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 claims
The amendment filed on May 18, 2026 is acknowledged. Claim 8 has been canceled. Claims 1-7 and 9-19 are under examination in the instant office action.
Applicants' arguments, filed on May 18, 2026, have been fully considered but they are moot in view of new grounds of rejection necessitated by the amendments (adding new limitations in claims 1, 7, and 19) and Applicant’s submission of an information disclosure statement under 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p) on July 2, 2026. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 1-7 and 9-19 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 pre-AIA the applicant regards as the invention. All the dependent claims are included.
Claim 1 as amended recites “artificial ventilation” in line 7”. While claim 1 as amended recites “controlled mechanical ventilation” in line 3, “controlled mechanical ventilation” is one form of “artificial ventilation”. The recitation of “artificial ventilation” in line 6 is indefinite as it is unclear whether said “artificial ventilation” refers back to “controlled mechanical ventilation” or in fact said “artificial ventilation” is not limited to “controlled mechanical ventilation”.
If “artificial ventilation” in line 7 is amended to --controlled mechanical ventilation--, the rejection will be obviated.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites “the subject is undergoing positive pressure mechanical ventilation”. However, claim 1 from which claim 6 depends is amended to recite “undergoing controlled mechanical ventilation”. The “controlled mechanical ventilation” is a form of positive pressure mechanical ventilation. Thus, claim 6 fails to further limit the subject matter of the claim 1 from which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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.
Claims 1-3, 5-7, 9-10, and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2022/223767 (hereafter, GRINNEMO; cited in the IDS filed on July 2, 2026) as further evidenced by Power et al. (Am J Physiol Regul Integr Comp Physiol 305: R464–R477, 2013, prior art of record).
GRINNEMO teaches methods for obtaining extracellular vesicles (EVs) from cells such as mesenchymal stromal cells (MSCs) and a method for treatment and prophylaxis of medical conditions such as critical illness myopathy (CIM) and ventilator induced diaphragm muscle dysfunction (VIDD) comprising to a subject in need thereof a therapeutically effective amount of EVs (abstract, p9, lines 9-16, claim 18, and Example 2).
GRINNEMO further teaches that the MSCs are obtained from bone marrow and can be differentiated from human pluripotent cells (p6, lines 28-30 and p11, lines 5-13). GRINNEMO specifically disclosed EV isolated from human bone marrow mesenchymal stromal cells (p18, lines 23-24).
GRINNEMO specifically disclose intensive care unit (ICU) rat model wherein adult female Sprague-Dawley rats were exposed to controlled mechanical ventilation, neuromuscular blockade (pharmacologically paralyzed postsynaptically with cobratoxin) and deep sedation for five days (prolonged immobilization) (p16, lines 11-19). The ICU rat model is the same model that experiences muscle wasting due to controlled mechanical ventilation and post-synaptic neuromuscular blockade as disclosed in the instant specification (see [0058]). Also, the subject is exposed to prolonged immobilization, which is necessarily characterized by muscular atrophy. This is further evidenced by Power et al., which teach that muscle wasting is caused by a prolonged immobilization, positive pressure mechanical ventilation (MV) or ventilator-induced diaphragm dysfunction (VIDD) (abstract). Power et al. teach that prolonged MV can promote diaphragmatic atrophy and contractile dysfunction, which is referred to as ventilator-induced diaphragm dysfunction (VIDD) and only 18–24 h of MV is sufficient to develop VIDD in both laboratory animals and humans (abstract). Power et al. further teach that prolonged MV results in rapid atrophy of diaphragm muscle fibers in humans (R466, col 2, para 1). Thus, the teachings of GRINNEMO reads on claims 1 and 5. In addition, the controlled mechanical ventilation in the ICU rat model is a form of positive pressure mechanical ventilation recited in claim 6.
GRINNEMO discloses therapeutic effects of biologically active EVs isolated from bone marrow MSCs in the treatment of the ICU rat model which is relevant to human ARDS and ventilator-induced diaphragm dysfunction (VIDD), wherein 1 ml of saline buffer, 3.6 x l09 baEVs and 0.5 million MSCs are intravenously administrated, respectively and further discloses that all rats in the baEV group survived until the end of the experiment, while both Control and MSCs groups exhibited significantly higher mortality, indicating significantly higher therapeutic effect of baEVs in comparison with that of the parental cells (Example 2, p19, line 28-p20, line 12, and Fig. 3). When the average body mass of female Sprague-Dawley rats is about 0.3-0.4 kg, the amount of EVs administered (3.6 x l09) is 6 x l09 to 1.2 x l010 EVs per kg of subject body mass, which falls within the range of claim 9.
GRINNEMO also discloses a method of isolation of extracellular vesicles from cultured cells comprising: MSCs cells were cultured as described above until 90% confluency; after that, the medium was changed to Opti-MEM medium (ThermoFisher, US) without serum and the cells were incubated for additional 48 hours in a humidified cell culture incubator at +37°C in 5% CO2; the medium (conditioned medium) was collected, centrifuged for 10 minutes at 120 x g to remove the floating cells, and then for additional 10 minutes at 300 x g to remove cellular debris; after that, the medium was filtered using 0.2 pm filter, EVs were collected using ultracentrifugation at 110,000 x g for 1 hour and solubilized in a small volume of phosphate-buffered saline (PBS) (p14, line 28-p15 line 19). GRINNEMO further discloses EVs can be stored using standard freezers and injected into patients directly after thawing without the need for pre-processing (p2, lines 25-27).
In addition, GRINNEMO discloses a pharmaceutical composition comprising an isolated extracellular vesicle and a pharmaceutically acceptable constituent (carrier or adjuvant) (claim 15-16 and p13, line 19-24).
As to the recitations, “an amount sufficient for the subject to have less than 40% decline in diaphragm muscle fiber area or less than 40% decline in diaphragm muscle specific force following a period of artificial ventilation lasting more than two days” in the amended claim 1 and “an amount sufficient to reduce oxidative stress and protease activation in diaphragm muscle fibers” in amended claim 7, those limitations are intended results of administering EVs in the claimed amount. Since GRINNEMO teaches administering the same EVs in the same amount to the same subject as claimed, the amount of EVs disclosed in GRINNEMO is necessarily sufficient for intended results as claimed. It should be noted that products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Also see In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”).
As such, the instant claims are anticipated by GRINNEMO.
Claim Rejections - 35 USC § 102/103
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.
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 of this title, 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 4, 11 and 18-19 are rejected under 35 U.S.C. 102 (a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over WO 2022/223767 (hereafter, GRINNEMO; cited in the IDS filed on July 2, 2026) as further evidenced by Power et al. (Am J Physiol Regul Integr Comp Physiol 305: R464–R477, 2013, prior art of record).
The teachings of GRINNEMO as evidenced by Power et al. as applied supra are herein applied for the same teachings in their entirety.
As to claims 4 and 11, the claim 4 further recites the EVs are obtained from bone marrow-derived mesenchymal stromal cells of the subject experiencing muscle wasting and claim 11 recites how the EVs for use is obtained. However, it appears that the EV of GRINNEMO is the same as claimed regardless of the source of bone marrow-derived mesenchymal stromal cells and the method steps to obtain it. There is no indication of any structural difference resulted from such source. When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process, either 102 or 103 rejection can be properly made. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP §2113. In the alternative, it would have been obvious to use bone marrow-derived MSCs of the subject experiencing muscle wasting or other subjects for obtaining EVs on the reasonable expectation that similar EVs would be obtained from the same type of cells in the absence of evidence to the contrary.
As to claims 18-19, the claims are product by process claims. As stated above, GRINNEMO teaches the same EVs derived from bone-marrow-derived mesenchymal stromal cells, obtained by almost identical process using the same cells and same medium as claimed although the reference is silent about detailed steps about freezing and thawing as recited in the instant claim 11. Also, GRINNEMO does disclose that EVs can be stored using standard freezers and injected into patients directly after thawing without the need for pre-processing (p2, lines 25-27). GRINNEMO specifically discloses a pharmaceutical composition comprising an isolated extracellular vesicle and a pharmaceutically acceptable constituent (carrier or adjuvant) (claim 15). Thus, GRINNEMO teaches a composition comprising the same purified EVs derived from bone-marrow-derived mesenchymal stromal cells, obtained by almost identical process using the same cells and same medium as claimed. Also, it does not appear that there is any difference in EVs resulting from the claimed process from those of the prior art. When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process, either 102 or 103 rejection can be properly made. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985).
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. See also MPEP §2113.
As such, claims 4, 11, and 18-19 are anticipated by or, in the alternative, obvious over GRINNEMO.
Claims 18-19 are rejected under 35 U.S.C. 102 (a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over US 2019/0125803 (hereafter, BRODIE, prior art of record).
BRODIE teaches a method of treating, preventing or ameliorating a muscle-associated disease or damage in a subject in need thereof, the method comprising administering a pharmaceutical composition comprising isolated extracellular vesicles (EVs) from mesenchymal stem cells (MSCs) wherein said muscle-associated disease or damage is selected from the group consisting of: a motor neuron disease characterized by gradual muscle weakening and wasting, uncontrolled twitching and eventually loss of control of voluntary movement, a muscular dystrophy, spinal cord injury, muscle wasting, cardiac muscle injury, inflammatory myopathy, myasthenia gravis, sarcopenia, cachexia, fibrosis, smooth muscle injury, and skeletal muscle injury (abstract, [0007],[0031], [0033], [0047], and claims 37, 40 and 42). The term “extracellular vesicles” refers to all cell-derived vesicles secreted from MSCs including but not limited to exosomes and microvesicles ([0079]).
BRODIE further teaches that the EVs are vesicles obtained from mesenchymal stem cell (MSC) wherein the MSC refers to multipotent stromal stem cells and is derived from bone marrow, adipose tissue, amniotic placenta, chorionic placenta, or umbilical cord ([0003], [0049], [0077], and [0201]). In some embodiments, the cell is a human cell ([0050]).
BRODIE teaches that exosomes, extracellular vesicles, or microvesicles can be obtained by growing MSCs in culture medium with serum depleted from exosomes or in serum-free media such as OptiMeM and subsequently isolating the exosomes by ultracentrifugation ([0081] and [0179]). BRODIE discloses intramuscular injection of 5×105 MSCs or their exosomes ([0038], Example 1, [0186]).
BRODIE discloses a pharmaceutical composition comprising an isolated extracellular vesicle and a pharmaceutically acceptable carrier or adjuvant ([0028]-[0030] and claims 38-39).
The claims are product by process claims. As stated above, BRODIE teaches that exosomes, extracellular vesicles, or microvesicles can be obtained by growing MSCs in culture medium with serum depleted from exosomes or in serum-free media such as OptiMeM and subsequently isolating the exosomes by ultracentrifugation ([0081] and [0179]). Thus, BRODIE teaches the same purified EVs derived from bone-marrow-derived mesenchymal stromal cells, obtained by almost identical process using the same cells and same medium as claimed although the reference is silent about detailed steps about filtering, freezing and thawing as recited in the instant claim 11. Also, it does not appear that there is any difference in EVs resulting from the claimed process from those of the prior art. When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process, either 102 or 103 rejection can be properly made. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. See also MPEP §2113.
As such, claims 18 and 19 are anticipated by or, in the alternative, obvious over BRODIE.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-7 and 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/223767 (hereafter, GRINNEMO; cited in the IDS filed on July 2, 2026)) in view of WO 2018195210 A1 (hereafter, MARBÁN, prior art of record) as evidenced by Power et al. (Am J Physiol Regul Integr Comp Physiol 305: R464–R477, 2013).
GRINNEMO as applied supra is herein applied for the same teachings in their entirety.
MARBÁN teaches a method for treating Duchenne muscular dystrophy (muscle wasting disease) and Becker muscular dystrophy, and symptoms or disease states associated therewith (including skeletal muscle myopathy associated with Duchenne muscular dystrophy) in a patient in need thereof, the method comprising administering cardiosphere-derived cells (CDC), extracellular vesicles derived therefrom (e.g., exosomes, etc.), and/or combinations thereof to the patient (abstract, [0003], [0004], [0006], [0007] and claims 35 and 37). MARBÁN further teaches that administration of CDCs and/or CDC-exosomes (XOs) delays the onset of muscular dysfunction (including in skeletal muscle dysfunction) and/or maintains, improves, and/or restores muscular function and integrity (including in skeletal muscles) in the subject having a dystrophinopathy and dystrophic skeletal muscles of the patient that are treated include one or more of the diaphragm, the limb muscles (e.g., in the arms and/or legs), and/or torso muscles ([0006] and [0023]). MARBÁN further teaches that CDC mediates their therapeutic effects via secreted vesicle exosomes in retarding or reversing Duchenne muscular dystrophy ([0227] and Fig. 9A).
MARBÁN teaches that the CDCs, CDC-XOs, and/or CDC-EVs are autologous or allogeneic to the subject (e.g., derived from their own tissue, from another subject's tissue, and/or from the tissue of another animal species) ([0008]).
MARBÁN discloses that the CDCs, CDC-EVs, and/or CDC-XOs are delivered to the subject systemically and locally and in some embodiments, they are injected or infused intravenously ([0009] and claim 44).
MARBÁN teaches that the administration of CDCs, CDC-EVs, and/or CDC- XOs to a subject in need thereof includes a single dose and/or multiple doses (e.g., 2, 4, 6, 8, 10, or more doses) ([0010] and claims 39-40). MARBÁN discloses that the administration of the multiple doses starts with a first dose and continues with a second dose, wherein the administration (one or more times) alters expression of one or more markers of T cell activation or proliferation, the markers comprising CD69 and/or HLA-DR ([0022], [0351], and claim 112).
MARBÁN discloses that the number of CDC-EVs or CDC-XOs administered in each dose (where a single or multiple doses are used) and/or over the course of a treatment regimen is equal to or at least about: 1 x 106, 1 x 107, 1 x 108, 1 x 109, 1 x 1010, 1 x 1011, 1 x 1012, or ranges including and/or spanning the aforementioned values ([0012] and [0014]). MARBÁN further discloses that "a therapeutically effective amount of CDCs" is a sufficient amount of CDCs administered to a subject to result in delivery of a sufficient amount of EVs to a targeted dystrophic skeletal muscle in a subject to increase and/or restore skeletal muscle function in the subject and to immune-modulate chronic inflammatory immune response ([0266]).
MARBÁN discloses that to generate exosomes, human CDCs were cultured until confluency at passage 5; the cells were washed with DPBS, and the media was supplanted to serum-free media; CDCs were then cultured in physiologically low oxygen (2% O2) for 24 hours; the conditioned media was then collected, sterile filtered using a 0.45 μm filter, and frozen for later use; later, the conditioned media was thawed and the exosomes were purified and concentrated by ultrafiltration via centrifugation using 3 kDa centrifugal filters (EMD Millipore) ([0257] and [0279]).
MARBÁN discloses a pharmaceutical composition comprising a CDC-XO or a CDC- derived extracellular vesicle (CDC-EV) and a pharmaceutically acceptable carrier ([0034] and claims 85 and 94).
As to claim 4, GRINNEMO does not specifically teach that the EVs are obtained from bone marrow-derived mesenchymal stromal cells of the subject experiencing muscle wasting. However, it was known in the art that the exosomes and/or EVs can be derived from their own tissue, from another subject's tissue, and/or from the tissue of another animal species as evidenced by MARBÁN ([0008]). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to obtain EVs from the patient’s own bone marrow-derived mesenchymal stromal cells or those of another subject for treating the patient experiencing muscle wasting as taught by MARBÁN. The skilled artisan would have reasonably expected that similar EVs would be obtained from the same type of cells.
As to claims 14-17, GRINNEMO does not specifically teach administering EVs as multiple doses. However, MARBÁN discloses that the number of CDC-EVs or CDC-XOs administered in each dose (where a single or multiple doses are used) and/or over the course of a treatment regimen is equal to or at least about: 1 x 106, 1 x 107, 1 x 108, 1 x 109, 1 x 1010, 1 x 1011, 1 x 1012, or ranges including and/or spanning the aforementioned values ([0012] and [0014]). MARBÁN further discloses that "a therapeutically effective amount of CDCs" is a sufficient amount of CDCs administered to a subject to result in delivery of a sufficient amount of EVs to a targeted dystrophic skeletal muscle in a subject to increase and/or restore skeletal muscle function in the subject and to immune-modulate chronic inflammatory immune response ([0266]). MARBÁN teaches that the administration of CDCs, CDC-EVs, and/or CDC- XOs to a subject in need thereof includes a single dose and/or multiple doses (e.g., 2, 4, 6, 8, 10, or more doses) ([0010] and claims 39-40). MARBÁN discloses that the administration of the multiple doses starts with a first dose and continues with a second dose, wherein the administration (one or more times) alters expression of one or more markers of T cell activation or proliferation, the markers comprising CD69 and/or HLA-DR ([0022], [0351], and claim 112).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize initial dose and maintenance dose of EVs and to adjust dosing frequency based on the patient’s response such as differences in expression of biomarkers because MARBÁN already teaches that the EVs can be administered in a single dose or multiple doses and administration (one or more times) of EVs alters expression of one or more markers of T cell activation or proliferation (e.g., CD69 and/or HLA-DR). Also, GRINNEMO teaches that the treatment with EVs produced from the cells cultured on laminin-521 or laminin-421 significantly decreased the level of expression of the marker of activated fibroblasts PBGFR-β (differentially expressed protein) in comparison with the treatment with PBS (p19, line 22-25). Thus, the skilled artisan would have been motivated to adjust dosing amount and frequency in response to known biomarkers showing the effects for maximizing therapeutic efficacy.
In addition, it is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); 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.”)
Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-7 and 9-19 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of copending application 19/222305.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘305 application are drawn to a method of administering bone marrow-derived mesenchymal stromal cell (BM-MSC) derived extracellular vesicles (EVs) to a subject experiencing at least one of mechanical ventilator induced diaphragm dysfunction, critical illness myopathy, sarcopenia, and cancer cachexia (muscle wasting conditions) and a composition comprising: bone marrow-derived mesenchymal stromal cell (BM-MSC) derived extracellular vesicles (EVs); and, at least one pharmaceutical excipient wherein the administration of the EVs results in a) less than a 40% decline in diaphragm muscle fiber area; b) less than a 40% decline in diaphragm muscle specific force; or, c) reduced inflammation in lung and diaphragm tissues.
As to claims 11 and 18-19, the claim further recites how the EV is obtained. The claims of ‘305 application recite the same extracellular vesicles obtained from the same cells as the instant claims. Also, it does not appear that there is any difference in EVs resulting from the claimed process from those of ‘305 application. When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process, either 102 or 103 rejection can be properly made. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP §2113. Thus, the instant claims 11 and 18-19 read on the method and the composition recited in ‘305 application.
As such, the instant claims are anticipated by or would have been obvious over the claims of the co-pending application.
Response to Applicants’ argument:
Applicant's request that the Double Patenting rejection be held in abeyance until the present claims are allowed and ‘305 case has issued is noted but such request is not a persuasive argument and thus the rejection is properly maintained in this Office Action.
Conclusion
No claims are allowed.
Applicant’s submission of an information disclosure statement under 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p) on July 2, 2026 prompted the new ground(s) of rejection presented in this Office action. Also, 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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