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USPTO Issues Guidance for Analyzing Process Patents

USPTO Issues Guidance for Analyzing Process Patents

On March fourth, 2014, the U.S. Patent and Trademark Office (USPTO) issued “2014 Procedures For Subject Material Eligibility Analysis Of Claims Reciting Or Involving Laws and regulations of Nature/Natural Concepts, Natural Phenomena, And/Or Natural Products“ Guidance, counseling examiners and also the public from the factors for figuring out whether an invention satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as put on patent-eligibility. See Assn. for Molecular Pathology v. Myriad Genetics, Corporation., 569 U.S. __, 133 S. Ct. 2107 (2013) (“Myriad“) and Mayo Collaborative Services v. Prometheus Laboratories, Corporation., 566 U.S. __, 132 S. Ct. 1289 (2012) (“Prometheus“). The Guidance advises examiners to use the Myriad and Prometheus holdings to the subject material that may be characterised like a judicial exception to patent-eligibility: legislation of nature an all natural principle an all natural phenomena, or perhaps a natural product. When the claimed subject material could fall within among the judicial exceptions to patent-eligibility, examiners are expected to assess the claimed subject material, while using following factors, to find out when the claim recites something considerably diverse from the judicial exception(s). My March fifth publish looks at the Guidance’s analysis of patent claims that may come under natural product exception to patent-eligibility. This publish will evaluate the Guidance’s overview of patent claims that may fall connect with legislation of nature exception to patent-eligibility. Claims forwarded to abstract ideas aren’t examined while using principals from the Guidance. Examiners are forwarded to MPEP 2106(II) for analysis of claims involving abstract ideas.

Factors Weighing Toward Eligibility

The Guidance notes six factors that will indicate the claimed subject material is considerably not the same as a judicial exception and for that reason weighted toward eligibility:

  1. 1. the claim is really a product claim reciting something which initially seems to become a natural product, but after analysis is decided to become non-naturally sourced and markedly different in structure from naturally sourced products
  2. the claim recites elements/steps additionally towards the judicial exception(s) that impose significant limits on claim scope, i.e., the weatherOractions narrow the scope from the claim to ensure that other medication is not substantially foreclosed by using the judicial exception
  3. the claim recites elements/steps additionally towards the judicial exception(s) that report towards the judicial exception inside a significant way, i.e., the weatherOractions tend to be more than nominally, insignificantly, or tangentially associated with the judicial exception(s)
  4. the claim recites elements/steps additionally towards the judicial exception(s) which do greater than describe the judicial exception(s) with general instructions to use or make use of the judicial exception(s)
  5. the claim recites elements/steps additionally towards the judicial exception(s) which include a specific machine or transformation of the particular article, in which the particular machine/transformation implements a number of judicial exception(s) or integrates the judicial exception(s) right into a particular request and
  6. the claim recites a number of elements/steps additionally towards the judicial exception(s) that give a feature that’s greater than well-understood, purely conventional or routine within the relevant field.

Factors Weighing Against Patent-Eligibility

The Guidance also lists six factors that will weigh against patent-eligibility:

  1. the claim is really a product claim reciting something which initially seems to become a natural product, that isn’t markedly different in structure from naturally sourced products
  2. the claim recites elements/steps additionally towards the judicial exception(s) at an advanced of generality so that substantially all practical applying the judicial exception(s) are covered
  3. the claim recites elements/steps additionally towards the judicial exception(s) that must definitely be used/taken by others to use the judicial exception(s)
  4. the claim recites elements/steps additionally towards the judicial exception(s) which are well-understood, purely conventional or routine within the relevant field
  5. the claim recites elements/steps additionally towards the judicial exception(s) which are minor extra-solution activity, e.g., are just appended towards the judicial exception(s) and
  6. the claim recites elements/steps additionally towards the judicial exception(s) that add simply only field useful.

The Guidance signifies that in analyzing the claim while using above factors which if, on balance the totality from the relevant factors weigh toward eligibility, the claim qualifies as qualified subject material. If however, the standards weigh against eligibility, the claim ought to be rejected. The Guidance also notes that, case study in general is really a factor based analysis, which requires consideration and subsequent weighing of multiple factors, and will be applied like the Wands factor based analysis to judge whether undue experimentation is needed to create and employ a specific claimed invention, citing MPEP 2164.01(a).

Process Claim Involving an all natural Principle and Reciting Natural Products

The hypothetical claim recites:

  1. A technique for figuring out whether an individual patient has degenerative disease X, comprising: acquiring a bloodstream sample from the patient figuring out whether misfolded protein ABC exists within the bloodstream sample, in which stated figuring out is conducted by contacting the bloodstream sample with antibody XYZ and discovering whether binding occurs between misfolded protein ABC and antibody XYZ using flow cytometry, in which antibody XYZ binds for an epitope that’s present on misfolded protein ABC although not on normal protein ABC and diagnosing the individual as getting degenerative disease X if misfolded protein ABC was resolute to trouble the bloodstream sample.

Antibody XYZ is mentioned to not appear in nature, and isn’t purely conventional or routine within the art (it had been recently produced through the inventors).

The Rules indicate the claim is patent-qualified, because using the novel antibody and discovering the resultant binding using flow cytometry within the claim narrow the scope from the claim, to ensure that other medication is not foreclosed by using other way to identify the misfolded protein. The claim also was noted to complete greater than describe an all natural principle with general instructions to use it.

Process Claims Involving an all natural Principle

The hypothetical claims recite:

  1. A technique for the treatment of a mood disorder inside a human patient, the atmosphere disorder connected with neuronal activity within the patient’s brain, comprising: exposing the individual to sunlight, in which the contact with sunlight alters the neuronal activity within the patient’s brain and mitigates the atmosphere disorder.
  2. A technique for the treatment of a mood disorder inside a human patient, the atmosphere disorder connected with neuronal activity within the patient’s brain, comprising: exposing the individual to some synthetic supply of white-colored light, in which the contact with white-colored light alters the neuronal activity within the patient’s brain and mitigates the atmosphere disorder.
  3. A technique for the treatment of a mood disorder inside a human patient, the atmosphere disorder connected with neuronal activity within the patient’s brain, comprising: supplying a white-colored source of light that emits white-colored light filtering the ultra-purple (Ultra violet) sun rays in the white-colored light and positioning the individual next to the source of light far away between 30-60 cm for any predetermined period varying from 30-an hour to reveal photosensitive parts of the patient’s brain towards the filtered white-colored light, in which the contact with the filtered white-colored light alters the neuronal activity within the patient’s brain and mitigates the atmosphere disorder.

Claims 1 and a pair of are determined to not be patent-eligibility because exposing the individual to sunlight isn’t a significant limit around the claim scope, for the reason that exposing the individual to sunlight forecloses others by using or applying sunlight. The claims are also a maximum of using the natural principle and natural phenomenon.

Claim 3 however, is patent-qualified since the filtering and positioning steps meaningfully limit the claim to particular use of natural principle. The extra steps from the claim are also not well-understood, purely conventional or routine in the skill of treating mood disorders.

Process Claim Reciting an Abstract Idea along with a Natural Product

The hypothetical claim recites:

  1. A technique for identifying a mutant BRCA2 nucleotide sequence inside a suspected mutant BRCA2 allele which comprises evaluating the nucleotide sequence from the suspected mutant BRCA2 allele using the wild-type BRCA2 nucleotide sequence, in which a noticeable difference between the suspected mutant and also the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

This claim is copied from claim 1 of Myriad’s U.S. Patent No. 6,033,857, which was held to become ineligible through the U.S. Top Court. The Guidance signifies that since the claim recites an abstract idea, the claim ought to be examined using MPEP 2106(II) although the claim also recites an all natural product.

What Let’s focus on Applicants?

Applicants getting pending claims forwarded to any natural product that aren’t structurally not the same as natural counterpart should anticipate seeing these claims rejected under Section 101 cellular the brand new Guidelines. However, as the Guidelines provide several examples to help examiners using their analysis, the rules are light on assistance with the quality of “markedly different” the claimed product is always to satisfy Section 101. Furthermore, set up courts would accept the USPTO’s undertake Myriad and Prometheus is definitely an open question that just a judicial challenge can answer.

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