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 .
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.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 20, line 5, there appears to be words missing before “axially”. Should “includes” be added?
In claim 20, line 7, “the handle” lacks antecedence.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6, 11-18, and 20-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McFadden (US 6,575,167 -previously cited).
Re claims 1, 20: McFadden discloses a disposable ultrasound transducer hand shield assembly for an ultrasound transducer of a type having a lower end supporting a longitudinal array of piezoelectric elements adapted to contact a patient’ skin during use and an upper end supporting a handgrip extending along an axis (Figure 4; see the shield 12 attachable to transducer 8 that has a transducer head containing the elements and upper end of a handgrip, wherein the transducer is placed against the patient) comprising:
a shroud that extends upwards from a point proximate to the array and extends at least partially around the transducer to create a barrier between the handgrip and a needle insertable into the tissue below the transducer (Figure 4; col 3 lines 14-39; see shield 12 and needle guide 4); and
a connector adapted to attach to the ultrasonic transducer
wherein the shroud as connected to the transducer extends downwardly over sides of the lower end and over sides of the piezoelectric elements to be proximate to the skin during use so that as so connected the shroud extends in front of the handgrip and upward from the lower end along the axis to create the physical barrier between the lower end and materials longitudinally displaced forward from the transducer (Figs 2 and 4; col 4 line 63-col 5 line 5; col 5 lines 9-18; col 5 lines 19-34; col 5 line 54-col 6 line 2; see the connectors 32, 34 that attached to the transducer 8 to create a physical barrier provided by shroud 12, wherein the second receiving means 24 is shown as being coupled to a handle portion but can also be configured to attach to the “head of a transducer” such that second securing means 26 secures the “transducer head”, wherein the shroud extends over the sides of the elements when the shroud is attached to the transducer head instead of the configuration that is attached to the handle portion); and
wherein the shroud includes axially extending side walls positioned on opposite sides of the ultrasonic transducer along a lateral direction perpendicular to the axis and adapted to protect a user’s hand holding the handle from laterally received needle sticks (Figures 2, 4: see the side walls (the portion that element 18 is directly pointed to) that extend perpendicular (front to back as shown) to the longitudinal axis of the probe when attached and, alternatively, see the side walls (the walls directly below elements 32 and 34 or 28 and 30 as shown) that extend perpendicular (left to right as shown) to the longitudinal axis of the probe when attached; in both instances the walls have a dimension that provides some protection against a lateral needle stick because a needle directed laterally toward the handle would be blocked from a needle stick when its path intersects one of the above mentioned side walls; In a different interpretation, the side walls correspond to the portion of the shield that a proximate to the transducer head and to the portion that is proximate the opposite end of the transducer (i.e. proximal to the handle), wherein these portions are on opposite ends of the transducer, extend perpendicular to the longitudinal axis of the probe when attached, and provide protection against lateral needle sticks).
Re claim 2: The shroud is sized to fit around the hand grip to receive a hand of a healthcare professional therein (see figure 4).
Re claims 3, 6: The shroud is curved about the axis by at least 100 mm from the axis at all angles about the axis extends at least 180 degrees around the transducer (figures 2 and 4; see the angles about the longitudinal axis of the probe 8 and see that the shroud is curved about the axis by at least 180 degrees around the transducer, i.e. see the portion curved about the handle portion).
Re claims 11, 13: The shroud provides a transparent window (col 13, lines 25-30; se ethe plexiglass material).
Re claims 12, 14: The connector attaches to a frame with a predefined curvature, and having releasable connectors/tabs releasably attaching the shroud to the frame via holes in the shroud, wherein the shroud is a flexible transparent film conforming to the shape of the frame (figure 1; col 5 lines 9-18; see the connectors 32, 34 that are releasably connected to the shroud 12 via holes as shown; col 3 – see the flexible shroud where the material may be plexiglass which is transparent).
Re claim 15: The shroud is curved around the axis to cover sides of the lower end (see figures 2 and 4).
Re claim 16: A bottom end of the shroud has rounded corners (col 3 line 56-col 4 line 6; see the arc/curved shape).
Re claim 17: The shield further including an ultrasound transducer (col 3, lines 14-39; see the transducer 8).
Re claim 18: The transducer further including a needle guide attached to the lower end and providing a guide channel permitting a needle to extend into to the tissue of the patient below the lower end (col 5 line 54-col 6 line 2; see the needle guide 4).
Re claim 21: The connector comprises transversely separated side walls that are transversely movable to engage longitudinally extending sidewalls of the transducer and a longitudinally fixed rearward wall engaging a rear side of the transducer to locate the transducer with respect to the shroud (col 5, lines 9-18; see the hook, clamp, or latch which includes sidewalls transversely moveable).
Re claims 22, 23: The shroud has a cutout through which a longitudinally forward portion of the transducer may extend (figure 2; see the semicircular cutout for the transducer), where the portion is configured to support a needle guide on the forward side of the shroud (figure 4; see the needle guide 4).
Re claim 24: The shroud provides a vertically extending outwardly concave channel forward from the handgrip along the height of the shroud (Figure 2; see the outwardly concave portion at the top and bottom of the structure, thereby providing a channel).
Re claim 25: The shroud tapers continuously inwardly from an upper portion to a lower portion (Figures 1, 3; see the portion from the central region to the bottom region that tapers inwardly as shown – this central region is considered to be part of an ‘upper portion’ while the bottom region is considered as a ‘lower portion’).
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.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over McFadden (US 6,575,167 -previously cited).
Re claims 4, 5: McFadden discloses all features including a shroud 12 with a top end and lower end of different widths (see figures 3, 4) but does not specifically disclose the top has a width of at least 150 mm and the bottom has a width that is less than 50 mm. However, it would have been obvious to the skilled artisan to configure the shroud such that the top has a width of at least 150 mm and the bottom has a width that is less than 50 mm. Such would be an obvious design configuration that would enhance the protection from possible needle punctures.
Response to Arguments
Applicant's arguments filed 11/12/25 have been fully considered but they are not persuasive. Applicant argues that the newly claimed feature of the side walls is not met by McFadden because the shield is a single curved arc that spans a user’s hand. Respectfully, the Examiner disagrees. While McFadden’s device is a curved arc, the particular limitations are still met for the reasons set forth in the action.
Conclusion
THIS ACTION IS MADE FINAL. 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 MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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, Christopher Koharski can be reached on 571-272-7230. 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.
/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
Prosecution Insights