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 .
Response to Amendment
The Amendment filed 12/3/2025 has been entered. Claims 1-18, 21 and 22 remain pending in the application. Applicant’s amendments to the Specification, Drawings and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 9/10/2025.
The specification was received on 12/3/2025. This specification is acceptable.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
414 in paragraph 0091. Examiner further notes that even though applicant has submitted drawings on 12/3/2025 to include element 414, no drawings were received on 12/3/2025.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 6, 8 and 22 are objected to because of the following informalities:
Regarding claim 1, line 15, the limitation “second membrane being” (appearing in second instance) appears to be amended to recite “the second membrane being” in order to refer to “a second membrane” recited in claim 1, line 15.
Regarding claim 6, lines 2 and 5, the recitation “chamber” appears to be amended to recite “the chamber” in order to refer to “a chamber” recited in claim 1, line 11.
Regarding claim 8, line 16, the limitation “second membrane being” (appearing in second instance) appears to be amended to recite “the second membrane being” in order to refer to “a second membrane” recited in claim 1, line 16.
Regarding claim 22, line 1, the recitation “chamber” appears to be amended to recite “the chamber” in order to refer to “a chamber” recited in claim 1, line 11.
Appropriate correction is required.
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.
Claim(s) 1, 7, 9 and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tempelman et al. (US 2019/0336267 A1) in view of Rotem et al. (US 8,444,630 B2).
Regarding claim 1, Tempelman discloses a device 100 (figure 1) for implantation in a subject, the device 100 comprising:
an electrochemical cell 400, configured to produce oxygen gas from water when a voltage is applied across the electrochemical cell (paragraph 0121, lines 4-8, paragraph 0124, lines 1-3), the electrochemical cell comprising:
a cathode 447;
an anode 445; and
a first membrane 446 (paragraph 0122, “H+” ions are passing) disposed between the cathode 447 and the anode 445, the first membrane 446 configured to permit passage of cations therebetween;
a circuit (420, 442-2 and any other wires/components inside element 400 that enables the power transmission, paragraph 0125) electrically coupled to the electrochemical cell 400 and configured to provide power to the electrochemical cell 400, the circuit configured to receive power wirelessly from a remote device (paragraph 0125, “larger energy compartment outside the body”, “external power source coupled to a magnetic coil located outside the body”);
a chamber 102 (figure 1) coupled to the electrochemical cell 400 to receive at least a portion of the oxygen gas produced by the electrochemical cell 400; and
a reservoir 601 (figure 7a, paragraph 0111, lines 2-8, “first internal cell compartment”) configured to hold a set of biological entities, the reservoir configured to receive oxygen gas from the chamber for consumption by the set of biological entities, a second membrane 608 forming a portion of the reservoir, second membrane 608 (paragraph 0135, lines 1-7) being permeable to one or more substances generated by the set of biological entities for delivery of the one or more substances to the subject via the second membrane.
Tempelman is silent regarding wherein the electrochemical cell, the chamber, and the reservoir are disposed together within a housing.
However, Rotem teaches a design of a device 20 (figure 1) for implantation in a subject wherein oxygen supply 24, the chamber (see “C” in figure 1 below) and the reservoir (hollow portion inside “C” in figure 1 below containing elements 30 and 28) are disposed together in a housing 22 (figure 1) for the purpose of using a well-known alternative approach to arrange the different components of the device into a single housing (column 4, lines 30-33).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of Tempelman to incorporate wherein the electrochemical cell, the chamber, and the reservoir are disposed together within a housing as taught by Rotem for the purpose of using a well-known alternative approach to arrange the different components of the device into a single housing (column 4, lines 30-33).
Furthermore, Tempelman discloses the use of electrochemical cell to supply oxygen and Rotem does disclose to include an oxygen generator that electrolyzes water to oxygen and hydrogen (column 4, lines 44-48). Therefore, Tempelman modified in Rotem will result in having wherein the electrochemical cell, the chamber, and the reservoir are disposed together within a housing.
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Regarding claim 7, Tempelman discloses further comprising a coating disposed on at least the second membrane, the coating including an anti-fibrotic substance (paragraph 0162, “macro-encapsulation membrane”).
Regarding claim 9, Tempelman discloses wherein the second membrane 608 (paragraph 0135, lines 1-7) is further permeable to oxygen and nutrients.
Regarding claim 12, Tempelman discloses wherein the chamber comprises at least one port to provide fluid communication between a fluid within the chamber and a biological fluid of the subject (paragraph 0135, lines 3-7, “allows liquids and gases”).
Regarding claim 13, Tempelman discloses wherein the chamber comprises liquid water disposed therein (paragraph 0111, a selective permeable membrane which allows gases and liquid to pass through but not cells, so some liquid water will end up disposed therein) and the chamber is sealed to prevent fluid communication with fluids outside the chamber (paragraph 0111, “gas impermeable polymer or plastic”).
Regarding claim 14, Temelman discloses wherein the device does not comprise a battery or an external oxygen supply (paragraph 0106, lines 13-24, when using electrical wiring or magnetic coil, battery is not required).
Regarding claim 15, Temelman discloses wherein the chamber is configured to maintain an oxygen partial pressure of about 30 kilopascals to about 50 kilopascals during operation (paragraph 0124, lines 5-7).
Regarding claim 16, Temelman discloses wherein the set of biological entities comprises at least one of primary human cells, stem cell derived cells, cell lines, or xenogeneic cells (paragraph 0172, “xenogeneic”).
Regarding claim 17, Temelman discloses wherein the primary human cells includes at least one of hepatocytes, islets, mesenchymal stem cells, human dermal fibroblasts, or neurons (paragraph 0172); the cell lines include at least one of Human Embryonic Kidney (HEK) cells, ARPE cells, or CHO-K1 cells; and the xenogeneic cells comprise pancreatic islets (paragraph 0138).
Regarding claim 18, Temelman discloses wherein the anode and the cathode each comprise at least one of platinum, gold, carbon, iridium, or an oxygen-containing compound (paragraph 0122, lines 1-11).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Tempelman et al. (US 2019/0336267 A1) in view of Rotem et al. (US 8,444,630 B2) and further in view of Mavor et al. (US 2004/0267189 A1).
Regarding claim 2, Tempelman/Rotem (hereinafter referred as “modified Tempelman”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Tempelman further discloses wherein the circuit comprises a circuit board 420, the circuit board 420 further comprising at least two bond pads (bond pads that allows connection between element 420 and 445, 447, paragraph 0122) disposed thereon but is silent regarding wherein the circuit is electrically coupled to the electrochemical cell via conductive adhesive bonding between at least part of a surface of the cathode and a first bond pad of the at least two bond pads, and at least part of a surface of the anode and a second bond pad of the at least two bond pads.
However, Mavor teaches a design of an electrochemical cell wherein the circuit is electrically coupled to the electrochemical cell via conductive adhesive bonding between at least part of a surface of the cathode and a first bond pad of the at least two bond pads, and at least part of a surface of the anode and a second bond pad of the at least two bond pads (paragraph 0029, lines 5-8) for the purpose of using a well-known technique to bond the electrodes to the circuit board/circuit (paragraph 0029, lines 5-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the connection of the cathode and anode to the two bond pads of modified Tempelman to incorporate wherein the circuit is electrically coupled to the electrochemical cell via conductive adhesive bonding between at least part of a surface of the cathode and a first bond pad of the at least two bond pads, and at least part of a surface of the anode and a second bond pad of the at least two bond pads as taught by Mavor for the purpose of using a well-known technique to bond the electrodes to the circuit board/circuit (paragraph 0029, lines 5-8).
Claims 3, 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Tempelman et al. (US 2019/0336267 A1) in view of Rotem et al. (US 8,444,630 B2), in view of Mavor et al. (US 2004/0267189 A1) and further in view of Vardi et al. (US 7,892,222 B2).
Regarding claim 3, Tempelman/Mavor (hereinafter referred as “modified Tempelman ‘67”) discloses the claimed invention substantially as claimed, as set forth above in claim 2. Modified Tempelman ’67 is silent regarding at least one light-emitting diode disposed on the circuit board and optically coupled to the reservoir, the at least one light-emitting diode configured to generate a light beam to enhance or modulate a function of the set of biological entities; and a microcontroller disposed on the circuit board and configured to modulate a pulse intensity, a pulse frequency, a duty cycle or a combination thereof, of the at least one light emitting diode.
However, Vardi teaches a design of an electrochemical cell 100 (figure 1B) for generating oxygen to modulate the function of the set of biological entities comprising at least one light-emitting diode 140 disposed on the circuit board (board/component supporting element 150 and wires connecting element 150, 155 to element 100) and optically coupled to the reservoir 115, the at least one light-emitting diode 140 configured to generate a light beam to enhance or modulate a function of the set of biological entities (column 5, lines 17-31); and a microcontroller 150 disposed on the circuit board and configured to modulate a pulse intensity, a pulse frequency, a duty cycle or a combination thereof, of the at least one light emitting diode (column 5, lines 17-31) for the purpose of regulating the function of the set of biological entities (column 5, lines 17-31) thereby controlling/treating patient’s medical condition (column 3, lines 39-44).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of modified Tempelman ’67 to incorporate at least one light-emitting diode disposed on the circuit board and optically coupled to the reservoir, the at least one light-emitting diode configured to generate a light beam to enhance or modulate a function of the set of biological entities; and a microcontroller disposed on the circuit board and configured to modulate a pulse intensity, a pulse frequency, a duty cycle or a combination thereof, of the at least one light emitting diode as taught by Vardi for the purpose of regulating the function of the set of biological entities (column 5, lines 17-31) thereby controlling/treating patient’s medical condition (column 3, lines 39-44).
Regarding claim 5, modified Tempelman ‘67 discloses the claimed invention as claimed, as set forth above in claim 2. Tempelman further discloses wherein the circuit further comprises a rechargeable battery (paragraph 0106, lines 5-8), wherein the microcontroller (processor that controls the operation of the device) and the rechargeable battery are collectively configured to store the received power to the rechargeable battery and to provide the power stored in the rechargeable battery to the electrochemical cell (paragraph 0106, lines 5-8, in order to operate the device, the power have to be stored).
Regarding claim 6, modified Tempelman ’67 discloses the claimed invention substantially as claimed, as set forth above in claim 2. Modified Tempelman ’67 is silent regarding further comprising an oxygen sensor disposed in the reservoir or chamber and communicably coupled to the microcontroller, the microcontroller further configured to modulate operation of the at least one light-emitting diode to maintain, based on an oxygen level detected by the oxygen sensor, the oxygen level in the reservoir or chamber within a predetermined range.
However, Vardi teaches further comprising an oxygen sensor 160 disposed in the reservoir 115 or chamber and communicably coupled to the microcontroller 150, the microcontroller 150 further configured to modulate operation of the at least one light-emitting diode 140 to maintain, based on an oxygen level detected by the oxygen sensor, the oxygen level in the reservoir or chamber within a predetermined range (column 5, lines 17-31) for the purpose of regulating the function of the set of biological entities (column 5, lines 17-31) thereby controlling/treating patient’s medical condition (column 3, lines 39-44).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of modified Tempelman ’67 to incorporate further comprising an oxygen sensor disposed in the reservoir or chamber and communicably coupled to the microcontroller, the microcontroller further configured to modulate operation of the at least one light-emitting diode to maintain, based on an oxygen level detected by the oxygen sensor, the oxygen level in the reservoir or chamber within a predetermined range as taught by Vardi for the purpose of regulating the function of the set of biological entities (column 5, lines 17-31) thereby controlling/treating patient’s medical condition (column 3, lines 39-44).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tempelman et al. (US 2019/0336267 A1) in view of Rotem et al. (US 8,444,630 B2) in view of Mavor et al. (US 2004/0267189 A1) in view of Vardi et al. (US 7,892,222 B2) and further in view of Brill (US 2017/0303838 A1).
Regarding claim 4, modified Tempelman ‘67/Vardi (hereinafter referred as “modified Tempelman ‘7”) discloses the claimed invention substantially as claimed, as set forth above in claim 3. Modified Tempelman ’7 is silent regarding wherein the at least one light-emitting diode comprises a plurality of light-emitting diodes optically coupled to the reservoir, and wherein the microcontroller is configured to multiplex the plurality of light-emitting diodes to sequentially address individual light-emitting diodes of the plurality of light-emitting diodes.
However, Brill teaches a design of an implantable analyte sensor (figure 3A) comprising wherein the at least one light-emitting diode comprises a plurality of light-emitting diodes 42, 126 optically coupled to the reservoir 86, and wherein the microcontroller (“processor”, paragraph 0326) is configured to multiplex the plurality of light-emitting diodes to sequentially address individual light-emitting diodes of the plurality of light-emitting diodes (paragraph 0326) for the purpose of uniformly distributing the light over the cell (paragraphs 0031, 0355).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the number of light-emitting diode of modified Tempelman ’7 to incorporate wherein the at least one light-emitting diode comprises a plurality of light-emitting diodes optically coupled to the reservoir, and wherein the microcontroller is configured to multiplex the plurality of light-emitting diodes to sequentially address individual light-emitting diodes of the plurality of light-emitting diodes as taught by Brill for the purpose of uniformly distributing the light over the cell (paragraphs 0031, 0355).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tempelman et al. (US 2019/0336267 A1) in view of Rotem et al. (US 8,444,630 B2) in view of Yao et al. (US 3,878,564).
Regarding claim 10, modified Tempelman discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Tempelman is silent regarding wherein the second membrane comprises at least one of polydimethylsiloxane or polycarbonate.
However, Yao teaches a method of detoxifying blood and tissue comprising a membrane wherein the membrane comprises at least one of polydimethylsiloxane or polycarbonate (abstract) for the purpose of using a well-known material to design the membrane that allows the passage of the oxygen gas (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of the second membrane of modified Tempelman to incorporate wherein the second membrane comprises at least one of polydimethylsiloxane or polycarbonate as taught by Yao for the purpose of using a well-known material to design the membrane that allows the passage of the oxygen gas (abstract).
Regarding claim 11, modified Tempelman discloses the claimed invention substantially as claimed, as set forth above in claim 1. Tempelman further discloses wherein the second membrane comprises a plurality of pores (paragraph 0108, lines 1-24, entire membrane will be covered with pores) having a surface coverage of at least 5% of a total surface area of the second membrane, each pore of the plurality of pores independently having a pore diameter of from about 20 nm to about 5 µm (paragraph 0108, lines 1-24, entire membrane will be covered with pores).
Allowable Subject Matter
Claim 8 would be allowable if rewritten to overcome the objection, as mentioned in the current Office Action.
Claims 21 and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 8 was previously indicated allowable in the Office Action mailed on 9/10/2025 if claim is rewritten in an independent form. Claim 8, as currently presented, is an independent form of previously presented claim 8.
The closest prior art of record, Tempelman et al. (US 2019/0336267 A1) in view of Rotem et al. (US 8,444,630 B2) is silent regarding wherein the reservoir is stacked directly on top of the chamber on a side of the chamber opposite from the anode in combination with other claimed limitations of claim 21.
The closest prior art of record, Tempelman et al. (US 2019/0336267 A1) in view of Rotem et al. (US 8,444,630 B2) is silent regarding where the reservoir and chamber share a wall bounding each of the reservoir and the chamber in combination with other claimed limitations of claim 22.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the arguments do not apply in view of the present rejection.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783