DETAILED ACTION
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 .
Status of the claims
The amendment filed 09/14/26 is acknowledged and has been entered. Claims 2-6 have been amended. Claims 1 and 7-8 have been canceled. New claims 9-15 have been added. Accordingly, claims 2-6 and 9-15 are under examination.
Withdrawn Rejections
In light of the amendment to claim 2 to recite “cerebral hemorrhage caused by head injury being excluded” and the support for such amendment in the disclosure in paragraph 0047 of the current specification disclosing that subarachnoid hemorrhage does not include cerebral hemorrhage caused by head injury and Applicant’s argument that Guo does not teach non-traumatic hemorrhagic stroke is found persuasive. Thus, the 102 Rejections based on Guo have been withdrawn.
All remaining rejections not reiterated herein, have been withdrawn.
Claim Objections
Claim 5 is objected to because of the following informalities: Claim 5, line 1 the recitation “a method” should be --A method--. Appropriate correction is required.
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.
Claim 4 is 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.
Claim 4 is vague and indefinite in reciting “a threshold of the soluble CLECS concentration is 137 pg/ml or less” because the current claim allows for the threshold to be zero. The specification in figure 2 shows that normal subjects have levels above zero. Therefore, how does the mere presence of CLEC-2 provide for the determination of hemorrhagic stroke in a patient if it is known that normal subjects comprise values greater than zero. The claim appears to be missing an essential element of comparison to a normal control or missing an essential level above that of normal subjects which provides how a threshold less than 137 pg/ml is positively correlated with hemorrhagic stroke. Applicant is reminded that although the claims are read in light of the specification limitations from the specification are not read into the claims.
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 2-6 and 9-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
The claims are directed to a naturally occurring correlation between the concentration of the recited biomarker in a subject suspected of having hemorrhagic stroke or having hemorrhagic. Also, claims 5-6 are directed to mathematical concepts and calculations are a thus directed to an abstract idea.
Step 2A, Prong 2
The additional elements of measuring a concentration of soluble CLEC2 in blood collected from a patient does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitation “correlating the soluble CLEC2 concentration with the presence or absence of hemorrhagic stroke in the patient, or likelihood of outcome”, “evaluating whether the patient is risk based on a change in the soluble CLEC2 concentration. The “correlating”, “evaluating” and “wherein” statements at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the recited marker being correlated with hemorrhagic stroke or outcome. No active method steps are invoked or clearly required; the “correlating”, “evaluating” and “wherein” statements do not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
As shown by Guo et al., (Clinica Chimica Acta, 496, 2019, pages 1-6) (submitted in the IDS filed 12/20/23). it is well known routine and conventional in the art to measure soluble CLEC2 in a blood sample from a patient.
With respect to the “administering one or more of a painkiller, an anti-nausea drug…” as recited in claims 2 and 5. Although the claims invoke administering a medicament to the subject the claims as currently recited do not positively recite a step of identifying the subject as having hemorrhagic stroke and allows for determining the absence of hemorrhagic stroke which allows for a scenario wherein the treatment would not be administered. Therefore, this scenario does not recite something significantly more than the judicial exception.
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
Response to Arguments
Applicant's arguments filed 09/14/26 have been fully considered but they are not persuasive.
101 Rejections:
Applicant argues that independent claims 2 and 5 include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception.
This argument is not found persuasive because of reasons stated above that the measurement of CLEC-2 in samples is known and conventional and that although the claims invoke administering a medicament to the subject the claims as currently recited do not positively recite a step of identifying the subject as having hemorrhagic stroke and allows for determining the absence of hemorrhagic stroke which allows for a scenario wherein the treatment would not be administered. Therefore, this scenario does not recite something significantly more than the judicial exception.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GARY COUNTS/ Primary Examiner, Art Unit 1678
Prosecution Insights