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 .
Claim Status
Claims 1-82 were canceled.
Claims 83-115 are pending and under consideration.
Withdrawn Rejections
All objections and rejections in previous office action are withdrawn because claims 1-82 were canceled and in view of new claim limitations “wherein the predetermined threshold of DPP3 concentration is between a 75-percentile and a 95-percentile of a healthy control group” and “wherein the predetermined threshold of DPP3 concentration is in a range between 5 ng/ml and 25 ng/ml” recited by new independent claims.
Claim Objections
Claims 105 and 109 are objected to because of the following informalities: “measuring a DPP3 concentration in the sample using a means for determining the DPP3 concentration comprising using a capture-binder that binds to DPP3” should read “measuring a DPP3 concentration in the sample using a means for determining the DPP3 concentration comprising a capture-binder that binds to DPP3”.
Appropriate correction is required.
NEW - Claim Rejections - 35 USC § 112
(necessitated by amendments)
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 83-115 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.
Independent claims 83, 87, 94, 98, 105 and 109 recite claim limitations “diagnosing in a subject a disease or condition that is accompanied by or related to necrotic processes” and “determining whether the measured DPP3 concentration is the sample is above a predetermined threshold of DPP3 concentration”, but do not recite how this determining step results in diagnosis. Does the measured DPP3 concentration above a predetermined threshold of DPP3 concentration mean that the subject has a disease or condition that is accompanied by or related to necrotic processes? Or does the measured DPP3 concentration below a predetermined threshold of DPP3 concentration mean that the subject has a disease or condition that is accompanied by or related to necrotic processes? One of ordinary skill in the art would not able to ascertain whether the subject has a disease or condition that is accompanied by or related to necrotic processes because instant claims do not recite the relationship between DPP3 concentration and diagnosis.
Instant specification disclosed that DPP3 activity is elevated in homogenates of ovarian and endometrial tumors and DPP3 activity even increases with the severity/malignancy of said tumors (page 2, line 25-29). Therefore, it seems that Applicant intends to claim method of diagnosis wherein DPP3 concentration above threshold value indicates that subject has a disease. In contrast, claims 83, 94 and 105 recite “wherein the pre-determined threshold of DPP3 concentration is between a 75-percentile and a 95-percentile of a healthy control group”. For example, let us suppose that the pre-determined threshold of DPP3 concentration is a 75-percentile of a healthy control group. This means that 75 percent of a healthy control group has DPP3 concentration below the threshold and 25 percent of a healthy control group has DPP3 concentration above the threshold. Does Applicant intend to claim a method of diagnosis which diagnoses that 25 percent of a healthy control group who has DPP3 concentration above the threshold has a disease? In this case, instant claims diagnose that healthy person has a disease which is preposterous. Thus, it is unclear what diagnosis step Applicant intends to recite.
Claims 91-93, 102-104 and 113-115 recite “the amount of DPP3 concentration”. There is insufficient antecedent basis for this limitation in the claim. Claims 91-93, 102-104 and 113-115 depend from claims 87, 98 and 109, respectively. While claims 87, 98 and 109 recite “DPP3 concentration”, claims 87, 98 and 109 do not recite “amount of DPP3 concentration”. Furthermore, it is unclear whether “the amount of DPP3 concentration” refers to “the measured DPP3 concentration in the sample” or “the predetermined threshold of DPP3 concentration”. If Applicant intends to recite the latter, it is suggested that Applicant amend “the amount of DPP3 concentration” to “the predetermined threshold of DPP3 concentration”.
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 83-115 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. The claims are directed to a judicial exception (natural phenomenon), specifically, the claims are drawn to a method to detect natural protein DPP3. Furthermore, the claims do not integrate said judicial exception into practical application, and the claims do not recite additional elements that amount to significantly more than said judicial exception.
The MPEP Section 2103 through 2106 provides a means of determining whether a particular claim is patent eligible under 35 U.S.C. 101.
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A.
Step 2A - A two-prong analysis. For prong one, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong two, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
In the instant case, the claims are drawn to a process, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because as indicated above, the claims are drawn to a natural phenomenon, specifically, the claims are drawn to a method to detect natural product DPP3 and also abstract idea (e.g. mental process) of “determining whether the measured DPP3 concentration in the sample is above a predetermined threshold of DPP3 concentration.”
With respect to prong two of Step 2A, the claim does not recite additional elements that integrate the judicial exception into a practical application. In addition to the recited judicial exception, the claims recite steps of contacting the bodily fluid with a capture-binder, and measuring a DPP3 concentration in the sample. However, these limitations relate to general methods of measuring DPP3 concentration in the sample and do not integrate the judicial exception into a practical application. Said limitations do not integrate the recited judicial exception, for example, by applying or using said judicial exception to effect a particular treatment for a disease or medical condition. Therefore, the answer to prong two of the Step 2A analysis is “No.”
With respect to Step 2B, using antibodies for detecting antigens, including DPP3, were well-understood, routine, and conventional data gathering steps that were practiced by investigators prior to Applicant’s invention. These steps do not amount to additional elements that amount to significantly more than the recited judicial exception. Accordingly, the answer to the Step 2B analysis is “No,” and therefore the claims are not eligible subject matter under 35 U.S.C. 101.
A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Recited elements such as “measuring” and "determining", based on the natural principle impose no meaningful limit on the performance of the claimed invention. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas). Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the recited natural principle. The claims do not "practically apply" the natural principle; rather, the claims "simply inform" the natural principle to one performing routine active method steps and do not amount to significantly more than the natural principle itself. Thus, the technology used by the instant claims is well-known in the art and does not contribute significantly more to the judicial exception.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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