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 .
Amendment
This office action is responsive to the amendment filed on 2/3/26. As directed by the amendment: claim 24 has been amended, claims 2, 5, 7, 14-19, 22-23, 28-38 and 40-46 have been canceled, and no new claims have been added. Thus, claims 1, 3-4, 6, 8-13, 20-21, 24-27 and 39 are presently pending in the application.
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.
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, 6, 8-13, 20-21, 24-27 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over McCully et al. (2018/0057610) in view of De Vrij (2022/0056081).
Regarding claim 1, McCully discloses a method of treating a subject having a respiratory disorder [0011][0205], the method comprising administering a composition comprising a therapeutically effective amount of respiration-competent [0289] mitochondria [0011] to the subject through respiratory tract [0127]. McCully teaches that the composition is delivered via inhalation, but is silent regarding that the composition is an aerosolized composition. However, De Vrij teaches delivering aerosolized cellular vesicle compositions via inhalation [0173][0175]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McCully’s composition being delivered via inhalation with an aerosolized composition delivered via inhalation, as taught by De Vrij, for the purpose of providing an alternate inhalation delivery having the predictable results of delivering the composition to the user’s lungs.
Regarding claim 6, the modified McCully discloses that the subject has acute lung injury, respiratory failure, reduced respiratory function, lung inflammation, lung carcinoma, skin wrinkles, baldness, and/or cancer ([0011][0204-0205] McCully).
Regarding claim 8, the modified McCully discloses that the concentration of mitochondria in the composition is about 1x105 to 5x108 ml-1 ([0310] McCully).
Regarding claim 9, the modified McCully discloses that the subject is administered about 1x105 to 1x109 of mitochondria per dose ([0151][0310] McCully).
Regarding claim 10, the modified McCully discloses that the mitochondria are autogenic, allogeneic, or xenogeneic ([0014] McCully).
Regarding claim 11, the modified McCully discloses that the composition further comprises a solution selected from the group consisting of: K+-HEPES with a pH from 7 to 8 ([0126] McCully), saline, phosphate-buffered saline (PBS), serum, and plasma.
Regarding claim 12, the modified McCully discloses that the composition further comprises one or more osmolytes selected from the group consisting of: trehalose, sucrose ([0126] McCully), mannose, glycine, proline, glycerol, mannitol, sorbitol, betaine, and sarcosine.
Regarding claim 13, the modified McCully discloses that the composition further comprises a pharmaceutical agent ([0044] McCully), a therapeutic agent, a diagnostic agent, a chemotherapeutic agent, and/or a pharmaceutically acceptable diluent, excipient, or carrier, wherein the therapeutic agent or the diagnostic agent is linked to the mitochondria by a covalent bond ([0044] McCully), is embedded in the mitochondria, or is internalized within the mitochondria.
Regarding claim 20, the modified McCully discloses that the mitochondria are genetically modified ([0221] McCully).
Regarding claim 21, the modified McCully discloses that the mitochondria comprise exogenous polypeptides, polynucleotides, DNA ([0014] McCully), RNA, mRNA, micro RNAs, nuclear RNAs, and/or siRNA.
Regarding claim 24, McCully discloses a composition [0011] comprising a plurality of liquid droplets comprising a buffer [0020][0126], wherein at least one liquid droplet in the plurality of liquid droplets comprises at least one respiration-competent [0289] mitochondrion [0020][0145], the composition is delivered via inhalation [0127], but is silent regarding that the composition is an aerosolized composition. However, De Vrij teaches delivering aerosolized cellular vesicle compositions via inhalation [0173][0175]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McCully’s composition being delivered via inhalation with an aerosolized composition delivered via inhalation, as taught by De Vrij, for the purpose of providing an alternate inhalation delivery having the predictable results of delivering the composition to the user’s lungs.
Regarding claim 25, the modified McCully discloses that the buffer is selected from the group consisting of: K+-HEPES with a pH from 7 to 8 ([0126] McCully), saline, phosphate-buffered saline (PBS), serum, and plasma.
Regarding claim 26, the modified McCully discloses that the composition further comprises one or more osmolytes selected from the group consisting of: trehalose, sucrose ([0126] McCully), mannose, glycine, proline, glycerol, mannitol, sorbitol, betaine, and sarcosine.
Regarding claim 27, the modified McCully discloses that the composition further comprises a pharmaceutical agent ([0044] McCully), a therapeutic agent, a diagnostic agent, a chemotherapeutic agent, and/or a pharmaceutically acceptable diluent, excipient, or carrier, wherein the therapeutic agent or the diagnostic agent is linked to the mitochondria by a covalent bond ([0044] McCully), is embedded in the mitochondria, or is internalized within the mitochondria.
Regarding claim 39, the modified McCully discloses the composition comprises autogenic mitochondria, allogeneic mitochondria, xenogeneic mitochondria, or a mixture thereof ([0014] McCully).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over McCully and De Vrij, as applied to claim 1 above, in further view of Dizerega (2019/0365700).
Regarding claim 3, the modified McCully teaches that the composition is delivered via aerosol inhalation, but is silent regarding that the composition is converted into an aerosol form prior to administration to the subject by using a nebulizer, a vaporizer, a nasal sprayer, a pressurized metered dose inhaler, or a breath activated pressurized metered dose inhaler. However, Dizerega teaches cellular compositions ([0012][0015] Embodiment 68) that are converted into an aerosol form prior to administration to the subject by using a nebulizer ([0015] Embodiment 54). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified McCully’s composition being delivered via aerosol inhalation with an aerosolized composition delivered via a nebulizer, as taught by Dizerega, for the purpose of providing an alternate inhalation delivery having the predictable results of delivering the composition to the user’s lungs.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over McCully, De Vrij and Dizerega, as applied to claim 3 above, in further view of Brosnan (2016/0113887).
Regarding claim 4, the modified McCully is silent regarding that the aerosol form of the composition comprises droplets that have a median size from 1 to 1000 microliters. However, Brosnan teaches an aerosol form of a composition comprises droplets that have a median size from 1 to 1000 microliters [0079]. It would have been obvious to one of ordinary skill in the art to modify the modified McCully’s droplet median size with a median size from 1 to 1000 microliters, as taught by Brosnan, for the purpose of providing respirable sized droplets.
Response to Arguments
Applicant's arguments filed 2/3/26 have been fully considered but they are not persuasive.
Applicant argues on pages 6-7 separately on page 8 that De Vrij does not demonstrate any aerosolization of any composition or particle described therein.
Examiner disagrees since De Vrij teaches aerosolization of cellular vesicle compositions for inhalation ([0173][0175] the cellular vesicles are delivered via inhalation, aerosol delivery).
Applicant argues on page 6 that De Vrij does not teaches that the composition could maintain respiratory competency or provide a therapeutic effect.
This argument is not taken well since the word “maintain” is not found in the claim language. Further, McCully is already applied to disclose the inhalation delivery of respiratory-competent [0289] mitochondria. Finally, McCully discloses providing an effective amount of the mitochondria [0011] to the user via inhalation [0127] and De Vrij teaches providing an effective amount of the extracellular vehicle [0177] to the user via aerosolized inhalation [0173][0175].
Applicant argues on pages 6-8 that De Vrij does not teach respiration-competent organelles and that the viral-infected vesicles are very different from mitochondria. Applicant argues that none of the examples 1-6 discuss any composition that can be aerosolized.
This argument is not taken well since again McCully is relied upon to teach the respiration-competent mitochondria [0289] that are delivered via inhalation [0127]. Further, De Vrij is looked to teach an alternate cellular organelle [0177] that is delivered to a user via aerosolized inhalation [0173][0175]. Considering McCully discloses providing mitochondria via inhalation to a user, it would have been obvious to look to De Vrij to further teach that the inhalation is performed via aerosolization since De Vrij teaches another cellular organelle delivered via aerosolized inhalation [0173][0175].
Applicant argues on page 8-9 that the present application is the first to the Applicant's knowledge to demonstrate mitochondria can be aerosolized successfully and further that the aerosolized mitochondria composition can be administered to provide a therapeutic effect.
This argument is not taken well. Aerosolization is a very common way to deliver compositions via inhalation. Since, again, McCully discloses providing mitochondria via inhalation to a user, it would have been obvious to look to De Vrij to further teach that the inhalation is performed via aerosolization since De Vrij teaches another cellular organelle delivered via aerosolized inhalation [0173][0175]. With respect to providing a therapeutic effect, McCully discloses providing an effective amount of the mitochondria [0011] to the user via inhalation [0127] and De Vrij also teaches providing an effective amount of the extracellular vehicle [0177] to the user via aerosolized inhalation [0173][0175].
Applicant argues on page 9-10 that Dizerega fails to teach that a composition comprising a composition of cells can be aerosolized.
Examiner disagrees since Dizerega teaches cellular compositions ([0012] “wherein the administering of the cellular composition is by…pulmonary administration” [0015] Embodiment 68 “the modified tumor-specific immune cells obtained by the method of any one of embodiments 1 to 67” where embodiment 54 recites “the pulmonary administration comprises nebulization and wherein the nebulizing results in pulmonary delivery of aerosol droplets of the composition”) that are converted into an aerosol form prior to administration to the subject by using a nebulizer ([0015] Embodiment 54). Therefore, from the above cited paragraphs, Dizerega does teach cellular compositions that are delivered via a nebulizer for inhalation.
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 RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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