Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 11/7/2023.
Claims 269-282 are pending.
Claims 269-282 are under examination in this Office Action.
Claim Rejections - 35 USC § 112 - 2nd paragraph
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 269-282 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims 270-282 depend directly or indirectly from claim 269.
Claim 269 provides for the use of a biobank, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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 269-282 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, an abstract idea, without significantly more. Claims 270-282 depend directly or indirectly from claim 269.
The claim 269 limitations directed to mental processes are a method for studying secretion, expression, and/or production of one or more EEC-specific proteins, wherein the method comprises detecting the secretion, expression, and/or production, respectively, of the one or more EEC-specific proteins by a biobank of human intestinal organoids, wherein the biobank comprises two or more human intestinal organoids that invention which are each established from different regions of the intestine, and wherein the human intestinal organoid comprises an inducible transcription factor for differentiating intestinal stem cells and/or intestinal cells with stem cell potential to EECs and further comprises one or more EEC-specific genes tagged at its endogenous locus with a detectable marker.
The claim 281 limitations directed to mental processes are determining whether secretion or production of one or more hormones and/or hormone precursors is affected and/or whether expression of one or more EEC-specific genes is affected.
The claim 282 limitations directed to mental processes are determining whether expression of one or more hormones, hormone precursors, and/or hormone synthesizing enzymes is affected.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites additional elements that consist of well understood, routine, conventional activity already engaged in by the scientific community.
The claim 281 limitation directed to well understood, routine, conventional activity already engaged in by the scientific community are contacting the biobank of human intestinal organoids with a compound.
The claim 282 limitation directed to well understood, routine, conventional activity already engaged in by the scientific community are contacting the biobank of human intestinal organoids.
Gerhart et al. (2019) Cell volume 176 pages 1158 to 1173 cited in the 11/07/2023 IDS (hereinafter known as "Gerhart") teaches contacting the biobank of intestinal organoids with a compound (see entire document especially Figure 1B, Table s3 and pages e3 to e6).
Claim Rejections - 35 USC § 103(a)
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103(a) 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.
5. Secondary considerations (objective evidence of nonobviousness): a) commercial success; b) long felt need; c) evidence of unexpected results; d) skepticism of experts; and e) copying.
Common Ownership of Claimed Invention Presumed
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the Examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the Examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 269-282 are rejected under 35 U.S.C. 103(a) as being unpatentable over
Gerhart et al. (2019) Cell volume 176 pages 1158 to 1173 cited in the 11/07/2023 IDS (hereinafter known as "Gerhart") in view of *Sinagoga et al. (2018) Development volume 145 pages 1 to 11 doi.10.1242/dev.165795 cited in the 11/07/2023 IDS (hereinafter known as "Sinagoga")
With regards to claims 269-282, Gerhart teaches:
a) as in claims 269-282, a method for studying secretion of one EEC-specific proteins, wherein the method comprises detecting the secretion of the one EEC-specific proteins by a biobank of intestinal organoids, wherein the biobank comprises two intestinal organoids that invention which are each established from different regions of the intestine, and wherein the intestinal organoid comprises an inducible transcription factor for differentiating intestinal stem cells with stem cell potential to EECs and further comprises one EEC-specific genes tagged at its endogenous locus with a detectable marker; wherein the one tagged EEC-specific genes are hormones; wherein the regions of the intestine are from the proximal small intestine (duodenum); wherein the biobank comprises intestinal organoids which together comprise organoids established from all of the regions of the intestinal tract; wherein the biobank comprises organoids established from the proximal small intestine; wherein the tagged hormone is CHGA; wherein the tagged hormone is CCK; wherein the hormone synthesizing enzyme tagged with a detectable marker is TPH1; wherein the hormone precursor tagged with a detectable marker is GCG; wherein the biobank comprises CHGA, MLN, GAST, GIP, CCK, GCG, GHRL, SST, NTS, and TPH1, each of which are tagged with a detectable marker; a method for screening a compound for suitability for modulating secretion of one hormone of one EEC-specific protein, wherein the method comprises: (i) contacting a biobank of intestinal organoids according to a method for studying secretion of one EEC-specific proteins, wherein the method comprises detecting the secretion of the one EEC-specific proteins by a biobank of intestinal organoids, wherein the biobank comprises two intestinal organoids that invention which are each established from different regions of the intestine, and wherein the intestinal organoid comprises an inducible transcription factor for differentiating intestinal stem cells with stem cell potential to EECs and further comprises one EEC-specific genes tagged at its endogenous locus with a detectable marker with the compound; and (ii) determining whether secretion of one hormones is affected; a method for screening a compound for suitability for modulating secretion or production of one hormones, wherein the method comprises: (i) contacting a biobank according to a method for studying secretion of one EEC-specific proteins, wherein the method comprises detecting the secretion of the one EEC-specific proteins by a biobank of intestinal organoids, wherein the biobank comprises two intestinal organoids that invention which are each established from different regions of the intestine, and wherein the intestinal organoid comprises an inducible transcription factor for differentiating intestinal stem cells with stem cell potential to EECs and further comprises one EEC-specific genes tagged at its endogenous locus with a detectable marker; and (ii) determining whether expression of one hormone is affected (see entire document especially Figure 1B, Table s3 and pages e3 to e6).
Gerhart does not explicitly teach:
a) as in claim 269, a biobank of human intestinal organoids.
With regards to claim 269, Sinagoga teaches:
a) as in claim 269, a biobank of human intestinal organoids (see entire document especially Abstract and pages 1 to 2 and 9 to 10).
One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have had a reasonable expectation of success in arriving at the Applicant's invention as claimed with the above cited references before them. One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have recognized the advantages of substituting Sinagoga's biobank of human intestinal organoids for Gerhart's biobank of mousse intestinal organoids in order to identify compounds useful for human therapeutics. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the time of the effective filing date of the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684