Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This action is in response to the amendment filed on 10/27/2025. Claims 1-12, 14-16, and 18-21 are pending. Claims 12, 14-16, and 18-20 are withdrawn. Claims 13 and 17 are canceled. Claim 21 is newly added.
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.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 21 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Hood (US Pat. No.: 5,695,510).
Regarding claim 21, Hood discloses an apparatus (24, Fig. 1), comprising: an ultrasonic surgical blade (26, Fig. 1) for cutting tissue, wherein the ultrasonic surgical blade comprises: a body (body of 26, Figs. 1-3) having a proximal end, a distal end, and an outer surface (proximal end, distal end and outer surface of 26, Figs. 1-3) comprising a tissue treatment region (cutting section 34 with the teeth), wherein the distal end is movable relative to a longitudinal axis in accordance with ultrasonic vibrations applied to the proximal end (Col. 1, lines 30-35, Col. 2, lines 27-31, and Col. 3, lines 29-45); and a lubricious coating (Col. 7, lines 30-57, ceramic coating, such as aluminum oxide) for contacting tissue, wherein the lubricious coating comprises a coefficient of friction that is less than the coefficient of friction of the outer surface of the body (Col. 7, lines 30-57, ceramic coating, such as aluminum oxide or chrome oxide, either of which has a coefficient of friction less than the coefficient of friction of the outer surface of the body formed of high carbon stainless steel), wherein the lubricious coating is formed by a surface treatment to at least a portion of the tissue treatment region (Col. 7, 51-57), wherein the lubricious coating comprises a metal oxide (Col. 7, lines 30-57, such as aluminum oxide or chrome oxide); and wherein the lubricious coating is coated on a distal-facing surface on the ultrasonic blade (Fig. 2 and Col. 7, lines 30-57, the lubricious coating is also coated on a distal-facing surface on the ultrasonic blade because the lubricious coating is applied on the teeth for cutting. As shown in Fig. 2, some of the teeth are facing distally).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1 and 4-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Okada et al. (US Pat. No.: 6,129,735) in view of Hood (US Pat. No.: 5,695,510).
Regarding claim 1, Okada discloses an apparatus (1, Figs. 1), comprising: an ultrasonic surgical blade (29, Figs. 1 and 8) for at least one of cutting and or coagulating tissue (Col. 8, lines 27-47), wherein the ultrasonic surgical blade comprises: a body (body of 29, Fig. 4B) having a proximal end (proximal end of 29, Fig. 4C), a distal end (distal end of 29, Fig. 4B), and an outer surface (outer surface of 19, Fig. 8) comprising a tissue treatment region (region of 29 facing 40, Fig. 8), wherein the distal end is movable relative to a longitudinal axis in accordance with ultrasonic vibrations applied to the proximal end (Col. 11, lines 39-48 and Fig. 4C); and a lubricious coating (Col. 11, lines 11-18 and Col. 17, lines 10-65 and Fig. 24, the ceramic coating is a lubricious coating since it improves smoothness; such as coating 110 having three layers 111, 112, and 113) for contacting tissue, wherein the lubricious coating comprises a coefficient of friction that is less than the coefficient of friction of the outer surface of the body (Col. 11, lines 11-18, the ceramic coating has a coefficient of friction that is less than the coefficient of friction of the outer surface of the body because it improves smoothness to the outer surface of the body of 29), wherein the lubricious coating is formed by a surface treatment to at least a portion of the tissue treatment region (Col. 11, lines 11-18 and Col. 17, lines 10-65 and Fig. 24, lubricious coating is formed by laying the coating to at least a portion of the tissue treatment region), and wherein the lubricious coating comprises a ceramic (Col. 11, lines 11-18). However, Okada does not disclose that the ceramic is a metal oxide.
Hood teaches, in the same field of endeavor (ultrasonic surgical blade), an ultrasonic surgical blade having a ceramic coating comprising metal oxide (e.g. aluminum oxide, Col. 7, lines 30-57).
At the time of the invention, it would have been obvious to one of ordinary skill to modify the ceramic coating of Okada to be formed of metal oxide, such aluminum oxide, as taught by Hood, since it has been held within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. See MPEP 2144.07
Regarding claim 4, Okada in view of Hood discloses that the metal oxide comprises a metal oxide of a blade material (Okada, Col. 8, lines 24-27 and Hood, Col. 7, lines 30-57. Okada discloses the base metal to be aluminum whereas Hood discloses that the metal oxide of the coating is aluminum oxide and the base metal is an aluminum material). At the time of the invention, it would have been obvious to one of ordinary skill to modify the ceramic coating of Okada to be formed of metal oxide, such aluminum oxide which is a metal oxide of blade material, aluminum, as taught by Hood, since it has been held within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. See MPEP 2144.07
Regarding claim 5, Hood discloses that the metal oxide comprises a ceramic material (Hood, Col. 7, lines 30-57).
Regarding claim 6, Okada discloses that the lubricious coating has a thickness of about 0.0001 to about 0.0005 inches (Col. 17, line 11-15, 9 microns is 0.000354 inches).
Regarding claim 7, Okada discloses that the lubricious coating is a first lubricious coating layer, and wherein the ultrasonic surgical blade further comprises a second lubricious coating layer (layer 112, Fig. 24).
Regarding claim 8, Okada discloses a clamp arm (41, Fig. 8), wherein the clamp arm and the ultrasonic surgical blade form an end effector (26, Fig. 8).
Regarding claim 9, Okada discloses an ultrasonic transducer (Col. 8, lines 13-17); and a waveguide (25, Figs. 2 and 4B and Col. 8, lines 13-19) operably coupled to the ultrasonic transducer, wherein the waveguide extends from the longitudinal axis of the ultrasonic surgical blade (Fig. 4B).
Claims 2 and 3 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Okada et al. (US Pat. No.: 6,129,735) in view of Hood (US Pat. No.: 5,695,510) as applied to claim 1 above, and further in view of Xiao et al. (US Pub. No.: 2008/0069854).
Regarding claims 2 and 3, Okada in view of Hood discloses all the limitations of claim 1 but fails to disclose that the surface treatment is an electrochemical treatment, wherein the electrochemical treatment is an anodizing treatment. The combination of the claimed phrases “wherein the lubricious coating is formed by a surface treatment,” “wherein the surface treatment is an electrochemical treatment,” and “wherein the electrochemical treatment is an anodizing treatment” is being treated as a product by process limitation; that is, that the lubricious coating (such as the metal oxide coating) is made by an electrochemical treatment which is an anodizing treatment. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Nevertheless, Xiao teaches, in the same field of endeavor (ceramic coating on a medical device), a ceramic / metal oxide coating (e.g. aluminum oxide, Para. [0022]) is formed on a medical device by an electrochemical treatment which is an anodizing treatment, which was a known method of forming a ceramic coating (Para. [0044]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention form the ceramic / metal oxide coating by an electrochemical treatment which is an anodizing treatment as taught by Xiao which discloses that anodizing treatment was a known useful technique for forming a ceramic or metal oxide coating on a medical device.
Response to Arguments
Applicant's arguments filed 10/27/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the newly added claim 21 have been considered but are moot in view of new ground(s) of rejection.
In response to the argument on page 6 of the remarks, the rejection of claim 7 under pre-AIA 35 U.S.C. 112 has been withdrawn in light of the amendment.
In response to the argument(s) on the art rejections on pages 6-11 of the remarks, Okada discloses an apparatus (1, Figs. 1), comprising: an ultrasonic surgical blade (29, Figs. 1 and 8) for at least one of cutting and or coagulating tissue (Col. 8, lines 27-47), wherein the ultrasonic surgical blade comprises: a body (body of 29, Fig. 4B) having a proximal end (proximal end of 29, Fig. 4C), a distal end (distal end of 29, Fig. 4B), and an outer surface (outer surface of 19, Fig. 8) comprising a tissue treatment region (region of 29 facing 40, Fig. 8), wherein the distal end is movable relative to a longitudinal axis in accordance with ultrasonic vibrations applied to the proximal end (Col. 11, lines 39-48 and Fig. 4C); and a lubricious coating (Col. 11, lines 11-18 and Col. 17, lines 10-65 and Fig. 24, the ceramic coating is a lubricious coating since it improves smoothness; such as coating 110 having three layers 111, 112, and 113) for contacting tissue, wherein the lubricious coating comprises a coefficient of friction that is less than the coefficient of friction of the outer surface of the body (Col. 11, lines 11-18, the ceramic coating has a coefficient of friction that is less than the coefficient of friction of the outer surface of the body because it improves smoothness to the outer surface of the body of 29), wherein the lubricious coating is formed by a surface treatment to at least a portion of the tissue treatment region (Col. 11, lines 11-18 and Col. 17, lines 10-65 and Fig. 24, lubricious coating is formed by laying the coating to at least a portion of the tissue treatment region), and wherein the lubricious coating comprises a ceramic (Col. 11, lines 11-18). However, Okada does not disclose that the ceramic is a metal oxide.
Hood teaches, in the same field of endeavor (ultrasonic surgical blade), an ultrasonic surgical blade having a ceramic coating comprising metal oxide (e.g. aluminum oxide, Col. 7, lines 30-57).
At the time of the invention, it would have been obvious to one of ordinary skill to modify the ceramic coating of Okada to be formed of metal oxide, such aluminum oxide, as taught by Hood, since it has been held within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. See MPEP 2144.07
The modification was merely to modify the ceramic coating of Okada to be formed of a metal-oxide ceramic material as taught by Hood. At the time of the invention, it would have been obvious to one of ordinary skill to modify the ceramic coating of Okada to be formed of metal oxide, such aluminum oxide, as taught by Hood, since it has been held within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. The modification does not involve modifying Okada’s invention to include teeth of the blade of Hood. Okada recognizes that a ceramic coating improves smoothness to the outer surface of the body of 29 (Col. 11, lines 11-18).
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 JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/ Primary Examiner, Art Unit 3771
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