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 .
DETAILED ACTION
Claims 1-17 are pending and under consideration in the instant application.
2. The first sentence of the Specification should be amended to reflect the status of the parent case 18/897,011, now abandon.
3. 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.
4. Claims 1-17 are rejected under 35 USC 101 because the claimed invention is directed to non-statutory subject matter.
The unpatentability of laws of nature was confirmed by the U.S. Supreme Courtin Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March20, 2012).
Based upon consideration of all of the relevant factors with respect to the claimsas a whole, claims 1-17 are held to claim a law of nature, and is therefore rejected as ineligible subject matter under 35 U.S.C. 101.
The practice of the method claims does not result in an inventive concept that transforms the natural phenomenon into a patentable invention.
The rationale for this finding is explained below:
The unpatentability of laws of nature was confirmed by the U.S. Supreme Courtin Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March20, 2012). "[L]aws of nature, natural phenomena, and abstract ideas" are notpatentable. Diamondv. Diehr, 450 U. S. 175, 185 (1981); see also Bilskiv. Kappos, 561U. S. __, __ (2010) (slip op., at 5). "Phenomena of nature, though just discovered,mental processes, and abstract intellectual concepts are not patentable, as they are thebasic tools of scientific and technological work." Gottschalkv. Benson, 409 U. S. 63, 67(1972). The Supreme Court does acknowledge that it is possible to transform anunpatentable law of nature, but one must do more than simply state the law of naturewhile adding the words "apply it." See, e.g., Benson, supra, at 71-72.
Mayo made clear that transformation into a patenteligible application requires “more than simply stat[ing] the law of nature while adding the words ‘apply it.’” Id. At 1294. A claim that recites an abstract idea, law of nature, or natural phenomenon must include “additional features”
to ensure “that the [claim] is more than a drafting effort designed to monopolize the [abstract idea, law of nature, or natural phenomenon].” Id. at 1297. For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful. See Parker v. Flook, 437 U.S. 584, 591 (1978) (“The process itself, not merely the mathematical algorithm, must be new and useful.”).
In other words using two-part test to identify the claims that are drawn to a judicial exception
Step 1 – yes, drawn to a method.
Step 2A prong 1 – yes, recites a judicial exception. In particular, the claim recites or describes the relationship between the physiological characteristic of these cells (high potency) and a biomarker (high levels of pS6 in response to a mitogen).
Step 2A prong 2 – no, the judicial exception is not integrated into a practical application. See MPEP 2106.04(d); in short because the claim does not act on, rely on, or use the law of nature it does not integrate into a practical application. Instead, the claim merely ends with the recitation of the law of nature.
Step 2B – no, does not add significantly more. The recited steps are necessary data-gathering steps required to feed into the law of nature. Finally, determining sample concentration of three or more biomarkers are well-understood, routine and conventional. ( see for Example the instant Specification paragraph 0039 in particular).
In Prometheus, a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder is the focus. This method comprises a) administering 6-thioguanine to patients and b) determining the level of 6-thioguanine in the patients and c) correlate the level of 6-thioguanine, i.e. a certain level/red blood cells, with the decision whether a need for increase or decrease the amount of 6-thioguanine treatment in said patients.
In this case, the claims inform a relevant audience about certain laws ofnature. The additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community (step b-c). The additional steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. The Court has made clear that 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." Essentially, appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.
In Prometheus, the Court found that "[i]f a law of nature is not patentable, neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Additionally, "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law". Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at __ (slip op., at 14) ("[T]he prohibition against patenting abstract ideas 'cannot be circumvented by'.., adding 'insignificant post-solution activity'" (quoting Diehr, supra, at 191-192)).
The Court also summarized their holding by stating "[t]o put the matter moresuccinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately."
In summary, it appears a three prong tests can be drawn from this case. First, does the case involve a process? Second, does the claim focus on use of a natural principle, i.e. a law of nature, a natural phenomenon, or naturally occurring relation or correlation (Is the natural principle a limiting feature of the claim?)? Third, does the claim include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself?
In Myriad v Ambry, the CAFC stated:
"Having determined that the comparison steps of claims 7 and 8 are abstract ideas, we move to the second step of Alice and ask whether the particular mechanism for the
comparisons added by claims 7 or 8 renders the claims patent-eligible. For this step, Alice dictates that we ask whether the remaining elements, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to "'transform the nature of the claim' into a patent-eligible application." Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297). There must be a further inventive concept to take the claim into the realm of patent-eligibility. Id. at 2355. The second paragraph of claim 7 describes the way in which the sequences are compared: they are compared by 1) hybridizing a BRCA gene probe and 2) detecting the presence of a hybridization
product. Similarly, claim 8 requires 1) amplification of the BRCA1 gene and 2) sequencing of the amplified nucleic acids. The non-patent-ineligible elements of claims 7 and 8 do not add "enough" to make the claims as a whole patent-eligible. The district court found, and Myriad does not
challenge, that the elements of the second paragraphs of claims 7 and 8 "set forth well-understood, routine and conventional activity engaged in by scientists at the time of Myriad's patent applications." J.A. 93 (internal capitalization removed). Moreover, "[a]ny scientist engaged in obtaining the sequence of a gene in a patient sample would rely on these techniques." J.A. 95. Myriad does not challenge the district court's finding that "the claims contain no otherwise new process for designing or using probes, primers, or arrays beyond the use of BRCA1 and BRCA2 sequences in those processes." Appellants' Rep. Br. 5 (quoting J.A. 93-94) (alterations omitted). The second paragraphs of claims 7 and 8 do nothing more than spell out what practitioners already knew-how to compare gene sequences using routine, ordinary techniques. Nothing is added by identifying the techniques to be used in making the comparison because
those comparison techniques were the well-understood, routine, and conventional techniques that a scientist would have thought of when instructed to compare two gene sequences.".
In Mayo 566 U.S., 132 S.Ct. at 1295, 101 USPQ2d at 1966-67, claim 1 stated:
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol
per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
The above claim was found to be ineligible in Mayo. The Supreme Court determined that the claim focused on use of a law of nature that was given weight during prosecution of the claim - specifically the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. See id. 566 U.S., 132 S.Ct. at 1298, 101 USPQ2d at 1968-69. The Court analyzed the claim as follows:
The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? We believe that the answer to this question is no. Id. 566 U.S., 132 S.Ct. at 1297, 101 USPQ2d at 1968.
The upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations. To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities. Id. 566 U.S., 132 S.Ct. at 1298, 101 USPQ2d at 1968.
The Court emphasized that while it takes a human action to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. See id. 566 U.S. 132 S.Ct. at 1297, 101 USPQ2d at 1967. The additional steps integrate the relationship into the process as the administering step involves the thiopurine drug, the determining step establishes the thiopurine drug level and the wherein clauses set forth the critical levels. The steps are not sufficient, however, to narrow the application such that others could still make use of the naturally occurring relationship in other practical applications. The claim essentially sets forth a law of nature with generalized instructions to apply it. It is also noted that the 6-thioguanine drug used in the aforementioned Mayo claim is a therapeutic agent which is administered to a patient. The claims recite a judicial exception in that they are drawn to a law of nature and abstract idea (aka relationship between a naturally occurring phenomenon and suitability for an art known treatment). The additional steps recited in the claim/additional claims set forth well-understood, routine and conventional activity engaged in by scientists at the time of the claimed invention. Therefore, the non-patent-ineligible elements of the claims do not add "enough" to make the claims as a whole patent-eligible. The claims are therefore not patent-eligible in view of the Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012).
Now turning to the instant application, the claims are directed to a method for monitoring the presence of JIA in a subject or for predicting flare activity in a subject having JIA by determining sample concentration for three or more biomarkers and compare them to the control group. The claims set forth laws of nature- namely relationships between the level of expression of three or more specific biomarkers and the presence of JIA or predicting flare activity in a subject having JIA. The relation is a consequence of the way in which an indicator of the presence or level of expression specific biomarkers increases or decreases and thus simply describes a relation set forth by a natural law.
In the instant case the claim provides analyzing step in addition to the natural correlation or judicial exception. These steps are generic as they provide no specific reagents, conditions, or guidance such these additional steps fail to provide a further inventive concept. Thus these additional steps are considered routine and conventional data gathering steps.
Thus, it the Examiner’s position that the instant claims as a whole do not integrates the recited judicial exception into practical application and do not recite any additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
As has been recently confirmed by the United States Court of Appeals for the Federal Circuit in UNIVERSITY OF UTAH RESEARCH FOUNDATION, THE TRUSTEES OF THE
UNIVERSITY OF PENNSYLVANIA, HSC RESEARCH AND DEVELOPMENT LIMITED
PARTNERSHIP, ENDORECHERCHE, INC., AND MYRIAD GENETICS, INC.,v. AMBRY GENETICS CORPORATION (2014-1361, -1366) Appeals from the United States District Court for the District of Utah in Nos. 2:13-cv-00640-RJS and 2:14-md- 02510-RJS, Judge Robert J. Shelby. ( December 17, 2014) "The non-patent-ineligible elements of claims 7 and 8 do not add "enough" to make the claims as a whole patent-eligible. The district court found, and Myriad does not challenge, that the elements of the second paragraphs of claims 7 and 8 "set forth well-understood, routine and conventional activity engaged in by scientists at the time of Myriad's patent applications." J.A. 93 (internal capitalization removed). Moreover, "[a]ny scientist engaged in obtaining the sequence of a gene in a patient sample
would rely on these techniques." J.A. 95. Myriad does not challenge the district court's finding that "the claims contain no otherwise new process for designing or using probes, primers, or arrays beyond the use of BRCA1 and BRCA2 sequences in those processes." Appellants' Rep. Br. 5 (quoting J.A. 93-94) (alterations omitted). The second paragraphs of claims 7 and 8 do nothing more than spell out what practitioners already knew-how to compare gene sequences using routine, ordinary techniques. Nothing is added by identifying the techniques to be used in making the comparison because those comparison techniques were the well-understood, routine, and conventional techniques that a scientist would have thought of when instructed to compare two gene sequences.
The instant claims satisfies the first two prong tests, i.e. a process involves applying a law of nature, i.e. detecting (measuring) level of one or more complement components in the subject which is an inherent known law of nature. However, the features recited in the claim do not amount to significantly more that the natural principle itself. It is similar to the Promethues case mentioned above, i.e. correlating a known amount of the analyte in the sample with a purported purpose (emphasis added).
In the instant case, the claims inform a relevant audience about certain laws ofnature. The additional steps consist of well-understood, routine, conventional activityalready engaged in by the scientific community. The additional steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. The Court has made clear that 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." Essentially, appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideascannot make those laws, phenomena, and ideas patent-eligible.
In Prometheus, the Court found that "[i]f a law of nature is not patentable, theneither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Additionally, "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law". Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at __ (slip op., at 14) ("[T]he prohibition against patentingabstract ideas 'cannot be circumvented by'.., adding 'insignificant post-solutionactivity'" (quoting Diehr, supra, at 191-192)).
The Court also summarized their holding by stating "[t]o put the matter moresuccinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity alreadyengaged in by the scientific community; and those steps, when viewed as a whole, addnothing significant beyond the sum of their parts taken separately."
The Supreme Court instructs that “[g]round breaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Myriad Genetics, Inc., 133 S. Ct. at 2117. The discovery of the BRCA1 and BRCA2 genes was a significant
contribution to the medical field, but it was not patentable. Id. at 2117.
For these reasons the claims are rejected under section 101 as being directed tonon-statutory subject matter. See MPEP § 2106.03. The Manual contains instructions to examiners, as well as other material in the nature of information and interpretation, and outlines the current procedures which the examiners are required or authorized to follow in appropriate cases in the normal examination of a patent application. The Manual does not have the force of law or the force of the rules in Title 37 of the Code of Federal Regulations.
5. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No.10718,765. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-7 of U.S. Patent No.10718,765 recited a method of treating JIA in a subject comprising measuring and determining a concentration of al least 3 biomarkers including MMP1, LEP, VCAM1 in a sample of bodily fluid taken from a subject. It would be immediately obvious to one skill in art that determining sample concentration of said biomarkers can be used for monitoring the presence of JIA and for prediction flare activity in a subject having JIA.
6. No claim is allowed.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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