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 .
Response to Amendment
Applicant’s amendments and remarks filed 09/08/2025 and 09/10/2025 are acknowledged. Claims 5, 8, and 18 are amended. Claims 1, 3, 7, 9, 11-13, 17, 19, 20, and 25-27 are cancelled. Claims 5, 8, 18, and 21-24 are under examination.
Objections Withdrawn
All previous objections of claims 1, 3, 11, 17, and 19 are hereby withdrawn in response to Applicant’s cancelation of the claims.
Specification
The objections to the disclosure for informalities is withdrawn in response to Applicant’s amendments to consistently use “fs” to refer to frameshift mutation and changing Cwh32 to Cwh43 in paragraphs [0006] and [0111].
The objection to the disclosure because of unconventional terminology used in the claims, specification, and drawings is withdrawn in response to Applicant’s amendments and arguments. The amendments to the claims make clear what part of the Cwh43 protein is truncated. Applicant’s arguments on page 4-5 that PGAP2-interacting protein is an art-recognized alias is found to be persuasive.
Rejections Withdrawn
All previous rejections of claims 1, 3, 7, 9, 11-13, 17, 19, 20, and 25-27 are hereby withdrawn in response to Applicant’s cancelation of the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112
The rejection of claim 8 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in response to Applicant’s amendment removing the indefinite language outlined at page 5 of the Office action mailed 05/08/2025.
Rejections Maintained
Claim Rejections - 35 USC § 101
Claims 5, 8, 18, and 21-24 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon judicial exception without significantly more. This is a modified rejection necessitated by Applicants’ amendments to the claims in the response filed on 09/10/2025.
The claims recite the natural phenomenon whereby a truncation of the Cwh43 protein is correlated with idiopathic normal pressure hydrocephalus. This judicial exception is not integrated into a practical application because the method does not set forth any of the considerations outlined in MPEP 2106.05(a-c), (e) and (h). The additional steps of exome sequencing and CSF drainage via a shunt does not constitute an improvement in technological field; and the steps recited in addition to the judicial exception do not integrate detection of the natural phenomenon into a particular treatment/prophylaxis according to MPEP 2106.04(d)(2). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements fail to provide either an inventive concept or impose meaningful limits upon the method such that the invention does not preempt every observance of the natural phenomenon itself.
The claims are directed to a method for diagnosing idiopathic normal pressure hydrocephalus (iNPH) in a human subject comprising detecting the presence of truncated Cwh43 protein in a sample. Methods are one of the statutory categories of invention (STEP 1:YES)
The claims recite diagnosis and comparing, which are an abstract mental concept that belong to enumerated group (c) of the Abstract Idea Groupings described in MPEP § 2106.04(a)(2): Mental processes — concepts performed in the human mind (including an observation, evaluation, judgment, opinion). But more importantly, the claims recite a natural correlation/phenomenon/law of nature whereby idiopathic normal pressure hydrocephalus is correlated with the presence of truncated Cwh43 protein. Therefore the claims recite at least one judicial exception (STEP 2A, Prong One: YES).
According to Step 2A, Prong Two, set forth in MPEP 2106.04 II A (2), the claims are next evaluated with respect to whether the judicial exception is integrated into a practical application. These considerations are set forth in MPEP 2106.05 (a) through (c), (e), and (h). This analysis turns to the additional steps/elements recited within the claim. The additional steps/elements are exome sequencing and CSF drainage via a shunt.
First, this treatment is conditional upon the presence of the biomarker, truncated Cwh43 protein. MPEP 2106.04(d)(2) states: “ that in order to qualify as a ‘treatment’ or ‘prophylaxis’ limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition.” Since treatment in the instant claims is conditional then it is not affirmatively recited and cannot integrate the judicial exception.
Second, there are no additional elements that reflect an improvement within the technical field; there are no additional elements that apply the natural correlation/phenomena judicial exception to a particular treatment or which utilize a particular machine; there are no additional elements that effect a transformation; and, there are no additional elements that apply the judicial exception in some other meaningful way beyond generally linking it to a field, namely, treatment of hydrocephalus. The specification itself states “Treatments for iNPH typically comprise, CSF shunting (e.g., CSF drainage)…” (specification paragraph [0038]). Regarding the additional element of assessing genes and gene products, the specification states “various techniques are known in the art” (specification paragraph [0043]). Therefore, in in accordance with MPEP 2106.07(a)(III)(A), the examiner has cited express statements in the specification indicating that the additional elements were sufficiently well-known that the specification does not need to describe the particulars thereof. In other words, the disclosure describes no new technology relating to the subjects addressed, but merely refers to techniques and elements that were known in the art at the time of filing.
Lastly, in accordance with MPEP 2106.07(a)(III)(C), the examiner cites publications within the field of technical expertise, that demonstrate the well-understood, routine, conventional nature of the additional element(s). The following prior art teaches it was well established in the field of technical expertise that idiopathic normal pressure hydrocephalus is known to be treated via cerebrospinal fluid drainage. This is explained in paragraph [003] of the instant specification. Toma (ref. of record) teaches that shunt insertion for the purpose of CSF drainage is a safe and effective management of idiopathic normal-pressure hydrocephalus and is the standard of treatment (Toma Introduction). Therefore, the steps/elements recited in addition to the judicial exception (treating idiopathic normal-pressure hydrocephalus with CSF drainage via a shunt) were well understood, routine, conventional activities in the field of iNPH prior to filing the application at hand (STEP 2B: NO). The claimed steps/elements recited in addition to the judicial exception(s), alone or in combination, do not make an inventive contribution over the methods that were known in the art prior to filing, and they amount to mere observation of the natural phenomenon itself by a technique that is well-known in the art with the words ‘apply it’ in order to append it to the field of iNPH.
For all of these reasons, claims 5, 8, 18, and 21-24 are directed to the judicial exception without significantly more and are rejected.
Response to Arguments
Applicant argues that the amended claims recite a specific treatment step (i.e., performing CSF drainage) on a specific patient population (i.e., subjects having a nucleic acid that encodes a truncated CWH43 protein), and therefore integrates the alleged judicial exception of "identifying" into a practical application.
This has been fully considered, but is not found to be persuasive. As detailed above, the practical application is the standard and routine treatment for a patient with hydrocephalus, whether or not they have a nucleic acid that encodes truncated CWH42. As such, there is no specific treatment claimed beyond what is routine in the art. By Applicants’ own admission in the instant specification, the “typical treatment” for hydrocephalus is CSF drainage. Therefore, there is no integration of the judicial exception into a practical application and the claimed invention would therefore preempt every observance of the natural phenomenon itself. Said another way, every ordinary artisan not in possession of the patent would be prevented from observing the natural phenomenon of truncated CWH42 in a patient and/or would be prevented from administering routine treatment to a patient if the natural phenomenon of truncated CWH42 is observed. Moreover, there is no inventive concept of the claimed invention; the claimed invention simply observes a natural phenomenon using routine techniques for assessing genes and gene products and administers a routine treatment for hydrocephalus (a treatment that the patient would have received regardless if truncated CWH42 was observed). Therefore, there is no specific patient population and no specific treatment step beyond what is standard in the art. As such, the judicial exception is not integrated into a practical application. The claimed invention amounts to nothing more than observing a natural phenomenon and administering a routine treatment.
Conclusion
THIS ACTION IS MADE FINAL. 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.
No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH CESARE whose telephone number is (571)272-6908. The examiner can normally be reached Monday - Friday 10am-4pm.
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/JOSEPH D. CESARE/
Examiner, Art Unit 1675
/JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675
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