DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Election/Restrictions
Claims 3-6 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/20/25.
Note: the applicant has indicated in the remarks filed 10/20/25 that claims 3-6 and 17-20 are withdrawn from further consideration however after further conversation with the attorney Anthony Josephson, claim 16 is withdrawn as well since it is directed to another (not elected) species.
Claim Objections
Claim 7 is objected to because of the following informalities: line 1 should be amended to - at least a portion of the at least one [[transition]] transformation member includes a shape… -. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: line 1 should be amended to - wherein the at least one pre-load component includes at least one of a pin… -. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: line 1 should be amended to - wherein the at least one pre-load component is arranged to support the at least one transformation member during an initial thermal event… -. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: line 1 should be amended to - claim 1, wherein the at least one preload component includes… -. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: line 1 should be amended to - further comprising removing the at least one pre-load component prior… -. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: line 1 should be amended to - wherein the at least one pre-load component is one of a pin, a wire… -. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: lines 1-2 should be amended to - wherein the at least one pre-load component is configured to support the at least one transformation member during the -. 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.
The following claim limitations
Mechanism (claims 1 and 11)
transformation member (claim s 1 and 11)
pre-load component (claims 1 and 11)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
mechanism (Mechanism - claims 1 and 11)
member (transformation member - claims 1 and 11)
component (pre-load component - claims 1 and 11)
coupled with functional language
mechanism (Mechanism - claims 1 and 11)
member (transformation member - claims 1 and 11)
component (pre-load component - claims 1 and 11)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1 and 11 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
links, sliding members, stationary members, transformation members (acting as one or more of the parts of the mechanism), pivot pin, guideway, crank, connecting rod, connection, bevel gear, gear, universal joint, shaft, cross journal, or a combination thereof (specification ¶0033) (Mechanism - claims 1 and 11)
shape-memory material/alloy (specification ¶0036)(transformation member - claims 1 and 11)
a pin, wire, flat or shaped plate, or any similar construction (specification ¶0040)(pre-load component - claims 1 and 11)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 7-9, 11-12 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20120203224 A1 to Kratoska et al. (Kratoska).
Kratoska discloses:
Regarding claim 1:
A surgical apparatus (figure 1-4) comprising:
a mechanism (42; stationary member or connection in accordance with 35 USC 112(f) interpretation above) configured to perform an operational motion of the surgical apparatus (¶0038, under the broadest reasonable interpretation, when the mechanism/contact 42 is in its proper position (in electrical contact with 60) the surgical apparatus is usable/moved/operated into different positions for cutting or coagulating as indicated in ¶0038);
at least one transformation member (20; ¶0034; shape memory alloy material in accordance with 35 USC 112(f) interpretation above) configured to respond to exposure to a transition temperature by deforming to inhibit the mechanism (42) from performing the operational motion (¶0034, “The embodiment illustrated in FIG. 1 illustrates a state of the shape-memory material 20 in which the shape-memory material 20 has been subjected to the transition temperature causing the shape-memory material 20 to bend upward (to its predetermined shape) to act on the circuit portion 40 and thus disable the apparatus 10. The shape-memory material 20 can disable the apparatus 10 by either making (closing) or breaking (opening) a disabling/enabling circuit in the circuit portion 40”); and
at least one pre-load component (30a; flat or shape plate as shown in figure 2 in accordance with 35 USC 112(f) interpretation above), configured to be removable before a first use of the surgical apparatus (¶0037, “The blocking element 30 is preferably configured such that a user is compelled to remove the pin 30A prior to a first use of the single-use device 10”), that is arranged to inhibit deformation of the at least one transformation member (20) before removal of the at least one pre-load component (30a) (¶0037, “In so doing, pin 30A prevents the shape-memory material 20 from bending and assuming its predetermined shape prematurely even if it is sterilized and thus heated above its transition temperature”).
Regarding claim 2:
The surgical apparatus of claim 1, wherein the mechanism (42) includes at least one of a gear, a housing, a pin, a universal joint, a link, a sliding member, a stationary member (see 42 as a stationary member), a transformation member, a pivot pin, a guideway, a crank, a connecting rod, a connection (see 42 as a connection/electrical connection), a bevel gear, a gear, a spur gear, a shaft, a cross-journal, or a combination of any of these.
Regarding claim 7:
The surgical apparatus of claim 1, wherein at least a portion of the transition member (20) includes a shape-memory material (¶0034).
Regarding claim 8:
The surgical apparatus of claim 1, wherein the pre-load component (30a) includes at least one of a pin, a wire, or a flat or shaped plate (see flat or plate shape of 30a as shown in figure 2).
Regarding claim 9:
The surgical apparatus of claim 1, wherein the pre-load component (30a) is arranged to support the transformation member (20) during an initial thermal event at or exceeding a transition temperature to inhibit deformation during an initial sterilization at manufacturing or packaging of the surgical apparatus (¶0037, “In so doing, pin 30A prevents the shape-memory material 20 from bending and assuming its predetermined shape prematurely even if it is sterilized and thus heated above its transition temperature”) .
Regarding claim 11:
A method of forming a surgical apparatus comprising:
providing a mechanism (42+60) having a first element (42) and a second element (60) configured to perform an operational motion of the surgical apparatus (¶0038, under the broadest reasonable interpretation, when the mechanism/contact 42 is in its proper position (in electrical contact with 60) the surgical apparatus is usable/moved/operated into different positions for cutting or coagulating as indicated in ¶0038);
coupling the first element (42) with the second element (60) with at least one transformation member (20) configured to respond to exposure to a transition temperature by deforming to inhibit the mechanism (42) from performing the operational motion (¶0034, “The embodiment illustrated in FIG. 1 illustrates a state of the shape-memory material 20 in which the shape-memory material 20 has been subjected to the transition temperature causing the shape-memory material 20 to bend upward (to its predetermined shape) to act on the circuit portion 40 and thus disable the apparatus 10. The shape-memory material 20 can disable the apparatus 10 by either making (closing) or breaking (opening) a disabling/enabling circuit in the circuit portion 40”);
providing at least one pre-load component (30a), configured to be removable before a first use of the surgical apparatus (¶0037, “The blocking element 30 is preferably configured such that a user is compelled to remove the pin 30A prior to a first use of the single-use device 10”), that is arranged to inhibit deformation of the at least one transformation member (20) before removal of the at least one pre-load component (30a) (¶0037, “In so doing, pin 30A prevents the shape-memory material 20 from bending and assuming its predetermined shape prematurely even if it is sterilized and thus heated above its transition temperature”); and
subjecting the mechanism (42) and the transformation member (20) to a heating process (¶0037, “In so doing, pin 30A prevents the shape-memory material 20 from bending and assuming its predetermined shape prematurely even if it is sterilized and thus heated above its transition temperature”).
Regarding claim 12:
The method of claim 11, the method further comprising removing the pre-load component (30a) prior to an initial use of the surgical apparatus (¶0037, “The blocking element 30 is preferably configured such that a user is compelled to remove the pin 30A prior to a first use of the single-use device 10”).
Regarding claim 14:
The method of claim 11, wherein the pre-load component (30a) is configured to support the transformation member (20) during the initial heating process (¶0037, “In so doing, pin 30A prevents the shape-memory material 20 from bending and assuming its predetermined shape prematurely even if it is sterilized and thus heated above its transition temperature”).
Regarding claim 15:
The method of claim 11, wherein the heating process is a sterilization (¶0037, “In so doing, pin 30A prevents the shape-memory material 20 from bending and assuming its predetermined shape prematurely even if it is sterilized and thus heated above its transition temperature”).
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.
Claim(s) 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20120203224 A1 to Kratoska et al. (Kratoska) as applied to claims 1 and 11 above, and further in view of WO 9205828 A1 to Pyka et al. (Pyka).
Regarding claim 10:
Kratoska fails to disclose:
The surgical apparatus of claim 1, wherein the preload component includes at least one of a metal, a polymer, or a ceramic.
Pyka teaches:
A surgical apparatus (figure 63) that includes a transformation member (136) supported by a bushing (136) made form a non-conducting polymer (page 51, ¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kratoska to make the preload component of a non-conductive polymer as taught by Pyka for the purpose of preventing conduction of electricity to the user when removing the preload component (Pyka, page 51, ¶3) since the mechanism is part of an electrical circuit.
Regarding claim 13:
Kratoska discloses:
The method of claim 11, wherein the pre-load component is one of a pin, a wire, a flat or shaped plate (see flat or plate shape of 30a as shown in figure 2).
Kratoska fails to disclose:
The pre-load component is formed from a metal, a polymer, or a ceramic.
Pyka teaches:
A surgical apparatus (figure 63) that includes a transformation member (136) supported by a bushing (136) made form a non-conducting polymer (page 51, ¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kratoska to make the preload component of a non-conductive polymer as taught by Pyka for the purpose of preventing conduction of electricity to the user when removing the preload component (Pyka, page 51, ¶3) since the mechanism is part of an electrical circuit.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-0698216-A
Newman
See the pivot “o” that can be removed.
US-1425995-A
MCGIVENEY
See the pivot “10” that can be removed.
US-20050143763-A1
Ortiz
See the shape memory alloy 16
EP-0062846-A1
KONOMURA
See the shape memory alloy 17a
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783