DETAILED ACTION
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:
“a first attachment mechanism configured to releasably engage a second attachment mechanism of the flexible crossbar” in claim 38. (i.e. each attachment mechanism invokes 112(f)). Structure disclosed to be “a fastener, ball and socket joint, or snap-fit connector, etc. to facilitate connection of neck 104 with radiation shield 106.” ([0050] of the published application)
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.
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 § 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 21-32 are 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.
The term “a radiation shielding device configured to block at least a substantial portion of scatter radiation” in claim 1 is a relative term which renders the claim indefinite. The term “substantial” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification is devoid of any standard for determining what a substantial portion of scatter radiation is to be understood as. Specifically, the specification provides no definition in terms of percentage of scatter radiation blocked or any other metric, leaving the scope of the claim unclear.
Claims 22-32 are vague and indefinite by virtue of their dependencies on claim 1.
Claim 28 is vague and indefinite for reciting “wherein the base comprises a planar surface configured to be positioned beneath an object while the radiation shield is supported by a portion of the base configured to be positioned above the object” because it is not clear whether the claim is suggesting the shield is configured to be positioned above the object or the base is configured to be positioned above the object, if it is the base the claim is indefinite because the base cannot both be beneath and above the object. For the purposes of examination it will be interpreted that the shield is positioned above the object.
Claim 29 is vague and indefinite by virtue of its dependency on claim 28.
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 21-40 are rejected under 35 U.S.C. 103 as being unpatentable over Cadwalader et al. (US pgPub 2008/0164425) (submitted with IDS of 13 March 2015) in view of Gainor et al. (US pgPub 2016/0158082) (submitted with IDS of 13 March 2015) or alternatively Gordon et al. (US pgPub 2016/0027540) (submitted with IDS of 13 March 2015).
Regarding claim 21, Cadwalader et al. teach a radiation shielding device (fig. 1) configured to block at least a substantial portion of scatter radiation that emanates from a radiation device that is imaging through a patient positioned on an operating room table ([0002] teaches lateral radiographic imaging wherein radiation is emitted at a lateral side of the patient and directed through an opposite side of the patient, wherein the radiation beam is emitted in a direction relatively horizontal and substantially parallel to a support surface of the object (i.e. patient). Paragraph [0022] teaches radiation shields or barriers attenuating the primary beam during lateral radiographic imaging, thus blocking the primary beam radiation) and towards a healthcare provider adjacent the patient ([0030] teaches shield medical personnel and possibly the patient, thus adjacent to patient), the radiation shielding device comprising:
a shield mounting device (elements 60 and drape 30) comprising:
a flexible horizontal crossbar (horizontal support member 60 is flexible ([0049]), see crossbar in annotated figure 1 below); and
a flexible elongate neck (vertical support members 60, see paragraph [0049] for flexible) having a first end and a second end, the first end coupled to the horizontal crossbar and the second end coupled (see annotated figure below);
PNG
media_image1.png
866
852
media_image1.png
Greyscale
and
a sterilized flexible radiation shield (50, [0044], [0065]) or alternatively the drape 30 and flap 50) comprising:
a first portion (58 see paragraph [0045]) and a second portion (56, see paragraph [0045]), the first portion flexibly connected to the second portion (via fold line 62, see paragraph [0046]);
wherein an edge of the first portion is removably attachable to the horizontal crossbar ([0053] 60 coupled to flap using mechanical fasteners, thus horizontal cross-bar 60 is removably attached to an edge of the first portion 58) such that the first portion hangs downward from the horizontal crossbar ([0053] teaches fasteners between 60 and 50 and paragraph [0043] teaches 60 provides rigidity to flap 50 and support or move flap to the extended position (i.e. first portion 58 hangs on support members 60)) in a direction along a vertical plane perpendicular to a plane of a top surface of the operating room table ([0049] teaches flap 50 in a position that is substantially perpendicular to drape 30. Since drape is on table (see figure 2), the flap 50 is perpendicular to the table (vertical plane defined to be perpendicular to the plate)), the horizontal crossbar positioned at or above a lower edge of the radiation device (since the lateral radiographic imaging is performed through the patient ([0002] and [0067]) and the flap is perpendicular to the drape, the flap 50 (i.e. portion 58) is above the lower edge of the radiation device) while the second portion lays atop the patient (56 lays flat on the drape via coupling [0045] and drape is over the patient ([0056]), thus second portion lays atop the patient); and
wherein at the coupling of the first end of the flexible elongate neck and the horizontal crossbar, the flexible elongate neck extends in a direction transverse to the vertical plane (members 60 are reconfigurable due to their flexible, pliable nature ([0049]), thus neck portion 60 at the first end and the horizontal crossbar indicated in the annotated figure above may extend in a direction traverse to the vertical plane perpendicular to the patient).
While Cadwalader et al. teaches the second end coupled to the drape and an opening for conducting various invasive procedures including guidance and/or manipulation instruments ([0039]), Cadwalader fails to disclose the drape coupled to the table and therefore fails to disclose the second end coupled to the table.
However, Gainor et al. teach magnets on a board for holding wires or catheters through a drape material ([0068]) or a clip holding tools to a table with a drape also clipped ([0069]).
Gainor modifies Cadwalader by suggesting a clip to clip or magnetically attach tools to the table via the drape, thus attaching the drape to the table (i.e. providing the second end of Cadwalder attached to the drape to be attached to the table).
Since both inventions are directed towards providing surgical tools during radiographic imaging and a drape, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the further attachment of the drape to the table in Cadwalader (i.e. attaching the second end of 60 to the table) as suggested by Gainor because it would hold tools in place therefore improve procedure safety and free the surgeon’s hands for other tasks ([0068]).
Alternatively, Gordon teaches attaching the base of the shield to a table as an alternative to other objects such as a body part of the patient or a bed rail ([0029]).
Gordon modifies Cadwalader by suggesting mount the shield (i.e. flap 50 with base 56 attached to the drape 30) to a table, therefore having the second end of the neck coupled to a table.
Since both inventions are directed towards vertical shields with bases, it would have been obvious to one of ordinary skill in the art to alternatively attach the flap shield 50 of Cadwalader to a table as suggested by Gordon because it would be lead to predictable results to one of ordinary skill in the art of providing shielding at a closer proximity to the user. That is, Cadwalader envisioned repositioning the shield about the drape ([0061]) which is on the patient. Gordon is evidence that a similar vertical shield with a base may be positioned and coupled to the patient or to the table. Therefore, coupling the shield of Cadwalader to the table would lead to predictable results of shielding the medical provider at a different location. See MPEP 2143 (I)(B).
Regarding claim 22, Cadwalader teaches wherein the horizontal crossbar comprises a first crossbar end and a second crossbar end, and the first end of the neck is coupled to the horizontal crossbar between the first crossbar end and the second crossbar end (see annotated figure below).
PNG
media_image2.png
517
1196
media_image2.png
Greyscale
Regarding claim 23, Cadwalader et al. teach wherein the vertical plane is transverse to a second plane that extends through the second end of the flexible elongate neck and the first and second crossbar ends (vertical plane perpendicular to patient, bending flexible elements 60 ([0049]) allows for the plane extending through the second end of the flexible neck and ends of cross-bar (see first annotated figure above)).
Regarding claim 24, Cadwalader et al. teach wherein the second portion of the radiation shield is configured to lie at least partially in a plane transverse to the vertical plane (56 attached to drape thus perpendicular to vertical plane (i.e. drape is horizontal)).
Regarding claim 25, Cadwalader et al. teach wherein at least a portion of the flexible elongate neck is configured to extend perpendicularly from an attachment point where the first end and the horizontal crossbar are coupled (see annotated figure below).
PNG
media_image3.png
482
951
media_image3.png
Greyscale
Regarding claim 26, Cadwalader et al. teach wherein a plane including the at least a portion of the flexible elongate neck and the attachment point is parallel to the top surface of the operating room table (when flap is closed over drape, the plane is parallel to the drape and thus the operating table ([0048] for flattening the flap 50)).
Regarding claim 27, Cadwalader et al. in view of Gainor teach wherein the second end of the flexible elongate neck is configured to magnetically engage a base (Cadwalader teaches attaching flap to drape (0061) Gainor teaches magnetic engagement by a board through the drape ([0068]). Thus second end of neck of Cadwalader indirectly engaged to a base via drape as suggested by Gainor).
Regarding claim 28, Cadwalader et al. in view of Gainor teach wherein the base comprises a planar surface ([0068] of Ganor teaches a board with magnets, thus a planar surface) configured to be positioned beneath an object ([0068] of Gainor beneath a drape and tools wherein table/board is beneath the patient (object)) while the radiation shield is supported by a portion of the base (drape over table/board) configured to be positioned above the object (drape over patient).
Regarding claim 29, Cadwalader et al. in view of Gainor teach herein the base comprises a clamp configured to secure the radiation shielding device to an object. ([0072] teaches a combination of attachment mechanisms could be used together [0069] teaches clips (i.e. clamp))
Regarding claim 30, Cadwalader et al. teach wherein the first portion is removably attachable to the horizontal crossbar by a snap fit fastener, button, hook-and-loop fastener, or adhesive ([0053]).
Regarding claim 31, Cadwalader et al. teach wherein the first portion comprises a first non-shape stable portion and the second portion comprises a second non-shape stable portion ([0044]).
Regarding claim 32, Cadwalader et al. teach wherein the radiation shield includes an opening (40) defined through a thickness of the radiation shield (through shielding drape 30), the opening configured to allow passage of an interventional tool from a first side of the radiation shield to a second side of the radiation shield ([0039]).
Claim 33 is commensurate in scope with claim 21 and is taught as discussed in the citations above. Moreover, Cadwalader teaches the second portion coupled to the first portion at a folded region (fold line 62)
Claim 34 is a combination of claims 25-26 and is taught as discussed above
Claim 35 is taught above with respect to citations in claim 22
Claim 36 is taught above with respect to the citations in claim 23.
Claim 37 is taught above with respect to the citations in claim 25.
Regarding claim 38, Cadwalader teaches wherein the first portion of the radiation shield further comprises a first attachment mechanism configured to releasably engage a second attachment mechanism of the flexible crossbar ([0053], hook and loop, clips, snaps would require attachment on both the shield and the members 60).
Claim 39 is taught above with respect to the citations in claim 27.
Claim 40 is taught above with respect to the citations in claim 28.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gordon (US pgPub 2019/0336088) teaches a vertical shield with a horizontal base coupled to a table (see figure 9 and [0092]).
Yadegari et al. (US pgPub 20210401383) teaches a crossbar and neck where one end is connected to the table and the second end is connected to the top of the radiation shield. Yadegari could be modified by EggNest below and Cawdawalder above to make obvious at least claims 21 and 33 (i.e. goose neck of EggNest and flexible support members of Cawdawalder)
EggNest (submitted herewith) teaches a gooseneck attached to a radiation shield see figure 17 on page 11.
Additional prior art is discussed in the office actions of parent application 17/085594.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LOGIE whose telephone number is (571)270-1616. The examiner can normally be reached M-F: 7:00AM-3:00PM.
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, Robert Kim can be reached at (571)272-2293. 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 J LOGIE/ Primary Examiner, Art Unit 2881