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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on the 21st of January 2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant’s claim for priority to a provisional application 63/050,736 is acknowledged. The effective filing date for claims 1-16 is July 10, 2020.
Claim Status
In the response filed on the 21st of January 2026, the Applicant has amended claim 1. Applicants’ election without traverse of claims 1-16 in the reply filed on July 05, 2023, is acknowledged. Claims 17-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 5, 2023.
Claims 1-16 are currently under examination.
Withdrawn Objections & Rejections
Rejections and/or objections not reiterated from the previous office action are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on the 3rd of March 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Applicant is reminded that the list of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a). Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlinks, located on p. 33 and 37 recites “www.ncbi”. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Affidavit or Declaration under 37 CFR 1.130(a)
The affidavit under 37 CFR 1.132 filed by Dr. Asimina Gkouti on 21st of January 2026, recites “I, Asimina Gkouti, declare that the invented subject matter of claim I as presently presented that is in the "Martins" reference and in the "Ichida" reference ("Organoids Develop Motor Skills: 3D Human Neuromuscular Junctions"; Cell Stem Cell 26.2: 131-133 (2020) was invented solely by me. The only way such subject matter in Ichida is present is due to me and my manuscript "Martins." Thus, the disclosure was made solely by me” (see p. 3, number 7), which is acknowledged as a sufficient declaration. However, it is noted that the obvious rejection of claims 1-16 does not rely on Ichida, et al., (Cell Stem Cell 26.2: 131-133, published Feb. 2020; cited IDS 11/17/2021) as prior art, but recites the reference as an evidence reference.
Claim Rejections - 35 USC § 112(a)
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
This is a new rejection of record.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Under the written description guidelines (see MPEP 2163) the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
SCOPE OF THE INVENTION:
Independent claims 1 and 9 encompasses a genus of method for generating a 3D neuromuscular organoid in vitro comprising cultivating neuromesodermal progenitor cells (NMPs) in a first differentiation medium and a second differentiation medium comprising a serum-free medium supplemented with at least one of a genus of activators or a genus of growth factor signaling pathways or of an insulin signaling pathway.
Since the specification does not provide a definition of an activator or a growth factor, the scope of claim 1 encompasses a genus of methods comprising cultivating NMPs in any serum-free medium supplemented with any types of activators (e.g., a protein ligand, a small molecule ligand, an mRNA encoding a ligand, a protein inhibitor of an inhibitory mediator, a small molecule inhibitor of an inhibitory mediator, an RNAi targeting an inhibitory mediator) of a genus of growth factor signaling pathways (e.g., any factor that has any growth-supporting function on any type of cells under any context), in any combination, at any concentration, for any duration, on any culture container, under any culture condition, so as to obtain a 3D neuromuscular organoid.
However, the specification only discloses one method comprising cultivating NMPs on an ultra-low binding 96-well plate in a neurobasal (NB) medium supplemented with 50uM ROCK inhibitor, 10ng/ml bFGF and 2ng/ml IGF1 and 2ng/ml HGF for two days (Day 0 – Day 2), partially changing media with a second medium comprising NB medium supplemented with 2ng/ml IGF1 and 2ng/ml HGF and cultivating for two days (Day 2 – Day 4), changing media to NB medium without addition of growth factors and maintaining for 6 days (Day 4 – Day 10, with possible media changes), and transferring to bigger dishes with the same medium without addition of growth factors for continuous cultivation to about Day 50 or more, and during the whole period organoids are maintained on an orbital shaker with rotation (see specification, page 30, para “Generation of neuromuscular organoids in 3D”).
Regarding dependent claims 2-8 and 10-16 encompass limitations regarding one of the aspects encompassed by independent claim 1, such as the serum-free medium, the first differentiation medium, the second differentiation medium, medium change schedule, or agitation. However, the specification only discloses a single species of method comprising a specific combination of the above aspects. Further, the dependent claims encompass a genus of second cell culture for obtaining NMPs by cultivating pluripotent stem cells (PSCs) in a first cultivation medium comprising any serum-free medium supplemented with a genus of activators of β-catenin signaling pathway and a genus of activators of a genus of growth factor signaling pathways, and in a second cultivation medium including a serum-free medium supplemented with a genus of activators of β-catenin signaling pathway and a genus of activators of a genus of growth factor signaling pathways, in any combination, at any concentration, for any duration. However, the specification only discloses a single species of the second cell culture comprising cultivating PSCs in a first cultivation medium comprising a specific serum-free medium (NB medium) supplemented with a specific set of activators and concentrations (10uM ROCK inhibitor, 3uM CHIR99021 and 40ng/ml bFGF) for one day, and cultivating in a second cultivation medium comprising a NB medium supplemented with a specific set of activators (3uM CHIR99021 and 40ng/ml bFGF) for one day, to obtain NMPs (see specification, p. 30, para “In vitro generation of NMPs from human pluripotent stem cells”).
ACTUAL REDUCTION TO PRACTICE
As stated supra, the claims encompass a genus of methods for generating neuromuscular organoid and a genus of methods for obtaining NMPs. However, the specification only discloses a single species of the method, respectively.
Accordingly, Applicant did not demonstrate a reduction to practice a genus of methods for generating neuromuscular organoid or a genus of methods for obtaining NMPs, nor did Applicant adequately set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that Applicant was in possession of the claimed genus of methods.
DISCLOSURE OF STRUCTURE
The Applicant has provided no other working examples besides the single example of the respective method as discussed above. Although generating an organoid is known in the field, the prior art is silent on a method of cultivating NMPs under the broad genus of conditions encompassed by the claims, nor indicate a relationship between the structure of the claimed conditions and the ability to generate a 3D neuromuscular organoid.
SUFFICIENT RELEVANT IDENTIFYING CHARACTERISTICS
As mentioned above, generating an organoid is known in the field, and the skilled artisan could co-culture neurons and muscular cells to generate a neuromuscular organoid.
The breadth of the claims encompasses a genus of methods comprising cultivating NMPs in any serum-free medium supplemented with any types of activators of a genus of growth factor signaling pathways, in any combination, at any concentration, for any duration, on any culture container, under any culture condition, so as to obtain a 3D neuromuscular organoid, yet the present specification provides no guidance nor description on how a neuromuscular organoid would be generated by cultivating NMPs under such a broad genus of conditions, therefore the skilled artisan would not know what rational approach to take to use the claimed method to predictably generate a neuromuscular organoid. Therefore, it is incumbent on the applicant to provide this nexus between structure and function, in order to be given credit for possession of the claimed genus of method.
An applicant may show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613.
STATE OF THE ART & QUANTITY OF EXPERIMENTATION
The method of making the claimed invention is not well established. Although the method for cultivating NMPs under a specific condition was known in the state of the art, one of skill in the art would neither expect nor predict the method may generate a neuromuscular organoid by cultivating NMPs under such a broad genus of conditions.
With respect to cultivating NMPs under different conditions, prior art Gouti et al., (PLoS Biol. 2014; 12(8): e1001937, p. 1-15. Cited in IDS 07/09/2021) teaches that cultivating NMPs (from Day 3 in Figures 1-3 and 5-6) in media supplemented with activators of different growth factor signaling pathways results in differentiating the NMPs into different terminal tissue types. For example, Figure 2 shows cultivating NMPs from D3 in media with RA/SAG (activators of hedgehog signaling pathway) generates “Np” (posterior spinal cord), while cultivating with CHIR (activator of Wnt signaling pathway) generates “Meso” (mesodermal tissue). Consequently, there is ample reason to conclude that there would be a high degree of unpredictability in generating a neuromuscular organoid by cultivating NMPs with any activators of a genus of growth factor signaling pathways. Thus, the method of generating a neuromuscular organoid by cultivating NMPs is highly unpredictable, and is not well established.
Applicant has claimed a genus of methods for generating a neuromuscular organoid by cultivating NMPs, yet the specification has only disclosed a single species of method, has not set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that Applicant was in possession of the claimed genus of method. Furthermore, the state of the art indicated that a method for generating a neuromuscular organoid by cultivating NMPs is not well established and would require undue experimentation, and one skill in the art would neither expect nor predict the claimed outcome of generating a neuromuscular organoid according to the claimed genus of method of cultivating NMPs encompassed by the scope of the claims.
CONCLUSION
In summary, the Examiner concludes that there is insufficient written description of the instantly claimed genus of method of generating a neuromuscular organoid by cultivating NMPs. Specifically, there is limited description of the method of generating a neuromuscular organoid by cultivating NMPs, and limited description of the structure-function relationship between the claimed genus of methods and their ability to generate a neuromuscular organoid. Thus, the Examiner concludes a skilled artisan would find the specification inadequately describes the claimed genus of method for generating a neuromuscular organoid by cultivating NMPs.
Therefore, the specification fails to provide sufficient written description to inform a skilled artisan that inventors were in possession of the broader invention as claimed.
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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Gouti et al., (Developmental cell 41.3: 243-261, 2017, cited IDS 7/9/2021; hereinafter as “Gouti”), Bolognin et al., (WO 2017/060884 A1, published 2017), Camp et al. (Proceedings of the National Academy of Sciences 112.51: 15672-15677, 2015, prior art of record), Afshar, et al. (elife 8: e44530, 2019, cited IDS 7/9/2021), Gouti, et al. (PLoS biology 12.8: e1001937, 2014; cited IDS 7/9/2021, hereinafter as “Gouti 2014”), Sareen et al., (WO 2018/170180 A1, 2018, cited IDS 11/17/2021), and Vernardis, et al., (Sci Rep 7, 42138, 2017, prior art of record), and as evidence by Ichida, et al., (Cell Stem Cell 26.2: 131-133, published Feb. 2020; cited IDS 11/17/2021) and Petersen, L. (Max Delbruck Center, published June 2019, pp. 1-5, cited IDS 3/3/2026).
This is a new rejection necessitated by amendment to the claims. It is noted that since this prior art rejection is substantially similar to the previous rejection set forth, any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
Claim Interpretation: It is noted that the prior art rejection is directed to the activators and growth factors that are disclosed in the written description rejection above.
Regarding claim 1, Gouti discloses a method for generating in vitro neuromesodermal progenitor cells (NMPs)(see e.g. Supplemental section page e3, ESC culture and Differentiation).
Regarding claim 1a, Gouti discloses single cell dissociation and that the cells may be dissociated into a single cell suspension using accutase (see e.g. Fig. 1, page e3). Gouti teaches providing a first cell culture comprising neuromesodermal progenitor cells (NMP) and cultivating the neuromesodermal progenitor cells in a first differentiation medium corresponding to the claim limitation of i) a non-supplemented serum-free cell culture medium. Gouti teaches ‘N2B27’ medium (NB) which is the same non-supplemented serum-free cell culture medium as recited in the specification (Specification see e.g. page 5). Further, Gouti teaches the serum-free culture medium is supplemented with an activator of a growth factor signaling pathway (e.g. basic fibroblast growth factor (bFGF))(see e.g. Supp. Sec. page e3, Fig. 2-4). Further, the bFGF reads on the claimed activator of a growth factor signaling pathway (see e.g. specification page 6).
Although Gouti discloses single cell dissociation and suggests that the cells may be dissociated into a single cell suspension using accutase (see e.g. Fig. 1, page e3). Further, the prior art of Bolognin discloses generating organoids with single cell suspensions (see e.g. para. 38 and sec. 2.3).
Accordingly, prior to the effective filing date of the instant claimed invention, it would have been prima facie to obvious for a person of ordinary skill in the art to have combined the methods, as taught by Gouti, with a single cell suspension, as taught by Bolognin and suggested by Gouti, with a reasonable expectation of success because one of ordinary skill in the art would know that in order to investigate the type of neuromesodermal progenitor cells (NMP) one would want to perform single-cell genomics (as suggested by Gouti, see e.g. supp. page e4). Further, Bolognin disclose that single-cell suspension allows for the multipotency to be tested (see para. 38) to obtain a specific type of organoid from s single colony (para. 16). Furthermore, a person of ordinary skill in the art of cell culture methods for obtaining organoids would have had predictable results with a reasonable expectation of success because both Gouti and Bolognin disclose single cell suspensions, as discussed above.
Regarding claim 1b, Gouti teaches replacing the first differentiation medium by a second differentiation medium within 3 days after cultivation start (see e.g. Supp. sec. page e3, ESC culture and Differentiation). Further, Gouti teaches i) the second differentiation medium is chosen from the group consisting of i) a non-supplemented serum-free cell culture medium (i.e. N2B27 medium).
Regarding claim 1c, Gouti teaches that the NMPs were passed every 3 days corresponding to the claim limitation of replacing the second differentiation medium by a non-supplemented serum-free cell culture medium within 1 to 3 days after replacing the first differentiation medium by the second differentiation medium (see e.g. Supp. Sec. page e3, ESC culture and Differentiation, fig. 2-4).
Regarding claim 1d, Gouti discloses that the cells were “dissociated into small cellular clumps mechanically using a plastic pipette tip” (see e.g. Supp. Sec. page e3, ESC culture and Differentiation, fig. 2-4) (i.e. neuromuscular organoids). Further, Gouti cites Camp for analyzing the small clumps of cells (i.e. organoids) by single-cell genomics (SCG) which allows for the characterization of cells at the level of chromatin organization and epigenetic marks (see e.g. p. 661 and 664). Thus, it would have been obvious for a person of ordinary skill in the art to associate the small cellular clumps as neuromuscular organoids because Camp teaches analyzing gene expression for cerebral organoids (see e.g. abstract of Camp).
Gouti does not explicitly disclose a three-dimensional neuromuscular organoid comprising two different tissues including spinal cord neurons and skeletal muscle fibers.
Nevertheless, providing guidance on instances where the method steps of the prior art and instant claims are the same, Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) states “[T]hat since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims.” In the instant case, the claims are drawn to an invention employing the same process steps, but the product(s) is(are) alleged to be different. Applicant is required to recite the missing steps to form the alleged different product(s) in view of the above-cited decision. If this is the case, Applicant is required to recite the missing steps.
In the instant case, as discussed above, Gouti discloses neuromuscular progenitor cells with a first and second differentiation medium, as discussed above. Therefore, the neuromesodermal progenitor cells as taught by Gouti would naturally include the two different tissues including spinal cord neurons and skeletal muscle fibers. Furthermore, the prior art Ichida 2020 provides evidence that neural/mesodermal organoids (i.e. neuromuscular organoids) were formed after 5 days of culture following the same protocol as Gouti protocol (i.e. both of the prior arts reference Gouti 2014, which discloses spinal cord neuron tissues)(see e.g. abstract, p. 131, Fig. 1), and Petersen 2019, provides evidence that neuromuscular organoids (from Gouti, same inventor) have great potential for studying development of the neuromuscular system and diseases (see e.g. p. 1). Additionally, the prior art of Afshar discloses methods of generating three-dimensional neuromuscular organoids from progenitor cells, where the progenitors are able to self-organize to form function NMJ connections (i.e. spinal cord neuron and skeletal muscle fiber tissue)(see e.g. abstract, p. 1-6, 19-20, fig. 1-2). Further, the prior art of Sareen discloses
Accordingly, prior to the effective filing date of the instant claimed invention, it would have been prima facie to obvious for a person of ordinary skill in the art to have obtained three-dimensional neuromuscular organoid from the non-supplemented serum-free cell culture medium as taught by Gouti with a reasonable expectation of success because a person of ordinary skill in the art would have been motivated to generate a three-dimensional neuromuscular organoid from neuromesodermal progenitor cells (NMPs), as taught by Gouti, because Gouti teaches that in vitro and in vivo NMPs are molecularly and functionally similar (see e.g. page 244), as evidence by Ichida, which cites Gouti 2014 for teaching the basis of the three-dimensional organoids from NMP cells strategy (see e.g. page 131, Figure 1). Furthermore, Gouti cites Gouti 2014 for their protocol of generating NMP cells (see e.g. page 246). Therefore, the nexus of Gouti and Ichida citing Gouti 2014 as the basis for the three-dimensional organoids from NMP cells provides a person of ordinary skill in the art a reasonable expectation of success of generating three-dimensional neuromesodermal organoids in vitro, as discussed above. Additionally, the prior art of Afshar discloses that a person of ordinary skill in the art would have generated the three-dimensional neuromuscular organoid system because the 3D cultures offer a simple method to model and evaluate adult human neuromuscular junction (NMJ) de novo development or disease in culture (as taught by Afshar, see page 1), as evidence by Petersen 2019, which discloses that neuromuscular organoids (from Gouti, same inventor) have great potential for studying development of the neuromuscular system and diseases (see e.g. p. 1). Thus, providing motivation to do. Furthermore, an artisan of ordinary skill in the art of methods for generating organoids has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Regarding claim 2, Gouti teaches wherein the non-supplemented serum-free cell culture medium is Dulbecco's Modified Eagle Medium comprising Ham's F12 medium and neurobasal medium (NB)(see e.g. Supp. Sec. page e3, Fig. 2-4).
Regarding claim 3, as discussed above, Gouti teaches wherein the activator of a growth factor signaling pathway is the fibroblast growth factor (i.e. bFGF) signaling pathway (Supplemental see page e3, fig. 2-4) as discussed above.
Regarding claim 4-5, as discussed above, Gouti teaches a second differentiation medium is a serum free cell culture medium (Supplemental see page e3). Further, Gouti teaches the serum-free culture medium is supplemented with an activator of a growth factor signaling pathway (e.g. basic fibroblast growth factor (bFGF))(see e.g. Supp. Sec. page e3, Fig. 2-4).
Gouti is silent regarding supplementing with a ROCK inhibitor, an insulin-like growth factor and hepatocyte growth factor.
However, the prior art of Gouti 2014 teaches supplementing the N2B27 medium with Y-27632 (i.e. ROCK inhibitor)( see e.g. page 12) and Sareen discloses supplementing a maturation media with hepatocyte growth factor (HGF), and insulin growth factor (IGF)(see e.g. page 31, table 2).
Accordingly, prior to the effective filing date of the instant claimed invention, it would have been prima facie to obvious for a person of ordinary skill in the art to have modified the method, as taught by Gouti, and incorporate supplementing the N2B27 medium with Y-27632 (i.e. ROCK inhibitor) and supplementing a maturation media with hepatocyte growth factor (HGF), and insulin growth factor (IGF), as taught by Gouti 2014 and Sareen, with a reasonable expectation of success because one of ordinary skill in the art would know that supplementing media with growth factors allows for optimal differentiation conditions for NMPs (as taught by Gouti 2014, see e.g. abstract, fig. 1, p. 12-13). Further, Gouti references Gouti’s (i.e. Gouti 2014) protocol for generating NMPs from pluripotent stem cells. Further, the use of growth factors for supplementing medium is extremely well known in the field of cell culture art. Moreover, an artisan of ordinary skill in the art of culturing skeletal muscle cells has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Regarding claim 6, as discussed above, Gouti teaches that the non-supplemented serum-free cell culture medium after step c) that was changed every other day (i.e. every 2 days)(Supplemental see page e3). Further, Gouti teaches that the NMP cells could be maintained for up to 10 days (see e.g. page 253).
Gouti is silent regarding wherein the time period exceeds 10 days after the start of cultivation.
However, Bolognin discloses culturing in a differentiation medium for at least 10 days or more (see e.g. para. 14-15, p. 14).
Further, the following is noted from the MPEP: MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” MPEP 2144.05(I) teaches “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).”
Accordingly, it would have been obvious for a person of ordinary skill in the art at the time of the invention to employ the method of obtaining a three-dimensional neuromuscular organoid from the non-supplemented serum-free cell culture medium, as taught by Gouti, with the culturing time period, as disclosed by Ichida and Bolognin, with a reasonable expectation of success. A person of ordinary skill in the art would have been motivated to do so because Ichida discloses that “over the next 50–100 days, the organoids reached 5–6 mm in diameter and displayed an elongated morphology with neural tissue on one end and muscle cells on the other” (see page 131, col. 3). Further, Ichida discloses that the “segregation of neural and muscle compartments was maintained at day 50 when anatomical and functional NMJs became apparent” (see page 131, col. 3). Thus, providing a reasonable expectation of success.
Regarding claim 7, Gouti is silent regarding wherein the method is carried out under agitation.
However, as discussed above, Bolognin teaches a method of generating brain organoids (see e.g. abstract). Further, Bolognin teaches a method of generating brain organoids by contacting them with differentiation medium under agitating conditions (see e.g. abstract, para. 14-15, p. 8 and 14).
Accordingly, it would have been obvious for a person of ordinary skill in the art at the time of the invention to modify the method of Gouti to obtain a three-dimensional neuromuscular organoid from the non-supplemented serum-free cell culture medium with agitation conditions, as taught by Bolognin, with a reasonable expectation of success. A person of ordinary skill in the art would have been motivated to do so because Bolognin teaches that under agitating conditions the stem cells that were embedded in three-dimensional cell culture grew further and quickly (see e.g. para. 9, fig. 4). Additionally, both Gouti and Bolognin discloses methods for obtaining a neural organoid in a three-dimensional cell culture from stem cells (e.g. embryonic stem cells). Thus, providing a reasonable expectation of success.
Regarding claim 8, Gouti teaches wherein the first cell culture comprises 30 % to 90% neuromesodermal progenitor cells co-expressing BRACHYURY(T/BRA or Bra)/SOX2 and 10 % to 70 % neuromesodermal progenitor cells co-expressing TBX6 (see e.g. page 244 and Fig. 3-5)
Regarding claims 9-12, Gouti teaches wherein the neuromesodermal progenitor cells are obtained by providing a second cell culture comprising pluripotent stem cells and cultivating the pluripotent stem cells in a first cultivation medium comprising a serum-free cell culture medium supplemented with an activator of β-catenin signaling pathway (i.e. CHIR99021 is 6-[[2-[[4-(2,4-Dichlorophenyl)-5-(5-methyl-1 H-imidazol-2-yl)-2-pyrimidinyl] amino]ethyl]amino ]-3-pyridinecarbonitrile)(see e.g. Supp. Sec. page e3, Fig. 6A). Further, CHIR99021 is a known activator of β-catenin signaling pathway is an inhibitor of glycogen synthase kinase 3 activity (Specification, see e.g. page 8-9).
Regarding claims 13-14, as discussed above, Gouti teaches wherein the activator of a growth factor signaling pathway is chosen from the group consisting of an activator of the fibroblast growth factor signaling pathway (see e.g. Supp. Sec. page e3, Fig. 2-4).
Regarding claim 15, as discussed above, Gouti teaches wherein the first cultivation medium is changed against (i.e. replaced with) a second cultivation medium 1 to 3 days after cultivation start, wherein the second cultivation medium comprises a serum-free cell culture medium supplemented with at least one of an activator of β-catenin signaling pathway and an activator of a growth factor signaling pathway(i.e. bFGF) (page e4) (see e.g. Supp. Sec. page e3, Fig. 2-4).
Regarding claim 16, as discussed above, Gouti teaches that the non-supplemented serum-free cell culture medium (see e.g. Supp. Sec. page e3, Fig. 2-4).
Gouti is silent regarding the first cultivation medium contains a ROCK inhibitor, but the second cultivation medium does not contain a ROCK inhibitor.
However, the prior art of Gouti 2014 teaches the first cultivation medium contains a ROCK inhibitor (i.e. Y-27632) and the second cultivation medium does not contain a ROCK inhibitor (see e.g. page 12).
Accordingly, it would have been obvious for a person of ordinary skill in the art at the time of the invention to modify the method of Gouti to obtain a three-dimensional neuromuscular organoid from the non-supplemented serum-free cell culture medium by supplementing with the first cultivation medium containing a ROCK inhibitor, but the second cultivation medium does not contain a ROCK inhibitor, as taught by Gouti, with a reasonable expectation of success. A person of ordinary skill in the art would have been motivated to do so because the prior art of Vernardis teaches that “robust differentiation protocols necessitate single cell cultures that are achieved by use of ROCK (Rho kinase) inhibitors” (see e.g. abstract). Further, Vernardis teaches that it was known in the prior art for “ROCK inhibition to enable maintenance of stem cell phenotype” (see e.g. abstract). Therefore, it would have been obvious for a person of ordinary skill in the art to remove the ROCK inhibitor during the second cultivation medium. Furthermore, Gouti references Gouti’s (i.e. Gouti 2014) protocol for generating NMPs from pluripotent stem cells. Thus, providing a reasonable expectation of success.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Traversal:
Applicant asserts that the declaration under 37 CFR 1.130(a) filed by Dr. Asimina Gkouti (i.e. Mina Gouti), Chien-Ping Ko, and Ichida on Jan. 21, 2026, disqualifies Ichida, et al., (Cell Stem Cell 26.2: 131-133, published Feb. 2020; cited IDS 11/17/2021) as prior art (Remarks, pages 8-10).
Applicants’ arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
As stated above, it is acknowledged that the declaration under 37 CFR 1.130(a) filed by Dr. Asimina Gkouti on Jan. 21, 2026, is a sufficient declaration. However, the obviousness rejection of claims 1-16 does not rely on Ichida, et al., (Cell Stem Cell 26.2: 131-133, published Feb. 2020; cited IDS 11/17/2021) as prior art, but recites the reference as an evidence reference. Therefore, the declaration is moot regarding the prior art rejection cited above.
Applicant argues that Gouti 2017 fails to teach or suggest single cells (Remarks, page 10).
Applicants’ arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
[AltContent: textbox ([img-media_image1.png]
Adapted Fig. 1 of Gouti)]In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed above, Bolognin is cited for single cell suspension (see e.g. para. 38, 107, p. 20, 45 and sec. 2.3). Contrary to Applicants belief, the prior art of Gouti does discloses single cell dissociation and suggests that the cells may be dissociated into a single cell suspension using accutase (see adapted Fig. 1’s box above, and page e3). Furthermore, the specification discloses that the “in vitro generation of NMPs from Human Pluripotent Stem Cells were grown for at least three passages and after they reached 70% confluency they were dissociated into single cells using accutase” (Spec. para. 156). Therefore, since both the methods of Gouti and Bolognin (see e.g. para. 107), and the specification discloses using accutase for generating single cell suspension. Thus, it would have been possible to modify the method to obtain a single cell suspension with a reasonable expectation of success because the method was known in the prior art.
Applicant argues that Camp is non-analogous art because Camp discloses cerebral (brain) organoids, and does not disclose neuromuscular progenitors (NMPs)(Remarks, page 11). Further, Applicant argues that Camp disclose data analysis methodology and argues impermissible hindsight because Camp is not relevant to the claimed invention (Remarks, page 12).
Applicants’ arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
As discussed above, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In response to applicants’ argument that Camp is non-analogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Applicants arguments are not persuasive because Camp is not cited for disclosing NMPs and Camps discloses methods related to organoids, as discussed above. Applicant is directed to pages 12-13 of KSR v Teleflex (550 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “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 (emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, 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 his or her skill.” Clearly in the instant case the Gouti cites Camp for analyzing the small clumps of cells (i.e. organoids) by single-cell genomics (SCG), which allows for the characterization of cells at the level of chromatin organization and epigenetic marks (see e.g. p. 661 and 664). Thus, it is unclear how Camp is non-analogous art if the prior art cites Camp. Furthermore, it would have been obvious for a person of ordinary skill in the art to associate the small cellular clumps as neuromuscular organoids because Camp teaches analyzing gene expression for cerebral organoids (see e.g. abstract of Camp) at the time the invention was made. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Applicant argues that Vernardis is non-analogous art because Vernardis discloses generic 3D aggregate formation by human pluripotent stem cells (PSC), and does not disclose neuromuscular progenitors (NMPs)(Remarks, page 12). Applicant argues that combining Vernardis with the cited references requires impermissible hindsight reconstruction, because Vernardis provides no teaching or motivation (Remarks, page 12).
Applicants’ arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
As discussed above, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Applicant arguments are not persuasive because the prior art of Vernardis is not cited for teaching NMPs, as discussed above. In response to applicants’ argument that Vernardis is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Gouti (2017) is cited for NMPs, and Vernardis is cited for disclosing the use of ROCK (Rho kinase) inhibitors in stem cell methods (see e.g. abstract), as discussed above. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Applicant argues that Sareen does not disclose neuromuscular progenitors (NMPs), 3D organoid formation or neuromuscular systems (Remarks, page 12). Applicant argues that Sareen does not provide any teaching or suggestion, and fails to cure the deficiencies of the primary references (Remarks, page 13).
Applicants’ arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
As discussed above, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Gouti (2017) is cited for NMPs, and Sareen is cited for disclosing the supplementing a maturation media with hepatocyte growth factor (HGF), and insulin growth factor (IGF)(see e.g. page 29-32), as discussed above. Further, both Gouti and Sareen are directed to methods regarding neuron cells with skeletal muscle cells (see abstracts, respectively). As discussed above, an artisan of ordinary skill in the art of methods for generating neuro-muscular organoids has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Applicant argues that Bolognin does not disclose neuromuscular progenitors (NMPs), and although Bolognin discloses 3D organoids, which are neural organoids, there is no teaching or motivation to combine the references without impermissible hindsight (Remarks, page 13-14).
Applicants’ arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
As discussed above, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In response to applicant's argument, the MPEP 2123 (I) states that patents are relevant as prior art for all they contain, and that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. In instant case, the TCRs and CARs to be included in the T cell taught by Valdes are typical agents found in the cell therapy art (see Background, [0004] of Valdes) and appear both in the specification and in the claims. Applicant is reminded that preferred embodiments are not the only teaching of a reference. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). In the instant case, Gouti (2017) is cited for NMPs, and Bolognin is cited for disclosing using agitating conditions when culturing organoids (see e.g. abstract). As discussed above, both Gouti and Bolognin discloses methods for culturing organoids. As discussed above, an artisan of ordinary skill in the art of methods for generating organoids has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Applicant argues that Gouti 2014 “teaches a method for generating NMPs from pluripotent stem cells; however, this reference remains strictly limited to 2D adherent monolayer culture and does not disclose or suggest any aspect of the presently claimed three dimensional neuromuscular organoid system” (Remarks, page 14).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
As discussed above, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, as discussed above, Gouti 2017 cites Gouti 2014 for their protocol of generating three-dimensional organoids from NMP cells (see e.g. page 246), and Ichida cites Gouti (2014) for teaching the basis of the three-dimensional neuromuscular organoids from NMP cells (see e.g. page 131, Figure 1). Hence, a person of ordinary skill in the art would have interpreted the cells obtained by Gouti’s method as having the ability to obtain neuromuscular organoids as taught by Gouti 2014. Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) provides "that since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims." Therefore, the teachings of Gouti 2017 and Gouti 2014, as evidence by Ichida, which cites Gouti 2014 for teaching the basis of the three-dimensional organoids from NMP cells strategy (see e.g. page 131, Figure 1) render the instant claims as obvious, as discussed above. Additionally, the prior art of Afshar is now cited for disclosing that methods of generating three-dimensional neuromuscular organoids from progenitor cells was known in the prior art (see e.g. abstract, p. 1, 6, 19-20, fig. 2). Thus, a person of ordinary skill in the art would have generated the three-dimensional organoids because Gouti teaches that in vitro and in vivo NMPs are molecularly and functionally similar (see e.g. page 244), and as evidence by Petersen 2019, which discloses that neuromuscular organoids (from Gouti, same inventor) have great potential for studying development of the neuromuscular system and diseases (see e.g. p. 1). Thus, providing motivation to do. Furthermore, an artisan of ordinary skill in the art of methods for generating organoids has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007). Furthermore, the claim recites “comprising the following steps” which allows for additional steps that are not recited between the recited steps (i.e. comprising is open-ended). See MPEP 2111.03. Further, it is noted by the examiner that the claims recite “d) obtaining three-dimensional neuromuscular organoids” but does not recite a three-dimensional structure. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Applicant asserts that Gouti 2014 teaches away from the claimed invention because Gouti 2014 does not disclose the combined generation of skeletal muscle cells and spinal cord neurons which is a prerequisite for forming functional neuromuscular junctions (Remarks, page 14).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
Applicant is reminded that preferred embodiments are not the only teaching of a reference. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).
In the instant case, it is noted that the recitation of skeletal muscle cells and spinal cord neurons as a prerequisite are not recited in the rejected claims as a prerequisite. MPEP 2111.04 (I) indicates that a “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” and a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” The examiner has determined that the “wherein” clause of instant claims does not limit the structure of the neuromuscular organoid, because the prior art of Gouti 2017 discloses the neuromesodermal progenitor cells, as recited in the claim, nor does it affect the method of providing the neuromesodermal progenitor cells, as recited in the claims. Therefore, the “wherein” language of the instant claim does not provide a limiting effect on the claimed method. Furthermore, 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). In the instant case,, it is noted that there is no claim limitation directed to a “forming functional neuromuscular junctions”(remarks, p. 14). In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claim is allowed.
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Josephine Gonzales PhD
Examiner
Art Unit 1638
/JOSEPHINE GONZALES/Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
