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 .
Status of Claims
Claims 1-20 are pending in this application. Claims 15-18 and 20 are withdrawn, and Claims 1-14 and 19 have been examined on the merits.
Election/Restrictions
Claims 15-18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention II and Invention III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/04/2025.
The species restriction of Group I between species A-B (Claims 6 and 7) and Group II between species A-C (Figures 1-3) have been withdrawn by the examiner after reconsideration of the examination burden.
Applicant's election with traverse of Invention I in the reply filed on 11/04/2025 is acknowledged. The traversal is on the ground(s) that Inventions I and II significantly overlap and the differences amounting to variations in claim scope of the same general invention. Further, Inventions I and III are claimed to significantly overlap and the differences amounting to variations in claim scope of the same general invention, with the surgical catheter being a cylindrically shaped object, thereby being the same general invention. Further, inventions II and III are claimed to significantly overlap and the differences amounting to variations in claim scope of the same general invention, with the surgical catheter being a cylindrically shaped object, thereby being the same general invention. This is not found persuasive because Inventions I and II are still different in Invention I being drawn to a surgical apparatus and Invention II being drawn to a system. Further, Invention I and Invention III are drawn to different inventions (a surgical apparatus vs a snap tool). Further, Inventions II and III are different as Invention II is drawn to a system while Invention III is drawn to a snap tool. There remains a serious search burden as the inventions have a separate status in the art in view of their different classification. Further, due to the varied inventions, they diverge in subject matter and thereby require a different field of search. Further, the prior art applicable to one invention would not likely be applicable to another invention.
The requirement is still deemed proper and is therefore made FINAL.
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 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:
In claim 1 “the longitudinal groove is configured to snap onto and hold a surgical catheter”. The limitation is interpreted as an opening which holds the catheter in place ([0049] “longitudinal groove 415 can include an opening along some or all of its bottom surface to facilitate snapping a catheter in place and also removing the catheter from the groove. Main body 410, or at least its region surrounding groove 415, can be formed from a material having enough flexibility to snap a catheter into the groove such that the catheter is then fixed in place with respect to the groove and the overall surgical catheter snap too”).
In Claim 3 “surgical apparatus is configured to function as a surgical fiducial marker localizer and also as a surgical catheter positioner”. The limitation is interpreted as a specific part of the apparatus (the pointed nose) being a reference point, which acts as a reference point (localizer/positioner) ([0050] “and it will be understood that such other variations and/or other features on surgical catheter snap tool400 can also or alternatively serve as known reference points to facilitate a localizer function of the tool”).
In claim 4 “surgical apparatus is configured to be handheld and used manually by a surgeon during a surgical procedure”. The limitation is interpreted as a device with a grip region allowing for manual use ([0054] “Main body 510 can similarly define a longitudinal axis therethrough and can similarly have a front end, back end, grip region 513 at a first side surface, and indentation 514 at a second side that can combine with the grip region to facilitate a good handheld grip of the main body and overall surgical catheter snap tool500.”).
In Claim 13 “surgical apparatus is configured such that the distances between the pointed nose and each fiducial marker site and the distances between all fiducial marker sites all remain constant during a surgical procedure”. The limitation is interpreted as the pointed nose and fiducial markers all being rigid and not moving during procedures after being marked at specific locations ([0050] “the distances between pointed nose 416 and some or all fiducial markers coupled to fiducial marker sites 430 can all remain at known constants during a surgical procedure, such that the front edge of pointed nose 416 can serve as a known reference location as the separate augmented reality system interacts with the fiducial markers”).
In Claim 14 “the pointed nose is configured to contact a patient”. The limitation is interpreted as the pointed nose contacting the patient as a reference point (“pointed nose 416 can have a blunted tip or other suitable feature such that it is configured to contact a patient safely or to contact another item to be referenced during a surgical procedure involving an augmented reality system”).
In Claim 14 “the pointed nose and is configured to position a front end of the surgical catheter”. The limitation is interpreted as the pointed nose acting as an extension and directly pointing towards the position of interest (patient) ([0051] “Longitudinal groove 415 can end beneath pointed nose 416 and can be configured to position a front end or front region of a surgical catheter held therein directly beneath the pointed nose to facilitate orientation of the catheter with respect to a patient during a surgical procedure. The surgical catheter can have a front end located at or proximate pointed nose 416, or the front end of the catheter can extend at a distance past the pointed nose such that a front region of the catheter is at the pointed nose”).
In Claim 19 “the system… is configured to function as a surgical fiducial marker localizer” The limitation is interpreted as a specific part of the apparatus (the pointed nose) being a reference point, which acts as a reference point (localizer/positioner) ([0050] “and it will be understood that such other variations and/or other features on surgical catheter snap tool400 can also or alternatively serve as known reference points to facilitate a localizer function of the tool”).
In Claim 19, “the system… is configured to function as a surgical catheter positioner”. The limitation is interpreted as a specific part of the apparatus (the pointed nose) being a reference point, which acts as a reference point (localizer/positioner) ([0050] “and it will be understood that such other variations and/or other features on surgical catheter snap tool400 can also or alternatively serve as known reference points to facilitate a localizer function of the tool”).
In Claim 19 “the system… is configured to be handheld and used manually by a surgeon during a surgical procedure”. The limitation is interpreted as a device with a grip region allowing for manual use ([0054] “Main body 510 can similarly define a longitudinal axis therethrough and can similarly have a front end, back end, grip region 513 at a first side surface, and indentation 514 at a second side that can combine with the grip region to facilitate a good handheld grip of the main body and overall surgical catheter snap tool500.”).
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 § 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.
Claims 3, 8-10, and 19 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.
Claim 3 recites the limitation of “a surgical fiducial marker localizer”. It is unclear what is meant by a localizer, and whether the apparatus is determining where the fiducial markers are, or if it is an apparatus with fiducial markers to assist with localizing distances. For purposes of examination, the limitation will be construed as an apparatus with fiducial markers to assist in localizing the unknown distances. However, further clarification is required.
Further, claim 3 recites the limitation of “a surgical catheter positioner”. It is unclear whether the apparatus itself has mechanisms of positioning the surgical catheter to a specific location, or if it is to position the catheter into place within the apparatus. For purposes of examination, the limitation will be construed as an apparatus that holds the surgical catheter into a secure position. However, further clarification is required.
Claim 8 recites the limitation “all fiducial marker sites are arranged in a pattern that is asymmetrical with respect to the longitudinal axis”. It is unclear in what respect the pattern of the marker sites are asymmetrical. Although [0053] in the Specifications recites “all fiducial marker sites 430 on surgical catheter snap tool400 can be arranged in an overall pattern that is asymmetrical with respect to longitudinal axis”, it is not clear whether the fiducial marker sites are asymmetrical by being at different angles, how they are asymmetrical, etc.. For purposes of examination, the limitation will be construed to be any arrangement of fiducial marker sites with no specific or particular distance between each one. However, further clarification is required.
Claim 9 recites the limitation of “a total of four fiducial marker sites”. It is unclear whether there must be exactly four fiducial marker sites, as Claim 5, which Claim 9 depends upon recites the limitation “one or more additional fiducial marker sites”, indicating that there can be one fiducial marker site. Further, [0053] of the Specifications recites that fewer fiducial marker sites may be used (“While exactly four fiducial marker sites 430 are shown on surgical catheter snap tool400 in the illustrative example provided herein, it will be understood that more or fewer fiducial marker sites may alternatively be used”). For purposes of examination, the limitation will be construed one or more fiducial marker sites. However, further clarification is required.
Claim 10 recites the limitation “fiducial marker sites are each configured to removably couple to an infrared reflective sphere as a fiducial marker”. It is unclear what is meant to removably couple the fiducial marker site to an infrared reflective sphere as a fiducial marker. For purposes of examination, the limitation will be construed to be infrared reflective spheres, which are fiducial markers, can be removed from the fiducial marker sites. However, further clarification is required.
Claim 19 recites the limitation “a separate augmented reality system”. It is unclear what is meant by a separate augmented reality system and whether it is separate from the system itself, or if there is a distinguishment between another augmented reality system, which is not disclosed in Claim 1. For purposes of examination, the limitation will be construed as an augmented reality system to be in use with the system. However, further clarification is required.
Claim limitation “surgical apparatus is configured for use with an augmented reality system” in claim 2 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. [0050] in the Specifications provides some detail in parts of the apparatus being used with an augmented reality. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Further, claim limitation “one or more fiducial marker sites are each configured to removably couple to an infrared reflective sphere as a fiducial marker” in claim 10 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. [0057] in the Specifications recites that the “Fiducial markers 650 can be removably coupled to the fiducial marker sites on surgical catheter snap tool”, but does not discuss how they are removably coupled. The written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-4, and 10-11, are rejected under 35 U.S.C. 103 as being unpatentable over Bratbak (US20210322107A1) in view of Burkholz (US20190321599A1)
Regarding Claim 1,
Bratbak teaches a surgical apparatus, comprising: an elongated main body defining a longitudinal axis and having a front end, a back end, a top surface, first and second side surfaces, and a bottom surface (corresponding disclosure in at least Figure 3, where there is an elongated body, which has a longitudinal axis, front end, back end, top surface, and a first and second side surface, and a bottom surface), wherein the elongated main body includes:
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Figure 3 of Bratbak
one or more fiducial marker sites configured to host fiducial markers at the top surface (corresponding disclosure in at least [0038] and Figure 3, where there are markers that are on the top surface “the navigation array may consist of optically detectable markers such as two dimensional (i.e. flat) or three-dimensional markers”),
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Figure 3 of Bratbak
a grip region at the first side surface (corresponding disclosure in at least Figure 3, where there is a grip region on the side surface), and
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Figure 3 of Bratbak
a longitudinal axis at the bottom surface and extending from the front end to the back end (corresponding disclosure in at least Figure 3 and [0061], where a surgical instrument is held into the configuration “The body 23 has the rigid lumen 19 fixedly mounted thereon such that the lumen 19 is fixed relative to a position of the body 23 and houses the needle 18 in a slidably movable manner. The instrument 15 also has a syringe 27 connected to the needle 18 via the proximal piece 25. The syringe 27 can be coupled to the needle 18 using any suitable coupling mechanism”)
Bratbak does not teach the longitudinal groove and wherein the longitudinal groove is configured to snap onto and hold a surgical catheter therein.
Burkholz, in a similar field of endeavor, teaches a similar concept (surgical navigation systems) of the longitudinal groove and wherein the longitudinal groove is configured to snap onto and hold a surgical catheter therein (corresponding disclosure in at least [0065], where there is a longitudinal groove to where the catheter can be connected into “an upper surface 74 of the stabilization feature 72 may include a groove 76, which may be aligned with a longitudinal axis of the catheter 20”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a longitudinal groove to snap and hold a surgical instrument as taught by Burkholz. One of the ordinary skill in the art would have been motivated to incorporate this because the grooves help serve as more secure fitting so the instrument will not move during procedures.
Regarding Claim 3, the combined references of Bratbak and Burkholz teach the limitations of Claim 1, and further teaches wherein the surgical apparatus is configured to function as a surgical fiducial marker localizer (corresponding disclosure in at least [0039] of Bratbak, where the markers are used to localize the unknown space relative to the instrument “the navigation array is optically detectable and it comprises reflectors comparable to those described above in relation to the calibrator. This allows for easy detection of the navigation array along with the calibrator. The reflectors may be located in plane with one another and at known irregularly spaced known locations relative to the tip of the instrument”)
and also as a surgical catheter positioner (corresponding disclosure in at least [0070], where the apparatus (the connector) is a positioner for the catheter (the catheter can be positioned into the apparatus) “the safety mechanism 69 may be disposed in and/or selectively coupled to the needle hub 70, the catheter 12, and/or the connector 30. In some embodiments, the safety mechanism 69 may be disposed in and/or selectively coupled to another connector, such as a needleless connector, which may be positioned between the connector 30 and the needle hub 70”).
Regarding Claim 4, the combined references of Bratkbak and Burkholz teach the limitations of Claim 1, and Bratbak further teaches wherein the surgical apparatus is configured to be handheld and used manually by a surgeon during a surgical procedure (corresponding disclosure in at least [0036] and Figure 3, where the device is handheld and manually used “These relatively small sizes help to ensure that the calibrator remains lightweight and can be handheld” and Figure 3 demonstrates the user holding the device.
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Figure 3 of Bratbak
Regarding Claim 10, the combined references of Bratbak and Burkholz teach the limitations of Claim 1, and Bratbak further teaches wherein the one or more fiducial marker sites are each configured to removably couple to an infrared reflective sphere as a fiducial marker (corresponding disclosure in at least [0028], where the sphere markers (reflector) can be removed from the site (adapter) “The adapter may be removably connected to the reflector such that a single reflector can be connected to and removed from a number of different adapters. Similarly, a single adapter can be connected to and removed from a number of different reflectors”)
Regarding Claim 11, the combined references of Bratbak and Burkholz teach the limitations of Claim 1, and Bratbak further teaches wherein the elongated main body further includes an indentation at the second side surface proximate and opposite to the grip region (corresponding disclosure in at least Figure 1, where there is an indentation on the side, which allows for the thumb to be positioned).
Bratbak discloses the claimed invention except for the indentation being at the second side surface proximate and opposite to the grip region It would have been obvious to one having ordinary skill in the art at the time the invention was made to have added the indentation towards the front portion of the device close to the grip region, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
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Figure 1 of Bratbak
Claims 2 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Bratbak (US20210322107A1) and Burkholz (US20190321599A1) as applied in Claim 1, and in further view of Corndorf (US20190053860A1).
Regarding Claim 2, the combined references of Bratbak and Burkholz teach the limitations of Claim 1, but does not teach wherein the surgical apparatus is configured for use with an augmented reality system.
Corndorf, in a similar field of endeavor, teaches a similar concept (surgical navigation systems) of wherein the surgical apparatus is configured for use with an augmented reality system (corresponding disclosure in at least [0065] and Figure 3, where the surgical apparatus (instrument) is used with augmented reality “FIG. 3 illustrates a schematic diagram of another example, non-limiting instrument 106 that facilitates surgery using augmented reality in accordance with one or more embodiments described herein”).
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Figure 3 of Corndorf
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of a surgical apparatus with augmented reality as taught by Corndorf. One of the ordinary skill in the art would have been motivated to incorporate this because augmented reality assists the view of the surgeon when facilitating surgical procedures.
Regarding Claim 19, the combined references of Bratbak and Burkholz teach the limitations of Claim 1, and further teaches wherein a surgical fiducial marker localizer (corresponding disclosure in at least [0039] of Bratbak, where the markers are used to localize the unknown space relative to the instrument “the navigation array is optically detectable and it comprises reflectors comparable to those described above in relation to the calibrator. This allows for easy detection of the navigation array along with the calibrator. The reflectors may be located in plane with one another and at known irregularly spaced known locations relative to the tip of the instrument”), is configured to function as a surgical catheter positioner (corresponding disclosure in at least [0070], where the apparatus (the connector) is a positioner for the catheter (the catheter can be positioned into the apparatus) “the safety mechanism 69 may be disposed in and/or selectively coupled to the needle hub 70, the catheter 12, and/or the connector 30. In some embodiments, the safety mechanism 69 may be disposed in and/or selectively coupled to another connector, such as a needleless connector, which may be positioned between the connector 30 and the needle hub 70”), and is configured to be handheld and used manually by a surgeon during a surgical procedure (corresponding disclosure in at least [0036] and Figure 3 of Bratbak, where the device is handheld and manually used “These relatively small sizes help to ensure that the calibrator remains lightweight and can be handheld” and Figure 3 demonstrates the user holding the device, but does not teach wherein the system is configured for use with a separate augmented reality system.
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Figure 3 of Bratbak
Corndorf, in a similar field of endeavor, teaches a similar concept (surgical navigation systems) of wherein the surgical apparatus is configured for use with an augmented reality system (corresponding disclosure in at least [0065] and Figure 3, where the surgical apparatus (instrument) is used with augmented reality “FIG. 3 illustrates a schematic diagram of another example, non-limiting instrument 106 that facilitates surgery using augmented reality in accordance with one or more embodiments described herein”).
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Figure 3 of Corndorf
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of a surgical apparatus with augmented reality as taught by Corndorf. One of the ordinary skill in the art would have been motivated to incorporate this because augmented reality assists the view of the surgeon when facilitating surgical procedures.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Bratbak (US20210322107A1) and Burkholz (US20190321599A1) as applied in Claim 1, and in further view of Maracaja-Neto (US20160199148A1).
Regarding Claim 5, the combined references of Bratbak and Burkholz teach the limitations of Claim 1, but do not teach one or more arms extending laterally from the elongated main body,
wherein each of the one or more arms includes one or more additional fiducial marker sites configured to host one or more additional fiducial markers at a top surface thereof (corresponding disclosure in at least [0059] and Figure 1, where there are fiducial markers (optical markers) on top of the device which are all hosted on a markersite “ optical tracking system 1 of the invention according to the location of the optical markers 22, 23 and 24 in FIG. 1. After establishing spatial coordinates the first reference point, ongoing motion of the tip may be tracked using the motion of the external markers 22-24”).
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Figure 1 of Maracaja-Neto
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated one or more arms with additional fiducial marker sites as incorporated by Maracaja-Neto. One of the ordinary skill in the art would have been motivated to incorporate this because the additional markers provide information of the location and position of the device during procedures.
Regarding Claim 6, the combined references noted above teach the limitations of Claim 5, and Maracaja-Neto further teaches wherein the one or more arms are integrally formed with the elongated main body (corresponding disclosure in at least Figure 1, where the arms are integrally formed with the main body).
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Figure 1 of Maracaja-Neto
Regarding Claim 7, the combined references noted above teach the limitations of Claim 5, and Maracaja-Neto further teaches wherein the one or more arms include two arms that extend from the back end of the elongated main body on opposite sides of the longitudinal axis (corresponding disclosure in at least Figure 4, where there are arms towards the back which are on opposite sides).
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Figure 4 of Maracaja-Neto
Regarding Claim 8, the combined references noted above teach the limitations of Claim 5, and Maracaja-Neto further teaches wherein all fiducial marker sites are arranged in a pattern that is asymmetrical with respect to the longitudinal axis (corresponding disclosure in at least [0014], where the fiducial markers can be of any placement or shape in any design “The fiducial can be of any design that meets the needs of the system. Some examples of a fiducial include a multi-pronged device having termini with distinguishing features, such as size, shape, color, etc. so that each individual fiducial of set of fiducials can be identified and tracked by the camera system… The arms of the fiducial can be set a predetermined angle with respect to other arms of the fiducial. In certain aspects a fiducial, arm, or termini can have reference marks identifiable by the camera system”).
Maracaja-Neto discloses the claimed invention except for the asymmetrical pattern of the fiducial marker sites. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange fiducial marker sites in any position or pattern depending on the procedure of usage of the device, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding Claim 9, the combined references noted above teach the limitations of Claim 5, and Maracaja-Neto further teaches wherein there are a total of four fiducial marker sites (corresponding disclosure in at least Figure 1, where there are three fiducial marker sites that are shown).
Maracaja-Neto discloses the claimed invention except for exactly four fiducial marker sites. It would have been an obvious matter of design choice to only include three marker sites in the figure shown, since applicant has not disclosed that the use of exactly four fiducial marker sites solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with three fiducial marker sites. Further, applicant discloses in [0053] of the Specifications that fewer fiducial marker sites may alternatively be used.
Further, Maracaja-Neto discloses the claimed invention except for the exactly four fiducial marker sites. It would have been obvious to one having ordinary skill in the art at the time the invention was made to only include three marker sites in the figure shown, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
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Figure 1 of Maracaja-Neto
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bratbak (US20210322107A1) and Burkholz (US20190321599A1) as applied in Claim 1, and in further view of Ma (US20220168547A1).
Regarding Claim 12, the combined references of Bratbak and Burkholz teach the limitations of Claim 1, but do not teach wherein the elongated main body further includes a pointed nose at the top surface of the front end.
Ma, in a similar field of endeavor, teaches a similar concept (catheter guidance) of wherein the elongated main body further includes a pointed nose at the top surface of the front end (corresponding disclosure in at least Figure 2 and [0046], where there is a pointed nose (distal opening) at the top surface of the front end “ the first catheter 12 may not extend into or through a distal opening 62”).
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Figure 2 of Ma
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the pointed nose at the top surface of the front end as taught by Ma. One of the ordinary skill in the art would have been motivated to incorporate this because the pointed nose provides as a stable guide particularly during insertions of the instrument.
Regarding Claim 13, the combined references noted above teach the limitations of Claim 12, and further teach wherein the surgical apparatus is configured such that the distances between the pointed nose (corresponding disclosure in at least Figure 2 and [0046] of Ma, where the apparatus has a pointed nose) and each fiducial marker site and the distances between all fiducial marker sites all remain constant during a surgical procedure (corresponding disclosure in at least [0063] of Bratbak, where each portion including the fiducial markers remain constant (rigid) at a fixed position, thus maintaining a constant distance between one another “The track 29 allows the navigation array 17 to slide along the body 23 in a manner that corresponds to the slide of the proximal piece 25 along the body 23. As such, the proximal piece 25, navigation array 17 and needle 18 can be slid relative to both the body 23 and the rigid lumen 19 along a primary axis of the instrument 15, whilst remaining in a fixed position relative to one another”).
Regarding Claim 14, the combined references noted above teach the limitations of Claim 12, and further teaches wherein the pointed nose is configured to contact a patient and the longitudinal groove ends beneath the pointed nose and is configured to position a front end of the surgical catheter directly beneath the pointed nose to facilitate orientation of the catheter with respect to the patient (corresponding disclosure in at least [0048]-[0049] and Figure 2 of Ma, where there is a longitudinal groove (other transition portion, which is tapered or stepped) “which ends at the pointed nose at least a portion of an outer surface of the other transition portion 60 may be tapered or stepped”. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).).
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Figure 2 of Ma
Applicant is respectfully reminded that a recitation of the intended use of the claimed 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. In the instant applicant, Ma teaches a longitudinal groove and a device with a pointed nose (which is the same as applicant's disclosed device with a longitudinal groove, which ends beneath the pointed nose; (“Longitudinal groove 415 can end beneath pointed nose 416 “ [0051]), and thus would be expected to be capable of performing the intended use claimed, e.g. configured to contact a patient, configured to position a front end of the surgical catheter directly beneath the pointed nose to facilitate orientation of the catheter with respect to the patient.
Conclusion
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/K.E.K./Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797