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 .
Status of the Application
Claims 1-20 have been examined in this application. This communication is the first action on merits. The Information Disclosure Statement (IDS) filed on 09/17/2024 has been acknowledged by the Office.
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 5 and 12 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 “comfort” in claim 5 is a relative term which renders the claim indefinite. The term “comfort” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “comfort” is not defined by the disclosure, further it does not define a precise numerical boundary making its meaning dependent on context, subjective interpretation and specific (often subjective) user experiences rather than objective, universally defined measurement.
Regarding claim 12, the limitations “wherein the thickness of the body at the first end is about one inch and the thickness of the body at the second end is about three inches.” are recited. There is a lack of clarity as to the scope and metes and bounds of the claim. Particularly because it is unclear what the scale a person of ordinary skill in the art would attribute to ‘about’ and particularly alongside a range. It’s unclear if ‘about’ should include values greater than one/three inches or lesser than one/three as applicant does not establish a scale for what the measure of ‘about’ should incorporate and such scale is left up to a broad and open-ended interpretation. For the purposes of examination, the limitations are construed as “wherein the thickness of the body at the first end is one inch and the thickness of the body at the second end is three inches.”
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 states the following: “a transverse cut which extends transversely from the first side side wall of the body the second side wall of the body”, however to be more consistent with the prior claim limitations and their respective antecedent basis the following is suggested: “a transverse cut which extends transversely from the first side wall of the body to the second side wall of the body”,
Appropriate correction is required.
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) 1-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Trevino (US 6067678 A) in view of Shah (US 20100122414 A1).
In regards to Claim 1, Trevino teaches: A positioning system (200 - Fig. 11) for positioning a patient (Col 7 Lines 19-44 and Figs. 11-13) [[on an operating table]], the positioning system comprising: a head rest (230 - Fig. 11); a pad (212 - Fig. 11) comprising a body (210 - Fig. 11) formed from a compressible material ("As illustrated in FIG. 1, all of the components, namely the body portion, leg portions and arm portions, of the preferred embodiment are constructed of a hard, firm yet soft supporting foam material, which is generally known in the art, and would allow in general a support for a patient lying thereupon, yet would allow support with comfort.") and having a first end (see annotated Fig. 11.1 from Trevino), a second end (see annotated Fig. 11.1 from Trevino), a first side wall (see annotated Fig. 11.1 from Trevino), and second side wall (see annotated Fig. 11.1 from Trevino); a first tether fixedly secured to the body and extending from the first side wall (see annotated Fig. 11.1 from Trevino); and a tether secured to the body and extending from the second side wall (see annotated Fig. 11.1 from Trevino), [[wherein each of the tethers are adapted to secure the pad the operating table]].
Trevino does not explicitly teach: on an operating table, wherein each of the tethers are adapted to secure the pad the operating table
Shah teaches: on an operating table (102 - Fig. 1), wherein each of the tethers are adapted to secure the pad the operating table (Fig. 1 shows tethers securing to operating table, noting "It is intended for use with standard sized operating table 102 commonly found in surgical suites around the world. The inventive table 100 is provided with at least one securing strap 104 or similar mechanisms which allow it to be securely fastened to the existing operating table 102 as shown.")
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Trevino’s positioning system to be used on an operating table and to adapt the tethers to secure the pad to the operating table as taught by Shah, because Shah expressly teaches securing straps for fastening a pad to a standard operating table, and incorporating such known securing features into Trevino’s system would have predictably improved stability and prevented shifting during surgical procedures, yielding no more than the predictable result of enhanced patient positioning security.
In regards to Claim 2, Trevino in view of Shah teaches: The system of claim 1, Trevino further teaches, wherein the head rest is separate from the pad (230 in Fig. 11 is shown to be separate from pad 212).
In regards to Claim 3, Trevino in view of Shah teaches: The system of claim 1, Trevino further teaches, wherein the body has a thickness which increases from the first end of the body to the second end of the body (see annotated Fig. 11.1 from Trevino).
In regards to Claim 4, Trevino in view of Shah teaches: The system of claim 1, Shah further teaches, further comprising at least one strap for securing the patient to the operating table (Fig. 1 shows straps securing to operating table, noting "It is intended for use with standard sized operating table 102 commonly found in surgical suites around the world. The inventive table 100 is provided with at least one securing strap 104 or similar mechanisms which allow it to be securely fastened to the existing operating table 102 as shown.").
It would have been obvious to one of ordinary skill in the art to further include at least one strap for securing the patient to the operating table as taught by Trevino in view of Shah, because Shah expressly discloses securing straps for fastening to an operating table, and incorporating such straps into the Trevino system would have been a predictable use of known elements to enhance patient restraint and during safety procedures
In regards to Claim 8, Trevino teaches: A pad (212- Fig. 1, Col 7 Lines 19-38) for use under a patient (Col 7 Lines 19-44 and Figs. 11-13) [[on an operating table]], the pad comprising: a body (210 - Fig. 11) formed from a compressible material ("As illustrated in FIG. 1, all of the components, namely the body portion, leg portions and arm portions, of the preferred embodiment are constructed of a hard, firm yet soft supporting foam material, which is generally known in the art, and would allow in general a support for a patient lying thereupon, yet would allow support with comfort.") and having a first end (see annotated Fig. 11.1 from Trevino), a second end (see annotated Fig. 11.1 from Trevino), a first side wall (see annotated Fig. 11.1 from Trevino), and second side wall (see annotated Fig. 11.1 from Trevino), the body having a thickness which increases from the first end of the body to the second end of the body (see annotated Fig. 11.1 from Trevino); a first tether fixedly secured to the body and extending from the first side wall (see annotated Fig. 11.1 from Trevino); and a second tether secured to the body and extending from the second side wall (see annotated Fig. 11.1 from Trevino), [[wherein each of the tethers are adapted to secure the pad the operating table]].
Trevino does not explicitly teach: on an operating table, wherein each of the tethers are adapted to secure the pad the operating table
Shah teaches: on an operating table (102 - Fig. 1), wherein each of the tethers are adapted to secure the pad the operating table (Fig. 1 shows tethers securing to operating table, noting "It is intended for use with standard sized operating table 102 commonly found in surgical suites around the world. The inventive table 100 is provided with at least one securing strap 104 or similar mechanisms which allow it to be securely fastened to the existing operating table 102 as shown.")
It would have been obvious to one of ordinary skill in the art to modify Trevino’s pad for use on an operating table and to adapt the tethers to secure the pad to the operating table as taught by Trevino in view of Shah, because Shah teaches fastening a support pad to a standard operating table using securing straps, and incorporating such known attachment features into Trevino’s pad would have predictably enhanced pad stability during surgical procedures.
Claim 5 rejected under 35 U.S.C. 103 as being unpatentable over Trevino (US 6067678 A) in view of Shah (US 20100122414 A1) and further in view of Eves (US 4712258 A).
In regards to Claim 5, Trevino in view of Shah teaches: The system of claim 4, but neither Trevino nor Shah teach, further comprising a comfort strip configured to be positioned between the strap and the patient, wherein the comfort strip is formed of a compressible material.
Eves teaches: further comprising a comfort strip ([7, 8] - Fig. 1) configured to be positioned between the strap and the patient (straps are local to top and bottom ends, comfort strip is centralized near middle of device, therefore 'between' strap and patient), wherein the comfort strip is formed of a compressible material (Col 5 Lines 2-5: "The straps 7, 8 may then be made of soft washable material such as towelling and may easily be detached from the mat for periodic washing.").
It would have been obvious to one of ordinary skill in the art to further include a comfort strip positioned between the strap and the patient and formed of compressible material as taught by Eves, because Eves discloses soft, washable strap materials positioned between securing straps and the patient, and incorporating such a compressible comfort strip into the Trevino system as modified by Shah would have predictably improved patient comfort while maintaining restraint functionality.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Trevino (US 6067678 A) in view of Shah (US 20100122414 A1) and further in view of Pigazzi et al., hereinafter 'Pigazzi' (US 20130174854 A1).
In regards to Claim 12, Trevino in view of Shah teaches: The pad of claim 8, Trevino nor Shah do not explicitly teach, wherein the thickness of the body at the first end is about one inch and the thickness of the body at the second end is about three inches.
Pigazzi teaches: wherein the thickness of the body at the first end is about one inch and the thickness of the body at the second end is about three inches (Para 0015: The thickness of the viscoelastic foam is in the range of from three-fourths of an inch to one inch, or to approximately one inch, or to one and a half inches, or to three inches or greater, which thickness is selected to minimize and/or prevent bottoming out on the operating table of one or more of the portions of the body of a patient lying on the viscoelastic foam pad, depending on the weight and/or size of the patient).
It would have been obvious to one of ordinary skill in the art to provide the pad of Trevino, as modified by Shah, with a thickness of about one inch at the first end and about three inches at the second end as taught by Pigazzi, because Pigazzi discloses viscoelastic foam pads having thicknesses within that range to prevent bottoming out on an operating table, and selecting such known thickness values would have been a matter of routine optimization to achieve predictable support and pressure distribution benefits.
Allowable Subject Matter
Claim(s) 6-7, 9-11, and 13-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to Claim 6 and 9, they both recite a transverse cut extending transversely from the first side wall to the second side wall and through the first and second side walls, the transverse cut being configured to allow placement of a sheet through the pad in spaced relation to a top surface of the body. Trevino in view of Shah discloses positioning pads and related support structures; however, neither reference teaches or suggests a transverse cut extending entirely through the body from one side wall to the opposing side wall. The art discloses layered positioning structures and sheet placement beneath a pad, but does not disclose a through-cut formed in the pad body itself. Further, the claimed transverse cut permits a sheet to pass through the body of the pad, rather than being positioned beneath it. The cited references show sheets placed under the positioning system, which would not require or suggest forming a cut extending fully through the pad body.
In regards to Claim 7 and Claim 13, they both recite a removable perforated section configured to correspond with a perineal cutout of an operating table. Although Heibert (US 20110191960 A1) discloses a perineal cutout (see e.g., element 32), none of Trevino, Shah, or Heibert teach or suggest a removable perforated section formed in the body of the pad. The cited references may disclose fixed cutouts or openings; however, a removable perforated section implies a selectively detachable portion integrally formed in the pad body and removable along perforations. The prior art does not disclose a perforated section that is selectively removable and reattachable or detachable to correspond to a perineal cutout. Rather, the references disclose static apertures or structural cutouts formed during manufacture. The structural and functional distinction between a fixed cutout and a removable perforated section is significant, and no teaching or suggestion of such a feature is found in the cited art.
In regards to Claim 14, which recites that the body is formed from first and second layers bonded together. Trevino and Shah disclose positioning pads and support surfaces; however, neither reference teaches or suggests that the pad body is formed from distinct first and second layers bonded together as claimed. The cited art generally describes monolithic foam bodies or layered structures without any specific teaching of bonded first and second layers forming the claimed body configuration. Additionally, no motivation is present in the cited references to modify the disclosed pad structures to include bonded first and second layers as claimed. The structural limitation of bonded layers forming the body is not disclosed or suggested by Trevino, Shah, or Heibert.
In regards to Claim 16, which recites a positioning pad including a body formed from a compressible material, the body having increasing thickness from a first end to a second end, a slip-resistant surface, and importantly, a transverse cut extending transversely from one side wall to the opposite side wall and through the body, the transverse cut being configured to allow placement of a sheet through the positioning pad in spaced relation to the slip-resistant surface, wherein the transverse cut is spaced from the first end and extends through the second end of the body. Trevino discloses a compressible positioning pad body having varying thickness. Shah teaches use on an operating table, and Eves teaches a slip-resistant underside. However, none of Trevino, Shah, or Eves; alone or in combination, teach or suggest the claimed transverse cut extending fully from one side wall to the opposite side wall and through the body for allowing a sheet to pass through the pad itself. The cited art discloses pads placed on surfaces and sheets positioned beneath pads, but does not disclose or suggest forming a through-cut in the body of the pad, particularly one spaced from the first end and extending through the second end as claimed. The modification required to arrive at the claimed structure would fundamentally alter the structural integrity and intended support function of the prior art pads, and no teaching, suggestion, or motivation is found in the cited references to provide such a transverse through-cut. Accordingly, Claim 16 is allowable over the recited art on record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kim et al., (US 5987675 A) teaches: A spinal support and stretch pillow system offers a distinct, adjustable support for sleeping in either a supine position or a lateral-lying position. The spinal support and stretch pillow system can be laid over a conventional mattress or a floor. The spinal support and stretch pillow system is comprised of a bottom liner pad, a cervical and spinal support pad, a height adjustment pad, an adjustable shoulder support, an adjustable thoracic and lumbar support pad, and a top support pad. The bottom liner pad is used as a container to retain the components of the spinal support and stretch pillow system and for covering the user's legs and feet. The cervical and spinal support pad has a U-shaped cutout portion for allowing the head of the user to fall back and stretch the neck of the user. The height adjustment pad is positioned underneath a cervical section of the cervical and spinal pad for adjusting the height of the cervical section. The adjustable shoulder support pad is located adjacent to the cervical and spinal support pad for supporting a shoulder region of a spinal section of the cervical and spinal support pad. The adjustable thoracic and lumbar support pad is positioned underneath a thoracic and lumbar region of the spinal section for further supporting the back of the human body. The top cover support pad is positioned over the cervical and spinal support pad. The top support pad has one end folded over against itself to retain an adjustable neck support member and the other end folded underneath against itself to retain an adjustable knee support member.
Giap (US 8661580 B2) teaches: A patient positioning device provided to position, protect and secure a patient on a support surface for transfer to another support surface or for preparation for surgery. The positioning device includes a sheet with a first and second flexible substrate coupled to the sheet's top surface. The first and second flexible substrates may be padded. These substrates are capable of wrapping around an adjacent arm of the patient creating a wrapped engagement. This wrapped engagement may pad, protect, secure and elevate the arms from injury caused by pressure imparted thereon during surgery or transport. This positioning device may be lifted or slid from one support surface to another. Optionally, a third and fourth flexible substrate capable of wrapping around an adjacent arm of the patient creating a second wrapped engagement may be used for additional securing. Optionally, an inflatable support may be used with the device to aid when sliding or translating the device 10 with the patient thereon.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON MATTHEWS whose telephone number is (571)272-8473. The examiner can normally be reached M-F 7:30-4:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justin Mikowski can be reached at (571)-272-8525. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MADISON MATTHEWS/Primary Examiner, Art Unit 3673