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 Arguments
Applicant's arguments filed 10/23/25 have been fully considered but they are not persuasive.
On pages 6-7 regarding drawing objections Applicant argues amendments overcome the objections of record (with the exception of those which are explained).
The Examiner respectfully withdraws objections where amendments corrected issues.
On page 7 however, regarding drawing objections, Applicant argues that the k pixels, k-1 pixels, central, peripheral, upper, lower, left, and right pixels are actually shown by the drawings and refers to figure 5.
The Examiner respectfully disagrees, noting that figure 5 shows only “a detailed configuration of a pixel array”. It refers to “five pixels set as one group”, and its reference numerals 1-5 refer to the order pixels are activated as the stimulation electrode. The specification states further that each unit group includes a central, upper, lower, left, and right pixels. However, while Applicant has stated that pixel 3 is a central pixel, and identifies other numerals as being upper, lower, left, and right pixels, there is no indication in the disclosure that this is accurate. The Examiner is unclear on whether Applicant (and so the person of ordinary skill) should just pick a random numeral in the array that defines all the pixels, or whether this is something that is defined. Further, the Examiner notes no labels that actually refer to these pixels, making it even more unclear whether these are actually defined or not. This also does not appear to address the peripheral, k, or k-1 pixels that are also not shown or described. The concept of these pixels is central to the understanding of the claim and apparently to the understanding of the subject matter of the invention, meaning these should be labeled and present in the drawings to understand.
On pages 8-9 regarding 112 rejections Applicant argues amendments overcome the rejections of record with the following exceptions:
On page 8 Applicant argues the term “multi-photodiode sensing technology” is “fully defined by its structural implementation” of “multiple photodiodes connected within one unit group” since the specification page 7 lines 5-8 states that “sensing accuracy is increased by sharing photodiodes of a plurality of return electrodes adjacent to the stimulation electrode”.
The Examiner respectfully notes that this renders the term further unclear, since it appears Applicant believes that the term “multi-photodiode sensing technology” must include some limitation of “multiple photodiodes connected within one unit group” (and also since a “unit group” is not defined or clear). Further, reference to page 7 line 5-8 appears to indicate that now this technology would require “a plurality of return electrodes adjacent to the stimulation electrode”. However, these are two distinct definitions with very different scopes, making the Examiner even more certain that the term is unclear.
On pages 8-9 regarding the term “stimulation parameter” Applicant argues the term has a definite meaning “as an electrical signal (e.g., counter value or current level) that controls the stimulation current” based on the specification page 9 lines 10-11.
The Examiner respectfully disagrees, noting the provided parts of the specification do not appear to reference an “electrical signal”, “counter value”, or “current level” at all, making this explanation unclear. There is nothing in the specification which guides the person of ordinary skill to understand what the “stimulation parameter” (and now, as presently worded, “stimulation parameter value”) is.
On page 10 regarding prior art rejections Applicant argues Kim’s prosthesis (figures 6-8) has photodiodes “operating independently” whereas Applicant’s device has structurally connected photodiodes for collective sensing.
The Examiner respectfully points out no part of the claimed invention appears to require or not require photodiodes operating in any manner, whether independently or not, making this argument unclear. Further, no part of the claim refers to “collective sensing” (which is also not a term whose scope is understood fully by the Examiner), making this argument further unclear.
On pages 10-11 Applicant argues further that Kim’s system activates electrode in patterns as opposed to with “dynamic role-swapping among grouped pixels based on time-delayed control”.
The Examiner respectfully points out no part of the claimed invention prevents operation of electrodes to activate “in patterns”, or requires electrodes to operate with “dynamic role-swapping among grouped pixels based on time-delayed control”, making this argument unpersuasive.
On page 11 Applicant argues Kim only converts photodiode currents to signals “without any intermediate parameter computation” and there is no “quantitative parameter” or “counter value” “based on aggregated currents”.
The Examiner respectfully disagrees, again pointing out that the claims do not appear to discuss “intermediate parameter computation”, “quantitative parameter[s]”, “counter value[s]”, or “aggregated currents”, making this argument unclear.
On page 11 Applicant argues combination of Kim and KR Kim would “merely add drivers to individual electrodes” and would not add drivers to “a unit group”. The Applicant argues further that the Examiner’s suggestion that it would be obvious to try is “unsupported” and includes “impermissible hindsight reconstruction”.
The Examiner respectfully disagrees, noting claims can only be interpreted as they are best understood by the Examiner. Further, lack of explanation regarding what a “unit group” is or what it’s scope entails makes it unclear what Applicant believes is missing. The Examiner disagrees that it would not be obvious to try the modification proposed based on the prior art.
On page 11 Applicant argues further pages 10-11 of the specification detail “unexpected results”.
The Examiner respectfully notes that it appears Applicant is stating their invention as a whole is “unexpected”, but has not linked these results to any particular feature in the claims which is not disclosed or taught by the prior art, making this argument unpersuasive.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the k pixels, k-1 pixels, the central pixel, the plurality of peripheral pixels, the upper, lower, left, and right pixels must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 3, 6 are objected to because of the following informalities:
Claim 3 is unclear for referring to “the number of the sensing circuits and the current drivers” and “the number of the unit groups” with improper antecedent basis.
Further, the claim is unclear for referring to “a separate sensing circuit” and “a separate current driver” when it is unclear how these relate, if at all, to the previously claimed “sensing circuit” and “current driver” of the unit group.
Claim 6 is objected to for claiming “one of the k pixels” is being activated, when it is unclear how, if at all, this relates to the previously “one of the k pixels” of claim 1.
Appropriate correction is required.
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.
Claims 1-7 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is rejected for having new matter for claiming “k being a natural number”, when there is no support in the originally filed specification for k to be a natural number. Natural numbers are not mentioned anywhere in the specification.
The claim is further rejected for having new matter for claiming the sensing circuit outputs a stimulation parameter value when there is no support in the originally filed disclosure for the stimulation parameter to be a “value”.
Remaining claims are rejected for depending on a claim with new matter.
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 1-7 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite for claiming the prosthesis uses “a multi-photodiode sensing technology” when it is unclear what this term means, as it is not a term known in the art, and the Examiner is unclear what the scope of the term means. Without understanding the scope of the term, the Examiner is unable to determine the scope of the claims themselves, as it is unclear what is required to consider the prosthesis to be using a “multi-photodiode sensing technology”. For the purposes of examination, this will simply be understood to mean that more than one photodiode is used.
Further, the claim is indefinite for claiming the pixel array contains “a plurality of pixels of which…pixels are set as one unit group”. It is unclear what a “unit group” is, since the specification does not appear to define this term in any way. It is unclear for example, if pixels can simply be called to be a “unit group”, or whether there need to be any defining characteristics for a “unit group” or not.
The claim is further indefinite for claiming the sensing circuit outputs “a stimulation parameter value” when it is unclear what a stimulation parameter value might be and what it might entail. The specification mentions the term, but does not elaborate on what it is, or give examples as to what it might be. Accordingly, its scope is unclear.
Claim 3 is indefinite for referring to “the unit groups” when claim 1, from which this depends, has only indicated that there is one unit group. It is unclear whether/how there are more than one unit group(s), and if there are, how they are related to one another, and if they must all have the same features as one another.
Remaining claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Kim et al. (US 20190209833 A1) hereinafter known as Kim in view of Kim (KR 101870599 B1) hereinafter known as KR Kim.
Regarding claim 1 Kim discloses a sub-retinal prosthesis (Abstract; the recitation of the prosthesis being “sub-retinal” is related to an intended location of implantation, as opposed to structurally limiting the prosthesis: The applicant is advised that a recitation of the “intended use” of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Kim was considered capable of performing the cited intended use. See, for example the Abstract.) configured for using a multi-photodiode sensing technology (This likewise appears to be recited as an “intended use” limitation of the prosthesis (see the explanation above). See also [0007], [0009] arrays of photodiodes indicate multiple photodiodes), comprising:
a pixel array including a plurality of pixels (Figure 8 “stimulating electrode”), of which a predetermined number k of pixels (k being a natural number) are set as one unit group (Figure 8: the pixels/electrodes in the upside down, backwards “L” shape are understood to be a unit group), and
a digital controller ([0014], [0022], [0055] control module 105) capable of controlling the pixel array to activate one pixel of the k pixels as a stimulation electrode and activate remaining k-1 pixels as return electrodes (This is stated as an “intended use” of the digital controller (see the explanation above), which does not structurally distinguish the controller of the prior art from that being claimed. See also [0022], [0055], etc.),
wherein the unit group includes k photodiodes respectively disposed in the k pixels (see also the photodiode in Figures 6-7 (triangle with a line on top within the circuit)), a sensing circuit (Figures 6-7 shows the circuit),
wherein the sensing circuit is capable of outputting a stimulation parameter value using currents respectively generated by the k photodiodes according to irradiation of light incident to the photodiodes (This is stated as an “intended use” of the sensing circuit (see the explanation above), which does not structurally distinguish the circuit of the prior art from that being claimed. See also [0007] the photodiodes detect light, and currents generated serve as an action potential through a conversion circuit), and
wherein the [prosthesis] is capable of outputting a stimulation current corresponding to the stimulation parameter value (This is stated as an “intended use” (see the explanation above), which does not structurally distinguish the prior art from that being claimed. See also [0005] the prosthesis replaces the photoreceptor cells [0007] with photodiodes which sends a stimulation signal through a conversion circuit [0003] the stimulation signal is sent to the optic nerve through),
but is silent with regards to whether or not there is a current driver.
However, regarding claim 1 KR Kim teaches that retinal stimulators can include current drivers (130-133). Kim and KR Kim are involved in the same field of endeavor, namely retinal stimulators. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the prosthesis of Kim to include drivers as is taught by KR Kim since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of a driver is understood to be obvious to try.
Regarding claim 2 the Kim KR Kim Combination teaches the prosthesis of claim 1 substantially as is claimed,
wherein Kim further discloses cathodes of the k photodiodes are connected to each other ([0007], [0009] there are multiple photodiodes (photodiodes inherently have cathodes), which are all connected on the substrate (see Figure 8, for example)).
Regarding claim 3 the Kim KR Kim Combination teaches the prosthesis of claim 1 substantially as is claimed,
wherein Kim further discloses a separate sensing circuit and a separate current driver are provided for each of the unit groups so that the number of sensing circuits and current drivers correspond to the number of unit groups (as is best understood (see 112 rejections above), there is one group, circuit, and driver (see the Combination above)).
Regarding claim 4 the Kim KR Kim Combination teaches the prosthesis of claim 1 substantially as is claimed,
wherein Kim further discloses the k pixels include a central pixel and a plurality of peripheral pixels adjacent to the central pixel (Figure 8 (or annotated figure 8, below) shows at least one central pixel with multiple peripheral pixels thereadjacent).
Regarding claim 5 the Kim KR Kim Combination teaches the prosthesis of claim 1 substantially as is claimed,
wherein Kim further discloses the k pixels include a central pixel, and upper, lower, left, and right pixels adjacent to the central pixel (Annotated Figure 8, below).
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Regarding claim 6 the Kim KR Kim Combination teaches the prosthesis of claim 1 substantially as is claimed,
wherein Kim further discloses the controller is capable of activating the pixels after a preset time has elapsed (this is stated as an “intended use” of the controller which does not materially affect the controller’s structure (see the explanation above regarding “intended use” statements). See also [0055] where it sis seen the controller switches pixels after light detection, which inherently involves a “time” elapsing).
Regarding claim 7 the Kim KR Kim Combination teaches the prosthesis of claim 1 substantially as is claimed,
wherein Kim further discloses the unit group includes a power supply voltage (Vb), a plurality of switches connected to the voltage (102), and capacitors ([0046] the return electrodes function as capacitors) each connected to the switches and k photodiodes.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 11/04/25
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