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 .
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/17/2025 has been entered.
Claims 3 and 6-8 have been cancelled. Claim 1 has been amended. Claim 10 is new.
Claims 1, 2, 4, 5, 9 and 10 are pending and under examination.
Double Patenting
2. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
3. Claims 1, 2, 5, 8, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 14 of U.S. Patent No. 10,632,305. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same method for treating FSHD in a subject via the transplantation of immortalized human myoblasts. The specific subject recited in the patent claims anticipate the genus recited in the instant claim 1. Thus, the instant claims and the patent claims are obvious variants.
Claim Rejections - 35 USC § 103
4. 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.
5. Claims 1, 2, 4, 5, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Law (PGPUB 2002/0031501), in view of both Zhu et al. (Aging Cell, 2007, p. 1-9) and Distefano et al. (PLoS One, March 2013, 8: 1-11).
Law teaches a method for treating a human subject having FSHD, the method comprising transplanting normal (i.e., genetically healthy) myoblasts into the human subject via injection into the limb having the dystrophic muscle. Law teaches that the transplanted normal myoblasts fuse to the genetic myofibers to repair them and they also fuse among themselves to form genetically normal myofibers replacing the dystrophic ones (claim 1, 2, 4 and 10) (see [0009]; [0017]; [0023]; [0047]; [0112]).
Law does not teach transplanting immortalized normal myoblasts (claim 1). However, Law teaches that there is a great demand for normal myoblasts for transplantation (see [0123]). Zhu et al. teach that myoblasts have a limited life span in culture; immortalization with hTERT and CDK4 greatly extends their proliferative life span, while maintaining their capacity to differentiate and participate in muscle formation. Zhu et al. teach that the immortalized myoblasts are useful for treating human diseases (see p. 2, column 1, last paragraph; paragraph bridging p. 2 and 3; p. 3, first full paragraph; paragraph bridging p. 4 and 5; p. 5, column 2, second paragraph). One of skill in the art would have found obvious to modify Law by immortalizing the normal myoblasts as taught by Zhu et al. with the reasonable expectation that doing so would continuously and consistently generate the large cell numbers required for transplantation.
Law and Zhu et al. do not teach intermittent neuromuscular electrical stimulation (iNMES) (claims 1, 5, and 9). Distefano et al. teach iNMES as an adjuvant for cell transplantation into the skeletal muscle (see Abstract; p. 2, column 2, last two paragraphs). One of skill in the art would have found obvious to further subject the limb to iNMES to achieve the predictable result of promoting myoblast engraftment and improve muscle function.
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
Response to Arguments
6. The argument that one of skill in the art would not look at another reference because Law solved the cell demand problem. The applicant argues that Law teaches a different method for obtaining large volume of cells, and thus, any art presuming to solve the cell quantity problem would interfere with Law’s principle of operation.
This is not found persuasive. The principle of operation in Law is not using automatic cell processors. The principle of operation in Law is inserting the wild type gene into the dystrophic muscle by using myoblasts. Immortalizing and using the immortalized myoblasts would not change the principle of operation in Law because the immortalization would not alter the capacity of inserting the wild type gene into the dystrophic muscle.
While Law only contemplates use of automatic cell processors, this does not mean that Law solved the cell demand problem and or that this would preclude one of skill in the art from searching for other solutions. Automatic cell processors would not solve the problem taught by the prior art regarding the limited life span of myoblasts in culture. Thus, one of skill in the art would have looked at art providing means for increasing the life span of myoblasts in culture, such as immortalization as taught by Zhu. Furthermore, one of skill in the art would have readily recognized that automatic cell processors could be used with any cell type, including immortalized myoblasts.
The argument that Law does not teach immortalized myoblasts is not found persuasive because Law does not have to tech every claim limitation.
The argument that the cited references do not teach that immortalized myoblasts could be used in Law’s method is not found persuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, as set forth in the rejection, the combined teachings of Law and Zhu suggest that Law's method could be practiced with immortalized myoblasts and provide the motivation to do so.
The argument that the goal in Law is to create mosaic cells is not found persuasive. Again, the goal is to treat the disease; the principle of operation is using normal myoblasts for inserting the wild type gene into the dystrophic muscle to repair it and also creating fusions among the normal myoblasts to form genetically normal myofibers (non-mosaic) replacing the dystrophic ones. This could be achieved by using either non-immortalized or immortalized myoblasts. By using immortalized myoblast, one of skill in the art would not have changed Law’s principle of operation and goal.
Immortalization does not change the capacity of myoblasts to fuse and form myofibers. The transplanted immortalized myoblasts would still fuse to the dystrophic and among themselves to replenish the muscle with myofibers comprising the wild type gene. One of skill in the art would have reasonably expected the immortalized myoblast to fuse and create more non-mosaic fibers replacing the damaged tissue.
The argument that Law recommends not using immortalized myoblasts is not found persuasive because there is no such teaching in Law.
For this reason, the argument that the teachings in Law and Zhu are contradictory is not found persuasive.
The applicant argues that the cells of the invention are precursor cells and not myoblasts. However, myoblasts are myogenic precursor cells as required by claim 1 (see also the specification, [0031]).
The applicant argues that, in the invention, the cells are immortalized for transplantation, not for the purpose of producing cells.
However, as set forth in the rejection, immortalizing the myoblasts is for transplantation purposes.
5. No claim is allowed. No claim is free of prior art.
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/ILEANA POPA/Primary Examiner, Art Unit 1633