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 1-10 in the reply filed on 12/15/2025 is acknowledged.
Claims 11-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/15/2025.
Claims 1-10 are examined in the instant application.
Claim Objections
Claim 2 is objected to because of the following informalities: claim 2 depends from claim 1 and recites the limitation “said modified cell” in line 2. While there is only one modified cell in claim 1, i.e. a modified pancreatic islet cell, claim 2 should be amended to recite “said modified pancreatic islet cell” to be consistent with the language in claim 1. Appropriate correction is required.
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 5-7, 9 and 10 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 modified pancreatic islet cell.
Teachings in the Art
Regarding claim 5, the art teaches that human pancreatic β cells (a species of islet cell) have a natural decrease in CD47 expression in Type I diabetics who are >13 years old, aka T1DE2 (see Lesli et al., 2021, Diabet. Med., Vol. 38:e14724, pgs. 1-15). specifically, pg. 5 parag. 6 and Fig. 3A).
Regarding claims 6 and 7, Leslie teaches that that the pancreatic β cells isolated from T1DE2 patients had lower CD47 levels as compared to controls (Fig. 3A).
Regarding claims 9 and 10, that the CD47 expression occurs ex vivo or in vitro and that the reduction is mediated by gene silencing, an antisense oligonucleotide or a CD47 blocking antibody does not markedly change the claimed pancreatic islet beta cell that would distinguish it from the naturally occurring pancreatic islet beta cell taught in Leslie.
With respect to claim 8, it should be noted that Leslie did not observe an increase in insulin expression and/or secretion in cells that also had reduced CD47 expression, but rather a decrease in insulin expression as compared to controls (see Fig. 3A, 1st column). This is in contrast to the teachings in Example 3 of the specification, taught below.
Teachings in the Specification
Regarding the term “modified”, the specification provides no limiting definition of what is encompassed by a “modified” pancreatic islet cell or how a modified pancreatic islet cell would be distinguished from a non-modified pancreatic islet cell.
The specification teaches contacting isolated human and mouse pancreatic β cells (from cadavers) with either an siRNA or an antisense morpholino oligonucleotide to reduce CD47 expression (see Example 2 starting on pg. 22).
The specification continues to teach in Example 3 the contacting of siRNA targeted to CD47 in mouse pancreatic β cells or an antisense oligonucleotide targeted to CD47 in human pancreatic β cells resulted in a significant increase in insulin expression and that, surprisingly, this increase in insulin was with or without glucose stimulation (see parags. 98-99 and Fig. 3A-D). In this regard, only claim 8 recites a function that would not be naturally occurring.
However, the pancreatic islet cells of claims 5-7, 9 and 10 were not subjected to any modification that would markedly distinguish them from their natural occurring counterparts. While the claimed pancreatic cells were contacted with siRNA and an antisense oligonucleotide, the pancreatic islet cells of claims 5-7, 9 and 10 recite no structural or functional feature that would distinguish the claimed pancreatic islet cells from those that occur in nature.
Accordingly, the claims are directed to a composition using only a nature-based product, i.e., pancreatic islet cells, 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 pancreatic islet cells which are identical (no difference in characteristics) to naturally occurring pancreatic islet cells in Type I diabetics that are 13> years old.
Because there is no difference between the pancreatic islet cells used in the claimed composition, the claimed pancreatic islet cells 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 cardiomyocytes and PSCs 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 pancreatic islet cells.
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. for use in pancreatic islet cell transplantation-claim 7). In this case only pancreatic islet cells 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 pancreatic islet cells, there are no additional components which impart any additional element or structural limitations to the recited cells. The pancreatic islet cells of the claims are indistinguishable from pancreatic islet cells that exist in nature in a Type I diabetic subject who is 13> years old. The pancreatic islet cells of the claims have the same capability as those that exist in nature and the fact that they are present in an isolated population or produced by a specific method does not change the pancreatic islet cells 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. a pancreatic islet cell.
How the pancreatic islet cells are obtained and the knowledge of using pancreatic islet cells 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 § 112
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 3, 4 and 7-10 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.
Regarding claim 3, the phrase "preferably” 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).
Claim 4 is unclear. Claim 4 recites that the method of claim 1 is performed in vivo. However, the first step in claim 1 is providing an isolated pancreatic islet cell and then reducing CD47 gene expression to produce a modified pancreatic islet cell. Thus, it is not clear how the method of claim 1 can be performed in vivo if the staring material, i.e. a pancreatic islet cell is first required to be isolated before any modification can occur.
Claim 7 is unclear. Claim 7 is comparing a genus, “modified pancreatic islet cells” to a species, “unmodified pancreatic islet beta cells” with respect to CD47 expression. However, it is unclear which species of pancreatic islet cells are being compared to the unmodified pancreatic beta cells. It is well established the art that there are five species of islet cells, α, β, Δ, ε and PP and it is not clear if claim 7 is comparing all five species of pancreatic islet cell to an unmodified pancreatic islet beta cell or just a single species, i.e. a modified pancreatic islet beta cell.
Claim 8 is unclear. Claim 8 is comparing a species “modified pancreatic islet beta cells”, to a genus, “unmodified pancreatic islet cell” with respect to insulin expression. However, it is unclear which species of unmodified pancreatic islet cells are being compared to the modified pancreatic beta cells. It is well established the art that there are five species of islet cells, α, β, Δ, ε and PP and it is not clear if claim 8 is comparing all five species of pancreatic islet cell to an modified pancreatic islet beta cell or just a single species, i.e. an unmodified pancreatic islet beta cell.
Claim 8 recites the limitation "the modified pancreatic islet beta cell" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 6 only recites the limitation “unmodified pancreatic islet beta cell” in line 4.
Claim 9 recites the limitation "the modified pancreatic islet beta cell" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the modified pancreatic islet beta cell" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 10, the phrase "preferably” 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).
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Isenberg et al. (WO 2008/060785 A2) and further evidenced by the teachings of Ghimire et al. (2023, Science Transl. Med., Vol. 15, pgs. 1-14).
Claim Interpretation: regarding the limitation “pancreatic islet cell”, the teachings of Isenberg do not explicitly recite the term “islet” but rather endocrine cells of the pancreas (pg. 67 line 19). However, all five species of islet cells in the pancreas are endocrine and therefore it is interpreted that the endocrine cells of the pancreas taught by Isenberg would be the same as the instantly claimed pancreatic islet cells.
Regarding claims 1 and 5, Isenberg et al. teach a method of preparing a transplantable pancreatic islet cell by contacting a pancreatic endocrine cell with a CD47 blocking antibody (pg. 57 lines 1-7, pg. 66 line 19 bridge pg. 67 line 24, pg. 95 lines 4-7).
Regarding claims 2, 3, 8 and 10, Isenberg teaches that their claimed method can be practiced by using a morpholino (an antisense oligonucleotide) against CD47 (pg. 127 lines 15-19 and pg. 135 lines 30-35).
Regarding the functional limitation of increased insulin expression in claims 2 and 8, while Isenberg did not assess insulin expression levels, this would be inherent to the method of Isenberg. For example, Ghimire et al. teach that when pancreatic β cells were contacted with a morpholino targeting CD47 this led to a significant increase in insulin expression in pancreatic β cells (pg. 3 col. 1 parag. 3 bridge col. 2 parag. 1). Thus, since both Isenberg and Ghimire are using a morpholino to target CD47 and down-regulate CD47 expression, it would be inherent that the pancreatic islet cells of Isenberg would also exhibit an increase in insulin expression.
Regarding claims 4 and 9, Isenberg teaches that their method can be practiced in vitro (pg. 135 lines 6-17).
Regarding claim 6 and 7, Isenberg teaches that treated cells had reduced CD47 expression as compared to controls (pg. 135 line 29 bridge pg. 136 line 1).
Thus the teachings of Isenberg clearly anticipate the invention of claims 1-10.
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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