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 .
Claims 1-4 are pending, all of which have been considered on the merits.
Priority
Acknowledgement is made of Applicants’ claim for benefit as a continuation of prior-filed US application 16/678521 (filed 11/8/2019, now USP 11649434), which claims benefit of US Provisional application 62/757553 (filed 11/8/2018).
Claim Interpretation
Claim 4 is directed to a method, comprising:
(a) differentiating human fetal lung bud tip progenitor organoids comprising Sox2+/Sox9+ cells into organoids comprising TP63+ cells… Human fetal lung bud tip progenitor cells are naturally occurring cells in developing human fetus at gestation age ~12 weeks. The fetal lung bud tip progenitor cells are characterized by Sox2/Sox9 co-expression. An ‘organoid’ is given its ordinary meaning in the art, which is a multicellular cluster which contains cells of multiple types and has some tissue-related function. Isolated human fetal lung bud tip tissue containing Sox2+/Sox9+ cells will read on an organoid.
The differentiating is achieved by culturing the human fetal lung bud tip progenitor organoids in the presence of TGF-ß and/or BMP4. Both TGF-ß and BMP4 are SMAD activators. The conditions must be effective to achieve differentiation of the Sox2+/Sox9+ human fetal lung bud tip progenitor organoids comprising Sox2+/Sox9+ cells to organoids comprising cells expressing TP63. TP63 is synonymous with p63. The TP63+ cells may be basal stem cells.
And then (b) expanding the organoids comprising cells expressing TP63 comprising contacting the organoids comprising cells expressing TP63 with one or more of FGF10, Y27632, A8301 and Noggin. It is noted A8301 and Noggin are each SMAD inhibitors. The additional step further defines the cells expressing TP63 as further expressing one or more of KRT5, KRT14 and F3, and further provides the functional limitation that the expanded organoids comprising cells expressing TP63 are capable of clonal expansion, self-renewal and multilineage differentiation.
Claim 1 is directed to a method comprising (a) (as above).
Claim 3 is directed to a method comprising (b) (as above).
Claim 2 is identical in scope to claim 4.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mou et al (Cell Stem Cell, 2016).
Mou et al study how TGFß/BMP/SMAD signaling regulates basal stem cell behavior (See Pg 219, col. 1). In the experimental section entitled “Dual Smad Signaling Inhibition enables long-term airway stem cell expansion” (Pg 222, col. 2-Pg 225, col. 1) Mou et al report culturing human airway stem cells in various conditions for 4 days, one of said conditions being a combination of ROCK inhibitor, DMH-1, and A8301. The supplemental information (Pg 5) states the human airway stem cells are p63+/KRT5+ basal stem cells are (Pg 5 “Human airway stem cell isolation and serial expansion”). The human airway stem cells cultured in the presence of the three inhibitors showed profound cell expansion (See Pg 223, col. 1 and Fig. 4A). Fig. 4 A shows the expanded organoids contain p63+/KRT5+ cells. P63 is synonymous with TP63.
Regarding claim 3: Mou et al teaches a method wherein organoids comprising p63+ (TP63+) cells are expanded by contacting the organoids with…A8301. The p63+ cells (TP63+ cells) are also positive for KRT5. Mou et al report the expanded cells were capable of clonal expansion (See Pg 225, col. 1), which also reads on self-renewal.
In the experiment titled “Expanded airway stem cells maintain the potential to differentiate into functional airway epithelia” (Pg 225, col. 2), Mou et al report the expanded cells are also capable of multilineage differentiation.
Duplicate Claim Warning
Applicant is advised that should claim 2 be found allowable, claim 4 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims have identical scope.
Non-Statutory 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 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11649434.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim anticipates the current claims. Specifically, patented claim 1 recites a method which is narrower in scope than the current claims, as the patented claim requires both the first differentiating step and second expanding step required by the instant claims, as well as all reagents and conditions required by the instant claims.
Examiner Comment
The prior art does not teach or suggest does not teach step (a) (i.e. the method of claim 1).
In the Reasons for Allowance in the Notice of Allowability (1/6/2023) of parent patent application 16/678521, it was erroneously stated that Miller et al (Stem Cell Reports, 2018) disclosed step (i) of parent patent application (which is a narrower species of step (a) of the current claims). The Reason for Allowance stated “the embodiment [of Miller et al] wherein lung bud tip progenitor cells from fetal lungs are cultured in Matrigel in the presence of 3F medium, to [ ] generate ‘fetal progenitor organoids’” read on step (i). And later stated “Both TGFß and BMP4 are in the 3F medium of Miller et al.” These statements were inaccurate. The 3F medium of Miller et al included FGF7, CHIR99021 and retinoic acid. There was no TGFß or BMP4 in the 3F medium. While Matrigel does include some TGFß (but no BMP4), the relied upon embodiment of Miller et al does not read on step (i) of the parent application claims (nor step (a) of instant claims) because the method does not result in differentiation of the Sox2+/Sox9+ lung bud tip progenitor cells to organoids comprising cells expressing TP63. Miller et al specifically notes that no P63 (synonymous with TP63) was found in the organoids after 4 weeks of culturing the 3F conditions (See Miller et al, Pg 104, col. 2). Therefore, the conditions of Miller et al do not satisfy the limitation of the current claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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/ALLISON M FOX/Primary Examiner, Art Unit 1633
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