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 .
Claims 1, 4, 7, 10, 12-17, and 19-22 are pending.
Applicant’s amendments and arguments of August 11, 2026, are entered.
Claims 1, 10, 12, 13, 14, 16, and 19 have been amended.
No new claims.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on August 11, 2026, was filed before the mailing of the First Office Action for the RCE requested on August 11, 2026. The Non-Patent Literature is in compliance with the provisions of 37 CFR 1.97 and are being considered by the examiner.
Claim Objections
In light of Applicant’s amendments, the objections to claims 1, 10, 12, and 13 are withdrawn.
Double Patenting
In light of Applicant’s amendments, the double patent objection to claim 19 is withdrawn.
Claim Rejections - 35 USC § 112
In light of Applicant’s amendments, the rejection to claim 14 under 35 U.S.C. §112(b) is withdrawn.
Claim Rejections - 35 USC § 112
In light of Applicant’s amendment, the rejection to claim 16 under 35 U.S.C. §112(d) is withdrawn.
Claim Rejections - 35 USC § 101
In light of Applicant’s argument, the rejection to claim 15-17 under 35 U.S.C. §101 is withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, 7, 19, and 20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a physical phenomenon without significantly more. The claim(s) recite(s) a composition comprising endometrial stem cells for use in a method for treating diminished ovarian reserve and that the endometrial stem cells are derived from an endometrial tissue sample. This judicial exception is not integrated into a practical application because there is no transformation of the realization. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than a judicial exception because the additional elements are simply preparation activities to prepare to realize the effect, or not, is being maintained.
Step 1: Is the claim to a process, machine, manufacture, or composition of matter? Yes, the claims are drawn to a composition, as seen in claim 1.
Step 2A: Prong 1: Are the claims directed to a Judicial Exception? Yes, the claims are drawn to a physical phenomenon, i.e., “endometrial stem cells for use in a method for the treatment of diminished ovarian reserve, wherein said endometrial stem cells are derived from an endometrial tissue sample”. The endometrial stem cells derived from the endometrial tissue sample are naturally occurring cells.
Step 2A: Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? No, the claim recites endometrial stem cells as part of a composition (solution) that is intended as a treatment for diminished ovarian reserve. These elements do not impart any structural or functional changes to the naturally occurring stem cells. Additionally, Claim 2 recites that the endometrial stem cells are autologous. Claim 3 recites the endometrial stem cells are in fact endometrial mesenchymal stem cells, and claims 4 and 5 describe what markers are present or absent for determining if the cell is in fact an endometrial mesenchymal stem cell, e.g. positive for CD90, CD146, etc. and negative for CD34 and CD31. Claim 6 describes the location of where the composition is to be administered. Claim 7 describes the solutions to be used to maintain the viability of the endometrial stem cells. Claims 8 describe the endometrial stem cell concentration relative to the solution, and Claim 9 describes the number of doses at a certain dosage range. None of these limitations provide a practical application of the judicial exception of Claim 1.
As the claims are directed to a judicial exception (endometrial stem cells derived from endometrial tissue samples for use in treating diminished ovarian reserve), and lack a transformation of the judicial exception into a practical application of it, the claims are properly rejected for being directed to a judicial exception.
Response to Argument
Applicant’s argument for the remaining claims being rejected under 35 U.S.C. §101 is that “the remaining claims are also statutory subject matter at least because, in the treatment, the cells are delivered to the ovary, which is a different biological environment from the endometrium. Under normal physiological conditions the cells are not known to migrate to the ovarian cortex in therapeutically effective numbers, nor are they naturally concentrated, retained or activated within the ovarian cortex in a manner that would restore ovarian function.”
Examiner appreciates Applicant’s argument but does not find this argument persuasive.
Claims 1, 4, 7, and 19-20 are directed to a composition comprising endometrial mesenchymal stem cells in a physiologically relevant solution for use in a method of treating diminished ovarian reserve, rather that to a method of treatment comprising delivering the cells to the ovarian cortex. Applicant’s assertions concerning delivery of the cells to the ovary, migration to the ovarian cortex, retention or activation of the cells within the ovarian cortex, and restoration of ovarian function do not identify a structural or other meaningful limitation of the claimed composition that removes the claims from the judicial exception.
The relevant inquiry is whether the claim as a whole integrates the alleged judicial exception into a practical application by reciting additional elements that further limit the exception. Here, the recited intended therapeutic use does not require that the claimed composition possess any particular structural or functional characteristic that distinguishes the endometrial mesenchymal stem cells from the same composition absent the recited use. Based on this, the rejection is maintained.
Claim Rejections - 35 USC § 103
Claims 1, 4, 7, 10, 12-17, 19, 20, 21, and 22 are rejected under 35 U.S.C. §103 as being unpatentable over Zuo et al. [The clinical applications of endometrial mesenchymal stem cells, Biopreserv Biobank, 2018], in view of Grady et al. [Effect of intra-ovarian injection of mesenchymal stem cells in aged mares, Reproductive Physiology and Disease, 2018], in view of Michl et al. [Evidence-based guidelines from controlling pH in mammalian live-cell culture systems, Communications Biology, 2019], in view of Liu et al. [Biological characteristics of human menstrual blood derived endometrial stem cells, Journal of Cellular and Molecular Medicine, 2017], in view of Zhang et al. [A protocol for isolation and culture of mesenchymal stem cells from human gingival tissue, Am J Clin Exp Immunol, 2019], in view of Gargett et al. [Endometrial stem/progenitor cells: the first 10 years, Hum Reprod Update, 2015], is being maintained.
With respect to Claim 1, Zuo et al., discussing the clinical applications of endometrial mesenchymal stem cells, teaches the use of endometrial mesenchymal stem cells in the possible treatment of premature ovarian syndrome [Abstract, Application of enMSCs in the immune system ¶ 2]. Although premature ovarian syndrome is characterized by a severe reduction or loss of ovarian function leading to infertility, diminished ovarian syndrome similarly involves reduced ovarian reserve and impaired infertility, but is typically less severe condition. Because of this, there is a reasonable expectation of success that a person skilled in the art would recognize the teachings of Zuo et al. could be applied diminished ovarian syndrome considering both conditions involve ovarian function with premature ovarian syndrome representing the more severe dysfunction. Therefore, a person of ordinary skill could reasonably expect that a therapy that capable of being utilized for a more severe condition with overlapping etiology could reasonably be applied to a less severe condition.
For claim 4 where the endometrial mesenchymal stem cells are positive for certain cell surface markers and negative for other cell surface markers, Zuo et al. discloses the endometrial mesenchymal stem cells used in this art reference were positive for CD90, CD105, and CD146 [Introduction ¶ 2, Biobanking of enMSCs ¶ 2], and negative for both CD34 and CD31 [Biobanking of enMSCs ¶ 2].
For Claim 7 where the composition comprises a physiologically relevant solution or culture medium maintained at 7.2-7.4 pH, Michl et al., discussing methods for controlling pH in mammalian live-cell culture systems, discloses that the pH should be around 7.4 being that this is near optimal growth for pH [Fig. 2].
For Claim 10 where a method for making the composition comprising endometrial mesenchymal stem cells, Zhang et al., utilizing a protocol for isolating and culturing mesenchymal stem cells from human gingival tissue, teaches soaking the tissue in a balanced salt solution, washing the tissue with PBS, mincing the gingival tissue, digesting the minced tissue, filtering and centrifuging the digested tissue, followed by culturing the gingival tissue [Procedure]. For parts (g) and (i), Zuo et al. teaches the presence of cell surface markers such as the presence of CD90, CD146, and CD105, marked by the absence of other cell surface markers such as CD 34 and CD31 [Introduction ¶ 2, Biobanking of enMSCs ¶ 2]. This is followed by characterization of endometrial stem cells through multipotency, e.g. differentiation into osteocytes and adipocyte cells [Introduction ¶ 4].
Here, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Zhang et al. that describes a method for isolating and culturing mesenchymal stem cells from gingival tissue with the teachings of Zuo et al. that discloses the presence or absence of certain cell surface markers associated with stemness. Because of the this, there is a reasonable expectation of success that an Artisan would be able to combine the teachings of Zhang et al. with the additional teachings of Zuo et al. that would allow the Artisan to derive endometrial mesenchymal stem cells from an endometrium tissue sample using the protocol as stated in Zhang et al., and then confirming the presence of endometrial mesenchymal stem cells based on the presence of absence of certain stem cell surface markers that would indicate the stem cell’s ability to differentiate into such things as osteocytes or adipocytes.
For claim 12 where the method of claim 11 includes maintaining the cultured stem cells at specific ranges for temperature, CO2 concentration, and humidity, Zhang et al. discloses maintaining the culture medium and culture at 37˚C, humidified, at 5% CO2 for up to two weeks [Procedure, Anticipated Results 2.].
For Claim 13 where the cells are exchanged every 3 days, Zhang et al. teaches that after being cultured, the non-adherent cells are removed and fresh complete culture medium will be added every 48 hours to 72 hours [Procedure Part 7.].
For Claim 14 where the method is similar to Claim 10 accept the addition of Hanks fluid for step a), Zhang et al teaches the use of MEM Alpha medium [Procedure 2.]. However, a person of ordinary skill in the art would recognize that Hank’s fluid could be substituted as a form of short-term maintenance prior to washing. Additionally, Zhang et al., utilizing a protocol for isolating and culturing mesenchymal stem cells from human gingival tissue, teaches soaking the tissue in a balanced salt solution, washing the tissue with PBS, mincing the gingival tissue, digesting the minced tissue, filtering and centrifuging the digested tissue, followed by culturing the gingival tissue [Procedure]. For parts (g) and (i), Zuo et al. teaches the presence of cell surface markers such as the presence of CD90, CD146, and CD105, marked by the absence of other cell surface markers such as CD 34 and CD31 [Introduction ¶ 2, Biobanking of enMSCs ¶ 2]. This is followed by characterization of endometrial stem cells through multipotency, e.g. differentiation into osteocytes and adipocyte cells [Introduction ¶ 4]. Lastly for step g., Zhang et al. discloses maintaining the culture medium and culture at 37˚C, humidified, at 5% CO2 for up to two weeks [Procedure, Anticipated Results 2.].
Again, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Zhang et al. that describes a method for isolating and culturing mesenchymal stem cells from gingival tissue with the teachings of Zuo et al. that discloses the presence or absence of certain cell surface markers associated with stemness. Because of the this, there is a reasonable expectation of success that an Artisan would be able to combine the teachings of Zhang et al. with the additional teachings of Zuo et al. that would allow the Artisan to derive endometrial mesenchymal stem cells from an endometrium tissue sample using the protocol as stated in Zhang et al., and then confirming the presence of endometrial mesenchymal stem cells based on the presence of absence of certain stem cell surface markers that would indicate the stem cell’s ability to differentiate into such things as osteocytes or adipocytes.
For claim 15 where a method for treating diminished ovarian syndrome using containing the endometrial mesenchymal stem cells is used, Zuo et al. teaches the use of endometrial mesenchymal stem cells in the possible treatment of premature ovarian syndrome [Abstract, Application of enMSCs in the immune system ¶ 2]. Although premature ovarian syndrome is characterized by a severe reduction or loss of ovarian function leading to infertility, diminished ovarian syndrome similarly involves reduced ovarian reserve and impaired infertility, but is typically less severe condition. Because of this, there is a reasonable expectation of success that a person skilled in the art would recognize the teachings of Zuo et al. could be applied diminished ovarian syndrome considering both conditions involve ovarian function with premature ovarian syndrome representing the more severe dysfunction. Therefore, a person of ordinary skill could reasonably expect that a therapy that capable of being utilized for a more severe condition with overlapping etiology could reasonably be applied to a less severe condition. Therefore, a person of ordinary skill could reasonably expect that a therapy that capable of being utilized for a more severe condition with overlapping etiology could reasonably be applied to a less severe condition.
For Claim 16 and Claim 17 where the cell concentration is about 0.95-8 million cells/mL and 1.5-6.5 million cells number/mL respectively, Liu et al. discloses mesenchymal stem cells that were analyzed at a concentration of 5 x 106 cells/ml. This converts to 10,000,000 cells per mL [Cell labelling and imaging ¶ 1]. This range falls with the range provide in the Liu et al. reference.
For Claim 19 where the endometrial mesenchymal stem cells are positive for certain cell surface markers and negative for other cell surface markers and the endometrial mesenchymal stem cells are express OCT-4, CD146, and STRO-1, Zuo et al. discloses the endometrial mesenchymal stem cells used in this art reference were positive for CD90, CD105, and CD146 [Introduction ¶ 2, Biobanking of enMSCs ¶ 2], and negative for both CD34 and CD31 [Biobanking of enMSCs ¶ 2]. Zuo et al. discloses the expression of OCT-4 and CD146 [Introduction ¶ 2, Biobanking of enMSCs ¶ 2]. Here, there is a reasonable expectation of success that a person ordinary skill would recognize the additional teachings of Zuo et al. that indicates the presence and absence of certain cell surface markers as a way of identifying the presence of endometrial mesenchymal stem cells. Because of this, it is prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Zuo et al. in furtherance the additional teachings instructing on what cell surface markers are expressed along with several other cell expression markers allowing a person of ordinary skill to determine the presence of endometrial mesenchymal stem cells.
With respect to Claim 19’s limitation where the autologous endometrial mesenchymal stem cells express Oct-4 and STRO-1, Gargett et al. teaches that STRO-1 is expressed by endothelial and perivascular cells in human endometrium [Markers of eMSCs ¶]. Furthermore, Gargett et al. also teaches that endometrial stem cells derived from the disclosed endometrial regenerative cell population were positive for Oct-4 [Table IV, Endometriosis ¶ 2].
For Claim 20 where the composition comprises a physiologically relevant solution or culture medium maintained at 7.2-7.4 pH and the cell composition of endometrial stem cells has a concentration of about 0.5-10 million cell number/mL, Michl et al., discussing methods for controlling pH in mammalian live-cell culture systems, discloses that the pH should be around 7.4 being that this is near optimal growth for pH [Fig. 2]. Liu et al. discloses mesenchymal stem cells that were analyzed at a concentration of 5 x 106 cells/ml. This converts to 10,000,000 cells per mL [Cell labelling and imaging ¶ 1]. Grady et al. further discloses the use of multiple injections [Experimental design-aged mares]. Here, there is a reasonable expectation of success given an Artisan would recognize that endometrial mesenchymal stem cells would need to be maintained in a physiologically relevant solution further maintained at a pH level that closely resembles the cell type’s natural environment would allow for cell concentration levels to reach between 0.5-10 million cell number/mL to include multiple injections as taught by Michl et al. with the additional teachings of Liu et al. and Grady et al. Because of this, it would have been prima facie obvious to a person of ordinary skill in the art to modify the methods and systems of Michl et al. where it was discussed on how best to control pH in mammalian live-cell cultures with the additional teachings of Liu et al. where researchers explored the possibility of menstrual blood endometrial stem cells with the further teachings of Grady et al. that taught the administration of multiple doses by intra-ovarian injections in adult mares.
For claim 21 where the composition according to claim 15 is administered intra-ovarian injection or to at least one ovary, Grady et al. specifically teaches the method of administering mesenchymal stem cells intra-ovarian [Methods ¶ 1].
For claim 22 where the cell composition of endometrial stem cells has a concentration of about 0.5-10 million cell number/mL and is administered 1-5 times at a given concentration range, Liu et al. discloses mesenchymal stem cells that were analyzed at a concentration of 5 x 106 cells/ml. This converts to 10,000,000 cells per mL [Cell labelling and imaging ¶ 1]. Additionally, cell concentration is a routine parameter where selecting the appropriate cell concentration to ensure viability, safety, and therapeutic efficacy is a matter of ordinary optimization routinely performed by a person of ordinary skill in the art. With respect to being administered over multiple doses, Grady et al. teaches the use of multiple doses administered by means of intra-ovarian injection to adult mares [Experimental design-aged mares], with the additional teachings of Liu et al. where the researchers disclose mesenchymal stem cells that were analyzed at a concentration of 5 x 106 cells/ml. This converts to 10,000,000 cells per mL [Cell labelling and imaging ¶ 1]. Based on this, there is a reasonable expectation of success that a person of ordinary skill in the art would recognize the teachings of both Liu et al. and Grady et al allowing the person of ordinary skill to determine the claimed composition concentration as well as recognizing the potential need for multiple doses.
The Supreme court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary
Response to Argument
Applicant argues that premature ovarian syndrome is distinct from diminished ovarian reserve due to one being pathological in nature and the other disorder being physiological in nature and that the underlying causes for fertility problems is different. Additionally, Applicant argues that “…too many inventive steps need to be taken in hindsight, using Applicant's claims as a guide, to arrive at the claimed invention as the cited references do not provide any reasonable expectation of success that the composition could restore ovarian reserve in women diagnosed with DOR”.
The examiner does not find this argument persuasive.
Both diminished ovarian reserve and premature ovarian syndrome involve a reduction in ovarian follicle quantity and/or quality relative to chronological age. Both conditions are characterized by impaired folliculogenesis, diminished granulosa cell function, reduced AMH levels, elevated follicle-stimulating hormone levels, and decreased fertility potential. The primary difference in ovarian dysfunction relates to degree and not difference in underlying biological mechanisms with premature ovarian syndrome being related things such as gene disorders, autoimmune causes, or such things as chemotherapy and/or pelvic radiation therapy. Additionally, mesenchymal stem cells are known in the art to exhibit therapeutic effects through such things as immunomodulation, anti-apoptotic activity, and enhancement of tissue microenvironments. Because of this, a person of ordinary skill would have reasonably expected that such mechanisms would be at least as effective, if not more effective, in diminished ovarian reserve given that ovarian tissue remains partially functional. Additionally, the rejection is not based on the conditions being clinically identical. The rejection is based on the overlapping biological features of the conditions and the prior art’s teachings that endometrial mesenchymal stem cells can be used to improve ovarian function in subjects having premature ovarian syndrome. Both diminished ovarian reserve and premature ovarian syndrome involve impaired ovarian function and abnormalities in the ovarian follicular pool. Thus, despite the differences in clinical diagnostic criteria, the prior art would have provided one of ordinary skill in the art with a reason to apply the demonstrated ovarian effects of endometrial stem cells in subjects with diminished ovarian reserve.
With respect to examiner using hindsight, examiner’s rejection is not relying on hindsight of applicant’s claims or require that any single reference expressly disclose the claimed treatment of diminished ovarian reserve. The rejection is based on the combined teachings of the cited references given that each reference is relied upon for a particular teaching relevant to the claimed invention. For instance, Zuo et al. teaches the use and therapeutic potential of endometrial mesenchymal stem cells. Grady et al. demonstrates that intra-ovarian administration of mesenchymal stem cells can produce beneficial effects on ovarian function. Liu et al. and Gargett et al. provide further teachings concerning the biological characteristics and therapeutic potential of endometrial/progenitor cells. Zhang et al. and Michl et al. are relied upon for additional teachings concerning conventional stem cell preparation and mammalian cell culture conditions. Furthermore, the rejection does not require a series of unrelated inventive steps, but rather applies known teachings that encompass endometrial stem cells and/or mesenchymal stem cell administration to the ovary, conventional cell preparation, and culture techniques known in the art. Additionally, the rejection is not based upon the assertion that the cited references establish, with scientific certainty, that the claimed composition would restore ovarian preserve in every woman diagnosed with diminished ovarian reserve. The relevant inquiry is whether the prior art would have provided one or ordinary skill in the art with a reason to make the proposed modification and a reasonable expectation of success. Again, Zuo et al. teaches the therapeutic application of endometrial mesenchymal stem cells. Grady et al. provides the evidence that intra-ovarian administration of mesenchymal stem cells can be beneficial on ovarian function, and given the overlap between diminished ovarian reserve and premature ovarian syndrome where both conditions involve impaired ovarian function, these teachings would have provided a reason to apply endometrial mesenchymal stem cells to subjects having diminished ovarian reserve with a reasonable expectation of success based on the art available at the time of filing. The remaining references merely provide evidence of known teachings directed to biological characteristics, preparation, and culturing of mesenchymal/endometrial stem cells that do not constitute separate inventive steps. MPEP § 2143.02(I) states “Where there is a reason to modify or combine the prior art to achieve the claimed invention, the claims may be rejected as prima facie obvious provided there is also a reasonable expectation of success. The reasonable expectation of success requirement refers to "the likelihood of success" in combining or modifying prior art disclosures to meet the limitations of the claimed invention. See Elekta Ltd. v. ZAP Surgical Sys., Inc., 81 F.4th 1368, 1375, 2023 USPQ2d 1100 (Fed. Cir. 2023) and Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367, 119 USPQ2d 1171, 1176 (Fed. Cir. 2016”. MPEP § 2143.02(I) goes on to state “Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute". The prior art teaches that isolated endometrial mesenchymal stem cells exhibiting the claimed expression markers could be obtained using known isolation and culture methods, and that such cells possessed known therapeutic potential. In view of these teachings and the demonstrated effects of mesenchymal stem cells on ovarian function, a person of ordinary skill in the art would have reasonably understood at the time of filing that the claimed endometrial mesenchymal stem cells could be used to treat conditions involving impaired ovarian function, such as diminished ovarian reserve. For these reasons, the §103 rejection for claims 1, 4, 7, 10-17, and 19-22 are maintained with claim 19’s limitation of “wherein the autologous endometrial mesenchymal stem cells express Oct-4 and STRO-1” is newly rejected.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN DAVID MOORE whose telephone number is (703)756-1887. The examiner can normally be reached M-F 8-5.
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/JOHN DAVID MOORE/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights