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 .
Priority
The instant application is a national stage entry under 35 USC 371 of PCT/US2023/029768, filed
08 August 2023. Acknowledgment is made of Applicant’s claim for benefit under 35 USC 119(e) to US Provisional Application No. 63370724, filed 08 August 2022.
Status of the Claims
Applicant’s preliminary submission filed 29 January 2026 has been entered. Claims 1-4, 6-7, 9-12, 14-18, 20-22, and 25-26 are pending. Claims 2-4, 6-7, 9-12, 14, 16-18, 20-21, and 25-26 have been amended, while claims 5, 8, 13, 20, and 23-24 have been cancelled without prejudice or disclaimer. Therefore, prosecution on the merits commences for claims 1-4, 6-7, 9-12, 14-18, 20-22, and 25-26.
Specification
The abstract of the disclosure is objected to because it contains more than 150 words and has exceeded 15 lines of text. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b)(C).
Appropriate correction is required.
Claim Objections
Claims 14 and 16 are objected to because of the following informalities:
Regarding claim 14: The instant claim is objected to for reciting a “method of making a composition…of claim 1” instead of a “method of making [[a]]the composition…of claim 1”.
Appropriate correction is required.
Regarding claim 16: The instant claim is objected to for reciting “biotin-loaded scaffold” in Lines 1-2 and 6-7 instead of “biotin-loaded PLG scaffold”, as is otherwise utilized throughout the claim language.
Appropriate correction is required.
Claim Interpretation
Instant claims 2-3 are directed to products which utilize product-by-process language. The
limitations of the process of production are considered only in so far as the process of production
imparts distinct structural or chemical characteristics or properties to the claimed product. Therefore, if
the product, as claimed, is the same or obvious over a product of the prior art (i.e. is not structurally or
chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art
product is made by a different process. See MPEP § 2113.
More specifically, claims 2-3 further define the cell type from which the immature β-cells are derived. When defining the source of cells, the source of the cells is only considered in as far as the source defines the cell as having distinct biochemical or morphological characteristics. In the instant case, the source of the immature β-cells does not impart a distinction to the cells, but rather their physical and structural characteristics dictates their classification as a particular cell type.
Therefore, the claims will be interpreted as if immature β-cells derived from any source fulfills the limitations detailed in the instant claims.
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 17-18, 21-22, and 25-26 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 17: The instant claim recites the limitation "the plate" in Line 4. There is insufficient antecedent basis for this limitation in the claim, as there is no prior recitation of a plate within the instant claim or parent claims 14 and 16.
Instant claim 18 is included in the rejection because it is dependent upon instant claim 17 and fails to correct the deficiencies of the parent claim.
Appropriate correction is required.
Regarding claim 21: The instant claim recites the limitation “a composition comprising a FasL-loaded PLG scaffold of claim 1” in Lines 2-3 (emphasis added). The scope of the claim is indefinite, as it is unclear if the claim is requiring just the FasL-loaded PLG scaffold comprised within the composition of claim 1, or is including the entire composition of claim 1 – which comprises the FasL-loaded PLG scaffold and immature β-cells. Therefore, the ordinary artisan cannot readily determine the metes and bounds of the claim, thus rendering the claim indefinite.
Instant claims 22 and 25-26 are included in the rejection because they are dependent upon instant claim 21 and fail to correct the deficiencies of the parent claim.
Appropriate correction is required.
For purposes of compact prosecution, instant claim 21 will be interpreted as requiring the entire composition of claim 1 comprising the FasL-loaded PLG scaffold and immature β-cells.
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 (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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-7, 9-12, 14-18, 20-22, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Shea et al (US 2021/0228774 A1) in view of Skoumal et al (Biomaterials, 2019, of record on IDS filed 10 March 2026).
Shea et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2), with a publication date of 29 July 2021. It is of note that this is greater than one year prior to the effective filing date of the instant invention. Skoumal et al is considered prior art under 35 USC 102(a)(1).
Regarding claim 1: Shea et al disclose an in vitro method of preparing insulin-producing cell clusters for transplantation into a subject (Abstract).
As such, Shea et al disclose a poly(lactide-co-glycolide) (PLG) scaffold comprising immature β-cells (Paragraphs [0010], [0014]-[0015], [0019], [0030], [0039], [0056]-[0058], [0061]-[0064], [0068], [0070], [0087]-[0088]). Shea et al further disclose that the PLG scaffolds can also comprise mature islet β-cells, wherein the mature β-cells are either directly seeded on the PLG scaffolds or the immature β-cells are allowed to differentiate into mature β-cells (Paragraphs [0032], [0041], [0061], [0063], [0067]).
Shea et al further disclose a composition comprising the PLG scaffold and immature β-cells (Paragraphs [0012], [0018], [0042]-[0045]).
Shea et al do not disclose that the PLG scaffold is loaded with FasL, as required by instant claim 1.
Skoumal et al, however, disclose the generation of FasL-loaded PLG scaffolds (Abstract; Pages 3-4). Skoumal et al further disclose that the FasL-loaded PLG scaffolds are seeded with either naïve or mature islet cells (Pages 5-9).
Therefore, it would have been prima facie obvious to have modified the PLG scaffold of Shea et al such that the FasL is loaded onto the PLG scaffold, as detailed in Skoumal et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to add FasL to the PLG scaffold, as it allows for the long-term survival of the FasL-loaded PLG scaffolds within a subject in need thereof with normoglycemia established within days of transplantation (Skoumal et al: Pages 8-9), and would have had a reasonable expectation of success given that the disclosures of both Shea et al and Skoumal et al are concerned with the generation of PLG scaffolds for the culture of β-cells. See MPEP § 2143(I)(G).
Consequently, Shea et al as modified by Skoumal et al render obvious a composition comprising a FasL-loaded PLG scaffold and immature β-cells. This therefore renders obvious the composition of the instant claim.
Regarding claims 2-3: The instant claims are a product-by-process limitation further describing the source of the immature β-cells. See Claim Interpretation section above. Accordingly, the source of the cells does not change the cells, per se. Therefore, the instant claims are rejected for the same reason as instant claim 1.
However, it is of note that Shea et al further disclose that the immature β-cells are derived from human induced pluripotent stem cells – which reads on each of instant claims 2-3 (Paragraphs [0009]-[0010], [0024], [0063], [0087]).
Regarding claims 4, 6-7, and 9: Following the discussion of claim 1, Shea et al further disclose that the PLG scaffold has a diameter of 5 mm or about 35 mm (claim 7) (Paragraphs [0040], [0070]).
Shea et al further disclose that the PLG scaffold has a height of 2 mm (claim 9) (Paragraphs [0014], [0070]).
Shea et al further disclose that the immature β-cells are seeded a final density of about 225 million per cm3 (Paragraph [0021]).
Accordingly, in the embodiment wherein the scaffold comprises a diameter of 35 mm and height of 2 mm, the PLG scaffold comprises about 430 million immature β-cells (claim 6). As this is greater than six million cells, this therefore reads on the composition of instant claim 4. See MPEP § 2131.03.
Regarding claim 10: Following the discussion of claim 1, Shea et al further disclose that the PLG scaffold has a pore size of 250-425 μm (Paragraphs [0014], [0030], [0039], [0064], [0071]). This therefore reads on the composition of the instant claim. See MPEP § 2131.03.
Regarding claim 11: Following the discussion of claim 1, Skoumal et al further disclose that 0.5 μg or 2.5 μg FasL is comprised within the PLG scaffold (Page 5, Islet isolation and engineering with SA-FasL protein). This therefore renders obvious the composition of the instant claim for the same reasons as discussed in the rejection of claim 1. See MPEP § 2131.03.
Regarding claim 12: Following the discussion of claim 1, Shea et al further disclose that the composition can comprise multiple PLG scaffolds (Paragraph [0052]). This therefore reads on the composition of the instant claim.
Regarding claim 14: Following the discussion of claim 1, Skoumal et al further disclose that the FasL-loaded PLG scaffold is made by a method comprising: a) loading PLG with biotin; b) making a biotin-loaded PLG scaffold from the biotin-loaded PLG; c) conjugating streptavidin-FasL to the biotin on the biotin-loaded PLG scaffold to form a FasL-loaded PLG scaffold; and d) seeding the FasL-loaded PLG scaffold with cells (Pages 3-6). This therefore renders obvious the method of the instant claim for the same reasons as discussed in the rejection of instant claim 1.
Regarding claim 15: Following the discussion of claim 14, Skoumal et al further disclose that loading the PLG with biotin comprises activating the carboxyl end group of PLG with EDC followed by NHS and then adding amine-PEG2-biotin (Page 4, Biotinylation of PLG and characterization). This therefore renders obvious the method of the instant claim for the same reasons as discussed in the rejection of instant claim 1.
Regarding claim 16: Following the discussion of claim 14, Skoumal et al further disclose that making the biotin-loaded scaffold from the biotin-loaded PLG comprises: a) combining the biotin-loaded PLG with unmodified PLG at a mass ratio of 3:1 and forming biotin-loaded PLG particles; b) mixing the biotin-loaded PLG particles with NaCl at a mass ratio of 1:30 and pressing the mixture into a 5 mm KBr die to form the biotin-loaded scaffold; and c) disinfecting the biotin-loaded scaffold by soaking it in 70% ethanol (Page 4, Particle and scaffold fabrication). This therefore renders obvious the method of the instant claim for the same reasons as discussed in the rejection of instant claim 1.
Regarding claim 17: Following the discussion of claim 16, Skoumal et al further disclose that conjugating streptavidin-FasL to the biotin on the biotin-loaded PLG scaffold comprises adding 0.5 μg or 2.5 μg streptavidin-FasL diluted in PBS to the biotin-loaded PLG scaffold and incubating it at 20°C for 30 minutes while rotating and shaking the plate every 10 minutes (Page 5, Islet isolation and engineering with SA-FasL protein). This therefore renders obvious the method of the instant claim for the same reasons as discussed in the rejection of instant claim 1. See MPEP § 2131.03.
Regarding claim 18: Following the discussion of claim 17, Shea et al further disclose that the immature β-cells are seeded a final density of about 50 million per cm3 in a volume of 30 μL, wherein the cells are seeded on both faces of the PLG scaffold (Paragraphs [0021]-[0023]).
Accordingly, in the embodiment wherein the scaffold comprises a diameter of 5 mm and height of 2 mm (Paragraph [0070]), the seeding density of the cells is about 2 million cells per 30 μL, with about 1 million cells per side of the scaffold. This therefore reads on the method of the instant claim. See MPEP § 2131.03.
Regarding claim 20: Following the discussion of claim 14, Shea et al further disclose that the immature β-cells are derived from human induced pluripotent stem cells (Paragraphs [0009]-[0010], [0024], [0063], [0087]). This therefore reads on the method of the instant claim.
Regarding claim 21: Following the discussion of claim 1, Shea et al further disclose that the composition can be administered to a subject suffering from type 1 diabetes, wherein the PLG scaffold is transplanted into the subject (Paragraphs [0010], [0013], [0051]-[0053], [0056], [0060], [0062]). This therefore renders obvious the method of the instant claim for the same reasons as discussed in the rejection of instant claim 1.
Regarding claim 22: Following the discussion of claim 21, Shea et al further disclose that the PLG scaffold is transplanted into the subject’s peritoneal fat (Paragraphs [0062]-[0063]). This therefore reads on the method of the instant claim.
Regarding claim 25: Following the discussion of claim 21, Shea et al further disclose that the subject is a human (Paragraph [0043]). This therefore reads on the method of the instant claim.
Regarding claim 26: Following the discussion of claim 21, Shea et al further disclose that the immature β-cells are derived from human induced pluripotent stem cells (Paragraphs [0006], [0009]-[0010], [0024], [0056]-[0057], [0063], [0087]). This therefore reads on the method of the instant claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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/ALYSSA G WESTON/Examiner, Art Unit 1633
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