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 .
FINAL ACTION
Amendment Entry
1. Applicant’s response to the Non-Final Action dated 3/13/25 is acknowledged (reply filed 7/14/25). In the amendment filed therein claims 1, 5, 6, 7, and 9 were modified. Claims 2, 8, 16, 22, and 24-26 were previously canceled without prejudice or disclaimer. Currently, claims 1, 3-7, 9-15, 17-21, and 23 are pending.
2. Claims 10, 21, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 11/25/24. Currently claims 1, 3-7, 9, 11-15, and 17-20 are under consideration.
3. Rejections and/or objections of record not reiterated herein have been withdrawn.
Priority
4. The instant application has a priority date of 3/27/19. This application is a U.S. National Phase Application of International Application No. PCT/SG2020/050177, filed March 27, 2020, which claims the benefit of priority of Singapore provisional application No. 10201902763U, filed March 27, 2019.
NEW GROUNDS OF REJECTIONS NECESSITATED BY AMENTMENTS
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.
5. Claims 1, 3-7, 9, 11-15, and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claims as a whole, the claims are determined to be directed to a law of nature/natural principle (abstract idea).
The rationale for this determination is explained below: A claim that focuses on use of a natural principle (such as the comparison of protein levels- see claim 1) must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. The analysis turns on whether the claim has added enough to show a practical application. See id. at 1968.
In other words, the claim cannot cover the natural principle itself such that it is effectively standing alone. A bare statement of a naturally occurring correlation, albeit a newly discovered natural correlation or very narrowly confined correlation, would fail this inquiry. See id. at 1965, 1971. It is not necessary that every recited element or step integrate or relate to the natural principle as long as it is applied in some practical manner.
However, there must be at least one additional element or step that applies, relies on or uses the natural principle so that the claim amounts to significantly more than the natural principle itself.
Along with integration, the additional steps must be sufficient to ensure that the claim amounts to significantly more than the natural principle itself by including one or more elements or steps that limit the scope of the claim and do more than generally describe the natural principle with generalized instructions to “apply it.” See id. at 1965,
1968. The additional elements or steps must narrow the scope of the claim such that others are not foreclosed from using the natural principle (a basic tool of scientific and technological work) for future innovation.
Elements or steps that are well-understood, purely conventional, and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular technological environment (field-of-use), would not be sufficiently specific. See id. at 1968.
The claimed method is drawn to the treatment of a subject having peritoneal carcinomatosis by administering a PAI-1 inhibitor when said subject’s sample exhibits increased concentrations of PAI-1 and increased phosphorylation of STAT3 or decreased concentrations of PAI-1 and increased phosphorylation of STAT3 when compared to a reference.
In the instant case the claims are directed to a naturally occurring correlation, namely the naturally occurring correlation or specific binding complexes formed in nature (such as between peptides and antibodies) and their possible differentiation in patients with disease/disease treatment.
These assay are routinely conducted in the prior art. For examples see Kubala et al. (Cell Reports, Vol.25, pages 2177-2191, 11/20/18) and Placencio et al.( PLOS ONE, July 24, 2015, pages 1-18).
Further analysis of indicative data (i.e. comparison to a reference) or information regarding a sample or test subject to a control or target data reads on “An Idea ‘Of Itself’” as when given its broadest reasonable interpretation, such a comparison would read on a mental process that could be performed in the human mind, or by a human using pen and paper. See July 2015 Update, Quick Reference Guide.
Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and comparing known information in Classen, or comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad
CAFC.
The specific information that is being compared “PAI-1 concentration and STAT3 phosphorylation” measurements compared to standards (known patient responses to treatment/non-treatments) merely narrows the abstract idea, which does not make the comparison step less abstract and is not sufficient to provide eligibility on its own.
In particular, the “measuring and determining” step is recited at a high level of generality and is not sufficient to ensure that the claims amount to significantly more than the naturally occurring correlation itself. This is because every application of the correlation would require determining biomarker levels; and also because the “quantifying” steps do not relate to the natural principle in a significant way to impose a meaningful limit on the claim scope (for example, see claim 1).
Limitations that are necessary for all practical applications of the natural principle, such that everyone practicing the natural principle would be required to perform those steps or every product embodying that natural principle would be required to include those features, would not be sufficient to confer patent eligibility.
In addition, appending conventional steps, specified at a high level of generality, to a natural principle does not make the claim patent-eligible. Steps that amount to instructions that are well-understood, routine, conventional activity, previously engaged in by those in the field add nothing specific to the natural principle that would render it patent-eligible.
The claims do not include additional elements/steps or a combination of elements/steps that are sufficient to ensure that the claims amount to significantly more than a natural principle itself. This is because (1) the claims would cover every substantial practical application of the correlation and (2) the additional steps recited in the claim were previously taken by those in the field. When the claims are considered as a whole, the steps taken together amount to no more than recognizing the law of nature itself.
The analysis is to be used for evaluating whether a claim is drawn to patent-eligible subject matter includes the following steps:
Step 1 determines whether the claim is directed to a process, machine, manufacture, or composition of matter. If the claim is directed to a statutory category, proceed to Step 2.
Step 2 is the two-part analysis from Alice Corp. (also called the Mayo test) for claims directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions).
In Step 2A, Prong 1 determine whether the claim is directed to a law of nature, a natural phenomenon, or an abstract idea enumerated in the 2019 PEG (judicial exceptions) and
Step 2A, Prong 2 determine whether the claim recites additional elements that integrate the exception into a practical application of the exception
If the exception is not integrated into a practical application, then proceed to Step 2B determines whether the claim as a whole amounts to significantly more than the exception.
Analysis of Claims 1, 3-7, 9, 11-15, and 17-20
I. The present claims are directed to a process so Step 1 is satisfied.
II. The present claims are directed to judicial exceptions? Wherein mental processes are utilized at least in claim 1 (analysis of concentration and determining phosphorylation do not include wet steps and therefore read on mental process or abstract ideas which are utilized to determine treatment. This judicial exception includes mental processes - concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Thus step 2A Prong 1 and Prong 2 is satisfied.
Claim 1 is directed to an abstract idea that is not integrated into a practical application (the data is compared but the JE is not integrated into a practical application). The scope of claim 1 encompasses embodiments where the PAI-1 inhibitor is not administered or the subject is not treated when STAT3 phosphorylation is not increased as compared to the reference. In this case, the JE is not integrated into an applicable process/method.
Therefore the recited abstract ideas are insufficient to make an otherwise ineligible claim patent eligible without significantly more recited in the claim(s). The measuring, determining, and comparing steps can be done by merely reviewing the data mentally and assessing whether treatment should be administered. See Bilski V. Kappos 95 USPQ2d 1001 (2010). Additionally, see Mayo Collaborative Services v. Prometheus Laboratories Inc. 101 USPQ2d 1961 (2012) at 1965, quoting Gottschalkv. Benson, 409 U.S. 63, 67 [175 USPQ 673] (1972). ("Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.").
Furthermore, the method of treating peritoneal carcinomatosis as recited does not actually require an active step of treatment (when STAT3 phosphorylation is not increased in the sample) but encompasses abstract ideas and are insufficient to make an otherwise ineligible claims patent eligible, the claims are ineligible subject matter under 35 U.S.C. 101. (Alice Corporation Pty. Ltd. v. CLS Bank International, et al.).
III. Step 2B, is to determine whether the claim as a whole amount to significantly more than the exception. The active method steps of claims 1 are measuring, determining, and administering.
All of the additional claim elements listed are well-understood, routine, and conventional in this art. The active method steps of the claims are readily recognized in the art as routine. For instance see Kubala et al. (Cell Reports, Vol.25, pages 2177-2191, 11/20/18) and Placencio et al.( PLOS ONE, July 24, 2015, pages 1-18). Thus, the active method steps of the present claims are conventional, well understood and routine.
These steps are the activities that a scientist would have relied upon to achieve the goals of the invention. The steps are interpreted as being drawn to mental steps and/or computer-implemented abstract ideas and are insufficient to make an otherwise ineligible claims patent eligible, the claims are ineligible subject matter under 35 U.S.C. 101. (Alice Corporation Pty. Ltd. v. CLS Bank International, et al).
In the present claims there are no other active method steps that transform the process into an inventive application of the measuring, determining, comparing, and administering steps.
In sum, when the relevant factors are analyzed, they weigh against the present claim amounting to significantly more than the judicial exceptions themselves. Accordingly, the claims do not qualify as eligible subject matter.
Unlike Vanda’s claims, where administering is required for all populations of patients, in the instant case, the broadest reasonable interpretation of the claimed scope is that the treatment steps are not necessarily performed. Therefore, the scope encompasses embodiments where the levels of STAT3 phosphorylation is decreased or remains normal in comparison with a reference value and does not require any treatment.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 1, 3-7, 9, 11-15, and 17-20 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter, which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Enablement requires that the specification teach those in the art to make and use the invention without undue experimentation. Factors to be considered in determining, whether a disclosure would require undue experimentation include 1) the nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the quantity of experimentation necessary, 7) the relative skill of those in the art, and 8) the breadth of the claims.
Claim 1 recites - A method of treating a subject suffering from peritoneal carcinomatosis with a plasminogen activator inhibitor 1 (PAI-1) inhibitor, the method comprising measuring the concentration of PAI-1 and determining the level of phosphorylation of signal transducer and activator of transcript 3 (STAT3) in a sample obtained from the subject; comparing the concentration of PAI-1 and the level of STAT3 phosphorylation in the sample to a reference value; and administering the PAI-1 inhibitor to the subject when the sample shows showing (a) an increase in PAI-1 concentration and an increase in STAT3 phosphorylation compared to the reference value, or (b) a decrease in PAI-1 concentration and an increase in STAT3 phosphorylation compared to the reference value, thereby treating the subject suffering from peritoneal carcinomatosis.
As recited, claims 1, 3-7, 9-15, and 17-20 are directed to methods of administering (in vivo) a plasminogen activator inhibitor (PAI-1) inhibitor to a subject in order to treat peritoneal carcinomatosis.
Additionally the PAI-1 inhibitor is administered based on the concentration of PAI-1 and phosphorylated STAT3. However, the method of claim 1 does not provide a connection between the measured biomarkers and their ability to access treatment efficacy. The method does not provide concentrations, dosages, treatment duration of the PAI-1 inhibitor as a means to treatment peritoneal carcinomatosis. In fact, the PAI-1 inhibitor (which would apparently reduce the levels of PAI-1 in the subject) is administered in cases that PAI-1 is increased in step a and in cases where PAI-1 is decreased in step b. See claim 1. It is therefore unclear as to how the PAI-1 inhibitor relates to PAI levels in the subject or the treatment of peritoneal carcinomatosis. It appears that the claims intend to demonstrate an involvement of the PAI-1 inhibitor on STAT3. Yet this involvement is not defined by the claims or the specification.
The specification does not provide an example of an in vivo treatment procedure that administers only a PAI-1 inhibitor to a patient with peritoneal carcinomatosis therein providing treatment as it relates to STAT3 (phosphorylated).
While the prior art teaches that the expression of PAI-1 in mice is associated with increased tumorigenicity, increased presence of M2 macrophages, higher levels of IL-6, and increased STAT3 phosphorylation in macrophages. As well as positive correlations between PAI-1, IL-6, and CD163 (M2 marker) expression by meta-analysis of transcriptome data in many human cancers. And altogether, the data provides evidence for a mechanism explaining the paradoxical pro-tumorigenic function of PAI-1 in cancer. See Kubala et al.
However, the current teaching in the art indicates that peritoneal carcinomatosis is uncurable as the disease reoccurs in every instance and the treatment based is still under review. See the reference to Dadgar et al.(Journal of Translational Medicine, 2024 22:402 pages 1-18).
Dadgar et al. disclose that “Peritoneal carcinomatosis (PC) is a late manifestation of abdominopelvic malignancies, commonly associated with gastrointestinal and gynecological cancers, such as ovarian, colorectal, and pancreatic cancer. [It is] marked by poor prognosis and limited treatment options. PC causes severe symptoms related to intestinal obstruction and nutritional compromise. Treatment is generally considered palliative, as disease recurrence is the rule rather than the exception”. See Dadgar page 1.
Dadgar et al. concludes that “Peritoneal carcinomatosis is a devastating sequela of many primary tumor types, with poor prognosis and limited treatment options. A significant body of evidence implicates the IL-6 pathway as a rational therapeutic target for treatment of PC, due to IL-6 involvement in peritoneal tumor dissemination, proliferation, mesothelial adhesion and invasion, stromal invasion, and immune response modulation.
Targeting IL-6 and its downstream signaling pathways in combination regimens has shown promise in preclinical and clinical studies for various types of cancer that commonly cause PC.” See page 18. Thus the treatment of PC remains unattainable.
Additionally, the prior art has demonstrated that administering PAI-1 inhibitors to treat cancer is undue. For example, Placencio et al. (PLOS ONE, 7/24/15, pages 1-18) highlights important insight into the “limitations and challenges of targeting PAI-I in cancer. A first limitation is the high concentrations (μM) of TM inhibitors needed to reach a biological effect in vitro and in vivo. The average experimental one-hour peak plasma concentration for TM5441 was near the IC50 for HT1080 cells and about half the IC50 for HCT116 cells.
This suggests that the lack of a significant effect on tumor growth in vivo is related to the inability to reach sustainable inhibitor plasma concentrations within the active range. …..Targeting PAI-1 in cancer requires the chronic administration of an inhibitor and thus a much more favorable pharmacokinetic profile where effective concentrations can be achieved for longer periods of time. This will require the development of small molecule inhibitors with activity in the nm. range and with a much longer half-life.” See page 12. These limitations have not been demonstrated in the instant specification as filed.
This data in Placencio et al. represents a first in vivo analysis of TM5441 PAI-1 inhibitor activity in cancer. TM5275 and TM5441 induced intrinsic apoptosis in several human cancer cell lines and inhibited EC branching in a manner that was independent from their apoptotic activity on EC in vitro. Yet, these in vivo results in HT1080 and HCT116 xenograft models showed that although TM5441 had a vascular disruptive effect (and a trend of decreased tumor growth and increased survival in the HT1080 model), these effects were not sufficient to affect tumor growth even as we documented a significant decrease in TUNEL staining in vivo. See page 10.
Applicants have not set forth any supporting evidence that suggests that the claimed methods do not require a connection and are operable as recited. Further, the prior art teaches that markers (detection and correlation) are highly unpredictable and require extensive experimentation.
Tascilar et al. (Annals of Oncology 10,Suppl. 4:S107-S110, 1999) reports on diagnostic methods in the realm of disease states, however this review article is relevant to Applicants’ claimed invention. It is art known that molecular–based assays are valid tools used in predicting and detecting diseases, however as assessed in the Tascilar review “…these tests should be interpreted with caution…”. and “the genetic changes found in sources other than the pancreas itself (blood, stool) should be evaluated prudently”.
Furthermore, Tockman et al. (Cancer Research 52:2711s-2718s, 1992) teach considerations necessary for a suspected cancer biomarker (intermediate end point marker) to have efficacy and success in a clinical application. Although the reference is drawn to biomarkers for early lung cancer detection, the basic principles taught are clearly applicable to other oncogenic disorders.
Tockman teaches that prior to the successful application of newly described markers, research must validate the markers against acknowledged disease end points, establish quantitative criteria for marker presence/absence and confirm marker predictive value in prospective population trials, see abstract. Early stage markers of carcinogenesis have clear biological plausibility as markers of preclinical cancer and if validated (emphasis added) can be used for population screening (p. 2713s, column 1). The reference further teaches that once selected, the sensitivity and specificity of the biomarker must be validated to a known (histology/cytology-confirmed) cancer outcome.
The essential element of the validation of an early detection marker is the ability to test the marker on clinical material obtained from subjects monitored in advance of clinical cancer and link those marker results with subsequent histological confirmation of disease.
“This irrefutable link between antecedent marker and subsequent acknowledged disease is the essence of a valid intermediate end point [marker]”, see page 2714s, column 1, Biomarker Validation against Acknowledged Disease End Points section.
Clearly, prior to the successful application of newly described markers, markers must be validated against acknowledged disease end points and the marker predictive value must be confirmed in prospective population trials, see page 2716s, column 2, Summary section. Tockman reiterates that the predictability of the art in regards to cancer prognosis and the estimation of life expectancies within a population with a disease or disorder are highly speculative and unpredictable.
The instant disclosure has not addressed the issues taught in the prior art as crucial to the discovery of a specific marker and there utility/measurement in vivo or in vitro.
The nature of the invention- the invention is directed to administering a PAI-1 inhibitor to confer treatment of PC in addition to the assessment various markers including STAT3 phosphorylation and IL6.
The state of the prior art- the prior art of record fails to disclose the particular in vivo method combinations that would meet the limitations of the claimed method. In other words it is not clear how the treatment of PC is confirmed.
The predictability or lack thereof in the art- there is no predictability based on the instant specification that the treatment and markers can be identified in vivo and utilized to evaluate PC toxicity and efficacy.
The amount of direction or guidance present- appropriate guidance is not provided by the specification for the claimed method.
The presence or absence of working examples- working examples are not provided in the specification that exemplify the method.
The quantity of experimentation necessary- it would require undue amount of experimentation for the skilled artisan to make and use the method as claimed.
The relative skill of those in the art-the level of skill in the art is high.
The breadth of the claims- as recited, the instant claims are directed to a multiple process (in vivo) biomarkers such as PAI-1, STAT3, IL6, etc. that are not related to the outcome parameter (PC treatment).
While it is not necessary to show working examples for every possible embodiment, there should be sufficient teachings in the specification that would suggest to the skilled artisan that the breadth of the claimed protein construct is enabled. This is not the case in the instant specification.
In view of the teachings of In re Wands, 8 USPQ2d 1400, it has been determined that the level of experimentation required to enable the breadth of the claims is undue.
Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966).
While every aspect of a generic claim does not have to be carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention. Genetech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001. That requirement has not been met in this specification with respect to the claimed method. Therefore, in view of the insufficient guidance in the specification, extensive experimentation would be required to enable the claims and to practice the invention as claimed.
Response to Arguments
Applicant’s arguments have been carefully considered but were not found persuasive. Applicant contends that based on the teachings of the current application, one of ordinary skill at the time of the invention would have understood how to practice the claimed method without undue experimentation.
Applicant submits that claim 1 as amended recite a nexus between the measured biomarkers and the treatment of peritoneal carcinomatosis. Examiner notes that the nexus between the claimed marker and the treatment efficacy is not supported by the claims. The prior art teaches that the administration of a PAI-1 inhibitor to treat cancers like peritoneal carcinomatosis requires specificity in dosage, half-life, treatment regime (duration), and assessments that have not been identified in the disclosure or the claims. See reference to Placencio et al. Therefore the method as claimed in not enabled.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., ascites with high PAI-1 levels and upstream Pai-1 levels) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that the as-filed application describes making an in vivo mouse model of peritoneal carcinomatosis and describes that upon treatment with a PAI-1 inhibitor (TM5441), the mice with increased concentrations of PAI-1 and STAT3 phosphorylation resulted in a significantly superior inhibition of tumor growth compared to vehicle control and fetal bovine serum (paragraphs [0077] to [0079] of the as-filed application). This argument was carefully considered but not found persuasive because the specificities that demonstrate the treatment with TM5441 in PC383 patient-derived ascites-dependent xenograft (PDADX) mice exposed to matched cell-free ascites from the same patient elicited a significantly superior inhibition of tumor growth compared to vehicle control and to fetal bovine serum (FBS) group has not been included in the claimed method. And the prior art teaches that in vivo results in HT1080 and HCT116 xenograft models showed that although TM5441 had a vascular disruptive effect (and a trend of decreased tumor growth and increased survival in the HT1080 model), these effects were not sufficient to affect tumor growth even as we documented a significant decrease in TUNEL staining in vivo. See page 10 of Placencio et al.
Accordingly the claims as recited are not enabled.
14. For reasons aforementioned, no claims are allowed.
15. 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.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Cook whose telephone number is 571-272-0816. The examiner works a flexible schedule but can normally be reached on Monday-Friday from 9am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached at telephone number 571-270-3505. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lisa V. Cook
Patent Examiner
Art Unit 1642
Remsen
571-272-0816
10/18/25
/LISA V COOK/Primary Examiner, Art Unit 1642