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 .
Election/Restrictions
Applicant's election with traverse of Invention I (claims 1-11 and 13-17) in the reply filed on October 23, 2025 is acknowledged. The traversal is on the ground(s) that independent claim 1 (Invention I) and independent claim 18 (Invention II) are linking claims as there is significant overlap in the subject matter of the inventions and thus there would not be a serious search and/or examination burden. This is not found persuasive. First of all, the Examiner conceded in the restriction requirement that there is overlapping subject matter by stating that the common technical features present in both claims 1 and 18 does not provide a contribution over the prior art of Haque. Thus that technical feature cannot be considered a special technical feature, and therefore the inventions lack unity of invention. The Examiner notes that Applicant has not challenged this assertion. Furthermore, searching for methods of manufacturing (Invention II) would necessitate a search of additional classification areas directed to methods of manufacturing that would not need to be searched for the apparatus (Invention I). The requirement is still deemed proper and is therefore made FINAL.
Claims 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on October 23, 2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim 16 is 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. Claim 16 recites “the arm” in line 3 and twice again in line 4. It is unclear whether “the arm” is referring to the first arm or the second arm. Because claim 16 depends from claim 15 and claim 15 recites “at least one of the first and second arms,” the Examiner is interpreting “the arm” in claim 16 as “the at least one of the first and second arms.”
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 9-11, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kreidler et al. (DE 102007035132 A1) in view of Joie (US 2010/0234690 A1) and Haque et al. (US 2017/0215858 A1).
Claim 1. Kreidler discloses a surgical retractor (spreader 10) comprising:
a support (spindle 11);
a first arm (arm 16) extending from the support;
a second arm (arm 17) extending from the support, the first and second arms extending from a same side of the support and spaced apart from each other along the support (see Fig. 1);
a first anatomy engaging member (valve 37) having a first interior face (see Fig. 1 inset) and a first exterior face (face opposite “first interior face” and facing away from valve 36 as shown in Fig. 1); and
a second anatomy engaging member (valve 36) having a second interior face (face opposite “second exterior face” and facing toward valve 37 as shown in Fig. 1) and a second exterior face (see Fig. 1 inset), 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 Fig. 1);
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 Fig. 1);
each of the first and second anatomy engaging members is formed from a plastics material (para. 0014 states that valves 36 and 37 should be made of a radiolucent material; para. 0018 states that the radiolucent material is PEEK; PEEK is a plastic material) (Figs. 1-5; entire disclosure).
Claim 9. Kreidler discloses wherein each of the first and second anatomy engaging members comprises a main body (see Fig. 1 inset) which defines the respective exterior and interior faces, the main body having the form of an elongate plate (Figs. 1-5; entire disclosure).
Claim 10. Kreidler discloses wherein at least one of the first and second anatomy engaging members is attached to the respective arm for movement of the anatomy engaging member along the arm (para. 0030 states that valve mounts 34 and 35 are pushed onto struts 31 and 32; valve mounts 34 and 35 attach valves 36 and 37 to arms 16 and 17 as shown in Fig. 1) (Figs. 1-5; entire disclosure).
Claim 11. Kreidler discloses wherein each of the first and second anatomy engaging members is configured such that it extends substantially orthogonally to the respective arm (see Fig. 1; see also Fig. 3, which shows that the downwardly-extending portion of valve 36 extends substantially orthogonally to the horizontally-extending upper portion of valve 36 where valve 36 is attached via valve mount 35 to arm 17) (Figs. 1-5; entire disclosure).
Claim 14. Kreidler discloses wherein the support is elongate and the first and second arms extend from respective locations on the elongate support, the respective locations spaced apart from each other along the longitudinal direction (axis L) of the elongate support (see Fig. 1) (Figs. 1-5; entire disclosure).
Claim 15. Kreidler discloses wherein at least one of the first and second arms is attached to the elongate support for movement along the elongate support (para. 0011 states that arms 16 and 17 are moved relative to each other by rotation of spindle 11) (Figs. 1-5; entire disclosure).
Claim 16. Kreidler discloses wherein the support is of generally cylindrical form (see Fig. 1) and defines a screw thread (threads 12 and 13) along at least part of its length, and the arm defines a threaded portion (arm 16 includes thread 18; arm 17 includes thread 19) which engages with the screw thread, whereby rotation of the support relative to the arm drives the arm along the support by way of engagement of the threaded portion and the screw thread (para. 0011 states that arms 16 and 17 are moved relative to each other by rotation of spindle 11) (Figs. 1-5; entire disclosure).
Claim 17. Kreidler discloses wherein the support, and the first and second arms are formed from a plastics material (para. 0029 states that the spindle and arms are made of PEEK; PEEK is a plastic material) (Figs. 1-5; entire disclosure).
[AltContent: textbox (First Interior Face)][AltContent: textbox (Second Exterior Face)][AltContent: textbox (Main Body)][AltContent: textbox (Main Body)]
Kreidler fails to disclose wherein each of the first exterior face and the second exterior face has a coating thereon, the coating comprising at least one haemostatic agent (claim 1), wherein the first and second interior faces have thereon a coating comprising at least one haemostatic agent (claim 2), wherein the coating comprises a polysaccharide as the haemostatic agent (claim 3), and wherein the polysaccharide comprises chitosan (claim 4).
Joie teaches a surgical retractor (retractor 1) comprising: a first anatomy engaging member (left blade 16 as shown in Fig. 14) having a first exterior face (face facing away from right blade 16 as shown in Fig. 14); a second anatomy engaging member (right blade 16 as shown in Fig. 4) having a second exterior face (face facing away from left blade 16 and covered with layer 38 as shown in Fig. 14); wherein the second exterior face has a coating (layer 38) thereon, the coating comprising at least one haemostatic agent (para. 0055 states that layer 38 is a haemostatic material) to control blood flow during a surgical procedure (see para. 0055) (Fig. 14; para. 0055).
Haque teaches a surgical retractor (device shown in Figs. 24 and 25) comprising: a first anatomy engaging member (left sternal end 1 as shown in Fig. 24) having a first interior face (face opposite hollow cusp 5 and facing right sternal end 1 as shown in Fig. 24) and a first exterior face (face at hollow cusp 5); a second anatomy engaging member (right sternal end 1 as shown in Fig. 24) having a second interior face (face opposite hollow cusp 5 and facing left sternal end 1 as shown in Fig. 24) and a second exterior face (face at hollow cusp 5); wherein each of the first exterior face and the second exterior face has a coating thereon (para. 0072 states that the device includes a coating; because the device includes sternal ends 1 and the entire device includes a coating per para. 0072, it is clear that the first and second exterior faces include a coating), the coating comprising at least one haemostatic agent in the form of chitosan (see para. 0072; chitosan is a haemostatic agent), wherein the first and second interior faces have thereon a coating (para. 0072 states that the device includes a coating; because the device includes sternal ends 1 and the entire device includes a coating per para. 0072, it is clear that the first and second interior faces include a coating) comprising at least one haemostatic agent in the form of chitosan (see para. 0072; chitosan is a haemostatic agent), and wherein the haemostatic agent in the form of chitosan also has antibiotic properties (see para. 0072) (Figs. 24-25; paras. 0069-0072).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical retractor of Kreidler such that each of the first exterior face and the second exterior face has a coating thereon, the coating comprising at least one haemostatic agent (claim 1), the first and second interior faces have thereon a coating comprising at least one haemostatic agent (claim 2), the coating comprises a polysaccharide as the haemostatic agent (claim 3), and the polysaccharide comprises chitosan (claim 4), as suggested by Joie and Haque, as a haemostatic agent can help control blood flow during a surgical procedure and chitosan also has antibiotic properties.
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kreidler et al. (DE 102007035132 A1) in view of Joie (US 2010/0234690 A1) and Haque et al. (US 2017/0215858 A1) as applied to claim 1 above, and further in view of White et al. (US 2010/0168864 A1).
Kreidler, Joie, and Haque fail to teach wherein the coating comprises plural different haemostatic agents, the plural different haemostatic agents stimulating haemostasis in respectively different ways (claim 5) and wherein the coating comprises at least one astringent as the haemostatic agent (claim 8).
White teaches that plural different haemostatic agents stimulating haemostasis in respectively different ways (para. 0158 states that the hemostatic agent can stimulate a thrombotic or coagulant response and/or organization of tissues or fluids in contact with the agent) and an astringent (para. 0158 states that the hemostatic agent can be anhydrous aluminum sulfate; anhydrous aluminum sulfate is an astringent) are alternatives to chitosan (see para. 0158).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the retractor of Kreidler such that the coating comprises plural different haemostatic agents, the plural different haemostatic agents stimulating haemostasis in respectively different ways (claim 5) and the coating comprises at least one astringent as the haemostatic agent (claim 8), as suggested by White, as different haemostatic agents may be preferable depending on the particular surgical procedure or patient.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kreidler et al. (DE 102007035132 A1) in view of Joie (US 2010/0234690 A1) and Haque et al. (US 2017/0215858 A1) as applied to claim 1 above, and further in view of Franke et al. (US 2019/0357847 A1).
Kreidler, Joie, and Haque fail to teach wherein the coating comprises at least one of a starch and a clay mineral as the haemostatic agent (claim 6) and wherein the clay mineral belongs to one of the kaolin group and the smectite group (claim 7).
Franke teaches that kaolin is an alternative haemostatic agent to chitosan (see para. 0572) and that kaolin activates the coagulation cascade (see para. 0416).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the retractor of Kreidler such that the coating comprises at least one of a starch and a clay mineral as the haemostatic agent (claim 6) and the clay mineral belongs to one of the kaolin group and the smectite group (claim 7), as suggested by Franke, as kaolin activates the coagulation cascade and such means of haemostasis may be desirable depending on the particular surgical procedure or patient.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kreidler et al. (DE 102007035132 A1) in view of Joie (US 2010/0234690 A1) and Haque et al. (US 2017/0215858 A1) as applied to claim 1 above, and further in view of Butterfield et al. (GB 2547792 A).
Kreidler, Joie, and Haque fail to teach wherein each of the first and second anatomy engaging members is formed from polyarylamide (claim 13).
Butterfield teaches a surgical retractor (retractor 10) comprising: a support (support member 16); a first arm (arm 18) and a second arm (arm 20); a first anatomy engaging member (anatomy engaging member 32) and a second anatomy engaging member (anatomy engaging member 32), wherein the entire retractor, including the first and second anatomy engaging members, is formed from an X-ray transparent plastic such as polyarylamide (see pg. 15, ll. 29-33) (Fig. 1; pg. 15, ll. 29-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the retractor of Kreidler such that each of the first and second anatomy engaging members is formed from polyarylamide (claim 13), as doing so is a simple substitution of one radiolucent plastic material for another.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dinkler (US 5,616,117 A) teaches a surgical retractor having a support (26), first and second arms (22 and 23), and first and second anatomy engaging members (24 and 25) as recited in at least claim 1 (see Fig. 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773