DETAILED ACTION
This action is in reply to papers filed 6/22/2020. Claims 1-18 are pending and examined herein.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20240197790A11, Published 6/20/2024.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-9 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Caplan et al. (WO1996039035, Published 12/12/1996).
Regarding claim 1, claim 4 and claim 5 (in-part), Caplan discloses plating a trypsin digestion of human skeletal muscle tissue in a coated culture dish containing culture medium for 30 minutes (Pg. 19, para. 1). The nonadherent muscle precursor cells are counted in a hemocytometer and the cell density is adjusted to 1.0 x 105 cells/ml with DMEM-LG supplemented with 20% fetal calf serum. Cells are then transferred to a second culture dish and incubated for 2 more days (Pg. 19, para 1, lines 11 -16). After 2 days, the media was replaced with new media. Caplan discloses the dishes are observed for about 11 days, (Pg. 19, para. 1, lines 18-19). Moreover, Caplan discloses administering the expanded muscle derived cells to a human (Pg. 4, para. 2, lines 1-5).
Regarding claim 2, Caplan discloses this medicament for treating muscular dystrophy or muscle regeneration in an individual so afflicted (Abstract).
Regarding claim 3, Caplan discloses the method of claim 1 to be applied to a human (Pg. 18).
Since Caplan discloses only non-adherent muscle precursor cells were counted in a hemocytometer, Caplan discloses step (b) of claim 5 (Pg. 19, para. 1).
Regarding claim 6, Caplan discloses the expanded MDCs to be injected into the skeletal muscle of the mammal (Pg. 10, para. 3, lines 4-9).
Regarding claim 7, Caplan discloses the mouse is a model for Duchenne-type human muscular dystrophy, wherein their skeletal and cardiac muscles are composed of predominantly dystrophin-negative myofibers and show an extensive myopathic lesion accompanied with muscle fiber necrosis and degeneration (paragraph bridging Pg. 7 and Pg. 8).
Regarding claims 8 and 9, Caplan discloses the myoblasts were injected into the tibialis anterior muscle of the mouse (Pg. 10, paragraph 3, lines 9-11).
Accordingly, Caplan anticipates the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 10-18 are rejected under 35 U.S.C. 103 (a) as being unpatentable over Caplan et al. (WO1996039035, Published 12/12/1996), Law et al. (US Patent 5,130,141, Patented 7/14/1992) and Chandler et al. (US Patent 5,895,745 Patented 4/20/1999).
Regarding claim 10 (in-part), claim 13 and claim 14 (in-part), Caplan teaches plating a trypsin digestion of human skeletal muscle tissue in a coated culture dish containing culture medium for 30 minutes (Pg. 19, para. 1). The nonadherent muscle precursor cells are counted in a hemocytometer and the cell density is adjusted to 1.0 x 105 cells/ml with DMEM-LG supplemented with 20% fetal calf serum. Cells are then transferred to a second culture dish and incubated for 2 more days (Pg. 19, para 1, lines 11 -16). After 2 days, the media was replaced with new media. Caplan teaches the dishes are observed for about 11 days, (Pg. 19, para. 1, lines 18-19). Moreover, Caplan teaches administering the expanded muscle derived cells to a human (Pg. 4, para. 2, lines 1-5).
Regarding claim 11, Caplan teaches this medicament for treating muscular dystrophy or muscle regeneration in an individual so afflicted (Abstract).
Regarding claim 12, Caplan teaches the method of claim 10 to be applied to a human (Pg. 18).
Since Caplan teaches only non-adherent muscle precursor cells were counted in a hemocytometer, Caplan makes obvious the limitations of step (b) of claim 14 (Pg. 19, para. 1).
Regarding claim 15, Caplan teaches the expanded MDCs to be injected into the skeletal muscle of the mammal (Pg. 10, para. 3, lines 4-9).
Regarding claim 16, Caplan teaches the mouse is a model for Duchenne-type human muscular dystrophy, wherein their skeletal and cardiac muscles are composed of predominantly dystrophin-negative myofibers and show an extensive myopathic lesion accompanied with muscle fiber necrosis and degeneration (paragraph bridging Pg. 7 and Pg. 8).
Regarding claims 17 and 18, Caplan teaches the myoblasts were injected into the tibialis anterior muscle of the mouse (Pg. 10, paragraph 3, lines 9-11).
However, Caplan fails to teach freezing the isolated MDCs to a temperature between about -25⁰ C and -90⁰ C and thawing the frozen isolated MDCs (as in claim 10 step b and step c).
Prior to the time of the claimed invention, it was routine and well known in the art to freeze cells as a means of maintaining the culture. For example, Law teaches a method of treating muscle degeneration and weakness in a host which comprises administering an effective amount of myogenic cells to at least one myopathic muscle of the host. Law teaches that it is routine to freeze cells to maintain the culture, wherein the cells can be put in deep freeze at -90 ⁰(Column 8, paragraph 3, lines 52- 55) (as in claim 10 (b)).
Furthermore, thawing frozen cells at room temperature is a matter of routine and well known to those with ordinary skill in the art. For example, Chandler teaches a method of processing cryopreserved cells. Specifically, Chandler teaches thawing and equilibrating the cells at warm temperatures (e.g., between 30°C and 43°C) (as in claim 10 (c)) by adding a medium to dilute the cell suspension at a temperature between 30°C and 43°C (Column 1, paragraph 3, lines 22-35).
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationale C and G are applicable. At the time of invention, it would have been prima facie obvious to an artisan of ordinary skill to apply the known and routine techniques of cell culturing in Law and Chandler in order to modify the method of Caplan (see Caplan, paragraph bridging Pg. 22-23).
Accordingly, the claimed invention, as a whole, was clearly prima facie obvious.
Double Patenting
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9499791. Although the claims at issue are not identical, they are not patentably distinct from each other because.
The instant claims are directed to a method of augmenting a skeletal muscle in a mammal in need thereof comprising a) isolating MDCs; b) expanding the isolated MDCs in culture between 10 and 20 days; and c) administering a therapeutically effective portion of the expanded MDCs to the skeletal muscle in the mammal in need thereof; thereby augmenting the skeletal muscle in the mammal in need thereof. Independent claim 10, similar in objective to claim 1, includes a step of freezing and thawing MDCs after isolation but prior to administration.
The claims of U.S. Patent ‘791 are directed to a method of augmenting a skeletal muscle in a mammal suffering from a muscle pathology. Specifically, claim 1 recites a method of augmenting a skeletal muscle in a mammal suffering from a muscle pathology comprising: a) isolating muscle-derived progenitor cells (MDCs) by a method comprising: (i) isolating skeletal muscle from a human; (ii) storing the skeletal muscle at 4° C. for 5 to 7 days; (iii) suspending the human skeletal muscle in a medium in a first cell culture container between 30 and 120 minutes thereby producing a cell population of adherent cells and a population of non-adherent cells; (iv) isolating the medium containing a population of non-adherent cells; (v) transferring the medium containing the population of the non-adherent cells to a second cell culture container; (vi) allowing the population of the transferred non-adherent cells from step (v) to attach to the walls of the second cell culture container, wherein the incubation is for 1 to 3 days; (vii) removing the medium from the second container and replacing with new medium after the 1 to 3 days of incubation; and (viii) isolating the cells from the walls of the second cell culture container, wherein the isolated cells are MDCs and are desmin+; b) expanding the isolated MDCs in culture for between 10 and 20 days; and c) administering a therapeutically effective amount of the expanded MDCs to the skeletal muscle in the mammal suffering from a muscle pathology; allowing the MDCS to engraft to the skeletal muscle and thereby augmenting the skeletal muscle in the mammal. Independent claim 7, similar in content, includes a step of freezing and thawing the isolated MDCs prior to administering.
It is clear that all the elements of the application claims are to be found in patent claims (as the application claims fully encompasses patent claims). The difference between the application claims and the patent claims lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus, the invention of claims of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims is anticipated by claims of the patent, it is not patentably distinct from claims of the patent.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632