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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 11, 2025 and December 22, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the feature of “the ultrasound probe housing comprises an actuator that is engageable to cause the first clamping arm and the second clamping art to become unlocked from the open position” in claim 13 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The feature of “the ultrasound probe housing comprises an actuator that is engageable to cause the first clamping arm and the second clamping art to become unlocked from the open position” in claim 13 is not disclosed in the specification. In the specification [0157], it merely discloses that the tabs or other actuator is part of the ultrasound device. Neither the ultrasound probe housing nor the supporting structure is disclosed to comprise an actuator.
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:
Claims 9 and 11: “a/the mechanism that enables the first clamping arm to be secured to the second clamping arm” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “mechanism” coupled with functional language “that enables” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “mechanism”.
Claim 13: “an actuator that is engageable to cause the first camping arm and the second clamping arm to become unlocked from the open position and rotate to a closed position” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “actuator” coupled with functional language “to cause and rotate” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “actuator”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claims 9 and 11: “a/the mechanism” refers to claims 10 and 23 that recite various structural components of the mechanism.
Claim 13: “an actuator” does not have any structural disclosure in the specification. In [0157], the actuator is disclosed to be different from a tab without further explanation in regard to its structure.
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.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claim 13 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, yet neither the claim nor the specification provides the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
As discussed above, the claim limitations below are interpreted under 35 U.S.C. 112 (f).
Claim 13: “an actuator that is engageable to cause the first camping arm and the second clamping arm to become unlocked from the open position and rotate to a closed position”.
The specification [0157] discloses the functions performed by a mechanism of the ultrasound device, with exemplary mechanism being a tab or other actuator. However, one of ordinary skill in the art would not understand the specification, the drawing and the original claims to disclose any particular structure associated with the actuator that achieves the disclosed functionality.
This limitation fails 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 fail to comply with the written description requirement. See MPEP 2181.II.A.
Further because claims including a 112(f)-invoking term are interpreted as requiring the disclosed corresponding structure for that term, absent the disclosure of any such corresponding structure, the written description is insufficient to show that Applicant was in possession of the invention as claimed at the time of the invention, and such a claim must be rejected under 35 USC 112(a). (MPEP 2181.IV).
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.
The following claim limitation invokes 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:
Claim 13: the limitation of “an actuator”.
A claim with a 112(f)-invoking term must be construed as requiring the corresponding structure for that term, or its equivalents. Consequently, absent the disclosure of such corresponding structure, the metes and bounds of the claim cannot be determined, and the claim must be rejected under 112(b) as being indefinite. (MPEP 2181.III)
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
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3 and 6-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tien et al., US 2020/0187981 A1, hereinafter Tien, as evidenced by Sliwa et al., US 2009/0093761 A1, hereinafter Sliwa.
Claim 1. Tien teaches in FIG.2 and [0049]-[0052] a device (200) comprising:
an ultrasound probe housing that contains a plurality of ultrasound probes (the left transducer 220 and the right transducer 230) configured to produce images of inside a body of a patient (250), wherein
the ultrasound probe housing (201) comprises an ambient side (the top side), a body side (the bottom side that is in contact to 240), a first side (the left side) that connects the ambient side to the body side, and a second side (the right side) that connects the ambient side to the body side and that is substantially opposite to the first side, and wherein
the ultrasound probes are positioned to provide a field of view beneath the body side of the ultrasound probe housing (the field of view 221 and 231).
Tien further teaches that the device is secured to a body of a patient such that the body side of the ultrasound probe is facing toward the body of the patient ([0058]: the device may be fixed to the patient’s body by tape, belt, or the like, for “hands-free” operation).
A conventional belt for making a device wearable and hands free is known in the field of art to comprise a first clamping arm that extends from one side of the device, and a second clamping arm that extends from the opposite side of the one side of the device to secure the device to the body of the patient.
In an analogous field of endeavor for securing a medical device to a patient, this conventional configuration is evidenced by Sliwa. Sliwa teaches
a first clamping arm that extends from the first side of the ultrasound probe housing; and a second clamping arm that extends from the second side of the ultrasound probe housing (FIG.2, [0068]: straps 11; and [0076]: the straps are attached to the device sides; and [0077]: the straps are actually pliable clamping or pinching arms), wherein
the first clamping arm and the second clamping arm are configured to secure the ultrasound probe housing to a body of a patient such that the body side of the ultrasound probe is facing toward the body of the patient ([0068]: two straps 11 in FIG.2 can serve a number of useful purposes as follows: [0069]: 1) to simply hold the device 1 upon the skink, limb, organ or tissue in a given fixed (at least relative to skin or tissue surface) location).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the device of Tien employ such a feature associated with a first clamping and a second clamping that are configured to secure the ultrasound probe housing to a body of a patient, as evidenced in Sliwa that provides a detailed teaching of the clamping configuration as claimed.
Claim 2. Tien further teaches
a guide channel cut-out or aperture (510) that extends through the ultrasound probe housing from the ambient side to the body side and through the plurality of ultrasound probes (FIG.5 and FIG.2),
the guide channel cut-out or aperture being adapted to accommodate passage of a needle through the guide channel cut-out or aperture for insertion into the body of the patient such that the needle is in the field of view of the plurality of ultrasound probes upon insertion into the body of the patient ([0056]: a probe 502 includes a needle-guiding channel 510 configured for placement of a needle; and FIG2: the needle 260 is inserted through the channel 210 into the body of the patient and is in the field of view 221 and 231 of the plurality of ultrasound probes 220 and 230).
Claim 3. Tien further teaches that
the guide channel cut-out or aperture comprises a guide channel cut-out that is open on a third side of the ultrasound probe housing (FIG.5: the front side where 502 and 510 is marked is the third side as claimed), wherein the third side connects the ambient side to the body side and is adjacent to both the first side and the second side (FIG.5: the third side connects to the top surface that is the first side as claimed, and the bottom surface that is the second side as claimed, and is adjacent to the first side and the second side that are the two sides that the securing strap 515 is positioned).
Claim 6. Tien further teaches that
the first clamping arm and the second clamping arm are each integrated with the ultrasound probe housing ([0050]: the tool-guiding system 400 may include a body attachment mechanism 415, such as for example a belt or band; and FIG.5: the belt 515 is integrated with the housing 501).
For the best interest of compact prosecution, Sliwa also teaches
the first clamping arm and the second clamping arm are each integrated with the ultrasound probe housing ([0075]: the straps 11 may be permanently attached to the device 1; and [0078]: the arms might even be an integral part of the device 1 housing).
To “integrate” is broadly interpret as “to combine two or more things so that they are linked and/or they work together.
Claim 7. Sliwa further teaches that
the first clamping arm and the second clamping arm collectively form a C-shaped structure or a U-shaped structure (Claim 12: the device is attached or juxtaposed to a patient’s body…utilizing any one or more of a) any type of retainment strap, cord, chain, clamp, belt, suction or adhesive, and c) the at least partial enwrapping or surrounding of a patient limb or organ by the inherent surrounding shape of the device itself, including for a bracelet or cuff shaped device).
The inherent partial-surrounding shape of a limb is a C-shape or U-shape.
Claim 8. Sliwa further teaches that
the first clamping arm and the second clamping arm each comprise an attached end that is connected to the ultrasound probe housing ([0075]: the straps 11 may be permanently attached to the device 1 or temporarily attached).
and a free end opposite the attached end ([0087]: all manner of locking clamps or members 11) – to have a locking manner to lock the two clamping arms indicate that the opposite end of the attached end is a free end that would be incorporated with the locking manner, wherein
the first clamping arm and the second clamping arm each comprise a rigid or semi-rigid material ([0078]: they may also be semi-rigid…and be more like clamps or clasps than flexible straps), and wherein
the first clamping arm and the second clamping arm are configured to secure the ultrasound probe housing to the body of a patient at least by natural circumferential movement of the first clamping arm and the second clamping arm after the respective free ends thereof are pulled apart to attach the ultrasound probe housing to the body of the patient ([0075]: the straps 11 may themselves totally enwrap the limb/organ or they may partially enwrap the limb/organ in the cases wherein [0077] the straps are actually pliable clamping or pinching arms; and [0087]: by strap we include all manner of locking clamps or members 11, which may have their own malleability, elastic or spring nature, limb-grasping or locking means, clips, buckles, snaps, self-adhering portions, or zippers).
Claim 9. Sliwa further teaches
a mechanism that enables the first clamping arm to be secured to the second clamping arm when the first clamping arm and the second clamping arm are placed around a body part of the patient ([0087]: manner of locking clamps or members 11: clips, buckles, snaps, self-adhering portions or zippers).
All these manners of locking are conventionally known to require the two arms to be secured together when wrapping around a body part of the patient.
Claim 10. Sliwa further teaches that
the mechanism comprises one or more of: ratchet straps; clips; tabs; snaps; ties; a zipper; Velcro; or an adhesive ([0087]: manner of locking clamps or members 11: clips, buckles, snaps, self-adhering portions, or zippers; and [0088]: adhesive or microscopically (e.g., Velcro®)).
Claim 11. Sliwa further teaches that
the mechanism enables the first clamping arm to be secured to the second clamping arm when the first clamping arm and the second clamping arm are placed around the body part of the patient and squeezed together ([0087]: snaps, self-adhering portions, and [0088]: Velcro®).
Claim 12. Sliwa further teaches that
the first clamping arm and the second clamping arm each comprise a rigid or semi-rigid material ([0078]: they may also be semi-rigid…and be more like clamps or clasps than flexible straps), and wherein
the first clamping arm and the second clamping arm are configured to secure the ultrasound probe housing to the body of a patient at least through compression of the first clamping arm and the second clamping arm in a circumferential or horizontal direction ([0087]: manner of locking clamps or members 11: snaps, self-adhering portions, and [0088]: Velcro®).
Claim 13. Sliwa further teaches that
the first clamping arm and the second clamping arm are configured to be locked in an open position in which the first clamping arm and the second clamping arm are separated ([0077]: the straps are actually pliable clamping or pinching arms and do not need to be completely enwrapped and co-linked to perform a useful limb or tissue gripping) to enable movement of the ultrasound probe housing relative to the body of the patient ([0070]: 2) to hold the device on the skin, limb organ or tissue while moving it from location to location, thus allowing for some sliding, bending or rotational freedom of the device housing arms); and
the ultrasound probe housing comprises an actuator ([0087]: buckles and snaps) that is engageable to cause the first clamping arm and the second clamping arm to become unlocked from the open position and rotate to a closed position in which the first clamping arm and the second clamping arm are brought closer together, thereby causing the device to be compressed around the body of the patient.
Either a buckle or a snap lock is conventionally known to engage the two arms together when they are brought close enough. The locking involves aligning the two arms by rotating one arm relative to another.
Claim 14. Sliwa further teaches
an adhesive material on at least an interior surface of the first clamping arm and an interior surface of the second clamping arm ([0087]: manner of locking clamps or members 11: snaps, self-adhering portions, and [0088]: Velcro®).
An adhesive locking manner between the two arms requires an adhesive material on one surface of the first arm and another surface of the second arm in order for the two arms to be adhered together.
Claim 15. Sliwa further teaches that
the adhesive material is also on the body side of the ultrasound probe housing ([0078]: the device housing itself may also or instead employ such attachment or friction-controlling means such as adhesives or suction between it and a skin or tissue surface).
Claim 16. Sliwa further teaches that
the adhesive material comprises a disposable adhesive material ([0088]: the straps, especially in the case of their being adhesive or microscopically interlocking limb or tissue adhering member, might be disposable; and [0118]: part of a strap 11 or other device retainment of fixation member being disposable).
Either the entire strap or any portion of the strap including the adhesive material on the strap is disposable would make the adhesive material disposable.
Claim 17. Sliwa further teaches that
the first clamping arm and the second clamping arm are configured to secure the ultrasound probe housing to at least one of: an arm of the patient; a leg of the patient; or a neck of the patient ([0075]: the straps 11 may themselves totally enwrap the limb/organ or they may partially enwrap the limb/organ).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tien et al., US 2020/0187981 A1, hereinafter Tien, as evidenced by Sliwa et al., US 2009/0093761 A1, hereinafter Sliwa, in view of Moskowitz et al., US 2019/0125470 A1, hereinafter Moskowitz.
Claim 4. Tien and Sliwa combined teaches all the limitations of claims 1-3.
Tien teaches a guide channel cut-out or aperture (Tien: 201, 501, 601).
Neither Tien nor Sliwa teaches an additional component of a needle guide assembly that is adapted to receive the needle that is slidable in the needle guide assembly and is connected to the ultrasound probe housing and disposed within the guide channel cut-out or aperture.
However, in an analogous portable ultrasound-based needle guide device field of endeavor, Moskowitz teaches
a guide channel cut-out or aperture comprises a guide channel cut-out that is open on a third side of the ultrasound probe housing (FIG.3: No.46 and FIG.4A: No.38a and 38b; [0105]: the needle guide 38 comprises a slot opening 38a and a lot terminus 38b), and
a needle guide assembly adapted to receive the needle that is slidable in the needle guide assembly, the needle guide assembly being connected to the ultrasound probe housing and disposed within the guide channel cut-out or aperture (FIG.4B, [0105]: the needle guide 2 has a proximal opening 134a and a distal opening 134b and a track therebetween configured to guide the needle 14 at a predetermined angle relative to the surface of the sensors and/or relative to the face of the sensor array as the needle 14 travels into the subject).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the device of Tien and Sliwa combined employ such a feature of “a needle guide assembly adapted to receive the needle that is slidable in the needle guide assembly, the needle guide assembly being connected to the ultrasound probe housing and disposed within the guide channel cut-out or aperture” as taught in Moskowitz for the advantage of “guide the needle 14 at a predetermined angle relative to the surface of the sensors and/or relative to the face of the sensor array as the needle 14 travels into the subject”, as suggested in Moskowitz, [0105].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claim 11 of U.S. Patent No. 11,129,588, (2) claim 1 of US Patent No. 11,701,082, (3) claim 1 of US Patent No. 11,701,083, (4) claim 1 of US Patent No. 11,701,085, (5) claim 11 of U.S. Patent No. 11,701,084, (6) U.S. Patent No. 11,696,738, (7) U.S. Patent No. 11,696,739, (8) claim 1 of U.S. Patent No. 12,097,069, (9) U.S. Patent No. 12,303,320 and (10) U.S. Patent No. 12,343,196 in view of Sliwa. The above identified claims of the related US patents teach all the limitations of claims 1-17 except for the features associated with the clamping arms.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claim 44 of U.S. Patent Application No. 18/322,399 in view of Sliwa. The above identified claims of the related US patents teach all the limitations of claims 1-17 except for the features associated with the clamping arms.
In regard to the clamping arms of claim 1 of the instant application:
In an analogous field of endeavor for securing a medical device to a patient, Sliwa teaches
a first clamping arm that extends from the first side of the ultrasound probe housing; and a second clamping arm that extends from the second side of the ultrasound probe housing (FIG.2, [0068]: straps 11; and [0076]: the straps are attached to the device sides; and [0077]: the straps are actually pliable clamping or pinching arms).
the first clamping arm and the second clamping arm are configured to secure the ultrasound probe housing to a body of a patient such that the body side of the ultrasound probe is facing toward the body of the patient ([0068]: two straps 11 in FIG.2 can serve a number of useful purposes as follows: [0069]: 1) to simply hold the device 1 upon the skink, limb, organ or tissue in a given fixed (at least relative to skin or tissue surface) location).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the device of Tien employ such a feature associated with a first clamping and a second clamping that are configured to secure the ultrasound probe housing to a body of a patient, as evidenced in Sliwa that provides a detailed teaching of the clamping configuration as claimed.
The rest of the claims are rejected based on the rejection of their base claim further in view of the corresponding prior arts cited in the rejections under U.S.C. 103.
Allowable Subject Matter
The limitation recited in claim 5 in regard to the feature of “the needle guide assembly is connected to the guide channel cut-out or aperture at a pivot point within the guide channel cut-out or aperture and is rotatable within the guide channel-cut-out or aperture and about the pivot point”, in combination with other claim elements, is not taught, disclosed or suggested in the prior arts.
The prior art relevant to the claimed invention are cited below:
Moskowitz et al., US 2019/0125470 A1. This art discloses in FIG.1Ban ultrasound probe housing having an ambient side and a body side, the ambident side comprises a first portion that is shaped to fit at least a portion of a hand and a second portion that is directly adjacent to the first portion; and a guide channel cut-out or aperture that extends through the ultrasound probe housing from the second portion and is adapted to accommodate passage of a needle such that the needle is in a field of view of the probe upon insertion. This art also reads on all the limitations of claims 2-7.
Oberg et al., US 2015/0112200 A1. This art discloses in FIG.15A and [0066] a guide cone 80 of an ultrasound probe, which is elliptically funnel-shaped so as to provide a tapered, elliptically conical three-dimensional funnel surface that guides a distal tip of a needle toward the needle channel 54. It further teaches in [0031] a button that is a finger-actuated control to active a functionality of the device. It further teaches in [0032] that the functionality comprises image capture, image depth control, and image display.
Mauldin et al., US 2016/0374644 A1. This art discloses a guide channel accommodating the needle and ultrasound imaging probes for determining a prospective needle path 810 in FIG.8. However, it does not teach that the guide channel (i.e., the “needle guide assembly” as claimed) is connected to a guide channel cut-out or aperture at a pivot point, and neither the needle channel nor the needle is capable of being rotated about the pivot point. This art further teaches in [0108] a camera having a field of view that encompasses at least a portion of the needle during insertion.
However, none of the above cited references teaches the above identified allowable subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal M 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YI-SHAN YANG/Primary Examiner, Art Unit 3798