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
The claim set submitted on 08 DECEMBER 2025 is acknowledged and considered.
In the claim set, Claims 1, 2, 6 and 8 are ‘Currently amended’; Claims 3-5 and 9 are ‘Previously presented’; Claims 7 and 10-13 are ‘Cancel’; and Claims 14-15 are ‘New’.
Current pending claims are Claims 1-6, 8, 9 and 14-15 and are considered on the merits below.
Response to Amendment/Arguments
Applicant’s arguments, see REMARKS, filed 08 DECEMBER 2025, with respect to the 112(b), claim objection has been fully considered and are persuasive. The 112(b), claim objection has been withdrawn.
Applicant's arguments filed 08 DECEMBER 2025 have been fully considered but they are not persuasive.
Applicant’s arguments rely on language solely recited in preamble recitations in claim(s) 1, 6 and 8. When reading the preamble in the context of the entire claim, the recitation ‘of preventing or treating Post-Traumatic Stress Disorder (PTSD)’ or ‘assessing a subject’s risk of having or developing Post-Traumatic Stress Disorder (PTSD) and treating the subject’ is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of Claim 1 is a method of administering Plasminogen activator inhibitor-1 (PAI-1) antagonist, Claims 6 and 8, the treatment is not particular, and is instead merely instructions to “apply” the exception in a generic way. The claim does not require any particular dosage, mode of administration or frequency of administration or even any step of diagnosis of PTSD.
In regards to Claim 1, the claim recites a mental step type abstract idea. The claim also recites “administering…a therapeutically effective amount of Plasminogen activator inhibitor (PAI-1) antagonist”. This administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.
In regards to Claim 6, the claim recites a mental step type abstract idea. The claim also recites “determining….; and treating...a level …compared to the control….”. This determining and treat steps does not apply the exception. While it is nominally related to the law of nature, the testing does not apply or use the exception in any way. Thus, this testing step does not integrate the law of nature into a practical application.
Similarly, in regards to Claim 8, the claim recites a mental step type abstract idea. The claim also recites “measuring…measuring…determining…treating… or determining…; and treating…”. The determining and treat steps does not apply the exception. While it is nominally related to the law of nature, the testing does not apply or use the exception in any way. Thus, this testing step does not integrate the law of nature into a practical application.
The above mentioned claims, Claims 1, 6 and 8, claims focus on the steps of measuring, determining and treating. Therefore, the methods continue to analyze this as the abstract idea of mental processes in the area of mathematical calculation. The grouping of “mathematical concepts”. The claims teach treating the subject and this treatment is not specifically detailed so there is no particular application claimed and is therefore not significantly more than an abstract idea.
All other claims appear the treatment noted of the protease inhibitor is not specific and highly general.
Regarding the 112(b) rejection regarding ‘effective’, the 112(b) rejection is maintained. The proper test is whether or not one skilled in the art could determine specific values for the amount based on the disclosure. See In reMattison, 509 F.2d 563, 184 USPQ 484 (CCPA 1975).
The claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art. In reFredericksen, 213 F.2d 547, 102 USPQ 35 (CCPA 1954). See MPEP 2173.
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.
Claims 1-5 are 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.
The term “effective” in claim 1 is a relative term which renders the claim indefinite. The term “effective” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art. In reFredericksen, 213 F.2d 547, 102 USPQ 35 (CCPA 1954).
Claims 2-5 depend directly or indirectly from Claim 1 and are also rejected under 112(b).
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention, Claim 1 is directed to an abstract idea without significantly more; Claim 6 is directed to an abstract idea without significantly more; and Claim 8 is directed to an abstract idea without significantly more;. The claim recites a method of administering a therapeutically effective amount of PAI-1 antagonist in Claim1; a method of measuring a level of PAI-1 protein, determining whether or not the level of PAI-1 protein is high and comparing the value to a control and treating the subject in Claim 6; and similarly in Claim 8 measuring a level of PAI-1 in a first sample, second sample and determining whether the level is decreased and comparing the levels of PAI-1 and treating the subject, which are all considered to be an abstract idea and can be performed with the human mind and is considered a mental analysis step.
The limitation in Claim 1 of ‘administering to the patient a therapeutically effective amount of PAI-1 antagonist’ is a mental-type abstract idea. This administration step is not particular and is merely instructions to “apply” the exception in a generic way. Thus the administering step does not integrate the mental analysis step into a practical application.
While in Claims 2-5 there some claim limitations directed to how the PAI-1 binds; this binding claimed does not integrate the law of nature into a practical application.
The limitation of Claim 6 of ‘measuring the level of PAI-1 in a subject…determining the subject has a high level of PAI-1 compared to a control reference value and ….treating…’ is a measuring step and is therefore data gathering and comparing can be done mentally is an abstract idea. In addition, the treating step is not particular and is merely instructions to “apply” the exception in a generic way. Thus the treating step does not integrate the mental analysis step into a practical application.
While in Claim 7 recites conditions of a ‘higher level’ and a ‘lower level’ conditions of diagnosis, this does not integrate the law of nature into a practical application. It is thus extra-solution activity, and does not integrate the judicial exception into a practical application.
The limitation in Claim 8 of measuring the levels of PAI-1 in a first sample and in a second sample, and determining the different levels and comparing and treating, as drafted measuring step is therefore data gathering and determining/comparing can be done mentally and is an abstract idea. While in the instant claim measuring level during or following therapy this is necessary for all uses of the recited exception thus it is an extra-solution activity , and does not integrate the judicial exception into a practical application. In addition, the treating step is not particular and is merely instructions to “apply” the exception in a generic way. Thus the treating step does not integrate the mental analysis step into a practical application.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In each of Claims 1, 6 and 8, the method as claim is recited at a high-level of generality and the claims as a whole does not integrate the judicial exception into a practical exception. In the claims, after the comparison step and generic treatment step; nothing else is done. As mentioned above, the treating step is not particular and is merely instructions to “apply” the exception in a generic way. There are no additional steps which are significantly more than the abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of ‘treating’ is not particular and is merely instructions to “apply” the exception in a generic way. Mere instructions for treating cannot provide an inventive concept.
The claims are not patent eligible.
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.
Claims 1, 3 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by VAUGHAN, PAI-1 ANTAGONISTS: THE PROMISE AND THE PERIL.
Applicant’s invention is directed towards a method.
Regarding Claims 1, 3 and 14-15, the reference The VAUGHAN reference discloses a method or treating disease in a patient, abstract. The method comprise administering to a patient a therapeutically effective amount of a Plasminogen activator inhibitor (PAI-1) antagonist, wherein the PAI-1 antagonist is not epigallocatechin gallate (EGCG), abstract, page 313-34 including Table 1.
It is well known in the art that the fibrinolytic system plays a crucial role in various physiological and pathological processes. The administration of a PAI-1 antagonist would aid in the physiological and pathological processes associated with PTSD.
Claims 1-6, 8 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BOMBI, submitted on the Information Disclosure Statement on 23 DECEMBER 2022, Non-Patent Literature Documents, Cite No. 1.
Applicant’s invention is directed towards a method.
Regarding Claim1 , the BOMBI reference discloses a method of preventing or treating Post Traumatic Stress Disorder (PTSD) in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a Plasminogen activator inhibitor (PAI-1) antagonist, title, abstract, Materials and Methods, Epigallocatechin gallate administration.
Additional Disclosures Included are: Claim 2: wherein the method according to claim 1, wherein said PAI-1 antagonist directly binds to PAI-1 protein or to a-nucleic sequence encoding PAI-1 and promotes tPA/plasmin activity to mediate the proteolytic processing of pro-Brain derived neurotrophic factor (pro-BDNF) to mature BDNF, Materials and Methods, Epigallocatechin gallate administration. ; Claim 3: wherein the method according to claim 1 wherein said PAI-I antagonist is 1) an inhibitor of PAI-1 activity and/or 2) an inhibitor of PAI-1 gene expression, Materials and Methods, Epigallocatechin gallate administration, It is known in the art that Epigallocatechin-3-gallate (EGCG) Serves as a Novel Scaffold for Designing an Inhibitor of Plasminogen Activator Inhibitor-1 (PAI-1). ; Claim 4: wherein the method according to claim 3 wherein said inhibitor of PAI-I activity is selected from the group consisting of a small organic molecule, an anti-PAI-1 neutralizing antibody, a polypeptide and an aptamer, abstract, Introduction EGCG, Materials and Methods, Epigallocatechin gallate administration.. ; Claim 5: wherein the method according to claim 3 wherein the inhibitor of PAI-1 gene expression is selected from the group consisting of an antisense oligonucleotide, a nuclease, siRNA, shRNA and a ribozyme nucleic acid sequence, abstract, Introduction EGCG, Materials and Methods, Epigallocatechin gallate administration.; Claim 14: wherein the method according to claim 1, wherein the PAI-1 antagonist reduces a number of pathological memories in the patient, abstract, Discussion.
Applicant’s invention is directed to a method.
Regarding Claim 6, the BOMBI reference discloses a method for assessing a subject's risk of having or developing Post Traumatic Stress Disorder (PTSD) and treating the subject, said method comprising measuring a level of PAI- protein in a body fluid sample obtained from said subject, Materials and Methods, Cortisone, corticotropin-releasing hormone…, Total RNA isolation… determining that the subject has a higher level of PAI-1 protein compared to a control reference value, Materials and Methods, Cortisone, corticotropin-releasing hormone…, Statistical analysis, and treating the subject determined to have a high level of PAI- protein compared to the control reference value by administering a PAI-1 antagonist, Results (entire section), Figure 2-7.
Regarding Claim 8, the BOMBI reference discloses a method for monitoring a therapy for treating Post Traumatic Stress Disorder (PTSD) in a subject and treating the subject comprising
measuring a level of Plasminogen activator inhibitor PAI-1 in a first body fluid sample obtained from said subject at t1, wherein tl is prior or during to therapy, Materials and Methods, Single prolonged stress, Object recognition task, MWM test, Open field test,
measuring a level of PAI-1 in a second body fluid sample obtained from said subject at t2, wherein t2 is during or following therapy, and when tl is during therapy, t2 is later during therapy or following therapy, Materials and Methods, Corticosterone, corticotropin-releasing…, Total RNA isolation, Statistical analysis
determining that the level of PAI- in the sample measured at t2 is decreased as compared to the level of PAI-1 in the Corticosterone, corticotropin-releasing…, Total RNA isolation , Results (entire section), Figure 2-7, and
treating the subject determined to have a decreased level of PAI-1 by administering the PAI-1 antagonist, wherein said pathological conditions associated with intense stress is Post- Traumatic Stress Disorder (PTSD),
or determining that the level of PAI-1 in the sample measured at t2 is increased compared to the level of PAI-1 in the sample measured at t1, and treating the subject determined to have an increased level of PAI-1 by increasing a dosage of the PAI-1 antagonist, Materials and Methods, Epigallocatechin gallate administration., and Results.
Claims 6, 8 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GIRARD, submitted on the Information Disclosure Statement on 23 DECEMBER 2022, Non-Patent Literature Documents, Cite No. 4.
Applicant’s invention is directed to a method.
Regarding Claim 6, the GIRARD reference discloses a method for assessing a subject's risk of having or developing Post Traumatic Stress Disorder (PTSD), and treating the subject, said method comprising measuring a level of Plasminogen activator inhibitor (PAI-1) protein in a body fluid sample obtained from said subject, Abstract, determining that the subject has a high level of PAI-1 protein compared to a control reference value, page 3423, Statistical analysis, Results , and treating the subject determined to have a high level of PAI- protein compared to the control reference value by administering a PAI-1 antagonist, page3421.
Additional Disclosures Included are: Claim 9: wherein the method of claim 6, wherein the body sample is blood and/or urine sample, page 3421, 3422, Cardiac perfusion and harvesting of brain tissues, Blood collection and human PAI-1 ELISA, page 3428.
20. Applicant’s invention is directed to a method.
Regarding Claim 8, the GIRARD reference discloses a method for monitoring a therapy for treating Post-Traumatic Stress Disorder (PTSD) in a subject and treating the subject , abstract, page 3421, comprising
measuring a level of Plasminogen activator inhibitor (PAI-1) in a first body fluid sample obtained from said subject at t1, wherein tl is prior to or during therapy, abstract, page 3423, Statistical analysis, Results,
measuring a level of PAI-1 in a second body fluid sample obtained from said subject at t2, wherein t2 is during or following therapy, and when tl is during therapy, t2 is later during therapy or following therapy, abstract, page 3423, Statistical analysis, Results, Discussion,
determining that the level of PAI- in the sample measured at t2 is decreased as compared to the level of PAI-1 in the sample measured at t1 abstract, page 3423, Statistical analysis, Results, and
treating the subject determined to have a decreased level of PAI-1 by maintaining a dosage of the PAI-1 antagonist, wherein said pathological condition associated with intense stress is Post- Traumatic Stress Disorder (PTSD); or
determining that the level of PAI-1 in the sample measured at t2 is increased compared to the level of PAI-1 in the sample measured at t1, and treating the subject determined to have an increased level of PAI-1 by increasing a dosage of the PAI-1 antagonist , abstract, page 3423, Statistical analysis, Results.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over BOMBI, submitted on the Information Disclosure Statement on 23 DECEMBER 2022, Non-Patent Literature Documents, Cite No. 1.
Regarding Claim 9, the BOMBI reference discloses the claimed invention, but is silent in regards to wherein the body fluid sample is blood sample and/or urine sample.
BOMBI rather teaches the sample is from plasma, Materials and Methods, Corticosterone, corticotropin-releasing…
It would be obvious to one having ordinary skill in the art before the effective filing date to modify where the body fluid sample is from blood or urine, rather it being from plasma of a subject, as blood or urine sample can be collected less invasively and can be collected without further processing of separation, such as in the case with plasma.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over BOMBI, submitted on the Information Disclosure Statement on 23 DECEMBER 2022, Non-Patent Literature Documents, Cite No. 1, and further in view of VAUGHAN, PAI-1 ANTAGONISTS: THE PROMISE AND THE PERIL.
Regarding Claim 15, the BOMBI reference discloses the claimed invention, but is silent in regards to wherein the PAI-1 antagonist is not epigallocatechin gallate (EGCG).
The VAUGHAN reference discloses a method or treating disease in a patient, abstract. The method comprise administering to a patient a therapeutically effective amount of a Plasminogen activator inhibitor (PAI-1) antagonist, wherein the PAI-1 antagonist is not epigallocatechin gallate (EGCG), abstract, page 313-34 including Table 1.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the BOMBI reference with the PAI-1 antagonist that is not epigallocatechin gallate (EGCG) for the method of treatment or prevention of a disease to effectively restore and augment
the activity of the fibrinolytic system. It is well known in the art that the fibrinolytic system plays a crucial role in various physiological and pathological processes. The administration of a PAI-1 antagonist would aid in the physiological and pathological processes associated with PTSD.
Conclusion
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797