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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14, 17 and 18 in the reply filed on 12/18/2025 is acknowledged.
Claims 15 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/18/2025.
The instant application is a CON of 16/461,147, now U.S. Pat. No. 11,767,515.
Claims 1-14, 17 and 18 are examined in the instant application.
Allowable Subject Matter
Claims 9 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 is not grammatically correct. A claim is a complete sentence which ends in a period, however claim 1 recites “a.” and “b.”. It is suggested that “a.” and “b.” be amended to “(a)” and “(b)” respectively, as set forth in claim 6 for example. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: claim 1 is not grammatically correct. The world “Claim” in line 1 should be replaced with “claim”. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14, 17 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11,767,515. Although the claims at issue are not identical, they are not patentably distinct from each other because instant steps (a) and (b) of claim 1 of produce the same HCO expressing SATB2 as set forth in claim 1 of ‘545. Further instant dependent claims 2-14, 17 and 18 are identical to or of the same scope as dependent claims 2-31 of ‘545.
The instant application was filed as a CON and the court has found that safe harbor does not apply when the continuing application is filed as CON. The court found that safe harbor from an ODP rejection only applies when a continuing application is filed as a DIV. See AMGEN INC., v. F. HOFFMANN-LA ROCHE LTD. 580 F.3d l340; 2009 U.S. App, LEXIS 20409; 92 U.S.P.Q.2D (BNA) 1289.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13, 17 and 18 are rejected and new claims 32-35 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
The Claims
The claims are directed to:
A human colon organoid.
Teachings in the Art
The art teaches that human colonic organoids are naturally occurring (see Whitehead et al., 1987, In Vitro Cellular and Developmental Biology, Vol. 23(6), pgs. 436-442, see the Introduction in particular).
Teachings in the Specification
The specification teaches that the claimed HCOs were derived from large intestinal epithelium of human (see parag. 83 on pg. 28).
However, the HCOs of the claimed invention were not subjected to any genetic modification or any modification that would distinguish them from their natural occurring counterparts.
Accordingly, the claims are directed to a composition using only a nature-based product, i.e., HCOs, this nature-based product is then analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. The claims thus encompass HCOs which are identical (no difference in characteristics) to naturally occurring HCOs as taught in Whitehead et al.
Because there is no difference between the HCOs used in the claimed composition, the claimed HCOs do not have markedly different characteristics, and thus are a “product of nature” exception. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1338-39 (Fed. Cir. 2014). Accordingly, the claimed compositions are directed to an exception. Because the claimed compositions do not include any additional features that could add significantly more to the exception, the claimed HCOs do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
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An examination of Step 2A in the revised 101 guidance, with respect to the claimed invention, the answer is yes since the claimed compositions comprise only a naturally occurring products (judicial exceptions), in the instant case this naturally occurring products are HCOs.
It is only the recited limitations in the claims that are examined under 101 and not aspects such as what the cells are capable of being used for (i.e. treatment). In this case only HCOs are examined with respect their status as a judicial exception. It is emphasized that the claimed invention is a composition and not a method.
An examination of Step 2B, the answer is no with respect to the claimed invention. There are no other additional elements recited in the claims that would amount to significantly more than the judicial exceptions. This is because while the claimed invention is drawn to HCOs, there are no additional components which impart any additional element or structural limitations to the recited cells. The HCOs of the claims are indistinguishable from HCOs that exist in nature. The HCOs of the claims have the same capability as those that exist in nature and the fact that they are isolated does not change the HCOs in significant or meaningful way to amount to more than the judicial exception.
The only factors which can be examined under 101 in the claimed composition are those that are recited in the claim i.e. an HCO.
How the HCOs are obtained and the knowledge of using HCOs are not considered with respect to a composition, it is only the judicial exceptions themselves that are analyzed under 101 and in this case all of the components in the claimed composition are naturally-occurring products and thus qualify as a judicial exception.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-13, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wells et al. (US 2013/0137130 A1) in view of Li et al. (2015, Int. J. Clin. Exp. Pathol., Vol. 8(6), pgs. 7072-7082).
Regarding claims 1, 3-5, 13, Wells et al. teach a method of inducing formation of an HCO comprising:
(a) contacting DE with FGF4 and Wnt3a to obtain mid-hindgut spheroid (see Abstract and parags. 21, 22, 39 and 84), and
(b) contacting the spheroid of (a) with BMP2 and EGF to form an HCO (parags. 151, 156, 191 and 192).
Regarding claim 2, Wells teaches that the DE are derived from human ES cells (parag. 83).
Regarding claim 6, Wells teaches that CDX2 expression is used to determine formation of a mid-hindgut spheroid (parag. 112).
Regarding claims 8 and 10, Wells teaches that the HCO comprises EEC and goblet cells (parag. 62).
Regarding claims 17 and 18, Wells teaches that that develop colon tissue from the HCO, and Wells does not teach that the colonoid comprise an immune function innervation, blood vessels, villi and Paneth cells (parag. 188).
Well does not teach:
(i) measuring SATB2 expression (claims 1 and 7).
(i) Regarding measuring SATB2 expression, Li et al. teach that SATB2 and CDX2 are markers for colon tissue (see Abstract and Table 6).
Li continues to teach “use of immunohistochemical markers is critical to make such distinction. Sensitive hindgut WDNET markers such as SATB2 are particularly useful in this aspect. Such diagnostic utility is even more appreciated in eastern Asian coun-tries given the large patient population and high proportion of rectal WDNETs.” (pg. 7079 col. 1 parag. 1 lines 5-11).
Thus at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Wells regarding a method of inducing formation of an HCO with the teachings of Li regarding SATB2 expression to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to examine the HCO of Wells for SATB2 expression since Li teaches that SATB2 is a sensitive hindgut marker for tissue of the colon.
There would have been a reasonable expectation of success that the HCO of Wells expresses SATB2 since Li teaches that SATB2 is a marker for colon tissue and particularly hindgut tissue of the colon.
Thus the cite art provides the requisite teachings and motivations to make and use the invention as claimed.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wells et al. (US 2013/0137130 A1) in view of Li et al. (2015, Int. J. Clin. Exp. Pathol., Vol. 8(6), pgs. 7072-7082) as applied to claims 1-13, 17 and 18 above, and further in view of Mashima et al. (2013, Biochem. Biophys. Res. Comm., Vol. 432, pgs. 586-592).
Wells and Li are relied upon above in teaching a method of inducing formation of an HCO.
Wells and Li do not teach:
(i) wherein the HCO secretes INSL5.
(i) Regarding INSL5 secretion, Mashima et al. teach that INSL5 may be a unique marker for EEC cells of the colon (see Abstract).
Mashima continues to teach “clarifying the molecular signaling pathways in EECs
and NETs is important for understanding the pathophysiology of the disease and for selecting or developing new strategies for their treatment. INSL5–RXFP4 signaling may play a role in an autocrine/paracrine fashion in the colorectum with effects other than those on cell proliferation, inflammation and mucosal healing, and INSL5 might represent a unique marker of colorectal EECs and NETs.” (pg. 591 col. 1 parag. 6).
Thus at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Wells and Li regarding a method of inducing formation of an HCO with the teachings of Mashima regarding INSL5 expression to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to examine the EEC cells in the HCO of Wells for INSL5 expression since Mashima teaches that INSL5 may be a unique marker for EEC cells.
There would have been a reasonable expectation of success that the EEC cells in the HCO of Wells expresses INSL5 since Mashima teaches that INSL5 may be a unique marker for EEC cells.
Thus the cite art provides the requisite teachings and motivations to make and use the invention as claimed.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wells et al. (US 2013/0137130 A1) in view of Li et al. (2015, Int. J. Clin. Exp. Pathol., Vol. 8(6), pgs. 7072-7082) as applied to claims 1-13, 17 and 18 above, and further in view of Watson et al. (2014, Nature Med., Vol. 20(11), pgs. 1310-1314).
Wells and Li are relied upon above in teaching a method of inducing formation of an HCO.
Wells and Li do not teach:
Engrafting the HCO under the kidney capsule of a mammal.
(i) Regarding engraftment of an HCO, Watson et al. teach engrafting an HCO, obtained from pluripotent stem cells, under the kidney capsule in a mouse to produce mature human intestinal tissue (Fig. 1, reproduced in part below and Fig. 4).
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Specifically, Watson teaches that that the achieved a 92.4% success in engraftment of their HCOs under the kidney capsule and “Transplanted intestinal tissues demonstrated digestive functions as shown by permeability and peptide uptake studies. Furthermore, transplanted HIO-derived tissue was responsive to systemic signals from the host mouse following ileocecal resection, suggesting a role for circulating factors in the intestinal adaptive response7–9. This model of the human small intestine may pave the way for studies of intestinal physiology, disease and translational studies.” (pg. 1311 col. 1 and Abstract last 8 lines).
Thus at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Wells and Li regarding a method of inducing formation of an HCO with the teachings of Watson regarding HCO engraftment to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to engraft the HCOs of Wells under the kidney capsule since Watson teaches that this permits the functional growth of the implanted tissue to further study tissue development and drug response.
There would have been a reasonable expectation of success that the HCO of Wells could be engrafted under the kidney capsule since Watson teaches that they achieved a 92.4% success rate with engraftment.
Thus the cite art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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