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 Claims
There are three (3) sets of claims submitted on 14 JULY 2023. The claim set considered is the claim set with status identifier and Claims 1-13 are ‘Cancelled’ and Claims 14-19 are ‘New’.
Current pending claims are Claims 14-19 and are considered on the merits below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 14 JULY 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification/Abstract
The abstract of the disclosure is objected to because the abstract is not range of 50 to 150 words in length.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The abstract submitted which consists of 1 sentence is significantly less than 50 words despite the document labeled ‘AMENDMENT TO THE ABSTRACT’.
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.
Claim 14 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea, a method of determining bladder cancer disease state in a subject, without significantly more.
The claim(s) recite(s) a method of determining bladder cancer disease state in a subject, the method comprising:
a) assaying a sample of a bodily fluid obtained from said subject for the level of integrin- presenting vesicles comprising a FUCa(1-2)Gal glycan structure, or for the level of integrin antigen comprising a FUCa(1-2)Gal glycan structure,
b) comparing the assayed level obtained in step a) with that of a control sample or a predetermined threshold value, and
c) determining the cancer disease state on the basis of said comparison.
The limitation of step a) assaying a level and then in step b) comparing; is a judicial exception, (an abstract idea that falls within the mathematical concept and mental process groupings in the 2019 PEG, and a law of nature). This claim identifies the recited exception as an abstract idea.
The limitation of steps b) and c) are performed where comparing an assayed level and determining the cancer disease state based on the comparison recites a judicial exception (an abstract idea that falls within the mathematical concept and mental process groupings in the 2019 PEG, and a law of nature). This claim attempts to diagnose/determine bladder cancer disease state based on an assayed level of a marker in a sample of a subject, which describes a correlation or relationship between the marker (level of integrin…comprising FUCa(1-2) Gal glucan structure in a subject and the presence of bladder cancer. This limitation sets forth a judicial exception, because this type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be in a law of nature by the Supreme Court in Mayo.
Comparing and determining are abstract ideas as they encompass observations and evaluations. This claim identifies the recited exception as an abstract idea. Comparing and determining are both abstract ideas in the form of mental processes. These steps are data gathering to be used in the abstract idea and are insignificant extra solution activities. Once step a) is conducted which is well-understood, routine and convention in the art, steps b) and c), as a process, that under its broadest reasonable interpretation, covers performance of the limitation of the mind. This limitation sets forth a judicial exception and can be performed by a human using mental steps or basic critical thinking which is an abstract idea, MPEP 2106.040 (a)(2)(III).
This judicial exception is not integrated into a practical application because the elements of steps b) and c) do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea. While, in some dependent claim include a techniques for analysis, Claims 16 and17, these steps do nothing with the findings. In addition, these additional steps are WURC as taught by the prior art, see below. Therefore, there is no application of the abstract ideas much less a particular practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the abstract idea into a practical application, the steps a)-c) are not an inventive concept as taught by the prior art and acknowledged by Applicant in the background section of the specification.
The steps a)-c) do not appear to have ‘significantly’ more as all steps are WURC (well understood routine and conventional). In a method of method of determining bladder cancer disease state in a subject, steps a) - c) are recited at a high level of generality such that it amounts to an insignificant presolution activity, e.g. mere data gathering is necessary to use to compare, in addition steps b) and c) are WURC as taught by the prior art and as seen in the rejection below. Since it is claimed at a high level of generality, there is no meaningful limitation claimed, such as a particular or unconventional machine or transformation of a particular article.
The claim is not patent eligible.
In addition, dependent claims 15-19 merely recite further limitation of the integrin species, binder molecules or a well-known technique for determining levels are WURC in the study of fluid within a microfluidic system. The limitations are also taught in the rejection below over LU.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by LU, submitted on the Information Disclosure Statement on 14 JULY 2023, Non-Patent Literature Documents, Cite No. 1.
Applicant’s invention is directed towards a method.
Regarding Claim 14, the LU reference discloses a method of determining bladder cancer disease state in a subject, abstract, the method comprising:
a) assaying a sample of a bodily fluid obtained from said subject for the level of integrin- presenting vesicles comprising a FUCa(1-2)Gal glycan structure, or for the level of integrin antigen comprising a FUCa(1-2)Gal glycan structure, page 70-71, Entire ‘EXPERIMENTAL’ Section, in particular, ‘Cell culture and generation …’;
b) comparing the assayed level obtained in step a) with that of a control sample or a predetermined threshold value, abstract, Figure 3(A), page 74, ‘Fucosylation status…’; and
c) determining the cancer disease state on the basis of said comparison, abstract, Figure 3 (A), page 75-77, DISCUSSION.
Additional Disclosures Included are: Claim 15: wherein the method according to claim 14, wherein the integrin species is selected from the group consisting of integrin subunit alpha 3 (ITGA3), integrin subunit alpha 1 (ITGA1), integrin subunit alpha 2 (ITGA2), integrin subunit alpha 4 (ITGA4), integrin subunit alpha 5 (ITGA5), integrin subunit alpha 6 (ITGA6), integrin subunit alpha 11 (ITGA11), integrin subunit alpha V (ITGAV), integrin subunit beta 2 (ITGB2), integrin subunit beta 5 (ITGB5), integrin subunit beta 8 (ITGB8), integrin alpha 2 beta 1 (ITGA2B1) and integrin alpha 3 beta 1 (ITGA3B1), abstract, page 70, ‘EXPERIMETNAL’ Section, in particular, ‘Cell adhesion assay’. ; Claim 16: wherein the method according to claim 14, wherein increased level of said integrin antigen or said integrin-presenting vesicle comprising the FUCa(1-2)Gal glycan structure as compared with that of the control sample or predetermined threshold value indicates that said subject has or is at risk of having bladder cancer, Figure 3(A), page 74, ‘Fucosylation status…’, page 75-77, DISCUSSION . ; Claim 17: wherein the method according to claim 14, wherein said assaying is carried out by using a binder molecule specific for a FUCa(1-2)Gal glycan structure or by using mass spectrometry, nuclear magnetic resonance (NMR) spectroscopy, electrophoresis, chromatography or a combination thereof, page 71-72, ‘Microarray analysis’, REMSA (RNA EMSA). ; Claim 18: wherein the method according to claim 17, wherein the binder molecule is Ulex europaeus agglutinin-I (UEA-I) or an antibody specific for the FUCa(1-2)Gal glycan structure, Figure 3(A), page 74, ‘Fucosylation status…’.; and Claim 19 : wherein the method according to claim 14, further comprising assaying said sample for mucin 1 (MUC1) capable of binding to wheat germ agglutinin (WGA) (MUC1WGA), MUC1 capable of binding to anti-Tn antigen antibody (Tn-AB) (MUClTn-AB), and/or MUC1 capable of binding to Helix pomatia agglutinin (HPA) (MUCIHPA), Table S1.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Litynska, A, et al., Differences of a3b1integrin glycans from different human bladder cell lines, Acta Biochimica Polonica, Vol 47, 2/2000, pages 427-434.
Islam, M. et al, Detection of bladder cancer with aberrantly fucosylated ITGA3 , Analytical Biochemistry 628 (2021) 114283.
Both of the above mentioned NPLs are relevant art as they both relate to a glycan structure as a biomarker for bladder cancer.
Litynska reference teaches a known biomarker integrin subunit and its presences in human bladder cell lines.
The Islam reference is relevant art, with common inventors as the instant application, but is published after the EFD of the instant application. The Islam reference describes a simple, non-invasive assay to identify fucosylated-glycoisoform of integrin alpha-3 (ITGA3) directly from unprocessed urine. ITGA3 was detected directly from the urine of bladder cancer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797