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 action is in response to the papers filed August 5, 2026.
Claim Amendments
Applicant’s amendment to the claims filed 08/05/2026 is acknowledged.
Claims 1-53 are pending.
Claim 28 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Claims 1-27, 29-53 are under examination.
Election/Restrictions
The following is a summary of the restriction/election requirements in the application. See, the Requirement for Restriction/Election mailed 02/09/2026.
In the reply filed 04/09/2026, Applicant elected without traverse the invention of Group 1, drawn to methods of treating diabetes by administering a dosage of islet cells.
Claim 28 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/09/2026.
Priority
The instant application 18/567,094 was filed on 12/05/2023. This application is a national stage of international application PCT/US2022/032878 filed 06/09/2022, claiming priority based on U.S. Provisional Patent Application 63/209,236 filed 06/10/2021.
Withdrawn Rejections/Objections
Rejections and/or objections from the previous Office action mailed 05/05/2026 are hereby withdrawn. The following rejections and/or objections are newly applied, necessitated by amendment. Applicant’s remarks filed 08/05/2026 have been carefully considered, but the arguments are moot or otherwise addressed by the new grounds of rejection.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-8, 25 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/005871 A1 to Casimiro et al.
Casimiro discloses methods for culturing and improving the quality of islet cells from administration to a subject in need thereof. See, e.g., Abstract; par. 4, 10-11.
The culture medium comprises gastrin. See, e.g., par. 89, 123.
The subject in need of the islet transplant is a subject having diabetes. See, e.g., par. 62-65, 145-146.
The islets are obtained from a human donor. See, par. 87.
The dosage of islet cells is less than 5,000 IEQ/kg. See, par. 147.
For these reasons, Casimiro is found to anticipate a method of treating diabetes in a subject in need thereof, said method comprising culturing human islet cells ex vivo in a medium comprising gastrin, and administering a dosage of gastrin-treated human islet cells to said subject, wherein said dosage comprises less than 9,000 IEQ/kg of islet cells, as claimed in claim 1.
Regarding dependent claims 2-5, Casimiro discloses the dosage of islet cells is less than 5,000 IEQ/kg. See, par. 147.
Regarding dependent claim 7, Casimiro discloses the islet cells are obtained from a human donor. See, par. 87.
Regarding dependent claim 8, as outlined above, Casimiro teaches obtaining islet cells from a human donor, culturing the islets in a medium containing gastrin, and administering the islets to a subject in need thereof. See, e.g., par. 4, 87, 89.
Regarding dependent claim 25, the subject has type 1 diabetes. See, par. 62-65, 145-146.
Regarding dependent claim 27, the claim recites the subject is rendered insulin-independent. Claim scope is not limited by claim language that does not limit a claim to a particular structure. See, MPEP 2111.04. In this case, the recitation that “the subject is rendered insulin-independent” indicates an intended result or functional property which naturally flows from performing the process steps positively recited in the claim and does not clearly limit the claim to a particular structure or manipulative action. A recitation of an intended result or functional property of the claimed invention must result in a structural or manipulative difference between the claimed invention and the cited prior art in order to patentably distinguish the claimed invention from the cited prior art. If the prior art structure is capable of performing the intended result, or if the functional property naturally flows from the cited prior art structure, then the cited prior art reads on the intended result or functional property recitation. There is no requirement that the cited prior art expressly teach or suggest the intended result or functional property recitation. As outlined above, the structure and manipulative actions positively recited by the claim 1 are anticipated by the cited prior art. In particular, Casimiro provides a method of treating diabetes in a subject in need thereof by the administration of gastrin-treated human islet cells at a dosage less than 9,000 IEQ/kg, as claimed in claim 1. Moreover, Casimiro acknowledges that islet transplantation is aimed at “restoring the insulin production in diabetic patients” (par. 3). Therefore, the intended result or functional property of rendering the subject insulin-independent, as recited by dependent claim 27, would have naturally flowed from the process of the prior art. Accordingly, for these reasons, the intended result or functional property recitation of claim 27 does not patentably distinguish the claimed invention from the cited prior art.
Claims 1 and 8 further recite that ex vivo treatment of islet cells with gastrin induces differentiation into insulin-expressing cells, i.e., “culturing human islet cells ex vivo in a medium comprising gastrin to induce differentiation of non-beta islet cells into insulin-expressing cells” (claim 1), and “culturing islet cells from a donor in the presence of gastrin to induce said differentiation” (claim 8).
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). See, MPEP 2112.
In this case, the limitation wherein the gastrin pretreatment induces differentiation into insulin-producing cells describes an intended result or functional property of performing the process steps (manipulative actions) positively recited in claim 1. A recitation of an intended result or functional property of the claimed process must result in a manipulative difference between the claimed process and the cited prior art in order to patentably distinguish the claimed process from the cited prior art. If the prior art process is capable of performing the intended result, or if the functional property naturally flows from the prior art process, then the prior art reads on the intended result or functional property recitation. There is no requirement that the cited prior art expressly teach or suggest the intended result or functional property recitation, but only that the subject matter is, in fact, present in the cited prior art. As outlined above, the manipulative actions positively recited by the claims are anticipated by the cited prior art. In particular, Casimiro discloses pretreating islet cells with gastrin, as claimed in claim 1. Therefore, the intended result or functional property of inducing differentiation into insulin-producing cells would have naturally flowed from performing the process steps taught by Casimiro.
Moreover, the induction of insulin-secreting cells from islet cells via gastrin treatment was an expected result prior to the effective filing date of the instantly claimed invention. As evidence, see the following prior art references:
US 2006/0234373 A1 to Rabinovitch et al. discloses that pretreating islet cells with gastrin induces differentiation into mature insulin-secreting cells. Rabinovitch further discloses a method of treating diabetes by either (i) transplanting undifferentiated islet cells combined with administration of gastrin or (ii) transplanting the pretreated, differentiated insulin-secreting cells. See, Abstract, and paragraphs 9, 23-26.
Lenz et al. (2019) “Islets from human donors with higher but not lower hemoglobin A1c levels respond to gastrin treatment in vitro” PLoS One, 14(8), e0221456, 16 pages, teaches gastrin is a peptide hormone, which in combination with other factors such as TGFα, EGF or GLP-1, is capable of increasing beta cell mass and lowering blood glucose levels in adult diabetic mice, and, in humans, administration of a bolus of gastrin alone induces insulin secretion suggesting that gastrin may target islet cells. Lenz examined the effects of gastrin alone on cultured adult human islets and found gastrin treatment resulted in increased expression of insulin, glucagon and somatostatin transcripts. Lenz concludes the data implies that gastrin may be a potential treatment for diabetic patients. See, Abstract.
Suarez-Pinzon et al. (2008) “Combination therapy with glucagon-like peptide-1 and gastrin induces β-cell neogenesis from pancreatic duct cells in human islets transplanted in immunodeficient diabetic mice” Cell transplantation, 17(6), 631-640, found that combination therapy with GLP-1 and gastrin expands the β-cell mass in human islets implanted in immunodeficient diabetic mice, largely from pancreatic duct cells associated with the islets, and this is sufficient to ameliorate hyperglycemia in the mice. See, Abstract.
Accordingly, the intended result or functional property recitations of claims 1 and 8 are not found to patentably distinguish the claimed invention from that of Casimiro.
Claim Rejections - 35 USC § 103
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.
Claims 1-27, 29-53 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/005871 A1 to Casimiro et al.; in view of Kandeel, Fouad, “Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes”, ClinicalTrials.gov Identifier: NCT03746769, record version 5, submission date: 02-Mar-2020, webpage: clinicaltrials.gov/study/NCT03746769?tab =history&a=5, printed copy: 15 pages.
Casimiro is relevant prior art for teaching methods for culturing and improving the quality of islet cells from administration to a subject in need thereof. See, e.g., Abstract; par. 4, 10-11. The culture medium comprises gastrin. See, e.g., par. 89, 123. The subject in need of the islet transplant is a subject having diabetes. See, e.g., par. 62-65, 145-146. The islets are obtained from a human donor. See, par. 87. The dosage of islet cells is less than 5,000 IEQ/kg. See, par. 147.
Accordingly, Casimiro is found to teach or fairly suggest a method of treating diabetes in a subject in need thereof, said method comprising culturing human islet cells ex vivo in a medium comprising gastrin, and administering a dosage of gastrin-treated human islet cells to said subject, wherein said dosage comprises less than 9,000 IEQ/kg of islet cells, as claimed in claim 1, and also pre-treatment of the islet cells with gastrin, as claimed in claims 29-30.
Casimiro does not teach or fairly suggest further administering a dosage of gastrin to the subject, as claimed in claims 9 and 29.
Kandeel is relevant prior art for disclosing a clinical study to evaluate the safety and effectiveness of gastrin treatment with islet transplantation in patients with type 1 diabetes. Patients are administered human allogenic islet cells and gastrin-17. See, Brief Summary on pg. 6-7.
Accordingly, Kandeel is found to teach or fairly suggest a method of treating diabetes in a subject in need thereof comprising administering a dosage of gastrin and a dosage of islet cells to said subject, as claimed in claims 9 and 29.
Kandeel further teaches that several studies have tried using gastrin to support the growth of insulin-producing islet cells in vitro or after transplantation of islet in animal models, and diabetic patients treated with gastrin and other growth factors in previous clinical trials required less insulin, suggesting that gastrin may have increased the number of cells that produce insulin. See, Study Description on pg. 6-7.
Therefore, prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of treatment taught by Casimiro by further administering a dosage of gastrin to the subject, as taught by Kandeel, with a reasonable expectation of success because Kandeel teaches the administration of gastrin for improving islet transplantation outcomes for patients with diabetes, previous laboratory experiments suggest gastrin supports the growth of insulin-producing islet cells, and diabetic patients treated with gastrin and other growth factors in previous clinical trials required less insulin, suggesting that gastrin may have increased the number of cells that produce insulin.
Claims 1, 8, 29 and 30 further recite that ex vivo treatment of islet cells with gastrin induces differentiation into insulin-expressing cells, i.e., “culturing human islet cells ex vivo in a medium comprising gastrin to induce differentiation of non-beta islet cells into insulin-expressing cells” (claim 1), “culturing islet cells from a donor in the presence of gastrin to induce said differentiation” (claim 8), “contacting donor islet cells ex vivo with gastrin to induce trans-differentiation of non-beta cells into insulin-producing cells” (claim 29), and “the islet cells are pre-treated ex vivo with gastrin to drive delta cell transformation into insulin and somatostatin cells” (claim 30).
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). See, MPEP 2112.
In this case, the limitation wherein the gastrin pretreatment induces differentiation into insulin-producing cells describes an intended result or functional property of performing the process steps (manipulative actions) positively recited in claims 1 and 29. A recitation of an intended result or functional property of the claimed process must result in a manipulative difference between the claimed process and the cited prior art in order to patentably distinguish the claimed process from the cited prior art. If the prior art process is capable of performing the intended result, or if the functional property naturally flows from the prior art process, then the prior art reads on the intended result or functional property recitation. There is no requirement that the cited prior art expressly teach or suggest the intended result or functional property recitation, but only that the subject matter is, in fact, present in the cited prior art. As outlined above, the manipulative actions positively recited by the claims would have been prima facie obvious over the cited prior art. In particular, Casimiro discloses pretreating islet cells with gastrin, as claimed in claims 1 and 29. Therefore, the intended result or functional property of inducing differentiation into insulin-producing cells would have naturally flowed from performing the process steps taught by Casimiro.
Moreover, the induction of insulin-secreting cells from islet cells via gastrin treatment was an expected result prior to the effective filing date of the instantly claimed invention. For example, Kandeel teaches that early clinical trials, wherein diabetic patients were treated with gastrin and other growth factors, suggested that gastrin may have increased the number of insulin-producing cells. See, pages 6-7, joining paragraph. As further evidence, see the following prior art references:
US 2006/0234373 A1 to Rabinovitch et al. discloses that pretreating islet cells with gastrin induces differentiation into mature insulin-secreting cells. Rabinovitch further discloses a method of treating diabetes by either (i) transplanting undifferentiated islet cells combined with administration of gastrin or (ii) transplanting the pretreated, differentiated insulin-secreting cells. See, Abstract, and paragraphs 9, 23-26.
Lenz et al. (2019) “Islets from human donors with higher but not lower hemoglobin A1c levels respond to gastrin treatment in vitro” PLoS One, 14(8), e0221456, 16 pages, teaches gastrin is a peptide hormone, which in combination with other factors such as TGFα, EGF or GLP-1, is capable of increasing beta cell mass and lowering blood glucose levels in adult diabetic mice, and, in humans, administration of a bolus of gastrin alone induces insulin secretion suggesting that gastrin may target islet cells. Lenz examined the effects of gastrin alone on cultured adult human islets and found gastrin treatment resulted in increased expression of insulin, glucagon and somatostatin transcripts. Lenz concludes the data implies that gastrin may be a potential treatment for diabetic patients. See, Abstract.
Suarez-Pinzon et al. (2008) “Combination therapy with glucagon-like peptide-1 and gastrin induces β-cell neogenesis from pancreatic duct cells in human islets transplanted in immunodeficient diabetic mice” Cell transplantation, 17(6), 631-640, found that combination therapy with GLP-1 and gastrin expands the β-cell mass in human islets implanted in immunodeficient diabetic mice, largely from pancreatic duct cells associated with the islets, and this is sufficient to ameliorate hyperglycemia in the mice. See, Abstract.
Accordingly, the intended result or functional property recitations of claims 1, 8, 29 and 30 are not found to patentably distinguish the claimed invention from the cited prior art.
For these reasons, claims 1, 8-9, 29-30 would have been prima facie obvious over the prior art.
Regarding dependent claims 2-5 and 31, Casimiro discloses the dosage of islet cells is less than 5,000 IEQ/kg. See, par. 147.
Regarding dependent claim 6, Kandeel teaches the gastrin is gastrin-17. See, Brief Summary on pg. 6-7.
Regarding dependent claim 7, Casimiro discloses the islet cells are obtained from a human donor. See, par. 87. Kandeel teaches that the human islet cells are allogeneic. See, Study Description on pg. 6-7.
Regarding dependent claim 8, as outlined above, Casimiro teaches obtaining islet cells from a human donor, culturing the islets in a medium containing gastrin, and administering the islets to a subject in need thereof. See, e.g., par. 4, 87, 89.
Regarding dependent claims 11, 13-14, 18-21, 32, 35-38, 41, 44-47, Kandeel discloses that patients receive treatment with a single islet transplant, followed by two rounds of gastrin treatment (twice daily injections for 30 days) immediately after transplantation and again 6 months later. See, Brief Summary on pg. 6-7.
Regarding dependent claims 10, 12, 15-16, 33-34, 39-40 and 42, the claims further recite the gastrin is administered prior to administration of the islet cells (claims 10 and 33); the gastrin is administered about two days after administration of the islet cells (claim 12); the gastrin is administered about two days after administration of the islet cells for two times per day for about 30 days (claim 30); the gastrin is administered at a dosage of about 15 μg/kg (claim 16); the gastrin is administered about one week, two weeks, three weeks, one month, or longer, prior to the administering of the islet cells (claim 34); the gastrin is administered about two weeks prior to administration of the islet cells, wherein the gastrin is continuously administered for two times per day, once per day, once per two days, once per three days, once per one week, or less frequent, for about one month, two months, three months, or longer (claim 39); the gastrin is administered about two days after administration of the islet cells, wherein the gastrin is continuously administered for two times per day, once per day, once per two days, once per three days, once per one week, or less frequent, for about one month, two months, three months, or longer (claim 40); and the gastrin is administered at a daily dosage of about 15 μg/kg to about 30 μg/kg, about 20 μg/kg to about 40 μg/kg, about 25 μg/kg to about 50 μg/kg, about 30 μg/kg to about 60 μg/kg, about 40 μg/kg to about 70 μg/kg, about 50 μg/kg to about 80 μg/kg, or more (claim 42).
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See, MPEP 2144.05.
In this case, the combinatorial therapeutic intervention of islet transplantation and gastrin administration for diabetes, as claimed, is taught or fairly suggested by the cited prior art references, as outlined above. There is no evidence of record for the criticality of any one of the regimens (i.e., the dosing amounts, frequency, duration and scheduling of the therapeutic interventions) recited by dependent claims 10, 12, 15-16, 33-34, 39-40 and 42. Moreover, the dosing amounts, frequency, duration and scheduling of the therapeutic interventions were known result-effective variables influencing the efficacy of treatment. Therefore, one of ordinary skill in the art would have been led to optimize the regimens for the therapeutic interventions, through routine experimentation (e.g., by animal models or clinical studies), in order to arrive at an optimal regimen for effectively achieving a desired therapeutic result.
For these reasons, absent a secondary consideration, the limitations of dependent claims 10, 12, 15-16, 33-34, 39-40 and 42 would have been prima facie obvious over the prior art.
Regarding dependent claims 17 and 43, Kandeel teaches that the gastrin is “injected under the skin” (i.e., subcutaneously). See, Arms and Interventions on pg. 9.
Regarding dependent claims 22-24, 48-50, Kandeel discloses that the outcome measures include an incidence of change or early discontinuation of sitagliptin/esomeprazole supportive therapy. See, Outcome Measures on pg. 9-10. Accordingly, the patient may be receiving sitagliptin and/or esomeprazole supportive therapy in addition to the combined gastrin and islet transplant therapy, as claimed.
Regarding dependent claims 25 and 51, Casimiro teaches the subject has type 1 diabetes. See, par. 62-65, 145-146. Kandeel discloses the patient has type 1 diabetes. See, Brief Summary on pg. 6-7.
Regarding dependent claims 26 and 52, Casimiro and Kandeel do not teach the subject has type 2 diabetes, as claimed. However, islet transplant was a known therapeutic for type 2 diabetes, prior to the effective filing date of the instantly claimed invention (Official Notice taken, if necessary). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of Casimiro and Kandeel combined by treating a subject having type 2 diabetes, as previously known in the art, with a reasonable expectation of success because islet transplantation would have been expected to benefit patients with type 2 diabetes, and one of ordinary skill in the art would have been motivated to alleviate the suffering of subjects with type 2 diabetes.
Regarding dependent claims 27 and 53, the claims recite the subject is rendered insulin-independent. Claim scope is not limited by claim language that does not limit a claim to a particular structure. See, MPEP 2111.04. In this case, the recitation that “the subject is rendered insulin-independent” indicates an intended result or functional property which naturally flows from performing the process steps positively recited in the claim and does not clearly limit the claim to a particular structure or manipulative action. A recitation of an intended result or functional property of the claimed invention must result in a structural or manipulative difference between the claimed invention and the cited prior art in order to patentably distinguish the claimed invention from the cited prior art. If the prior art structure is capable of performing the intended result, or if the functional property naturally flows from the cited prior art structure, then the cited prior art reads on the intended result or functional property recitation. There is no requirement that the cited prior art expressly teach or suggest the intended result or functional property recitation. As outlined above, the structure and manipulative actions positively recited by the claims 1 and 29 are taught or fairly suggested by the cited prior art. In particular, the prior art references provide a method of treating diabetes in a subject in need thereof by the administration of gastrin and human islet cells pre-treated with gastrin, as claimed. Moreover, Casimiro acknowledges that islet transplantation is aimed at “restoring the insulin production in diabetic patients” (par. 3), and Kandeel acknowledges that a primary outcome measure of the therapy is insulin independence (Outcome Measures on pg. 9-10). Therefore, the intended result or functional property of rendering the subject insulin-independent, as recited by dependent claims 27 and 53, would have naturally flowed from the process of the prior art. Accordingly, for these reasons, the intended result or functional property recitation of claims 27 and 53 does not patentably distinguish the claimed invention from the cited prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES J GRABER whose telephone number is (571)270-3988. The examiner can normally be reached Monday-Thursday: 9:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James D Schultz can be reached at (571)272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
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