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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 4, 2025 has been entered.
Detailed Action
This action is in response to the papers filed August 19, 2025.
Amendments
Applicant's response and amendments, filed August 19, 2025, to the prior Office Action is acknowledged. Applicant has cancelled Claims 2, 6-7, and 10-13, and amended Claims 1, 3-5, and 8-9.
Claims 1, 3-5, and 8-9 are pending and under consideration.
Information Disclosure Statement
Applicant has filed an Information Disclosure Statement on August 19, 2025 that has been considered.
The signed and initialed PTO Forms 1449 are mailed with this action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
1. The prior rejections of Claims 10-12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in light of Applicant’s cancellation of the claims.
2. Claim(s) 1, 3-5, and 8-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite a chimeric cell population comprising cells produced by ex vivo fusion and expansion of:
a) a first myoblast; and
b) a second myoblast, mesenchymal stem cell, or stromal cell [structure],
wherein the chimeric cell population is capable of differentiation into myocytes [function].
Either this is an inherent property of (that naturally flows from) the chimeric cells produced by ex vivo fusion and expansion of:
a) a first myoblast; and
b) a second myoblast, mesenchymal stem cell, or stromal cell [structure], or it is not, and something must change.
The claim denotes that not all of the myoblast cell fusions are able to achieve the functional property(ies) of being capable of differentiation into myocytes.
To the extent it is not an inherent property (that naturally flows) from the positively recited Product-by-Process cells, then something must change. The claim is considered to lack adequate written description for failing to recite the structure(s) and/or Product-by-Process method step(s) that is/are necessary and sufficient to cause the recited functional language.
The limitation “capable of differentiation into myocytes” merely states a functional characteristic without providing any indication about how the functional characteristic is provided. The functional characteristic does not follow from (is not an inherent property of) the Product-by-Process recited in the claim, and thus the ordinary artisan would not know what modification(s) must be made in order to fulfill the instant recitation.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The disclosure of a single species is rarely, if ever, sufficient to describe a broad genus, particularly when the specification fails to describe the features of that genus, even in passing. (see In re Shokal 113USPQ283(CCPA1957); Purdue Pharma L.P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000).
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997).
The claims fail to recite, and the specification fails to disclose, a nexus between the required first and second cells to be fused, the Product-by-Process fusion step(s) recited at a high level of generality, and the corresponding functional property of being capable of differentiation into myocytes, as opposed to the claimed myoblast fusions that are not capable of differentiation into myocytes.
The claims fail to recite, and the specification fails to disclose, a first chimeric cell population comprising cells produced by ex vivo fusion and expansion of:
a) a first myoblast; and
b) a second myoblast, mesenchymal stem cell, or stromal cell [structure],
that is not capable of differentiation into myocytes, as opposed to
a second chimeric cell population comprising cells produced by ex vivo fusion and expansion of:
a) a first myoblast; and
b) a second myoblast, mesenchymal stem cell, or stromal cell [structure], that is necessarily and predictably capable of differentiation into myocytes, for example.
The claims fail to recite, and the specification fails to disclose what modification(s) to a Product-by-Process chimeric cell fusion step(s) that yields chimeric cells unable to differentiate into myocytes, transforms said first Product-by-Process chimeric cell fusion step(s) into one that is now necessarily and predictably yields chimeric cells capable of differentiation into myocytes, for example.
Denetclaw et al (Heterokaryon Myotubes with Normal Mouse and Duchenne Nuclei Exhibit Sarcolemmal Dystrophin Staining and Efficient Intracellular Free Calcium Control, Mol. Biol. of the Cell 4: 963-972, 1993; of record) is considered relevant prior art for having taught a population of MDCC cells produced ex vivo via cell fusion of a first cell obtained from a healthy donor and a second cell obtained from a dystrophin-deficient donor suffering from a muscular dystrophy (e.g. pg 964, col. 2, Materials and Methods, Muscle Cell Cultures, first cell being satellite cell myoblasts from healthy mouse donors, second cell being human myoblasts from a DMD patient).
However, Applicant argues that Denetclaw et al taught chimeric myotubes, and does not teach or suggest the chimeric human/mouse myoblasts are capable of differentiating into myocytes.
Kong et al (Dynamic Restoration of Dystrophin to Dystrophin-deficient Myotubes, Muscle & Nerve 24: 77-88, 2001; of record) is considered relevant prior art for having taught a population of MDCC cells produced ex vivo via cell fusion of a first satellite cell obtained from a healthy donor and a second satellite cell obtained from a dystrophin-deficient donor suffering from a muscular dystrophy (e.g. pg 80, col.s 1-2, joining para, “wildtype skeletal muscle satellite cells were cocultured with dystrophin-deficient mdx satellite cells”, “hybrid myotubes”).
However, Applicant argues that Kong et al taught chimeric myotubes, and does not teach or suggest the chimeric myoblasts are capable of differentiating into myocytes.
Goncalves et al (Human mesenchymal stem cells ectopically expressing full-length dystrophin can complement Duchenne muscular dystrophy myotubes by cell fusion, Human Molecular Genetics 15(2): 213-221, 2006; of record) is considered relevant prior art for having taught a population of MDCC cells produced ex vivo via cell fusion of a first cell obtained from a healthy donor and a second cell obtained from a dystrophin-deficient donor suffering from a muscular dystrophy (e.g. pg 219, col. 2, Materials and Methods, Cells, first cell being human MSCs from healthy donors, second cell being human myoblasts from a DMD patient).
However, Applicant argues that Goncalves et al taught chimeric myotubes, and does not teach or suggest the chimeric myoblasts are capable of differentiating into myocytes.
Miller et al (Myoblast implantation in Duchenne muscular dystrophy: The San Francisco study, Muscle & Nerve 20(4): 469-478, 1998; of record) is considered relevant prior art for having myoblast therapy for the treatment of DMD in a human patient, wherein healthy donor myoblasts were obtained from the patient’s healthy brother or father (e.g. pg 469, col. 2; pg 470, col. 1, “in most cases, the donors were the biological father”), wherein the donor myoblasts were formulated with a pharmaceutically acceptable carrier prior to transplantation (e.g. pg 472, col. 1, saline).
However, Applicant argues that Miller et al do not teach or suggest the chimeric myoblasts are capable of differentiating into myocytes.
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
While it is clear that the claims recite a fusion-promoting agent selected from the group consisting of PEG, an inactivated virus, and electrical stimulation, as evidenced by Figure 1, such produces a heterokaryon cell comprising the nuclei of both starting cells, as is also achieved by the myoblast cell fusions of Denetclaw et al (e.g. Figures 1c, 2a, and 4c-d) and Kong et al (e.g. pg 80, col. 2, “young myotubes…..very often contained only one to two nuclei”; “older myotubes….contained two or more nuclei”). Thus, the positively recited fusion promoting agents are not considered to be, in and of themselves, dispositive of necessarily and predictably producing a chimeric myoblast fusion heterokaryon that has the functional property of being capable of differentiating into myocytes.
Furthermore, the Product-by-Process recitation recites the use of said fusion-promoting agents at a high level of generality, e.g. no working concentrations and/or culturing steps, respectively.
Thus, for the reasons outlined above, it is concluded that the claims do not meet the requirements for written description under 35 U.S.C. 112, first paragraph.
MPEP 2163 - 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention ....” This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc)
Dependent claims are included in the basis of the rejection because they do not clarify the nature of the corresponding structure that is necessary and sufficient to cause the recited functional language.
Claim Rejections - 35 USC § 102
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 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 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.
(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.
3. Claim(s) 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Denetclaw et al (Heterokaryon Myotubes with Normal Mouse and Duchenne Nuclei Exhibit Sarcolemmal Dystrophin Staining and Efficient Intracellular Free Calcium Control, Mol. Biol. of the Cell 4: 963-972, 1993).
With respect to Claim 1, Denetclaw et al is considered relevant prior art for having taught a population of MDCC cells produced ex vivo via cell fusion of a first cell obtained from a healthy donor and a second cell obtained from a dystrophin-deficient donor suffering from a muscular dystrophy (e.g. pg 964, col. 2, Materials and Methods, Muscle Cell Cultures, first cell being satellite cell myoblasts from healthy mouse donors, second cell being human myoblasts from a DMD patient).
The recitation of a process limitation in Claim 1 is not viewed as positively limiting the claimed MDCC population product absent a showing that the process of making using PEG, inactivated virus, or electrical stimulation recited in Claim 1 imparts a novel or unexpected property to the claimed MDCC product, as it is assumed that equivalent MDCC products are obtainable by multiple methods. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced MDCC products. The method in which the MDCCs were produced is immaterial to their patentability.
"Even 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. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Denetclaw et al do not teach ipsis verbis that the chimeric myoblasts are capable of differentiating into myocytes. However, such is considered to be natural law of cell biology, as admitted by Applicant (Remarks Made in Amendment, pg 2, August 19, 2025, “as is known in the art”):
myoblasts>>myocytes>>myotubes.
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description rejection.
With respect to Claim 3, Denetclaw et al taught wherein the second cell is dystrophin-deficient human cell, and thus is allogeneic to a human subject and/or autologous to the human subject suffering from muscular dystrophy.
Thus, Denetclaw et al anticipate the claims.
Response to Arguments
Applicant argues that Denetclaw et al taught chimeric myotubes, and does not teach or suggest the chimeric human/mouse myoblasts are capable of differentiating into myocytes.
Applicant’s argument(s) has been fully considered, but is not persuasive. That Denetclaw et al did not stop the cell culture from differentiating into myotubes does not take away from the natural law of cell biology, as admitted by Applicant (Remarks Made in Amendment, pg 2, August 19, 2025, “as is known in the art”):
myoblasts>>myocytes>>myotubes.
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description rejection.
4. Claim(s) 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kong et al (Dynamic Restoration of Dystrophin to Dystrophin-deficient Myotubes, Muscle & Nerve 24: 77-88, 2001).
With respect to Claim 1, Kong et al is considered relevant prior art for having taught a population of MDCC cells produced ex vivo via cell fusion of a first satellite cell obtained from a healthy donor and a second satellite cell obtained from a dystrophin-deficient donor suffering from a muscular dystrophy (e.g. pg 80, col.s 1-2, joining para, “wildtype skeletal muscle satellite cells were cocultured with dystrophin-deficient mdx satellite cells”, “hybrid myotubes”).
The recitation of a process limitation in Claim 1, “ex vivo fusion and expansion of a first myoblast and a second myoblast, MSC, or stromal cell (which reads on satellite cells of Kong et al) is not viewed as positively limiting the claimed product absent a showing that the process of making recited in Claim 1 imparts a novel or unexpected property to the claimed cell fusion product, as it is assumed that equivalent cell fusion products are obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. The method in which the muscular dystrophy chimeric cell population were produced is immaterial to their patentability.
The recitation of a process limitation in Claim 1 is not viewed as positively limiting the claimed MDCC population product absent a showing that the process of making using PEG, inactivated virus, or electrical stimulation recited in Claim 1 imparts a novel or unexpected property to the claimed MDCC product, as it is assumed that equivalent MDCC products are obtainable by multiple methods. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced MDCC products. The method in which the MDCCs were produced is immaterial to their patentability.
"Even 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. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Satellite cells are art-recognized stromal cells that differentiate into myoblasts, and Kong et al taught the formation of chimeric myotubes comprising as few as two nuclei (e.g. pg 80, col. 2). Thus, the ordinary artisan would have understood the satellite cells to have naturally differentiated into myoblasts before or during cell fusion in order to form the chimeric myotubes.
Kong et al do not teach ipsis verbis that the chimeric myoblasts are capable of differentiating into myocytes. However, such is considered to be natural law of cell biology, as admitted by Applicant (Remarks Made in Amendment, pg 2, August 19, 2025, “as is known in the art”):
myoblasts>>myocytes>>myotubes.
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description rejection.
With respect to Claim 3, Kong et al taught wherein the second satellite cell is dystrophin-deficient mouse cell and thus is allogeneic to a mouse subject and/or autologous to the mouse subject suffering from muscular dystrophy (e.g. pg 78, col. 2, Materials and Methods).
Thus, Kong et al anticipate the claims.
Response to Arguments
Applicant argues that Kong et al taught chimeric myotubes, and does not teach or suggest the chimeric human/mouse myoblasts are capable of differentiating into myocytes.
Applicant’s argument(s) has been fully considered, but is not persuasive. That Kong et al did not stop the cell culture from differentiating into myotubes does not take away from the natural law of cell biology, as admitted by Applicant (Remarks Made in Amendment, pg 2, August 19, 2025, “as is known in the art”):
myoblasts>>myocytes>>myotubes.
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description rejection.
5. Claim(s) 1, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goncalves et al (Human mesenchymal stem cells ectopically expressing full-length dystrophin can complement Duchenne muscular dystrophy myotubes by cell fusion, Human Molecular Genetics 15(2): 213-221, 2006).
With respect to Claim 1, Goncalves et al is considered relevant prior art for having taught a population of MDCC cells produced ex vivo via cell fusion of a first cell obtained from a healthy donor and a second cell obtained from a dystrophin-deficient donor suffering from a muscular dystrophy (e.g. pg 219, col. 2, Materials and Methods, Cells, first cell being human MSCs from healthy donors, second cell being human myoblasts from a DMD patient).
The recitation of a process limitation in Claim 1 is not viewed as positively limiting the claimed MDCC population product absent a showing that the process of making using PEG, inactivated virus, or electrical stimulation recited in Claim 1 imparts a novel or unexpected property to the claimed MDCC product, as it is assumed that equivalent MDCC products are obtainable by multiple methods. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced MDCC products. The method in which the MDCCs were produced is immaterial to their patentability.
"Even 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. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Goncalves et al do not teach ipsis verbis that the chimeric myoblasts are capable of differentiating into myocytes. However, such is considered to be natural law of cell biology, as admitted by Applicant (Remarks Made in Amendment, pg 2, August 19, 2025, “as is known in the art”):
myoblasts>>myocytes>>myotubes.
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description rejection.
With respect to Claim 3, Goncalves et al taught wherein the first cell is wildtype human cell (allogeneic or autologous; depending on the reference human subject) and the second cell is dystrophin-deficient human cell (allogeneic or autologous; depending upon the reference human subject). Goncalves et al also taught that “allogeneic Dys-positive myoblasts have been and remain at the forefront of cell-based DMD therapy” (e.g. pg 214, col. 1).
With respect to Claim 5, Goncalves et al taught wherein the human MSCs were obtained from bone marrow of healthy donors (e.g. pg 214, col. 1, “BM-derived hMSCs in human myogenesis occurs through cellular fusion”; pg 219, col. 2, Materials and Methods, Cells, “isolation… of hMSCs from BM”).
Thus, Goncalves et al anticipate the claims.
Response to Arguments
Applicant argues that Goncalves et al taught chimeric myotubes, and does not teach or suggest the chimeric human/mouse myoblasts are capable of differentiating into myocytes.
Applicant’s argument(s) has been fully considered, but is not persuasive. That Goncalves et al did not stop the cell culture from differentiating into myotubes does not take away from the natural law of cell biology, as admitted by Applicant (Remarks Made in Amendment, pg 2, August 19, 2025, “as is known in the art”):
myoblasts>>myocytes>>myotubes.
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description rejection.
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 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.
6. The prior rejection of Claims 10-12 under AIA 35 U.S.C. 103 as being unpatentable over Bouchentouf et al (Exercise improves the success of myoblast transplantation in mdx mice, Neuromuscular Disorders 6: 518-529, 2006) in view of Kong et al (2001) is withdrawn in light of Applicant’s cancellation of the claims.
7. Claims 1, 3 and 5 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Denetclaw et al (1993; of record) in view of Kong et al (2001; of record), and Goncalves et al (2006; of record).
Determining the scope and contents of the prior art, and Ascertaining the differences between the prior art and the claims at issue.
With respect to Claim 1, Denetclaw et al is considered relevant prior art for having taught a population of MDCC cells produced ex vivo via cell fusion of a first cell obtained from a healthy donor and a second cell obtained from a dystrophin-deficient donor suffering from a muscular dystrophy (e.g. pg 964, col. 2, Materials and Methods, Muscle Cell Cultures, first cell being satellite cell myoblasts from healthy mouse donors, second cell being human myoblasts from a DMD patient).
The recitation of a process limitation in Claim 1 is not viewed as positively limiting the claimed MDCC population product absent a showing that the process of making using PEG, inactivated virus, or electrical stimulation recited in Claim 1 imparts a novel or unexpected property to the claimed MDCC product, as it is assumed that equivalent MDCC products are obtainable by multiple methods. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced MDCC products. The method in which the MDCCs were produced is immaterial to their patentability.
"Even 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. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Denetclaw et al do not teach wherein the healthy cells and the dystrophin-deficient cells are obtained from the same species.
However, prior to the effective filing date of the instantly claimed invention, and with respect to Claim 1, Kong et al is considered relevant prior art for having taught a population of MDCC cells produced ex vivo via cell fusion of a first satellite cell obtained from a healthy mouse donor and a second satellite cell obtained from a dystrophin-deficient mouse donor suffering from a muscular dystrophy (e.g. pg 80, col.s 1-2, joining para, “wildtype skeletal muscle satellite cells were cocultured with dystrophin-deficient mdx satellite cells”, “hybrid myotubes”).
The recitation of a process limitation in Claim 1, “ex vivo fusion and expansion of a first myoblast and a second myoblast, MSC, or stromal cell (which reads on satellite cells of Kong et al) is not viewed as positively limiting the claimed product absent a showing that the process of making recited in Claim 1 imparts a novel or unexpected property to the claimed cell fusion product, as it is assumed that equivalent cell fusion products are obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. The method in which the muscular dystrophy chimeric cell population were produced is immaterial to their patentability.
The recitation of a process limitation in Claim 1 is not viewed as positively limiting the claimed MDCC population product absent a showing that the process of making using PEG, inactivated virus, or electrical stimulation recited in Claim 1 imparts a novel or unexpected property to the claimed MDCC product, as it is assumed that equivalent MDCC products are obtainable by multiple methods. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced MDCC products. The method in which the MDCCs were produced is immaterial to their patentability.
"Even 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. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Satellite cells are art-recognized stromal cells that differentiate into myoblasts, and Kong et al taught the formation of chimeric myotubes comprising as few as two nuclei (e.g. pg 80, col. 2). Thus, the ordinary artisan would have understood the satellite cells to have naturally differentiated into myoblasts before or during cell fusion in order to form the chimeric myotubes.
Goncalves et al is considered relevant prior art for having taught a population of MDCC cells produced ex vivo via cell fusion of a first cell obtained from a healthy human donor and a second cell obtained from a dystrophin-deficient human donor suffering from a muscular dystrophy (e.g. pg 219, col. 2, Materials and Methods, Cells, first cell being human MSCs from healthy donors, second cell being human myoblasts from a DMD patient).
The recitation of a process limitation in Claim 1 is not viewed as positively limiting the claimed MDCC population product absent a showing that the process of making using PEG, inactivated virus, or electrical stimulation recited in Claim 1 imparts a novel or unexpected property to the claimed MDCC product, as it is assumed that equivalent MDCC products are obtainable by multiple methods. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced MDCC products. The method in which the MDCCs were produced is immaterial to their patentability.
"Even 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. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Resolving the level of ordinary skill in the pertinent art.
People of the ordinary skill in the art will be highly educated individuals such as medical doctors, scientists, or engineers possessing advanced degrees, including M.D.'s and Ph.D.'s. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in cell biology and the creation of myoblast heterokaryons, including for the treatment of DMD. Therefore, the level of ordinary skill in this art is high.
"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at ___, 82 USPQ2d at 1396.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge. This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. M.P.E.P. §2141.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). See MPEP §2144.
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to substitute a first cell xenogeneic to the second cell, as taught by Denetclaw et al, with a second cell being allogeneic to the second cell, e.g. mouse-mouse, as taught by Kong et al, or human-human, as taught by Goncalves et al, in a Dys+:Dys- myoblast fusion cell population with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06. An artisan would be motivated to substitute a first cell xenogeneic to the second cell with a second cell being allogeneic to the second cell, e.g. mouse-mouse or human-human, in a Dys+:Dys- myoblast fusion cell population because those of ordinary skill in the art previously recognized and successfully reduced to practice the scientific and technical concepts of creating myoblast heterokaryons using a first cell and a second cell from the same species, e.g. mouse-mouse (Kong et al) or human-human (Goncalves et al), thereby eliminating immunological or graft-vs-host disease issues should the Dys+:Dys- myoblast fusion cell population be administered to a DMD subject for the treatment of a muscular dystrophy.
A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipate success, it is likely that product not of innovation but of ordinary skill and common sense.”
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, —USPQ2d—, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925 .pdf).
With respect to Claim 3, Denetclaw et al taught wherein the second cell is dystrophin-deficient human cell, and thus is allogeneic to a human subject and/or autologous to the human subject suffering from muscular dystrophy.
Kong et al taught wherein the second satellite cell is dystrophin-deficient mouse cell and thus is allogeneic to a mouse subject and/or autologous to the mouse subject suffering from muscular dystrophy (e.g. pg 78, col. 2, Materials and Methods).
Goncalves et al taught wherein the first cell is wildtype human cell (allogeneic or autologous; depending on the reference human subject) and the second cell is dystrophin-deficient human cell (allogeneic or autologous; depending upon the reference human subject). Goncalves et al also taught that “allogeneic Dys-positive myoblasts have been and remain at the forefront of cell-based DMD therapy” (e.g. pg 214, col. 1).
With respect to Claim 5, Goncalves et al taught wherein the human MSCs were obtained from bone marrow of healthy donors (e.g. pg 214, col. 1, “BM-derived hMSCs in human myogenesis occurs through cellular fusion”; pg 219, col. 2, Materials and Methods, Cells, “isolation… of hMSCs from BM”).
The cited prior art meets the criteria set forth in both Graham and KSR, and the teachings of the cited prior art provide the requisite teachings and motivations with a clear, reasonable expectation of success. Thus, the invention as a whole is prima facie obvious.
8. Claims 1, 3, and 8 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Denetclaw et al (1993; of record) in view of Kong et al (2001; of record), and Goncalves et al (2006; of record), as applied to Claims 1, 3, and 5 above, and in further view of Konieczny et al (Analysis of Muscle Protein Expression in Polyethylene Glycol-induced Chicken:Rat Myoblast Heterokaryons, J. Cell Biology 97: 1348-1355, 1983; of record).
Determining the scope and contents of the prior art, and Ascertaining the differences between the prior art and the claims at issue.
Neither Denetclaw et al, Kong et al, nor Goncalves et al teach wherein the ex vivo cell fusion comprises the step of exposing the cells to a fusion-promoting agent.
However, prior to the effective filing date of the instantly claimed invention, and with respect to Claims 1 and 8, Konieczny et al is considered relevant prior art for having taught the use of PEG to induce cell fusion ex vivo between a first myocyte differentiated from a rat myoblast and a second myoblast, e.g. chicken myoblast, to produce myoblast heterokaryons (Title; pg 1349, col. 1, “rat monocytes to….chicken myoblasts”; col. 2, section heading).
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge. This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. M.P.E.P. §2141.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). See MPEP §2144.
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to modify the ex vivo myoblast fusion steps of Denetclaw et al, Kong et al, and/or Goncalves et al to comprise the use of a fusion-promoting agent such as PEG with a reasonable expectation of success because, as of the filing date of the instantly claimed invention (2015), PEG had long-been used as a cell fusion promoting agent, including for fusing a first myoblast to a second myoblast (Konieczny et al, 1983).
A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipate success, it is likely that product not of innovation but of ordinary skill and common sense.”
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, —USPQ2d—, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925 .pdf).
With respect to Claim 3, Denetclaw et al taught wherein the second cell is dystrophin-deficient human cell, and thus is allogeneic to a human subject and/or autologous to the human subject suffering from muscular dystrophy.
Kong et al taught wherein the second satellite cell is dystrophin-deficient mouse cell and thus is allogeneic to a mouse subject and/or autologous to the mouse subject suffering from muscular dystrophy (e.g. pg 78, col. 2, Materials and Methods).
Goncalves et al taught wherein the first cell is wildtype human cell (allogeneic or autologous; depending on the reference human subject) and the second cell is dystrophin-deficient human cell (allogeneic or autologous; depending upon the reference human subject). Goncalves et al also taught that “allogeneic Dys-positive myoblasts have been and remain at the forefront of cell-based DMD therapy” (e.g. pg 214, col. 1).
Konieczny et al taught wherein the second myoblast cell is rat cell, and thus is allogeneic or autologous to a rat subject (e.g. Title).
The cited prior art meets the criteria set forth in both Graham and KSR, and the teachings of the cited prior art provide the requisite teachings and motivations with a clear, reasonable expectation of success. Thus, the invention as a whole is prima facie obvious.
Response to Arguments
Applicant argues that Konieczny et al does not make up for the deficiencies of Denetclaw et al, Kong et al, and Goncalves et al.
Applicant’s argument(s) has been fully considered, but is not persuasive. The Examiner’s response to Applicant's argument(s) regarding Denetclaw et al, Kong et al, and Goncalves et al are discussed above and incorporated herein. Applicant does not contest the teachings of Konieczny et al as applied to the obviousness to modify the ex vivo myoblast fusion steps of Denetclaw et al, Kong et al, and/or Goncalves et al to comprise the use of a fusion-promoting agent such as PEG with a reasonable expectation of success because, as of the filing date of the instantly claimed invention (2015), PEG had long-been used as a cell fusion promoting agent, including for fusing a first myoblast to a second myoblast (Konieczny et al, 1983).
A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipate success, it is likely that product not of innovation but of ordinary skill and common sense.”
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, —USPQ2d—, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925 .pdf).
9. Claims 3-4 and 9 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Denetclaw et al (1993; of record) in view of Kong et al (2001; of record), and Goncalves et al (2006; of record), as applied to Claims 1, 3 and 5 above, and in further view of Miller et al (Myoblast implantation in Duchenne muscular dystrophy: The San Francisco study, Muscle & Nerve 20(4): 469-478, 1998; of record).
Determining the scope and contents of the prior art, and Ascertaining the differences between the prior art and the claims at issue.
Neither Denetclaw et al, Kong et al, nor Goncalves et al teach wherein the healthy donor cells are obtained from the subject's father.
However, prior to the effective filing date of the instantly claimed invention, and with respect to Claims 4 and 9, Miller et al is considered relevant prior art for having myoblast therapy for the treatment of DMD in a human patient, wherein healthy donor myoblasts were obtained from the patient’s healthy brother or father (e.g. pg 469, col. 2; pg 470, col. 1, “in most cases, the donors were the biological father”), wherein the donor myoblasts were formulated with a pharmaceutically acceptable carrier prior to transplantation (e.g. pg 472, col. 1, saline).
Miller et al do not teach ipsis verbis that the chimeric myoblasts are capable differentiating into myotube. However, such is considered to be natural law of cell biology, as admitted by Applicant (Remarks Made in Amendment, pg 2, August 19, 2025, “as is known in the art”):
myoblasts>>myocytes>>myotubes.
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description rejection.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge. This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. M.P.E.P. §2141.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). See MPEP §2144.
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to substitute a first healthy donor cell with a second healthy donor cell obtained from a subject’s father, as taught by Miller et al, in a Dys+:Dys- myoblast fusion cell population with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06. An artisan would be motivated to substitute a first healthy donor cell with a second healthy donor cell obtained from a subject’s father in a Dys+:Dys- myoblast fusion cell population because those of ordinary skill in the art previously recognized and successfully reduced to practice the scientific and technical concepts of using the patient’s father’s myoblasts in a cell therapy method for treating DMD, being motivated to do so because those of ordinary skill in the art would have immediately recognized that it is natural law of biology that the father’s X chromosome contains a normal dystrophin gene, and said father’s cells would comprise at least a 50% HLA match to the patient, and Miller et al successfully reduced to practice the use of a patient’s father’s healthy myoblasts as donor cells in myoblast therapy for the treatment of DMD.
A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipate success, it is likely that product not of innovation but of ordinary skill and common sense.”
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, —USPQ2d—, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925 .pdf).
With respect to Claim 3, Denetclaw et al taught wherein the second cell is dystrophin-deficient human cell, and thus is allogeneic to a human subject and/or autologous to the human subject suffering from muscular dystrophy.
Kong et al taught wherein the second satellite cell is dystrophin-deficient mouse cell and thus is allogeneic to a mouse subject and/or autologous to the mouse subject suffering from muscular dystrophy (e.g. pg 78, col. 2, Materials and Methods).
Goncalves et al taught wherein the first cell is wildtype human cell (allogeneic or autologous; depending on the reference human subject) and the second cell is dystrophin-deficient human cell (allogeneic or autologous; depending upon the reference human subject). Goncalves et al also taught that “allogeneic Dys-positive myoblasts have been and remain at the forefront of cell-based DMD therapy” (e.g. pg 214, col. 1).
Miller et al taught the use of the patient’s father’s myoblasts, syn. allogeneic (e.g. pg 470, col. 1).
The cited prior art meets the criteria set forth in both Graham and KSR, and the teachings of the cited prior art provide the requisite teachings and motivations with a clear, reasonable expectation of success. Thus, the invention as a whole is prima facie obvious.
Response to Arguments
Applicant argues that Miller et al do not teach or suggest the chimeric myoblasts are capable of differentiating into myocytes.
Applicant’s argument(s) has been fully considered, but is not persuasive. That Miller et al did not teach ipsis verbis that the chimeric myoblasts are capable differentiating into myotubes does not take away from the natural law of cell biology, as admitted by Applicant (Remarks Made in Amendment, pg 2, August 19, 2025, “as is known in the art”):
myoblasts>>myocytes>>myotubes.
To the extent Applicant argues otherwise, see the above 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description rejection.
Double Patenting
10. The prior rejection of Claims 1-13 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11147840 B2 is withdrawn in light of Applicant’s filing of a Terminal Disclaimer, which the Examiner finds persuasive.
Terminal Disclaimer
11. The terminal disclaimer filed on May 12, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11147840 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Conclusion
12. No claims are allowed.
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KEVIN K. HILL
Examiner
Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638