DETAILED ACTION
In Applicant’s Response filed 1/8/26, Applicant amended claim 13. Currently, claims 1-15 are pending.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-12) in the reply filed on 1/8/26 is acknowledged.
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/8/26.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-4, and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olfert et al (US 2008/0216844).
With respect to claim 1, Olfert discloses a device for imaging at least a part of a patient (para [0010]; MRI system in fig 1), the device comprising: a detection apparatus comprising a tunnel configured to receive the patient for imaging purposes (MRI scanner comprising a cylindrical bore 13; fig 1; patient is imaged inside the bore – para [0033]); a sterile cover (drape that forms a cylindrical sleeve-shaped structure 21 when expanded – para [0027]; figs 1-2) configured to be initially rolled up or folded outside of the tunnel (the drape sleeve is collapsed axially to form an annular structure that is housed within container 20 prior to use – para [0057]; the drape can also be rolled up and later released to uncoil from the rolled condition to the cylindrical condition – para [0071,0075]); and a covering mechanism configured to unroll or unfold the sterile cover and drape the sterile cover in the tunnel, such that an inner wall of the tunnel is at least partially covered by the sterile cover (helical wire 30 expands axially to expand the drape and support the drape fabric against the internal surface/wall of the bore – para [0035,0061]).
With respect to claim 2, Olfert discloses the device as claimed (see rejection of claim 1) and Olfert also discloses that the detection apparatus is based on MRT technology or CT technology (MRI systems – para [0002]; MRI is a form of magnetic resonance tomography (MRT) technology).
With respect to claim 3, Olfert discloses the device as claimed (see rejection of claim 1) and Olfert also discloses a table configured to transport the patient into the tunnel (table 18), wherein the table is configured to be moved into the tunnel covered by the sterile cover without damaging the sterile cover (para [0059]; the table can be moved within the bore and removed as a means to deploy the drape along the bore prior to use as described in para [0059] and it is inherent that the table moves back into the covered tunnel for imaging without damaging the drape otherwise the sterile field would be breached/compromised).
With respect to claim 4, Olfert discloses the device as claimed (see rejection of claim 1) and Olfert also discloses that the sterile cover has a cylindrical shape (drape forms a cylindrical sleeve-shaped structure 21 when expanded – para [0057]) with a diameter of an order of the tunnel (para [0033]).
With respect to claim 9, Olfert discloses the device as claimed (see rejection of claim 1) and Olfert also discloses that the sterile cover is fixed in a rolled up state or a folded state at a first axial end of the tunnel, and wherein the covering mechanism comprises a guiding element configured to automatically pull the sterile cover through the tunnel in an axial direction of the tunnel to a second end of the tunnel opposite to the first axial end and unroll or unfold the sterile cover. (para [0034-0035; 0057-0058; 0062-0063] figs 1-2).
With respect to claim 10, Olfert discloses the device as claimed (see rejection of claim 1) and Olfert also discloses that the sterile cover, the inner wall of the tunnel, or both the sterile cover and the inner wall of the tunnel comprise a sticky material configured to fix the sterile cover at the inner wall of the tunnel (adhesive strips – para [0018;0065]).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Olfert et al (US 2008/0216844) in view of Asmus et al (WO 9816167 A1).
With respect to claim 5, Olfert discloses the device as claimed (see rejection of claim 4) but does not disclose that the sterile cover is one cover of a series of covers each separated from another cover of the series of covers by a respective perforation.
Asmus, however, teaches a system wherein drape material is cut/separated into discrete lengths whereby the drape sections are separated from one another via perforations in the material (pg 9 lines 17-21; pg 13 lines 25-31). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the sterile cover of Olfert so that it is one cover of a series of covers each separated from another cover of the series of covers by a respective perforation, like the drape material of Asmus, in order to permit customization of the size of the drape material for use in varied situations and applications.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Olfert et al (US 2008/0216844) in view of Asmus et al (WO 9816167 A1) and further in view of Breegi et al (US 20160074268).
With respect to claim 6, Olfert in view of Asmus discloses the device substantially as claimed (see rejection of claim 5) and Olfert also discloses that the covering mechanism is configured to unfold the sterile cover and press the sterile cover to the inner wall of the tunnel when the mechanism is pushed through the sterile cover in the tunnel (para [0057;0061;0063]). Olfert does not, however, disclose that the covering mechanism comprises an umbrella device.
Breegi, however, teaches a surgical drape structure which includes a frame mechanism that is configured like an umbrella (see figs 1;10; umbrella is interpreted as comprising a folding/collapsible frame having a plurality of ribs that expands to open/support a material canopy on the frame) wherein the frame is provided in a collapsed state and expands outwardly against the drape material to unfold/expand the drape and support/maintain the drape in the expanded configuration for use (deployment and then use is shown in figs 10-11). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have substituted the covering mechanism of Olfert for an umbrella frame mechanism as taught by Breegi in order to provide a structure which is not only expandable but also collapsible to permit fast and easy set up prior to use and removal thereafter.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Olfert et al (US 2008/0216844) in view of Breegi et al (US 20160074268).
With respect to claim 7, Olfert discloses the device as claimed (see rejection of claim 4) and Olfert also discloses that the covering mechanism is configured to unfold the sterile cover and press the sterile cover to the inner wall of the tunnel when the mechanism is pushed through the sterile cover in the tunnel (para [0057;0061;0063]). Olfert does not, however, disclose that the covering mechanism comprises an umbrella device.
Breegi, however, teaches a surgical drape structure which includes a frame mechanism that is configured like an umbrella (see figs 1;10; umbrella is interpreted as comprising a folding/collapsible frame having a plurality of ribs that expands to open/support a material canopy on the frame) wherein the frame is provided in a collapsed state and expands outwardly against the drape material to unfold/expand the drape and support/maintain the drape in the expanded configuration for use (deployment and then use is shown in figs 10-11). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have substituted the covering mechanism of Olfert for an umbrella frame mechanism as taught by Breegi in order to provide a structure which is not only expandable but also collapsible to permit fast and easy set up prior to use and removal thereafter.
Claim(s) 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Olfert et al (US 2008/0216844) in view of Doerrfuss et al (DE 102010040956 A1).
With respect to claim 8, Olfert discloses the device as claimed (see rejection of claim 1) and Olfert also discloses that the sterile cover is a single-layer (the surgical drape is described as comprising “a sheet of surgical drape material” (para [0012]) which is interpreted as referring to a single sheet of material) wound on a roll (fig 4A; para [0071-0072]), and wherein the covering mechanism comprises a guiding element configured to transport the roll into the tunnel along an axial direction of the tunnel and then guide the roll in the tunnel in a circumferential direction along the inner wall of the tunnel, thereby unrolling the sterile cover (non-magnetic rod 53 with handles 54 – para [0022;0072]).
Olfert does not, however, explicitly disclose that the sterile cover is a film.
Doerrfuss teaches a similar cover that is configured for the cylindrical tube-shaped tunnel of a gantry of a medical imaging device such as an MRI device wherein the cover includes a tubular element configured for covering the tunnel of the imaging device wherein the tubular element is formed from a plastic film that is form-stable, partially flexible and resilient (see abstract). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the sterile cover of Olfert from a plastic film material like the cover of Doerrfuss in order to provide the requisite flexibility and resiliency to permit successful application and conformity of the cover to the tunnel of a gantry of an imaging device and provide protection during use. Furthermore, use of a plastic film material for the sterile cover would have been obvious since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
With respect to claim 11, Olfert discloses the device as claimed (see rejection of claim 1) but does not disclose that the sterile cover comprises paper or a plastic film.
Doerrfuss teaches a similar cover that is configured for the cylindrical tube-shaped tunnel of a gantry of a medical imaging device such as an MRI device wherein the cover includes a tubular element configured for covering the tunnel of the imaging device wherein the tubular element is formed from a plastic film that is form-stable, partially flexible and resilient (see abstract). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the sterile cover of Olfert from a plastic film material like the cover of Doerrfuss in order to provide the requisite flexibility and resiliency to permit successful application and conformity of the cover to the tunnel of a gantry of an imaging device and provide protection during use. Furthermore, use of a plastic film material for the sterile cover would have been obvious since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Olfert et al (US 2008/0216844) in view of Murphy et al (US 2003/0181810).
With respect to claim 12, Olfert discloses a device for imaging at least a part of a patient (para [0010]; MRI system in fig 1), the device comprising: a detection apparatus comprising a tunnel configured to receive the patient for imaging purposes (MRI scanner comprising a cylindrical bore 13; fig 1; patient is imaged inside the bore – para [0033]); a sterile cover (drape that forms a cylindrical sleeve-shaped structure 21 when expanded – para [0027]; figs 1-2) configured to be initially rolled up or folded outside of the tunnel (the drape sleeve is collapsed axially to form an annular structure that is housed within container 20 prior to use – para [0057]; the drape can also be rolled up and later released to uncoil from the rolled condition to the cylindrical condition – para [0071,0075]); and a covering mechanism configured to unroll or unfold the sterile cover and drape the sterile cover in the tunnel, such that an inner wall of the tunnel is at least partially covered by the sterile cover (helical wire 30 expands axially to expand the drape and support the drape fabric against the internal surface/wall of the bore – para [0035,0061]).
Olfert does not, however, disclose that the device is part of a system configured to perform an image guided intervention which also comprises an intervention device.
Murphy, however, teaches a kit that comprises a sterile drape for use with an imaging device (abstract) and a biopsy needle configured to be used during imaging (para [0011;0038;0061]; fig 6-8). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used the device of Olfert as part of a system configured to perform an image guided intervention which also comprises an intervention device, like the kit of Murphy which includes a drape and biopsy needle/needle system, in order to provide a quick and easy means to conduct an image-guided procedure while maintaining a sterile environment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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, Rachael Bredefeld can be reached at 571-270-5237. 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.
/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786