” March 29, 2018. Opinion by Marina Miller, PhD. IP Partner at Oblon

    “In re Urvashi Bhagat – The Slippery Slope of Natural Product Claims,” March 22, 2018. Opinion by Warren Woessner, PhD, Schwegman Lundberg & Woessner;

    “Omega-6 fatty acid” Wikipedia, accessed March 5, 2018

    Patents for Humanity Application

  16. Enlightened September 15, 2018 4:16 pm

    Correction to comment #15 above:

    Third paragraph, first sentence should read,
    “With regard to innovation it should be noted that invention of oils took place about 6000 years ago, but since then lipid delivery fundamental to health has not materially advanced.”

  17. Enlightened September 18, 2018 2:39 pm

    Further to comments 1, 3, and 4 above:
    If SCOTUS reverses § 101, it is not correct that the case is lost under § 102. All dependent claims are not rejected under § 102.

    For example, see Claim.

    102. The formulation of claim 65, wherein the dosage of total fat is 10-100 grams, the dosage of omega-6 fatty acids is from 1 to 40 grams; the dosage of omega-3 fatty acids is from 0.1 to 5 grams, the ratio of monounsaturated fatty acids to polyunsaturated fatty acids is in the range of 1:1 to 3:1, the ratio of monounsaturated fatty acids to saturated fatty acids is 1:1 to 5:1, the ratio of omega-9 to omega-6 fatty acids is in the range of 1:1-3:1, and the ratio of omega-6 to omega-3 fatty acids is in the range of 4:1 to 45:1.

    USPTO did not reject Claim 102 under § 102, it was improperly rejected under § 101 as by-process. None of the cited references, Mark, “olives”, “olive oil”, “walnuts”, or “walnut oil” meet all the ratios. And the Examiner admitted, there does not appear to be a natural product that meets all the recited ratios in Claim 102.

    Not only are independent claims clear of §§ 101 and 102, there are more than 30 dependent claims that have been improperly rejected.

  18. Enlightened September 29, 2018 1:06 pm

    The US Government has waived its right to file a response to Bhagat cert petition. See https://www.supremecourt.gov/DocketPDF/18/18-277/65201/20180928155457768_Waiver%2018-0277.pdf

    This is evidence of strength of the case.

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