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 .
DETAILED ACTION
This Office Action is in response to Applicant’s Arguments and Amendment filed, 06/02/2026, wherein the Amendment amended claims 1, 7-8 13, and 39, cancelled claims 61 and 63-65, and added claims 70-73.
Claims 1, 4-14, 38-40, and 70-73 are pending.
Election/Restrictions
Applicant elected Group I, a method of use, and COVID-19 as the disease; APX-115 as the species of a compound that inhibits endothelial injury; AG-1031, as the compound that promotes endothelial regeneration and inflammation; and a SIRT1 inhibiting nucleic acid as the species of an expressing or inhibiting nucleic acid, in the reply filed on 09/18/2025. As detailed in the 01/02/2026, Office Action, in the course of the search, the election of species requirement for a compound that promotes endothelial regeneration and inflammation was extended to rabeprazole, and the election of species requirement for a compound that inhibits endothelial injury was extended to dexamethasone.
The amendment filed 06/02/2026 amends claim 1, limiting it to a method of treating lung inflammation in an elderly subject by administering “one or more compounds” selected from a Markush group. Applicant additionally added independent claim 73 directed toward a method of treating restenosis or critical limb ischemia by administering “one or more compounds” selected from a Markush group.
Thus, Applicant has deleted claims directed toward the elected disease, i.e., COVID-19, and has amended the claims to recite a Markush group of “one or more compounds” instead of “a compound that inhibits endothelial injury and inflammation and/or a compound that promotes endothelial regeneration, vascular repair, and optionally resolution of inflammation.
It is respectfully pointed out that MPEP 819 states, “The general policy of the Office is that applicants are not permitted to shift to claim another invention after an election is made and an Office action on the merits is made on the elected invention. Specifically, the applicant may not disaffirm or change their election, as a matter of right, after making an oral election and receiving an Office action based upon that oral election in a pending application. See 37 CFR 1.142(b).” However, MPEP 819 also states, “While applicant, as a matter of right, may not shift from claiming one invention to claiming another, the examiner is not precluded from permitting a shift.”
In view of compact prosecution, the examiner is extending the search of the disease to “lung inflammation,” and is interpreting the election of APX-115 as a compound that inhibits endothelial injury and the election of AG-1031 as compound that promotes endothelial regeneration and inflammation, as the species elected as “one or more compounds” as recited in independent claim 1. Since the previous Office Action extended the search to rabeprazole as the compound that promotes endothelial regeneration and inflammation, and extended the search to dexamethasone as the compound that inhibits endothelial injury, the election of species requirement is additionally extended to rabeprazole and dexamethasone.
Claims 4-6, 8-12, 14, 39, 70-71 and 73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and subject matter, there being no allowable generic or linking claim.
Claims 1, 7, 13, 38, 40 and 72 are examined on the merits herein.
Claim Interpretation
Claim 72 is interpreted as a method of treating lung inflammation in an elderly subject, wherein the subject has sepsis, by administering one or more compounds selected from AG-1031. . .or thienopyridine.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Drawing Objections
Applicant’s amendment to [0029] of the specification is sufficient to overcome this objection.
Specification Objections
Applicant’s amendment to the specification is sufficient to overcome this objection.
Claim Objections
Applicant’s amendments to claims 1 and 8 are sufficient to overcome these objections.
35 U.S.C. § 112(b)
Applicant’s amendments to the claims are sufficient to overcome these rejections.
35 U.S.C. § 112(a) Written Description-in-part
Applicant’s amendments to the claims are sufficient to overcome this rejection in-part.
35 U.S.C. § 112(a) Scope of Enablement
Applicant’s amendments to the claims are sufficient to overcome this rejection.
35 U.S.C. § 102 & 103
Applicant’s amendments to the claims are sufficient to overcome these rejections.
REJECTIONS-MODIFIED & NEW
Claim Rejections - 35 USC § 112(b)
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.
(New) Claims 1, 38 and 40 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.
-In claim 1, last line, the phrase "NOX2 inhibiting peptide (NOX2ds-tat),” renders the claim indefinite because it is unclear whether the limitation within the parentheses, which is a species of a NOX2 inhibiting peptide, is part of the claimed invention or merely exemplary, and therefore not further limiting the claim. See MPEP § 2173.05(d).
In view of compact prosecution, for the purpose of applying prior art, NOX2ds-tat is interpreted as exemplary and as not further limiting the claim.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 112(a)-Written Description
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.
(Modified) Claims 1, 38 and 40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See MPEP 2163.
The instant specification provides one species of decitabine analogue (per PubChem, Vidaza and ONUREG are synonyms, PTO-892 of 01/02/2026), which is not a representative number of species of decitabine analogues.
Regarding analogs, Cannon (Burger’s Medicinal Chemistry and Drug Discovery, 6th ed, 2003, PTO-892 01/02/2026) teaches that in analog design, molecular modification of the lead compound can involve one or more of bioisosteric replacement, design of rigid analogs, homologation of alkyl chains or alteration of chain branching, design of aromatic ring-position isomers, alteration of ring size, substitution of an aromatic ring for a saturated one, alteration of stereochemistry, design of geometric isomers or stereoisomers, design of fragments of the lead molecule that contain the pharmacophoric group, and alteration of interatomic distances within the pharmacophoric group or in other parts of the molecule. Cannon teaches that a combination of these strategies to the lead molecule may be advantageous. Cannon further teaches that considering the possible permutations and combinations of these changes that are possible within a single lead molecule, the number of analogs that can be designed from a lead molecule is extremely large (pg. 689).
Fisher (Analog based Drug Discovery, PTO-892 01/02/2026) teaches that the term analogue is a drug whose structure is related to that of another drug but whose chemical and biological properties may be quite different (pg. XXIII). Fisher teaches several types of analogs:
-Structural and Pharmacological analogues which have similar chemical structures, and a similar main pharmacological activity (pg. XXIII),
-Structural analogues which have a similar chemical structure but have quite different pharmacological properties (pg. XXIV), and
-Pharmacological analogues which have a similar pharmacological activity without having any discernible chemical or structural relationship (pg. XXIV).
In view of Cannon and Fisher, drug analogs do not necessarily share a common structure, and if they do share a common structure, they do not necessarily share the same pharmacological activity.
Thus, it is impossible to determine a structure-function relationship between decitabine and its analogs that is critical to impart its function as a compound that treats lung inflammation.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(New) Claims 1, 13, 38 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsugeno (A Proton-Pump Inhibitor, Rabeprazole, Improves Ventilatory Function in Patients with Asthma Associated with Gastroesophageal Reflux, published 2003, PTO-892).
Tsugeno teaches a method of treating asthma by administering rabeprazole to patients (title, abstract; pgs. 460-461, “Discussion”), wherein asthma is an inflammatory lung disease.
Tsugeno teaches its subjects as having a mean age of 67.3, i.e., an elderly subject (pgs. 456-457, “Patients and Methods”).
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 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.
Claims 1, 13, 38, 40, and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Tsugeno (A Proton-Pump Inhibitor, Rabeprazole, Improves Ventilatory Function in Patients with Asthma Associated with Gastroesophageal Reflux, published 2003, PTO-892) in view of Kabirdas (An elderly woman with asthma, eosinophilia, and septic shock, published 2007, PTO-892).
Tsugeno is applied to claims 1, 13, 38. and 40 as discussed above and incorporated herein.
Tsugeno differs from that of instant claim 72 in that it does not teach its patients as having sepsis.
Kabirdas teaches that some patients suffer from asthma and septic shock (title).
As such, an ordinary skilled artisan would reasonably expect that some patients with asthma, i.e., lung inflammation, also suffer from sepsis. It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to apply the methods of Tsugeno, to treat the asthma in patients with sepsis, to arrive at instant claim 72. One of ordinary skill in the art would have been motivated to make such an application, with a reasonably expectation of success because Kabirdas teaches that it is known in the art that patients with asthma also have sepsis, and that the asthma is treated alongside the sepsis (879, Col. 2, 1st full paragraph).
Thus, an ordinary skilled artisan would have been motivated to make such an application to predictably arrive at a method that treats the asthma, i.e., lung inflammation, in a patient also suffering from and being treated for sepsis, thereby stabilizing the patient.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art is US 2021/0253590 to Ge (effectively filed 2018, PTO-892) which teaches a method of treating non-small cell lung cancer by administering AG-1031 ([0156]-[0161]). However, Ge does not teach its methods as treating lung inflammation, which is a distinct feature of the instantly claimed method.
Conclusion
No claims are allowed.
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 LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622
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