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 .
Status of the Claims
Claims 1-15 are pending (claim set as filed on 01/23/2024).
Election/Restrictions
Applicant’s election without traverse of Group I, method claims, in the reply filed on 04/30/2026 is acknowledged.
Claim 15, drawn to the composition, is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Therefore, only method claims 1-14 are under examination.
Priority
This application is a 371 of PCT/EP2022/072088 which has a foreign application to EP 21190102.0 filed on 08/06/2021.
Drawings
The drawings filed on 01/23/2024 have been accepted.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 01/23/2024, 06/07/2024, 08/23/2024, 02/20/2025, 02/03/2026, and 03/10/2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Claim Rejections - 35 USC §112, Indefinite
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.
Claims 1-14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 3, 5, 7, 9-11, and 13-14 recite the words “preferably” and “in particular” in several occurrences and therefore, are rejected as being indefinite because these are considered to be examples and preferences that may lead to confusion over the intended scope of a claim (MPEP 2173.05(d): Exemplary Claim Language).
The dependent claims are rejected because they are dependent claims that do not overcome the deficiencies of the rejected claim from which they depend.
Claim Rejections - 35 USC §102, Anticipation
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.
Claims 1-5 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thurner (Generation of myogenic progenitor cell-derived smooth muscle cells for sphincter regeneration, 2020 - previously cited and by the ISA and in the IDS filed on 01/23/2024).
Thurner discloses that degeneration of smooth muscles in sphincters can cause debilitating diseases such as fecal incontinence. Thurner teaches myogenic progenitor cells (MPC) were isolated for in vivo engraftment by transplanting reporter protein-expressing cells into the pyloric sphincter of immunodeficient mice (see abstract).
Thurner teaches “Human skeletal muscle-derived cells were isolated from adult human skeletal muscle tissue. Both CD56+ and CD56− cells were enriched by MACS as described before. CD56+ cells, known to be committed to the myogenic lineage, are referred to as myogenic progenitor cells (MPC) hereafter, while CD56− cells, hypothesized to be utmost multipotent mesenchymal stromal cells, are termed MSC. We characterized MPC and MSC following isolation to confirm the efficiency of their separations (Fig. 1a). They were tested for the presence of mesenchymal lineage markers (CD105, CD90, CD73) and hematopoietic markers (CD14, CD19, CD45, CD34, MHCII), constituting the consensus minimal panel for the characterization of MSC by flow cytometry. CD56+ MPC highly expressed all mesenchymal lineage markers tested and were negative for tested hematopoietic markers. Thus, our marker panel confirmed the mesenchymal character of CD56+ MPC (Fig. 1a)” (see page 6: Results).
Claims 1 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thurner (WO 2019/115790 A1 - cited in the IDS filed on 01/23/2024, citations are being made the English equivalent US Patent no. 11,617,768 B2).
Thurner teaches “A method of treating incontinence comprising administering a skeletal muscle derived cell population comprising at least 60% CD56 positive and 60% A2B5 positive cells to a subject in need thereof” and wherein the incontinence is anal incontinence (see ‘768’s claims 1-4).
Claims 1-2, 5, 11, and 14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Thurner (WO 2020/193460 A1 - cited in the IDS filed on 01/23/2024, citations are being made the English equivalent US Patent no. 12,312,600 B2).
Thurner teaches the present invention provides induced smooth muscle cells for use in cell therapy wherein the disease or disorder is selected from anal incontinence, the method comprising injection of said cells into a subject wherein said cells are CD56+ (see col. 17, lines 5-35). Thurner teaches the cells are administered into the anal sphincter puborectalis muscle (see col. 6, lines 19-29).
Claims 1-2, 5, and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marksteiner (US 2015/0247856 A1).
Marksteiner’s general disclosure relates to skeletal muscle derived cells (SMDC) for use in the treatment of a muscle dysfunction (see abstract & ¶ [0005]).
Regarding claim 1 pertaining to the treatment of anal incontinence, Marksteiner first discloses “skeletal muscle derived cells comprising myoblasts are known as progenitor cells of skeletal muscles which can undergo differentiation in order to repair muscle injuries in adults” (see ¶ [0001]-[0004]). Marksteiner teaches “the present invention relates to methods of preventing or treating urinary and/or anal incontinence, wherein the method comprises the following steps: (a) verifying the potency of previously obtained MSDC by the potency assay according to the present invention, (b) introducing of an injection device through the skin or urethra of a patient, (c) moving the injection device forward until the injection device reaches the injection site of interest, and (d) injecting of said previously obtained and verified MSDC via said injection device into said injection site of interest, wherein the injection site of interest is, or is adjacent to, muscle-tissue providing for urinary and/or anal continence” (see ¶ [0079]).
Regarding claim 2 pertaining to the muscle damage, Marksteiner teaches muscle-derived cell therapy allows repair and improvement of damaged anal sphincter (see ¶ [0084]). Marksteiner discloses “the term ‘anal incontinence’ or ‘feces incontinence’ as used herein, refers to any undesired loss of intestine content through the anus, like flatus, liquid or solid feces. The term comprises all three severity grades: Grade 1 =only gaseous, grade 2=liquid and soft feces, grade 3=solid, formed feces” (see ¶ [0024]).
Regarding claims 5 and 14 pertaining to the administration, Marksteiner discloses “the muscle-tissue providing for urinary and/or anal continence is the anal sphincter system, the internal anal sphincter, and the external anal sphincter. In a further embodiment, the muscle-tissue for anal continence is M. puborectalis” (see ¶ [0026], [0080]). Marksteiner teaches “the term ‘injection,’ as used herein, refers to the expulsion of an injection solution comprising above mentioned cells out of an injection device into a specific site within the human body, in particular into or adjacent to muscle-tissue providing for urinary and/or anal continence” (see ¶ [0028]-[0030]).
Regarding claims 11-13 pertaining to the expression markers and effective amount, Marksteiner teaches the skeletal muscle derived cells (SMDC) are preferably cells isolated from a muscle tissue, in particular a skeletal muscle tissue wherein the SMDC consists of at least 50-99% CD56+ cells (see ¶ [0048]). Marksteiner teaches the AChE multiplication is at least a factor of 3-20 (see ¶ [0076]). Marksteiner teaches “a therapeutically effective amount of cells in solution or suspension, e.g., about 1x105 to about 6x106 cells per 100 μL of injection solution. In particular, for the treatment of urinary incontinence an amount of 100,000 to 300,000 cells, more preferably 200,000 is preferred. For the treatment of anal incontinence a higher amount of cells is preferred” (see ¶ [0090], [0093]-[0094]).
Claim Rejections - 35 USC §103, Obviousness
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.
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 non-obviousness.
Claims 3-4 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Marksteiner as applied to claims 1-2, 5, and 11-14 above, in view of Herman (US 2015/0265388 A1).
Marksteiner’s disclosure is taught above as it pertains to a method for the prevention and treatment of anal incontinence comprising administering myogenic progenitor cells.
However, Marksteiner does not teach: wherein the subject has a severity of incontinence weekly episodes of greater than 2 prior to treatment (claims 3-4); or performing stimulation of the anal sphincter via Kegel exercise and/or by electrical stimulation for a set amount of duration (claims 6-10).
Herman’s general disclosure relates to apparatus and methods for treating fecal incontinence (see abstract & ¶ [0002]). Herman discloses “variety of treatment options are currently available for treating fecal incontinence. Some of these include external devices, behavioral therapy (such as biofeedback, electrical stimulation, or Kegel exercises), prosthetic fecal sphincters (including the Acticon Neosphincter available from American Medical Systems), and surgery. Depending on the age, medical condition, and personal preference of a patient, surgical procedures can be used to completely restore continence” (see ¶ [0003]-[0004]).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to envisage a patient population having anal incontinence severity defined as more than 2, 6, or more weekly episodes. As noted in the prior arts, anal incontinence can range in symptoms or severity and can occur in people of every age (see, e.g., Marksteiner at ¶ [0004], [0024]; or Herman at ¶ [0003]). Thus, it would be reasonable for an ordinary artisan such as a medical practitioner to perform questionnaires or assessments to determine the severity of the incontinence prognosis to determine a treatment guideline.
Furthermore, it would have been secondly obvious to perform stimulation of the anal sphincter via Kegel exercise and/or electrical stimulation such as taught by Herman in the method of Marksteiner. The ordinary artisan would have been motivated to do so is because Herman teaches theses are known in the art as treatment options for fecal incontinence (see Herman at ¶ [0004]). Thus, the performing of the claimed stimulation would have been readily predictable combinations of the prior arts as additive or adjunct therapy of anal incontinence. Moreover, note that the primary reference of Marksteiner suggests that the patient can start the next day after injection of cells with physical exercises to further the treatment of urinary and/or anal incontinence (see Marksteiner at ¶ [0095]). Regarding the stimulation duration to be performed (e.g., for at least 2 weeks, twice daily, or at least 10 minutes), these parameters are considered within the purview of the ordinary artisan to be optimizable and performed depending upon several patient factors including the age, medical condition, and personal preference of a patient and can be used to completely restore continence (see Herman at ¶ [0003]-[0004]).
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent no. 11,617,768 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because Patent ‘768 teaches “A method of treating incontinence comprising administering a skeletal muscle derived cell population comprising at least 60% CD56 positive and 60% A2B5 positive cells to a subject in need thereof” and wherein the incontinence is anal incontinence (see ‘768’s claims 1-4).
Conclusion
No claims were allowed.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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