DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-17 are objected to because of the following informalities:
Applicant strongly advised to use clear and consistent language throughout the claims.
In regards to claim 1, the term “the device” in line 6 should be changed to “the modular implantable device”. Claims 2-15 are objected to by virtue of depending on an objected claim. A similar correction should also be made in claim 2, lns 2-3.
In regards to claim 3, the term “the cell module” in lines 1-2 should be changed to “the at least one cell module”.
In regards to claim 9, the term “the oxygen module” in lines 1-2 should be changed to “the at least one oxygen module”.
In regards to claim 10, the term “the immune-isolating membrane” in lines 1-2 should be changed to “the at least one immune-isolating membrane”.
In regards to claim 14, the term “the oxygen module” in lines 1-2 and line 3 should be changed to “the at least one oxygen module”.
In regards to claim 15, the term “the cell module” in lines 1-2 should be changed to “the at least one cell module”.
In regards to claim 16, the term “the cell module” in line 5 should be changed to “the at least one cell module”. Claim 17 is objected to by virtue of depending on an objected claim.
In regards to claim 16, the term “the device” in line 8 should be changed to “the modular implantable device”. A similar correction should also be made in claim 17, ln 3.
Appropriate correction is required.
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 2-10, 13-17 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.
Applicant is strongly advised to carefully review claims and utilize clear and consistent terminology throughout the claims.
Claim 2, ln 1 recites “a cell module”. However, claim 1 already recites “at least one cell module”. It is unclear whether “a cell module” in claim 2, ln 1 is and additional cell module or part of the “at least one cell module” recited in claim 1. For purposes of examination, the phrase has been interpreted to mean “wherein the at least one cell module is arranged in…”
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “… comprises a cell arrangement”, and the claim also recites “in particular a microwell array, preferably a microwell hydrogel array” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Applicant is strongly advised to review all claims and remove all claim recitations that recite “in particular” and/or “preferably”.
The same issue is present via recitations of “in particular” and/or “preferably” in claims 4, 5, 6, 7, 8, 9, 10, 11, 13, 15, and 16 are hereby rejected for the same reasons. Claim 17 is rejected by virtue of depending on a rejected base claim.
Claim 6 recites the limitation "the hydrogel" in 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 6 depends on claim 1 which does not recite a hydrogel. A hydrogel is recited in claim 3. Thus, it is unclear what the appropriate claim dependency should be. For purposes of this examination, claim 6 has been interpreted to depend on claim 3.
Claim 7 recites the limitation "the microwell" in ln 2. There is insufficient antecedent basis for this limitation in the claim. Claim 7 depends on claim 3 which recites “a microwell array” and “a microwell hydrogel array”. Thus, it is unclear what the applicant is attempting to reference those arrays or recite a new microwell in claim 7. For purposes of this examination, “the microwell” in claim 7, ln 2 has been interpreted to be “the microwell hydrogel array”.
Claim 8 recites the limitation "the oxygen-releasing material" in ln 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 8 depends on claim 3 which does not recite an oxygen-releasing material. Claim 5 recites an oxygen-releasing material. Thus, it is unclear what the intended claim dependency is for claim 8. For purposes of this examination, claim 8 has been interpreted to depend on claim 5.
Claim 13 recites the limitation "the wells of the microarray" in lns 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 13 depends on claim 1, which does not recite wells or a microarray. Claim 3 recites a microwell array, but not wells. Thus, it is unclear what the applicant is attempting to recite and what the proper claim dependency is for claim 13. For purposes of this examination, claim 13 has been interpreted to depend on claim 3 and mean “wherein the microwell array comprises a plurality of wells, each well having a width…”.
Claim 14 recites the limitation "the bracket" in ln 3. There is insufficient antecedent basis for this limitation in the claim. Claim 14 recites “two brackets” in ln 2. Claim 14 depends on claim 1 which recites “at least one bracket”. Thus, it is unclear whether “the bracket” is intended to be “the two brackets” or “the at least one bracket”. For purposes of this examination, claim 14 has been interpreted to mean “wherein the at least one bracket comprises two brackets, wherein the at least one oxygen module is arranged between the two brackets … in a shell formed by the two brackets and …”
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(s) 1-6, 10-12, 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barkai et al (NPL: “Survival of encapsulated islets: More than a membrane story” (2016)).
Regarding claim 1, Barkai et al discloses a modular implantable device for the macroencapsulation of cells (e.g. Fig 7a-d, Fig 9a-f, and Fig 12a-b), comprising: at least one bracket (peri-selective membrane, e.g. Fig 7b; see ¶118 of applicant’s PGPUB US 2025/00064574 A1 defining “bracket” as a structure that is configured to fix or support an object. Here, in Barkai et al, the islets are fixed or supported between the peri-selective membrane and the silicone membrane. So the peri-selective membrane is “a bracket” as claimed under the broadest reasonable interpretation. Additionally, ¶118 states the at least one bracket can be part of a membrane module) configured for accommodating at least one cell module (e.g. islets) within the modular implantable device (Fig 7b), at least one oxygen module (see oxygen module, Fig 7b), and at least one immuno-isolating membrane (peri-selective membrane, Fig 7b; see discussion above regarding how the definition provided by applicant in ¶118 provides that the at least one bracket can be part of a membrane module. Thus, the peri-selective membrane in Fig 7b can be both the bracket, e.g. because it fixes or supports the islets, and the immune-isolating membrane), wherein the at least one oxygen module (oxygen module; Fig 7b) is contained within the modular implantable device in a shell formed by the at least one bracket and the at least one immuno-isolating membrane (Fig 7b), optionally together with the at least one cell module (Fig 7b).
Regarding claim 2, Barkai et al discloses wherein the at least one cell module (e.g. islets; Fig 7b) is arranged in the at least one bracket configured for accommodating at least one cell module in the device (Fig 7b).
Regarding claim 3, Barkai et al discloses wherein the cell module (e.g. islets) comprises a hydrogel (e.g. islet modules are planar, 600 micrometer thick, alginate hydrogel encapsulating donor islets; see pg 79, col 1, ¶2) or a solid carrier comprising a cell arrangement pattern, in particular a microwell array, preferably a microwell hydrogel array.
Regarding claim 4, Barkai et al discloses wherein the hydrogel or solid carrier further comprises at least one bioactive compound (e.g. alginates; see pg 79, col 1, ¶2 and pg 82, col 2, “alginates were critical in activating mechanotransduction”), preferably at least one bioactive compound effecting survival, functionality and/or maturation of cells.
Regarding claim 5, Barkai et al discloses wherein the at least one oxygen module (e.g. Fig 7b) is configured to release oxygen in the shell (e.g. pg 77, col 2, ¶2; oxygen added to oxygen module via connection to oxygen port and connected access ports), in particular comprises an oxygen-releasing material.
Regarding claim 6, Barkai et al discloses wherein the hydrogel is alginate (alginate hydrogel; see pg 79, col 1, ¶2).
Regarding claim 10-11, Barkai et al discloses wherein the immuno-isolating membrane is a composite membrane comprising a meso- or macroporous membrane (see pg 74, col 2, ¶3 disclosing the peri-selective membrane in Fig 7b is a hydrophilized PTFE membrane with a pore size of 0.45 micrometers which is 450 nanometers which makes it a meso- or microporous membrane as defined by applicant in ¶76 of the PGPUB), preferably expanded polytetrafluoroethylene (ePTFE), and a GAG-based hydrogel or a synthetic highly sulfated or sulfonated hydrogel. Regarding claim 11, see 112 discussions above regarding claim 10 and the use of “preferably” and note the recited limitation further defines the GAG-based hydrogel and due to the 112 issues it is not clear whether this limitation is required for the claim.
Regarding claim 12, Barkai et al discloses wherein the at least one bracket (e.g. the per-selective membrane in Fig 7b, see discussion above) is PTFE (see pg 74, col 2, ¶3 disclosing the peri-selective membrane in Fig 7b is a hydrophilized PTFE membrane).
Regarding claim 14, Barkai et al discloses wherein the at least one bracket comprises two brackets (see annotated Fig 7b); wherein the oxygen module is arranged between the two brackets configured for accommodating at least one cell module (see annotated Fig 7b), and wherein the oxygen module is contained in a shell formed by the two brackets and at least one immuno-isolating membrane (see annotated Fig 7b and discussion above in claim 1).
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Regarding claim 15, Barkai et al discloses wherein the at least one cell module comprises islets cells (e.g. Fig 7b; see 112 discussion above).
Regarding claim 16, Barkai et al discloses a method of preparing a modular implantable device (e.g. Fig 7a-d, Fig 9a-f, and Fig 12a-b), comprising: a) providing at least one bracket configured for accommodating at least one cell module within the device (Fig 7b; peri-selective membrane accommodates islet cells, see additional discussion above in claim 1), at least one oxygen module (e.g. oxygen module; Fig 7b), at least one cell module (e.g. islets; Fig 7b) and at least one immuno-isolating membrane (e.g. peri-selective membrane, Fig 7b; see additional discussion above in claim 1), b) loading the at least one cell module (e.g. islet modules are planar, 600 micrometer thick, alginate hydrogel encapsulating donor islets; see pg 79, col 1, ¶2; Fig 7b), in particular a hydrogel or a solid carrier, preferably a cell arrangement pattern, with cells, preferably isolated endocrine cells, c) assembling the modular implantable device by arranging the at least one oxygen module and the at least one cell module within the modular implantable device in a shell formed by the at least one bracket and the at least one immuno-isolating membrane (e.g. Fig 7b).
Regarding claim 17, Barkai et al discloses wherein the at least one oxygen module is contained within the modular implantable device in a shell formed by the at least one bracket and the at least one immuno-isolating membrane together with the at least one cell module (e.g. Fig 7b).
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.
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.
Claim(s) 7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barkai et al, as applied to claim 3 above (see 112 discussion above), in view of Brauker et al (5807406). Barkai et al discloses the invention substantially as claimed except for expressly disclosing wherein the cell arrangement pattern, in particular the microwell array and/or the microwell, has a hexagonal geometry and the specific width and spacing of the wells.
Brauker teaches that it is known to have an immuno-isolation implant (Fig 1-2) for islet cells (col 4, lns 25-31) a hexagonal cell arrangement pattern (e.g. Fig 2, 3a, 3b; col 6, lns 61-65), in particular the microwell array and/or the microwell, has a hexagonal geometry (e.g. Fig 2, 3a, 3b; col 6, lns 61-65) with a width of, e.g. 50 micrometers (Fig 4) and a spacing of at least 5 micrometers (col 5, lns 40-46; where a 5 micrometer strand size provides at least a 5 micrometer spacing between the wells) for the purpose of providing a porous polymer membrane structure with chemical inertness and robust mechanical properties suitable for implantation in host tissue (col 2, lns 49-54). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cell module as taught by Barkai with the hexagonal cell arrangement pattern and sizes as taught by Brauker et al for the purpose of providing a porous polymer membrane structure with chemical inertness and robust mechanical properties suitable for implantation in host tissue (col 2, lns 49-54).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barkai et al, as applied to claim 5 above (see 112 discussion above), in view of Stabler et al (8986725). Barkai et al discloses the invention substantially as claimed except for expressly disclosing wherein the oxygen-releasing material is a peroxide, in particular a peroxide selected from the group consisting of calcium peroxide, magnesium peroxide, sodium peroxide, potassium peroxide, lithium peroxide, benzoylperoxide, hydrogen peroxide, and combinations thereof, and wherein the oxygen-releasing material of the oxygen module is embedded in a carrier material, preferably a hydrophobic polymer, in particular silicone, preferably polydimethylsiloxane (PDMS). Note, see 112 discussions above.
Stabler et al teaches that it is known to have a composite for extended release of oxygen comprising an oxygen-releasing material being a peroxide (e.g. col 1, lns 50-62) embedded in a silicone carrier material (e.g. col 1, lns 50-62) for the purpose of providing controlled release of oxygen to cells when exposed to biological fluids (e.g. col 1, lns 16-20; col 2, lns 65-col 3, ln 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modify the at least one oxygen module as taught by Barkai with the peroxide oxygen-releasing material embedded in a silicone carrier material as taught by Stabler et al for the purpose of providing controlled release of oxygen to cells when exposed to biological fluids (e.g. col 1, lns 16-20; col 2, lns 65-col 3, ln 3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form. Specifically:
Implantable encapsulation devices: 12310719, 20240352392, 20240342343, 20240293308, 12059682, 20220233299, 20220143374, 20210170072, 20170239391, 20150112247, 20100150984, and 20100121446.
To expedite prosecution in the event the applicant has any questions or proposed claim amendments to discuss the applicant is invited to contact the examiner at the telephone number listed below.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew M. Gilbert whose telephone number is (571)272-7216. The examiner can normally be reached 9:00 am - 5:30 pm (EST), Monday - Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4726. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW M GILBERT/Primary Examiner, Art Unit 3700
Prosecution Insights