DETAILED ACTION
This Office action is responsive to communications filed on 08/18/2026. Claims 1-10 have been amended. Presently, Claims 1-10 remain pending and are hereinafter examined on the merits.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Priority documents received on 08/18/2026 are accepted.
Previous objections to the Drawings are withdrawn in view of the replacement sheets filed on 08/18/2026.
Previous claim objections are withdrawn in view of the amendments filed on 08/18/2026.
Previous interpretations under 35 USC § 112(f) for the phrases: “image fusion module”, “display module”, “ultrasound image calibration unit”, “ablation probe calibration unit”, “coordinate unification unit”, & “three-dimensional reconstruction unit” are withdrawn in view of the amendments filed on 08/18/2026, while previous interpretations under 35 USC § 112(f) for the phrase: “electromagnetic positioning reading device” is NOT withdrawn in view of the amendments filed on 08/18/2026.
Previous rejections under 35 USC § 112(a) are withdrawn in view of the amendments filed on under 35 USC § 112(f) for the phrases: “image fusion module”, “display module”, “ultrasound image calibration unit”, “ablation probe calibration unit”, “coordinate unification unit”, & “three-dimensional reconstruction unit” are withdrawn in view of the amendments filed on 08/18/2026, while Previous rejections under 35 USC § 112(a) for the phrase: “electromagnetic positioning reading device” is NOT withdrawn in view of the amendments filed on 08/18/2026.
Previous rejections under 35 USC § 112(b) are for claim 6 regarding the lack of antecedence is withdrawn in view of the amendments filed on 08/18/2026, while previous rejections under 35 USC § 112(b) are for claim 1-2 & 6-9 NOT withdrawn in view of the amendments filed on 08/18/2026.
Claims 6-9 are rejection under 35 USC § 112(b) is being indefinite. Claims 6 depends on a system claim (claim 2) and appears to recite method steps and its unclear what components of the system performs those steps. Claims 6-9 should be directed to further limiting the structure of the system. The amendments filed do not attempt to address this 35 USC § 112(b). Appropriate correction is required.
The Applicant’s arguments regarding the 35 USC § 112(a), have been fully considered regarding the alleged structure for “electromagnetic positioning reading device”, have been found to be unpersuasive.
There is no supporting structure for “electromagnetic positioning reading device”. In fact, the specification does not describe any internal hardware components of the electromagnetic positioning reading device itself or a first processor or second processor. The specification describes the electromagnetic positioning reading device integration, and coordinate acquisition, and trajectory and tracking positions. The Applicant’s characterization of that the system can utilize mutli-thread or CPU fast calculation, ¶0118, as the structure for the “electromagnetic positioning reading device” and one or more first and second processors is incorrect. The specifciation does not specify that this is the CPU housed directly with the electromagnetic positioning reading device to perform its corresponding functions. The CPU/GPU is only mentioned in the context of acceleration and parallel computing for image processing. The hardware-level processing details are not in the specification for how the electromagnetic positioning reading device and the first and second processor calculate coordinates and trajectory positioning as described in the claims. The CPU/GPU processing references are reserved for 3D ultrasound image reconstruction and overall speed. Its reliance to perform these functions as described in the claims is improper and not proper written description for the alleged structure. Accordingly, there is nothing to suggest in the specification that one or more processors are configured to perform the corresponding operations of the claims.
For these reasons, the 35 USC § 112(a) is maintained.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f), 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f), is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
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) 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) because the claim limitations use 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:
The nonce term “electromagnetic positioning reading device” is used in claim(s) 1-2, for acquiring real-time coordinates of the sensors invokes 35 USC 112(f) & uses a generic placeholder that is coupled with functional language without reciting sufficient structure.
The term, “device” & “unit” & “module” are a non-structural generic placeholder that does not include any specific structure for performing the accompany functions. See MPEP 2181.I.A: The following is a list of non-structural generic placeholders that may invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, paragraph 6: "mechanism for," "module for," "device for," "unit for," "component for," "element for," "member for," "apparatus for," "machine for," or "system for." Welker Bearing Co., v. PHD, Inc., 550 F.3d 1090, 1096, 89 USPQ2d 1289, 1293-94 (Fed. Cir. 2008); Massachusetts Inst. of Tech. v. Abacus Software, 462 F.3d 1344, 1354, 80 USPQ2d 1225, 1228 (Fed. Cir. 2006); Personalized Media, 161 F.3d at 704, 48 USPQ2d at 1886–87; Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1214-1215, 48 USPQ2d 1010, 1017 (Fed. Cir. 1998).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) they 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 these limitations interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f).
Please note that for the purposes of this examination the following phrases, “electromagnetic positioning reading device” are interpreted as a generic processor as performing the respective claimed functions and equivalents thereof.
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.
As discussed above, the claim limitations below are interpreted under 35 U.S.C. 112 (f).
Claims 1: “electromagnetic positioning reading device comprising one or more first processors”.
Claims 1-2: “electromagnetic positioning reading device”.
Claims 1-2, ‘one or more first processors’.
Claims 2, 4-6, ‘one or more second processors’.
In the specification, at least ¶Abstract, ¶0005, ¶0010, ¶0063, &¶0116 mention the term “electromagnetic positioning reading device” and its corresponding functions and equivalents thereof.
There is no evidence or support for a processor to perform the function and algorithms of the one or more first & second processors & for the electromagnetic positioning reading device to comprise one or more first processor. In fact, there is no mention of a processor in the specification. The specification does not specify or correlate any computing and/or hardware like a dedicated processor within the electromagnetic positioning reading device itself. In addition, the specification does not in any way provide relational context that this CPU/GPU in ¶0118 perform the task of the one or more first and second processors. The CPU/GPU is only mentioned in the context of acceleration and parallel computing for image processing. In summary, the hardware-level processing details are not in the specification for how the electromagnetic positioning reading device and the second processor calculate coordinates and trajectory positioning, and the CPU/GPU processing references are reserved for 3D ultrasound image reconstruction and overall speed. Its reliance to perform these functions as described in the claims is improper and not proper written description for the alleged structure. Accordingly, there is nothing to suggest in the specification that one or more processors are configured to perform the corresponding operations of the claims.
The drawings do not provide any further detail for these terms. However, one of ordinary skill in the art would not understand the specification, the drawing and the original claims to disclose any particular structure that achieves the disclosed functionality.
These limitations fail to comply with the written description requirement as the limitations are unbound functional imitations which cover all ways of performing the respective functions and inventor has not provided sufficient disclosure to show possession of such an invention. The limitations therefore fails to comply with the written description requirement. See MPEP 2181.II.A.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claims 6-9 are rejection under 35 USC § 112(b) is being indefinite. Claims 6 depends on a system claim (claim 2) and appears to recite method steps and its unclear what components of the system performs those steps. Claims 6-9 should be directed to further limiting the structure of the system. Appropriate correction is required.
The following claim limitations invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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:
Claims 1-2: “electromagnetic positioning reading device”.
For examination purposes, the Examiner assumes these following phrases, “electromagnetic positioning reading device” are interpreted as a generic processor as performing the respective claimed functions and equivalents thereof.
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.
The dependent claims of the above rejected claims are rejected due to their dependency.
Allowable Subject Matter
Claim 1 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) and 35 USC § 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:
The limitations recited in claims 1 in regard to the feature of “so as to obtain a real-time movement trajectory of the second electromagnetic positioning sensor relative to the first electromagnetic positioning sensor, thereby determining whether a real-time needle insertion trajectory of the puncture needle body portion entering a human body conforms to a system-default needle insertion trajectory.”, in combination with the other claimed elements are not taught or disclosed in the prior art.
The prior arts relevant to the claimed invention are cited below:
XIAOJIAN (CN 113855244 A) discloses, a surgical robot for pain treatment with magnetic navigation technology and ultrasonic imaging for puncture procedures, ¶Abstract. The system includes a robotic arm and at the end of this arm, a first quick installation device 3, the puncture part 3 with the puncture needle, FIG. 1. The system features an electromagnetic navigation module and reading device (i.e., the electromagnetic tracking system connected to the control console) which acquires and tracks the positions of the sensors in the coordinate system, ¶0011, ¶0014, ¶0028-0032. The first electromagnetic positioning sensor 5, the second electromagnetic positioning sensor 6. The system acquires the coordinates in real-time, ¶0028-0032, ¶0057. Xiaojian fails to disclose: a handle portion, that the second electromagnetic positioning sensor is slidably sleeved on the puncture needle body portion, a coordinate acquisition so as to obtain a real-time movement trajectory of the second electromagnetic positioning sensor sliding relative to the first electromagnetic positioning sensor, thereby determining whether a real-time needle insertion trajectory of the puncture needle body portion entering a human body conforms to a system-default needle insertion trajectory.
Paltieli et al (US 20030163142 A) discloses, a puncture instrument with a handheld portion and a puncture needle body portion, FIG. 16 while linking via coordinate acquisition the transmitter and receivers. Paltieli fails to disclose that one sensor is adjacent to the handheld portion while the second sensor is slidably sleeved on the needle body, see ¶0004, ¶0050-0051, ¶0109. Paltieli movement comparison is directed to relative vectors and positions of the sensors for navigation and safety detection, ¶0050, ¶0109, ¶0113-0114, rather than comparing the movement to a default path.
Pelissier et al (US 20100298705 A1) discloses, a puncture instrument a handheld portion and needle body, ¶0131, FIG. 1. The EM sensors disclose a 3D positioning system 16 that includes a position base unit 17 (i.e., reading device) and multiple EM sensors, ¶¶0128-¶0129, ¶0131. Pelissier acquires real-time spatial locations of the position markers to determined pose and trajectory of the needle, ¶¶0128-0129. Pelissier fails to disclose a slidable sleeved EM sensor, determining the movement relative to the first sensor, thereby determining whether a real-time needle insertion trajectory of the puncture needle body portion entering a human body conforms to a system-default needle insertion trajectory.
Liu et al (US 20150051482 A1) discloses, two EM sensors (264, 266, FIG. 12). The axillary tracker 266 is fixed along the shaft adjacent to the proximal hub. The shaft tracker 264 encircles the shaft and is moveable (i.e., slidable) along the shaft, and is located between the distal tip and the auxiliary tracker away form the hub, ¶0036-0037. Liu fails to disclose: obtaining coordinates to acquire a real-time movement trajectory of ono sensor relative to another, (i.e., the slidable second electromagnetic sensor on the puncture needle portion relative to the first electromagnetic sensor), to thereby determining whether a real-time needle insertion trajectory of the puncture needle body portion entering a human body conforms to a system-default needle insertion trajectory.
Any comments considered necessary by applicant must be submitted no later than the payment
of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such
submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 Nicholas Robinson whose telephone number is (571)272-9019. The examiner can normally be reached M-F 9:00AM-5:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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