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 .
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated (as described in the specification on page 1, lines 17-26 and page 10, line 5). 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 sign(s) mentioned in the description: 88.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 81 in Fig. 13.
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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 following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copies has been filed in parent Application Nos. GB2409502.8, filed on 07/01/2024 and GB2417126.6, filed on 11/21/2024.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. GB2409502.8, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. GB2409502.8 fails to disclose a supporting surface for two digits as required by claim 1 and a securing device with a contacting surface having a length of at least 3 cm as required by claim 13. Accordingly, claims 1-20 have an effective filing date of 11/21/2024.
Claim Objections
Claim 16 is objected to because of the following informalities: Claim 16, line 4, “contact surface” should be “contacting surface” for consistency purposes. 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 3 and 10 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 “generally” in claim 3 and 10 is a relative term which renders the claim indefinite. The term “generally” 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.
Claim 3 recites that the support portion is “generally square”. For examination purposes, “generally square” will be interpreted as having visually identifiable four sides with the same lengths.
Claim 10 recites “generally U-shaped”. For examination purposes, “generally U-shaped” will be interpreted as a single curve with two free ends.
Claim Rejections - 35 USC § 102
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 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(s) 1-2, 7, 9-11, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rowland et al. (US Publication No. 2005/0171405 A1).
Regarding Claim 1, Rowland discloses a frame (10, Fig. 4) fully capable of supporting a hand during surgery [0051], the frame comprising:
a plate having two wings which define a plane and a space therebetween (see below);and a support portion (40) positioned between the two wings which comprises a supporting surface fully capable of receiving two digits which is elevated relative to the plane defined by the wings ([0040] discloses that the support portion 40 can pivot with respect to the frame to match the contour of the surgical site), wherein each wing is provided with an engaging feature (notches shown below) for removably engaging a retaining tie [0034].
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Regarding Claim 2, the support portion is provided with two recesses or two concave shapes or raised portions (two raised portions shown below) fully capable for accommodating the two digits.
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Regarding Claim 7, an edge of the support portion is provided with three engaging features (notches shown below) for removably engaging retaining ties [0034].
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Regarding Claim 9, the supporting surface (40) defines a ramp which is inclined with respect to the plane defined by the plate (when pivoted at an angle as described in [0036], the flat top surface of 40 will be a ramp compared to the flat top surface of the ring 10).
Regarding Claim 10, the space between the wings is generally U-shaped, V-shaped or has a semi-circular shape (see below).
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Regarding Claim 11, the frame further comprising: two retainer ribs (32) which protrude from the plate on an opposite side of the plate to the support portion (40) (Fig. 4), wherein the retainer ribs are positioned on opposite sides of the support portion (shown in Fig. 4).
Regarding Claim 18, Rowland describes the frame as rejected in claim 1 above. Rowland discloses using the frame for hand surgeries in [0051]. It would be inherent when using the frame for a hand surgery that the frame is provided and engaged with a hand.
Claim(s) 1, 4, 6, 8, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grabow (US Publication No. 2021/0145682 A1).
Regarding Claim 1, Grabow discloses a frame (Fig. 1) fully capable of supporting a hand during surgery [0020], the frame comprising:
a plate (110) having two wings (120-1, 120-2) which define a plane and a space therebetween (see below);
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and a support portion (support portion can be 1) element 155 shown in Fig. 4-6 or 2) the support shown in Fig. 7 below) positioned between the two wings which comprises a supporting surface fully capable of receiving two digits which is elevated relative to the plane defined by the wings (155 shown in Fig. 4 as holding two digits and Fig. 7 support shown holding two digits below),
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wherein each wing (120-1, 120-2) is provided with an engaging feature (magnets and magnetic clips 130, 145 described in [0023-0024], shown in Fig. 4) for removably engaging a retaining tie ([0024] describes the clips as being able to hold surgical retraction instruments and the text in Fig 4 describes 145 as able to be a custom holder with suture holes for holding non-magnetic instruments, and holding sutures).
Regarding Claim 4, the support portion has a width of greater than 30 mm (as shown in Fig. 4, the support portion (155 holding the hand) is as big as the adult hand in the picture which must be larger than 30 mm wide.
Regarding Claim 6, the support portion (155, Fig. 4) has a W-shaped surface (see figure below).
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Regarding Claim 8, an area of the support portion (are of 155 shown in Fig. 4) is greater than 30 cm2. (support portion is size of adult hand as shown in Fig. 5 which would be larger than 30 cm2 as shown in the scale of the photographs of Fig. 4-5)
Regarding Claim 18, Grabow describes the frame as rejected in claim 1 above. Grabow discloses using the frame for hand surgeries that the frame is provided and engaged with a hand (see Fig. 4-7, 9).
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.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bishop (US Patent No. 5121743) in view of Seymour et al. (US Publication No. 2022/0071795 A1).
Regarding Claim 13, Bishop discloses a securing device (21+27) fully capable of securing two digits on a frame (on portion 37 of frame 13, col. 2; ln. 50-56) during surgery (col. 3; ln. 2-6), the securing device comprising:
a rigid body (27, described as rigid in col. 2; ln. 50-56) with a contacting surface for contacting a digit which is supported on a frame (surface which faces the knuckles); and
elongate retaining ties (straps 21 extending from left and right sides of rigid body 27) extending from opposite sides of the rigid body (from openings 71 and 73 shown in Fig. 2),wherein the elongate retaining ties (straps 21).
Bishop is silent to the material of the straps 21 being that which would be stretchable in a longitudinal direction.
Seymour teaches surgical hand restraints in the same field of endeavor wherein the strap (16) which restrains the fingers is made from an elastic or elastomer material [0039], a material which can stretch in the longitudinal direction, in order to restrain the hand in position. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the material of the strap of Bishop from an elastomer as taught by Seymour in order to use a suitable material in the art of restraint straps to effectively hold the fingers in position.
Bishop is silent to the specific dimensions of the contacting surface of rigid member 27 including a length of at least 3 cm. However Bishop does disclose that the rigid member is intended to cover the knuckles of the three middle fingers of the hand (col. 1; ln. 38-45) and that the device may be used with adolescents and adults (col. 3; ln. 2-6). Given that adults and adolescents can have hands wherein the three middle fingers have a combined width of over 3 cm, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the length of the contacting surface of rigid member 27 of Bishop at least 3 cm in length in order to achieve the intended use of covering the knuckles in patients with larger hands.
Regarding Claim 14, Bishop does disclose that the rigid member is intended to cover the knuckles of the three middle fingers of the hand (col. 1; ln. 38-45) and that the device may be used with adolescents and adults (col. 3; ln. 2-6). Given that adults and adolescents can have hands with large fingers and knuckles (see figure below which depicts a centimeter ruler alongside a hand) that would make an at least 5 cm2 contacting surface area appropriately sized for the intended purpose of covering the three middle finger knuckles, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select a surface area dimension for the contacting surface which is at least 5 cm2 in order to achieve the intended use of covering the knuckles in patients with larger hands.
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Regarding Claim 15, Bishop discloses the body (27) comprises two apertures (openings 71 and 73 shown in Fig. 2) in the plane of the body through which an elongate tie member (21) passes to form the elongate retaining ties (fig. 2, Bishop).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bishop (US Patent No. 5121743) in view of Seymour et al. (US Publication No. 2022/0071795 A1) in further view of Hustedt (US Publication No. 2022/0167936 A1).
Bishop in view of Seymour disclose the securing device as described in the rejection of claim 15 above. Regarding Claim 16, as shown in Fig. 1 and 2 of Bishop, the elongate tie member 21 passes in between the apertures 71 and 73 over the top surface of the rigid member 27 to push the rigid member down against the fingers of the patient. The top surface is on the opposite side of the rigid body from the contacting surface which would face the patient’s fingers. Bishop is silent to the top surface having a groove which accommodates the strap.
Hustedt discloses a securing device in the analogous art of rigid securing members for straps in surgical applications. Hustedt discloses that the securing device (Fig. 9B) has a pair of holes (121) which a strap/suture passes in and out of [0078]. On the top surface of the securing device between the holes is a recessed channel (122) for accepting the suture/strap between the holes (see fig. 28B) [0078]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the top surface of the rigid member 27 of Bishop in view of Seymour to have a recessed channel (groove) as taught by Hustedt in order to accept the strap passing through the two holes which would function to help align the strap on the surface of the rigid member.
Claim(s) 3 (as best understood) is/are rejected under 35 U.S.C. 103 as being unpatentable over Grabow (US Publication No. 2021/0145682 A1) in view of Allen (US Publication No. 2015/0320928 A1).
Regarding Claim 3, Grabow discloses the frame as described in the rejection of claim 1 above. Grabow discloses that the support portion (portion which the hand rests on between elevated edges) can vary within the table (shown by different configuration in Fig. 7 than in Fig. 4-6) however is silent to the support portion being generally square (having visually identifiable four sides with the same lengths) when viewed from above or below.
Allen discloses a hand support in the same field of endeavor wherein the hand support section (stand 34, Fig. 1, 3) is generally square (having visually identifiable four sides with the same lengths) when viewed from above or below in order to provide a surface for the hand to rest on during surgery [0032].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the support section of Grabow to be generally square as taught by Allen in order to provide a shaped support to predictably rest the hand on during surgery.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grabow (US Publication No. 2021/0145682 A1).
Regarding Claim 5, Grabow discloses the frame as described in the rejection of claim 1 above. Grabow discloses that the support portion (portion which the hand rests on between elevated edges) can vary within the table (shown by different configuration in Fig. 7 than in Fig. 4-6) however is silent to the support portion having a width of between 30 mm and 60 mm. The embodiment of the support portion shown in Fig. 4-6 of Grabow supports all four middle fingers across. Given that adults and adolescents can have hands with various sized fingers and knuckles (see figure below which depicts a centimeter ruler alongside a hand) it would be obvious to have a surface area of the hand support appropriately sized for the intended purpose of covering the fingers of the hand. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select a surface width dimension for the contacting surface which is between 30 mm and 60 mm in order to achieve the intended use of supporting a patient with that size of hand.
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Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grabow (US Publication No. 2021/0145682 A1) in view of Austin et al. (US Patent No. 6090043).
Regarding Claim 17, Grabow discloses the frame as described in the rejection of claim 1 above. Grabow discloses that the elevated sides of the frame can be used with non-magnetic and magnetic surgical retraction instruments and suture holes for holding sutures (Fig. 4). However Grabow is silent to the frame being part of a kit which further comprises a securing device for securing two digits on the frame during surgery, wherein the securing device comprises: a rigid body with a contacting surface for contacting a digit which is supported on a frame; and elongate retaining ties extending from opposite sides of the rigid body, wherein the elongate retaining ties are stretchable in a longitudinal direction, and wherein the contacting surface has a length of at least 3 cm.
Austin discloses a hand retractor in the same field of endeavor which comprises a securing device (80) to secure the fingers of the patient between the sides of the retractor frame (60) (Fig. 21) to prevent finger curl during surgery (col. 2; ln. 23-26). In Fig. 21, the device’s contacting surface (surface of solid central section 86) is shown as spanning 4 fingers of a hand, therefore the length of the central section is at least 3 cm. Austin describes the strap as elastomeric and the tie portions 82, 84 can be softer for desired retention characteristics (col. 9; ln. 29-49)
It would have been obvious to one having ordinary skill in the art before the effective filing date to provide a securing device as disclosed by Austin with the frame of Grabow in order to provide a securement strap which can assisting holding fingers down to prevent curl during a procedure. It would have been obvious to package parts used together as a kit as one of ordinary skill would be motivated to provide an efficient shipping and stocking inventory to the surgeon as well as the ease of use of having all the parts needed or possibly needed being provided together to ensure all the tools necessary are present for the surgery.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowland et al. (US Publication No. 2005/0171405 A1) in view of Rioux et al. (US Publication No. 2007/0293730 A1).
Regarding Claim 12, Rowland discloses the frame as described in the rejection of claim 1 above. However, Rowland is silent to the frame being formed from a single piece of material.
Rioux discloses a retractor frame in the same field of endeavor which comprises an adjustable, pivotable frame configuration, wherein the parts of the frame (12) that pivot relative to one another are formed from a unitary or single piece of material which can fold and flex as opposed to having mechanical pivots [0044].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the multi-part pivoting frame of Rowland with a flexible unitary construction as taught by Rioux in order to use a suitable construction method known in the art to create a pivoting retractor frame.
Allowable Subject Matter
Claims 19-20 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.
The prior art of record does not describe the specific step of inserting two digits such that the digits are supported on the supporting surface and another digit of the hand remains on the opposite side of the plane defined by the plate to the supporting surface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773