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 .
Response to Amendment
Applicant’s amendments to claims 1-4, 6, 9, 11-12, 15-17, and 19, the cancellation of claim 10, and the addition of claim 21 filed 11/04/2025 is acknowledged by the examiner.
Claims 1-9 and 11-21 are currently pending and are under examination.
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
Applicant’s argument: Kluba’s polyurethane foam or silicone is different from the “biodegradable viscoelastic foam” of the claimed invention, which has surfaces with “a coefficient of friction of 0.2 to 2.5” and which is “configured to contact the medical procedure table for holding the patient support device in position against the medical procedure table, and a peripheral edge extending therebetween.” Significantly, Kluba is silent regarding whether a viscoelastic foam can be made to be both biodegradable and with a coefficient of friction surfficient for patient positioning. Instead, Kluba discloses that the shaped body (1) includes detachable means (e.g., Velcro) for fastening the pad (1) to a base surface (e.g., mattress) so that the “shaped body can be fixed and slipping of the shaped body on the base surface can be prevented.” (see [0084] of Kluba). Accordingly, a person skilled in the art would not be led to modify Pigazzi’s pad to include biodegradable viscoelastic foam with a coefficient of friction suitable for patient positioning based on Kluba. Furthermore, the person skilled in the art would have no expectation of success in modifying Pigazzi to include Kluba’s biodegradable viscoelastic foam because Kluba does not disclose or suggest that such foam has a sufficient coefficient of friction and is configured for patient positioning without use of other securing means as in the claimed invention.
Examiner’s response: In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, the primary reference, Pigazzi, already discloses a viscoelastic foam with surfaces with a coefficient of friction of 0.2 to 2.5 configured to contact the medical procedure table for holding the patient support device in position against the medical procedure table, and a peripheral edge extending therebetween. KLUBA is a teaching reference that only teaches the viscoelastic foam material of Pigazzi to be a biodegradable viscoelastic foam material.
Applicant’s argument: Applicant submits that a person skilled in the art would not be led to modify the viscoelastic foam in Pigazzi based on the disclosures of Robinson and Mitchell at least because the foams disclosed in Robinson and Mitchell are not suitable for surgical settings. In particular, Robinson’s poly-ester-based polyurethane foam comprises the mixture of soil-dwelling carbon-digesting bacteria in a carrier compound. The skilled person would not consider materials with embedded bacteria for use in a surgical setting, such as for use in a pad or support device configured to be positioned on a surgical table during a surgical procedure, due to contamination risks and risks associated with introduction of bacteria to a surgical site. Similarly, Mitchell discloses viscoelastic foam used for fishing lures. Mitchell does not disclose or suggest that the foam can be cleaned, sterilized, or otherwise made free from bacteria and contaminants, as would be required for use during a surgical procedure. Therefore, a person skilled in the art seeking to modify Pigazzi’s patient positioning device to include biodegradable viscoelastic foam would not be led to consider the foams disclosed in Robinson and Mitchell.
Examiner’s response: In response to applicant's argument that the skilled person would not consider materials with embedded bacteria for use in a surgical setting or that Mitchell does not disclose or suggest that the foam can be cleaned, sterilized, or otherwise made free from bacteria and contaminants, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Therefore, ROBINSON is a teaching reference that only teaches the biodegradable viscoelastic foam being configured to partially or completely degrade by action of microbes over a period of days, weeks, months, or years. Further, Mitchell is a teaching reference that only teaches the biodegradable foam degrading into one or more of simple carbohydrates or complex carbohydrates. Mitchell does not need to disclose that the foam be cleaned or sterilized in any way as the claim does not require that. The claim only recites that a biodegradable foam degrades into one or more simple carbohydrates or complex carbohydrates, which Mitchell teaches.
Applicant’s argument: Pigazzi, Kluba, and the other cited references are silent regarding components or materials that form the viscoelastic foam. Therefore, these cited references do not disclose or suggest the “polyhydroxy polyol” and “toluene di-isocyanate, polyester polyols, or polyether” of new claim 21.
Examiner’s response: Pigazzi explicitly discloses a foam made by mixing polyhydroxy polyol with toluene di-isocyanate and polyester polyols and polyether, see Col. 9 lines 4-9 of Pigazzi.
Claim Objections
Claims 15-16 are objected to because of the following informalities:
Regarding claim 15, “the first block” in line 2 should be recited as “the first foam block”.
Regarding claim 15, “the second block” in line 3 should be recited as “the second foam block”.
Regarding claim 16, “the first block” in line 2 should be recited as “the first foam block.”
Regarding claim 16, “the second block” in line 3 should be recited as “the second foam block.”
Appropriate correction is required.
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 1-20 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 “substantially” in claim 1 is a relative term which renders the claim indefinite. The term “substantially” 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. As no explicit definition is given, the Examiner has defined “substantially flat” as “flat” with minor deviations.
The term “about” in claim 11 is a relative term which renders the claim indefinite. The term “about” 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. As no explicit definition is given, the Examiner has defined “about 35 kilograms per cubic meter to about 128 kilograms per cubic meter,” as “35 kilograms per cubic meter to 128 kilograms per cubic meter”.
The term “about” in claim 17 is a relative term which renders the claim indefinite. The term “about” 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. As no explicit definition is given, the Examiner has defined “about 0.5 inch to about 3.0 inches” and “about 1.5 inches,” as “0.5 inch to 3.0 inches” and “1.5 inches”.
The term “about” in claim 18 is a relative term which renders the claim indefinite. The term “about” 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. As no explicit definition is given, the Examiner has defined “about 25 inches to 80 inches” and “about 10 inches to about 40 inches,” as “25 inches to 80 inches” and “10 inches to 40 inches”.
Claims 2-9, 12-16, and 19-21 are rejected for depending on a previously rejected claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 5-6, 8-9, 11, and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pigazzi et al. (referred to as “Pigazzi”) (US 8,511,314 B2) in view of KLUBA (US 2021/0244210 A1) further in view of ROBINSON et al. (referred to as “ROBINSON”) (US 2022/0098571 A1).
Regarding claim 1, Pigazzi discloses a patient support device (102) for positioning a patient on a medical procedure table (120) during a medical procedure (see Abstract, Col. 1 lines 65-67 et seq. Col. 2 lines 1-5, and Figs. 1-2 and 4-6; Trendelenburg pad 102 is a patient support device for positioning a patient on operating table 120 during a medical procedure), comprising:
a pad (102) comprising a viscoelastic foam (see Figs. 1-2 and 4-6, and Col. 1 lines 65-67, and Col. 4 lines 65-67; Trendelenburg pad 102 comprises viscoelastic foam), the pad (102) further comprising a substantially flat first surface with a coefficient of friction of 0.2 to 2.5 configured to be in contact with the patient (see Fig. 1 which shows a top view of the Trendelenburg pad 102, and thus the top view shows a flat first surface configured to be in contact with the patient, also see Figs. 4-7, and see Col. 2 lines 58-61 and Col. 5 lines 11-14 which discusses how the pad has a coefficient of friction of 0.2 to 1.0, which is within the claimed range, also see claim 16), an opposing substantially flat second surface with a coefficient of friction of 0.2 to 2.5 configured to contact the medical procedure table (120) for holding the patient support device (102) in position against the medical procedure table (120) (see Fig. 2 which shows a bottom view of the Trendelenburg pad 102 and thus the bottom view shows an opposing flat second surface which is configured to contact the operating table 120 for holding the Trendelenburg pad 102 in position against the operating table 120, also see Figs. 4-7, and see Col. 2 lines 58-61 which discusses how the pad has a coefficient of friction of 0.2 to 1.0, which is within the claimed range), and a peripheral edge extending therebetween (see Annotated Fig. 5 of Pigazzi; a peripheral edge is labeled and extends between the first surface and second surface).
Pigazzi is silent on the pad comprising a biodegradable foam, and wherein the biodegradable viscoelastic foam is configured to partially completely degrade through chemical reactions and/or by action of living organisms into one or more of simple carbohydrates, complex carbohydrates, water, carbon dioxide, or biomass over a period of days, weeks, months, or years.
However, KLUBA teaches an analogous pad (1) comprising a foam (see Fig. 1; shaped body 1 is an analogous pad as it is a cushion and is made from a polyurethane foam, see [0067], [0160]), and the pad (1) comprising a biodegradable foam (see Fig. 1 and [0067]; the polyurethane foam is biodegradable), providing a more sustainable device that reduces waste.
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 pad (102) comprising a viscoelastic foam of Pigazzi to be biodegradable as taught by KLUBA to have provided an improved patient support device that is more sustainable by reducing waste.
Pigazzi in view of KLUBA discloses the invention as discussed above.
Pigazzi in view of KLUBA is silent on wherein the biodegradable viscoelastic foam is configured to partially completely degrade through chemical reactions and/or by action of living organisms into one or more of simple carbohydrates, complex carbohydrates, water, carbon dioxide, or biomass over a period of days, weeks, months, or years.
However, ROBINSON teaches an analogous biodegradable foam (see Abstract and [0001]), wherein the biodegradable viscoelastic foam is configured to partially completely degrade through chemical reactions and/or by action of living organisms into one or more of simple carbohydrates, complex carbohydrates, water, carbon dioxide, or biomass over a period of days, weeks, months, or years (see [0005]-[0007] and [0046]-[0047] which discusses how the biodegradable foam material is configured to partially or completely degrade by action of living organisms such as soil-dwelling carbon-digesting bacteria such as Bacillus, which is a microbe or living organism, and then water, carbon dioxide, and biomass are the final products of deterioration or degradation of the biodegradable foam, and the biodegradable foam material may degrade over a period of years, also see [0074] which discusses how the rate of biodegradation can be controlled depending on the use of the final foam product and the concentration of bacteria in the foam), providing to be able to control the rate of biodegradation(see [0074]) and provide a more sustainable device that reduces waste.
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 biodegradable viscoelastic foam of Pigazzi in view of KLUBA to be configured to partially or completely degrade by action of living organisms over a period of days, weeks, months, or years as taught by ROBINSON to have provided an improved patient support device that is able to control the rate of biodegradation (see [0074]) and provide a more sustainable device that reduces waste.
Regarding claim 2, Pigazzi in view of KLUBA further in view of ROBINSON discloses the invention as discussed in claim 1. Pigazzi in view of KLUBA further in view of ROBINSON further discloses wherein the medical procedure is a procedure configured to be performed with the patient in a Trendelenburg or reverse Trendelenburg position (see Fig. 6 of Pigazzi and Col. 4 lines 39-40, and Col. 5 lines 40-42 of Pigazzi; the medical procedure is a procedure performed with the patient in a Trendelenburg position, as a patient is positioned on the Trendelenburg pad 102 of Pigazzi in a Trendelenburg position).
Regarding claim 3, Pigazzi in view of KLUBA further in view of ROBINSON discloses the invention as discussed in claim 1. Pigazzi in view of KLUBA further in view of ROBINSON further discloses wherein the biodegradable viscoelastic foam is configured to partially or completely degrade by action of microbes over a period of days, weeks, months or years (as previously modified above, see claim 1, the biodegradable viscoelastic foam is configured to partially or completely degrade by action of microbes over a period of years, see [0005]-[0007] and [0046]-[0047] of ROBINSON, also see [0074] which discusses how the rate of biodegradation can be controlled depending on the use of the final foam product and the concentration of bacteria in the foam).
Regarding claim 5, Pigazzi in view of KLUBA further in view of ROBINSON discloses the invention as discussed in claim 3. Pigazzi in view of KLUBA further in view of ROBINSON further discloses wherein the biodegradable viscoelastic foam degrades into water, carbon dioxide, and biomass (as previously modified above, see claim 1, water, carbon dioxide, and biomass are the final products of deterioration or degradation of the viscoelastic biodegradable foam, see [0047] of ROBINSON).
Regarding claim 6, Pigazzi in view of KLUBA further in view of ROBINSON discloses the invention as discussed in claim 1. Pigazzi in view of KLUBA further in view of ROBINSON further discloses at least one strap (104 of Pigazzi) comprising a first portion (112 of Pigazzi) connected to the pad (102 of Pigazzi) (see Figs. 1-3B of Pigazzi; fasteners 104 of Pigazzi are straps and the fasteners 104 of Pigazzi comprise a central portion 112 of Pigazzi, which is connected to the Trendelenburg pad 102 of Pigazzi, see Col. 3 lines 58-61 of Pigazzi) and a second portion (106,108 of Pigazzi) configured to be connected to the medical procedure table (120 of Pigazzi) for securing the patient support device to the medical procedure table (120 of Pigazzi) (see Figs. 1-3B and 6 of Pigazzi; hook portion 108 and loop portion 106 of Pigazzi are second portions of fasteners 104 of Pigazzi which are configured to be connected to the operating table 120 of Pigazzi for securing the Trendelenburg pad 102 of Pigazzi to the operating table 120 of Pigazzi, as seen in Fig. 6 of Pigazzi, also see Col. 3 lines 40-49 of Pigazzi and Col.4 lines 22-26 of Pigazzi).
Regarding claim 8, Pigazzi in view of KLUBA further in view of ROBINSON discloses the invention as discussed in claim 1. Pigazzi in view of KLUBA further in view of ROBINSON further discloses wherein the pad (102 of Pigazzi) has a length sufficient to extend from at least thighs of the patient to at least shoulders of the patient to support a torso of the patient placed on the pad (102 of Pigazzi) (see Fig. 6 of Pigazzi; the Trendelenburg pad 102 of Pigazzi has a length that is sufficient to extend from at least thighs of the patient to at least shoulders of the patient to support a torso of the patient placed on the Trendelenburg pad 102 of Pigazzi, see Col. 3 lines 31-34 of Pigazzi).
Regarding claim 9, Pigazzi in view of KLUBA discloses the invention as discussed in claim 1. Pigazzi in view of KLUBA further in view of ROBINSON discloses wherein the biodegradable viscoelastic foam comprises a polyurethane foam (as previously modified above, the biodegradable viscoelastic foam material of Pigazzi is a polyurethane foam, see Col. 9 lines 4-9 of Pigazzi, and the biodegradable foam material of KLUBA is also a polyurethane foam, see [0067] of KLUBA).
Regarding claim 11, Pigazzi in view of KLUBA discloses the invention as discussed in claim 1. Pigazzi in view of KLUBA further discloses wherein the biodegradable viscoelastic foam that forms the pad (102 of Pigazzi) has a density of about 35 kilograms per cubic meter to about 128 kilograms per cubic meter (see Col. 3 lines 22-27 of Pigazzi; as previously modified above, the biodegradable viscoelastic foam that forms the Trendelenburg pad 102 of Pigazzi has a density of 75 kilograms per cubic meter to 110 kilograms per cubic meter, which is within the claimed range).
Regarding claim 17, Pigazzi in view of KLUBA further in view of ROBINSON discloses the invention as discussed in claim 1. Pigazzi in view of KLUBA further in view of ROBINSON further discloses wherein the pad (102 of Pigazzi) has a length that is greater than its width (see Col. 9 lines 10-12 of Pigazzi which discusses the Trendelenburg pad 102 of Pigazzi is 20 inches wide and 30 inches long, and thus the length is greater than its width), and wherein the pad (102 of Pigazzi) is from about 0.5 inch to about 3.0 inches thick (see Col. 3 lines 3-6 of Pigazzi which discusses the thickness of the Trendelenburg pad 102 of Pigazzi has a thickness of .75 inches to 3 inches or greater, and thus is within the claimed range).
Regarding claim 18, Pigazzi in view of KLUBA further in view of ROBINSON discloses the invention as discussed in claim 1. Pigazzi in view of KLUBA further in view of ROBINSON further discloses wherein the pad (102 of Pigazzi) is substantially rectangular having a length of about 25 inches to about 80 inches and a width of about 10 inches to about 40 inches (see Figs. 1-2 of Pigazzi which shows the Trendelenburg pad 102 of Pigazzi is a rectangular shape, and see Col. 9 lines 10-12 of Pigazzi which discusses the Trendelenburg pad 102 of Pigazzi has a length of 30 inches which is within the claimed range and the Trendelenburg pad 102 of Pigazzi has a width of 20 inches which is also within the claimed range).
Regarding claim 19, Pigazzi in view of KLUBA further in view of ROBINSON discloses the invention as discussed in claim 1.
Pigazzi in view of KLUBA further in view of ROBINSON further discloses a method of positioning a patient on a medical procedure table (120 of Pigazzi) during a medical procedure (see Abstract, Col. 1 lines 65-67 et seq. Col. 2 lines 1-5 of Pigazzi, and Figs. 1-2 and 4-6 of Pigazzi), the method comprising:
positioning the patient support device of claim 1 (102 of Pigazzi) on a tiltable medical procedure table (120 of Pigazzi) (see Figs. 4 and 6 of Pigazzi and Col. 4 lines 13-40 of Pigazzi which discusses positioning the Trendelenburg pad 102 of Pigazzi on operating table 120 of Pigazzi which is tiltable as the operating table may be placed in the Trendelenburg position), such that the opposing substantially flat second surface of the pad (102 of Pigazzi) contacts a surface of the medical procedure table (see Figs. 1-2 and 4-7 of Pigazzi; the second surface or back side of Trendelenburg pad 102 of Pigazzi, which is shown in Fig. 2 of Pigazzi, contacts a surface of the operating table 120 of Pigazzi as best seen in Fig. 6 of Pigazzi);
positioning a torso of the patient (128 of Pigazzi) on the substantially flat first surface of the pad (102 of Pigazzi) (see Figs. 1-2 and 4-7 of Pigazzi; a torso of patient 128 of Pigazzi is positioned on the first surface or front surface of the Trendelenburg pad 102 of Pigazzi, which is best seen in Figs. 6-7 of Pigazzi, also see Col. 4 lines 28-31 of Pigazzi and Col. 4 lines 41-46 of Pigazzi); and
tilting the medical procedure table (120 of Pigazzi) to position the torso of the patient at an angle suitable for performing the medical procedure (see Figs. 1-2 and 4-7 of Pigazzi, and Col. 4 lines 13-40 of Pigazzi which discusses tilting the operating table 120 of Pigazzi to the Trendelenburg position to position the torso of the patient at an angle suitable for performing the medical procedure).
Regarding claim 20, Pigazzi in view of KLUBA further in view of ROBINSON discloses the method as discussed in claim 19. Pigazzi in view of KLUBA further in view of ROBINSON further discloses wherein the medical procedure is a procedure performed with the patient in a Trendelenburg or the reverse Trendelenburg position (see Fig. 6 of Pigazzi and Col. 4 lines 39-40, and Col. 5 lines 40-42 of Pigazzi; the medical procedure is a procedure performed with the patient in a Trendelenburg position, as a patient is positioned on the Trendelenburg pad 102 of Pigazzi in a Trendelenburg position).
Regarding claim 21, Pigazzi in view of KLUBA further in view of ROBINSON discloses the invention as discussed in claim 1. Pigazzi in view of KLUBA further in view of ROBINSON further discloses wherein the biodegradable viscoelastic foam comprises a foam made by mixing polyhydroxy polyol with at least one of toluene di-isocyanate, polyester polyols, or polyether (as previously modified above, see claim 1, the biodegradable viscoelastic foam of Pigazzi comprises a foam made by mixing polyhydroxy polyol with toluene di-isocyanate and polyester polyols and polyether, see Col. 9 lines 4-9 of Pigazzi).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pigazzi in view of KLUBA in view of ROBINSON further in view of Mitchell et al. (referred to as “Mitchell”) (US 2008/0000140 A1).
Regarding claim 4, Pigazzi in view of KLUBA further in view of ROBINSON discloses the invention as discussed in claim 3.
Pigazzi in view of KLUBA further in view of ROBINSON is silent on wherein the biodegradable viscoelastic foam degrades into one or more of simple carbohydrates or complex carbohydrates.
However, Mitchell teaches an analogous biodegradable foam (see [0073] which discusses a foam type polymer that is biodegradable), wherein the biodegradable foam degrades into simple or complex carbohydrates (see [0073] which discusses how a foam type polymer is biodegradable and degrades into carbohydrates, such as cellulose, which is a complex carbohydrate), providing a more sustainable device that is environmentally safe for beings.
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 biodegradable viscoelastic foam of Pigazzi in view of KLUBA further in view of ROBINSON to degrade into simple or complex carbohydrates as taught by Mitchell to have provided an improved patient support device that is a more sustainable device that is environmentally safe for beings.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pigazzi in view of KLUBA in view of ROBINSON further in view of Holladay (US 2018/0200132 A1).
Regarding claim 7, Pigazzi in view of KLUBA further in view of ROBINSON discloses the invention as discussed in claim 6.
Pigazzi in view of KLUBA further in view of ROBINSON is silent on wherein the first portion of the at least one strap is connected to the pad by an adhesive and/or is sewn to the pad.
However, Holladay discloses an analogous patient support device (110) and an analogous at least one strap (140-143) (see Figs. 1-3; the table pad 110 supports a patient as seen in Fig. 2), and wherein the first portion of the at least one strap (140-143) is connected to the pad by an adhesive and/or is sewn to the pad (see Figs. 1-3; straps 140-143 may be provided to the table pad 110 on the bottom side as discussed in [0046], and thus there is a first portion of the straps 140-143 that is connected to the pad, and this portion is connected to the table pad 110 by adhesive, see [0047]), providing a more secure attachment mechanism so that the patient support device is further secured to the operating table when in use.
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 first portion (112 of Pigazzi) of the at least one strap (104 of Pigazzi) in the device of Pigazzi in view of KLUBA further in view of ROBINSON to be connected to the pad by an adhesive as taught by Holladay to have provided an improved patient support device that provides a more secure attachment mechanism so that the patient support device is further secured to the operating table when in use.
Claim(s) 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pigazzi in view of KLUBA in view of ROBINSON further in view of Gomez (US 2022/0000692 A1).
Regarding claim 12, Pigazzi in view of KLUBA further in view of ROBINSON discloses the invention as discussed in claim 1.
Pigazzi in view of KLUBA further in view of ROBINSON is silent on wherein the pad comprises a first foam block comprising the substantially flat first surface and a second foam block comprising the opposing substantially flat second surface.
However, Gomez teaches an analogous patient support device (305) and an analogous pad (307+318) (see Fig. 1 and Abstract, and [0033]; bi-wing arm support apparatus 305 is an analogous patient support device as the bi-wing arm support apparatus 305 is made up of upper member 307 + lower member 318 which are both pads to provide a patient with support), and wherein the pad (307+318) comprises a first foam block (307) comprising the substantially flat first surface (see Fig. 1 and [0033]; the pad is made up of upper member 307 which comprises a foam material that is viscoelastic and thus is a first foam block, and the upper member 307 rests on top of the lower member 318 and thus the upper member 307 comprises the substantially flat first surface) and a second foam block (318) comprising the second surface (see Fig. 1 and [0033]; the pad is also made up of lower member 318 which comprises a foam material that may also be viscoelastic material and thus forms a second foam block, and the lower member 318 rests below the upper member 307 and thus the lower member 318 comprises the opposing substantially flat second surface, also see [0006] which discusses the bottom surface of the lower member 3181 facing the top surface of a surgical table), providing a patient support device that is well cushioned so that the patient is comfortable.
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 pad (102 of Pigazzi) in the device of Pigazzi in view of KLUBA further in view of ROBINSON to comprise a first foam block (307) comprising the substantially flat first surface and a second foam block comprising the opposing substantially flat second surface as taught by Gomez to have provided an improved patient support device that is well cushioned so that the patient is comfortable.
Regarding claim 14, Pigazzi in view of KLUBA in view of ROBINSON further in view of Gomez discloses the invention as discussed in claim 12. Pigazzi in view of KLUBA in view of ROBINSON further in view of Gomez further discloses wherein the first foam block (307 of Gomez) and the second foam block (318 of Gomez) are formed from different types of viscoelastic foam materials (see [0033] of Gomez and Fig. 1 of Gomez; the upper member 307 of Gomez may be constructed of a viscoelastic material and the lower member 318 of Gomez may be constructed of other viscoelastic materials having different recovery properties, and thus is formed from a different type of viscoelastic foam material).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pigazzi in view of KLUBA in view of ROBINSON in view of Gomez further in view of STIHLER (DE 102009001941 A1) (translation provided).
Regarding claim 13, Pigazzi in view of KLUBA in view of ROBINSON further in view of Gomez discloses the invention as discussed in claim 12.
Pigazzi in view of KLUBA in view of ROBINSON further in view of Gomez is silent on wherein the first foam block is connected to the second foam block by at least one of an adhesive or a mechanical fastener.
However, STIHLER teaches an analogous first foam block (12) and an analogous second foam block (11) (see Fig. 1 and [0028]; foam core 10 comprises an upper foam layer 12, which is a first foam block, and a lower foam layer 11, which is a second foam block), and wherein the first foam block (12) is connected to the second foam block (11) by at least one of an adhesive or a mechanical fastener (see Fig. 1 and [0010], [0028]; the foam layers 12, 11 are adhered to each other by an adhesive), providing a strong connection mechanism so that the foam blocks do not move relative to each other when in use.
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 a connection mechanism between first foam block (307 of Gomez) and the second foam block (318 of Gomez) in the device of Pigazzi in view of KLUBA in view of ROBINSON further in view of Gomez such that the first foam block is connected to the second foam block by at least one of an adhesive as taught by STIHLER to have provided an improved patient support device that provides a strong connection mechanism so that the foam blocks do not move relative to each other when in use.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pigazzi in view of KLUBA in view of ROBINSON in view of Gomez further in view of Adams et al. (referred to as “Adams”) (US 2008/0057814 A1).
Regarding claim 15, Pigazzi in view of KLUBA in view of ROBINSON further in view of Gomez discloses the invention as discussed in claim 12.
Pigazzi in view of KLUBA in view of ROBINSON further in view of Gomez is silent on wherein the first block is more absorbent than the second block.
However, Adams teaches an analogous first foam block (12) and an analogous second foam block (14) (see Fig. 1; foam layer 12 is a first foam block as it is an upper layer and foam layer 14 is a second foam block as it is a lower layer), and wherein the first block (12) is more absorbent than the second block (14) (see Fig. 1 and [0017]; the foam layers 12, 14 may be different materials, and thus the foam layer 12 may be an open cell foam material and the foam layer 14 may be a closed cell foam material, and thus the foam material of the foam layer 12 is more absorbent than the foam material of the foam layer 14 due to the open cells of the foam), providing a top foam layer that is more absorbent than the bottom foam layer such that the top layer is able to quickly absorb any fluids on the outer surface to keep the area clean.
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 first foam block (307 of Gomez) and the second foam block (318 of Gomez) in the device of Pigazzi in view of KLUBA in view of ROBINSON further in view of Gomez such that the first block is more absorbent than the second block as taught by Adams to have provided an improved patient support device that provides a top foam layer that is more absorbent than the bottom foam layer such that the top layer is able to quickly absorb any fluids on the outer surface to keep the area clean.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pigazzi in view of KLUBA in view of ROBINSON in view of Gomez further in view of Roleder et al. (referred to as “Roleder”) (US 2006/0290195 A1).
Regarding claim 16, Pigazzi in view of KLUBA in view of ROBINSON further in view of Gomez discloses the invention as discussed in claim 12.
Pigazzi in view of KLUBA in view of ROBINSON further in view of Gomez is silent on wherein the first block is less dense than the second block.
However, Roleder teaches an analogous first foam block (472A) and an analogous second foam block (472B) (see Fig. 4A and [0094]; the first layer 472A and second layer 472B are both made of a foam material and thus the first layer is a first foam block and the second layer is a second foam block), and wherein the first block (472A) is less dense than the second block (472B) (see Fig. 4A and [0094]; the density of the first layer 472A is 4 pound density per cubic foot of memory foam, which is known in the art as viscoelastic foam, as Applicant also states on Pg. 9 paragraph [0049] of Applicant’s specification that memory foam is viscoelastic foam, and the density of the second layer 472B is 6 pound density per cubic foot of a stiffer memory foam/viscoelastic foam material, and thus the first layer 472A is less dense than the second layer 472B), providing a softer foam material that directly touches a patient’s skin, while the stiffer viscoelastic material helps to reduce the softer foam material from bottoming out (see [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 the first block (307 of Gomez) and the second block (318 of Gomez) in the device of Pigazzi in view of KLUBA in view of ROBINSON further in view of Gomez such that the first block is less dense than the second block as taught by Roleder to have provided an improved patient support device that provides a softer foam material that directly touches a patient’s skin, while the stiffer viscoelastic material helps to reduce the softer foam material from bottoming out (see [0095]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/ROBIN HAN/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786