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 .
Detailed Action
This is in response to the amendment filed 10/01/2025.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3, 5-7, 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0080925 (Schulte et al.) in view of U.S. Patent Publication Number 2010/0274160 (Yachi et al.), U.S. Patent Publication Number 2013/0116717 (Balek et al.)
Regarding claims 1-3, 5-7, 11-15 Schulte et al. discloses as shown in Figures 1, 2 a surgical instrument, comprising: (a) a body (body 22, see paragraph [0078]); (b) a shaft assembly (shaft assembly 30, see paragraph [0078]) extending distally from the body, wherein the shaft assembly includes an outer sheath (structure of shaft assembly supporting projection 34) and a first pivot portion (projection 34 or pivot member 36, or recess in projection 34, see paragraph [0078]), wherein the outer sheath and the first pivot portion are integrally formed together with each other as a first unitary piece; (c) an ultrasonic blade (blade 42, see paragraph [0078]) positioned distal to the shaft assembly; and (d) a clamp arm assembly (clamp arm assembly 50, see paragraph [0078]) including a clamp arm and a second pivot portion (recess which receives pivot member 36 or pivot member 36, see paragraph [0078]), wherein the clamp arm and the second pivot portion are integrally formed together with each other as a second unitary piece, wherein the clamp arm assembly is pivotally coupled to the shaft assembly via the first and second pivot portions, wherein the first pivot portion includes a first pivot member, and wherein the second pivot portion includes a second pivot member, wherein the first pivot member comprises a first material, wherein the second pivot member comprises a second material different from the first material (first and second pivot members are not integral and are thus different materials), wherein the first pivot member comprises at least one boss, wherein the second pivot member comprises at least one receptacle configured to pivotally receive the at least one boss, wherein the second pivot member comprises at least one boss, wherein the first pivot member comprises at least one receptacle configured to pivotally receive the at least one boss, wherein the outer sheath includes a fin, wherein the first pivot member is disposed on the fin, wherein the first pivot portion includes a first receptacle, wherein the second pivot portion includes a first boss, and wherein the first receptacles receives the first boss, wherein the outer sheath includes a fin, and wherein the fin defines the first receptacle, wherein the outer sheath includes a lumen, wherein the first pivot portion includes a first boss and a second boss, wherein the second pivot portion includes a first receptacle and a second receptacle, and wherein the first and second receptacles respectively receive the first and second bosses, wherein the outer sheath includes a fin, and wherein the first and second bosses extend from the fin. See paragraph [0078].
Schulte fails to disclose the outer sheath includes a first lumen, where the shaft assembly includes a metal insert tube disposed within the first lumen, wherein the metal insert includes a second lumen, an acoustic waveguide at least partially received within the second lumen.
Balek et al., from the same field of endeavor teaches a similar surgical instrument as shown in Figure 2 wherein the shaft assembly includes an outer sheath (plastic sheath), includes a first lumen, where the shaft assembly includes a metal insert tube (metal sheath) disposed within the first lumen, wherein the metal insert includes a second lumen, an acoustic waveguide (ultrasonic waveguide 80) at least partially received within the second lumen, wherein the inner tube is formed of a second material, and wherein the first material is different than the second material, wherein the first material is a plastic material, wherein the second material is a metal material, for the purpose of better conducting thermal energy. See paragraph [0068].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Schulte by substituting the cylindrical portion of the shaft assembly disclosed by Schulte for the plastic and metal sheath disclosed by Balek et al. such that the outer sheath includes a first lumen, where the shaft assembly includes a metal insert tube disposed within the first lumen, wherein the metal insert includes a second lumen, an acoustic waveguide at least partially received within the second lumen in order to better conduct thermal energy or because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Yachi et al., from the same field of endeavor teaches a similar surgical instrument as shown in Figures 8, were pivot portion is integrally formed with another part of the instrument forming a unitary piece. See paragraph [0060].
Alternatively, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the surgical instrument disclosed by Yachi by substituting the means of attaching the outer sheath and the first pivot portion and the means of attaching the clamp arm and the second pivot portion for an integral formation technique such that an outer sheath and the first pivot portion are integrally formed together with each other as a first unitary piece clamp arm and the second pivot portion are integrally formed together because it would require the simple substitution of one known alternative technique for another to produce nothing but predictable results or because it was obvious to try because it represents choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
More specifically, components of surgical tools can be connected in only so many ways. Integrally forming a pivot portion and clamp arm or a pivot portion and an outer sheath represents choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0080925 (Schulte et al.) in view of U.S. Patent Publication Number 2010/0274160 (Yachi et al.), U.S. Patent Publication Number 2013/0116717 (Balek et al.), as applied to claim 3 above, and further in view of U.S. Patent Publication Number 2010/0094323 (Issacs et al.)
Regarding claim 4, Schulte et al. fails to disclose wherein one of the first or second materials comprises a plastic material, wherein the other of the first or second materials comprises a metal material.
Issacs et al., from the same field of endeavor teaches a similar instrument as shown in Figure 1, where it known to make members of an instrument either plastic or metal. See paragraph [0079].
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Schulte et al. such that one of the first or second materials comprises a plastic material, wherein the other of the first or second materials comprises a metal material because it would only require the simple substitution of one known material for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 8, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0080925 (Schulte et al.) in view of U.S. Patent Publication Number 2010/0274160 (Yachi et al.), U.S. Patent Publication Number 2013/0116717 (Balek et al.)6 as applied to claim 3 above, and further in view of U.S. Patent Number 5,925,064 (Meyers et al.)
Regarding claim 8, Schulte et al. fails to disclose a metal insert plate disposed within the fin.
Meyers et al., from the same field of endeavor teaches a similar surgical instrument as shown in Figure 1, where it is known to use metal insert plates for the purpose of providing strength. See col. 9, lines 46-56.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the surgical instrument disclosed by Meyers et al. to include a metal insert plate for the purpose of providing strength to the fin.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0080925 (Schulte et al.) in view of U.S. Patent Publication Number 2010/0274160 (Yachi et al.), U.S. Patent Number 5,925,064 (Meyers et al.) and as applied to claim 10 above, and further in view of U.S. Patent Publication Number 2003/0050634 (Ellman et al.)
Regarding claim 11, Schulte et al. fails to disclose wherein the outer sheath comprises a plastic material.
Ellman, from the same field of endeavor teaches a similar instrument as shown Figure 1 where in the outer sheath comprises a plastic material.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the sheath disclosed by Schulte by substituting the material of the sheath disclosed by Shulte for the material of the sheath disclosed by Ellman because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 16, 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0080925 (Schulte et al.) in view of U.S. Patent Publication Number 2013/0116717 (Balek et al.)
Regrading claims 16, 18, 19, Schulte et al. discloses as shown in Figures 1, 2 a surgical instrument, comprising: (a) a body (body 22, see paragraph [0078]); (b) a shaft assembly (shaft assembly 30, see paragraph [0078]) extending distally from the body, and a first pivot portion (projection 34 or pivot member 36, or recess in projection 34, see paragraph [0078]), wherein the shaft assembly includes (c) an ultrasonic blade (blade 42, see paragraph [0078]) positioned distal to the shaft assembly; and (d) a clamp arm assembly (clamp arm assembly 50, see paragraph [0078]) including a clamp arm and a second pivot portion (recess which receives pivot member 36 or pivot member 36, see paragraph [0078]), wherein the clamp arm assembly is pivotally coupled to the shaft assembly via the first and second pivot portions.
Schulte et al fails to disclose the shaft assembly comprises an outer sheath, an inner tube, , wherein the inner tube extends through the outer sheath defining a lumen therethrough; wherein the outer sheath is formed of a first material, wherein the inner tube is formed of a second material, and wherein the first material is different than the second material.
Balek et al., from the same field of endeavor teaches a similar surgical instrument as shown in Figure 2 wherein the shaft assembly includes an outer sheath (plastic sheath), an inner tube (metal sheath) , wherein the inner tube extends through the outer sheath defining a lumen therethrough; wherein the outer sheath is formed of a first material, wherein the inner tube is formed of a second material, and wherein the first material is different than the second material, wherein the first material is a plastic material, wherein the second material is a metal material, for the purpose of better conducting thermal energy. See paragraph [0068].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Schulte by substituting the cylindrical portion of the shaft assembly disclosed by Schulte for the plastic and metal sheath disclosed by Balek et al. such that the shaft assembly comprises an outer sheath, an inner tube, wherein the inner tube extends through the outer sheath defining a lumen therethrough; wherein the outer sheath is formed of a first material, wherein the inner tube is formed of a second material, and wherein the first material is different than the second material in order to better conduct thermal energy or because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claim(s) 16, 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0080925 (Schulte et al.) in view of U.S. Patent Publication Number 2013/0116717 (Balek et al.)
as applied to claim 16 above, and further in view of U.S. Patent Publication Number 2010/02566623 (Nicolas)
Regarding claim 17, the limitations of “the outer sheath is overmolded to the inner tube” are being interested as a product by process.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).
In this case, the applicant’s specification does not describe any structure that is a by product of the process of overmolding that is not present in Schulte et al. in view of Balek et al. Accordingly, the Office interprets Schulte et al. in view of Balek as disclosing the same or similar structure and meets the limitations.
Nicolas, from a related field of endeavor teaches a similar outer sheath and inner tube as shown in Figure 11, wherein the outer sheath is overmolded to the inner tube. See paragraph [0036].
Alternatively, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the device disclosed by Schulte in view of Balek by substituting the means the outer sheath and inner tube are attached for the overmodling process taught by Nicolas such that the outer sheath is overmolded to the inner tube because it would only require the simple substitution of one known alternative technique for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claim(s) 16, 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0080925 (Schulte et al.), U.S. Patent Publication Number 2013/0116717 (Balek et al.)
as applied to claim 16 above, and further in view of U.S. Patent Publication Number 2010/0256623 (Nicolas)
Regarding claim 20, Schulte et al. discloses as shown in Figures 1, 2 a method of assembling at least a portion of a surgical instrument, the surgical instrument including (a) a body (body 22, see paragraph [0078]); (b) a shaft assembly (shaft assembly 30, see paragraph [0078]) extending distally from the body, and a first pivot portion (projection 34 or pivot member 36, or recess in projection 34, see paragraph [0078]), (c) an ultrasonic blade (blade 42, see paragraph [0078]) positioned distal to the shaft assembly; and (d) a clamp arm assembly (clamp arm assembly 50, see paragraph [0078]) including a clamp arm and a second pivot portion (recess which receives pivot member 36 or pivot member 36, see paragraph [0078]), wherein the clamp arm assembly is pivotally coupled to the shaft assembly via the first and second pivot portions.
Schulte et al. fails to disclose wherein the shaft assembly includes an outer sheath, an inner tube, wherein the inner tube extends through the outer sheath defining a lumen therethrough; wherein the outer sheath is formed of a first material, wherein the inner tube is formed of a second material, and wherein the first material is different than the second material, the method comprising: (a) overmolding the outer sheath to the inner tube thereby assembling at least the portion of the surgical instrument.
Balek et al., from the same field of endeavor teaches a similar method of assembling a surgical instrument as shown in Figure 2 wherein the shaft assembly includes an outer sheath (plastic sheath), an inner tube (metal sheath) , wherein the inner tube extends through the outer sheath defining a lumen therethrough; wherein the outer sheath is formed of a first material, wherein the inner tube is formed of a second material, and wherein the first material is different than the second material, wherein the first material is a plastic material, wherein the second material is a metal material, for the purpose of better conducting thermal energy. See paragraph [0068].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the instrument disclosed by Schulte by substituting the cylindrical portion of the shaft assembly disclosed by Schulte for the one disclosed by Balek et al. such that the shaft assembly comprises an outer sheath, an inner tube, wherein the inner tube extends through the outer sheath defining a lumen therethrough; wherein the outer sheath is formed of a first material, wherein the inner tube is formed of a second material, and wherein the first material is different than the second material in order to better conduct thermal energy or because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Nicolas, from a related field of endeavor teaches a similar method of assembly a surgical instrument with an outer sheath and inner tube as shown in Figure 11, wherein the outer sheath is overmolded to the inner tube. See paragraph [0036].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Schulte in view of Balek by substituting the means the outer sheath and inner tube are attached for the overmodling process taught by Nicolas such that the outer sheath is overmolded to the inner tube because it would only require the simple substitution of one known alternative technique for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Response to Arguments
Applicant’s arguments filed 10/01/2025, see pages 6-13 with respect to claim(s) to the rejections of claims 1-8, 11-20 have been considered but are largely moot because the new ground of rejection does not rely the new references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The office will note, one page 9 of their remarks the applicant argues the Office’s position does not clearly explain the proposed modification.
In response, the Office respectfully disagrees. The applicant concedes the Office specified the substitution of the cylindrical portion of the shaft assembly disclosed by Schulte for the one disclosed by the secondary reference, but states that this is somehow unclear. Figures 1, 2 of Schulte discloses shaft assembly 30 has a cylindrical portion. It is clear and unambiguous. In the current rejection, the Office’s position is substituting the clear and unambiguous cylindrical portion of the shaft assembly 30 disclosed by Schulte for the plastic and metal sheaths disclosed by Balek.
The applicant also argues Office’s position was devoid of a valid rationale. In response, the Office respectfully disagrees. In the prior action (and the current one), the Office has articulated the primary and secondary references are either from the same field of endeavor or a related field of endeavor and taught similar structure. The Office also articulated that it consider it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to substitute one alternative structure for another because it would only produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007). This is valid rationale recognized by the Court in KSR.
The applicant’s remarks did not address these specific factual findings: 1.) The references where from an analogous or related field of endeavor
2.) The references taught similar structures
3.) The structures being substituted where known alternatives
4.) Substituting one for another would produce nothing but predictable results.
“When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)
Since the applicant’s argument did not address all of the factual findings of the rejection, they have failed to carry their burden, and cannot be considered persuasive.
The applicant argues the Office’s position does not explain any perceived advantage the Office revisions as resulting from the proposed modification. In response, the Office will not this not the standard for obviousness. The substitution of one known alternative structure for another to produce nothing but predictable result is recognized as obvious to one of ordinary skill in the under KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007). The Federal Circuit explained that the Supreme Court’s requirement for an explicit analysis does not require record evidence of an explicit teaching of a motivation to combine in the prior art. See MPEP 2143.
The applicant notes a Board decision which they characterizing as finding no motivation to combine refers when the problem alleged by the Examiner to exists in the primary reference was already solved by the primary reference. In response, the Office respectfully disagrees this board decision makes the claims distinguishable. First, the Board decision is not binding. Second, the Office’s position was not there was a problem in the primary reference that was solved by substituting one alternative structure for another, and thus the decision is distinguishable. Third, it ignores the explicit hold of the KSR decision, which is binding on the patent office:
"In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result." See MPEP 2141.
The applicant makes reference to two other PTAB decisions (also non-binding) which relate to combing prior art elements according to known methods yielding predictable results. In response, the Office respectfully disagrees this is persuasive, as it was the rationale used to reject the claims. The substitution of one known element for another to produce nothing but predictable results is a separate rationale from combing prior art elements according to known methods yielding predictable results. Thus, even if the PTAB decision were binding (they are not), they are distinguishable as they don’t relate to the actual grounds of rejection.
The applicant also argues the Office’s position is clearly based on hindsight. In response, the Office respectfully disagrees. Nowhere in the prior rejection was there a reference to the applicant’s disclosure. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771