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 with traverse of Group I and Species A2 in the reply filed on 07/15/2026 is acknowledged. The traversal is on the ground(s) that “search and examination of all currently pending claims would not pose an undue burden on the Examiner”. This is not found persuasive because, with regards to the currently pending claims, claims 37-41 directed to the different needle actuation mechanisms of Species A, the examination burden is not limited exclusively to a prior art search but also includes that effort required to apply the art by making and discussing all appropriate grounds of rejection. Multiple inventions, such as those in the present application, normally require additional reference material and further discussion for each additional invention examined. Concurrent examination of multiple inventions would thus typically involve a significant burden even if all searches were coextensive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 37 and 40-41 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/15/2026.
Response to Amendment
This office action is responsive to the amendment filed on 07/15/2026. As directed by the amendment: claims 25, 57, and 63-64 have been amended, claims 1-24, 43-56, 58-62, and 65-105 have been cancelled, and no new claims have been added. Thus, claims 25-42, 57, and 63-64 are presently pending in this application, with claims 37 and 40-41 being withdrawn from consideration.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show “a flexible film” as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 28-29, 57, and 63-64 are objected to because of the following informalities:
Regarding claim 28, the phrase “wherein the at least one electrolyte chamber is filled with citric acid“ in lines 1-2 should read “wherein the aqueous electrolyte in the at least one electrolyte chamber is
Regarding claim 29, the phrase “the citric acid solution” in line 4 should read “the citric acid” for consistency,
Regarding claim 57, the phrase “to monitoring local thermal gradients” in line 18 should read “to monitor local thermal gradients” for proper grammar,
Regarding claim 63, the phrase “the drug delivery member” in line 16 should read “the delivering member” for proper antecedent basis,
Regarding claim 64, the phrase “the drug delivery member” in line 16 should read “the delivering member” for proper antecedent basis,
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Regarding “other means to increase peak power delivery capabilities” in claim 63, 112(f) is invoked because: (i) it uses a generic placeholder (means), (ii) it is coupled with functional language (to increase peak power delivery capabilities), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. P.8, lines 17-19 and P.27, lines 4-6 recites verbatim the claim language in claim 63 wherein “the drug delivery device comprises a booster including integrating supercapacitors or other means to increase the peak power delivery capabilities for accelerating the rates of drug delivery.”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 63 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 63, the claim is directed towards “other means to increase peak power delivery capabilities” which is being interpreted under 112(f) as the claim uses the term “means” and is modified by functional language, and the limitation is not modified by sufficient structure for performing the claimed function. The specification is devoid of any structure which is capable of performing the claimed function of increasing peak power delivery capabilities and merely describes the “other means” verbatim as the claim using functional language (see P.8, lines 17-19 and P.27, lines 4-6). Thus, it is the examiner’s opinion that the claim lacks written description support because the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed (see MPEP 2163. 03).
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 25-36, 38-39, 42, 57, and 63-64 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 claims 25, 57, 63, and 64, the phrase “a controller coupled to… for wireless data transmission and power harvesting; obtaining the physiological status of the living subject, and controlling operations of the delivering member based on the physiological status of the living subject” in lines 11-15 renders the claim indefinite because it is unclear. Lines 9-10 of these claims disclose that the wireless communication system and the power management system are for wireless data transmission and wireless power harvesting, so the instant phrase creates confusion on whether these structures or the controller are performing these functions. The placement of the semi-colon after the term “power harvesting” causes the limitations after the semi-colon to be separate and not linked to the controller and creates confusion whether these are functions of the controller (as supported by the specification) or method steps (as presently drafted). Examiner is interpreting it as the former and suggests amending to state “a controller coupled to the power management system, the wireless communication system, the sensor member, and the delivering member and configured for obtaining the physiological status of the living subject, and controlling operations of the delivering member based on the physiological status of the living subject.”
Regarding claim 25, the phrase “powered/operated by water electrolysis” in line 17 renders the claim indefinite because it is unclear whether the scope of the claims is to be power and operated by water electrolysis or powered or operated by water electrolysis. Examiner suggest stating “powered by”, “operated by”, or “powered and/or operated by”. Examiner is interpreting this limitation as powered and/or operated by water electrolysis.
Regarding claim 27, the phrase “powered/operated by the electrolysis” in lines 1-2 enders the claim indefinite because it is unclear whether the scope of the claims is to be power and operated by water electrolysis or powered or operated by water electrolysis. Examiner suggest stating “powered by”, “operated by”, or “powered and/or operated by”. Examiner is interpreting this limitation as powered and/or operated by water electrolysis.
Regarding claim 34, the phrase “it pushes the flexible membrane and the low-friction hollow piston to a block position” in lines 3-4 renders the claim indefinite due to it being unclear. The spec. p.23 and Fig. 22 disclose the operation of the delivering member and at least one drug reservoir with p.23, lines 28-31 explicitly disclosing the block position. The spec. does not provide an adequate description of the scope of “a block position”. Thus, the examiner cannot ascertain the scope of this limitation. Examiner is interpreting this limitation as the pressure increases, it pushes the flexible membrane to pressurize the at least one drug solution as well as pushes the piston to translate through the fibrous capsule until it is stopped by the block shown in Fig. 22A.
Claim 34 recites the limitation "the fibrous capsule" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 35-36 and 38-39, the phrases:
“a cartridge module for deployment of the needle in the device” in lines 1-2 of claim 35,
“wherein the cartridge module is actuated linearly to pierce nearby tissue with the needle or uses a rotational actuation to operate a blade for the deployment of the needle in the device” in lines 1-3 of claim 36,
“wherein the cartridge module is equipped with a permanent ring magnet and at least two solenoid coils, wherein a needle penetration force is generated by polarization of the at least two solenoid coils” in lines 1-3 in claim 38,
and “wherein the needle is actuatable repeatedly for multiple piercing events” in lines 1-2 of claim 39
render the claims indefinite because they are unclear. Claims 35-36 and 38-39 are dependent upon claim 33 dependent upon claim 32 dependent upon claim 31. Claims 31-33 introduce the drug reservoir as the low-friction hollow piston filled with the drug, the flexible film, and hollow needle seen in Fig. 22. From the spec. p.23, lines 22-31, the operation of the hollow piston is understood to be used with the water electrolysis structures wherein “as the pressure increased [in the effervescent reservoir], it pushes the flexible membrane and the low-friction hollow piston to a block position, while at the same time the fibrous capsule is punched through by the hollow needle.” Thus, it is understood that the needle is translated by the water electrolysis process. Therefore, claims 35-36 create confusion on how a separate cartridge module having linear actuation or rotational actuation structures would be implemented, as described in Fig. 28A-B, alongside the structures in Fig. 22. Claims 38-39 further create confusion in this same manner on how the magnet and solenoid structures would be implemented, as described in Fig. 30A-C, alongside the structures in Fig. 22.
Claim 42 recites the limitation "the body of the device" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 63, the limitation “other means to increase peak power delivery capabilities” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, as discussed above. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. P.8, lines 17-19 and P.27, lines 4-6 recites verbatim the claim language in claim 63 wherein “the drug delivery device comprises a booster including integrating supercapacitors or other means to increase the peak power delivery capabilities for accelerating the rates of drug delivery.” There is no discussion about what structures would be considered “other means” for carrying out said function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding claims 26 and 28-33, these claims are rejected due to being dependent upon a rejected base claim.
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.
Claim(s) 57 is rejected under 35 U.S.C. 103 as being unpatentable over Tyson (U.S Patent Pub. No. 20180147343 A1) in view of John (U.S Patent Pub. No. 20100318025 A1) in view of Arne et al. (U.S Patent Pub. No. 20140051946 A1, “Arne”).
Regarding claim 57, Tyson discloses the limitations of (Claim 57) an implantable device (100 in at least Fig. 1) for monitoring a physiological status of a living subject and administering drugs therefor (see para. 0024-0025), comprising:
at least one drug reservoir (130 in Fig. 1) for containing at least one drug solution (see para. 0028);
a delivering member (116, 117 in Fig. 1) coupled to the at least one drug reservoir (130) for operably delivering the at least one drug solution from the at least one drug reservoir (130) to the living subject (see Fig. 1 and para. 0030);
a sensor member (120 in Fig. 1) for measuring physiological parameters of the living subject so as to monitor a physiological status of the living subject (see para. 0025);
a wireless communication system (160 in Fig. 1) for wireless data transmission (see para. 0033);
a power management system (140 in Fig. 1) for wireless power harvesting (see para. 0026 - power management system may be in the form of a battery which is capable of wireless power harvesting); and
a controller (170 in Fig. 1) coupled to the power management system (140), the wireless communication system (160), the sensor member (120) and the delivering member (116, 117) for wireless data transmission and power harvesting (see para. 0034); obtaining the physiological status of the living subject (see para. 0038), and controlling operations of the delivering member (116, 117) based on the physiological status of the living subject (see para. 0038).
However, Tyson fails to disclose the limitations (Claim 57) wherein the sensor member comprises at least one optical sensor; and wherein the sensor member comprises at least two temperature sensors separated by a distance to monitoring local thermal gradients for preventing tissue damage during battery charging.
John discloses an implantable drug delivery device (10 in Fig. 1) comprising sensors (21) which provide sensed data relating to physical, chemical, physiological, or other measurements relating to the drug delivery device operation, drug delivery, or the living subject (see para. 0067). John teaches that said sensors (21) may comprise optical sensors for detecting oxygen, carbon dioxide, and PH levels and can take the form of pulse oximeters or other biosensors (see para. 0068).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more sensors (120) of Tyson interpreted as the sensor member to comprise at least one optical sensor as taught by John as John provides an optical sensor can be configured as a pulse oximeter (see para. 0068 of John) which Tyson discusses as a pertinent to its opioid overdose prevention device (see para. 0025 of Tyson). Thus, John provides that an optical sensor can detect several physiological parameters of the subject and may be configured as a pulse oximeter or biosensor providing insight into a subject’s physiological status (see para. 0068).
Arne discloses a wearable physiological monitoring device (102 in Fig. 1) comprising two temperature sensors (224) placed in different locations and configured to measure and record skin, ambient, and circuit board temperature to determine the heat flux between the skin and the ambient environment (see para. 0048). Thus, the two temperature sensors (224) are separated by a distance and monitor a local heat flux which can only be determined by knowing the temperature gradient between the two locations and can be configured for preventing tissue damage from the rechargeable battery (214 in Fig. 2, see para. 0043 and 0048).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more sensors (120) of modified Tyson interpreted as the sensor member to comprise two temperature sensors as taught by Arne in addition to the optical sensor of John. Arne provides temperature sensors for measuring temperature of the subject’s skin, the ambient environment, and the circuit board to monitor the subject’s physiological status and the status of the electronics of the device (see para. 0048).
Claim(s) 63 is rejected under 35 U.S.C. 103 as being unpatentable over Tyson (U.S Patent Pub. No. 20180147343 A1) in view of Joshi (W.O Patent Pub. No. 9641159 A1) in view of Sarkinen et al. (U.S Patent Pub. No. 20130289539 A1, “Sarkinen”).
Regarding claim 63, Tyson discloses the limitations of (Claim 63) an implantable device (100 in at least Fig. 1) for monitoring a physiological status of a living subject and administering drugs therefor (see para. 0024-0025), comprising:
at least one drug reservoir (130 in Fig. 1) for containing at least one drug solution (see para. 0028);
a delivering member (116, 117 in Fig. 1) coupled to the at least one drug reservoir (130) for operably delivering the at least one drug solution from the at least one drug reservoir (130) to the living subject (see Fig. 1 and para. 0030);
a sensor member (120 in Fig. 1) for measuring physiological parameters of the living subject so as to monitor a physiological status of the living subject (see para. 0025);
a wireless communication system (160 in Fig. 1) for wireless data transmission (see para. 0033);
a power management system (140 in Fig. 1) for wireless power harvesting (see para. 0026 - power management system may be in the form of a battery which is capable of wireless power harvesting); and
a controller (170 in Fig. 1) coupled to the power management system (140), the wireless communication system (160), the sensor member (120) and the delivering member (116, 117) for wireless data transmission and power harvesting (see para. 0034); obtaining the physiological status of the living subject (see para. 0038), and controlling operations of the delivering member (116, 117) based on the physiological status of the living subject (see para. 0038).
While Tyson discloses the power source (140 in Fig. 1) as a battery, accelerometer, or other suitable means for powering the sensors (120, see para. 0026 of Tyson) and that the pump (116) may be in the form of an electrochemical pump (see para. 0030), Tyson fails to disclose the limitations (Claim 63) wherein the drug delivery member comprises a booster including integrating supercapacitors or other means to increase peak power delivery capabilities for accelerating the rates of drug delivery. Examiner notes the “drug delivery member” is being interpreted as the “delivering member”.
Joshi discloses embodiments of medical devices (10 in Fig. 1-10) having various electrochemical pump mechanisms, wherein each electrochemical cell (12 in Fig. 1) is powered by a battery (20 in Fig. 1, see p.4, line 32 – p.5, line 3).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrochemical pump (116) to be powered by the battery (140) of Tyson as taught by Joshi according to known methods to yield predictable results. Joshi teaches that the electrochemical cell may be powered by a battery, transformed direct current, fuel cell, or equivalent source of electricity as the electrochemical cell requires electricity to operate (see p.4, line 32 – p.5, line 3). Thus, if Tyson was operated as an electrochemical pump it was similarly require a source of electricity to operate. Therefore, one of ordinary skill in the art would have recognized that powering said electrochemical pump of Tyson with a battery or other power source would yield results that are predictable.
Sarkinen discloses an implantable infusion device (200 in Fig. 2) comprising a battery (204 in Fig. 2) and a pump (212 in Fig. 2) powered by said battery (204) for delivering the drug (see para. 0047-0051), wherein the device (200) further comprises a voltage boost circuit (240) interpreted as a booster which includes means such a voltage doubler and/or voltage tripler for boosting the voltage of the battery (204) to actuate the pump (212, see para. 0050-0052). Thus, Sarkinen teaches (Claim 63) wherein the drug delivery member (212 in Fig. 2) comprises a booster (240 in Fig. 2) including integrating supercapacitors or other means to increase peak power delivery capabilities for accelerating the rates of drug delivery (see para. 0050-0052 – the boosted voltage provided by booster 240 and its voltage double and/or voltage tripler means increase peak power delivery capabilities of the battery 204 and are configured for accelerating the rate of delivery from pump 212 as the pump 212 operates as a function of its applied voltage).
Since Joshi in modified Tyson discloses an electrochemical cell requiring the voltage from a battery to operate its pumping mechanism, and Sarkinen discloses an a solenoid-operated pump requiring the voltage from a battery to operate its pumping mechanism, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the circuitry of modified Tyson to include a booster as taught by Sarkinen to boost the voltage when the required voltage of the pumping mechanism is close to or even greater than the battery voltage (see para. 0050-0051).
Claim(s) 64 is rejected under 35 U.S.C. 103 as being unpatentable over Tyson (U.S Patent Pub. No. 20180147343 A1) in view of Ellis et al. (U.S Patent Pub. No. 20220339351 A1,”Ellis”).
Regarding claim 64, Tyson discloses the limitations of (Claim 64) an implantable device (100 in at least Fig. 1) for monitoring a physiological status of a living subject and administering drugs therefor (see para. 0024-0025), comprising:
at least one drug reservoir (130 in Fig. 1) for containing at least one drug solution (see para. 0028);
a delivering member (116, 117 in Fig. 1) coupled to the at least one drug reservoir (130) for operably delivering the at least one drug solution from the at least one drug reservoir (130) to the living subject (see Fig. 1 and para. 0030);
a sensor member (120 in Fig. 1) for measuring physiological parameters of the living subject so as to monitor a physiological status of the living subject (see para. 0025);
a wireless communication system (160 in Fig. 1) for wireless data transmission (see para. 0033);
a power management system (140 in Fig. 1) for wireless power harvesting (see para. 0026 - power management system may be in the form of a battery which is capable of wireless power harvesting); and
a controller (170 in Fig. 1) coupled to the power management system (140), the wireless communication system (160), the sensor member (120) and the delivering member (116, 117) for wireless data transmission and power harvesting (see para. 0034); obtaining the physiological status of the living subject (see para. 0038), and controlling operations of the delivering member (116, 117) based on the physiological status of the living subject (see para. 0038).
While Tyson discloses the delivering member (116, 117) may comprise the pump (116) which may be an electrochemical pump (see para. 0030), Tyson fails to disclose (Claim 64) wherein the drug delivery member comprises self-powered pumping mechanisms, wherein the power management system operably triggers a release of chemical energy through an exothermic chemical reaction, thereby ensuring proper, fast operation of the device even with a depleted battery.
Ellis discloses an electrochemical pump mechanism for a medical device such as a syringe (400 in Fig. 4), wherein the medical device comprises an electronically activated switch (492 in Fig. 4) powered by an electrical power source (see para. 0018, 0020, and 0069), wherein when the switch (492) is electrically activated, it triggers a self-powered pumping mechanism in the form of a release of chemical energy through an exothermic chemical reaction (see para. 0012 and 0069-0070), thereby ensuring proper, fast operation of the device (400, see abstract).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrochemical pump (116) activated by the controller (170) of Tyson to have the power management system trigger the operation of the electrochemical pump and for it be an exothermic reaction as taught by Ellis such that it is self-powered and configured to operate even with a depleted battery. Ellis provides that the exothermic chemical reaction is very fast and results in a fast ejection (see Abstract).
Allowable Subject Matter
Claims 25-36, 38-39, and 42 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Tyson (U.S Patent Pub. No. 20180147343 A1), Ellis et al. (U.S Patent Pub. No. 20220339351 A1,”Ellis”), and Joshi (W.O Patent Pub. No. 9541159 A1).
Tyson discloses an implantable device (100 in at least Fig. 1) for monitoring a physiological status of a living subject and administering drugs for use in opioid overdose prevention (see para. 0024-0025), comprising: at least one drug reservoir (130 in Fig. 1) for containing at least one drug solution (see para. 0028); a delivering member (116, 117 in Fig. 1) coupled to the at least one drug reservoir (130) for operably delivering the at least one drug solution from the at least one drug reservoir (130) to the living subject (see Fig. 1 and para. 0030); a sensor member (120 in Fig. 1) for measuring physiological parameters of the living subject so as to monitor a physiological status of the living subject (see para. 0025); a wireless communication system (160 in Fig. 1) for wireless data transmission (see para. 0033); a power management system (140 in Fig. 1) for wireless power harvesting (see para. 0026 - power management system may be in the form of a battery which is capable of wireless power harvesting); and a controller (170 in Fig. 1) coupled to the power management system (140), the wireless communication system (160), the sensor member (120) and the delivering member (116, 117) for wireless data transmission and power harvesting (see para. 0034); obtaining the physiological status of the living subject (see para. 0038), and controlling operations of the delivering member (116, 117) based on the physiological status of the living subject (see para. 0038). While Tyson discloses the delivering member having pump (116), the pump is only generically recites as being an electrochemical pump or other suitable pump (see para. 0030). Thus, Tyson fails to disclose the delivering member comprising microfluidics, water electrolysis, the flexible membrane, electrolyte reservoir and chamber, electrode, effervescent reservoir, and gate as claimed in claim 25.
Ellis discloses a syringe illustrated as a syringe (400 in Fig. 2) that uses a chemical reaction to deliver a high-viscosity fluid (see para. 0064). The syringe (400) comprises a drug reservoir (440 in Fig. 2) comprises the drug solution (486 in Fig. 2, see para. 0065), a reagent chamber (420 in Fig. 2) containing hydrogen peroxide or water which would be analogous in structure to the electrolyte chamber (see para. 0065-0067), an effervescent reservoir (430 in Fig. 2) containing two different catalysts (482, 484 in Fig. 2 and para. 0067), and a gate (450 in Fig. 2) in the form of a heat activatable valve (see para. 0069). The syringe (400) operates by activating switch (492) which causes the heat activatable valve (450) to be opened which allows the liquid reagent (480) to enter into the effervescent reservoir (430) to react with the catalysts (482, 484) to produce a gas (see para. 0069-0070). As the amount of gas increases, a pressure is exerted onto the piston (480 in Fig. 2) to move said piston (480) downwards to dispense the drug solution (486, see para. 0070). While Ellis does disclose a gate structure that is openable and closable to allow the chemical reaction to occur and a piston that could be modified to be a flexible membrane instead, Ellis fails to disclose the water electrolysis of claim 25 occurring in addition to the chemical reaction.
Joshi discloses a fluid delivery device (see Fig. 8) driven both by electrolysis and a chemical reaction (see p.11, lines 1-8), wherein the fluid delivery device (see Fig. 8) comprises an electrochemical cell (12) that drives delivery of a reactive fluid (30) such as citric acid into an effervescent chamber (28) containing a material (34) such as sodium bicarbonate wherein the gas produced from the chemical reaction between the citric acid and sodium bicarbonate drives a flexible membrane (36) to dispel a drug (38, see Col.11, lines 1-8). Joshi teaches an effervescent reservoir (28 in Fig. 8) coupled to the flexible membrane (36 in Fig. 8, see p.11, lines 1-8 - chamber 28 comprises reactive solid 34 which may be sodium bicarbonate which is an effervescent compound and chamber 28 is coupled to diaphragm 36); and at least one electrolyte chamber (30 in Fig. 8) containing the aqueous electrolyte (see p.11, lines 1-8 - chamber 30 comprises citric acid), wherein the at least one electrolyte chamber (30) has a gate and is coupled to the effervescent reservoir (28, see Fig. 8 and p.11, lines 1- 8 - chamber 30 is illustrated with an aperture such as 54 shown in Fig. 7 which is interpreted as the gate and is coupled to the effervescent reservoir 28). However, Joshi fails to disclose the limitation “the electrolysis of the aqueous electrolyte” and the aperture having the function of being openable and closable. The examiner notes that Joshi explicitly discloses the electrochemical cell performing water electrolysis separately of the aqueous solution (30), and that they are separated by a diaphragm (26).
Therefore, there is no reference that teaches or discloses the implantable device of claim 25.
Conclusion
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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