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 .
Applicants filed remarks on 12/15/2025 has been received and entered.
Claims 8, 10, 12-18 and 20 have been canceled.
Claims 1-7, 9, 11 and 19 are pending.
Claims 1-6 and 9 are under examination. Claims 7, 11 and 19 are withdrawn from further consideration.
The rejection on Claims 1-6, 8-9 and 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn because of amendment.
The rejection on Claims 1-6, 8-9 and 19 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn because of amendment.
The rejection on claims 1-6 and 9 under 35 USC 101 judicial exception is maintained and of record. Applicants’ remarks are summarized below:
“In the present case, claim 1 as amended with this response is directed to a method which is a practical application. The Examiner has already identified Table 1 in the specification with clinical data supporting the practical application for bladder cancer. Furthermore, dependent claims provide additional practical details of the method.
In view of this, amended claim 1 and its dependent claims are not directed to a judicial acception or abstract idea, instead these claims are a concrete and practical application. Therefore, the claims are patent-elegable under step 2A.
Still further, as is further explained in the Memo, where claims amount to significantly more, the claims are also patent-eligible under step 2B.
In the present case, the Examiner has already determined that no prior art teaches or suggests using nLc4 in detecting bladder cancer. See paragraph 12 of the Office Action. Accordingly, present claims provide a significant novel and inventive improvement to the technical field of bladder cancer diagnosis and as such, the claimed method includes significantly more. Thus, present claims are also patent-elegible under step 2B.
In view of the foregoing, we respectfully submit that the 101 rejecion may be properly reconsidered and withdrawn”.
Applicant’s arguments have been considered but are not persuasive.
First, the amended claim 1 is reproduced as following:
“A method for analysing a sample to detect bladder cancer in a subject the urinary tract and/or in the urogenital tract, the method comprising analysing a urine sample from the subject for the presence of the a~glycan consisting of Galp31 -4GlcNAcp31-3 Galp31 -4Glc (lacto-N-neo-tetraose, neolactotetra, nLc4) and measuring a concentration of nLc4 in the urine sample, comparing a the measured concentration of one or more of nL c4, lactose, and Gb3 to a nLc4 concentrationina control group, and identifying the subjectas having bladdersample as indicting presence of cancer when the measured concentration is high compared to the control group”.
The current method is a process using natural occurring relationship, namely nLc4 (also having alias as Galp31 -4GlcNAcp31-3 Galp31 -4Glc, lacto-N-neo-tetraose or neolactotetra) concentration correlating with the presence of bladder cancer by comparison with a control. Such correlation itself constitutes an abstract idea (See Mayo Collaborative Servs. v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012); where the level of drug 6-thioguanine in blood cells providing advice clinician for treatment). Note, novelty or unobviousness is NOT the test used to evaluate judicial exception unlike argued by applicants (emphasis added). The primary principle lies in the Mayo vs. Prometheus (2012)(see above).
Applicants pointed out that the clinical data as listed in Table 1 can be construed as a practical application. However this alone cannot be held as a practical application since NO additional feature(s) is incorporated in the claim other than common, routine and well known sample collecting, analyzing and comparing. It is suggested a feature, e.g. immunotherapy comprising nLc4 in the claim as suggested by the court in Vanda Pharmaceuticals vs. West-Ward Pharmaceutical, where the court held a treatment to the patient with an amount of a particular medication, i.e. iloperidone, is an integrated practical application more than law of nature (887 F.3d at 1134-36, 126 USPQ2d at 1279-81).
As to the step B (significant more as a whole), no additional step is added plus the measuring steps (mass spectrometry or fluorescence chromatography; section 0023) all fall into common, routine and well-known domain. These steps are recited at a high level of generality, and are necessary data gathering steps that feed into the determining step. One cannot do the determining step without getting the data. This weighs against it being significantly more.
Conclusion
No claim is allowed.
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.
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CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/Primary Examiner, Art Unit 1678
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