DETAILED ACTION
Response to Arguments
Applicant's arguments filed 23 June 2026 have been fully considered but they are not persuasive.
Munday:
The remark have been found unpersuasive. Specifically, while Munday teaches the tube, the tube 36 is clearly multi-sectional (i.e. each section is around the periphery of the device). While Munday teaches the tube is flexible, as understood by the instant specification rigidity is a degree. Specifically, for instance paragraph [0015] teaches the rigidity of pre-formed lines greater than the rigidity of the sheet material. Therefore, when inflated, the material of 36 and air is more rigid then the protector itself allowing the protector to extend into the rectangular body.
Shasky:
The remarks take the position that Shashkey is not multisectoral. This has not been found persuasive, as the claim does not require any structural significance to “multi-sectional”. Because the rod can be arbitrarily divided in sections (i.e. distal end of rod, proximal end of rod, intervening section of rod), the device of Shaskey is multi-sectional.
With respect to Rees, the remarks have been found persuasive. Specifically Reese fails to disclose the required hem. However, while not applied here, at least figure 14 of Rees could be modified in the same manner as Cadwalader to make obvious the claimed invention.
Cadwalader et al. (Cadwalader 2006)
The remarks take the position that Cadwalader 2006 fails to disclose a multi-sectional spine as required by claim 1, wherein the spine itself be positioned at a side edge of the sheet. This has not been found persuasive. Specifically, Cadwalader 2006 clearly shows in figures 1-2 support members 60 forming a multisectoral spine. That is, the claimed spine has no requirements other than that it has multiple sections. Since each support member is shown to be overlapping, all members 60 together form a multi-sectional spine as seen in figure 1. Alternatively, Cadwalader could be interpreted as Shasky above, wherein multiple sections are interpreted as proximal and distal ends of side band 60. There is no requirement that the multiple sections are coupled or integrated in any manner, therefore provided that there are multiple supports, the limitation of multi-sectional spine is met. Moreover, as discussed in the last office action, Cadwalader fails to disclose how the supports are mounted. Each of the secondary references teaches hemming the support at the side edge as required by the claim. Lastly, there is no requirement that the entire multi-sectional spine be mounted at the side edge, therefore provided that a single section is mounted at the side the claim fails be distinguished over the combination.
Regarding claim 24, the remarks take the position that modifying the members of Cadwalader 2006 to have a circular cross-sectional shape would depend on impermissible hindsight because modifying the shape would had to the thickness of the structure, which is a disadvantage when flattened for storage.
Initially, it is noted that the instant specification provides no criticality to the circular cross-sectional shape. Indeed, as in Cadwalader, the instant specification teaches the spine may be made of a band material instead of cylindrical ([0019] of the published application). Cadwalader teaches that the strips or bands are only in the exemplary embodiment, therefore does not teach away from circular cross-sectional shapes (i.e. cylinders).
As the circular cross-section is non-critical and the instant specification teaches like in Cadwalader teaches the shape may be band shaped and circular cross-sectional shapes were known to the art (as in the secondary references), it would have been obvious to one of ordinary skill in the art to modify Cadwalader to use a circular cross-sectional shape because the cross sectional shape of the spine is a matter of design choice absent persuasive evidence that the particular configuration to the claimed spine is significant (MPEP 2144.04 (IV)B). Here, the specification teaches no significance the to cross-sectional shape and additionally envisioned a band shape as in Cadwalader, therefore, there remarks have been found unpersuasive and the rejection stands as reiterated herein below.
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.
Claim 11 requires means for detecting ionizing radiation .
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 18-19 and 23 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.
Each of claims 18-19 and 23 depend upon cancelled claims 16-17. Since claim 1 has been amended in part to include the limitations of claim 16, for the purposes of examination, it will be interpreted that these limitations are dependent upon claim 1.
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.
Claim 1, 9, 18-19 and 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Munday (USPN 2,640,937).
Regarding claim 1, Munday teaches a radiation shield device (fig. 4) for radiation and radiation-guided imaging, therapy, diagnosis or prognosis of a subject (intended use, subject is person under protector) comprising a sheet of material (foldable blanket 1), wherein the sheet comprises a barrier to ionizing radiation (col. 1, lines 46-51 teaches rubber compounded with lead or lead oxide, lead is a barrier to ionizing radiation), wherein the device comprises a peripheral hem (blanket is formed with a marginal pocket 9 by a looped shaped binding 10 see col. 2, lines 5-8 and figure 4. Binding 10 is interpreted to be the hem) partially or completely along the periphery of the device and/or sheet (10/9 shown along the periphery of the blanket 1 in figure 4), and the peripheral hem comprises a spine (tube 36 forms a spin when filled with gas thus forming a spine by unfolding the blanket see col. 3, lines 57-63) wherein the spine is bendable or shapable (flexible see col. 3, lines 18-19, shapable by inflation), wherein the spine is a multi- sectional spine that comprises a plurality of elongated members (fig. 4, 36, each section along a side of the rectangle) made of a rigid material (when inflated, the protector expands thus rigid compared to protector itself see col. 2, lines 54-55 through col. 6, lines 1-6), and wherein the spine is positioned at a side edge of the sheet (36 at a side edge of protector).
Regarding claim 9, Munday teaches wherein the barrier to ionizing radiation comprises one or more heavy metals (col. 1, lines 46-51 teaches lead or lead oxide thus heavy metal).
Regarding claim 18, Munday teaches wherein the spine is made of a bendable material (bends via inflation and deflation to fold to return from fig. 4 back to folded configuration of figures 1-2).
Regarding claim 19, Munday teaches wherein the spine is made of a material which can be bent to confer a desired shape to the spine (via inflation, the spine is bended from folded configuration (figures 1-2) to flat configuration (fig. 4)).
Regarding claim 23, Munday teaches wherein the device comprises a pocket (pocket 9 formed by binding 10) arranged and configured to embed the spine in the device (best seen in figure 5).
Regarding claim 24, Munday teaches A radiation shield device for radiation and radiation-guided imaging, therapy, diagnosis or prognosis of a subject comprising a sheet of material, wherein the sheet comprises a barrier to ionizing radiation and the device comprises a peripheral hem partially or completely along the peripheral of the device and/or sheet, and the peripheral hem comprises a spine, wherein the spine is bendable or shapable and consists of a single elongated member and is made of a shapable material which enables a user to shape the spine, and therefore the sheet, as required during a procedure, wherein the spine has a circular cross- sectional shape (see discussion above with respect to claim 1, 16-17. 36 is defined as a tube, thus having a circular (circle like) cross sectional shape).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shashy (USPN 2,794,128).
Regarding claim 1, Shashy teaches a radiation shield device (figures 1-3, 14) for radiation and radiation-guided imaging, therapy, diagnosis or prognosis of a subject (x-ray shield for preventing x-rays from reaching the operator (see col. 1, lines 15-19)) comprising
a sheet of material (14) wherein the sheet comprises a barrier to ionizing radiation (col. 2, lines 1-3), wherein the device comprises a peripheral hem (loop 24 encasing rod 18 wherein edge of flap 30 is held in place by stitching 22, see col. 2, lines 10-11 and lines 16-17 and figure 3) partially or completely along the periphery of the device and/or sheet (along the top portion of the device as seen in figures 1-3), and the peripheral hem comprises a spine (18)
wherein the spine is bendable or shapable (rod 18 is elongated, thus capable of being bent), wherein the spine is a multi- sectional spine that comprises a plurality of elongated members (arbitrary distal end, proximal end and middle section of rod) made of a rigid material (rigid to support curtain), and wherein the spine is positioned at a side edge of the sheet (as seen in figure 18 is at a side edge).
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 1, 9, 16-22 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Cadwalader et al. (US pgPub 2006/0251219)1 in view of Shashy (USPN 2,794,128) or alternatively in view of Lieb (US52902) or Munday (USPN 2,640,937).
Regarding claim 1, Cadwalader et al. teach a radiation shield device (figure 1, 20) for radiation and radiation-guided imaging, therapy, diagnosis or prognosis of a subject ([0019] and [0021]) comprising
a sheet of material (30) wherein the sheet comprises a barrier to ionizing radiation ([0022] teaches 30 provides a barrier or shield for attenuating scatter radiation and protecting a portion of patient, paragraph [0025] teaches each barrier includes radiation attenuating member or pad 39 (see figure 2) and paragraph [0026] teaches a number of materials including lead which is known to be a barrier to ionizing radiation) and a spine (elements 60 or element 60 alongside edge, see figures 1 and 2) wherein the spine is bendable or shapable ([0031]), wherein the spine is a multi- sectional spine that comprises a plurality of elongated members (either each individual support member 60 comprising multiple sections (ends and intervening elongated sections) or all the elements 60 together are overlapping thus a multi-sectional spine) made of a rigid material ([0036] bending to achieve the desired position, thus rigid).
While Cadwalader teaches support members 60 made of metal ([0031]) and coupled to barrier 30 via stitching ([0033]) to the periphery of barrier 30 (as seen in figures 1-2), Cadwalader fails to expressly suggest how the support members are secured.
However, Shashy teaches wherein the device comprises a peripheral hem (loop 24 encasing rod 18 wherein edge of flap 30 is held in place by stitching 22, see col. 2, lines 10-11 and lines 16-17 and figure 3) partially or completely along the periphery of the device and/or sheet (along the top portion of the device as seen in figures 1-3), and the peripheral hem comprises a spine (18) wherein the spine is positioned at a side edge of the sheet (as seen in figure).
Shashy modifies Cadwalader by suggesting stitching the support members of Cadwalader in a loop at the edge of the shield.
Since both inventions are directed towards radiation shields, it would have been obvious to one of ordinary skill in the art to stitch the support members of Cadawalader in the manner suggested by Shashy because it would resolve the problem as to how to secure the support members to the barrier suggested in Cadwalader.
Alternatively, Lieb teaches wherein the device comprises a peripheral hem (fig. 4, b) partially or completely along the periphery of the device and/or sheet (along periphery of cloth as seen in figure 4) and the peripheral hem comprises the spine (rod c inserted into loop formed in hem see col. 1, last paragraph) wherein the spine is positioned at a side edge of the sheet (as seen in figure 4).
Lieb modifies Cadwalader by suggesting how to secure a rod to a cloth.
Since both inventions are directed towards securing a rod to a cloth, it would have been obvious to one of ordinary skill in the art before the effective filing date to stitch the support rods of Cadwalader into a hem as suggested by Lieb because it would resolve the problem as to how to stitch a metal support rod to the flexible shield of Cadwalader in a cheap way (note Lieb envisioned rods joined at angles (column 2, last sentence of first full paragraph)).
Alternatively Munday teaches wherein the device comprises a peripheral hem (blanket is formed with a marginal pocket 9 by a looped shaped binding 10 see col. 2, lines 5-8 and figure 4. Binding 10 is interpreted to be the hem) partially or completely along the periphery of the device and/or sheet (9 shown along the periphery of the blanket 1 in figure 4), and the peripheral hem comprises the spine (tube 36 forms a spin when filled with gas thus forming a spine by unfolding the blanket see col. 3, lines 57-63) wherein the spine is positioned at a side edge of the sheet (36 along the edge).
Munday modifies Cadwalader by suggesting a means to secure the spine to the shield of Cadwalader.
Since both devices are directed towards radiation shielding devices, it would have been obvious to one of ordinary skill in the art to secure the support members of Cadwalader (i.e. along the periphery edges) in the manner suggested by Munday because it would resolve the problem as to how to secure the support members to the shield. Moreover, enclosing the edges would resolve the issues with potential fraying therefore improving the life-time of the shield.
Regarding claim 9, Cadwalader teaches wherein the barrier to ionizing radiation comprises one or more heavy metals ([0026]).
Regarding claim 18, Cadwalader teaches wherein the spine is made of a bendable material ([0031]).
Regarding claim 19, Cadwalader teaches wherein the spine is made of a material which can be bent to confer a desired shape to said spine ([0031]).
Regarding claim 24, Cadwalader in view of Shashy or Leib or Munday teaches a radiation shield device for radiation and radiation-guided imaging, therapy, diagnosis or prognosis of a subject comprising a sheet of material, wherein the sheet comprises a barrier to ionizing radiation and a spine, wherein the spine consists of a single elongated member and is made of a shapable material which enables a user to shape the spine, and therefore the sheet, as required during a procedure, wherein the spine has a circular cross- sectional shape (see discussion above with respect to claim 1. Shahy and Lieb both teach rods, thus circular cross-sectional shapes and Munday teaches a tubular shape thus circular cross section). Note, the instant specification teaches no criticality to the circular cross-section and suggests that alternative shapes may be used such as band shaped ([0019] of the published application). As the circular cross-section is non-critical and the instant specification teaches like in Cadwalader teaches the shape may be band shaped and circular cross-sectional shapes were known to the art (as in the secondary references), it would have been obvious to one of ordinary skill in the art to modify Cadwalader to use a circular cross-sectional shape because the cross sectional shape of the spine is a matter of design choice absent persuasive evidence that the particular configuration to the claimed spine is significant (MPEP 2144.04 (IV)B).
Regarding claim 25, Cadwalader teaches wherein the spine consists of metal ([0031]).
Regarding claim 26, Cadwalader alone or in view of Munday teaches wherein the spine is embedded in the device (Cadwalader teaches support members sandwiched in between 30 ([0033]) alternatively, figure 4 of Munday shows 36 embedded in the pocket).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Cadwalader et al. in view of Shashy or Lieb or Monday and further in view of Toure et al. (US2020/0155260).
Regarding claim 10, Cadwalader et al. differs from the claimed invention by not disclosing wherein the device comprises one or more antimicrobial layers, antibacterial agents, antifungal agents, antiyeast agents and/or antiviral agents, or combinations thereof.
However, Toure et al. teach the device comprises one or more antimicrobial layers ([0019]).
Toure et al. modifies Cadwalader by suggesting applying a coat of anti-microbial to the drape.
Since both inventions are directed towards a drape to be used in radiological medical applications, it would have been obvious to one of ordinary skill in the art to apply a antimicrobial coating suggested by Toure to the drape of Cadwalader because the coating would kill bacteria, therefore mitigating the spread of infection.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Cadwalader et al. in view of Shashy or Lieb or Monday and further in view of Stegehuis et al. (US pgPub 2019/0142353).
Regarding claims 11-12, Cadwalader et al. differs from the claimed invention by not disclosing means for detecting ionizing radiation; wherein the device comprises a compound or component capable of emitting light upon exposure to ionizing radiation.
However, Stegehuis et al. teach means for detecting ionizing radiation; wherein the device comprises a compound or component capable of emitting light upon exposure to ionizing radiation ([0079] teaches smart materials and/or electronics provide an tell-tale color change for a more visible indication to an operator as to sections, sectors or zones of the radiation shield where higher or lower scatter radiation intensities. Color change suggests emitting a different wavelength of light upon exposure to radiation. Paragraph [0007] teaches x-ray radiation scattering, thus ionizing radiation).
Stegehuis et al. modifies Cadwalader et al. by suggesting an indicator to be incorporated into the shield to identify areas that are not sufficiently shielded.
Since both inventions are directed towards a shield to protect against ionizing radiation, it would be obvious to incorporate the smart materials/electronics suggested in Stegehuis et al. in the drape of Cadwalader because a color change will indicate to the medical personnel of locations with higher/lower radiation scatter so that the operator may move out of harms way and/or adjust the shield to provide better radiation attenuation ([0079]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20160317110 to Rees teaches an alternative embodiment in figures 14-15 that is similar to Cadwalader above and may be used to make obvious at least claim 1
US2015/0262720—see figure 7 and paragraphs [0063]-[0064]
US2019/0336088—figures 4-5 and paragraph [0081]
US2640937 see figures 1-5
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 J LOGIE whose telephone number is (571)270-1616. The examiner can normally be reached M-F: 7:00AM-3:00PM.
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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.
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/MICHAEL J LOGIE/ Primary Examiner, Art Unit 2881
1 Note Cadwalader et al. US2008/0164425 could alternatively make obvious the claimed invention in view of Shashy or Lieb or Munday, specifically like Cadwalader et al. 2006, Cadwalader et al. 2008 teaches support members stitched to the fabric see paragraph [0053]. Alternatively, note Rees teaches a similar embodiment that using malleable rods 58 in figure 14 and paragraph [0058] that may be used instead of Cadwalader 2006 to make obvious claim 1.
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