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 .
Specification
The amendment to the specification filed 10/1/25 has been entered.
Drawings
The drawing objection raised in the non-final rejection mailed 6/3/25 has been withdrawn in light of the amendments to the claims.
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 8, 9, 26 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 8 and 9 recite the height of the first and second protrusions decrease “progressively”. There is no discussion of the profile of decrease of the heights of the protrusions in the specification, only that they decrease. This “progressive decrease” is also not clearly shown in the drawings. Therefore, claims 8 and 9 contain new matter.
Claim 26 recites that the protrusion land is flat between the sides. That limitation is not explicitly shown in the drawing nor is it described in the specification. Therefore the limitation of claim 26 is considered new matter.
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) 1-2, 4-5, 13-18, 23-25, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beger et al. (US Publication No. 2012/0265302 A1) in view of Swift et al. (US Publication No. 2019/0254771 A1).
Regarding Claim 1, Beger discloses surgical retractor (fig. 1A) comprising:
a support (see figure below);
first and second arms (see figure below) extending from a same side of the support and spaced apart from each other along the support;
a first anatomy engaging member (see figure below) having a first interior face and a first exterior face; and
a second anatomy engaging member (see figure below) having a second interior face and a second exterior face, wherein:
the first anatomy engaging member depends along its length from the first arm whereby the first exterior face faces away from the second anatomy engaging member (see figure below);
the second anatomy engaging member depends along its length from the second arm whereby the second exterior face faces away from the first anatomy engaging member (see figure below);
PNG
media_image1.png
616
617
media_image1.png
Greyscale
each of the first and second exterior faces integrally defines on their surfaces at least one elongate protrusion (see figure below) across the surface of the respective exterior faces (Fig. 4A), the elongate protrusion having an elongate axis extending transversely on the surface of the respective anatomy engaging member (see figure below) whereby the elongate protrusion is integral to the exterior face of the respective anatomy engaging member (shown integral in Fig. 4A);
PNG
media_image2.png
561
583
media_image2.png
Greyscale
each elongate protrusion has first and second protrusion sides extending up from and transversely across the surface of the respective exterior face (shown in figure below), the first protrusion side closer than the second protrusion side to a proximal end of the respective anatomy engaging member (shown in figure below).
PNG
media_image3.png
702
1118
media_image3.png
Greyscale
Beger discloses each elongate protrusion defines an angle with the respective exterior face (shown in the figure above), the angle defined between the first protrusion side and a first part of the exterior face on a first side of the elongate protrusion, the first part of the exterior face nearer to the proximal end of the respective anatomy engaging member than a second part of the exterior face on a second side of the elongate protrusion. Although Beger appears to show each elongate protrusion defines an acute angle with the respective exterior face (shown in the figure above), Beger has no written disclosure describing the angle which the proximal side of the protrusions extend from the surface of the exterior face as being acute.
Swift discloses a tissue gripping feature (1100, Fig. 11E) in the analogous art of surgical retractor blades. Swift discloses that the tissue gripping feature is an elongated protrusion extending from an exterior face of the retractor blade. Swift discloses the angle between the blade's surface and the inclined rib wall is about 84 degrees facing the proximal end of the blade, and 17 degrees facing the distal end of the blade [0100].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specifically create the angle of the proximal face of the protrusion of Beger to be at an 84 degree angle (which is an acute angle) with the exterior face as taught by Swift in order to provide an angle proven suitable in the art to retain the blade in engagement with the tissue wall.
Regarding Claim 2, Beger discloses each of the first and second arms extends from a respective location, the two locations spaced apart from each other along the support (see figure 1A of Beger below).
PNG
media_image4.png
640
592
media_image4.png
Greyscale
Regarding Claim 4, Beger discloses the surgical retractor is configured for change in separation between the first and second arms along the support, whereby separation between the first and second exterior faces is changed (see figure 1A of Beger below).
PNG
media_image5.png
645
592
media_image5.png
Greyscale
Regarding Claim 5, Beger discloses change in separation between the first and second arms is by movement of at least one of the first and second arms along the support (shown in figure 1A of Beger above).
Regarding Claim 13, Beger discloses each elongate protrusion defines an obtuse angle with the respective exterior face, the obtuse angle defined between the second protrusion side and the second part of the exterior face (see figure below).
PNG
media_image6.png
702
1118
media_image6.png
Greyscale
Regarding Claims 14 and 15, Beger in view of Swift discloses the retractor as described in the rejection of claim 13 above. However, Beger in view of Swift is silent to the specific obtuse angle formed between the vertical base of the protrusion and the proximal and distal exterior faces, respectively being 150°.
However, Swift further teaches that the distal face of the tissue gripping protrusion can be 17° from the proximal side which equates to a 163° obtuse angle from the distal perspective and that a dimensional deviation of +/- 20-25% is acceptable [0100, Swift]. A range of +/-25% of 163° results in a range of 122.25-203.75°.
It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the obtuse angle of the distal surface to 150° since Swift teaches that a range containing this value is a suitable angle for a distal surface of a tissue gripping ridge to be oriented relative to the exterior face of the retractor. It would have been obvious to select 150° from the range disclosed by Swift as a matter of routine optimization since it has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Regarding Claim 16, Beger discloses at least one of the first and second exterior faces defines plural elongate protrusions spaced apart in a longitudinal direction of the respective anatomy engaging member (Fig. 1A Beger).
Regarding Claim 17, Beger discloses the anatomy engaging member comprises a main body which defines the respective exterior and interior faces, the main body having the form of an elongate plate (Fig. 1A, 4A of Beger below).
PNG
media_image7.png
614
602
media_image7.png
Greyscale
Regarding Claim 18, Beger discloses the main body is arcuate in the transverse direction whereby the exterior face is convex and the interior face is concave (see figure above).
Regarding Claim 23, Berger in view of Swift discloses the retractor as described in the rejection of claim 1 above. Swift further teaches that the distal face of the tissue gripping protrusion can be 17 degrees [0100, Swift]. It would have been obvious to specifically create the angle of the distal face of the protrusion to be 17 degrees as taught by Swift in order to provide an angle proven suitable in the art to retain the blade in engagement with the tissue wall. This renders both the proximal and distal faces at an acute angle to the first part of the exterior face.
Regarding Claim 24, Berger in view of Swift discloses the retractor as described in the rejection of claim 16 above. Swift further teaches that the tissue gripping features may have a distance of about 0.9 mm between adjacent ribs (Fig. 11E, [0100] Swift). It would have been obvious to space the protrusions about 0.9mm apart as taught by Swift in order to provide a gripping surface configuration proven suitable in the art to retain the blade in engagement with the tissue wall. This renders the protrusions not contiguously adjacent each other.
Regarding Claim 25, Berger in view of Swift discloses the retractor as described in the rejection of claim 24 above. Although the references are silent to the spacing of the protrusions explicitly being more than the width of the protrusions, Swift teaches that the width of the protrusions can be about 1mm and the spacing between them about 0.9mm and that a dimensional deviation of +/- 20-25% is acceptable [0100, Swift].
It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the spacing between the protrusions to be greater than their widths because Swift teaches that deviations ranges containing these relative values is acceptable and the spacing distance vs the width of the protrusion would have been a matter of routine optimization since it has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Making the spacing between the protrusions greater than their length would have predictable results to changing the locations that the tissue gripping structures are located on the blade of the retractor to engage tissue at those locations.
Regarding Claim 27, the elongate protrusions taught by Beger are immovable relative to the respective anatomy engaging members as they are surface features formed thereon with no moving parts.
Claim(s) 6, 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beger et al. (US Publication No. 2012/0265302 A1) in view of Swift et al. (US Publication No. 2019/0254771 A1) in further view of Paolitto et al. (US Publication No. 2011/0144450 A1).
Regarding Claim 6, Beger in view of Swift discloses the retractor as described in the rejection of claim 1 above. The arms have elongate protrusion is defined by first and second protrusion sides extending up from the respective exterior face (see figure below); however, Beger in view of Swift does not show or describe a protrusion land extending between the distal ends of the first protrusion side and the second protrusion side.
PNG
media_image8.png
666
516
media_image8.png
Greyscale
Paolitto discloses a retractor blade in the same field of endeavor which comprises tissue gripping features on the exterior surface being transverse ridges (473, 483, 493) [0033] with a pair of sides and a land therebetween (see figure below), the ridges enhancing the friction or traction exerted by said blades on said tissue being retracted [0033].
PNG
media_image9.png
268
414
media_image9.png
Greyscale
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 profile of the protrusion of Beger in view of Swift to be the shape shown by Paolitto (having a protrusion land between a pair of sides) in order to provide a suitable shape for engaging tissue and enhancing friction on the exterior of the retractor blade.
Regarding Claim 8, the protrusion land is convex in the transverse direction (this wouldn’t change from Beger wherein the protrusions follow the convex contour of the engaging member) whereby the height of the first and second protrusion sides decreases towards the ends of the protrusion (Beger shows this in the figure below). Further, Swift teaches that each rib may also have gradually inclined lateral ends in order to minimize lateral gripping forces [0100, Swift].
It would have been obvious to modify the lateral ends
PNG
media_image10.png
452
622
media_image10.png
Greyscale
Regarding Claim 9, the height of the first and second protrusion sides decreases progressively to substantially zero at each end of the protrusion land (see figure above from Beger, it is a ramp surface, not a straight edge).
Claim(s) 1 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butterfield et al. (GB 2547792 A) in view of Swift et al. (US Publication No. 2019/0254771 A1).
Regarding Claim 1, Butterfield discloses surgical retractor (100, Fig. 7) comprising:
a support (104);
a first arm (106) and a second arm (108) extending from the support (104), the first and second arms extending from a same side of the support and spaced apart from each other along the support (Fig. 7) (page 23, lines 27- page 25, line 14);
a first anatomy engaging member (128) having a first interior face and a first exterior face; and
a second anatomy engaging member (128) having a second interior face (interior faces are sides of the blade facing towards each other) and a second exterior face (exterior faces are sides of blade facing away from each other intended to engage tissue for retraction), wherein:
the first anatomy engaging member depends along its length from the first arm whereby the first exterior face faces away from the second anatomy engaging member (Fig. 7);
the second anatomy engaging member depends along its length from the second arm whereby the second exterior face faces away from the first anatomy engaging member (Fig. 7) (page 23, lines 27- page 25, line 14).
However, Butterfield is silent to each of the first and second exterior faces integrally defines on their surfaces at least one elongate protrusion across the surface of the respective exterior faces, the elongate protrusion having an elongate axis extending transversely on the surface of the respective anatomy engaging member whereby the elongate protrusion is integral to the exterior face of the respective anatomy engaging member; each elongate protrusion has first and second protrusion sides extending up from and transversely across the surface of the respective exterior face, the first protrusion side closer than the second protrusion side to a proximal end of the respective anatomy engaging member, and each elongate protrusion defines an acute angle with the respective exterior face, the acute angle defined between the first protrusion side and a first part of the exterior face on a first side of the elongate protrusion, the first part of the exterior face nearer to the proximal end of the respective anatomy engaging member than a second part of the exterior face on a second side of the elongate protrusion..
Swift discloses a tissue gripping feature (1100, Fig. 11E) in the analogous art of surgical retractor blades. Swift discloses that the tissue gripping feature is an elongated protrusion extending integrally from and transversely along an exterior face of the retractor blade (Fig. 11E) [0096-0100, Swift]. Swift discloses the angle between the blade's surface and the inclined rib wall is about 84 degrees facing the proximal end of the blade, and 17 degrees facing the distal end of the blade [0100]. The tissue gripping feature provides the retractor with a non-slip surface to assist in the procedure [0096].
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the exterior faces of the blades of Butterfield to include transverse protrusions in the configuration taught by Swift in order to prevent slipping of the blade from the retracted tissue.
Regarding Claim 19, Butterfield further discloses each of the first and second anatomy engaging members (128) is attached to the respective arm (16, 108) for sliding movement of the anatomy engaging member along the arm (page 19, line 1-16).
Regarding Claim 20, Butterfield further discloses the support (104) is elongate (Fig. 7), the first and second arms (106, 108) are attached at first and second locations respectively on the elongate support (Fig. 7), the first and second locations are spaced apart from each other (Fig. 7), and at least one of the first and second arms is attached to the elongate support for movement along the elongate support, and in which the elongate support and the arm define cooperating surface profiles (120, 122 and internal threads of portions 112 and 116) which move the arm along the elongate support (page 24; ln. 12-23).
Allowable Subject Matter
Claims 7, 11, 12 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 following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 7, although protrusions with substantially parallel sides are shown in US 2011/0144450 A1 (Paolitto et al.) shown in the figure below, there is no motivation to combine parallel sides with an acute angle on the proximal side. Any prior art which expressly discloses the acute angles between proximal surfaces of tissue gripping surfaces and the retractor blades (see Ferro US 2016/0150158, Swift US 2019/0254771) all have triangular, tapering tissue gripping projections and the distal surface is expressly disclosed as having a different angle or intersecting the proximal facing surface.
PNG
media_image9.png
268
414
media_image9.png
Greyscale
Regarding Claims 11 and 12, any acute angles disclosed in the prior art with regards to integral tissue gripping protrusions are beyond the range required by claims 11 and 12. Swift US 2019/0254771 discloses an angle range of the anterior surface of 63-105 degrees [0100, Swift] while Ferro US 2016/0150158 discloses an anterior angle of 60-120 degrees [0077, Ferro].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form 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.
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, 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.
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.
/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773