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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-10 in the reply filed on 11/18/25 is acknowledged.
Claims 1-16 are currently pending.
Claims 11-16 are withdrawn as directed to non-elected inventions.
Claims 1-10 are elected and examined on the merits.
Claim Objections
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Applicant is advised that should claim 1 be found allowable, claims 7-10 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Each of claims 7-10 refer to an additional optional step. As the step is optional, it appears that each of claims 7-10 do not require any further limitations beyond those recited in independent claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4, 6-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 contains the limitations “at a temperature lower than 16°C, preferably at a temperature range from 1 to 16°C, preferably 4 to 10°C, in particular preferred at 7°C”. It is unclear whether the narrower recited ranges are required limitations, or merely preferred embodiments. See MPEP § 2173.05. For examination purposes claim 2 is interpreted as “at a temperature lower than 16°C
Claim 4 contains the limitations “at a temperature in the range of 1 to 16°C, preferably 4 to 8°C, in particular preferred at 4°C”. It is unclear whether the narrower recited ranges are required limitations, or merely preferred embodiments. See MPEP § 2173.05. For examination purposes claim 4 is interpreted as “at a temperature in the range of 1 to 16°C
Claim 6 contains the limitations “at a temperature in the range of 25 to 38°C, preferably 36 to 38°C, in particular preferred at 37°C”. It is unclear whether the narrower recited ranges are required limitations, or merely preferred embodiments. See MPEP § 2173.05. For examination purposes claim 6 is interpreted as “at a temperature in the range of 25 to 38°C”.
Claim 7 contains the limitations “(d) comprises preferably a methods selected from…”. It is unclear if any of the subsequent limitations are requirements of the claim or merely optional.
Claim 8 contains the limitations “wherein a further optional step (e)”. It is unclear if any of the subsequent limitations are requirements of the claim or merely optional.
Claim 8 contains the limitation “the incubation in step (e) is preferably conducted at a temperature in the range of 25 to 38°C, preferably 36 to 38°C, in particular preferred at 37°C”. It is unclear whether the narrower recited ranges are required limitations, or merely preferred embodiments. See MPEP § 2173.05.
Claim 9 contains the limitation “wherein after step (e)”. Claim 9 depends from claim 1, which does not contain a step (e). Therefore it is unclear what this limitation is intending to convey.
Claim 9 contains the limitation “wherein after step (e) optionally a further step (f) is conducted”. It is unclear if this limitation is indicating that step (e) is a required limitation of the claim, and step (f) is merely optional, or if both steps (e) and (f) are optional.
Claim 9 contains the limitation “step (f) is preferably conducted after at least 6 hours to 4 days”. It is unclear if this limitation is a required limitation of the claim, or merely a preferred embodiment. See MPEP § 2173.05.
Claim 10 contains the limitation “wherein after step (f)”. Claim 9 depends from claim 1, which does not contain a step (f). Therefore it is unclear what this limitation is intending to convey.
Claim 10 contains the limitation “the propagating in step (h)”. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 contains the limitation wherein after step (f) optionally a further step (g) is conducted”. It is unclear if this limitation is indicating that step (e) is a required limitation of the claim, and step (f) is merely optional, or if both steps (e) and (f) are optional.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharifiaghdas F., Taheri, M., & Moghadasali, R. Isolation of human adult stem cells from muscle biopsy for future treatment of urinary incontinence. Urology Journal, Vol. 8, No. 1 (2011) pp. 54-59 (cited on IDS dated 4/27/23, hereinafter Sharifiaghdas) in view of R. Ian Freshney, “Primary Culture.” and “Subculture.” In: Culture of Animal Cell: A Manual of Basic Technique and Specialized Applications. (Hoboken, NJ, John Wiley & Sons, Inc., 2010), pp. 163-206. QH585.2.F74 2010 (hereinafter Freshney).
Regarding claims 1, 5-6, Sharifiaghdas discloses methods of obtaining muscle derived stem cells (MDSCs) for the treatment of urinary incontinence (Abstract). Sharifiaghdas discloses obtaining a sample of muscle and placing in phosphate buffered saline solution (PBS) on ice (Cell isolation; preplate and tissue explant techniques; placing in PBS on ice is interpreted as cooling the sample). The muscle sample is then minced and chopped using razor blades (Cell isolation; preplate and tissue explant techniques). The minced sample is then subjected to enzymatic digestion using collagenase IV for 1 hour, dispase for 45 minutes, and trypsin-ethylenediaminetetraccetic acid (EDTA) for 30 minutes, each at 37°C (Cell isolation; preplate and tissue explant techniques). Each enzymatic digestion step is followed by centrifugation, decanting, and resuspension of the cells (Cell isolation; preplate and tissue explant techniques). The resultant cells are cultured to produce a population of adherent cells (Cell isolation; preplate and tissue explant techniques). The cells are further subcultured for up to 6 passages (Cell isolation; preplate and tissue explant techniques).
Regarding claim 7, Sharifiaghdas discloses that after 2 to 3 weeks in culture the cells are collected and analyzed using flow cytometry (Flow cytometry).
Sharifiaghdas does not disclose that the enzymatic digestion is performed in the presence of serum. However, as explained in Freshney, serum is commonly used in disaggregation of tissue, and promotes survival of the cells (11.1.2). It would be obvious to one of ordinary skill in the art to try including serum in the enzymatic digestion cocktails as one of a finite number of identified solutions for enzymatic digestion, with a reasonable expectation that the tissue would be digested. A skilled artisan would be motivated to use serum to improve survival of the cells contained in the tissue sample.
Regarding claims 2, 4, Sharifiaghdas does not disclose that the cooling is performed at a temperature of between 1 and 16°C. However, Sharifiaghdas discloses that the muscle is placed in PBS on ice (Cell isolation; preplate and tissue explant techniques). Therefore, there is a suggestion present in Sharifiaghdas that the muscle tissue should be maintained and processed at a temperature wherein the sample is maintained at a refrigeration temperature (e.g., between 2 and 6°C).
Regarding claim 3, Sharifiaghdas does not disclose that the processing comprises the use of scissors, scalpel, tweezers, filter, or ball mill. However, Sharifiaghdas discloses processing the tissue with razor blades. Freshney explains that one of the common features of disaggregation is that the tissue would be finely chopped with sharp scalpels to cause minimal damage (11.1.2). It would be obvious to one of ordinary skill in the art that the razor blades of Sharifiaghdas could be substituted for the scalpel of Freshney as a simple substitution of one known means for processing a tissue sample for another with the predictable result that the tissue would be processed.
Regarding claims 8-10, Sharifiaghdas does not disclose the cells are first sorted then cultured. However, change in sequence is considered a routine expedient requiring no more than ordinary skill in the art. See MPEP § 2144.04. Therefore, it would be obvious to one of ordinary skill in the art that the cells could be sorted prior to further culture. Further, it is routine in the art to perform subculture at approximately 70 to 80% confluency as demonstrated by Freshney (12.4).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632