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 .
Claims 1-17 are pending. Claims 18-28 are canceled.
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 12 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.
Claims 12 recites the terms “no perform no monitoring post-treatment” which is confusing and ambiguous because the phrase is undeciperable.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 3-4, 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) is/are directed to a natural phenomenon and mental steps. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The rationale for this determination is explained below and is based on USPTO’s 2014 Interim Guidance on Patent Subject Matter Eligibility, called ‘‘Interim Eligibility Guidance’’ (published in Federal Register /Vol. 79, No. 241 /Tuesday, December 16, 2014) and Interim Guidance published May 4, 2016 for use by USPTO personnel in determining subject matter eligibility under 35 U.S.C. 101 in view of recent decisions by the U.S. Supreme Court (Supreme Court). In Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo) 101 USPQ2d 1961, 1965-1966 (SC 2012) it was stated:
“Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972). And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it. (Emphasis added).
Still, as the Court has also made clear, to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words “apply it.”
Our conclusion rests upon an examination of the particular claims before us in light of the Court’s precedents. Those cases warn us against interpreting patent statutes in ways that make patent eligibility “depend simply on the draftsman’s art” without reference to the “principles underlying the prohibition against patents for [natural laws].” Flook, supra, at 593. They warn us against upholding patents that claim processes that too broadly preempt the use of a natural law. Morse, supra, at 112– 120; Benson, supra, at 71–72.
And they insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an “inventive concept,” sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself. Flook, supra, at 594; see also Bilski, supra, at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant post solution activity’” (quoting Diehr, supra, at 191–192)). (Emphasis added).
We find that the process claims at issue here do not satisfy these conditions. In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries. (Emphasis added)
1. Is the claimed invention directed to one of the four statutory categories, i.e. a process, machine, manufacture, or composition of matter?
2. Does the claim recite or involve judicial exception(s), i.e. abstract ideas, laws of nature/natural principles, natural phenomena, and natural products?
3. Does the claim as a whole recite something significantly different than the judicial exception(s)?
In the present case, the claims are directed to a naturally occurring correlation between identification of Neu5Ac on PSA and diagnosing prostate cancer. The answer to the first two questions of the claim eligibility chart is yes because the claim is to a method and the claim recites judicial exceptions of laws of nature or natural principles where the correlation between identification Neu5Ac on PSA and diagnosing prostate cancer.
The answer to the question three is no because the claims as a whole does not recite something significantly different than the natural principle.
The diagnostic steps recited in claims do not contain any additional elements or steps beyond the observation of a natural principle, and as a result, these claims do not satisfy the third inquiry. The method of claims involves instructions that are well-understood, routine, and conventionally practiced by those in the field i.e. marker identification assay. Thus, the claim also fails to satisfy the third inquiry. Since the claim satisfies all three inquiries, it is rejected under 35 U.S.C. 101 as not being drawn to patent-eligible subject matter.
In the present case, the claims are directed to a naturally occurring correlation between identification of Neu5Ac on PSA and diagnosing prostate cancer. No treatment are recited in these claims thus does not have a significantly different solution for the judicial exception.
The claims as a whole does not recite something significantly different than the natural principle. The natural principle of a claim must contain steps amounting to a practical application of the claimed invention, and the practical application must amount to significantly more than the natural principal itself. Along with integration, the additional steps must be sufficient to ensure that the claim amounts to significantly more than the natural principle itself by including one or more elements or steps that limit the scope of the claim and do more than generally describe the natural principle with generalized instructions to "apply it." The additional elements or steps must narrow the scope of the claim such that others are not foreclosed from using the natural principle (a basic tool of scientific and technological work) for future innovation. Elements or steps that are well-understood, purely conventional, and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular technological environment (field-of- use), would not be sufficiently specific.
The diagnostic steps recited in claims do not contain any additional elements or steps beyond the observation of a natural principle, and as a result, these claims do not satisfy the third inquiry. The method of claims involves instructions that are well-understood, routine, and conventionally practiced by those in the field. The method of treatment steps is generic and do not contain any additional elements or steps beyond the natural principle. The treatment is generic therapy and is well known in the art. Thus, the claim also fails to satisfy the third inquiry. Since the claim satisfies all three inquiries, it is rejected under 35 U.S.C. 101 as not being drawn to patent-eligible subject matter.
In sum, when the relevant factors are analyzed, they weigh against significant difference from naturally occurring principle and thus claims do not qualify as eligible subject matter.
Claims 1-2, 5-11, 13-15 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible time.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL D PAK/Primary Examiner, Art Unit 1674
Prosecution Insights