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 .
Withdrawn Rejections
The rejection of claims 137-156, on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,759,482, is withdrawn. The amendments to the claims have been limited to CDC-XOs and the patent claims teach CDC cells.
The provisional rejection of claim 137, on the ground of nonstatutory double patenting as being unpatentable over claim 88 of copending Application No. 17/608,636 (reference application), is withdrawn. The amendments to the claims have been limited to CDC-XOs and the copending claims teach CDC cells.
The rejection of claim(s) 137, 139-144, and 149, under 35 U.S.C. 102(a)(1) as being anticipated by Aminzadeh and Marban (Ciculation Research 12/4/2015 117(12): E125, abstract no. 22919), is withdrawn. The amendments to the claims have been limited to CDC-XOs and Aminzadeh and Marban teach CDC cells, not CDC-XOs.
The rejection of claim(s) 146-148, under 35 U.S.C. 103 as being unpatentable over Aminzadeh and Marban (Ciculation Research 12/4/2015 117(12): E125, abstract no. 22919), is withdrawn. The amendments to the claims have been limited to CDC-XOs and Aminzadeh and Marban teach CDC cells, not CDC-XOs.
The rejection of claim 148, 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn. The amendments cancel claim 148, rendering its rejection moot.
The following rejections of record are being modified to take the amendments into consideration:
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)(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.
Claim(s) 137-142 and 144-145, as amended or previously presented, is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Marban (US 11,357,799 B1 effectively filed 10/3/2014)
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 137, Marban discloses administering a plurality of CDC-XOs alters gene expression in damaged or dysfunctional tissue, improves viability of damaged tissue and/or enhances regeneration or production of new tissue in the individual. In various embodiments, administration of the exosome results in functional improvement in the tissue. In several embodiments, the damaged or dysfunctional tissue includes skeletal muscle tissue. See col 24, lines 48-55 (i.e. subject with dystrophinopathy involving skeletal muscle). For example, in certain embodiments in which skeletal muscle is damaged or dysfunctional, functional improvement may include increased contractile strength, improved ability to walk (for example, and increase in the six-minute walk test results), improved ability to stand from a seated position, improved ability to sit from a recumbent or supine position, or improved manual dexterity such as pointing and/or clicking in a mouse. See col 3, lines 56-63. As such, Marban expressly discloses the limitations of claim 137.
Regarding claim 138, Marban discloses improvements including increased skeletal muscle contractile strength, which is a measurement of isometric force production as discussed above. Marban also discloses measure of ability to walk, sit to stand, and recombinant to supine position which all require isometric skeletal muscle contraction, and as such a measure of isometric force production.
Regarding claims 139-140, Marban discloses a dystrophinopathy (claim 139), more particularly one involving skeletal muscle as discussed above (claim 140).
Regarding claim 141, Marban discloses, in other embodiments, tissue is also subject to damage due chronic conditions such as in DMD (col 25, lines 8-12).
Regarding claim 142, Marban disclose improvement in walking, sit to stand, and sitting up as discussed above. Walking and sit to stand inherently used and measure skeletal muscle of the legs as least (i.e. limbs as claimed).
Regarding claims 144 and 145, Marban discloses administration of exosome to the subject occurs through any known techniques in the art. In various embodiments, deliver can be intra-arterial or intravenous (claim 145). Intravenous is considered a systemic delivery as well (claim 144).
Regarding claim 148, this claim is written in the alternative and specifies concentration of CDC in the dosage. The claim does not specify that the administration is of CDC, the limitations remain in the alternative and thus the exosome therapy disclosed by Marban meet the requisite limitations of this claim.
In conclusion, the prior art of Marban anticipates the claims because it expressly or inherently discloses all of the required limitations of the claims.
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.
Claims 146-147, 149, 151-153, and 155-156, as amended or previously presented, is/are rejected under 35 U.S.C. 103 as being obvious over Marban (US 11,357,799 B1 effectively filed 10/3/2014).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claims 146-147, Marban teach the CDC-XOs therapy for improvement of skeletal muscle function, more particularly isometric force production as discussed above. Marban does not teach two or more administrations (claim 146) or a three month interval between administrations (claim 147). However before the time of effectively filing determining number of doses and intervals between doses was routine optimization and thus obvious variant of the teachings of the Marban method.
Regarding claim 149, Marban does not teach the concentration of the doses claimed in this claim. However, dosage concentration is routine optimization and convention in the prior art as the time of Marban and thus the claimed concentrations are obvious variants of the exosome method of Marban.
Regarding claim 151, Marban teach that the method is intended to used with DMD patients and the measure of skeletal muscle improvement taught by Marban are walking, sit to stand, sitting up right from a supine to recumbent position, all of which are human measures. As such, it would have been obvious to an artisan that the CDC-XOs would be human and the subject would be a human with dysphinopathy involving skeletal muscle.
Regarding claim 152, Marban teaches a method of improving (restoring) skeletal muscle isometric force production in a subject with muscular dystrophy as discussed above. Marban teaches administering CDC-XOs as discussed above. Marban does not teach multiple administrations with the claimed intervals and at the recited concentrations. However, as already discussed above administration schedule and dosing is routine and conventions in the prior art and would be obvious. Thus Marban is an obvious variant of claim 152.
However, MPEP § 2144.05 (II) states the following:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
Regarding claim 153, Marban teaches intravenous administration as discussed above.
Regarding claim 155, Marban teaches DMD as discussed above.
Regarding claim 156, Marban teaches at leg dystrophic skeletal muscle as discussed above.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Response to Arguments
Applicant's arguments filed 2/19/2026 have been fully considered but they are not persuasive.
Applicant submits that Marban discloses the application of administering a composition of CDC in treating heart failure secondary to muscular dystrophy. As such, Marban does not disclose or teach the amended claims.
In response, Marban additionally discloses/teaches administering CDC-XO to treat skeletal myopathy as discussed above in the rejection of record. See the rejection above for more details.
The following new objection is necessitated by the amendments to the claims:
Claims 143 and 154 are 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.
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 MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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