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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 - 22 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 – 14 and 19 – 20 (as best understood) and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duggal et al. (US 2012/0149992 A1) in view of Vayser et al. (US 2015/0080666 A1) and in view of Vaquero (US 2008/0027461 A1) and in view of Ritland (US 2004/0254428).
Regarding claim 1, Duggal discloses a surgical retractor (Abstract, Fig. 9), comprising:
a body (ref. 800) molded as a single piece from a polymer (Fig. 9 shows the body as a single piece and paragraph [0039] discloses a polymer material in the form of polycarbonate) having at least a predetermined flexural modulus (this is a material property), the body comprising:
a blade portion (see remarked Fig. 9 below) molded from a polymer having at least a predetermined flexural modulus (paragraph [0039]);
a handle portion (see remarked Fig. 9) extending from the blade portion (Fig. 9); and
a curved section (see remarked Fig. 9) connecting the handle portion to the blade portion at a non- adjustable angle (Fig. 9 shows the curved section connecting the handle to the blade portion and the disclosure makes no mention of the curved second being adjustable); and
at least one direct light source (ref. 810) positioned on the blade portion and substantially directed toward a distal portion of the blade portion (Fig. 9);
a predetermined thickness along the length such that the blade portion does not interfere with a user's work space in an operating cavity (the device is a hand retractor and thus the thickness will be predetermined at the time of design and is designed to aid in a medical capacity which would require the blade portion to not interfere with a user’s work space).
Duggal is silent regarding the limitation that the light source is oriented at an able with respect to the blade so as to direct substantially all light emitted towards the distal end of the blade portion and the limitation that the blade portion has a length of 50 mm to 150 mm, and wherein the blade portion, being molded from the polymer, is capable of withstanding more than 30 lbs of force applied to its distal portion without breaking.
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Vayser teaches an analogous retractor (Abstract) having a blade portion and a direct light source wherein the light emitted is substantially directed distally (paragraph [0051], Fig. 4 shows the light source ref. 42 directed towards the distal end ref. 46). It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the blade of Duggal such that the light source directs the light towards the distal end, as taught by Vayser, for the purpose of distributing the energy density only towards the distal end (paragraph [0051]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the blade of Duggal to have a length of 50 mm to 150 mm which is a known range for blades targeting soft tissue where moderate depth is required without excessive reach, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Vaquero teaches medical plunger, in the related field of medical devices (Abstract). Vaquero teaches that the plunger may be made a polymer, more specifically may be made from IXEF 1022, for the purpose of providing moldability characteristics that permit small features to be manufactured (paragraph [0054]). 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 retractor of Duggal to be formed from IXEF 1022, as taught by Vaquero, for the purpose of ease of manufacture of detailed or small features. Please note the attached NPL by Solvay, hereafter “Solvay”, describing KEF PARA/1022 (page 1, “Healthcare”) which is relied upon solely to provide evidence of the material properties and inherent characteristics of IXEF.
Ritland teaches a surgical retractor (Abstract) having a blade (paragraph [0050], refs. 12, Fig. 1) with a thickness of 2mm (paragraph [0055], Fig. 5). Ritland teaches that such a thickness provides a relatively narrow device with which to initiate separation of tissue (paragraph [0055]). 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 blade of Duggal in view of Vaquero to have a thickness of 2 mm for the purpose of better imitating tissue separation. Please note that by applicant's admission, a blade formed of a polyacrylamide infused with glass fiber, such IXEF, having a thickness of 2 mm can withstand over 30 lbs of tip force (Written Description, page 20), thus the retractor of Wan in view of Vaquero and in view of Ritland would be able to withstand over 30 Ibs of force.
Regarding claim 2, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 1, wherein the predetermined flexural modulus is at least 17 Gpa (IXEF has a flexural modulus greater than 17 GPa by applicant’s admission, Fig. 10 and SOLVAY page 2).
Regarding claim 4, Duggal in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 1, wherein the polymer has a predetermined flexural strength of at least 375 Mpa (applicant’s admission Fig. 19 and Solvay, page 2, “Flexural Strength” table).
Regarding claim 5, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 1, wherein the polymer is a glass-fiber reinforced polymer (Vaquero, paragraph [0054]).
Regarding claim 6, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 5, wherein the polymer is at least 50 wt% glass-fiber reinforced polymer (Vaquero, paragraph [0054]).
Regarding claim 7, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 1, wherein the polymer is a thermoplastic crystalline polymer (IXEF is a polyacrylamide and by applicant’s admission is a thermoplastic crystalline polymer, see also Solvay page 4).
Regarding claim 8, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 7, wherein the polymer is a thermoplastic crystalline polymer of aromatic diamines and aromatic dicarboxylic anhydrides (Applicant’s admission, Written Description page 16).
Regarding claim 9, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 7, wherein the polymer is polyacrylamide (Vaquero, paragraph [0054]).
Regarding claim 10, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 9, wherein the polymer is at least 50 wt% glass-fiber reinforced polyacrylamide (Vaquero, paragraph [0054[).
Regarding claim 11, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 1, wherein the polymer has an impact strength of at least 100 J/M (this is a material property of IXEF, Solvay page 5).
Regarding claim 12, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 1, wherein the predetermined thickness is 2 mm (Ritland, paragraph [0055]).
Regarding claim 13, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 1, wherein the polymer comprises a non-conductive material that limits currents to less than 10-6 A (this is a material property, see applicant’s admission, Written Description, page 17).
Regarding claim 14, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 1, wherein the polymer is a radiolucent polymer (the material as disclosed by Vaquero and Solvay is radiolucent since the polymer is formed from low atomic number elements which typically allow X-rays to pass).
Regarding claim 19, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 1, wherein the blade portion, being molded from the polymer, deforms less than 10 mm under 15 lbs of force applied thereto (applicant’s admission that the blade, being molded from IEXEF 1022, would deform less than 10 mm under 15 lbs of force applied).
Regarding claim 20, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 1, further comprising an illumination assembly comprising the at least one direct light source (Duggal, ref. 810).
Regarding claim 21, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses surgical retractor of claim 1, wherein the blade portion, the handle portion, and the curved section are integrally molded from the polymer as a single piece to form the body (the components are formed from a polymer as disclosed above per Vaquero and when assembled comprise an integrally single piece, see Fig. 9 of Duggal. Note that “integrally” is being defined as “essential to completeness” per Merriam-Webster).
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Regarding claim 22, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses surgical retractor of claim 1, wherein the distal portion comprises a lip (see remarked Fig. 9 of Duggal below).
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Claims 15 – 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duggal et al. (US 2012/0149992 A1) in view of in view of Vayser et al. (US 2015/0080666 A1) and in view of Vaquero (US 2008/0027461 A1) and in view of Ritland (US 2004/0254428) and in view of Wan (US 2017/0296162 A1).
Regarding claim 15, Duggal in view of Vayser and in view of Vaquero and in view of Ritland discloses the surgical retractor of claim 1, except for further comprising that the curved section comprises a deepened portion connecting a proximal end of the blade portion to the handle portion, and wherein the deepened portion increases in depth from the proximal end of the blade portion toward the handle portion.
Wan teaches an analogously shaped surgical retractor (Abstract, Fig. 6) comprising a deepened portion (formed by wings ref. 36, Fig. 6) connecting a proximal end of the blade portion (ref. 14) to the handle portion (ref. 12), wherein the deepened portion increases in depth from the proximal end of the blade portion toward the handle portion (Fig. 6). 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 blade of Duggal in view of Vayser and in view of Vaquero and in view of Ritland to modify the retractor such that a deepened portion connecting a proximal end of the blade portion to the handle portion, wherein the deepened portion increases in depth from the proximal end of the blade portion toward the handle portion, as taught by Wan, for the purpose of re-enforcing the blade (paragraph [0041]).
Regarding claim 16, Duggal in view of Vayser and in view of Vaquero and in view of Ritland and in view of Wan discloses the surgical retractor of claim 15, wherein the blade portion, the deepened portion and the handle portion are integrally molded from the polymer (because the deepened portion is part of the curved section, which is integral or monolithic with the blade portion and the hand portion it is considered to be integrally molded from the polymer).
Regarding claim 17, Duggal in view of Vayser and in view of Vaquero and in view of Ritland and in view of Wan discloses the surgical retractor of claim 15, wherein the deepened portion includes flanges along its sides, said flanges tapering in a direction of the blade portion (Wan, Fig. 6, ref. 36).
Regarding claim 18, Duggal in view of Vayser and in view of Vaquero and in view of Ritland and in view of Wan discloses the surgical retractor of claim 15, wherein the blade portion and the deepened portion have a concave surface (Duggal as modified by Wan results in a concave surface due to the deepened portion).
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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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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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/TESSA M MATTHEWS/Examiner, Art Unit 3773
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