I have recently posted a blog of mechanical device patents becoming ensnared in the patentability swamp. The swamp is the ineligibility of patenting “natural laws”, “natural phenomena” and “abstract ideas”. This has followed the adverse rulings for patenting medical procedures and business methods.
There has been another shift in the ground underlying this swamp. Further guidance was issued from the USPTO on October 17, 2019. The 21 pages of guidance re-affirmed, expanded and amended the guidance issued by the USPTO on January 7, 2019. The January guidance was intended to clarify earlier guidance in light of then then recent court rulings. And so it goes.
In spite of the grim background summarized in the introduction, it is still a very much worthwhile endeavor to seek patent protection for your innovations. I am not changing my prejudice against relying on “trade secret” protection.
Further, I am not changing my recommendation that filing your own provisional application for patent is a worthwhile endeavor. Throwing up your hands and doing nothing is not an option for the savvy entrepreneur or successful startup. In my opinion filing your own provisional application can never hurt you. See my blogs of DIY Provisionals and Provisional Applications.
The guidelines again focus upon the need to have a well thought out description of the invention, with the description synchronized with well drafted claims.
That said, part of the reason for the legal mis-mash coming from the USPTO is that they are trying to reconcile a multitude of cases extending over 40 years. Some of these cases are inconsistent, if not outright contradictory. It should be remembered that technology, particularly computing technology and the use of that technology, has changed drastically over the 40 years. Stated differently, what may have been factually valid in 1979 may not be valid in 2019.
The new guidelines are directed to the examiners. The guidelines provide examples demonstrating how the examiners are supposed to parse patent applications and determine first, do the claims of the application “recite” natural law, natural phenomena or abstract ideas, and second, do the claims (read with the description/specification) add enough additional matter or limitations so that the claimed subject matter does not result in the monopolization of a natural law, etc.
The term “recite” when used with the claims is intended to mean does the claim set forth or describe” ineligible subject matter, i.e., an abstract idea, etc.
The October 17 guidelines provide 4 examples intended to illustrate the principles of the guidelines. One example pertains to a patent for treating kidney disease. (This single USPTO example spans several pages so the following is merely a short summary.)
In the example, the recited disease (Nephritic Autoimmune Syndrome Type 3) and biomarkers (C11 and C13) are hypothetical, but the recited treatments (glucocorticoids, non-steroidal agents, rapamycin, and plasmapheresis) are known treatments in the medical field.
The patent claims at issue state:
1. A treatment method comprising:
(a) calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype;
(b) administering a treatment to the patient having a non-responder phenotype.
2. The method of claim 1, wherein the treatment is a non-steroidal agent capable of treating NAS-3.
3. The method of claim 1, wherein the treatment is rapamycin.
4. The method of claim 1, wherein the treatment is a course of plasmapheresis.
5. A treatment method comprising administering rapamycin to a patient identified as having Nephritic Autoimmune Syndrome Type 3 (NAS-3).
Claim 1 is not eligible, i.e., it does not recite or claim patentable subject matter. This is because it is merely reciting a factor of a disease (calculating a ratio of bodily factors) and stating to treat the patient having the responder phenotype. This is akin to the Supreme Court admonishment of Mayo v Prometheus (discussed in a linked blog) wherein the claim was deemed to say merely “observe a malady and treat it with natural law”.
Examined with further detail, the claim recites ineligible subject matter, i.e., natural phenomena where the ratio of C11 to C13 levels are measured to identify a patient having a non-responder phenotype. The second step of analysis is to look whether the remainder of the patent claim integrates the exception into a practical application. It does not. It merely states to apply treatment.
Claim 2 is eligible. Claim 2 depends from claim 1 and adds a wherein clause specifying that the administered treatment is a non-steroidal agent capable of treating NAS-3. It is important to remember during claim interpretation that no limitations can be disregarded and the mere fact that the limitation appears in a “wherein” clause does not automatically mean that it is not given weight.
In this case, when the wherein clause is considered in view of the specification, it is clear that the wherein clause has patentable weight because the claim requires that the treatment be an agent (e.g., a medicament) that is not a steroid and that has the function of being capable of treating NAS-3. No particular agent is required, so long as the agent is not a glucocorticoid or other steroid, and that it has the claimed function of treating NAS-3.
The following is Key: The treatment limitation, “a non-steroidal agent capable of treating NAS-3” integrates the recited judicial exception into a practical application such that the claim is not directed to a judicial exception. Recall the judicial exception is “calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype”, i.e., utilizing a natural phenomena.
It must be cautioned that this analysis does not consider whether the treatment with a non-steroid agent capable of treating NAS-3 is a well known treatment regimen and therefore would be obvious (non patentable).
Please further note that claims are given their broadest reasonable application. Stated differently, under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111.
Note claims 3, 4 and 5 are similarly eligible for protection (assuming they are not obvious or well known remedies for this type of malady).
Note claim 5 is also an independent method claim stating “treatment method comprising administering rapamycin to a patient identified as having Nephritic Autoimmune Syndrome Type 3 (NAS-3)”. Note rapamycin is a nature based product. The October guidelines raise the issue for this example of whether use of a nature based product triggers an exception (non-eligibility for patent) based upon a product of nature exception. The USPTO goes on to say that the exception question is not applicable since this is a process or method claim. That is to say, the method claim is not directed to rapamycin as a stand alone product but rather the claim is directed to a process of administering rapamycin to a patient having NAS-3.
I mention this side issue hesitantly since is likely only to further confuse this muddled situation. But I mention it to again point out the complexity of good drafting of the specification and the claims. But I also want to repeat that for a provisional application, all that is required is that enough detail is provided to enable a person skilled in the art to learn and understand how to apply your innovation. A comprehensive description is key.
I have attempted to provide a further alert to the swamp created in court’s recent (last 10 years) examination and rejection of patentable subject matter under 35 USC Section 101, exceptions to patent eligibility. Again, it is not possible to obtain patent protection for laws of nature, products of nature, natural phenomena and abstract ideas. These are patent ineligible subject matter.
I have also attempted to provide limited guidance to the thought process that the USPTO requires of examiners to determine whether the subject matter of a claim, viewed as a whole, is claiming ineligible subject matter.
Finally, remember my advice (and opinion) that seeking patent protection is a very worthwhile endeavor and filing a DIY provisional application for patent will not hurt you. But sooner rather than later, seeking the advice of a qualified patent attorney is needed. Free of charge legal mentoring through a business startup accelerator is often available.
© David McEwing, 2019