DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 04/06/2026 have been fully considered but they are not persuasive.
Regarding the amendments to claim 1, the rejections under 35 USC 102 have been withdrawn. However, newly-found reference of Cermak has been introduced to teach the amended limitation. Examiner asserts that the combination of Burkholz and Cermak reads on the full scope of the claim.
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 limitation(s) is/are: “electro-mechanical guide adjustment mechanism” in claim 6, “probe orientation monitoring system” in claim 9, and “needle tracking system” in claim 10.
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.
Regarding “electro-mechanical guide adjustment mechanism”, [0043] of the specification states “The electro-mechanical mechanism 140 may include a number of electro-mechanical actuators, such as rotational motors, linear motors, or solenoids, for example along with other mechanical elements to facilitate adjustment of the position and/or orientation of the needle guide connector 130 based on electrical signals defined by the guide position logic 134. The electro-mechanical mechanism 140 may be configured to adjust one or more of a longitudinal position, a lateral position, or orientation of the needle guide connector 130 with respect to the head portion 121/longitudinal axis 227, where the orientation includes an angle of the needle guide connector 130 with respect to the longitudinal axis 227”. Therefore, “electro-mechanical guide adjustment mechanism” has been interpreted to be equivalent to the electro-mechanical mechanism 140, which is any electoral-mechanical device capable of adjusting a longitudinal position, lateral position, orientation of the needle guide connector.
Regarding “probe orientation monitoring system”, [0040] of the specification states “The probe orientation monitoring system 146 may include a gyroscope and/or an inertial measurement unit (IMU) to determine the orientation and/or an orientation disturbance of the probe 120”. Therefore, “probe orientation monitoring system” has been interpreted to be any device capable of determining the orientation of the probe.
Regarding “needle tracking system”, [0041] of the specification states “The optional needle tracking system 147 is generally configured to monitor (e.g., magnetically monitor) the position and/or orientation of a needle with respect to the probe 120 during use”. Therefore, “needle tracking system” has been interpreted to be a computerized system capable of monitoring the position and/or orientation of the needle.
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 § 102
Rejections under 35 USC 102 have been withdrawn in response to Applicant’s amendments filed 04/02/2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6-7, & 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 2020/0230391) in view of Cermak (US 2016/0128719).
Regarding claim 1, Burkholz teaches an ultrasound system, comprising:
an ultrasound probe (US probe 175, [0039]) having:
a head portion (Figure 7B) configured to obtain ultrasound image data ([0039]);
a guide connector (drive mechanism, [0105]) protruding from the head portion (Figure 7B), the guide connector operatively coupled with the ultrasound probe via an electro-mechanical guide adjustment mechanism (one or more motors, [0107]) of the ultrasound probe, wherein the electro-mechanical guide adjustment mechanism facilitates a linear adjustment of a position of the guide connector (“the drive mechanism 201 may include…linear motors”, [0107]) and an angular orientation of the guide connector (“the drive mechanism 201 may include…rotational motors”, [0107]) with respect to the head portion ([0107]); and
a needle guide (catheter 213 of VAD 200, [0067], [0105], & [0107]) coupled with the guide connector (Figure 7B), the needle guide including a needle channel (Figure 7B), wherein the needle channel:
is configured to define a lateral position and an angle (Figure 7B) of a needle (needle, [0105]) disposed within the needle channel with respect to the needle guide (Figure 7B); and
enables distal sliding displacement of the needle with respect to the needle guide during insertion of the needle into the patient ([0107]).
However, Burkholz fails to disclose that the needle guide includes a pocket configured to receive the needle guide connector.
Cermak teaches that the needle guide (needle guide device 20, [0068], Figure 1) includes a pocket (window 38, [0069], Figure 6) configured to receive the needle guide connector (coupling member 16, [0068], Figure 3) (Figure 7).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Burkholz such that the needle guide includes a pocket configured to receive the needle guide connector, as taught by Cermak. This configuration allows the needle guide to be removed from the ultrasound probe, facilitating a simpler replacement process if one or more components requires replacement, or a disassembly for ease of transporting the probe.
Regarding claim 6, Burkholz in view of Cermak teach the ultrasound system of claim 1, and Burkholz further teaches:
one or more processors (processor, [0045]); and
a non-transitory computer-readable storage medium (computer readable program code, [0045]) having logic stored thereon that, when executed by the one or more processors, performs operations that include automatically adjusting the position and/or the angular orientation of the guide connector with respect to the head portion via the electro-mechanical guide adjustment mechanism ([0045]).
Regarding claim 7, Burkholz in view of Cermak teach the ultrasound system of claim 6, and Burkholz further teaches that the operations further include: receiving a desired entry point and/or a desired insertion angle ([0077] & [0081]-[0082]) of the needle from a clinician (clinician or other HCP, [0077]) via a user input device (video display device 110, [0077]) of the system, and automatically adjusting the position and/or the angle of the needle guide with respect to the head portion based on the desired entry point and/or the insertion angle ([0081]-[0082]).
Paragraph [0082] teaches that the clinician may select a projected position 191; [0081] teaches that the angle and position of the needle are adjusted to target the projected position 191.
Regarding claim 9, Burkholz in view of Cermak teach the ultrasound system of claim 6, and Burkholz further teaches a probe orientation monitoring system configured to determine at least an orientation of the ultrasound probe, wherein the operations further include: receiving probe orientation data from the probe orientation monitoring system, and automatically adjusting the angular orientation of the guide connector with respect to the head portion based on the probed orientation data (“Once the trajectory is calculated, the trajectory may be used during automatic insertion of the VAD by a VAD advancement system”, [0077]; [0081], [0105], & [0107]).
In order for the angle of the needle to be adjusted to reach the target area, as is taught in [0081], the initial angle must be known. Because, per [0105] & [0107], the drive mechanism 201 controls the angle and position of the needle, the angle and position of the needle corresponds to the angle and position of the drive mechanism 201 (guide connector).
Regarding claim 10, Burkholz in view of Cermak teach the ultrasound system of claim 6, and Burkholz further teaches a needle tracking system configured to determine a position and an angle of the needle with respect to the ultrasound probe when the needle is disposed within the needle channel, wherein the operations further include: receiving needle tracking data from the needle tracking system, and automatically adjusting the position and/or the angular orientation of the guide connector with respect to the head portion based on the probed orientation data (“Once the trajectory is calculated, the trajectory may be used during automatic insertion of the VAD by a VAD advancement system”, [0077]; [0081], [0105], & [0107]).
In order for the angle of the needle to be adjusted to reach the target area, as is taught in [0081], the initial angle must be known. Because, per [0105] & [0107], the drive mechanism 201 controls the angle and position of the needle, the angle and position of the needle corresponds to the angle and position of the drive mechanism 201 (guide connector).
Regarding claim 11, Burkholz in view of Cermak teach the ultrasound system of claim 6, and Burkholz further teaches that the operations further include:
obtaining ultrasound image data of a target area of a patient from the head portion of the ultrasound probe ([0039]);
identifying at least a target blood vessel (blood vessel 125, [0039]) within the image data ([0039]); and
automatically adjusting the position and/or the angular orientation of the guide connector with respect to the head portion based on the ultrasound image data ([0081]).
Regarding claim 12, Burkholz in view of Cermak teach the ultrasound system of claim 11, and Burkholz further teaches that operations further include automatically adjusting the position and/or the angular orientation of the guide connector with respect to the head portion to define an entry point and/or an insertion angle of the needle with respect to the identified target blood vessel ([0081]-[0082]).
Regarding claim 13, Burkholz in view of Cermak teach the ultrasound system of claim 12, and Burkholz further teaches that the operations further include:
identifying the target blood vessel ([0039]) and at least one other anatomical structure ([0133]); and
automatically adjusting the position and/or the angular orientation of the guide connector with respect to the head portion to further define the entry point and/or the insertion angle of the needle such that a longitudinal axis of the needle avoids the at least one other anatomical structure ([0133]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Cermak, as applied to claim 7, above, in further view of Orome (US 2012/0165679).
Regarding claim 8, Burkholz in view of Cermak teach the ultrasound system of claim 7, and Burkholz further teaches: the electro-mechanical guide adjustment mechanism further facilitates a lateral linear adjustment of the position of the guide connector with respect to the head portion ([0105] & [0107]), and the operations further include automatically adjusting the lateral position of the needle guide to centrally align the needle channel that defines the desired insertion angle ([0081]-[0082], [0105], & [0107]).
However, Burkholz in view of Cermak fail to disclose that the needle guide includes two or more needle channels disposed laterally with respect to each other, each needle channel defining an insertion angle that is different from the other needle channels.
Orome teaches that the needle guide includes two or more needle channels disposed laterally with respect to each other (guide channel 20A-C, [0021] & Figure 1), each needle channel defining an insertion angle that is different from the other needle channels ([0021]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system taught by Burkholz and Cermak such that the needle guide includes two or more needle channels disposed laterally with respect to each other, each needle channel defining an insertion angle that is different from the other needle channels, as taught by Orome. Each needle channel can define a different angle of reproach for insertion depth, allowing the user to select the most appropriate needle channel to reduce the overall amount of adjustment. Additionally, these can be used to insert multiple needles into a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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