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 .
1. Claims 1 – 20 are pending.
Examiner’s Note
2. Claims 1, 2, 4 – 17 and 20 are “use” claims and therefore read on both a product and a method. These claims have been rejected under 35 U.S.C. 112(b) as set forth below per MPEP 2173.05(q), and have not been considered with respect to prior art as it is unclear if these claims are directed to a product or method.
Priority
3. This application is a U.S. National Phase Entry of International PCT Application No. PCT/CN2023/106157 having an international filing date of July 06, 2023, which claims priority to Chinese Patent Application No. 202210877855.7 filed on July 25, 2022.
4. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on 09/20/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
6. Non-patent literature document No. 6 (Yang) has not been considered as a substantial portion of the document is not in English.
Drawings
7. The drawings filed on 03/23/2024 are acknowledged.
Specification
8. The specification filed 03/23/2024 is acknowledged.
Claim Objections
9. Claim 3 is objected to because of “wherein” is not necessary and the claim broadly recites “the uterus” but the preamble is directed to treating a uterine scar. A suggested wording of claim 3 to remove “wherein” and recite the active step based on Applicant’s Examples 3, 4 is as follows: “A method for treating a uterine scar at a uterus suture site in a subject comprising applying a human mesenchymal stem cell sheet to the suture site of the uterus”. Appropriate correction is required.
10. Claim 18 is objected to because the wording is confusing. A suggested clarification of the wording of claim 18 is as follows: “The method according to claim 3, wherein the human mesenchymal stem cell sheet is a semicircle with a diameter of about 3-55 mm or a shape of approximately the same area as the semicircle. Appropriate correction is required.
11. Claim 19 is objected to because claim recites “according to claim 2”, which does not recite a method. A suggested clarification is “The method according to claim 3” because claim 3 recites a method. Appropriate correction is required.
Claim Interpretation
12. Claim 19 is interpreted as depending from claim 3.
13. Claim 20 is interpreted as depending from claim 2.
14. For the purpose of applying prior art, “a suitable shape of approximate area” is interpreted to include any shape that is has an area that is within one or more than one standard deviations of the area of a semicircle having a diameter of about 3 – 55 mm, where “about” is interpreted to include a range of up to 20% of 3 – 55 mm based on Applicant’s specification at page 6, para. 4 – 5. Therefore, “approximate area” is interpreted to include a value of 3.5 mm2 to 1187 mm2 (0.35 cm2 to 118.7 cm2).
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.
15. Claims 1, 2, 4 – 18, and 20 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.
16. Regarding claims 1, 2, 4 – 17 and 20, recitation of “Use of” renders the claims indefinite per MPEP 2173.05(q) because it is unclear if the claims are directed to a product or method.
17. The term “suitable” in claim 18 is a relative term which renders the claim indefinite. The term “suitable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “shape” is rendered indefinite by the use of the term “suitable”.
Claim Rejections - 35 USC § 102
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.
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.
18. Claim(s) 3 and 18 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kuramoto (US20210386790-A1; Filed 01/15/2020; Published 12/16/2021), hereinafter Kuramoto which is cited on the IDS filed 09/20/2024.
Claim 3 is drawn to a method for treating uterine scar in a subject, wherein, the method
comprises locally applying a human mesenchymal stem cell sheet to the uterus of the subject.
Regarding claim 3, Kuramoto teaches a method of treating a uterine scar by applying a human umbilical cord-mesenchymal stem cell (hUC-MSC) sheet to the uterus (page 16, para. 0185 – 0187; page 17, para. 0188 and 0191; Figure 21, 22, and 28). Kuramoto teaches the fibrotic area in the hUC-MSC sheet transplantation group was significantly smaller than in the control group (page 17, para. 0192). Kuramoto teaches hUC-MSC transplantation was associated with increased uterine wall thickness, decreased wound site fibrosis, and reduced wound fibroblast cell presence (page 18, para. 0200). Kuramoto teaches these findings suggest that hUC-MSC sheet transplantation improves wound healing in nude rat hysterotomy (page 18, para. 0200).
Regarding claim 18, Kuramoto teaches the hUC-MSC sheet is a circle with an area of 1 cm2 (Figure 28A; page 3, para. 0037; page 16, para. 0186 – 0187).
Therefore, Kuramoto anticipates claims 3 and 18.
19. Claim(s) 3 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuramoto-2020 (Kuramoto et. al., American Journal of Perinatology, ISSN 0735-1631, 2020), hereinafter Kuramoto-2020 which is cited on the IDS filed 09/20/2024.
Claim 3 is drawn to a method for treating uterine scar in a subject, wherein, the method
comprises locally applying a human mesenchymal stem cell sheet to the uterus of the subject.
Regarding claim 3, Kuramoto-2020 teaches a method of treating a uterine scar by applying a human umbilical cord-mesenchymal stem cell (hUC-MSC) sheet to the uterus (page 3, left col. para. 3 and right col. para. 1). Kuramoto-2020 teaches the stem cell sheet transplantation stimulates improved wound healing (page 7, right col. para. 1).
Regarding claim 18, Kuramoto-2020 teaches the hUC-MSC sheet is a circle with a diameter of 1 cm (page 3, left col. para. 3; Figure 1).
Therefore, Kuramoto-2020 anticipates claims 3 and 18.
Claim Rejections - 35 USC § 103
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.
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.
20. Claim(s) 3, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuramoto (US20210386790-A1; Filed 01/15/2020; Published 12/16/2021), hereinafter Kuramoto which is cited on the IDS filed 09/20/2024 in view of Sun (Sun, Huijun, et al. Biology of Reproduction 99.5 (2018): 1057-1069.), hereinafter Sun in view of Bij de Vaate (Bij de Vaate, A. J. M., et al. Ultrasound in obstetrics & gynecology 37.1 (2011): 93-99.), hereinafter Bij de Vaate.
Kuramoto anticipates claims 3 and 18 as set forth above. Kuramoto teaches the hUC-MSC sheet applied to the uterus is a circle but does not teach the diameter is 13 – 20 mm, 22 – 28 mm, or 35 – 55 mm of claim 19. However, Kuramoto teaches the hUC-MSC sheet was formed in and detached from a 35 mm cell culture dish (page 9, para. 0099 – 0100). Therefore, Kuramoto teaches a hUC-MSC stem cell sheet that is a circle with a diameter of 35 mm. Kuramoto teaches uterine scar development after Cesarean delivery and other uterine surgeries can cause complications such as uterine rupture and abnormal placentation (page 1, para. 0002). Kuramoto teaches a need exists to prevent potential complications resulting from Cesarean deliveries and other uterine surgeries (page 1, para. 0002).
Sun teaches a method of forming circular adipose-derived stem cell sheets in a 6 well plate that are cut into rectangles and layered and applied to a circular uterine wound that is approximately 1.5 cm in length and 0.5 cm in width (page 1058, right col. para. 3; Figure S1C – F; Figure 2 and 3; page 1059, left col. para. 2; page 1060, left col.). Sun teaches at 60 days orderly arrangement of smooth muscle cell fascicles at near-normal levels were observed when the cell sheet was applied but scars formed in the control group (page 1062, left col. last para.; Figure 4). Sun teaches cell sheets are easily shaped into different structures for different applications and are especially suitable for the narrow uterine lumen (page 1065, right col. para. 2). Sun teaches pregnancy rates at the scar site were 69.23% in the cell sheet group compared to 15.38% in the control group (page 1066, left col. para. 2). Sun teaches the method not only remodeled the structure of the injured uterus by recovering the lumen-adjacent epithelial layer, basal layer, and smooth muscle layer but also restored functionality as evidenced by successful pregnancy (page 1066, right col. para. 1; Table 1). Sun teaches cell sheet therapy may be a new approach for treating partial uterine defects due to dilatation and curettage after abortion or postpartum, myomectomy for uterine fibroids, adenomyomectomy for uterine adenomyosis, severe IUA from endometrial tuberculosis, and conization in uterine cervical cancer (page 1066, right col. para. 2). Sun teaches a variety of diseases or traumas are capable of causing severe uterine damage that may lead to scar formation (page 1057, right col. para. 1). Sun teaches several therapeutic methods such as surgery, hormonal drugs, and cell therapy have been adopted for the treatment of endometrial fibrosis but have not shown much benefit (page 1057, right col. last para.; page 1058, left col. para. 1). Sun teaches tissue engineering may represent a new method for the repair of uterine function (page 1058, left col. para. 1). One would have been motivated to combine the teachings of Kuramoto and Sun as both teach stem cell sheet methods for treating uterine scars and the formation of the circular cell sheets with a diameter of 35 mm.
Bij de Vaate teaches in a study to determine a relationship between a niche at the site of the Cesarean scar and abnormal uterine bleeding that the shape of the niche includes semicircles and circles with the most common shape being semicircular (page 93, right col.; page 94, left col. para. 1; Figure 2; Table 4; page 97, left col. para. 2). Bij de Vaate teaches there is a significant relationship between the presence of a niche and postmenstrual spotting in women with a previous Cesarean section (page 97, right col. last para.). Bij de Vaate teaches that this spotting may be due to poor contractility of the uterine muscle around the scar (page 99, left col. para. 2). Bij de Vaate teaches it has been suggested that subfertility after a Cesarean section might be caused by the presence of a niche (page 99, left col. para. 3).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to combine the teachings of Kuramoto regarding a method of treating uterine wound by applying a hUC-MSC cell sheet to the site with the teachings of Sun regarding treating a circular uterine wound with triple-layer stem cell sheet with the teachings of Bij de Vaate regarding the niche at the site of the Cesarean scar can be semi-circular or circular shaped and that subfertility after a Cesarean section might be caused by the presence of a niche to arrive at the claimed method wherein, the human mesenchymal stem cell sheet is a circle with a diameter of 13-20 mm, 22-28 mm, or 35-55 mm, or a semicircle with a diameter of 13-20 mm, 22-28 mm, or 35-55 mm. One would have been motivated to combine the teachings of Kuramoto, Sun, and Bij de Vaate to improve uterine function, improve fertility, and minimize abnormal uterine bleeding as Kuramoto teaches a need exists to prevent potential complications resulting from Cesarean deliveries and other uterine surgeries and Sun teaches several therapeutic methods such as surgery, hormonal drugs, and cell therapy have been adopted for the treatment of endometrial fibrosis but have not shown much benefit and Sun teaches tissue engineering may represent a new method for the repair of uterine function and Bij de Vaate teaches that postmenstrual spotting may be due to poor contractility of the uterine muscle around the scar and Bij de Vaate teaches it has been suggested that subfertility after a Cesarean section might be caused by the presence of a niche. One would have a reasonable expectation of success in combining the teachings as Kuramoto teaches the fibrotic area in the hUC-MSC sheet transplantation group was significantly smaller than in the control group and Kuramoto teaches hUC-MSC transplantation was associated with increased uterine wall thickness, decreased wound site fibrosis, and reduced wound fibroblast cell presence and Sun teaches the method not only remodeled the structure of the injured uterus by recovering the lumen-adjacent epithelial layer, basal layer, and smooth muscle layer but also restored functionality as evidenced by successful pregnancy and Sun teaches cell sheet therapy may be a new approach for treating partial uterine defects due to dilatation and curettage after abortion or postpartum, myomectomy for uterine fibroids, adenomyomectomy for uterine adenomyosis, severe IUA from endometrial tuberculosis, and conization in uterine cervical cancer.
Double Patenting
21. Claims 3, 18, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 31 of copending Application No. 17430086 in view of Kuramoto (US20210386790-A1; Filed 01/15/2020; Published 12/16/2021), hereinafter Kuramoto which is cited on the IDS filed 09/20/2024.
Reference claim 1 recites a method of treating acute ischemic heart failure in a subject in
need thereof, comprising applying an effective amount of a mesenchymal stem cell sheet to the
heart of the subject, wherein the mesenchymal stem cells are umbilical cord mesenchymal stem cells; and wherein the mesenchymal stem cell sheet is prepared by a method comprising the following step:
a. culturing the mesenchymal stem cells in a thermo-sensitive petri dish pre-coated with
adhesion matrix or serum; and wherein the effective amount of the mesenchymal stem cell sheet is a single-dose of one to four mesenchymal stem cell sheets, and wherein 2x 107 to 8x 107 mesenchymal stem cells are comprised in each of the sheets. Reference claim 1 lacks treating a uterine scar and applying a human mesenchymal stem cell sheet to the uterus of the subject. Kuramoto teaches applying a human mesenchymal stem cell sheet to a uterus to treat a scar and that the cells used were the same cells that were previously used for treating human heart failure as clinically injected cell suspensions (page 16, para. 0185 – 0187; page 17, para. 0188, 0191, 0192, 0198). Kuramoto teaches uterine scar development after Cesarean delivery and other uterine surgeries can cause complications such as uterine rupture and abnormal placentation (page 1, para. 0002). Kuramoto teaches a need exists to prevent potential complications resulting from Cesarean deliveries and other uterine surgeries (page 1, para. 0002). It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to have applied the mesenchymal stem cell sheet of reference claim 1 to the uterus as taught by Kuramoto to treat uterine scars to prevent potential complications resulting from Cesarean deliveries and other uterine surgeries.
Instant claims 18 and 19 map to reference claim 31 as both recite a diameter of the cell sheet of 15 – 55 mm.
This is a provisional nonstatutory double patenting rejection.
22. Claims 3, 18, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of copending Application No. 19021864 in view of Kuramoto (US20210386790-A1; Filed 01/15/2020; Published 12/16/2021), hereinafter Kuramoto which is cited on the IDS filed 09/20/2024.
Reference claim 1 recites a method for performing damage repair of a damaged tissue in a subject, comprising administrating the cell sheet culture supernatant prepared by the method
of claim 19 to the subject. Reference claim 19 lacks treating a uterine scar and applying a human mesenchymal stem cell sheet to the uterus of the subject. Kuramoto teaches applying a human mesenchymal stem cell sheet to a uterus to treat a scar and that the cells used were the same cells that were previously used for treating human heart failure as clinically injected cell suspensions (page 16, para. 0185 – 0187; page 17, para. 0188, 0191, 0192, 0198). Kuramoto teaches uterine scar development after Cesarean delivery and other uterine surgeries can cause complications such as uterine rupture and abnormal placentation (page 1, para. 0002). Kuramoto teaches a need exists to prevent potential complications resulting from Cesarean deliveries and other uterine surgeries (page 1, para. 0002). It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to have applied the mesenchymal stem cell sheet of reference claim 19 to the uterus as taught by Kuramoto to treat uterine scars to prevent potential complications resulting from Cesarean deliveries and other uterine surgeries.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZANNA M BEHARRY whose telephone number is (571)270-0411. The examiner can normally be reached Monday - Friday 8:45 am - 5:45 pm.
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/ZANNA MARIA BEHARRY/Examiner, Art Unit 1632
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