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
Status of 17/775,713
Claims 1-3, 5-7, 9-11, 15, 17-20, 23-27, and 29 are currently pending.
Priority
Instant application 17/775,713, filed 5/10/2022, claims priority as follows:
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Support for the instant claims is found in the provisional application and thus, claims 1-3, 5-7, 9-11, 15, 17-20, 23-27, and 29 are granted the effective filing date of 11/10/2019.
Information Disclosure Statement
All references from the IDS’s submitted on 8/10/2022, 8/29/2023, 8/30/2023, 9/26/2024, and 9/29/2025 have been considered unless marked with a strikethrough. The IDS’s submitted 5/14/2025 are incomplete, and therefore were not considered.
Response to Applicants Arguments/Amendments
The amendment filed 9/29/2025 has been entered. Claims 1-3, 5-7, 9-11, 15, and 17 have been amended. Additionally, claims 18-20 and 23-26 have also been amended, though they were withdrawn in the Non-Final dated 6/27/2025. No claims have been added and no claims have been cancelled.
In the Non-Final dated 6/27/2025, the drawings were objected to for pixelated and illegible text. In response, Applicant has submitted replacement drawing sheets with corrected images to overcome the objection. Thus, the objection is withdrawn.
Claim 11 was objected to in the Non-Final dated 6/27/2025 for improper dependency and a minor informality. Upon correction of the claim to ensure proper dependency and to replace “Nanoparticle” with “nanoparticle”, the objection is overcome and withdrawn.
Claims 2-3, 5-6, 11, 15, and 17 were rejected under 35 U.S.C. 112(b) in the Non-Final dated 6/27/2025. In response, Applicant has amended the claim 1 to solely recite “biodegradable polymer”, and amended the claims to omit parentheses, the term “e.g.”, the term “about”, the term “preferably”, and the term “for example”. Additionally, claims 5-6 and 11 have been amended to recite narrow range limitations in the claims. Thus, the rejections are overcome and withdrawn.
In the Non-Final dated 6/27/2025, claims 1-3, 5-7, 9-11, 15, and 17 were rejected under 35 U.S.C. 103. Applicant’s arguments, particularly with respect to the unexpected results sections affirming the synergistic effect of the combination of T3 and phosphocreatine in the restoration of ATP levels in cardiac myocytes under hypoxic conditions of Figure 1, have been fully considered and are deemed persuasive. Therefore, the rejection under 35 U.S.C. 103 of claims 1-3, 5-7, 9-11, 15, and 17 is overcome and withdrawn.
Claims 1-3, 5-7, 9-11, and 17 were rejected on the ground of nonstatutory double patenting in the Non-Final dated 6/27/2025. As stated above in the response to the 103 rejection, Applicant’s arguments with respect to the unexpected results section, have been considered and are deemed persuasive. The synergistic, beneficial result is unexpected and thus, the rejection is overcome and withdrawn.
Election/Restriction
Applicant’s election of Group I, claims 1-3, 5-7, 9-11, 15, and 17, drawn to compositions comprising nanoparticles of T3 and phosphocreatine encapsulated or immobilized by a bioabsorbable layer, without traverse, in the reply filed 5/14/2025 is acknowledged. Applicant’s election of a PLGA based composition comprising nanoparticles of T3 and phosphocreatine in the reply filed 5/14/2025, is also acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
In the Non-Final dated 6/27/2025, the elected species was searched and prior art was identified. In response, Applicant has argued that there are unexpected results affirming the synergistic effect of the combination of T3 and phosphocreatine in the restoration of ATP levels in cardiac myocytes under hypoxic conditions, presented in Figure 1. Thus, the rejection was overcome and withdrawn. Subsequent examination is based on the search of the full scope of the Group I claims, claims 1-3, 5-7, 9-11, 15, and 17. Claims 18-20, 23-27, and 29 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim. The Examiner notes the withdrawn claims are not in condition for allowance; there are 112(a) issues with claims 18-20, 23-27, and 29.
Claim Interpretation
Claim 9 recites the limitation, “bioabsorbable polymer”. The instant specification does not explicitly define this limitation, but does give an example as chitosan (para [0050]). Additionally, the term “biodegradable polymer” is used in claims 1, 2, and 17, and is also not explicitly defined in the instant specification. Chitosan is listed as an example of a “biodegradable polymer” as well (para [0039], lines 1.16). However, because one of ordinary skill would easily be able to differentiate between the two terms, these terms are currently being interpreted as distinct and not interchangeable.
NEW REJECTIONS NECESSITATED BY AMENDMENT
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.
Claim 9 is 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.
Claim 9 recite the limitation “bioabsorbable polymer”. However, upon amendment to the claims, there is no longer a recitation of a bioabsorbable polymer in claim 1, the claim from which claim 9 depends, thus creating a lack of antecedent basis. Appropriate correction is required.
Close Prior Art Not Cited
Close prior art not cited is Avant Garde Therapeutics Inc. (WO 2012/170017 A1, cited in the IDS of 8/29/2023, herein after “Avant”), which is drawn to chitosan-based nanoparticle formulations containing triiodothyronine (T3) and poly (lactic-co-glycolic acid) (PLGA) (page 5, Table) for use in the treatment of cardiac conditions (page 1, para [0001). As discussed in the Non-Final dated 6/27/2025, Avant teaches T3 nanoparticles encapsulated or immobilized by the bioabsorbable polymer chitosan (page 5, Table and para [0006]), that the T3 can be covalently linked to the polymer (page 3, para [0007) and page 4, para [0010]), and the addition of PLGA (page 5, Table), where PLGA has 50/50 co-polymerization of D,L-lactic acid and glycolic acid (para [0006], part b.) to the nanoparticle formulation. Furthermore, Avant teaches that the T3 nanoparticles have an average diameter of 50-1000 nm, further narrowing to 100-500 nm, then 50-250 nm, and finally 50-100 nm (para [0006], part f. and claim 7), zeta potentials that range from 10-100 mV, that the nanoparticles may comprise a second pharmacologically active ingredient (claim 9, and para [0006], part h.), and that the T3 nanoparticles may be dispensable in physiological saline, which is a physiological sterile medium. Though Avant teaches most of the limitations of the instant claims, Avant differs from the instant claims because does not teach the addition of phosphocreatine in the nanoparticle formula.
The reference Alfasigma S. P. A. (WO 2019/180199 A1, cited in the IDS of 8/10/2022, herein after “Alfasigma”) was used in the Non-Final dated 6/27/2025 to supply the limitation missing from Avant, as it teaches that phosphocreatine can be used in the treatment of acute and chronic heart failure, as well as in acute ischemic attack of the myocardium and in cardiac surgery (page 4, lines 13-14). However, Alfasigma differs from the instant claims because it does not teach the limitations of the nanoparticles and does not teach a formulation containing T3. Though the Examiner initially made an obviousness argument with the two references, Applicant’s arguments, particularly with respect to the unexpected results sections affirming the synergistic effect of the combination of T3 and phosphocreatine in the restoration of ATP levels in cardiac myocytes under hypoxic conditions of Figure 1, have been fully considered and are deemed persuasive. There is no other motivation, teaching, or suggestion in Avant, Alfasigma, or in additional prior art, to modify the nanoparticle formulations to arrive at the instant claims.
Allowable Subject Matter
Claims 1-3, 5-7, 10-11, 15, and 17 are allowed.
Conclusion
Claims 1-3, 5-7, 10-11, 15, and 17 are allowed. Claim 9 is rejected. Claims 18-20, 23-27, and 29 remain withdrawn.
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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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621