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 .
Response to Arguments
Applicant's arguments filed 3/18/2026 have been fully considered but they are not persuasive.
Applicant contends that the device of Isch (US 2012/0059407 A1)(previously of record) cannot reasonably be used to read on the amended limitations of “wherein, during use, the surgical clamping device clamps the patient’s skin along the edges of a wound to temporarily close the wound” and “wherein, after use, the surgical clamp is removed, and the previously-clamped skin is in suitable condition for sampling or final wound closure” on the grounds that the device of Isch are configured to be used to grasping “objects of varying sizes such as, without limitation, semispherical implant components” (Isch Para. [0051]) and the shape of the jaws are configured and specialized therefore. Specifically, Applicant contends that the shape of the jaws of Isch are configured to be utilized to grasp non-deformable implants. Should the jaws of Isch be utilized to grasp tissue, the skin would be damaged due to its nature as a compressible material, ill-suited for use with the jaws of Isch. The resulting utilization would not facilitate having the skin be in “suitable condition for sampling or final wound closure” .
The Examiner respectfully disagrees with Applicant’s characterization of the device of Isch in light of the claimed limitations. While the jaws of Isch may be disclosed to be useable in grasping implant devices, Isch expressly notes that such a use is a single use case “without limitation” and that the jaws may be utilized to grasp “objects”, in general (see Isch Para. [0051]). Further, the jaws of Isch comprise all of the required structural limitations of the independent claims and thus are understood to be useable in the claimed manner, barring any express disclosure to the contrary. The Examiner contends that a user is fully capable of using the jaws of Isch to grip and hold tissue at a wound site by moderating the amount of closing pressure applied thereto, so as not to damage the tissue. This is understood to be a user-dependent variable, as opposed to an inherent structural characteristic, since most surgical jaws are held to be useable to grip tissue, so long as a user is careful with the amount of closing pressure applied to the site via the jaws. The Examiner therefore respectfully contends that the jaws of Isch are fully capable of performing the amended limitations until further structure is amended to differentiate the jaws of the claimed invention, in pertaining to the specialized function of gripping tissue at a wound site, from the jaws of Isch.
Additionally, the term “suitable condition” is held to be indefinite under 35 USC 112(b) as it is unclear by which metric the previously-clamped skin is defined to be in “suitable condition”. The specification does not appear to provide any additional details that define the scope of “suitable condition” and thus the term is rendered indefinite as it cannot be understood how a “suitable condition” is defined to be met within the context of the claimed invention.
Claim Objections
Applicant's arguments filed 3/18/2026 with respect to the objection to claims 1-3, 8-9 and 18 regarding the recitation of functional language have been fully considered but they are not persuasive.
Applicant contends that the previously-cited language of claims 1-3, 8-9 and 18 regarding the recitation of functional language lacking the phrase “configured to” has been amended to overcome the objections to the claims. The Examiner respectfully disagrees as it appears that none of the cited claim language has been amended, in the updates claims filed 3/18/2026, to include the phrase “configured to” and thus contends that the objection to the claims should be maintained below. Without a recitation of “configured to”, the claim language appears to suggest that the surgical device itself, rather than a user utilizing the device, may accomplish the recited functional language which is not seen to be possible without proper handling by a user. As the currently-recited claims are drawn to an apparatus, as opposed to a method, the functional language should comprise the phrase “configured to” to be in better form.
Claim Objections
Claims 1-3, 8-9 and 18 are objected to because of the following informalities:
Claim 1 recites, “wherein each jaw member comprises a tip means for holding and clamping a patient’s skin” and should be corrected to recite, “wherein each jaw member comprises a tip means configured to hold and clamping a patient’s skin” to better recite the functional language to be in-line with Claim 1’s designation as an apparatus claim.
Claim 1 recites, “wherein, during use, the surgical clamping device clamps the patient’s skin…” and should be corrected to recite “where, during use, the surgical clamping device is configured to clamp a patient’s skin…” to better recite the functional language to be in-line with Claim 1’s designation as an apparatus claim.
Claim 2 recites, “wherein, during use, the surgical clamping device is applied beneath pressure bandaging to achieve a desired amount of hemostasis” and should be corrected to recite, “wherein, during use, the surgical clamping device is configured to be applied beneath pressure bandaging to achieve a desired amount of hemostasis” to better recite the functional language to be in-line with Claim 1’s designation as an apparatus claim.
Claim 3 recites, “wherein the surgical clamping device is applied and removed following at least one stage of a multiple-stage Mohs micrographic surgery” and should be corrected to recite, “wherein the surgical clamping device configured to be applied and removed following at least one stage of a multiple-stage Mohs micrographic surgery” better recite the functional language to be in-line with Claim 1’s designation as an apparatus claim.
Claim 8 recites, “wherein each jaw member comprises a tip means for holding and clamping a patient’s skin” and should be corrected to recite, “wherein each jaw member comprises a tip means configured to hold and clamping a patient’s skin” to better recite the functional language to be in-line with Claim 8’s designation as an apparatus claim.
Claim 8 recites, “wherein the surgical clamping device is applied and removed following at least one stage of a multiple-stage Mohs micrographic surgery” and should be corrected to recite, “wherein the surgical clamping device configured to be applied and removed following at least one stage of a multiple-stage Mohs micrographic surgery” better recite the functional language to be in-line with Claim 8’s designation as an apparatus claim.
Claim 9 recites, “wherein, during use, the surgical clamping device is applied beneath pressure bandaging to achieve a desired amount of hemostasis” and should be corrected to recite, “wherein, during use, the surgical clamping device is configured to be applied beneath pressure bandaging to achieve a desired amount of hemostasis” to better recite the functional language to be in-line with Claim 8’s designation as an apparatus claim.
Claim 18 recites, “wherein each jaw member comprises a tip means for holding and clamping a patient’s skin” and should be corrected to recite, “wherein each jaw member comprises a tip means configured to hold and clamping a patient’s skin” to better recite the functional language to be in-line with Claim 18’s designation as an apparatus claim.
Claim 18 recites, “wherein, during use, the surgical clamping device is applied and removed following at least one stage of a multiple-stage Mohs micrographic surgery” and should be corrected to recite, “wherein, during use, the surgical clamping device configured to be applied and removed following at least one stage of a multiple-stage Mohs micrographic surgery” better recite the functional language to be in-line with Claim 8’s designation as an apparatus claim.
Appropriate correction is required.
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 1-20 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.
Independent claims 1, 8 and 18 recite the limitation “wherein, after the surgical clamping device is removed, the previously-clamped skin is in suitable condition for sampling or wound closure” and it is unclear by which metric the previously-clamped skin is defined as within “suitable condition”. The specification does not appear to provide any additional details that define the scope of “suitable condition” and thus the term is rendered indefinite as it cannot be understood how a “suitable condition” is defined to be met within the context of the claimed invention.
Claims 2-7, 9-17 and 19-20 are also rendered indefinite due to their dependency from and further modification of claims 1, 8 and 18.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 8-11, 13-14 and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Isch (US 2012/0059407 A1)(previously of record).
Regarding claim 1, Isch discloses:
A surgical clamping device (instrument 210, see Fig. 12) comprising:
a pair of shaft members (arms 216 and 218, see Fig. 12), each of which comprises a jaw member extending from a proximal end of the shaft member (jaws 214 and 212, see Fig. 12 – the term “proximal” is understood to refer to the side of the device opposite to the finger grips (16A) of the claimed invention along the shaft members as designated and shown in Figs. 1-3 of the disclosed drawings) and a finger grip extending from an opposing distal end of the shaft member (finger holds 220 and 222, see Fig. 12 – the term “distal” is understood to refer to the side of the device opposite the jaw members (12A) of the claimed invention along the shaft members as designated and shown in Figs. 1-3 of the disclosed drawings);
wherein each jaw member comprises a tip means (see Fig. 14 showing distal tips of each jaw including a pair of prongs 70 and 72) for holding and clamping a patient’s skin along edges of a wound (prongs 70 and 72 are fully capable of being utilized for clamping a patient’s skin along an edge of a wound given the identical structural limitations to those of the claimed invention; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114);
wherein the tip means comprises at least two pointed teeth (see Figs. 12 and 14 showing two flanges 88 on each jaw) that are angled inward and downward from the shaft member (see Fig. 12 and 15 showing wherein each flange is angled radially inward and downward when compared to the disclosed drawings (Figs. 2-3) of the claimed invention);
wherein, during use, the surgical clamping device clamps the patient’s skin along the edges of the wound to temporarily close the wound (jaws 214 and 212 are fully capable of being utilized to clamp a patient’s skin along the edges of a wound to temporarily close the wound given the identical structural limitations to those of the claimed invention; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114; as the jaws are configured to clamp and grip and implant head 322 (see Para. [0051]-[0052] and Fig. 15), the jaws are thus seen to be fully capable of gripping and manipulating tissue therebetween); and
wherein, after use, the surgical clamping device is removed, and the previously-clamped skin is in suitable condition for sampling or final wound closure (a user is understood to be capable of utilizing the device of Isch to manipulate the skin at a wound site such that the skin is placed in “suitable condition” for sampling or wound closure; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114; since the device of Isch comprises all of the structural limitations of the claimed invention thus far, the device of Isch is understood to be fully capable of being used in the claimed manner of preparing skin at a wound site).
Regarding claim 2, Isch discloses the invention of claim 1, Isch further discloses wherein, during use, the surgical clamping device is applied beneath pressure bandaging to achieve a desired amount of hemostasis (the device of Isch, comprising all of the claimed structural elements of claim 1, is fully capable of being applied beneath a pressure bandage to achieve a desired amount of hemostasis; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114).
Regarding claim 3, Isch discloses the invention of claim 1, Isch further discloses wherein the surgical clamping device is applied and removed following at least one stage of a multiple-stage Mohs micrographic surgery (the device of Isch, comprising all of the claimed structural elements of claim 1, is fully capable of being applied and removed following at least one stage of a multiple-stage Mohs micrographic surgery; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114).
Regarding claim 4, Isch discloses the invention of claim 1, Isch further discloses wherein the at least two pointed teeth of one of the jaw members are spaced apart from the at least two pointed teeth of the other of the jaw members (see Figs. 12-15).
Regarding claim 8, Isch discloses:
A surgical clamping device (instrument 210, see Fig. 12) comprising:
a pair of shaft members (arms 216 and 218, see Fig. 12), each of which comprises a jaw member extending from a proximal end of the shaft member (jaws 214 and 212, see Fig. 12 – the term “proximal” is understood to refer to the side of the device opposite to the finger grips (16A) of the claimed invention along the shaft members as designated and shown in Figs. 1-3 of the disclosed drawings) and a finger grip extending from an opposing distal end of the shaft member (finger holds 220 and 222, see Fig. 12 – the term “distal” is understood to refer to the side of the device opposite the jaw members (12A) of the claimed invention along the shaft members as designated and shown in Figs. 1-3 of the disclosed drawings);
wherein each jaw member comprises a tip means (see Fig. 14 showing distal tips of each jaw including a pair of prongs 70 and 72) for holding and clamping a patient’s skin along edges of a wound (prongs 70 and 72 are fully capable of being utilized for clamping a patient’s skin along an edge of a wound given the identical structural limitations to those of the claimed invention; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114); and
wherein the surgical clamping device is applied and removed following at least one stage of a multiple-stage Mohs micrographic surgery (the device of Isch, comprising all of the claimed structural elements of claim 8, is fully capable of being applied and removed following at least one stage of a multiple-stage Mohs micrographic surgery; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114); and
wherein, after the surgical clamping device is removed, the previously-clamped skin is in suitable condition for sampling or final wound closure (a user is understood to be capable of utilizing the device of Isch to manipulate the skin at a wound site such that the skin is placed in “suitable condition” for sampling or wound closure; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114; since the device of Isch comprises all of the structural limitations of the claimed invention thus far, the device of Isch is understood to be fully capable of being used in the claimed manner of preparing skin at a wound site).
Regarding claim 9, Isch discloses the invention of claim 8, Isch further discloses wherein, during use, the surgical clamping device is applied beneath pressure bandaging to achieve a desired amount of hemostasis (the device of Isch, comprising all of the claimed structural elements of claim 8, is fully capable of being applied beneath a pressure bandage to achieve a desired amount of hemostasis; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114).
Regarding claim 10, Isch discloses the invention of claim 8, Isch further discloses wherein the tip means comprises at least one pointed tooth (see Figs. 12 and 14 showing wherein each jaw comprises two flanges 88 thereon) that is angled inward and downward from the shaft member (see Fig. 12 and 15 showing wherein each flange is angled radially inward and downward when compared to the disclosed drawings (Figs. 2-3) of the claimed invention).
Regarding claim 11, Isch discloses the invention of claim 10, Isch further discloses wherein the at least one pointed tooth of one of the jaw members is spaced apart from the at least one pointed tooth of the other of the jaw members (see Figs. 12-15).
Regarding claim 13, Isch discloses the invention of claim 8, Isch further discloses wherein the tip means comprises at least two pointed teeth (see Figs. 12 and 14 showing two flanges 88 on each jaw) that are angled inward and downward from the shaft member (see Fig. 12 and 15 showing wherein each flange is angled radially inward and downward when compared to the disclosed drawings (Figs. 2-3) of the claimed invention).
Regarding claim 14, Isch discloses the invention of claim 13, Isch further discloses wherein the at least two pointed teeth of one of the jaw members is spaced apart from the at least two pointed teeth of the other of the jaw members (see Figs. 12-15).
Regarding claim 18, Isch discloses:
A surgical clamping device (instrument 210, see Fig. 12) comprising:
a pair of shaft members (arms 216 and 218, see Fig. 12), each of which comprises a jaw member extending from a proximal end of the shaft member (jaws 214 and 212, see Fig. 12 – the term “proximal” is understood to refer to the side of the device opposite to the finger grips (16A) of the claimed invention along the shaft members as designated and shown in Figs. 1-3 of the disclosed drawings) and a finger grip extending from an opposing distal end of the shaft member (finger holds 220 and 222, see Fig. 12 – the term “distal” is understood to refer to the side of the device opposite the jaw members (12A) of the claimed invention along the shaft members as designated and shown in Figs. 1-3 of the disclosed drawings);
wherein each jaw member comprises a tip means (see Fig. 14 showing distal tips of each jaw including a pair of prongs 70 and 72) for holding and clamping a patient’s skin along edges of a wound (prongs 70 and 72 are fully capable of being utilized for clamping a patient’s skin along an edge of a wound given the identical structural limitations to those of the claimed invention; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114);
wherein the tip means comprises at least two pointed teeth (see Figs. 12 and 14 showing wherein each jaw comprises two flanges 88 thereon) that are angled inward and downward from the shaft member (see Fig. 12 and 15 showing wherein each flange is angled radially inward and downward when compared to the disclosed drawings (Figs. 2-3) of the claimed invention);
wherein, during use, the surgical clamping device is applied beneath pressure bandaging to achieve a desired amount of hemostasis (the device of Isch, comprising all of the claimed structural elements of claim 18, is fully capable of being applied beneath a pressure bandage to achieve a desired amount of hemostasis; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114);
wherein the surgical clamping device is applied and removed following at least one stage of a multiple-stage Mohs micrographic surgery (the device of Isch, comprising all of the claimed structural elements of claim 18, is fully capable of being applied and removed following at least one stage of a multiple-stage Mohs micrographic surgery; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114); and
wherein, after the surgical clamping device is removed, the previously-clamped skin is in suitable condition for sampling or wound closure (a user is understood to be capable of utilizing the device of Isch to manipulate the skin at a wound site such that the skin is placed in “suitable condition” for sampling or wound closure; as these limitations are recited as functional language, the device of Isch merely needs to be capable of being used in the same manner, see MPEP 2114; since the device of Isch comprises all of the structural limitations of the claimed invention thus far, the device of Isch is understood to be fully capable of being used in the claimed manner of preparing skin at a wound site).
Regarding claim 19, Isch discloses the invention of claim 18, Isch further discloses wherein the at least two pointed teeth of one of the jaw members is spaced apart from the at least two pointed teeth of the other of the jaw members (see Figs. 12-15).
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.
Claim(s) 5, 12, 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isch (US 2012/0059407 A1)(previously of record).
Regarding claim 5, Isch discloses all of the limitations of the invention of claim 4.
However, Isch does not expressly disclose wherein a distance between at least one of the at least two pointed teeth of one of the jaw members and at least one of the adjacent at least two pointed teeth of the other of the jaw members is 1-2 cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have caused the pointed teeth of at least one jaw member of Isch et al. to be spaced apart from the pointed teeth of the opposing jaw member by between 1-2cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, since the jaws of Isch are configured to be opened and closed (see Para. [0050]) to grasp an object therebetween, the device of Isch et al. would not operate differently with the claimed distances between the teeth of the two opposing jaw members at least for a point in time during use. Specifically, if the device of Isch is configured to pick up a small object of between 1-2cm in diameter, a user would be fully capable of opening the jaw members relative to one-another a distance of between 1-2cm to grasp said object with a reasonable expectation of success. Further, applicant places no criticality on the range claimed, indicating simply that the distance of separation “may” be within the claimed ranges (see Specification Para. [0014] and [0040]).
Regarding claim 12, Isch discloses all of the limitations of the invention of claim 11.
However, Isch does not expressly disclose wherein a distance between the at least one pointed tooth of one of the jaw members and the at least one pointed tooth of the other of the jaw members is 1-2 cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have caused the pointed teeth of at least one jaw member of Isch et al. to be spaced apart from the pointed teeth of the opposing jaw member by between 1-2cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, since the jaws of Isch are configured to be opened and closed (see Para. [0050]) to grasp an object therebetween, the device of Isch et al. would not operate differently with the claimed distances between the teeth of the two opposing jaw members at least for a point in time during use. Specifically, if the device of Isch is configured to pick up a small object of between 1-2cm in diameter, a user would be fully capable of opening the jaw members relative to one-another a distance of between 1-2cm to grasp said object with a reasonable expectation of success. Further, applicant places no criticality on the range claimed, indicating simply that the distance of separation “may” be within the claimed ranges (see Specification Para. [0014] and [0040]).
Regarding claim 15, Isch discloses all of the limitations of the invention of claim 14.
However, Isch does not expressly disclose wherein a distance between at least one of the at least two pointed teeth of one of the jaw members and at least one of the adjacent at least two pointed teeth of the other of the jaw members is 1-2 cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have caused the pointed teeth of at least one jaw member of Isch et al. to be spaced apart from the pointed teeth of the opposing jaw member by between 1-2cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, since the jaws of Isch are configured to be opened and closed (see Para. [0050]) to grasp an object therebetween, the device of Isch et al. would not operate differently with the claimed distances between the teeth of the two opposing jaw members at least for a point in time during use. Specifically, if the device of Isch is configured to pick up a small object of between 1-2cm in diameter, a user would be fully capable of opening the jaw members relative to one-another a distance of between 1-2cm to grasp said object with a reasonable expectation of success. Further, applicant places no criticality on the range claimed, indicating simply that the distance of separation “may” be within the claimed ranges (see Specification Para. [0014] and [0040]).
Regarding claim 20, Isch discloses all of the limitations of the invention of claim 19.
However, Isch does not expressly disclose wherein a distance between at least one of the at least two pointed teeth of one of the jaw members and at least one of the adjacent at least two pointed teeth of the other of the jaw members is 1-2 cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have caused the pointed teeth of at least one jaw member of Isch et al. to be spaced apart from the pointed teeth of the opposing jaw member by between 1-2cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, since the jaws of Isch are configured to be opened and closed (see Para. [0050]) to grasp an object therebetween, the device of Isch et al. would not operate differently with the claimed distances between the teeth of the two opposing jaw members at least for a point in time during use. Specifically, if the device of Isch is configured to pick up a small object of between 1-2cm in diameter, a user would be fully capable of opening the jaw members relative to one-another a distance of between 1-2cm to grasp said object with a reasonable expectation of success. Further, applicant places no criticality on the range claimed, indicating simply that the distance of separation “may” be within the claimed ranges (see Specification Para. [0014] and [0040]).
Claim(s) 6-7 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isch (US 2012/0059407 A1)(previously of record) in view of Wittenberger (US 2004/0254606 A1)(previously of record).
Regarding claim 6, Isch discloses all of the limitations of the invention of claim 1.
However, Isch does not expressly disclose wherein the surgical clamping device is shaped to substantially contour to a patient’s face.
In the same field of endeavor, namely surgical forceps devices configured to grasp tissue, Wittenberger teaches wherein a surgical forceps (see Fig. 1) comprises a pair of jaws (20 and 22, see Fig. 1), wherein the forceps comprise a shape retaining feature(s) along the jaws and/or the elongate arm members that allow a user to bend either the jaw members or arm members around an organ or tissue structure to allow for an optimal configuration for positioning and or orienting the jaws around a particular anatomy of a patient and the location of the treatment site (see Para. [0055], [0063] and [0075] and Figs. 5-6).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the forceps instrument of Isch to comprise shape retaining features along the jaw members and the elongate arms members thereof as taught and suggested by Wittenberger to, in this case, allow a user to bend either the jaw members or arm members around an organ or tissue structure to allow for an optimal configuration for positioning and or orienting the jaws around a particular anatomy of a patient (i.e., a patient’s face) and the location of the treatment site (see Wittenberger Para. [0055], [0063] and [0075] and Figs. 5-6).
Regarding claim 7, Isch discloses all of the limitations of the invention of claim 1.
However, Isch does not expressly disclose wherein the surgical clamping device is shaped to substantially contour to a patient’s head.
In the same field of endeavor, namely surgical forceps devices configured to grasp tissue, Wittenberger teaches wherein a surgical forceps (see Fig. 1) comprises a pair of jaws (20 and 22, see Fig. 1), wherein the forceps comprise a shape retaining feature(s) along the jaws and/or the elongate arm members that allow a user to bend either the jaw members or arm members around an organ or tissue structure to allow for an optimal configuration for positioning and or orienting the jaws around a particular anatomy of a patient and the location of the treatment site (see Para. [0055], [0063] and [0075] and Figs. 5-6).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the forceps instrument of Isch to comprise shape retaining features along the jaw members and the elongate arms members thereof as taught and suggested by Wittenberger to, in this case, allow a user to bend either the jaw members or arm members around an organ or tissue structure to allow for an optimal configuration for positioning and or orienting the jaws around a particular anatomy of a patient (i.e., a patient’s head) and the location of the treatment site (see Wittenberger Para. [0055], [0063] and [0075] and Figs. 5-6).
Regarding claim 16, Isch discloses all of the limitations of the invention of claim 8.
However, Isch does not expressly disclose wherein the surgical clamping device is shaped to substantially contour to a patient’s face.
In the same field of endeavor, namely surgical forceps devices configured to grasp tissue, Wittenberger teaches wherein a surgical forceps (see Fig. 1) comprises a pair of jaws (20 and 22, see Fig. 1), wherein the forceps comprise a shape retaining feature(s) along the jaws and/or the elongate arm members that allow a user to bend either the jaw members or arm members around an organ or tissue structure to allow for an optimal configuration for positioning and or orienting the jaws around a particular anatomy of a patient and the location of the treatment site (see Para. [0055], [0063] and [0075] and Figs. 5-6).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the forceps instrument of Isch to comprise shape retaining features along the jaw members and the elongate arms members thereof as taught and suggested by Wittenberger to, in this case, allow a user to bend either the jaw members or arm members around an organ or tissue structure to allow for an optimal configuration for positioning and or orienting the jaws around a particular anatomy of a patient (i.e., a patient’s face) and the location of the treatment site (see Wittenberger Para. [0055], [0063] and [0075] and Figs. 5-6).
Regarding claim 17, Isch discloses all of the limitations of the invention of claim 8.
However, Isch does not expressly disclose wherein the surgical clamping device is shaped to substantially contour to a patient’s head.
In the same field of endeavor, namely surgical forceps devices configured to grasp tissue, Wittenberger teaches wherein a surgical forceps (see Fig. 1) comprises a pair of jaws (20 and 22, see Fig. 1), wherein the forceps comprise a shape retaining feature(s) along the jaws and/or the elongate arm members that allow a user to bend either the jaw members or arm members around an organ or tissue structure to allow for an optimal configuration for positioning and or orienting the jaws around a particular anatomy of a patient and the location of the treatment site (see Para. [0055], [0063] and [0075] and Figs. 5-6).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the forceps instrument of Isch to comprise shape retaining features along the jaw members and the elongate arms members thereof as taught and suggested by Wittenberger to, in this case, allow a user to bend either the jaw members or arm members around an organ or tissue structure to allow for an optimal configuration for positioning and or orienting the jaws around a particular anatomy of a patient (i.e., a patient’s head) and the location of the treatment site (see Wittenberger Para. [0055], [0063] and [0075] and Figs. 5-6).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 9216029 B1 to Hahn, US 11324492 B2 to Constantini, US 9375226 B2 to Li, US 10390856 B2 to Journey and US 8425520 B2 to Zalenski all disclose surgical tissue grasping devices configured to be placed over or grasp tissue across a wound having a shape contoured to the desired surgical site in addition to having at least two prongs on each jaw.
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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771