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 .
Claim Objections
Claim(s) 9 and 29-30 is/are objected to because of the following informalities:
Regarding Claim 9, this Claim is dependent on Claim 2, but is interceded by Claims 3-8. Originally filed claims should not contain dependent claims interceded by non-dependent claims. This requirement will be held in abeyance, but it is noted that upon any ultimate allowability the claims will be renumbered to ensure an uninterrupted chain of dependency.
Regarding Claim 29-30, these claims are dependent upon Claim 21 despite be interceded by Claims 26-28 which do not depend from Claim 21 (either directly or indirectly). This requirement will be held in abeyance, but it is noted that upon any ultimate allowability the claims will be renumbered to ensure an uninterrupted chain of dependency.
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.
Claim(s) 1, 4, 5, 21, 26, and dependents is/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 1, Applicant recites the limitation “and the sensing system…” However, no “sensing system” has been previously recited in the claims. It is unclear if the “sensing system” is a new, separate component, refers to a function of an earlier component (e.g. a feature of the optical stimulating system), is positively required, functionally required, and what “sensing” function this component might perform.
Regarding Claim 1, Applicant recites the limitation “a second cannula end in fluid communication with the subject”. However, this limitation is indefinite as it is unclear if Applicant is positively reciting the second cannula end to necessarily be installed in fluid communication with the subject for infringement to occur. Examiner notes that such positive recitation in a device claim would necessarily require the subject itself to be a positively required component which would therefore cause the claim to be non-compliant with 35 USC 101. As such, despite the suggestive grammar of the claim, it is believed that this limitation only seeks to cover a functional capability of the second cannula to be installed in a subject, not the positive recitation of the cannula to actually be installed in the subject.
Regarding Claims 4 and 5, these claims make reference to “engineer cells”. While this is believed to be a typographical error of “engineered cells” it is not immediately clear whether they are necessarily the same as the “engineered cells” or may be claiming a different type of cell with a different function.
Regarding Claim 5, it is unclear if the “a sensing system” introduced in Claim 5 is the same or different from “the sensing system” recited in parent Claim 1.
Regarding Claim 21, Applicant recites the limitation “comprising a media cartridge in fluid communication with the cell cartridge”. However, parent Claim 13 already requires such a cartridge and therefore it is unclear if these two cartridges are the same or different.
Regarding Claim 26, Applicant recites “the sensing system”. However, no such “sensing system” has been previously introduced in Claim 13, on which Claim 26 exclusively depends.
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.
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) 1-6, 8-11, 13-18, 20-28, 30, 32, 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0047810 (“Park”) in view of U.S. Patent No. 5,011,472 (“Aebischer”), U.S. Publication No. 2022/0325240 (“McFarland”).
Regarding Claims 1, 13, 17-18, 21-23, 26-27, Park discloses a hybrid bioelectric device (100) containing engineered cells for delivery of a therapeutic agent to a subject (Abstract).
Park fails to disclose that the device is “wearable”, but rather suggests that it “may be implanted” (Par. 48). However, Aebischer discloses a similar bioreactor device (20) which likewise comprises a source of engineered cells (30) which are configured to produce a therapeutic agent for delivery to a subject (Abstract). Aebischer discloses that this device could be implanted or provided “worn extracorporeally” (Abstract, Col. 5). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Park to be worn, instead of implanted, as disclosed by Aebischer, as an obvious design choice. While Aebischer fails to explicitly disclose any particular or specific benefits to extracorporeal devices versus implanted, the prior art does establish the two configurations to be suitable alternatives to one another, whereby it has been held that simple selection between two particularly recognized alternatives is obvious, requiring only routine and customary skill in the art, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, Examiner notes that the ordinary artisan being a person of ordinary knowledge and creativity would be able to immediately recognize and appreciate various particular benefits to an extracorporeal system versus an implanted system which would flow naturally from such a substitution. For example, an extracorporeal device would eliminate the need for an expensive and invasive surgical procedure to implant the device, would allow the device to be more easily replaced or serviced without surgical revision, would allow the device to be made using different materials and different engineering standards simplifying construction and reducing costs, would allow the device to be larger…etc. Any of these benefits which would be immediately appreciated by the ordinary artisan without express suggestion, directly by the prior art constitutes a sufficient motivation to consider modification of the device of Park to be wearable. Furthermore, Examiner notes that Park, in reciting the device to be implantable, uses the indefinite “may”, i.e. a term used to indicate a possibility or probability. As such, it must be understood that Park does not believe this to be a critical and necessary feature, but rather an optional feature which some clinicians might find desirable, but may be eschewed by others without necessarily departing from the aims and goals of the invention.
Park discloses the device to comprise:
A cell cartridge (120) containing at least one type of engineered cells, wherein each of the engineered cells contains an optogenetic system (Abstract; Par. 15, 51);
An optical stimulating system (110) disposed adjacent to the cell cartridge (see Fig. 1), wherein the optical stimulating system has at least one light source, wherein the optogenetic systems of the engineered cells are configured to receive a light generated from the at least one light source such that the generated light operably controls production of at least one type of therapeutic agent (Par. 15, 51); and
A controller (140) in communication with the optical stimulating system and a sensing system (e.g. 130 – but consider also configurations with additional sensors 660), wherein the controller is configured to control the production of the at least one type of therapeutic agent according to a control algorithm (Par. 53, 54, 82, 83) provided on a memory unit (see generally 650, Par. 97).
Park discloses the invention substantially as claimed except that optogenetically engineered cells also release a “reporter agent”. In the instant case, lacking any reference to the utility of the “reporter agent” it is submitted that such a “reporter agent” could logically be considered to comprise any molecule other than the specific therapeutic agent of interest. For example, Park discloses that in some instances the cells may be stimulated to secrete insulin (Par. 52 – among other drugs), but also suggests that the cells could ALSO be stimulated to secrete glucagon (Par. 73). In such instances it is submitted that insulin could be considered the “therapeutic agent” and glucagon could be considered a “reporter agent”. However, other molecules understood to be released during production of the therapeutic agent of interest, e.g. inactive waste products and analytes (e.g. C-terminus basic amino acids) indicative of insulin synthesis and activation.
However, should Examiner’s arguments not be found persuasive the following is presented. McFarland discloses a related bioreactor device (Fig. 1A) wherein along with the molecule/therapeutic agent of interest the cells may be configured to produce a “detectable label” (e.g. a reporter agent) along with therapeutic in order to allow detection of the target molecule more easily (Par. 117). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the cells of Park to product a detectable, reporter agent along with the therapeutic agent, as disclosed by McFarland, in order to permit a secondary method by which production of the therapeutic can be confirmed and quantified, thereby helping to assist with accurate and effective dosing allowing the device to start and stop agent synthesis dependent upon confirmation (see also Park, Par. 54 with photosensor determination of agent production supplemented by any of the various detectable labels suggested by McFarland inclusive to biochemical signals and fluoro-tags).
Park discloses the invention substantially as claimed except that device further comprises a “media cartridge” in fluid communication with the cell cartridge providing cell media to the cell cartridge. Rather Park (and Aebischer) suggests that endogenous bodily fluids could supply the cells with the necessary media for their metabolism (Par. 61. However, as discussed above, McFarland discloses a similar bioreactor for using bioengineered cells to produce various agents (Abstract). McFarland discloses that the device may have a media module/cartridge (178) integrated therewith (Par. 516) which can supply the cell source/cartridge with necessary cell media (180) to permit their cell metabolism and production of the agent of interest (Par. 93, 159, 244, 614), the device comprising a pump (160 – Par. 519, 384) in fluid communication with the media cartridge and the cell cartridge, wherein the pump is configured to pump the cell media from the media cartridge into the cell cartridge. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of modified Park to include a media cartridge and pump, as disclosed by McFarland, in order to provide the cells with any additional nutrients, reagents…etc. that they might need for optimal cell maintenance and product of the therapeutic agent thereby supplanting the need to utilize endogenous bodily fluids for cell metabolism.
Park discloses the invention substantially as claimed except that that the device comprises a “cannula” for affecting delivery. Park does not explicitly discuss how the agent is secreted into the blood stream. However, as discussed above, Aebischer discloses a similar bioreactor (20) which likewise uses engineered cells to produce therapeutic agents. Aebischer discloses the device to comprise a cannula (re: catheter 22) having a first cannula end in fluid communication with the cell cartridge (see Fig. 2) and a second cannula end configured to be in fluid communication with the subject (see Fig. 1). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize a catheter/cannula to convey the agent between the cell cartridge and the subject in the device of Park, as disclosed by Aebischer, in order to utilize a known component which has been appreciated by the prior art for such a utility thereby solving the generic disclosure of Park via a known, predictable solution to obtain only an expected outcome via a system with which the ordinary artisan would be reasonably familiar.
Regarding Claims 2 and 24, Park discloses a filter (re: “selective membrane”) disposed between the cell cartridge and the agent outlet (re: the second end of the cannula as modified in view of Aebischer), wherein the filter is configured to selectively permit the at least one type of therapeutic agent passing through the filter and entering into the subject's body through the second end of the cannula (Par. 16, 51, 61).
Regarding Claims 3 and 28, Park discloses a battery (550) configured to provide power supply to the device. While such a power source is only explicitly discussed with respect to the embodiment 500, Examiner submits that inclusion of such a power supply to power the electronic components of the other embodiments of Park is both obvious and expected (see Par. 94).
Regarding Claims 4 and 14-16, Park discloses the engineered cells start production of the at least one type of therapeutic agent when the optogenetic systems of the engineered cells receive a first light having a first wavelength from the optical stimulating system (see Fig. 4 – Par. 50, 51), wherein the device can also generate a second wavelength of light which is used to generate a different therapeutic agent (e.g. the cells will cease to generate the first therapeutic when the first wavelength is ceased and the second wavelength is activated).
Regarding Claim 5, Park discloses, the device further comprising a sensing system (130) disposed adjacent to the cell cartridge, wherein the sensing system is configured to sense a fluorescent signal or bioluminescence signal generated by the reporter agent (see modifications in view of McFarland), wherein the engineer cells stop the production of the at least one type of therapeutic agent when either the optogenetic systems of the engineered cells receive a second light having a second wavelength, or the sensing system detects a predetermined level of the fluorescent signal or bioluminance signal generated by the reporter agent (see Par. 53-54, Park with consideration of modifications using various detectable labels suggested by McFarland, Par. 117, e.g. “fluorescent molecules such as fluorophores or barcodes”).
Regarding Claims 6 and 20, Examiner submits that while not expressly discussed a ratio of the amount of the produced reporter agent to the amount of the produced at least one type of therapeutic agent is fixed dependent upon the particular conditions and wavelengths of light to which cells are exposed.
Regarding Claims 8 and 30, Park discloses the invention substantially as claimed except that the media cartridge is refillable. However, Park does suggest refilling of the drug cartridge (Par. 85). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to also permit refilling of the media cartridge of modified Park, as discussed in association with the cell cartridge, in order to ensure that the cells are provided with a sufficient source of media to permit agent production.
Regarding Claims 9 and 25, Park, as modified (see McFarland as applied above), provides for the pump to create a pressure necessary for the at least one type of therapeutic agent passing through the filter and entering into the subject's body through the second end of the cannula.
Regarding Claims 10 and 32, Park, as modified, discloses the invention substantially as claimed except that the device further comprises an intake cannula in fluid communication with the subject and is configured to receive body fluid from the subject. Park does suggest that bodily fluids can be conveyed to the system, but does not particularly affect a system to do so. However, Aebischer discloses that such systems may be configured with a portal (104) for permitting the introduction of bodily fluids into the system, wherein pumps can be used to affect the drawing of such fluids into the system. While Aebischer does not explicitly recite a cannula associated with that particular inlet, Examiner submits that it would have been obvious to utilize an additional catheter/cannula (see e.g. 22), particularly in instances where the system is provided extracorporeally. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the device of Park to include an inlet cannula/catheter, in order to permit the drawing of various bodily fluids into the device for purposes of analyte sensing, distribution of nutrients, etc.
Regarding Claims 11 and 33, Park, as modified by Aebischer, discloses the intake cannula is in fluid communication with the cell cartridge, wherein in use, the received body fluid enters into the cell cartridge, wherein the cell cartridge is configured to collect, expand, and prime cells in the body fluid of the subject (see generally Fig. 2 and 5 – Aebischer).
Claim(s) 7, 12, 29, 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0047810 (“Park”) in view of U.S. Patent No. 5,011,472 (“Aebischer”), U.S. Publication No. 2022/0325240 (“McFarland”) as applied above, and further in view of U.S. Publication No. 2019/0090801 (“Rogers”).
Regarding Claims 7 and 29, Park, as modified, discloses the invention substantially as claimed except that the media cartridge is replaceable and detachable (as opposed to merely refillable). However, McFarland discloses “in various embodiments, cartridges can be replaced…” (Par. 115). Furthermore, Rogers discloses a similar optogenetic bioreactor where “replaceable fluid-containing cartridges (analogous to ink jet printer cartridges) might represent an attractive future design feature. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the media cartridge of Park to be detachable and replaceable, as disclosed by Rogers, in order to ensure that a sufficient supply of cell media is provided at all times. It has been held that constructing a device of a plurality of separable and replaceable parts is obvious and predictable, see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding Claims 12 and 31, Park suggests that the cell cartridge may be replaceable (Par. 10, 17), although this recitation might only suggest refilling of the drug reservoir when it recites “replace” (see Par. 22 and 85). However, McFarland discloses “in various embodiments, cartridges can be replaced…” (Par. 115). Furthermore, Rogers discloses a similar optogenetic bioreactor where “replaceable fluid-containing cartridges (analogous to ink jet printer cartridges) might represent an attractive future design feature. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the cell cartridge of Park to be detachable and replaceable, as disclosed by Rogers, in order to ensure that a sufficient supply of cell media is provided at all times. It has been held that constructing a device of a plurality of separable and replaceable parts is obvious and predictable, see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0047810 (“Park”) in view of U.S. Patent No. 5,011,472 (“Aebischer”), U.S. Publication No. 2022/0325240 (“McFarland”) as applied above, and further in view of U.S. Publication No. 2009/0311133 (“Pang”).
Regarding Claim 19, Park, as modified, discloses the invention substantially as claimed except that the sensing system comprises a photodiode. While both Park and McFarland disclose that photosensors can be used to detect reporter agents/detectable tags, use of a “photodiode” is never explicitly suggested. However, Pang discloses that such photosensing arrangements can be affected by a photodiode (Par. 151). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize a photodiode, as disclosed by Pang, as the photosensor of modified Park, in order to sense the presence of various detectable tags (see e.g. McFarland), and permit control of therapeutic generation response to the sensed agent/tag (see Park), in order to utilize a known, specific species of solution in replace of a generic recitation to obtain a known, predictable, and expected outcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/ Primary Examiner, Art Unit 3783
02/16/2026