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 .
Claim Status
To expedite the compact prosecution, the Examiner is pursuing the amended claims dated 07 January 2025, in which applicants are claimed claims 1-11. Therefore, claims 1-11 are pending in the application.
Priority
This application was filed 01/07/2025 and is a continuation of 17332532, filed 05/27/2021, now U.S. Patent # 12188051, which claims benefit to the Provisional Application 63030621, filed 05/27/2020. Thus, the earliest possible priority for the instant application is 05/27/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/07/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, and the signed and initialed PTO Forms 1449 are mailed with this action.
Claim Objections
Claim 1 is objected to because terms such as “EC” should be spelled out in full at the first occurrence of the terms.
Claim 2 is objected to because terms such as “ENR”, “EGF”, “BMP4” and “bFGF” should be spelled out in full at the first occurrence of the terms.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
(Scope of Enablement)
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, and 7-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while enabling the culturing of hindgut spheroid tissue in vitro with the specific culturing steps recited in claims 2-6 to obtain the vascularized human intestinal organoid tissue (VHIOT) having an intestine-specific EC transcriptional signature, does not reasonably provide enablement for any culturing method that allows to culture hindgut spheroid tissue and differentiate into VHIOT having an intestine-specific EC transcriptional signature. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Claim 2 and those dependent thereon are excluded from this rejection since they are considered as enabled.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: “Enablement is not precluded by the necessity for some 'experimentation.'” Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The office has analyzed the specification in direct accordance to the factors outlined in In re Wands. MPEP 2164.04 states: "[W]hile the analysis and conclusion of a lack of enablement are based on factors discussed in MPEP 2164.01(a) and the evidence as whole, it is not necessary to discuss each factor in written enablement rejection." These factors will be analyzed, in turn, to demonstrate that one of ordinary skill in the art would have had to perform "undue experimentation" to make and/or use the invention and therefore, Applicant's claims are not enabled commensurate with the scope of the invention.
Furthermore, MPEP 2164.03 as set forth in In re Fisher, 166 USPQ 18 (CCPA 1970), compliance with 35 USC 112, first paragraph requires: “That scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved.” Moreover, the courts have also stated that reasonable correlation must exist between scope of exclusive right to patent application and scope of enablement set forth in the patent application (27 USPQ2d 1662 Ex parte Maize!.).
THE BREADTH OF THE CLAIMS
The breadth of the claim 1 encompasses the in vitro culturing of hindgut spheroid tissue using any culturing method to induce the hindgut spheroid tissue into VHIOT and the VHIOT has an intestine-specific EC transcriptional signature.
Dependent claims 7-9 encompasses the in vitro culturing compositions to obtain the hindgut spheroid tissue.
THE NATURE OF THE INVENTION
The specification and claims 2-6 disclose a specific in vitro culturing method of the hindgut spheroid tissue with particular components and steps (i.e., a) incubating the hindgut spheroid tissue with ENR media, wherein the ENR media comprises EGF, Noggin and R-Spondin2; b) incubating the result of step a with ENR media and vascular endothelial growth factor (VEGF), wherein the ENR media comprises EGF, Noggin and R-Spondin2; c) incubating the result of step b with EGF, BMP4 and bFGF; and d) incubating the result of step c with EGF and VEGF) that enable the differentiation of the hindgut spheroid tissue into VHIOT having an intestine-specific EC transcriptional signature (see the specification p. 4 lines 29-33 and p. 5 lines 1-33).
Therefore, skilled in the art can differentiate the hindgut spheroid tissue into VHIOT having an intestine-specific EC transcriptional signature with the specific in vitro culturing method as disclosed in specification and claims 2-6.
THE STATE OF THE PRIOR ART
Holloway et al. (Developmental Cell 54, 516–528, August 24, 2020; cited in PTO892; hereinafter “Holloway”) in the state of the prior art teaches in vitro culturing of human pluripotent stem cell (hPSC)-derived intestinal organoids (HIOs) can be differentiated and maintained under definite culture conditions into native EC population with an intestine-specific EC transcriptional signature (Fig. 1a and 4 of Holloway). The culturing condition achieved by Holloway with the combined culturing steps and the components that are also found in the instant claims 2-6 was significantly important for the culturing and development of vascularized human intestinal organoid tissue having an intestine-specific EC transcriptional signature (p. 517 2nd lane of Holloway). However, in contrast, the instantly rejected claims 1, and 7-9 do not require these steps. The art appears to be silent to use any other method except that appears in claims 2-6 that allows to culture of the hindgut spheroid tissue and differentiate into VHIOT having an intestine-specific EC transcriptional signature.
THE LEVEL OF ORDINARY SKILL IN THE ART
An ordinary artisan in the area of cell biology would have experience in vitro culturing of human pluripotent stem cell (hPSC)-derived intestinal organoids (HIOs) can be differentiated and maintained under definite culture conditions into native EC population with an intestine-specific EC transcriptional signature. The culturing and development of vascularized human intestinal organoid tissue having an intestine-specific EC transcriptional signature, is routine in the art. The process of culturing of human pluripotent stem cell (hPSC)-derived intestinal organoids (HIOs), using culturing steps and the components are significantly important for the culturing and development of vascularized human intestinal organoid tissue having an intestine-specific EC transcriptional signature is well known. Additionally, in vitro culturing of hindgut spheroid tissue using any culturing method to induce the hindgut spheroid tissue into VHIOT and the VHIOT has an intestine-specific EC transcriptional signature as claimed, is generally not well-known or routine, given the complexity of certain biological systems.
Thus, the level of ordinary skill in the art of differentiating the hindgut spheroid tissue into VHIOT having an intestine-specific EC transcriptional signature with any culturing method is high, as an ordinary artisan in this art needs specialized knowledge of the complex nature of the hindgut spheroid tissue.
THE LEVEL OF PREDICTABILITY IN THE ART
While the in vitro culturing of hindgut spheroid tissue using specific culturing method to induce the hindgut spheroid tissue into VHIOT and the VHIOT has an intestine-specific EC transcriptional signature is well known, the use of any culturing method to induce the hindgut spheroid tissue into VHIOT within the scope of the claim is not predictable. For instance, Holloway teaches in vitro culturing of human pluripotent stem cell (hPSC)-derived intestinal organoids (HIOs) can be differentiated and maintained under definite culture conditions into native EC population with an intestine-specific EC transcriptional signature (Fig. 1a and 4 of Holloway). The culturing condition achieved by Holloway with the combined culturing steps and the components that are also found in the instant claims 2-6 was significantly important for the culturing and development of vascularized human intestinal organoid tissue having an intestine-specific EC transcriptional signature (p. 517 2nd lane of Holloway).
Thus, it is unpredictable whether any culturing method can be inducing the hindgut spheroid tissue into VHIOT and the VHIOT has an intestine-specific EC transcriptional signature. The predictability of applying any culturing method to inducing the hindgut spheroid tissue into VHIOT encompassed by the instant claim would be low given that there doesn’t appear to a link between the hindgut spheroid tissue and the claimed conditions.
THE AMOUNT OF GUIDANCE AND WORKING EXAMPLES DISCUSSION
The specification shows that the first culturing of the hindgut spheroid tissue comprises incubating the hindgut spheroid tissue with ENR media, wherein the ENR media comprises EGF, an inhibitor of the BMP signaling pathway (e.g., Noggin) and a co-activator of the WNT signaling pathway (e.g., R-Spondin2), wherein the first culturing of the hindgut spheroid 5 tissue in vitro occurs for approximately two days (e.g., 0.5 days, 1 day, 1.5 days, 2 days, 3 days), wherein the first culturing of the hindgut spheroid tissue occurs prior to the second culturing of the hindgut spheroid tissue; (see SPEC p. 5 lns 1-7). However, specification does not provide preferred embodiments that enable any culturing method can be inducing the hindgut spheroid tissue into VHIOT and the VHIOT has an intestine-specific EC transcriptional signature. Therefore, POSITA can induce the hindgut spheroid tissue into VHIOT at the time of filling, with the specific culturing method as disclosed in specification and claims 2-6.
Thus, the instant specification reasonably enables a specific culturing method recited in claims 2-6 to culture hindgut spheroid tissue and derive VHIOT with an intestine-specific EC transcriptional signature. There are no other methods describe in the specification to culture hindgut spheroid tissue and derive VHIOT with an intestine-specific EC transcriptional signature. Therefore, a skilled artisan would find the specification does not enable any culturing method that is commensurate in scope with the applicant’s disclosure to culture hindgut spheroid tissue and derive it into VHIOT having an intestine-specific EC transcriptional signature that does not involve the method recited of claims 2-6. The specification does not enable any person skilled in the art to which it pertains or with which it is most nearly connected to practice the invention commensurate in scope with claims 1 and 7-9.
CONCLUSION
Since both the instant specification and the prior art at the effective filing date of the present application provide a guide to use a specific culturing method of claims 2-6 to culture the hindgut spheroid tissue and derive it into VHIOT having an intestine-specific EC transcriptional signature, and since there does not appear to be any other teaching in the specification and/or prior art that does same, it is therefore unpredictable to use any culturing method that is not limited to claims 2-6 to derive the hindgut spheroid tissue into VHIOT with an intestine-specific EC transcriptional signature. In view of the foregoing, due to the lack of sufficient guidance provided by the specification regarding the issues set forth above, the state of the relevant art, and the breadth of the claims, it would have required undue experimentation for one skilled in the art to make and use the instant broadly claimed invention as recited.
In conclusion, given the breadth of the claims and the limited scope of the specification, an undue quantity of experimentation is required to make and use the invention beyond the scope of a specific culturing method of the hindgut spheroid tissue and derive it into VHIOT having intestine-specific EC transcriptional signature. Therefore, the instant application has not fully enabled the entire scope of the invention.
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.
Claim 1-11 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. The claim contains subject matter that 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, at the time the application was filed, had possession of the claimed invention.
Independent claims 1, 10 and 11 encompasses a genus of an intestine-specific endothelial cell (EC) transcriptional signature. However, the specification doesn't have adequate support in the disclosure to characterize any intestine-specific EC transcriptional signature.
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 so 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.
REQUIREMENTS TO ESTABLISH ACTUAL REDUCTION TO PRACTICE
"In an interference proceeding, a party seeking to establish an actual reduction to practice must satisfy a two-prong test: (1) the party constructed an embodiment or performed a process that met every element of the interference count, and (2) the embodiment or process operated for its intended purpose." Eaton v. Evans, 204 F.3d 1094, 1097, 53 USPQ2d 1696, 1698 (Fed. Cir. 2000).
The same evidence sufficient for a constructive reduction to practice may be insufficient to establish an actual reduction to practice, which requires a showing of the invention in a physical or tangible form that shows every element of the count. Wetmore v. Quick, 536 F.2d 937, 942, 190 USPQ 223, 227 (CCPA 1976). For an actual reduction to practice, the invention must have been sufficiently tested to demonstrate that it will work for its intended purpose, but it need not be in a commercially satisfactory stage of development. See, e.g., Scott v. Finney, 34 F.3d 1058, 1062, 32 USPQ2d 1115, 1118-19 (Fed. Cir. 1994) (citing numerous cases wherein the character of the testing necessary to support an actual reduction to practice varied with the complexity of the invention and the problem it solved). If a device is so simple, and its purpose and efficacy so obvious, construction alone is sufficient to demonstrate workability. King Instrument Corp. v. Otari Corp., 767 F.2d 853, 860, 226 USPQ 402, 407 (Fed. Cir. 1985).
For additional cases pertaining to the requirements necessary to establish actual reduction to practice see DSL Dynamic Sciences, Ltd. v. Union Switch & Signal, Inc., 928 F.2d 1122, 1126, 18 USPQ2d 1152, 1155 (Fed. Cir. 1991) ("events occurring after an alleged actual reduction to practice can call into question whether reduction to practice has in fact occurred"); Fitzgerald v. Arbib, 268 F.2d 763, 765-66, 122 USPQ 530, 531-32 (CCPA 1959) ("the reduction to practice of a three-dimensional design invention requires the production of an article embodying that design" in "other than a mere drawing"); Birmingham v. Randall, 171 F.2d 957, 80 USPQ 371, 372 (CCPA 1948) (To establish an actual reduction to practice of an invention directed to a method of making a product, it is not enough to show that the method was performed. "[S]uch an invention is not reduced to practice until it is established that the product made by the process is satisfactory, and this may require successful testing of the product."). See MPEP 2138.05.
TEACHINGS OF THE SPECIFICATION:
The specification discloses that the directed differentiation of definitive endoderm into vascularized human intestinal organoid tissue having an intestine-specific EC transcriptional signature is accomplished first through directed differentiation of definitive endoderm into hindgut spheroid tissue, then directed differentiation of the hindgut spheroid tissue into vascularized human intestinal organoid tissue having an intestine-specific EC transcriptional signature (p. 19 lns 13-18). Furthermore, Three EC-specific organ-enriched genes were selected from intestine (MEOXJ, NKX2.3, FABP4) for validation by multiplexed FISH (Figure SE, Figure 6). This approach confirmed organ specific EC enriched markers across human intestine can be used in combination with computational analysis to assess the patterning of ECs co-differentiated within HIOs (p. 27 lns 23-28). Further spec discloses a genus of an intestine-specific endothelial cell (EC) transcriptional signature derived from over 100 organ-specific EC genes (see Table 1, p. 37 of the specification). However, specification does not disclose to characterize any intestine-specific EC transcriptional signature. Therefore, the specification fails to identify any intestine-specific EC transcriptional signature
ACTUAL REDUCTION TO PRACTICE OF THE SPECIFICATION:
Applicant discloses three EC-specific organ-enriched genes were selected from intestine (MEOXJ, NKX2.3, FABP4) for validation by multiplexed FISH (Figure SE, Figure 6). This approach confirmed organ specific EC enriched markers across human intestine can be used in combination with computational analysis to assess the patterning of ECs co-differentiated within HIOs (p. 27 lns 23-28). Furthermore, spec discloses intestine-specific EC transcriptional signature derived from over 100 organ-specific EC-enriched genes (Table 1, p. 37 of the specification). However, the specification does not show any intestine-specific endothelial cell (EC) transcriptional signature, therefore, any embodiments that meet all the limitations of the claim are reduced to practice. Therefore, an actual reduction to practice of an invention directed to the differentiation of the hindgut spheroid tissue into tissue comprising vascularized human intestinal organoid tissue (VHIOT) having any intestine-specific EC transcriptional signature of instant method/product is not established at the time of filling and POSITA cannot predictably identify a differentiation of the hindgut spheroid tissue that exercise the instant invention of any intestine-specific EC transcriptional signature. Accordingly, the successful testing of the product of the current invention is not shows reduced to practice, therefore, it is not established that the method is satisfactory.
MPEP § 2163, besides an actual reduction to practice, Applicant may prove possession of the claimed invention by a showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention. Further, as per MPEP § 2163, “[f]or some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement.”
STATE OF THE ART AT THE TIME OF FILING:
The teaching of Chi et al.,1979 (PNAS, 100, 19, pp. 10623–10628, 2003; IDS filed 09/29/2023) indicates that approximately 6,900 genes are defined in endothelial cells (ECs) from skin, lung, intestine, and myometrium (Fig. 1A&B). Therefore, Chi provides additional evidence that certain genes are associated with intestine-specific EC.
Additionally, Spence et al. (Nature, 470(7332), pp.105-109, 2011; cited in IDS filed on 09/29/2023) discloses that intestinal transcription factor KLF5, CDX2, SOX9 expression has been characterized during the differentiation of human pluripotent stem cells into intestinal tissue in vitro (Fig. 3 or Spence, p. 107). Furthermore, in Fig. 4i–k, S15d–f, Spence et al. demonstrated that intestinal enteroendocrine cell development highly depends on NEUROG3 expression. Therefore, Spence is disclosing a collection of genes associated with intestinal tissue; however, Spence does not describe a definitive gene or collection of genes to characterize vascularized human intestinal organoid tissue with any intestine-specific EC transcriptional signature.
Furthermore, Zhang et al. (Stem Cell Reports, 10(3), pp.780-793, 2018; cited in PTO892) teaches that to achieve the expansion of the gut endoderm, it is likely that posterior gut endoderm cells (PGECs) rearrangement and proliferation are required. Zhang et al. confirmed that CDX2, SOX17, FOXA2, and c-KIT genes are broadly present in PGECs during the differentiation process of PGECs from pluripotent cells (Fig. 1D of Zhang). Therefore, Zhang et al. provide additional evidence that several genes are associated with intestine specific cells, however Zhang does not teach an intestine-specific EC transcriptional signature to characterize vascularized human intestinal organoid tissue.
Recently Holloway taught an in vitro culturing of Human pluripotent stem cell (hPSC)-derived intestinal organoids (HIOs) can be differentiated and maintained under definite culture conditions into native EC population with an intestine-specific EC transcriptional signature (Fig. 1a and 4 of Holloway). However, Holloway use EC cell markers to identify intestine-specific EC transcriptional signatures (i.e., EC CD31+/CD144+ and non-EC CD31-/CD144-) (Figure 3B and 4A). Holloway does not teach a definitive gene or collection of genes to characterize the genus of an intestine-specific EC transcriptional signature.
Therefore, it is obvious that prior arts do not support the differentiation of the hindgut spheroid tissue into tissue comprising vascularized human intestinal organoid tissue (VHIOT) and identify any intestine-specific EC transcriptional signature using instant method.
THE QUANTITY OF EXPERIMENTATION NEEDED TO MAKE OR USE THE INVENTION:
Applicant has claimed a genus of an intestine-specific EC transcriptional signature. The specification only indicating three EC-specific organ-enriched genes were selected from intestine (MEOXJ, NKX2.3, FABP4). The Applicant further has provided a genus of an intestine-specific EC transcriptional signature that is derived from over 100 organ-specific EC-enriched genes. See p. 26 lines 28-31; Fig. 11. However, the Applicant has not disclosed the specific collection of genes that would constitute a representative of intestine-specific EC transcriptional signature nor, have they sufficiently described that all collections of genes necessarily possess such a signature. The genus of intestine-specific EC transcriptional signature with the instant method claim by applicant cannot be predictably made or used by the ordinary artisan.
Such random experimentation to identify any intestine-specific EC transcriptional signature as embraced by Applicant's claims is required undue experimentation. Furthermore, functionally defined genus claims can be inherently vulnerable to invalidity challenges for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus.
With these additional evidence, the ordinary artisan cannot predictably identify a single gene or a collection of genes to make the claimed genus of an intestine-specific EC transcriptional signature. Furthermore, functionally defined genus claims can be inherently vulnerable for lack of adequate written description, especially in highly unpredictable technology fields, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus.
See ABBVIE DEUTSCHLAND GMBH & 2 CO. v. JANSSEN BIOTECH, INC., Appeals from the United States District Court for the District of Massachusetts in Nos. 09-CV-11340-FDS, 10-CV-40003-FDS, and 10-CV-40004-FDS, Judge F. Dennis Saylor, IV. See also Ariad, 598 F.3d at 1351 ("[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011) (noting the technical challenges in developing fully human antibodies of a known human protein).
CONCLUSION
With these additional evidence, it concludes that the claimed genus of an intestine-specific EC transcriptional signature doesn't have an adequate written description. Specifically, the specification does not identify a single definitive gene or a collection of genes to characterize any intestine-specific EC transcriptional signature. Therefore, it concludes that a skilled artisan would find the specification inadequately described. Accordingly, the Applicant did not sufficiently possess the broader invention as claimed in claims 1, 10-11 and dependent claims 2-9.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 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.
MPEP 2173.05(b) states that Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)); see also Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1373, 112 USPQ2d 1188 (Fed. Cir. 2014) (holding the claim phrase "unobtrusive manner" indefinite because the specification did not "provide a reasonably clear and exclusive definition, leaving the facially subjective claim language without an objective boundary").
The term “an intestine-specific EC transcriptional signature” in claim 1 is a subjective term that renders the claim indefinite. The term “an intestine-specific EC transcriptional signature” is not defined by the claim, and the specification does not provide a standard for ascertaining the requisite degree. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention of claims 1-9.
Claims 3-5, and 7-8 are recite the limitation of “approximately” is an indefinite term. A claim may be rendered indefinite by reference to term of degree (see MPEP 2173.05(b), I). Specifically, when a term of degree is used in the claim, the examiner should determine whether the specification provides some standard for measuring that degree. Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357, 1367, 94 USPQ2d 1385, 1391 (Fed. Cir. 2010); Enzo Biochem, Inc., v. Applera Corp., 599 F.3d 1325, 1332, 94 USPQ2d 1321, 1326 (Fed. Cir. 2010); Seattle Box Co., Inc. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 826, 221 USPQ 568, 574 (Fed. Cir. 1984). In instant case, the specification does not provide some standard for measuring that degree (i.e., what constitutes “approximately”). For example, in Ex parte Oetiker, 23 USPQ2d 1641 (Bd. Pat. App. & Inter. 1992), the phrases "relatively shallow," "of the order of," "the order of about 5mm," and "substantial portion" were held to be indefinite because the specification lacked some standard for measuring the degrees intended.
Regarding claims 3-8, the phrase “e.g.” means "for example", which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 9, the limitation “Steps” has no antecedent basis; there is only one step in claim 1.
Pertinent References
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is the following:
McCracken et al., (Nat Protoc. 2011 Nov 10;6(12):1920–1928; cited in PTO892; hereinafter “McCracken”) provides an in vitro culturing of hindgut spheroid tissue, and the differentiation of the hindgut spheroid tissue into Intestinal organoid tissue (see Fig. 1, Step 22-35) comprising all of the major intestinal cell types (abstract). However, McCracken does not teach or reasonably suggest differentiating the hindgut spheroid tissue into a vascularized intestinal organoid tissue.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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