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 .
Claim Objections
Claim 110 is objected to because of the following informalities: In line 1 of claim 110, “on” should be changed to “one”. Appropriate correction is required.
Drawings
FIGs 3A-3B and 41A-41E are objected to because the use of shading in the drawings fails to aid in understanding of the invention and it reduces legibility. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. See 37 CFR 1.84 (m) and (I).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 7-12, 14, 15, 17, 21, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mensch et al. (US 2016/0296274).
Regarding claim 1, Mensch et al. discloses a device for excising tissue (10, FIG 1), comprising: a body (52a,b, FIG 2); a first curved member coupled to the body (42a, 42b, and 46) and comprising a first tissue contact surface (Surface of teeth 46, shown best in FIG 5), the first tissue contact surface comprising a first radius of curvature (Curvature the pocket formed between 50 and 48); a second curved member (54a, 54b, 62) movable relative to the first curved member (when moved between open position 30 and gripped position 32, [0084]) and comprising a second tissue contact surface (Surface of teeth 62, best shown in FIG 5) comprising a second, smaller ROC (curvature of the tooth/projection formed between 66 and 64; the radius of curvature is shown to be smaller to create gap 80, FIG 5, [0084]); an actuator coupled to the body and configured to decrease a distance between the first and second curved members (“controls on the hand piece to move and/or actuate the gripping assembly” [0051] such as controls 28 and 34, FIG 1. [0033-0034, 0073, 0076]); and a cutting assembly (26) configured to excise the tissue ([0040, 0047, 0073, 0076]).
Regarding claim 4, Mensch et al. discloses when the first and second curved members are in a closed configuration (Gripping position 32, FIG 5), a gap (80/81) is formed between both of a first end and a second end of each of the first and second tissue contact surfaces ([0084-0085]); the first end of the first and second contact surfaces is interpreted as the proximal end of 42a/54a and the second end of the first and second contact surfaces is interpreted as the proximal end of 42b/54b. Between these two ends, gaps 80 and 81 exist).
Regarding claim 7, Mensch et al. discloses the second curved member further comprises a tissue support surface adjacent to the second tissue contact surface (The vertical wall that extends perpendicular to the second tissue contact surface and forms the jaw 40, FIG 2 and 5).
Regarding claim 8, Mensch et al. discloses the tissue support surface is raised relative to the second tissue contact surface along a longitudinal axis of the device (having a dimension in the perpendicular direction to the surface is interpreted as being raised relative to).
Regarding claim 9, Mensch et al. discloses the tissue support surface and the second tissue contact surface form a slot (channel 58, FIG 2, [0075]) therebetween, and wherein the slot is configured to receive a portion of a cutting element (27) of the cutting assembly therein during excision of the tissue (FIG 2, [0076]).
Regarding claim 10, Mensch et al. discloses the first curved member is fixed to the body (FIG 2 shows the continuous integral formation of 42a,b with 52a,b).
Regarding claim 11, Mensch et al. discloses the first curved member is integrally formed with the body (FIG 2 shows the continuous integral formation of 42a,b with 52a,b).
Regarding claim 12, Mensch et al. discloses the first and second tissue contact surfaces face one another (FIG 2 and 5).
Regarding claim 14, Mensch et al. discloses the actuator comprises a lever (Controller 28 and 34 are shown as levers).
Regarding claim 15, Mensch et al. discloses the cutting assembly is coupled to and moveable along the first curved member (Blade 37 slides within slot 44 of the first curved member, [0076]).
Regarding claim 17, Mensch et al. discloses the cutting assembly comprises a housing comprising a handle (12) and a cutting element (27) coupled to the housing ([0073] discloses 26, which includes blade 27, is coupled to body 12).
Regarding claim 21, Mensch et al. discloses the device is configured to be used on an upper eyelid, a lower eyelid, an eyeball, an eyebrow, a cheek, a jaw, an underarm, or a neck of a patient ([0029] the instrument is used to grip tissue in a medical procedure therefore it is at least configured to be used on an upper eyelid of a patient).
Regarding claim 22, Mensch et al. discloses the device is configured to be used on only an upper right eyelid or only an upper left eyelid of the patient ([0029] the instrument is used to grip tissue in a medical procedure therefore it is at least configured to be used on an upper eyelid of a patient. To be used “only” on an upper eyelid is an intended use of the device, which the device of Mensch is capable for example in a single procedure).
Regarding claim 24, Mensch et al. discloses the tissue comprises a lesion on the patient ([0029] the instrument is used to grip tissue in a medical procedure therefore it is at least configured to be used on a tissue lesion of a patient).
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) 1-3, 5, 6, 10-12, 14, 17-19, 21, 22, 24 and 111 are rejected under 35 U.S.C. 103 as being unpatentable over Buehler (US 2023/0346375) in view of Mensch et al. (US 2016/0296274).
Regarding claim 1, Buehler et al. discloses a device for excising tissue (300, FIG 8A-8B, [0073]), comprising: a body (Proximal projections on the left and right side of 302, FIG 8A); a first curved member coupled to the body (Curved jaw 302) and comprising a first tissue contact surface (306, [0075]), the first tissue contact surface comprising a first radius of curvature (see curvature in FIGs 8A-8B); a second curved member (Curved jaw 304) movable relative to the first curved member (when moved between open position FIG 8A and gripped position FIG 8B) and comprising a second tissue contact surface (308, [0075]) comprising a second ROC (cee curvature in FIGs 8A-8B); an actuator (lever 320) coupled to the body and configured to decrease a distance between the first and second curved members ([0077-0078]); and a cutting assembly configured to excise the tissue ([0078] “a device can include or be configured to operate in association with a cutting attachment, and the cutting attachment can include an actuating mechanism to cut the clamped eyelid skin tissue”).
Buehler et al. is silent regarding the second ROC being smaller than the first ROC.
However, Mensch et al. teaches in the same filed of endeavor a device for excising tissue (10, FIG 1) comprising a first curved member (42a, 42b, and 46) having a first tissue contact surface (Surface of teeth 46, shown best in FIG 5) comprising a first radius of curvature (Curvature the pocket formed between 50 and 48) and a second curved member (54a, 54b, 62) movable relative to the first curved member (when moved between open position 30 and gripped position 32, [0084]) and comprising a second tissue contact surface (Surface of teeth 62, best shown in FIG 5) having a second, smaller ROC (curvature of the tooth/projection formed between 66 and 64; the radius of curvature is shown to be smaller to create gap 80, FIG 5, [0084]), wherein the purpose of the mismatched ROC is such that tissue can be gripped therebetween in a manner that leaves a gap to reduce damage or tearing to the clamped tissue ([0071]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the second ROC of Buehler et al. to be smaller than the first ROC, as taught by Mensch et al., for the purpose of creating a slight gap between the tissue contact surfaces such that the tissue being clamped therebetween is sufficiently gripped for the purpose of the procedure but is not damaged once released by the device (Mensch [0071]).
Regarding claim 2, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 1.
The device as modified is silent regarding the first ROC is about 30 mm to about 40 mm and the second ROC is about 25 mm to about 35 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device to have a first ROC of about 30 mm to about 40 mm and a second ROC of about 25 mm to about 35 mm 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, the device would not operate differently with the claimed ROC and since the curvature should be sufficient wide to clamp an eyelid, the device would function appropriately having the claimed radiuses. Further, applicant places no criticality on the range claimed, indicating simply that the ROC “may” be within the claimed ranges (specification [0006]).
Regarding claim 3, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 1.
The device as modified is silent regarding the first ROC is about 1 to about 1.5 times greater than the second ROC.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device to have a first ROC of about 1 to about 1.5 times greater than the second ROC 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, the device would not operate differently with the claimed ratio of ROC and since the curvature should be sufficiently offset to create a gap for receiving the tissue, the device would function appropriately having the claimed radiuses. Further, applicant places no criticality on the range claimed, indicating simply that the ROC ratios “may” be within the claimed ranges (specification [0006]).
Regarding claim 5 and 6, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 1. Buehler further discloses the second curved member further comprises a first projection coupled to a first end of the second curved member and a second projection coupled to a second, opposite end of the second curved member (See FIG 8A wherein the left and right ends of 304 each comprise a projection that seats within a sliding track of 302) and the first curved member comprises a first channel at least partially surrounding first projection (Downwardly extending track on the left side of 302) and a second channel at least partially surrounding the second projection (Downwardly extending track on the right side of 302), and wherein the first and second projections are configured to be translated vertically within the first and second channels, respectively, in response to actuation of the actuator (See translation in FIGs 8A-8B).
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Regarding claim 10, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 1. Buehler further discloses the first curved member is fixed to the body (FIG 8A shows the continuous integral formation).
Regarding claim 11, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 10. Buehler further discloses the first curved member is integrally formed with the body (FIG 8A shows the continuous integral formation).
Regarding claim 12, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 1. Buehler further discloses the first and second tissue contact surfaces face one another (FIG 8A-8B).
Regarding claim 14, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 1. Buehler further discloses the actuator comprises a lever (320 is shown as a lever).
Regarding claims 17-19, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 1.
Buehler is silent regarding the cutting assembly comprising a housing comprising a handle and a cutting element coupled to the housing, a cutting assembly lock coupled to one or both of the first and second curved members, wherein the cutting assembly lock is configured to prevent movement of the cutting element after the cutting assembly is moved from a first position to a second position along the first curved member and wherein the first position is an initial position of the cutting assembly prior to tissue excision and the second position is a final position of the cutting assembly after tissue excision.
However, Buehler teaches in the alternative embodiment of FIG 1 and 6, a device having a first curved member (102), a second curved member (104) and a cutting assembly (140, FIGs 6A-6F, [0066]), the cutting assembly comprising a housing comprising a handle (Exposed top portion of 140, FIG 6A, 6C, 6E) and a cutting element (Blade 142) coupled to the housing, a cutting assembly lock (The closed left and right ends of the slot formed in 102, best shown in FIG 6C) coupled to one or both of the first and second curved members (Coupled to at least the first curved member), wherein the cutting assembly lock is configured to prevent movement of the cutting element after the cutting assembly is moved from a first position (FIG 6A/6B) to a second position (FIG 6E/6F) along the first curved member (The mechanical strut which limits further sliding of the blade along the slot is configured to prevent movement past the second position) and wherein the first position is an initial position of the cutting assembly prior to tissue excision (FIG 6A, where tissue is gripped but not yet excised) and the second position is a final position of the cutting assembly after tissue excision (FIG 6E, after the blade has been passed across the clamped tissue, [0066]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the embodiment of FIG 8 to include the slot in the first curved member which retains the cutting assembly, as taught by the alternative embodiment of FIG 6, for the purpose of configuring the present embodiment to excise the gripped tissue while providing stop limits on either end of the curved member to define the first and second position of the blade, thereby controlling the length of tissue which is to be severed.
Regarding claim 21, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 1. Buehler further discloses the device is configured to be used on an upper eyelid, a lower eyelid, an eyeball, an eyebrow, a cheek, a jaw, an underarm, or a neck of a patient ([0078] discloses use on an eyelid of a patient).
Regarding claim 22, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 21. Buehler further discloses the device is configured to be used on only an upper right eyelid or only an upper left eyelid of the patient ([0078] discloses use on an eyelid of a patient. To be used “only” on an upper eyelid is an intended use of the device, which the device of Mensch is capable for example in a single procedure).
Regarding claim 24, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 1. Buehler further discloses the tissue comprises a lesion on the patient ([0078] the instrument is used to grip tissue in a medical procedure therefore it is at least configured to be used on a tissue lesion of a patient).
Regarding claim 111, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 1. Buehler further discloses the first curved member comprises one or more markings configured to aid in alignment of the device with the tissue (The serrations of the teeth on surface 306 are interpreted as markings which aid in alignment with the tissue by indicating to the user where to insert the tissue to be clamped).
Claim(s) 110 is rejected under 35 U.S.C. 103 as being unpatentable over Buehler (US 2023/0346375) in view of Mensch et al. (US 2016/0296274), further in view of Gutwein et al. (US 2017/0105710).
Regarding claim 110, Buehler/Mensch discloses the invention substantially as claimed, as set forth above for claim 1.
Buehler is silent regarding the on or both of the first or second curved members is transparent.
However, Gutwein teaches a device (300, FIG 3) for excising tissue using a cutting assembly (blade 314, [0027-0031]) wherein a body of the device (310) is transparent ([0030]) to enable the clinician or technician to view the skin and/or the skin lesion when the fixture 300 is positioned on the skin and/or as the fixture 300 is being placed (e.g., lowered) onto the skin.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify one or both of the first or second curved members to be transparent, as taught by Gutwein, for the purpose of enabling the user to better visualize the tissue being positioned against the contact surface to ensure proper positioning of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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