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
The drawings were received on 1/22/2026. These drawings are unacceptable. The Office submits that although the replacement sheet filed 1/22/2026 attempted to remove the extraneous shading in figures 1-4, the resultant quality and character of the outlines of the device will result in unsatisfactory reproduction characteristics. Applicant is requested to resubmit a replacement drawing sheet with lines (ideally line drawings) which are durable, clean, black, sufficiently dense and dark, and uniformly thick and well-defined enough to permit adequate reproduction.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 5 and 12 have been amended to recite that the sharpened endpoint of the hook is capped. There is no disclosure of the capping of the sharp point of the hook, therefore these limitations are considered new matter.
Claims 1-3, 5-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 10 have been amended to recite the shaft as “colinear” along the central axis of the handle. In Applicant’s remarks on page 9, Applicant argues that one of ordinary skill in the art would understand the phrase “along the central axis” as meaning sharing the same axis along its entire length (emphasis added). Applicant emphasizes this configuration through amending the claims so that the shaft is a “colinear shaft” along the central axis [of the handle]. However, the shaft of claim 1 and 10 requires “a distal portion”. This distal portion is shown and described as element 13 (see fig 4 below). The distal portion 13 is described in the specification as “square” [0013] or “curved” [0014] and as a 180 degree arc [0015]. There is no disclosure that the shaft along its entire length is colinear with the central axis because the distal portion of the shaft is expressly disclosed as bending/curving away from the remaining portion of the shaft.
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Therefore the limitations of claim 1 and 10 of “a handle with a central axis; a colinear shaft along the central axis with a distal portion” is considered new matter.
Dependent claims 2-3, 5-9, 11-21 are rejected under 112(a) as they contain all the deficiencies of claims 1 or 10 from which they depend.
Claims 8, 9, 19, 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The concept of the shaft (with a distal portion as required in claims 1 and 10) being colinear with the central axis such that they share the same axis along its entire length would be impossible to also have the distal portion be angular as required in claims 8 and 20, or curved as required in claims 9 and 19 because the terms “angular” and “curved” require deviation from an established trajectory/axis and therefore would be incapable of being parts of a colinear shaft-handle axis. Considering the Wands Factors, and the question of Does the specification provide enough information so that one of ordinary skill in the art can make and/or use the full scope of the claimed invention without “undue experimentation”? it would appear impossible to one of ordinary skill to make a distal portion of a shaft which is both colinear with a central axis of a handle as well as angled or curved. Therefore the subject matter of claims 8, 9, 19 and 20 is not enabled by the disclosure.
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, 6-7, 10-11, 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rabban (US Patent No. 4122844) in view of Ley (US Patent No. 5514076) .
Regarding Claim 1, Rabban discloses a surgical retractor (Fig. 3), comprising: a handle (10a) with a central axis (longitudinal axis); a colinear shaft (10, see figure below) along the central axis (as shown below) with a distal portion (see figure below); and a head (see below) distal to the shaft (10), the head having at least one hook (21) oriented such that an end (21b) of the at least one hook faces a direction opposite that of the handle (upwards arrows in Fig. 3), wherein the head runs along a parallel axis to the central axis and is offset from the central axis (shown below, col. 1; ln. 55 describes 10 is bent or curved through 180 degrees).
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Rabban discloses that different shapes of blades (hooks 21) can be substituted on the device (col. 3; ln. 10-13) but is silent to the hooks being shaped so as to form an 180 degree arc culminating in a sharpened endpoint.
Ley discloses a retractor blade in the same field of endeavor which is shaped as an 180 degree arc culminating in a sharpened endpoint (col. 5; ln. 14-42, Fig. 1-2) for the purpose of being adapted for a particular surgical procedure and adequately grasping tissue.
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the shapes of the two hooks (21, 21a) of Rabban to be an 180 degree arc culminating in a sharpened endpoint as taught by Ley in order to use blade shape known in the art to predictably grasp tissue for retraction purposes.
Regarding Claim 2, the head has two hooks (fig. 3 Rabban, two hooks 21, 21a).
Regarding Claim 3, Rabban shows the retractor of Fig 3 has a variety of locations 20a to which the blades can be attached. Figure 3 does not show two hooks (36) are spaced equidistant from the parallel axis, however Rabban describes that the hooks can be mounted at various spacings (col. 2; ln. 62-col. 3; ln. 13). Rabban shows that the plates have a symmetrical hole pattern for mounting the hooks (shown in curved version of Fig. 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date to attach the hooks symmetrically on both sides of the parallel axis in order to try a configuration which would evenly distribute the pressure from pushing the retractor. It would have been obvious to try as there are a limited number of holes to which the retractor hooks could be attached and one would have attached the hooks at any given combination of hole patterns , including a symmetrical configuration, with an expectation of success of being able to provide pressure to the incision when pushing the retractor.
Regarding Claim 6, the head is offset to the left of the shaft or to the right of the shaft (Fig 3 Rabban shows head to the left of shaft).
Regarding Claim 7, the head is offset anterior to the shaft (Fig 3 Rabban shows the head anterior to the distal end of the shaft).
Regarding Claim 10, Rabban discloses a method of using a surgical retractor (shown in Fig. 3), comprising:
attaching a surgical retractor to a tissue at an incision site (col. 2; ln. 7-8, “Each blade is positioned in the incision”),
the surgical retractor comprising handle (10a) with a central axis (longitudinal axis); a colinear shaft (10) along the central axis with a distal portion (see claim 1 rejection above); and a head (see claim 1 rejection above) distal to the colinear shaft (10), the head having at least one hook (21) oriented such that an end (21b) of the at least one hook faces a direction opposite that of the handle (upwards arrows in Fig. 3), wherein the head runs along a parallel axis to the central axis and is offset from the central axis (shown in claim 1 rejection above, col. 1; ln. 55 describes the 10 is bent or curved through 180 degrees);
pushing the surgical retractor distally, thereby retracting the tissue away from the incision site (col. 2; ln. 8-9, “the shaft is pushed to hold the incision open where desired”); and
securing the tissue in a retracted position away from the incision site (as described in the paragraph of col. 2; ln. 3-24, the surgical assistant holds the incision open which is considered manually securing the tissue in a retracted position).
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Rabban discloses that different shapes of blades (hooks 21) can be substituted on the device (col. 3; ln. 10-13) but is silent to the hooks being shaped so as to form an 180 degree arc culminating in a sharpened endpoint.
Ley discloses a retractor blade in the same field of endeavor which is shaped as an 180 degree arc culminating in a sharpened endpoint (col. 5; ln. 14-42, Fig. 1-2) for the purpose of being adapted for a particular surgical procedure and adequately grasping tissue.
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the shapes of the two hooks (21, 21a) of Rabban to be an 180 degree arc culminating in a sharpened endpoint as taught by Ley in order to use blade shape known in the art to predictably grasp tissue for retraction purposes.
Regarding Claim 11, Ley discloses the sharpened configuration is for grasping the skin tissue (col. 6; ln. 45-48). It would have been obvious to use the retractor of Rabban in view of Ley to pierce the tissue with the sharp tip of the hooks in order to grasp the skin tissue during normal use of the retractor.
Regarding Claim 13, wherein securing the tissue comprises manually holding the surgical retractor in place (col. 2; ln. 3-24 Rabban).
Regarding Claim 14, securing the tissue comprises positioning the surgical retractor such that the surgical retractor is free standing while the tissue is retracted (the assistant is supporting the retractor as described in col. 2; ln. 3-24 Rabban, it is not attached to (e.g. clamped) any other structure of the surgical environment).
Regarding claim 15, Rabban teaches the retractor is adaptable to a variety of surgical procedures (col. 2; ln. 61-65) and Ley teaches the retractors are used on skin (col. 6; ln. 45-49). It would have been obvious to one of ordinary skill in the art to use the retractor of Rabban in view of Ley to hold skin of a patient in an incision in order to predictably retract the tissue (skin).
Regarding Claim 16, the head comprises two hooks (21, Fig. 3 Rabban).
Regarding Claim 17, Rabban shows the retractor of Fig 3 has a variety of locations 20a to which the blades can be attached. Figure 3 does not show two hooks (36) are spaced equidistant from the parallel axis, however Rabban describes that the hooks can be mounted at various spacings (col. 2; ln. 62-col. 3; ln. 13). Rabban shows that the plates have a symmetrical hole pattern for mounting the hooks (shown in curved version of Fig. 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date to attach the hooks symmetrically on both sides of the parallel axis in order to try a configuration which would evenly distribute the pressure from pushing the retractor. It would have been obvious to try as there are a limited number of holes to which the retractor hooks could be attached and one would have attached the hooks at any given combination of hole patterns , including a symmetrical configuration, with an expectation of success of being able to provide pressure to the incision when pushing the retractor.
Regarding Claim 18, the head is offset to the left of the shaft or to the right of the shaft (Fig 3 Rabban shows head to the left of shaft).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rabban (US Patent No. 4122844) in view of Ley (US Patent No. 5514076) in further view of Ritland (US Publication No. 2004/0254428 A1).
Regarding Claim 21, Rabban in view of Ley are silent to the retractor being produced by a single piece of material.
Ritland discloses a retractor in the analogous art of retractors. Ritland discloses that the device including handle and retractor blades can be made using connecting pieces or can be formed integrally (made from a single piece) [0058]. It would have been obvious to one having ordinary skill in the art to form the components of the retractor of Rabban in view of Ley in a single piece as taught by Ritland since this would allow for a sturdy construction with less opportunity for missing parts. It would also decrease the number of parts required for assembly or sterilization.
Response to Arguments
Applicant’s arguments with respect to all claim(s) have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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