DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06 February 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 1, 9-12 and 16-26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 § 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 and 16-24 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).
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 16, Munday teaches wherein the spine is shapable (tube 36 is shapeable and bendable via inflation, see col. 3, lines 57-63).
Regarding claim 17, Munday teaches wherein the spine comprises a single elongated member (tube 36, inherently a single elongated member to inflate and unfold the blanket. Alternatively interpreting the left lateral 36 of blanket to be the single elongated member).
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 20, Munday teaches wherein the spine is a multi-sectional spine that comprises a plurality of members (each section of tube 36 along the periphery is interpreted to be a member).
Regarding claim 21, Munday teaches wherein the spine is made of a rigid material (when inflated with air the tube is rigid).
Regarding claim 22, Munday teaches wherein each of the plurality of members is elongated (each side of tube 36 seen in figure 4 is elongated).
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 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, 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).
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rees (US pgPub 20160317110) (figure 13).
Regarding claim 1, Rees teaches a radiation shield device (fig. 13) for radiation and radiation-guided imaging, therapy, diagnosis or prognosis of a subject comprising a sheet of material (fig. 13, [0086] patient is the subject seen in figure 10a-10b. Intended use (see discussion in the Final Rejection of 08 October 2025)), wherein the sheet (12) comprises a barrier to ionizing radiation (lead [0080]) and a spine (46), wherein the spine consists of a single elongated member (as seen in figure 13) and is made of a shapable material which enables a user to shape the spine (via tensioning or releasing 46 via 44, see paragraph [0086]), and therefore the sheet ([0086] releasing the applied tension allowing the joints or hinges to flex freely), as required during a procedure (if necessary during a procedure 44 may release tension to adjust 56 as discussed in paragraph [0086]), wherein the spine has a circular cross- sectional shape (figure 13a shows spin 46 through hinge 58 having a cylindrical shape thus circular cross section).
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rees (US pgPub 20160317110) (figure 14).
a radiation shield device (fig. 14) for radiation and radiation-guided imaging, therapy, diagnosis or prognosis of a subject comprising a sheet of material (fig. 14, [0086] patient is the subject seen in figure 10a-10b. Intended use (see discussion in the Final Rejection of 08 October 2025)), wherein the sheet (12) comprises a barrier to ionizing radiation (lead [0080]) and a spine (58), wherein the spine consists of a single elongated member (as seen in figure 14) and is made of a shapable material which enables a user to shape the spine ([0087]), and therefore the sheet ([0087]), as required during a procedure ([0087], note conform to various shapes of body and table configurations), wherein the spine has a circular cross- sectional shape ([0087], note: rod thus circular cross-section).
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 or alternatively in view of Lieb (US52902) or Munday.
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, see figures 1 and 2).
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).
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).
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).
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 16, Cadwalader teaches wherein the spine is bendable or shapable ([0031]).
Regarding claim 17, Cadwalader teaches wherein the spine comprises a single elongated member (a single member 60).
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 20, Cadwalader teaches wherein the spine is a multi-sectional spine that comprises a plurality of members (multiple parts 60)
Regarding claim 21, Cadwalader teaches wherein the spine is made of a rigid material ([0032]).
Regarding claim 22, Cadwalader teaches wherein each of the plurality of members is elongated (as seen in figures 1-2 each member 60 is elongated).
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, 16-17. Shahy and Lieb both teach rods, thus circular cross-sectional shapes and Munday teaches a tubular shape thus circular cross section).
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]).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Rees (fig. 13) in view of Roberts (USPN 3,378,999).
Regarding claim 25, while Reese teaches a filament as the claimed spine, Rees fails to disclose the material.
However, Roberts teaches a metal yarn structure (see abstract).
Roberts modifies Reese by suggesting a metal structure for the filament.
Since both inventions are directed towards filaments, it would have been obvious to one of ordinary skill in the art to have the metal filament of Roberts in the device of Reese because they are known for their high tensile strength and highly flexible nature (col. 1, lines 28-31), therefore suitable for the intended use of Rees (i.e. tension and release of the filament) and would improve the durability of the tensioning structure.
Regarding claim 26, Rees teaches wherein the spine is embedded in the device (fig. 13 shows 46 embedded in the device via hinge 58).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Rees (fig. 14) in view of Cadwalader
Regarding claim 25, while Reese teaches a malleable rod, Rees fails to disclose the material.
However, Cadwalader teaches a metal yarn structure ([0031]).
Cadwalder modifies Reese by suggesting a metal structure for the malleable rod.
Since both inventions are directed towards filaments, it would have been obvious to one of ordinary skill in the art to have the metal filament of Cadwalader in the device of Reese because metal is known to be malleable thus suitable for the intended purpose of Rees.
Regarding claim 26, Rees teaches wherein the spine is embedded in the device ([0087] either via pocket or permanently located inside the insert 12).
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
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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.