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 .
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.
Response to Amendment
Claims 1-8 and 10-20 are currently pending in the present application, with claims 1 and 15 being written in independent form. Claims 1-5, 7-8, 10-15, and 17-20 have been amended. Claim 9 is cancelled.
Response to Arguments
Applicant’s arguments, see Remarks, filed 5/11/2026, with respect to the rejections of claims 1-8 and 12-17 under 35 U.S.C. 102(a)(2) as being anticipated by Holthuizen (US 2020/0085506) have been fully considered and are persuasive. Holthuzien does not teach the amended claim 1 as filed. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Vrba (US 2019/0069949).
Applicant’s arguments, see Remarks, filed 5/11/2026 with respect to the rejections of claim 19 under 35 U.S.C. 112(b) for failing to particular point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention has been fully considered and are persuasive. The rejection has been rendered moot by the present amendments, and therefore the rejection has been withdrawn.
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 1-20 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 1 and 15, the claims recite “an evaluation unit”, but do not describe how the evaluation unit is constructed, nor how it is used to accomplish measuring data for evaluation. The Examiner has assumed that the evaluation unit is a computer of some form running a software to achieve these tasks, but no where in the specification is it explicitly stated what the evaluation unit is physically or moreover what software is used. Appropriate correction is required.
Regarding claims 2-14 and 16-20, these claims inherit the deficiencies of claim 1 and 15 above. Appropriate correction is required.
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 1-20 is 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, the claim recites “an evaluation unit configured to evaluate measuring data” but does not provide sufficient structure or explanation to how the evaluation unit is able to evaluated measuring data, rendering the claim indefinite. Appropriate correction is required.
Regarding claims 2-14 and 16-20, the claims inherit the deficiencies of claim 1 above. Appropriate correction is required.
Regarding claim 15, the claim recites “evaluating, by an evaluation unit of the measuring device, measuring data describing the received spectrum of the received light” but does not provide sufficient structure or explanation on how the evaluation unit is able to evaluate measuring data, rendering the claim indefinite. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., abstract idea) without significantly more. Claims 1 and 15 recite “evaluating, by an evaluation unit”. This judicial exception is not integrated into a practical application because creating, receiving, evaluating, and measuring light from a light source with a detector are all high level and could be seen as routine, well-known, and conventional in the art and could be functionally performed in the human mind or with pen and paper. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements presented do not present any novel or inventive concept. The additional elements of “an elongated medical instrument” with “optical waveguide” do not take any output from the measuring, receiving, creating, or evaluating steps to arrive at an inventive concept. See the two-prong analysis below.
Regarding Claims 1-20 - Step 2A Prong 1: Does the claim recite a judicial exception?
Yes, independent claims 1 and 15 recite at least one step or instruction for a method, which is grouped as a mental process or a certain method of organizing human activity. The claimed limitations involve managing data (evaluating), a type of mental process where concepts can be performed in the human mind, which is an example of an abstract idea.
Further, dependent claims 2-14 and 16-20 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely identical or token additions to the claims (evaluation unit, examination object, output unit, imaging facility, activation unit, light detector, light source) that do not alter or affect how the claimed functions/steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A Prong 2: Is the abstract idea integrated into a practical application?
No. The above identified abstract idea in each of the independent claims 1 and 15 (and their respective dependent claims 2-14 and 16-20) is not integrated into a practical application because the additional elements (identified above), either alone or in combination, generally link the use of the above identified abstract idea to a particular technological environment or field of use or represent insignificant extra-solution activity. More specifically, the additional elements of an evaluation unit, output unit, and activation unit are generally recited computer elements which do not improve the functioning of a computer or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation, provide a particular treatment or prophylaxis of apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that a claim as a whole is more than a drafting effort to monopolize the exception.
Step 2B: Does the claim provide an inventive concept?
No. As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere extra solution activity to apply the exception using a generic computer component. Mere instructions to apply an exception on a generic computer (or otherwise) cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. There is no indication that the output unit, activation unit, or evaluation unit is anything other than a generic, off-the-shelf computer component and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well-understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the collecting step is well-understood, routine, conventional activity is supported under Berkheimer Option 2. Furthermore, the ability to adjust a value with feedback is seen as well-understood, routine and conventional as different control structures using off-the-shelf computers integrate feedback into their systems. For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
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. This application includes one or more claim limitations that use the word “means” and are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: claim 13, “treatment means”. See the three prong analysis for the claim below.
Claim 13 – Step A: The claim limitation uses the term means and a generic placeholder having no structural meaning (a treatment means).
Step B: The term treatment means is modified by functional language (for treatment of a target tissue).
Step C: The term treatment means is not modified by sufficient structure for performing the claimed function.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “an evaluation unit” in claim 1, “output unit” in claim 6, “activation unit” in claim 14. See the three-prong analysis for each claim below.
Claim 1 – Step A: The claim limitation uses a generic placeholder having no structural meaning (an evaluation unit).
Step B: The generic placeholder is modified by functional language (configured to evaluate measuring data).
Step C: The generic placeholder (an evaluation unit) is not modified by sufficient structure for performing the claimed function (evaluate measuring data).
Claim 6 – Step A: The claim limitation uses a generic placeholder having no structural meaning (an output unit).
Step B: The generic placeholder (an output unit) is modified by functional language (configured to output a display).
Step C: The generic placeholder (an output unit) is not modified by sufficient structure for performing the claimed function (configured to output a display).
Claim 14 – Step A: The claim limitation uses a generic placeholder having no structural meaning (an activation unit).
Step B: The generic placeholder is modified by functional language (being configured to activate at least one of the patient couch).
Step C: The generic placeholder (an output unit) is not modified by sufficient structure for performing the claimed function (being configured to activate at least one of the patient couch).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-8 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Holthuizen (US Patent Publication 2020/0085506), herein after “Holthuizen” in view of Vrba (US 2019/0069949), herein after “Vrba”.
Regarding claim 1 and 15, Holthuizen teaches
“an elongated medical instrument for partial introduction into an intervention region of an examination object (Figures 3 and 5), wherein within the elongated medical instrument includes at least one optical waveguide is routed to
“a measuring device (246, p.[0043]) connected to a proximal end of the at least one optical waveguide (p.[0043]), the measuring device including a light source configured to create transmit light having a transmit spectrum to be transmitted through at least one of the at least one optical waveguides to the
“a light detector configured to received light guided having a received spectrum from the
“an evaluation unit configured to evaluate measuring data describing the received spectrum of the received, (p.[0043]) determine a reflection characteristic of the received light based on the measuring data, determine at least one material of the examination object based on the reflection characteristic, and determine a position information describing the position of the elongated medical instrument in the examination object based on the at least one materials (p.[0007, 0008, 0021])”, and
“a display facility configured to output the position information (p.[0014])”.
Holthuizen does not teach using a plurality of measuring positions located on the distal portion of elongated medical instrument, but Vrba does in an analogous medical device. Vrba teaches in p.[0379] "FIGS. 42A and 42B, with marker bands 4210 (e.g., radiopaque marker bands) defining the proximal and distal extents of the tube structure", which shows measuring positions spaced across the elongated medical instrument and teaches the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use measuring positions spaced along the distal portion of the device, as taught in Vrba, in Holthuizen. The use of the marker bands allows for the monitoring of the position of the device external to the body, and produces predictable results of monitoring the device position (p.[0727]).
Regarding claim 15 specifically, the computer method describes the same limitations as claim 1, and therefore is taught by the rejection of claim 1 above. The Examiner notes that Holthuizen does teach that a computer method is performed within the scope of the rejection above as stated in p.[0001], "The invention further relates to a computer program causing a system to perform steps of a method resulting in a detection of a position of a device within tissue based on a determination of tissue types."
Regarding claim 2, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein the evaluation unit configured to, during the determination of the position information, use a course of the measuring data from an advance into the examination object, the transmit spectrum including a number of wavelengths or wavelength ranges to determine the position information,” in p.[0007-0008], which describes how the device is able to determine the position information of the device via optical sensors and therefore teaches the limitation as described.
Regarding claim 3, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein the evaluation unit is further configured to determine at least one of material class of a material at least one of the plurality of measuring positions reflecting the transmit light into the received light, or a transition between material classes” in p.[0007-0008], see tissue type discussion which constitutes as a material class and therefore teaches the limitation as described.
Regarding claim 4, the limitations of claim 3 are taught as described above. Holthuizen teaches “wherein the position information describes an arrangement of at least one of the plurality of measuring position in a section of material of the examination object” in Fig. 6, which shows position information of the bone screw within a section of the material of the examination object (in cancellous bone versus cortical bone, p.[0046]) and therefore teaches the limitation as described.
Regarding claim 5, the limitations of claim 3 are taught as described above. Holthuizen teaches “wherein the evaluation unit is further configured to use image data of the intervention region of the examination object to at least one of determine the at least one material class or assign at least one of the plurality of measuring positions to a section of material visible in the image data” in Fig. 6, and further in p.[0007] which states "The imaging system may be capable of generating an image of a region of interest, for example of a spine, and the planning and navigation system may be adapted for a planning of an insertion of a device into the region of interest, for example of an insertion of a pedicle screw in one of the vertebra of the spine. On the one hand, the tissue types that may be encountered during a device placement are stored in a table. On the other hand, a navigation system, which at least provides information assisting in guiding the device placement, may determine an actual position of the device based on a determination of the tissue at or in front of the device and based on the sequence of tissue types stored in the table. This may be done based on a real-time tissue sensing which may be performed by the device being inserted into the region of interest. Such a device may be a k-wire, an awl or a tap, or a screw. The system may thus compare a predicted tissue type determined by means of imaging and during planning with a real-time measured tissue type determined by means of sensing".
Regarding claim 6, the limitations of claim 5 are taught as described above. Holthuizen teaches “an output unit configured to output a display based on the image data showing the position information” in Fig. 6, which shows the output display image based on the image data showing the position information, and therefore teaches the limitation as described.
Regarding claim 7, the limitations of claim 3 are taught as described above. Holthuizen teaches “wherein the evaluation unit is further configured to use a trained function to determine the at least one material class” in p.[0007, 0050, 0051], which describes that an algorithm is used to produce a table of tissue properties (i.e., material classes) and therefore teaches the limitation as described.
Regarding claim 8, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein at least one of the plurality of measuring position is provided at a distal end of the elongated medical instrument” in Figure 5 shows the measuring position is provided at the end of the elongated medical instrument, when viewed in combination with Vrba which does measure multiple positions as described above and therefore teaches the limitation as described. See also, abstract ("to determine possible positions of the distal end of the optical guide on the path based on the comparison of tissue types, and to generate a signal indicative for the possible positions.").
Regarding claim 10, the limitations of claim 1 are taught as described above. Holthuizen does not teach that the measuring positions are spaced across in a longitudinal direction along a distal portion of the elongated medical device, but Vrba does in an analogous electrosurgical device. Vrba teaches in p.[0379] "FIGS. 42A and 42B, with marker bands 4210 (e.g., radiopaque marker bands) defining the proximal and distal extents of the tube structure", which shows measuring positions spaced across the elongated medical instrument and teaches the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use measuring positions spaced along the distal portion of the device, as taught in Vrba, in Holthuizen. The use of the marker bands allows for the monitoring of the position of the device external to the body, and produces predictable results (p.[0727]).
Regarding claim 11 and 19, the limitations of claim 10 are taught as described above. Holthuizen teaches “a common optical waveguide of the at least one optical waveguide is configured to guide the receive light from the plurality of measuring positions, and
the evaluation unit is configured to determine at least one of,
the position information as a function of an increasing intensity of the received light as a number of measuring positions located in the examination object increases, or
for at least one measuring position wherein an overall measuring data describes receive light from the plurality of measuring positions, measuring position measuring data by subtracting a subtraction measuring data, from the overall measuring data” in p.[0025] which teaches "Furthermore, the device may be adapted to perform at least one out of the group consisting of diffuse reflectance spectroscopy, diffuse optical tomography, differential path length spectroscopy, and Raman spectroscopy. The console may comprise at least one spectrometer." Note that a diffuse reflectance spectroscopy operates using evaluations of light intensity with using comparative measuring data and therefore teaches the limitation as described. Note further that Vrba teaches the use of a plurality of measuring positions as described above.
Regarding claim 12, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein at least one of the at least one optical waveguide for guidance of transmit light to at least one of the plurality of measuring position has an interruption point for coupling out the transmit light at the at least one measuring position” in Claim 1, which states "comprising an optical sensing device including an optical guide with a distal end, the optical guide being arrangeable within the insertable device, and a processing unit, wherein the processing unit is configured (i) to receive tissue type information of a region of interest including different tissue types, (ii) to receive an input identifying a path through the region of interest, (iii) to determine a sequence of tissue types along the identified path, based on the received tissue type information (iv) to receive optical information from the optical sensing device (v) to determine a tissue type at the distal end of the optical guide based on the received optical information, (vi) to compare the determined tissue type with the sequence of tissue types along the path, (vii) to determine possible positions of the distal end of the optical guide on the path based on the comparison of the tissue types, and (viii) to generate a signal indicative for a mismatch between the determination tissue type based on the received optical information and the possible tissue types for the possible positions along the path through the region of interest."
Regarding claim 13, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein the elongated medical instrument includes a treatment means at a tip of the elongated medical instrument for treatment of a target tissue class” in Fig. 3, which shows a pedicle bone screw at the tip of the medical instrument, considered to be a treatment means, teaches the limitation as described.
Regarding claim 14, the limitations of claim 1 are taught as described above. Holthuizen teaches “an imaging facility including a patient couch for the examination object and an activation unit, the activation unit being configured to activate at least one of the patient couch or a recording arrangement of the imaging facility for positioning for a recording of image data with the imaging facility using the position information” in Figure 1, which shows an examination table, couch, bed, or the like (112), inside a facility (implied, given that the patient is in a room), with recording arrangements via the camera (124, 130), which is activated responsive to the first range of wavelengths in the visible spectrum to image the position information. This is further described in p.[0039-0040].
Regarding claim 16, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein the reflection characteristics are reflection characteristics of tissues of the examination object” in the Abstract, which states "The optical sensing means may include an optical guide with a distal end, wherein the optical guide may be configured to be arranged in a device to be inserted into tissue in a region of interest. The processing unit may be configured to receive information of a region of interest including different tissue types as well as of a path through the tissues, to determine a sequence of tissue types along the path, to determine a tissue type at the distal end of the optical guide based on information received from the optical sensing means, to compare the determined tissue type with the tissue types on the path, ". Note that the optical sensing means is further described in p.[0044] and teaches a form of spectroscopy that operates using reflected light and therefore teaches the limitation as described.
Regarding claim 17, the limitations of claim 1 are taught as described above. Holthuizen teaches “wherein at least one of the plurality of measuring positions is at a tip of the elongated medical instrument” in Figs. 5-6, which shows the measuring position is at the tip of the instrument and therefore teaches the limitation as described.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Holthuizen in view of Vrba and Sudre (US Patent Publication 2024/0350208), herein after “Sudre”.
Regarding claim 18, the limitations of claim 10 are taught as described above. Holthuizen/Vrba does not teach that the measuring positions are spaced apart equidistantly, but Sudre does in Figure 6 and 7, which shows optical markers 23, 24, and 42 are markers that are used to measure position and are spaced apart equally from one another. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Sudre in Holthuizen. As taught in Sudre, the use of the optical markers allows for the position of the device to be known and produces predictable results (p.[0090-0091]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Holthuizen and Vrba in view of Roh (US Patent No. 11,950,851).
Regarding claim 20, the limitations of claim 13 are taught as described above. Holthuizen/Vrba does not teach the use of an ablation needle for tumor treatment, but Roh does in an analogous image analysis device for navigation in tissue. Roh teaches in col. 14, lines 19-23] that the treatment may be for tumor tissue, and further in col. 11, lines 26-29, ablation needles can be used to treat desired tissue, therefore teaching the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Roh in Holthuizen. As stated in Roh, the use of the imaging system in addition to a treatment means allows for more effective treatment to reduce surgical time and likelihood of injury and improve the chance of positive patient outcomes (col. 4, lines 9-27).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights