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 .
Information Disclosure Statement
The listing of references in the specification (e.g., WO2014163574, EP2981975B1) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
Figure 7 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference signs mentioned in the description:
Radiation protection garment 17;
Edge 7a;
Fenestration Z4.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Page 7, line 6: “the second section 6” should read “the second section [[6]]4”;
Page 7, line 20: “the first section 4” should read “the first section [[4]]3”;
Page 7, line 24: “the second portion 4a” should read “the second portion [[4a]]4b”
Appropriate correction is required.
The use of the following terms, which are trade names or marks used in commerce, has been noted in this application:
Zero-Gravity®
TIDI®
Rampart®
M1128®
DXT-RAD Ringlets TLD™-100
Mavig® GmBH
Philips Multi Diagnost Eleva FD (Koninklijke Philips Electronics N.V.)
RaySafe® (Unfors™ RaySafe® AB)
Mavig®
Kenex®
Texray®
The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-8, and 18 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Gordon (U.S. Patent Application Publication No. 2019/0336088 A1), hereinafter Gordon.
Regarding claim 1, Gordon discloses a radiation protection shielding system for a patient lying on an operating table (paragraph 0103), the system comprising:
a radiation protection drape sized to at least partially cover the patient from a proximity of a radiated area of the patient to the feet of the patient (paragraph 0098), wherein the radiation protection drape comprises at least a first section (FIG. 12, element 1100a) and a second section (FIG. 12, element 1100b), wherein the first section is partitioned from the second section along a partition between the first section and the second section that extends at least partially from a first edge of the radiation protection drape towards a second edge of the radiation protection drape (FIG. 12, partition 1100c extending from the rightmost edge of radiation protection drape 1100 to passage 1128).
Regarding claim 2, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
In addition, Gordon discloses that the partition extends from the first edge to the second edge of the radiation protection drape (FIG. 12, partition 1100c extending from the rightmost edge of radiation protection drape 1100 to passage 1128), the first section being separable from the second section along the partition (paragraph 0100).
Regarding claim 3, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
In addition, Gordon discloses that the partition extends from the first edge partly to the second edge (FIG. 12, partition 1100c extending partially from the leftmost edge to the rightmost edge of radiation protection drape 1100, interrupted by passage 1128), the first section being partly separable from the second section along the partition (paragraph 0100).
Regarding claim 5, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
In addition, Gordon discloses that the second section (FIG. 12, element 1100b) comprises a first portion (FIG. 12, first portion of section 1100b, excluding element 1128b) and a second portion (FIG. 12, element 1128b), wherein the first portion and the second portion are separably fastened to each other along an edge of each of the first portion and the second portion (paragraph 0105, edge 1128a).
Regarding claim 6, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
In addition, Gordon discloses that the radiation protection drape comprises a fenestration for a femoralis area of the patient (FIG. 12, fenestration 1128), wherein the fenestration is located along the partition between the first section and the second section (FIG. 12: fenestration 1128 is located along partition 1100c).
Regarding claim 7, Gordon as applied to claim 6 discloses the radiation protection shielding system of claim 6.
In addition, Gordon discloses that the second edge is located at the fenestration, and wherein the partition between the first section and the second section extends from the first edge to the second edge (FIG. 12, partition 1100c extending from the rightmost edge of radiation protection drape 1100 to passage 1128).
Regarding claim 8, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
In addition, Gordon discloses that the radiation protection drape includes a fenestrated area (FIG. 12, fenestration 1128), and wherein the radiation protection drape comprises a third section configured to partially cover the fenestrated area of the radiation protection drape (FIG. 12, third section 1128b).
Regarding claim 18, Gordon discloses a method for covering a patient with a radiation protection shielding system during a medical intervention including radiation with ionizing radiation (paragraphs 0098, 0103), comprising:
at least partially covering the patient with a radiation protection drape from a proximity of a radiated area of the patient to the feet of the patient (paragraph 0098), wherein said covering comprises covering a first portion of the patient with a first section of the radiation protection drape (FIG. 12, element 1100a) and a second portion of the patient with a second section of the radiation protection drape (FIG. 12, element 1100b), wherein the first section is partitioned from the second section from a first edge of the radiation protection drape towards a second edge of the radiation protection drape (FIG. 12, partition 1100c extending partially from the leftmost edge to the rightmost edge of radiation protection drape 1100, interrupted by passage 1128).
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.
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.
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon.
Regarding claim 4, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
An alternative embodiment of Gordon discloses that the first section has a varying radiation protection level across the first section (paragraph 0084).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the embodiment of Gordon which anticipates the limitations of claim 1 to include that the first section has a varying radiation protection level across the first section, based on the additional teachings of Gordon that this provides greater flexibility in the degree of radiation shielding at different areas of the radiation protection drape (Gordon, paragraph 0084).
Regarding claim 17, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
An alternative embodiment of Gordon discloses a closure indicator positioned at an overlap between the first section and the second section (paragraph 0058, lines 5-11).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the embodiment of Gordon which anticipates the limitations of claim 1 to include a closure indicator positioned at an overlap between the first section and the second section, based on the additional teachings of Gordon that this ensures proper protection of the healthcare practitioner while also decreasing the required dose of radiation (Gordon, paragraph 0058).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon as applied to claim 1 above, in view of Cadwalader et al. (U.S. Patent Application Publication No. 2008/0164425 A1), hereinafter Cadwalader.
Regarding claim 9, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
Gordon fails to disclose a fastening device located at the partition between the first section and the second section.
However, Cadwalader discloses a fastening device (paragraph 0061, hook and loop fastener) located at the partition (FIG. 8, element 62) between the first section (FIG. 8, element 56) and the second section (FIG. 8, element 58).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gordon to include a fastening device located at the partition between the first section and the second section, based on the teachings of Cadwalader that this enables greater flexibility in terms of relocating portions of the shielding device (Cadwalader, paragraph 0061).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon as applied to claim 1 above, in view of Goldstein et al. (U.S. Patent Application Publication No. 2021/0275115 A1), hereinafter Goldstein.
Regarding claim 10, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
In addition, Gordon discloses that the operating table has a rim (Dictionary.com defines “rim” as “the outer edge, border, margin, or brink of something”; FIG. 2 shows an outer edge of an operating table below the radiation shielding device 100).
Gordon fails to disclose that the radiation protection drape is sized to extend over the rim of the operating table, when positioned over the patient lying on the operating table, and towards a floor on at least one side of the operating table.
However, Goldstein discloses that the radiation protection drape is sized to extend over the rim of the operating table (FIG. 2, radiation protection drape 26), when positioned over the patient (FIG. 2, patient S) lying on the operating table (FIG. 2, element 22), and towards a floor on at least one side of the operating table (FIG. 2, radiation protection drape 26).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gordon to include that the radiation protection drape is sized to extend over the rim of the operating table, when positioned over the patient lying on the operating table, and towards a floor on at least one side of the operating table, based on the teachings of Goldstein that this ensures that the area directly adjacent to the patient is properly shielded (Goldstein, paragraph 0063).
Regarding claim 11, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
Gordon fails to disclose a radiation shielding screen configured to be positioned between clinical staff in the proximity of the operating table and a radiated area at an upper body portion of the patient.
However, Goldstein discloses a radiation shielding screen (FIG. 37, element 450) configured to be positioned between clinical staff in the proximity of the operating table and a radiated area at an upper body portion of the patient (paragraph 0095).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gordon to include a radiation shielding screen configured to be positioned between clinical staff in the proximity of the operating table and a radiated area at an upper body portion of the patient, based on the teachings of Goldstein that this provides flexible positioning of the shield in accordance with different shielding requirements (Goldstein, paragraph 0095).
Regarding claim 12, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
Gordon fails to disclose that the radiation protection drape further comprises a third section configured to cover an area under the operating table.
However, Goldstein discloses that the radiation protection drape further comprises a third section (FIG. 21, element 202) configured to cover an area under the operating table (FIG. 21, element 22).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gordon to include that the radiation protection drape further comprises a third section configured to cover an area under the operating table, based on the teachings of Goldstein that this provides additional shielding for the lower portions of healthcare professionals’ bodies (Goldstein, paragraph 0074).
Claims 13-15 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon as applied to claim 1 above, in view of Apell et al. (U.S. Patent Application Publication No. 2016/0060791 A1), hereinafter Apell.
Regarding claim 13, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
Gordon fails to disclose that the radiation protection drape has a radiation protection level corresponding to 0.1 to 1 mm lead equivalency.
However, Apell discloses that the radiation protection drape has a radiation protection level corresponding to 0.1 to 1 mm lead equivalency (paragraph 0043).
When a claimed range “overlap[s] or lie[s] inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05 I; In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the case at hand, Apell teaches a range of “at least 0.10 mm” (paragraph 0043), which overlaps with the claimed range of 0.1 to 1 mm. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gordon to meet the claimed range of lead equivalency.
Regarding claim 14, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
Gordon fails to disclose a radiation protection garment.
However, Apell discloses a radiation protection garment (paragraph 0034).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gordon to include a radiation protection garment, based on the teachings of Apell that radiation protection garments are easy to perform maintenance on, and are easy to fold without decreasing the radiation protection effects (Apell, paragraph 0026).
Regarding claim 15, Gordon in view of Apell as applied to claim 14 discloses the radiation protection shielding system according to claim 14.
In addition, Apell discloses that the radiation protection garment comprises a panel sized to extend over at least a torso front side of a wearer (paragraph 0034), the panel having a radiation protection level of 0.05 to 0.35 mm lead equivalency (paragraph 0043).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gordon in view of Apell to include that the radiation protection garment comprises a panel sized to extend over at least a torso front side of a wearer, based on the additional teachings of Apell that this provides protection of healthcare workers with flexibility to adapt to different protection requirements (Apell, paragraph 0003).
When a claimed range “overlap[s] or lie[s] inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05 I; In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the case at hand, Apell teaches a range of “at least 0.10 mm” (paragraph 0043), which overlaps with the claimed range of 0.05 to 0.35 mm. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gordon in view of Apell to meet the claimed range of lead equivalency.
Regarding claim 19, Gordon as applied to claim 1 discloses the radiation protection shielding system according to claim 1.
Gordon fails to disclose that the radiation protection drape includes antimony as a radiation attenuating ingredient.
However, Apell discloses that the radiation protection drape includes antimony as a radiation attenuating ingredient (paragraph 0042).
The disclosure of Apell demonstrates that the function of antimony is known in the art of radiation shielding. Apell also shows that substituting antimony for another radiation attenuating ingredient in a radiation protection garment yields the predictable result of providing sufficient radiation shielding while being more environmentally friendly and lighter weight as compared to lead (Apell, paragraph 0005). “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” United States v. Adams, 383 U.S. 39 (1966). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gordon to include that the radiation protection drape includes antimony as a radiation attenuating ingredient because it is not inventive to substitute one known element for another which yields predictable results to one of ordinary skill in the art. See MPEP 2143 I (B).
Regarding claim 20, Gordon in view of Apell as applied to claim 14 discloses the radiation protection shielding system of claim 14.
In addition, Gordon discloses that the radiation protection drape includes a first radiation attenuating ingredient (paragraph 0101, aluminum).
In addition, Apell discloses that the radiation protection garment includes a second radiation attenuating ingredient different from the first radiation attenuating ingredient (paragraph 0072, Wolfram (Tungsten) oxide).
The disclosure of Apell demonstrates that the function of Wolfram (Tungsten) oxide is known in the art of radiation shielding. Apell also shows that substituting Wolfram (Tungsten) oxide for another radiation attenuating ingredient in a radiation protection garment yields the predictable result of providing sufficient absorption of radiation (Apell, paragraph 0072). “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” United States v. Adams, 383 U.S. 39 (1966). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gordon in view of Apell to include that the radiation protection garment includes a second radiation attenuating ingredient different from the first radiation attenuating ingredient because it is not inventive to substitute one known element for another which yields predictable results to one of ordinary skill in the art. See MPEP 2143 I (B).
Regarding claim 21, Gordon in view of Apell as applied to claim 20 discloses the radiation protection shielding system of claim 20.
In addition, Apell discloses that the first radiation attenuating ingredient comprises antimony (paragraph 0042), and the second radiation attenuating ingredient comprises at least one of bismuth and wolfram (paragraph 0044).
The disclosure of Apell demonstrates that the functions of antimony and wolfram are known in the art of radiation shielding. Apell also shows that substituting antimony or wolfram for another radiation attenuating ingredient in a radiation protection garment yields the predictable result of providing sufficient radiation shielding while being more environmentally friendly and lighter weight as compared to lead (Apell, paragraph 0005). “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” United States v. Adams, 383 U.S. 39 (1966). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gordon in view of Apell to include that the first radiation attenuating ingredient comprises antimony, and the second radiation attenuating ingredient comprises at least one of bismuth and wolfram, because it is not inventive to substitute one known element for another which yields predictable results to one of ordinary skill in the art. See MPEP 2143 I (B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lenhart (U.S. Patent No. 4,581,538 A), hereinafter Lenhart, teaches a radiation shielding screen configured to be positioned between clinical staff in the proximity of the operating table and a radiated area at an upper body portion of the patient.
Cadwalader et al. (U.S. Patent Application Publication No. 2006/0108548 A1), hereinafter Cadwalader (2006), teaches a radiation protection garment comprising a panel sized to extend over at least a torso front side of a wearer.
Milstein et al. (U.S. Patent Application Publication No. 2015/0004131 A1), hereinafter Milstein, teaches bismuth as a radiation attenuating ingredient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALINA R KALISZEWSKI whose telephone number is (703)756-5581. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/A.K./Examiner, Art Unit 2881
/ROBERT H KIM/Supervisory Patent Examiner, Art Unit 2881
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