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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-17 and 25, drawn to two surgical control systems, classified in A61B1/126.
II. Claims 18-24, drawn to a method for controlling a surgical pump, classified in G16H40/63.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the method as claimed requires controlling a surgical pump in coordination with a plurality of surgical devices, whereas the product claims require that the pump is one of the plurality of surgical devices (claim 1) or are not specific to any relation between the surgical pump and the plurality of surgical devices (claim 25) and therefore the method can significantly differ in terms of how the pump is used/connected to the plurality of surgical devices. Additionally, the method does not explicitly require at least one controller configured to perform the functions listed by claim 1 or 25, and therefore several of the steps of claim 18 could performed manually by user, rather than by at least one controller specifically configured for performing each and every function.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The different invention would require a different search, including different classes/subclass and/or search strings. For example, the search for invention II would require searching specifically for steps that could be performed manually as opposed to being controlled by a controller. Additionally, since Group I is the only group that specifically mentions a communication bus, it would require searching in G06F13/36 which may not be required in a search for invention II. These examples are not exhaustive and there are likely other differences in terms of the search that is required for each invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Daniel R. Hoovler on 6/15/26 a provisional election was made with traverse to prosecute the invention of Group I, claims 1-17 and 25. Affirmation of this election must be made by applicant in replying to this Office action. Claims 18-24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 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.
Claims 1-17 and 25 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.
The beginning of claim 1 states “A surgical system in communication with a plurality of surgical devices, the control system comprising: a camera apparatus of the plurality of surgical devices” (emphasis added). The camera apparatus is thus being claimed as part of two different components (the surgical system and the plurality of surgical devices) which are in communication with each other. This leads to confusion over whether the plurality of surgical devices are truly a separate entity from the surgical control system or whether the applicant intended for the plurality of surgical devices to be considered part of the surgical control system and whether the camera should be considered part of the surgical system or the plurality of surgical devices.
Claim 1 recites the limitation "the surgical site" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites a method step of “wherein the pressure setting is controlled within a pressure range…”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (see MPEP 2173.05(p)).
Claim 4 recites a method step of “wherein the pressure range is updated in response to…”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (see MPEP 2173.05(p)).
Claim 7 recites a method step of “wherein the patient condition is accessed…”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (see MPEP 2173.05(p)).
Claims 8 and 10-13 each recite “the controller”, which is inconsistent with “at least one controller” as recited in claim 1 and therefore unclear in scenarios where more than one controller is present.
Claim 25 recites the limitation "the plurality of surgical devices" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the surgical site" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the control setting" in the final line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims inherit the deficiencies of the claims from which they depend.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamel et al. (US 2011/0237880 A1), hereafter “Hamel”.
As to claim 1, Hamel discloses a surgical control system in communication with a plurality of surgical devices (42, 50, 54, 64, 66, 67), the control system comprising:
a camera apparatus (64) of the plurality of surgical devices configured to capture image data depicting the surgical site (80) (see Fig. 2, para 0033, 0036, 0038, 0079); and
at least one controller (34 & 60) in communication with the plurality of surgical devices via a communication bus (see Fig. 3, para 0033), the plurality of surgical devices comprising a surgical pump (50) configured to control a flow of surgical fluid to a surgical site (para 0032, 0035, 0041), wherein the at least one controller is configured to:
receive the image data from the camera apparatus (Figs. 2, para 0033);
identify a visibility metric based on the image data (see paragraphs 0019, & 0042-0070 describing video signature analysis and image analysis subroutine);
determine a control setting for the surgical pump in response to changes in the visibility metric indicating a diminished visibility or blood content in the image data (see para 0069-0075); and
output a control state for the surgical pump in response to the control setting (para 0035, 0070-0075, 0084, 0085).
As to claim 15, Hamel discloses the surgical control system according to claim 1, wherein the plurality of surgical devices comprise at least one of a resection device (42; see para 0030).
As to claim 16, Hamel discloses the surgical control system according to claim 1, wherein the control setting of the surgical pump comprises at least one of an inflow rate, an outflow rate, and an inflow pressure (see para 0018, 0067, 0072-0074, 0079).
As to claim 17, Hamel discloses the surgical control system according to claim 1, wherein the visibility metric comprises at least one of a blood-presence classification (para 0053, 0065, 0069, 0074).
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 of this title, 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) 2-3, 8, 9, 12, 13, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamel in view of Stubkjaer et al. (US 2008/0154095 A1), hereafter “Stubkjaer”.
As to claims 2-3, Hamel discloses the surgical control system according to claim 1, and further wherein the control setting comprises a pressure setting of the surgical pump (see at least para 0072-0074, 0079), but does not expressly recite wherein the pressure setting is controlled within a pressure range, or wherein the pressure range is defined in response to at least one of a user preference, a patient condition, and a procedure performed on the surgical site.
Stubkjaer discloses a dual pump arthroscopic irrigation/aspiration system with outflow control and teaches “The pump is suitable for use during a variety of selected surgical procedures and is, therefore, designed to be operable over a wide range of pressure and flow as selected by the user on control panel display 11 by up/down pressure control buttons to set desired pressure and up/down flow rate control buttons to set desired flow” (para 0040) and “Various pressure data sources are provided and a selected source is used in the feedback control loop to maintain the set pressure within a predetermined range. The system determines which pressure data sources are available and compares data to determine reliability of the data before selecting the pressure data source to be used” (para 0022).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hamel such that the pressure setting is controlled within a pressure range, and wherein the pressure range is defined in response to at least a user preference and a procedure performed on the surgical site based off of Stubkjaer. One would have been motivated to do so in order to ensure that the pump controls fluid delivery within a pressure range that is appropriate (see para 0022, 0040, 0041 of Stubkjaer).
As to claim 8, Hamel in view of Tubjkaer teaches the surgical control system according to claim 2 as described above, and further wherein the controller is further configured to: automatically update the control state of the surgical pump within the pressure range in response to the visibility metric indicating changes in the blood content in the image data (see abstract, Figs. 3-4, para 0042-0070 of Hamel and para 0022, 0040, 0041 of Stubkjaer).
As to claim 9, Hamel in view of Stubjkaer teaches the surgical control system according to claim 8 as described above, and further wherein the control state of the pump is updated to increase a pump pressure within the pressure range in response to the blood content increasing and to decrease pump pressure within the pressure range in response to the blood content decreasing (see abstract, Figs. 3-4, para 0042-0070 of Hamel and para 0022, 0040, 0041 of Stubkjaer).
As to claims 12-13, Hamel discloses the surgical control system according to claim 1 as described above, but does not expressly recite wherein the controller is further configured to: identify a style or model or a connected accessory of a first surgical device of the plurality of surgical devices and further wherein the controller is further configured to: adjust the control setting for the surgical pump in response to the style or model or the connected accessory of the first surgical device. Stubjkaer discloses a dual pump arthroscopic irrigation/aspiration system with outflow control and teaches “It is also an object of this invention to produce a multi-purpose irrigation/aspiration system capable of operating with a variety of specific types of tubing sets which are each identified with a particular coding means associated with that tubing set type to identify the use for which the tubing set and/or the system associated therewith is intended” (para 0010), “…The different colors or other indicia could indicate that the code associated with the tubing set causes the system to be programmed to automatically limit flow and pressure ranges depending upon the procedure for which the tubing set is designed” (see para 0041). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hamel such that the controller is further configured to: identify a style or model or a connected accessory of a first surgical device of the plurality of surgical devices and further wherein the controller is further configured to: adjust the control setting for the surgical pump in response to the style or model or the connected accessory of the first surgical device, for example by providing indicia on the one or more plurality of surgical devices that can be identified by the system of Hamel in manner similar to Stubjkaer. One would have been motivated to do so as a way to automatically adjust the programming of the system to be optimized for the style or model of the first surgical device or a connected accessory (e.g. a tubing) of the first surgical device (see para 0010 & 0041 of Stubkjaer).
As to claim 25, Hamel discloses a surgical system in communication with a surgical pump (50), the system comprising:
a camera apparatus (64) of the plurality of surgical devices configured to capture image data depicting the surgical site (80) (see Fig. 2, para 0033, 0036, 0038, 0079); and
at least one controller (34 & 60) in communication with the surgical pump (50) configured to control a flow of surgical fluid to the surgical site (para 0032, 0035, 0041), the at least one controller configured to:
receive the image data from the camera apparatus (Fig. 2, para 0033);
identify a visibility metric based on the image data (see paragraphs 0019, & 0042-0070 describing video signature analysis and image analysis subroutine);
determine a pressure setting of the surgical pump, wherein the pressure setting is controlled in response to changes in the visibility metric indicating a diminished visibility or blood content in the image data (see para 0069-0075); and
output a control state for the surgical pump in response to the control setting (para 0035, 0070-0075, 0084, 0085).
Hamel does not expressly recite wherein the pressure setting is controlled within a pressure range, wherein the pressure range is defined based on at least one of a patient condition and a procedure performed on the surgical site
Stubkjaer discloses a dual pump arthroscopic irrigation/aspiration system with outflow control and teaches “The pump is suitable for use during a variety of selected surgical procedures and is, therefore, designed to be operable over a wide range of pressure and flow as selected by the user on control panel display 11 by up/down pressure control buttons to set desired pressure and up/down flow rate control buttons to set desired flow” (para 0040) and “Various pressure data sources are provided and a selected source is used in the feedback control loop to maintain the set pressure within a predetermined range. The system determines which pressure data sources are available and compares data to determine reliability of the data before selecting the pressure data source to be used” (para 0022).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hamel such that the pressure setting is controlled within a pressure range, and wherein the pressure range is defined in response to a procedure performed on the surgical site based off of Stubkjaer. One would have been motivated to do so in order to ensure that the pump controls fluid delivery within a pressure range that is appropriate (see para 0022, 0040, 0041 of Stubkjaer).
Claim(s) 2-3, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamel in view of Nagyszalanczy et al. (US 6,048,363).
As to claims 2 and 3, Hamel discloses the surgical control system according to claim 1, and further wherein the control setting comprises a pressure setting of the surgical pump (see at least para 0072-0074, 0079), but does not expressly recite wherein the pressure setting is controlled within a pressure range, or wherein the pressure range is defined in response to at least one of a user preference, a patient condition, and a procedure performed on the surgical site.
Nagyszalanczy teaches “The programming may be done by people conversed in the art of control system designs for medical purposes … A further constraint imposed on the control system may be a restricted operating envelope (pressure and flow rate), selectable as external input to the control system by the cognizant physician in consideration of the individual patient's general and specific health” (para beginning line 49 col. 15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hamel such that the pressure setting is controlled within a pressure range, or wherein the pressure range is defined in response to at least one of a user preference and a patient condition in view of Nagyszalanczy. One would have been motivated to do so in order to provide a pressure range that is appropriate for the patient (see para beginning line 49 col. 15 of Nagyszalanczy).
As to claim 25, Hamel discloses a surgical system in communication with a surgical pump (50), the system comprising:
a camera apparatus (64) of the plurality of surgical devices configured to capture image data depicting the surgical site (80) (see Fig. 2, para 0033, 0036, 0038, 0079); and
at least one controller (34 & 60) in communication with the surgical pump (50) configured to control a flow of surgical fluid to the surgical site (para 0032, 0035, 0041), the at least one controller configured to:
receive the image data from the camera apparatus (Fig. 2, para 0033);
identify a visibility metric based on the image data (see paragraphs 0019, & 0042-0070 describing video signature analysis and image analysis subroutine);
determine a pressure setting of the surgical pump, wherein the pressure setting is controlled in response to changes in the visibility metric indicating a diminished visibility or blood content in the image data (see para 0069-0075); and
output a control state for the surgical pump in response to the control setting (para 0035, 0070-0075, 0084, 0085).
Hamel does not expressly recite wherein the pressure setting is controlled within a pressure range, wherein the pressure range is defined based on at least one of a patient condition and a procedure performed on the surgical site
Nagyszalanczy teaches “The programming may be done by people conversed in the art of control system designs for medical purposes … A further constraint imposed on the control system may be a restricted operating envelope (pressure and flow rate), selectable as external input to the control system by the cognizant physician in consideration of the individual patient's general and specific health” (para beginning line 49 col. 15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hamel such that the pressure setting is controlled within a pressure range, or wherein the pressure range is defined in response to a patient condition in view of Nagyszalanczy. One would have been motivated to do so in order to provide a pressure range that is appropriate for the patient (see para beginning line 49 col. 15 of Nagyszalanczy).
Allowable Subject Matter
Claims 4-7, 10-11, 14 would be allowable if rewritten 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 and to include 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:
As to claim 4, while Hamel in view of Stubkjaer and Hamel in view of Nagyszalanczy each teach the surgical control system according to claim 3, each of the references is silent to wherein the pressure range is updated in response to a preexisting health condition identified in patient data for a patient of the procedure in combination.
Claims 5-6 depend from claim 4.
As to claim 7, while Hamel in view of Stubkjaer and Hamel in view of Nagyszalanczy each teach the surgical control system according to claim 3, each of the references is silent to wherein the patient condition is accessed via patient data in a patient database in combination.
As to claim 10, while Hamel in view of Stubkjaer and Hamel in view of Nagyszalanczy each teach the surgical control system according to claim 2, each of the references is silent to wherein the controller is further configured to: identify a proposed control setting of the surgical pump outside the pressure range in response to a blood content in the image data exceeding a blood content threshold for a predetermined period of time in combination.
Claim 11 depends from claim 10.
As to claim 14, while Hamel in view of Stubkjaer teaches the surgical control system according to claim 12, each of the references is silent to wherein a computer vision module of the at least one controller updates a visibility threshold of the visibility metric in response to the style or model or the connected accessory of the first surgical device in combination.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
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