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 Objections
Claims 3 and 6 are objected to because of the following informalities:
In claim 3, line 3, the phrase “wherein ends of the pivot pin” should read “wherein the ends of the pivot pin”.
In claim 6, line 3, the phrase “the outer tube” appears to be referring to the inner tube and should read “the inner tube”, to remain consistent in referring to the pushing force of the inner tube.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “protruding element” in claim 7.
Figure 3 of the instant spec. depicts the protruding element (see also para. [0034] of the published application). “Protruding element” uses the generic placeholder “element” coupled with the term “protruding”, which is functional in that the limitation alternatively recites an element for protruding, and the term “element” is not preceded by a structural modifier since the term “protruding” does not imply any structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 11-15 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.
Regarding claim 11, the claim recites “the first pivot” in lines 2 and 4. There is insufficient antecedent basis for this limitation in the claim, since a first pivot has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the pivot introduced in claim 5.
Regarding claim 15, the claim recites “the first pivot” in line 3. There is insufficient antecedent basis for this limitation in the claim, since a first pivot has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the pivot introduced in claim 5.
Claims 12-14 are indefinite due to their dependencies on indefinite base claim 11.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 9-12, 15-17 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 18-20 of U.S. Patent No. 12,357,335 B2 to Netzel in view of Craig (US 2018/0042637 A1).
Regarding claim 1, Netzel claims the instrument of claim 1 (claim 1, note the inner tube and outer tube are considered to have movement relative to each other), but fails to claim the proximal end portion of the jaw drive arm secured in fixed position to the inner tube, and the proximal flange portion pivotably coupled to the outer tube about the second pivot; in contrast, Netzel claims the reversed configuration, such that the proximal end portion of the jaw drive arm is secured in fixed position to the outer tube, and the proximal flange portion is pivotably coupled to the inner tube about the second pivot.
Craig teaches (para. [0031]), in the same field of endeavor, a surgical instrument comprising an inner tube (146) and an outer tube (50) which may be reversed in configuration (para. [0031]).
The substitution of one known element (50 disposed about drive sleeve 146) for another (drive sleeve 146 disposed about 50) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the shaft 50 disposed about drive sleeve 146 as taught by Craig, would have yielded predictable results, specifically, providing longitudinal transition of the tubes relative to each other to pivot the clamp arm between open and clamping positions (para. [0038]). Regarding claim 2, Netzel (as modified) claims the instrument of claim 2 (claim 2).
Regarding claim 3, Netzel (as modified) claims the instrument of claim 3 (claim 3).
Regarding claim 4, Netzel (as modified) claims the instrument of claim 4 (claim 4).
Regarding claim 5, Netzel claims the instrument of claim 5 (claim 18, note the inner tube and outer tube are considered to have movement relative to each other), but fails to claim the proximal end portion of the jaw drive arm secured to the inner tube, and the jaw member pivotably coupled to the outer tube; in contrast, Netzel claims the reversed configuration, such that the proximal end portion of the jaw drive arm is secured to the outer tube, and the jaw member is pivotably coupled to the inner tube.
Craig teaches (para. [0031]), in the same field of endeavor, a surgical instrument comprising an inner tube (146) and an outer tube (50) which may be reversed in configuration (para. [0031]).
The substitution of one known element (50 disposed about drive sleeve 146) for another (drive sleeve 146 disposed about 50) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the shaft 50 disposed about drive sleeve 146 as taught by Craig, would have yielded predictable results, specifically, providing longitudinal transition of the tubes relative to each other to pivot the clamp arm between open and clamping positions (para. [0038]). Regarding claim 6, Netzel (as modified) claims the instrument of claim 6 (claim 19).
Regarding claim 7, Netzel (as modified) claims the instrument of claim 7 (claim 18), but fails to claim wherein at least one protruding element is disposed on the proximal end portion of the jaw drive arm and configured to be inserted into at least one fastening aperture defined within the inner tube.
Craig teaches (para. [0038]; annotated fig. 4), in the same field of endeavor, at least one protruding element (annotated fig. 4) disposed on the proximal end portion of a jaw drive arm (drive link 116) and configured to be inserted into at least one fastening aperture defined within the inner tube (drive sleeve 146 receives proximal base 117 of drive link 116, para. [0038]), for the purpose of securing the drive link to the drive sleeve (para. [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein at least one protruding element is disposed on the proximal end portion of the jaw drive arm and configured to be inserted into at least one fastening aperture defined within the inner tube, in order to provide proper securement of the jaw drive arm to the inner tube, based on the teachings of Craig (para. [0038]).
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Annotated Figure 4 of Craig
Regarding claim 9, Netzel (as modified) claims the instrument of claim 9 (claim 18), but fails to claim wherein the at least one protruding element is welded within the at least one fastening aperture such that the drive arm is permanently engaged to the inner tube.
Craig teaches (para. [0038]) wherein the at least one protruding element is welded within the at least one fastening aperture such that the drive arm is permanently engaged to the inner tube (secured via welding, para. [0038]), for the purpose of providing permanent securement of the drive arm to the inner tube.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the at least one protruding element is welded within the at least one fastening aperture such that the drive arm is permanently engaged to the inner tube, in order to provide permanent securement of the structures relative to each other via welding, based on the teachings of Craig (para. [0038]).
Regarding claim 10, Netzel (as modified) claims the instrument of claim 10 (claim 18), but fails to claim wherein the proximal end portion of the jaw member defines a pair of spaced-apart flanges.
Craig teaches wherein the proximal end portion of the jaw member defines a pair of spaced-apart flanges (106a, fig. 4), for the purpose of pivotably coupling the clamp arm to the distal end of shaft 50 (para. [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the proximal end portion of the jaw member defines a pair of spaced-apart flanges, in order to pivotably couple the jaw member to the outer tube, based on the teachings of Craig (para. [0037]).
Regarding claim 11, Netzel (as modified) claims the instrument of claim 11 (claim 18), but fails to claim wherein a first flange of the pair of spaced-apart flanges defines a first groove configured to receive a first portion of the first pivot, and a second flange of the pair of spaced-apart flanges defines a second groove configured to receive a second portion of the first pivot.
Craig teaches wherein a first flange of the pair of spaced-apart flanges defines a first groove configured to receive a first portion of the first pivot, and a second flange of the pair of spaced-apart flanges defines a second groove configured to receive a second portion of the first pivot (slots 106d, depicted in fig. 4 as slots 106b), for the purpose of operably coupling the drive sleeve to the clamp arm (para. [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein a first flange of the pair of spaced-apart flanges defines a first groove configured to receive a first portion of the first pivot, and a second flange of the pair of spaced-apart flanges defines a second groove configured to receive a second portion of the first pivot, in order to operably couple the drive arm to the jaw member, based on the teachings of Craig (para. [0038]).
Regarding claim 12, Netzel (as modified) claims the instrument of claim 12 (claim 18), but fails to claim wherein the first pivot is a pivot pin and wherein the first portion of the first pivot is a first end of the pivot pin, and the second portion of the first pivot is a second end of the pivot pin.
Craig teaches wherein the first pivot is a pivot pin (119) and wherein the first portion of the first pivot is a first end of the pivot pin, and the second portion of the first pivot is a second end of the pivot pin (ends received within slot 106d, paras. [0037]-[0038]), for the purpose of coupling the drive sleeve to the clamp arm via a pivot pin (para. [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the first pivot is a pivot pin and wherein the first portion of the first pivot is a first end of the pivot pin, and the second portion of the first pivot is a second end of the pivot pin, in order to couple the jaw member to the jaw drive arm, based on the teachings of Craig (para. [0038]).
Regarding claim 15, Netzel (as modified) claims the instrument of claim 15 (claim 18), but fails to claim wherein a spacing between the pair of spaced-apart flanges of the proximal end portion is greater than a width of the distal end portion of the jaw drive arm, and less than a length of the first pivot.
Craig teaches wherein a spacing between the pair of spaced-apart flanges of the proximal flange portion is greater than a width of the distal end portion of the jaw drive arm (depicted in figs. 1 and 4, extends outward of drive link 116), and less than a length of the first pivot (depicted in fig. 1, pivot posts 119 extend into and past proximal flanges 106a), for the purpose of properly seating pivot posts within the slots (para. [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein a spacing between the pair of spaced-apart flanges of the proximal end portion is greater than a width of the distal end portion of the jaw drive arm, and less than a length of the first pivot, in order to properly seat the pivot, based on the teachings of Craig (para. [0038]).
Regarding claim 16, Netzel claims the instrument of claim 16 (claim 20, note the inner tube and outer tube are considered to have movement relative to each other), but fails to claim the proximal end portion of the jaw drive arm secured to the inner tube, and the jaw member pivotably coupled to the outer tube; in contrast, Netzel claims the reversed configuration, such that the proximal end portion of the jaw drive arm is secured to the outer tube, and the jaw member is pivotably coupled to the inner tube.
Craig teaches (para. [0031]), in the same field of endeavor, a surgical instrument comprising an inner tube (146) and an outer tube (50) which may be reversed in configuration (para. [0031]).
The substitution of one known element (50 disposed about drive sleeve 146) for another (drive sleeve 146 disposed about 50) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the shaft 50 disposed about drive sleeve 146 as taught by Craig, would have yielded predictable results, specifically, providing longitudinal transition of the tubes relative to each other to pivot the clamp arm between open and clamping positions (para. [0038]).
Regarding claim 17, Netzel (as modified) claims the instrument of claim 17 (claim 20), but fails to claim wherein the proximal end portion of the jaw drive arm is wider than the distal end portion of the jaw drive arm.
Craig teaches wherein the proximal end portion of the jaw drive arm is wider than the distal end portion of the jaw drive arm (fig. 4 depicts proximal base 117 wider than distal extension 118 inward of pivot posts 119), for the purpose of seating the proximal base of drive link 116 within cut-out slot 148 (para. [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the proximal end portion of the jaw drive arm is wider than the distal end portion of the jaw drive arm, in order to seat the proximal base of drive arm in the inner tube (para. [0038]).
Regarding claim 19, Netzel (as modified) claims the instrument of claim 19 (claim 20), but fails to claim an opposing structure extending from the elongated body portion, wherein the jaw member opposes the opposing structure in at least one position of the jaw member to clamp tissue therebetween.
Craig teaches an opposing structure (124, para. [0030]) extending from the elongated body portion (fig. 1), wherein the jaw member opposes the opposing structure in at least one position of the jaw member to clamp tissue therebetween (clamp arm 102 pivotable towards and away from blade 124 to clamp tissue, para. [0030]), for the purpose of clamping tissue (para. [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim an opposing structure extending from the elongated body portion, wherein the jaw member opposes the opposing structure in at least one position of the jaw member to clamp tissue therebetween, in order to clamp tissue between the jaw member and an opposing structure, based on the teachings of Craig (para. [0039]).
Regarding claim 20, Netzel (as modified) claims the instrument of claim 20 (claim 20), but fails to claim wherein the opposing structure is an ultrasonic blade.
Craig teaches wherein the opposing structure is an ultrasonic blade (paras. [0025] and [0035]), for the purpose of energizing the blade to treat tissue (para. [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the opposing structure is an ultrasonic blade, in order to energize the blade appropriately to treat tissue, based on the teachings of Craig (para. [0048]).
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 12,357,335 B2 to Netzel in view of Craig as applied to claim 12 above, and further in view of Price (US 2012/0116396 A1).
Regarding claim 13, Netzel (as modified) claims the instrument of claim 13 (claim 18), but fails to claim wherein the first end of the pivot pin is welded into the first groove and the second end of the pivot pin is welded into the second groove such that the pivot pin is permanently affixed to the proximal end portion of the jaw member.
Price teaches (para. [0066]; fig. 7), in the same field of endeavor, a surgical instrument (figs. 6-7) comprising a jaw drive arm (outer sheath portion 710, considered to function as a drive arm via coupling to outer sheath 660, para. [0066]) supporting a pivot (722), and a jaw member (750) having a proximal flange portion (proximal end of 750, fig. 7) defining grooves (holes in clamp arm 750) configured to receive the pivot pin (para. [0066]), wherein first and second ends of the pivot pin are welded into the grooves such that the pivot pin is permanently affixed to the proximal flange portion of the jaw member (may be attached via welding, para. [0066]), in place of mechanical attachment of the jaw drive arm to the jaw member (para. [0066]).
The substitution of one known element (attachment of clamp arm and drive link via welding) for another (attachment of clamp arm and drive link via mechanical attachment, para. [0038] of Craig, para. [0066] of Price) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of welding of the clamp arm and drive link as taught by Price, would have yielded predictable results, specifically, providing attachment between the clamp arm and drive link for pivoting the clamp arm between open and clamping positions (para. [0038] of Craig).
Allowable Subject Matter
Claims 8 and 18 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.
Claims 1, 5 and 16 would be allowable if rewritten or amended to overcome the double patenting rejection and the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 2-4, 6-7, 9-15, 17 and 19-20 would be allowable if rewritten to overcome the double patenting rejection and the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 base claim 1, the closest prior art of record cited to Craig fails to teach the first pivot entirely disposed on a first side of the plane bisecting an elongated body portion of the instrument, and the distal body portion disposed entirely on the first side of the plane, in combination with the remaining structural features of the claim. Pivot posts 119 of Craig are instead depicted as being on a separate side of the bisecting plane relative to the distal body portion.
Regarding base claim 5, Craig does not disclose drive link 116 capable of flexing as claimed or flexing to absorb force, and one of ordinary skill in the art would not be motivated to modify drive link 116 of Craig to be capable of flexing when compressed.
Regarding base claim 16, Craig fails to disclose the jaw drive arm tapering in thickness along its length (see the dictionary definition of the term ‘taper’, defined as becoming progressively smaller, such that a change in width would not meet the claimed limitation, in combination with the remaining structural features of the claim. It would not be obvious to modify Craig to include a tapering in thickness of the jaw drive arm, since Craig already discloses a secondary structure including a difference in width on the jaw drive arm.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2016/0175001 A1 to Hibner, disclosing an ultrasonic surgical instrument.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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