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 . 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.
Priority
The instant application is a 371 of PCT/EP2022/064534 filed on 05/30/2022 and claims foreign priority to application no. IT102021000014333 filed on 06/01/2021. The certified copy of the foreign priority application filed on 11/28/2023 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/20/2026 and 05/18/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Claims
The claim amendments and remarks filed on 06/18/2026 is acknowledged. Claims 11 and 20 are amended. Claims 1-10, 12, 17-19, 21, and 26-28 are cancelled.
Accordingly, claims 11, 13-16, 20, and 22-25 are pending and being examined on the merits herein.
Withdrawn Rejections
The cancellation of claims 12, 17-19, 21, and 26-28 render the prior art rejections over these claims moot.
The 35 USC 102 rejections over Yennurajalingam for claims 11, 13-15, 20, and 22-24 and over Lee for claims 11, 16, 20, and 25, and the 35 USC 103 rejection over Yennurajalingam for claims 20-24, 26, and 28 are withdrawn because these rejections previously relied on administering dexamethasone to arrive at the claimed invention, however, dexamethasone has been removed from the instant claims. Furthermore, the instant claims recite the new limitation “wherein the method does not included administration of any other inhibitor compound”, which was not previously considered in these rejections.
The following grounds of rejection are new as necessitated by Applicant’s amendments.
Claim Interpretation
The limitation “wherein the method does not include administration of any other inhibitor compound” as recited in claims 11 and 20 is being interpreted as excluding out any D2 inhibitor compounds and not necessarily compounds that inhibit an activity other than D2 because the specification on page 5 lines 18-22 defines the term “inhibitor compound” as a substance capable of reducing and/or blocking the activity of an enzyme by binding to “this protein” (referring to type 2 iodothyronine deiodinase (D2) enzyme protein) and modifying the catalytic properties of the enzyme, and that the expression “inhibitor compound” is understood to encompass both selected and non-selective D2 inhibitors. Furthermore, the method claims recited the transitional phrase “comprising”, which means any additional, unrecited elements or method steps are not excluded. See MPEP 2111.03.
Therefore, administering compounds that inhibit an activity other than D2 are within scope of the claimed invention.
Claim Rejections - 35 USC § 102
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(s) 11, 16, 20, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (Food Funct., published 04/06/2021 in PTO-892).
Xu teaches that genistein suppresses allergic contact dermatitis through regulating the MAP2K2/ERK pathway (Abstract).
Xu evaluated the role of genistein in alleviating squaric acid dibutylester (SADBE)-induced allergic contact dermatitis (ACD) in mice (Abstract). Xu demonstrates that mice were subcutaneously injected with genistein at dosages ranging 10 to 40 mg/kg (section 2.3 left column page 4558). Since the genistein was injected into mice, the genistein disclosed in Xu would necessarily be a pharmaceutical composition with at least an acceptable vehicle.
Xu demonstrates in Fig 1-6 (pages 4557, 4560, 4562-4564) that the genistein exerted protective effects on skin damage and inflammatory cell infiltration in treated mice and further inhibited the increased expressions of pro-inflammatory factors in skin and peripheral blood, and down-regulated the levels of p-ERK, p-p38 and p-STAT3 in skin and dorsal root ganglions (DRGs) (Abstract).
Xu discloses that their findings demonstrate that genistein exhibits strong antipruritic and anti-inflammatory effects in ACD mice by inhibiting the production of pro-inflammatory cytokines and intracellular MAP2K2/ ERK cell signaling, which makes genistein a potentially valuable candidate for the treatment of skin conditions and systemic syndromes in the setting of contact dermatitis (Abstract).
Therefore, instant claims 11, 16, 20, and 25 are anticipated.
Claim Rejections - 35 USC § 103
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.
Claim(s) 11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Anker (US20090248101A1 in PTO-892).
Anker discloses a therapy with a cardiac pacemaker for the treatment of subjects without cardiac diseases, in particular human patients with any cancer or patients with cachexia due to acute or chronic illness other than cardiac illness, including malignant tumor disease, COPD, chronic renal failure, liver cirrhosis, chronic infections, and/or AIDS (Abstract, paragraph 0003, and claims 1-18). Anker teaches the invention is implemented by a method comprising the connection of the heart of the human subject with the cardiac pacemaker, in particular to reverse muscle wasting, improve compliance to cancer therapy, and others (Abstract and 1-2).
Anker discloses that patients with cachexia without cardiac disease have an increased frequency of arrhythmias leading to an increased frequency of sudden death (paragraph 0023-0024). Anker further demonstrates in Example 1 (paragraphs 0037-0040) that there was a significant increase in arrythmias in patients with cachexia due to pancreatic cancer compared to healthy controls.
Anker demonstrates in Examples 2-4 (paragraphs 0041-0047) that treating this patient population with their cardiac pacemakers results in reduced cardiac death and decreased overall mortality rate, reduced frequency and/or intensity of weight loss or reverse prior weight, and improved symptom status with regards to shortness of breath and fatigue status, muscle strength, and exercise capacity.
Anker further discloses that their cardiac pacemaker treatment method can further include the use of an anti-arrhythmic drug such as amiodarone and others (claims 33-34 and paragraph 0020).
Even though Anker does not demonstrate the use of the disclosed anti-arrhythmic drug such as amiodarone in combination with their cardiac pacemakers, it would have been prima facie obvious before the effective filing date of the claimed invention to have used an anti-arrhythmic drug such as amiodarone in combination with their cardiac pacemakers to treat patients with cachexia due to cancers and improve their symptoms such as reversing muscle wasting as disclosed in Anker to arrive at the claimed invention.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Anker discloses that the application of their cardiac pacemaker to treat in patients with cachexia due to pancreatic cancer and increased arrythmias resulted in improved symptoms, and Anker further discloses including anti-arrythmias drugs such as amiodarone in their treatment method.
Furthermore, the method of Anker as described above meets the limitation “wherein the method does not include administration of any other inhibitor” because the cardiac pacemaker is not an inhibitor compound and no other D2 inhibitor compounds besides the recited amiodarone are included in the method of Anker as described above.
Claim(s) 20 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Anker (US20090248101A1 in PTO-892) in view of Mosher et al. (US20030216353A1 in PTO-892).
The teachings of Anker as described above.
Even though Anker provides guidance of using amiodarone in combination with their cardiac pacemakers to treat patients with cachexia due to cancers and improve their symptoms such as reversing muscle wasting as discussed above, Anker does not disclose a pharmaceutical composition comprising the amiodarone and a pharmaceutically acceptable vehicle, excipient, and/or diluent.
Mosher discloses improved anti-arrhythmic formulations and in particular to a parenteral formulation containing amiodarone and a sulfoalkyl ether cyclodextrin and to its use in the treatment of cardiac disorders (paragraph 0001).
Mosher discloses that their amiodarone formulations provides a commercially viable formulation that can be prepared and stored in aqueous liquids at a wide range of physiologically acceptable pH values and concentrations of amiodarone without significant precipitation of the amiodarone in vitro and further discloses that their formulations are pharmaceutically stable with a wide range of buffers, saline, or lactated Ringers solutions and has a greater surface tension than other marketed formulation and therefore allows for more accurate dosing when administered in drip counter infusion sets (paragraph 0037).
Mosher discloses that their formulations are reconstitutable solid pharmaceutical composition comprising the antiarrhythmic agent, a sulfoalkyl ether cyclodextrin (SAE-CD), and optionally at least one other pharmaceutical excipient (paragraph 0047).
It would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the amiodarone of Anker as described above into the amiodarone pharmaceutical formulations disclosed in Mosher to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this modification because Mosher discloses that their amiodarone formulations have several advantages such as being stable at a wide range of physiologically acceptable pH values and concentrations of amiodarone without significant precipitation of the amiodarone in vitro and having a greater surface tension than other marketed formulation, which allows for more accurate dosing when administered in drip counter infusion sets.
One of ordinary skill in the art would have a reasonable expectation of success because both Anker and Mosher disclose the use of amiodarone as an anti-arrhythmic drug.
Response to Arguments
Applicant’s arguments filed on 06/18/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant presents arguments against the teaching of Yennurajalingam and Lee on the basis that the instant claims exclude administering the dexamethasone disclosed in these references.
However, the teachings of Yennurajalingam and Lee are not relied upon in the new rejections discussed above, rendering Applicant’s arguments moot. Furthermore, the new rejections anticipate or make obvious administering a recited D2 inhibitor compound (genistein or amiodarone) as discussed above to arrive at the claimed invention.
Conclusion
No claim is found allowable.
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.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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