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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 03, 2025 has been entered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is in response to the papers filed on June 3, 2025. Claims 6, 7, 9, 11, 14, 20, and 24-26 have been canceled. Claims 2 and 27 stand withdrawn as being drawn to a non-elected Group of claims. Claim 28, depending on claim 1, is hereby rejoined with Group I. The requirement for restriction between Groups I-III was previously made FINAL.
Therefore claims 1, 3-5, 8, 10, 12-13, 15-19, 21-23, and 28 are currently under examination.
Priority
This application is claiming the benefit under 35 U.S.C. 119(e) of prior-filed U.S. provisional 62793195 filed on January 16, 2019, filed prior to PCT application, PCT/US2020/013622 on January 15, 2020.
Thus, the earliest possible priority for the instant application is January 16, 2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/05/2024, 06/09/2025, and 09/19/2025 are acknowledged. The submissions are in compliance with the provisions of 37 CPR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Withdrawn Claim Objections
In view of Applicants’ amendment to claim 18, reciting “the initial cell density,” the objections to improper form are moot and have been withdrawn.
Specification Objection
The disclosure is objected to because of the following informalities: The specification references color drawings, specifically referring to Fig. 15, 22, 23, 28A-28B, and 30A; See pg. 9, para. 2; pg. 41, line 3; pg. 45, line 26; pg. 46, last para. Necessary correction is required. Applicant may obviate the objection by filing the petition for color drawings.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show color designated and as described in the specification, see Fig. 15, 22, 23, 28A-28B, and 30A. Additionally, multiple figures are poorly rendered, such as Fig. 2, 4, 10, 12, 18, 23, 30. The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawings will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
Additionally, any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
New claim objections
Claims 15 and 21 are objected to for the following informalities: The recitation of “a tissue in a host organism” should be replaced with “the uterus of a subject in need thereof”. Regarding the recitation of “a host”, there is no clear correlation to the “subject in need thereof” recited in claim 1. Additionally, the recitation of “a tissue” encompasses any tissue and should properly be limited to the specific tissue, corresponding to the scope of claim 1, the uterus.
Applicant may obviate the objection by amending claims 15 and 21 to recite: “the uterus of a subject in need thereof”.
Claim interpretation
As has been previously communicated, in the instant application, the independent claim l recitation of “reducing formation of fibrotic tissue in a uterus of a subject in need thereof,” in lines 1-2 is non-limiting, and does not imply any procedural or structural limitation to the claimed methodology. However, for the sake of compact prosecution, limiting and non-limiting claim elements are addressed below. When reading the preamble in the context of the entire claim, the recitation of intended methodological effects is not limiting because the body of the claim describes a complete invention, and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention's limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Also, examples of claim language, that may raise a question as to the limiting effect of the language in a claim are “whereby” clauses. The claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby” clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. See M.P.E.P. § 2111.04.
Additionally, MSCs are well known in the art to be adherent and naturally express and secrete hepatocyte growth factor (HGF) as part of their inherent paracrine profile, and thus the recited HGF expression is an expected property of MSCs. Passaging adherent MSCs and culturing them on a support to achieve attachment, growth, and confluence are conventional steps that do not impose a meaningful structural or functional distinction on the resulting MSC sheet. Thus, these limitations therefore encompass ordinary cell-culture practices and do not patentably differentiate the claimed method from what is already taught in the prior art. The operative step of applying the MSC cell layer or sheet to the uterus is already recited in lines 2-3, and the recitation in lines 7-9 that “applying the MSC sheet to the uterus reduces the formation of fibrotic tissue in the uterus relative to a uterus in which the MSC sheet is not applied” merely expresses an intended result of a previously recited process step. Ex parte Attig, 7 USPQ2d 1092 (Bd. Pat. App. & Inter. 1986). MPEP 2173.05 III E.
Hence, regarding independent claim 1, the claim is interpreted as being limited by a step of applying a layer of mesenchymal stem cells (MSC), or sheet, to the uterus of the subject. Confluent cells are, by definition, cells that have been cultured or grown to cover an entire surface in a culture vessel, forming a continuous, single layer with no gaps in between. The means of obtaining MSC confluence is established and standard. Laboratory practices of cellular expansion or passaging the cells through rounds of subculture to increase biomass, obtaining a sufficient number of cells for downstream applications while also preventing overgrowth in a single culture vessel for subsequent culture on a dish or support (in a new vessel with new media), are routinely employed by the ordinary artisan. Culturing adherent MSCs to confluence, on a support, is a routine technique used in standard laboratory MSC cell culture and will be further expounded upon in the illustrative references which follow.
Withdrawn Claim Rejections - 35 USC § 103
In view of Claim 28 being rejoined with Group I, the rejection under 35 U.S.C. 103 as being unpatentable over Hammad et al. ("Stem Cell Sheet Transplantation to Prevent Uterine Scar Formation and Promote Myometrial Regeneration in Rate", American Journal of Obstetrics Gynecology, January 1, 2019, Volume 220, No. 1, Pages 1- 2; referenced in IDS submitted 07/13/2021) in view of Guo et al. (US 2018/0362923 A1) and Kerkis (US 9,498,498 B2), and evidenced by Han et al. (Signal Transduct Target Ther. 2022 Mar 21;7(1):92. doi: 10.1038/s41392-022-00932-0.) has been withdrawn. Applicants’ arguments are moot in view of the withdrawn rejection. A response to Applicant’s arguments pertinent to a new or remaining rejection can be found below.
Claim Rejections - 35 USC § 103
Claims 1, 3-4, 5, 8, 12-13, 15-19, 21-23 remain rejected, and claim 28 is newly rejected, under 35 U.S.C. 103 as being unpatentable over Hammad et al. ("Stem Cell Sheet Transplantation to Prevent Uterine Scar Formation and Promote Myometrial Regeneration in Rate", American Journal of Obstetrics Gynecology, January 1, 2019, Volume 220, No. 1, Pages 1- 2; referenced in IDS submitted 07/13/2021) in view of Guo et al. (US 2018/0362923 A1, published Dec. 20, 2018) and Kerkis (US 9,498,498 B2, published Nov. 22, 2016), and evidenced by Han et al. (Signal Transduct Target Ther. 2022 Mar 21;7(1):92. doi: 10.1038/s41392-022-00932-0.) and Zhao et al. (Mol Ther. 2010 May;18(5):1010-8. Epub 2010 Feb 23.).
Regarding claims 1 and 28, Hammad teaches stem cell sheet (SCS) hUC-MSCs transplantation to promote hysterotomy healing by decreasing fibrosis and promoting normal myometrial regeneration in a rat model (abstract). Hammad teaches the stem cell sheet transplantation decreases fibrotic tissue and promotes myometrial regeneration after hysterotomy repair, compared to non-transplanted hysterotomies in a rat model, and the potential to improve uterine healing and decrease morbidity related to abnormal scar formation (Conclusion).
Hammad does not expressly teach wherein the MSCs are passed through 4 to 8 subcultures prior to culturing the MSCs on a cell culture support used to prepare the cell sheet.
However, Guo teaches that passage amplification of MSCs until the rate of confluence of the cells reaches over 90%, for separating MSCs for downstream applications (abstract, [0046] and [0095]). Furthermore, Guo explicitly teaches passage amplifications relationship to the rate of confluence (abstract and [0095]). Prior to the effective filing date of the instant application, it would have been obvious for the ordinary artisan to have applied the know technique of passage application or employing rounds of subculturing and cell culture to a point of confluence, as taught by Guo, to the known method of stem cell sheet transplantation to prevent uterine scar formation and regeneration, as taught by Hammad. In doing so, the ordinary artisan would have yielded the predictable result of generating a method of reducing formation of fibrotic tissue in a uterus of a subject in need thereof by applying the layer of MSCs to the uterus of a subject in need thereof. The disclosure of Han evidence hepatocyte growth factor is secreted by MSCs and are constituent of their natural secretion profile (pg. 7, column 2, para. 2). Hence this is a natural property of the cell type.
Regarding claim 3, Hammad additionally teaches the MSC sheet is applied to an incision site in the uterus (para. 3).
Regarding claim 4, Hammad additionally teaches the application of the stem cell sheet decreases fibrotic tissue (Conclusion), an intended result of the application of the MSC layer to the uterus. The percentage of fibrotic reduction, such as 20%, as claimed would have varied relative to dose, time, or period of treatment. Where a variable, fibrotic surface area, is disclosed in a range in the prior art is taught, there exists a prima facie case of obviousness based on optimization where the variable was recognized in the prior art to be a result-effective variable. That is to say that the particular parameter was taught and known to affect the result, being a reduction in the formation of fibrotic tissue.
Regarding claim 5, Hammad expressly teaches a confluent sheet of hUC-MSCs (para. 2). “A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus.” The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989).
Regarding claims 8, 15 and 21, the presence of adhesion and cell junction proteins is a natural occurring property and intrinsic characteristic to the confluent MSCs sheet, composed of an adherent cell type; because the MSC sheet taught by Hammad is confluent, the presence of extracellular matrix proteins, cell-junctions proteins, and sustained attachment is a natural biological property of the unmodified MSCs and would naturally occur upon implantation. The ordinary artisan would have recognized this is how the cells adhere and attach, thus Hammad already teaches the limitation of extracellular matrix proteins.
Consequently, since Hammad teaches that the harvested cell sheet is confluent, it must necessarily have cell junctions, i.e., the cell express cell junction proteins. With respect to claim 21, it is noted that the applicant has not modified the MSCs ability to express proteins. There has been no modification to the MSCs with respect to the prior art, and thus, the claimed limitation of the cell sheet remaining attached for 10 days would have been an intrinsic property of the hUC-MSCs sheet taught by Hammad if this cell sheet would have been characterized upon implantation.
Regarding claims 12-13, this expression is an implicit property, there has been no modification to the MSCs with respect to the prior art, and thus, the claimed limitation of the cell sheet secreting more cytokines would have been a naturally occurring property of the hUC-MSCs sheet taught by Hammad, if this cell sheet would have been characterized. This is evidenced by the disclosures of Kerkis and Han. Kerkis discloses MSCs secret a diverse set of bioactive molecules, which are immunomodulatory and provide regeneration and remodeling of injured tissue, through their trophic activities, including stimulation of MSC mediated angiogenesis by secretion of VEGF (column 2, lines 24-39). Absent modification, a person of ordinary skill in the art would have expected MSCs to express and secret VEGF, as taught by Kerkis. The disclosure of Han also evidences mesenchymal stem cells express VEGF endogenously (pg. 7, column 2, para. 2).
Regarding claims 16-17, it is noted that the applicant has not modified the MSCs ability to express proteins. There has been no modification to the MSCs with respect to the prior art, and thus, the claimed limitations would have been inherent properties of the cellular hUC-MSCs sheet taught by Hammad if this cell sheet would have been characterized upon implantation. The disclosure of Zhao evidences the natural expression of MSCs of the recited extracellular matrix proteins and cell junctions, such as fibronectin, laminin, collagen, connexin-43 (pg. 1012, column 2, para. 2)
Regarding claim 18, it is noted that there is no evidence of record that using the claimed cell density range is associated with unexpected results. Routine optimization is not considered inventive and no evidence has been presented that the selection of the claimed range was other than routine or that the results should be considered unexpected in any way as compared to the closest prior art (see MPEP 2144.05 II).
Regarding claim 19, Guo teaches the analysis of MSC surface markers and negative expression of HLA-DR ([0136]).
Regarding claims 22 and 23, Kerkis further teaches the utility of allogeneic MSCs (claim 24) to that of a human (claim 2). The POSITA would have found it obvious to use the known technique of utilizing allogenic human MSCs to improve the similar methods, as taught by Hammad and Guo, in the same way.
***
Claims 1, 3-4, 5, 8, 10, 12-13, 15-19, 21-23, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Hammad, Guo, Kerkis, and evidenced by Han et al., and Zhao et al., and further in view of Patel et al. (Cell Transplant. 2013;22(3):513-9. Epub 2012 Sep 21.).
The combined teachings of Hammad, Guo, and Kerkis are applied as above in the 103, the content of which are incorporated herein rendering obvious the limitations of claims 1, 3-4, 5, 8, 12-13, 15-19, and 21-23.
Regarding claims 10, Hammad teaches SCS were created from human umbilical cord. Furthermore, Patel additionally teaches the isolation of mesenchymal stem cells from the subepithelial layer of umbilical cord tissue for therapeutic to treat diseases and injuries in regenerative medicine. Significantly, Patel teaches cells isolated from the subepithelial layer have a higher proliferation capacity (pg. 519, para. 1).
Prior to the effective filing date, it would have been prima facie obvious for the ordinary artisan to have applied the known technique of isolating mesenchymal stem cells from the subepithelial lay of the umbilical cord tissue, as taught by Patel, to obtain a MSC sample for the combined methods of Kuramoto, Kagawa, Guo, Xu, with a reasonable expectation of success.
Response to Applicants’ arguments as they apply to the rejection of Claims 1-5, 8, 10, 12-13, 15-19, 21-23, and 28 under 35 USC § 103
Applicant's arguments filed June 3, 2025, have been fully considered but they are not persuasive.
At pages 5-9 of the remarks filed on June 3, 2025, Applicants essentially argue the following:
Applicant argues that the Examiner failed to address the limitation requiring HGF expression for at least 10 days after application to the uterus. Applicant argues the Examiner seems to be incorrectly equating inherent obviousness with inherent anticipation, and inherency cannot apply because the property was previously unknown.
Applicants’ arguments are not persuasive because the examiner has not ‘equated inherent obviousness with inherent anticipate,’ but simply pointed to where these claim language recites natural inherent features of the confluent MSCs which have been applied as a sheet. The combined teachings of Hammad, Guo, and Kerkis reasonably establish that MSC sheets maintain cytokine secretion and viability after transplantation. Absent a showing that the results are unpredictable in view of the art, such data does not rebut a prima facie case of obviousness. This argument is not persuasive because the prior art references are clearly capable of performing the intended use; hence, they meet the claimed limitations. Furthermore, if a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed.Cir. 1997). “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). Furthermore, these descriptions of intended methodological effects are non-limiting, and do not imply any procedural or structural limitation to the claimed methodology.
The following references are cited as evidence without relying on the rejection. MSCs naturally secrete hepatocyte growth factor, as evidenced by the disclosures of Wen et al. (J Cell Mol Med. 2012 Jun;16(6):1260-73.) and Han. Wen discloses MSCs play a crucial role in tissue repair by secretion of tissue nutrient factors such as hepatocyte growth factor (Abstract). Likewise, Han discloses hepatocyte growth factor is secreted by MSCs and are constituent of their natural secretion profile (pg. 7, column 2, para. 2). Hence, this is a natural property of the cell type.
The cited references describe MSC sheets retaining functionality, ECM, and paracrine signaling for sustained periods. Furthermore, applicants’ own evidence does not demonstrate that 10-day HGF expression is unique to the claimed method or absent from the prior art. Applicant points to page 44, lines 4-12; and Fig. 18A-B, as evidence of this feature claimed to be “unknown and unexpected”; however, Fig. 18 does not clearly support the claim, thus the content of pg. 44, para. 2 is merely conclusory. Applicants’ arguments of unexpected results lack a sufficiently detailed description of the experimental conditions and results, commensurate with the scope of the claims. Thus, the alleged “unexpected” benefits are not sufficiently substantiated and are in fact predictable in light of the prior art, since they fail to show a significant departure from known results, see MPEP § 2145.
The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 CCPA 1965). Examples of attorney statements which are not evidence, and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.
Applicant argues that the criticality of passage number, 4-8 subcultures, generating quality cell sheets having significantly maintained and high hepatocyte growth factor (HGF), was not considered.
This argument is not persuasive because the assertion is unsupported by data showing a non-obvious, unexpected improvement relative to adjacent passage number. The cited evidence is limited to subcutaneous implantation in immune-deficient mice and does not demonstrate that the claimed MSC sheet exhibits unexpected behavior specifically in uterine tissues. The specification merely demonstrates quantitative differences in cytokine levels, which is a predictable outcome of varying MSC passage number, an optimization variable well known in the art. Applicant has not provided sufficient evidence of unexpected results over the prior art, as the claimed method merely requires the step of applying a mesenchymal stem cell (MSC) sheet to the uterus of the subject, while reciting expected properties of the application.
The prior art teaches selecting passages that suitable for the intended cells. The examiner deems the passaging of subcultures to a point of confluence, for naturally adherent cells, merely a matter of judicious selection and routine optimization, well within the purview of skilled artisan. As evidence of this consideration, the disclosure of Xu further evidences the differences and changes that occur as MSCs are passaged, and the effect of matrix stiffness on the proliferation, differentiation, and confluence of MSCs to the 6th generation or passaging of cells (Abstract, Fig. 1, and pg. 31, Sections 3.1 and 3.2). Additionally, the disclosure of Kagawa et al. (US 11,697,794 B2, citation are from WO 2019/004361) further evidences the predictability of culturing cells until confluence over the entire culture surface to obtain a cell sheet a method for swiftly producing a mesenchymal stem cell layered cell sheet that is used for transplantation, where the confluent cells are cultured with the aim of regenerating uterine mucous membrane (abstract; column 1, line 35; column 6, lines 20-23; column 10, lines 5 – column 11, para. 1; column 10, lines 58-59).
The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The prior art clearly renders the same method for the same purposes obvious. Thus, the alleged “unexpected” benefits are not sufficiently substantiated and are in fact predictable in light of the prior art, since they fail to show a significant departure from known results. The experimental data cited lacks the specificity, scope, and statistical analysis necessary to overcome a strong prima facie case of obviousness. Additionally, the results cited are not commensurate in scope with the claims, such as transplantation site and subculture number, and cannot be relied upon to demonstrate unexpected results across the full breath of the claims.
Additionally, this argument is not persuasive because the claim does not recite the MSC sheets can maintain significant or high HGF expression 10 days after implantation within subcutaneous tissue, as argued. The claims merely recite the cells of the MSC sheet expresses HGF 10 days after being applied to uterus of a subject. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., significant HGF expression 10 days after implantation within subcutaneous tissue) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
Claims 1, 3-5, 8, 10, 12-13, 15-19, 21-23, and 28 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL D LEVIN whose telephone number is (571)270-0616. The examiner can normally be reached Fulltime Teleworker.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.L./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699