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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 2/12/2024 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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.
Currently no claims are 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 6, 16-18 and 20 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 6, the phrase "a first abrasion resistance" in lines 4-5 renders the claim(s) indefinite because a first abrasion resistance was already introduced in line 2, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the first abrasion resistance of line 2 or introduce a new, additional first abrasion resistance. To move prosecution forward, the examiner assumed applicant intended to refer back to the first abrasion resistance of line 2. Appropriate correction is required.
Regarding claim 14 (and thereby dependent claim 15), the phrase "the contact surface is formed of a coating" in line 2 renders the claim(s) indefinite because the contact layer of claim 1 comprises a second resin layer layered over a first resin layer, thereby rendering the scope of the claim(s) unascertainable. It is unclear how a single coating layer (required in claim 14) can comprise the two separate resin layers of claim 1 wherein the second layer is layered over the first resin layer. Appropriate correction/clarification is required.
Regarding claim 16 (and thereby dependent claims 17-18 and 20), the phrase "a first thickness" in line 18 renders the claim(s) indefinite because a first thickness was already introduced in line 13, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the first thickness of line 13 or introduce a new, additional first thickness. To move prosecution forward, the examiner assumed applicant intended to refer back to the first thickness of line 13. Appropriate correction is required.
Regarding claim 17 (and thereby dependent claims 18 and 20), the phrase "the contact surface is formed of a coating" in line 2 renders the claim(s) indefinite because the contact layer of claim 16 comprises a second resin layer layered over a first resin layer, thereby rendering the scope of the claim(s) unascertainable. It is unclear how a single coating layer (required in claim 14) can comprise the two separate resin layers of claim 16 wherein the second layer is layered over the first resin layer. Appropriate correction/clarification is required.
Regarding claim 20, the phrase "according to claim 17" in line 1 renders the claim(s) indefinite because claim 17 already introduced both first and second resin layers, thereby rendering the scope of the claim(s) unascertainable. It appears that the dependency may include a typographical error if applicant intended to have claim 20 depend from independent claim 19 (which does not introduce any specific “resin layers”). To move prosecution forward, the examiner assumed applicant intended claim 20 depend from independent claim 19. Whichever case is true, appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 7 and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hibner et al. (US 2017/0119425).
Hibner discloses (see Figs. 2 and 10-14) an ultrasonic surgical instrument comprising the following claim limitations:
(claim 1) An ultrasound treatment tool (100, Fig. 2), comprising: an ultrasound blade (160, Fig. 2; 379, Figs. 11-14) including a treatment portion located at a distal end of the ultrasound blade (160) (as shown in Fig. 2, i.e., upper surface of blade 160 comprises a treatment portion); and a jaw (144, Fig. 2; 356, Figs. 11-14) configured to (i.e., capable of) open and close relative to the treatment portion (as shown in Figs. 12A-12B; [0056]; [0086]), the jaw including: a surface (e.g., upper, exterior surface of clamp arm 356, Fig. 11); and a contact surface (358, Figs. 11-14) facing the ultrasound blade (379) (as shown in Figs. 12A-12B and 14), the contact surface (358) configured to be in contact with the treatment portion when the jaw (356) is closed relative to the treatment portion (as shown in Figs. 12B and 14), wherein the contact surface (358) comprises: a first resin layer positioned on the surface (as shown in Figs. 11-14), the first resin layer formed of a first resin ([0088]; the contact surface/clamp pad 358 expressly may comprise polytetrafluoroethylene (PTFE)); and a second resin layer layered over the first resin layer, the second resin layer formed of a mixed resin, the mixed resin being a mixture of a second resin and the first resin ([0088]; the contact surface/clamp pad 358 expressly discloses an embodiment comprising a pad composed of polytetrafluoroethylene (PTFE) and further having an additional coating layer of one or more resins including at least both fluorinated ethylene propylene (FEP) and polytetrafluoroethylene (PTFE));
(claim 2) wherein the first resin layer has a first thickness, the second resin layer has a second thickness, and the second thickness is smaller than the first thickness ([0088]; a coating layer composed of both fluorinated ethylene propylene (FEP) and polytetrafluoroethylene (PTFE) is expressly disclosed to coat the contact surface/clamp pad 358 wherein a thickness of a mere coating layer is thinner than the thickness of clamp pad 358, shown in Figs. 11-14);
(claim 7) wherein the first resin is polytetrafluoroethylene (PTFE) ([0088]; the contact surface/clamp pad 358 expressly may comprise polytetrafluoroethylene (PTFE));
(claim 14) wherein the contact surface (358) is formed of a coating ([0088]; the contact surface/clamp pad 358 expressly discloses an embodiment comprising a contact surface/clamp pad having a coating layer of both fluorinated ethylene propylene (FEP) and polytetrafluoroethylene (PTFE) disposed thereon);
(claim 15) wherein a plating layer (at 386, Fig. 14) is located between the surface (of 356) and the contact surface (358) (as shown in Fig. 14);
(claim 16) An ultrasound treatment tool (100, Fig. 2), comprising: an ultrasound blade (160, Fig. 2; 379, Figs. 11-14) including a treatment portion located at a distal end of the ultrasound blade (160) (as shown in Fig. 2, i.e., upper surface of blade 160 comprises a treatment portion); and a jaw (144, Fig. 2; 356, Figs. 11-14) configured to (i.e., capable of) open and close relative to the treatment portion (as shown in Figs. 12A-12B; [0056]; [0086]), the jaw including: a surface (e.g., upper, exterior surface of clamp arm 356, Fig. 11); and a contact surface (358, Figs. 11-14) facing the ultrasound blade (379) (as shown in Figs. 12A-12B and 14), the contact surface (358) configured to be in contact with the treatment portion when the jaw (356) is closed relative to the treatment portion (as shown in Figs. 12B and 14), wherein the contact surface (358) comprises: a first resin layer positioned on the surface (as shown in Figs. 11-14), the first resin layer formed of a first resin ([0088]; the clamp pad 358 expressly may be composed a resin such as polyetheretherketone (PEEK)), the first resin layer having a first thickness (i.e., thickness of the clamp pad 358, as bets shown in Fig. 14); and a second resin layer layered over the first resin layer, the second resin layer formed of a second resin, the second resin layer having a second thickness, and wherein the second thickness is smaller than a first thickness ([0088]; a coating layer composed of polytetrafluoroethylene (PTFE) is expressly disclosed to coat the clamp pad 358 wherein a thickness of a mere coating layer is thinner than the thickness of clamp pad 358, shown in Figs. 11-14);
(claim 17) wherein the contact surface (358) is formed of a coating ([0088]; the contact surface/clamp pad 358 expressly discloses an embodiment comprising a pad composed of combinations of materials including polyetheretherketone (PEEK) and polytetrafluoroethylene (PTFE)) with a further coating layer of polytetrafluoroethylene (PTFE) disposed thereon);
(claim 18) wherein a plating layer (at 386, Fig. 14) is located between the surface (of 356) and the contact surface (358) (as shown in Fig. 14);
(claim 19) An ultrasound treatment tool (100, Fig. 2), comprising: an ultrasound blade (160, Fig. 2; 379, Figs. 11-14) including a treatment portion located at a distal end of the ultrasound blade (160) (as shown in Fig. 2, i.e., upper surface of blade 160 comprises a treatment portion); and a jaw (144, Fig. 2; 356, Figs. 11-14) configured to (i.e., capable of) open and close relative to the treatment portion (as shown in Figs. 12A-12B; [0056]; [0086]), the jaw including: a surface (e.g., upper, exterior surface of clamp arm 356, Fig. 11); and a contact surface (358, Figs. 11-14) facing the ultrasound blade (379) (as shown in Figs. 12A-12B and 14), the contact surface (358) configured to be in contact with the treatment portion when the jaw (356) is closed relative to the treatment portion (as shown in Figs. 12B and 14), wherein the contact surface (358) is formed of a mixed resin, the mixed resin is a mixture of polyetheretherketone (PEEK) and polytetrafluoroethylene (PTFE) ([0088]; the contact surface 358 expressly disclosed to comprise combinations of materials including polyetheretherketone (PEEK) and polytetrafluoroethylene (PTFE)); and
(claim 20) wherein the contact surface (358) comprises a plurality of resin layers, the plurality of resin layers includes the contact surface (358), the plurality of resin layers is formed of a resin ([0088]; the contact surface/clamp pad 358 expressly disclosed an embodiment comprising a pad composed of combinations of materials including polyetheretherketone (PEEK) and polytetrafluoroethylene (PTFE)) with a further coating layer of polytetrafluoroethylene (PTFE) disposed thereon).
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.
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.
Claim(s) 3, 5-6 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hibner as applied to claims 1 and 7 above, and further in view of Akagane (US 2016/0374744).
Hibner, as applied above, discloses an ultrasonic surgical instrument comprising all the limitations of the claim except for the second resin being a resin having an ether group and a ketone group (such as polyetheretherketone (PEEK)) and a thickness between 5 µm and 15 µm.
However, Akagane teaches (see Fig. 6) a similar ultrasonic surgical instrument comprising an outer coating having a thickness of 10 µm and comprising polyetheretherketone (PEEK) (see Fig. 6; [0045]; [0047]; [0058]) in order to beneficially provide an electrically insulating resin layer that additionally provides for efficient heat insulation ([0045]; [0047]; [0058]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Hibner to have the second resin incorporate polyetheretherketone (PEEK) with a thickness of 10 µm in order to beneficially provide an electrically insulating resin layer that additionally provides for efficient heat insulation, as taught by Hibner.
Regarding claims 5-6 and 10-11, as the device of Hibner in view of Akagane teaches the same materials within both the first resin layer (i.e., polytetrafluoroethylene (PTFE)) and the second resin layer (i.e., polytetrafluoroethylene (PTFE) and polyetheretherketone (PEEK)) as claimed, the same physical characteristics would be provided to the device of Hibner in view of Akagane. Additionally, and/or in the alternative, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the resin layers having the claimed thicknesses and/or mixing ratios, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hibner, as applied to claim 1 above.
Hibner, as applied above, discloses an ultrasonic surgical instrument comprising all the limitations of the claim except for wherein the first resin layer has a first thickness, the second resin layer has a second thickness, a total thickness value is a sum of a value of the first thickness and a value of the second thickness, and the second thickness is 1/20 of the total thickness value or more and 3/20 of the total thickness value or less.
With regard to claim 4, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the first and second resin layers at the claimed thicknesses, 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.
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment of Figs. 11-14 of Hibner as applied to claim 1 above, and further in view of the embodiment of Figs. 23A-23B of Hibner.
The embodiment of Figs. 11-14 of Hibner, as applied above, discloses an ultrasonic surgical instrument comprising all the limitations of the claim except for wherein both the jaw and the treatment portion comprise an electrode.
However, the embodiment of Figs. 23A-23B of Hibner teaches a similar ultrasonic surgical instrument comprising both the jaw and the treatment portion including an electrode in order to beneficially deliver RF electrosurgical energy to a surgical site through bipolar operation to generate a tissue sealing effect ([0129]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of the embodiment of Figs. 11-14 of Hibner to have both the jaw and the treatment portion include an electrode in order to beneficially deliver RF electrosurgical energy to a surgical site through bipolar operation to generate a tissue sealing effect, as taught by the embodiment of Figs. 23A-23B of Hibner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A LYNCH/Primary Examiner, Art Unit 3771