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 .
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 4-9 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.
Claim 4, “the retractor” lacks antecedent basis.
Claim 5, line 6, “the proximal ends” lacks antecedent basis.
Claim 5, line 8, “the proximal ends” lacks antecedent basis.
Claims 6-9 are also rejected because they depend from and include the limitations of their parent claim (claim 5), which is rejected.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over McBride et al. (2003/0055320; cited by Applicant) in view of Pretts (1,194,319; cited by Applicant) and Adams (2017/0333023; cited by Applicant).
Regarding independent claim 1, McBride et al. disclose a device for tissue retraction, comprising:
first and second elongated curved members 12/20’, 12/20’’ (Figs. 1 and 2), each having respective proximal (handle) and distal ends (blades 14);
a hinge 18 pivotably connecting the first and second elongated curved members, wherein the first and second curved members curve away from one another (e.g., at the blades 14 and at the hinge 18);
a first blade 14 extending from the distal end of the first elongated curved member 12/20’;
a second blade 14 extending from the distal end of the second elongated curved member 12/20’’;
a first latching portion 28 extending from the proximal end of the first elongated curved member 12/20’;
a second latching portion 30 extending from the proximal end of the second elongated curved member 12/20’’;
a release member 34 attached to the first latching portion 28 and disposed between the first and second elongated members 12/20’, 12/20’’;
wherein the first and second latching portions 28, 30 are lockingly engageable;
wherein the release member 34 releases the first latching member 28 from the second latching member 30. The device for tissue retraction is capable of being disposed of if desired.
Thus, McBride et al. disclose the claimed invention except for a third bladed elongated member lockingly engageable to the hinge, and
wherein the retractor is made of a generally electrically insulating nonmagnetic radiolucent material.
Pretts teach that a retractor (Figs. 1 and 2) can be provided with a third bladed elongate member 22 lockingly engageable to a hinge (page 2, lines 26-38) to fully retract tissue and remain out of the field of operation (page 1, lines 21-28).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to provide the device for tissue retraction of McBride et al. with a third bladed elongate member lockingly engageable to the hinge, in view of Pretts, to fully retract tissue and remain out of the field of operation.
Adams discloses a retractor device and teaches that it may advantageously be formed of a generally electrically insulating nonmagnetic material such as PEEK (poly ether ether ketone, a thermopolymer) (para. 0118). Adams teaches that this material is advantageous because it is radiolucent. Radiolucent materials allow x-ray imaging as they are by definition transparent to such electromagnetic radiation.
Therefore, it would have also been obvious to a person having ordinary skill in the art before the effective filing date to form the retractor of McBride et al., including as modified by Pretts, from a generally electrically insulating nonmagnetic material such as PEEK, in view of Adams, because it is radiolucent and therefore allows x-ray imaging. It is further noted that forming the device from a low-cost thermopolymer would be further obvious as it would also introduce cost and time savings compared to machining the parts from surgical metals such as stainless steel and titanium.
Regarding claim 2, PEEK (poly ether ether ketone) is a nonporous medical grade thermoplastic resin.
Regarding claim 3, a plurality of fingers 16 extend from each respective blade 14 (McBride et al., Fig. 2).
Regarding claim 4, each finger 16 is curved away from the retractor (i.e., the device for tissue retraction) (id.).
Claims 5-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bester et al. (6,196,969; cited by Applicant) in view of Risto et al. (2011/0060194; cited by Applicant).
Regarding claim 5, Bester et al. discloses a method for retracting tissue (col. 1, lines 7-22) comprising:
a) moving distal ends of respective first and second prongs 11, 12 of a retractor 10 together (id.);
b) inserting the distal ends into an incision (id.); and
c) allowing the distal ends to exert a first urging force away from one another on the incision by compressing the proximal ends of the retractor together (id. and col. 2, lines 5-10);
d) locking the distal ends of the retractor together with a locking mechanism 27, 31 disposed between (e.g., at least portion 31 thereof) the proximal ends (Fig. 2);
e) unlocking the distal ends of the retractor with a release member 26 disposed on the locking mechanism 27, 31 (id.);
wherein the first and second prongs 11, 12 are connected by a hinge 15, 40, 22 and curve away from one another (e.g., at bend near pivot 91; Fig. 1).
Bester et al. do not explicitly recite forming the retractor from a thermoplastic resin, f) removing the retractor from the incision and g) discarding the retractor.
Risto et al. teach that a retractor can be formed from a thermoplastic resin such as a radiolucent plastic pervious to x-rays to facilitate imaging during a surgical procedure (paras. 0006 and 0007) and that the retractor can be removed from the incision and discarded at the conclusion of the procedure (paras. 0008 and 0053; the retractor is removed from the incision in order to be disposed of).
Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to form the retractor from a thermoplastic resin such as a radiolucent plastic pervious to x-rays, to remove the retractor from the incision, and to discard the retractor, in view of Risto et al., to facilitate imaging during a surgical procedure, and to conclude the procedure in an efficient and hygienic manner.
Regarding claim 6, the method of the combination further comprises:
h) after c) and before f), x-ray imaging through the retractor (para. 0007 of Risto et al.).
Regarding claim 7, the method of the combination further comprises:
i) after c) and before f), locking proximal ends of the first and second prongs 11, 12 together with a radiolucent latch 27, 31 (i.e., the teeth thereof) (Fig. 2 of Bester et al.).
Regarding claim 9, the method further comprises:
k) before f), engaging a third member 45 into the incision;
l) exerting a second urging force orthogonal to the first urging force on the incision; and
m) operationally connecting the third member 45 to the hinge 15, 40, 22 via element 61 (Fig. 2 of Bester et al.).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bester et al. (6,196,969; cited by Applicant) in view of Risto et al. (2011/0060194; cited by Applicant), as applied to claim 5 above, and further in view of Adams (2017/0333023; cited by Applicant).
The combination of Bester et al. and Risto et al. discloses the claimed method except for disinfecting the retractor with ethylene oxide.
Adams teaches that ethylene oxide is used in a known sterilization technique for surgical polymers (para. 0118). Ensuring equipment is sterile before surgery is necessary for patient safety.
Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to have disinfected (i.e., sterilized) the retractor of the combination of Bester et al. and Risto et al., in view of Adams, for patient safety. It is noted that this disinfecting step could be performed before step a) either as by processes carried out prior to the surgery by the manufacturer, or at the surgical location to ensure hygienic equipment, as necessary or desired, e.g., after handling by hospital staff. It is further noted that in the latter case, the advantages of single-use disposable devices are not diminished, in that subsequent sterilization steps after the surgery would still be avoided.
Double Patenting
The double patenting rejection set forth in the Office action mailed 15 September 2025 has been withdrawn in light of the amendments to the claims adding limitations not recited in U.S. Pat. No. 12,011,150.
Response to Arguments
Applicant’s arguments regarding the rejections under 35 U.S.C. 112(b) with respect to the amended claims have been considered and are persuasive. Accordingly, these rejections have been withdrawn.
Applicant’s arguments regarding the rejection of claims 5-6 under 35 U.S.C. 102(a)(1) as being anticipated by Risto (2011/0060194) have been considered and are persuasive. Accordingly, this rejection has been withdrawn.
Applicant’s arguments regarding the rejection of claims 1-4 under 35 U.S.C. 103 as being obvious over Bester et al. (6,196,969) in view of Adams (2017/0333023) have been considered and are persuasive. Accordingly, this rejection has been withdrawn. However, new grounds of rejection are set forth above.
Applicant's arguments regarding the rejection of claims 5-7 and 9 under 35 U.S.C. 103 as being obvious over Bester et al. (6,196,969) in view of Risto (2011/0060194) have been fully considered but they are not persuasive. As noted above in the rejection, the locking mechanism 27, 31 of Bester et al. is disposed between (e.g., at least portion 31 thereof) the proximal ends of the first and second prongs (Fig. 2), and the locking mechanism 27, 31 includes a release member 26 disposed thereon for unlocking the distal ends of the first and second prongs. It is noted that claim 5 does not necessarily require the release member to be between the proximal ends of the first and second prongs.
Applicant's arguments regarding the rejection of claim 8 under 35 U.S.C. 103 as being obvious over Bester et al. (6,196,969) in view of Risto (2011/0060194) and further in view of Adams (2017/0333023) have been fully considered but they are not persuasive.
Applicant did not separately argue the merits of this rejection but pointed to the alleged shortcomings of Bester et al. However, as noted above, the amendments do not overcome the rejection based on Bester et al. (because the release member of claim 5 does not necessarily need to be disposed between the proximal ends of the first and second prongs).
The double patenting rejection has been withdrawn in light of the amendments made to the claims adding limitations not recited in the claims of U.S. Pat. No. 12,011,150.
Conclusion
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 DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773