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 Amendment
This Office action is responsive to the amendment filed 01/02/2026. Claims 1, 7-9, 12, 20 and 29 have been amended. Claims 33-34 have been newly added. Claims 1-2, 6-10, 12-13, 15-16, 20-21, 23-25, 29, 31 and 33-34 are currently pending in the application with claims 20-21, 23-25, 29 and 31 being withdrawn from further consideration.
Response to Arguments
Applicant’s arguments, see pg. 6-7, filed 01/02/2026, with respect to the rejections of claims 1 and 6 under 35 U.S.C. 102(a)(1) as being anticipated by Bell et al. (US 2007/0225734), have been fully considered but they are not persuasive.
Applicant argues that Bell fails to teach “positioning a size reduction apparatus having an integrated cutting device around the base portion of the inverted appendix” and “separating the inverted appendix from the cecum at the base portion of the inverted appendix adjacent to the one or more closure devices with the integrated cutting device” as recited by amended claim 1.
The Examiner disagrees. It is the Examiner’s position that cautery snare 70 of Bell can be considered a size reduction apparatus having an integrated cutting device since it functions to both reduce the size of the appendix and resect tissue when it is tightened around the tissue and energized (see Bell [0063]). The rejections are maintained.
Applicant makes similar arguments, see pg. 8-9, with respect to the rejections of claims 7-9 under 35 U.S.C. 103 as being unpatentable over Bell in view of Kappel et al. (US 2012/0172662). Therefore, the Examiner’s arguments with respect to claim 1 also apply to claims 7-9.
Applicant’s arguments, see pg. 7, with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Gasche et al. (US 2008/0262514), have been fully considered but they are not persuasive.
Applicant argues that Gasche fails to teach “positioning a size reduction apparatus having an integrated cutting device around the base portion of the inverted appendix” and “separating the inverted appendix from the cecum at the base portion of the inverted appendix adjacent to the one or more closure devices with the integrated cutting device” as recited by amended claim 1.
The Examiner disagrees. It is the Examiner’s position that tissue heating device 102 of Gasche, which includes arms 104, 106 can be considered a size reduction apparatus having an integrated cutting devices since the arms function to both reduce the size of the tissue and cut tissue when the arms clamp tissue and are energized (see Gasche [0063]-[0064]). The rejections are maintained.
Applicant makes similar arguments, see pg. 9, with respect to the rejection of claim 10 under 35 U.S.C. 103 as being unpatentable over Gasche. Therefore, the Examiner’s arguments with respect to claim 1 also apply to claim 10.
Applicant’s arguments with respect to the rejections of claims 1, 2, 12, 13, 15-16 and 18 under 35 U.S.C. 103 as being unpatentable over Hawkins in view of Gasche have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15-16 and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 15 recites the limitation “wherein the size reduction apparatus comprises articulating arms” which in combination with “a size reduction apparatus having an integrated cutting device” recited in claim 1 is considered new matter since the claimed arrangement of the size reduction apparatus was not disclosed in the application as originally filed.
There is support for the size reduction apparatus comprising articulating arms (see Specification [0030] which states “[i]n some examples, the size reduction apparatus may comprise articulating arms”). There is also support for the size reduction having an integrated cutting device (see Specification [0030] which states “[i]n some embodiments, the size reduction apparatus may comprise a cutting device”). However, these features were not disclosed as part of a single embodiment and seem to be disclosed as alternatives. The embodiment of the size reduction apparatus having articulating arms is not disclosed as being capable of cutting tissue and none of the devices disclosed as “cutting devices” by Applicant include articulating arms (see [0041] and Fig. 12-14).
Claim 16 recites the limitation “the size reduction apparatus further comprises a metallic or polymeric mesh” which in combination with “a size reduction apparatus having an integrated cutting device” recited in claim 1 is considered new matter since the claimed arrangement of the size reduction apparatus was not disclosed in the application as originally filed.
There is support for the size reduction apparatus comprising a metallic or polymeric mesh (see Specification [0030], [0037], [0038] and Fig. 7-8). There is also support for the size reduction having an integrated cutting device (see Specification [0030] which states “[i]n some embodiments, the size reduction apparatus may comprise a cutting device”). However, these features were not disclosed as part of a single embodiment and seem to be disclosed as alternatives. The embodiments of the size reduction apparatus comprising a metallic or polymeric mesh are not disclosed as being capable of cutting tissue (see [0030]) and none of the devices disclosed as “cutting devices” by Applicant are made of a metallic or polymeric mesh (see [0041] and Fig. 12-14).
Claim 33 recites the limitation “wherein size reduction is achieved by…chemical degradation” which in combination with “a size reduction apparatus having an integrated cutting device” recited in claim 1 is considered new matter since the claimed arrangement of the size reduction apparatus was not disclosed in the application as originally filed.
There is support for size reduction being achieved by chemical degradation (see Specification [0030] which states “[t]he size of the separated appendix may be reduced by cutting, crushing, chemical degradation” and “the size reduction apparatus may comprise degradation chemicals, such as an acid or a base”). There is also support for the size reduction having an integrated cutting device (see Specification [0030] which states “[i]n some embodiments, the size reduction apparatus may comprise a cutting device”). However, these features were not disclosed as part of a single embodiment. The embodiment of the method including size reduction occurring by chemical degradation does not include the size reduction apparatus also being capable of cutting tissue (see [0030]) and none of the devices disclosed as “cutting devices” by Applicant comprise degradation chemicals (see [0041] and Fig. 12-14).
Appropriate action is required.
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.
Claims 1, 6, 12 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bell et al. (US 2007/0225734).
Regarding claim 1, Bell discloses a method for minimally-invasive appendectomy (see Fig. 11-15) comprising: inserting an inverter apparatus (46) into an interior cavity of the appendix (12) of a subject; engaging the inverter apparatus with an interior wall of the appendix (see Fig. 11); inverting the appendix by pulling the inverter apparatus into the cecum until the appendix is substantially inverted (see Fig. 12 and [0049]); positioning one or more closure devices (54) around a base portion of the inverted appendix; closing the base portion of the inverted appendix with the one or more closure devices (see Fig. 13); positioning a size reduction apparatus having an integrated cutting device (cautery snare 70 is considered a size reduction apparatus having an integrated cutting device since it functions to both reduce the size of the appendix and resect tissue, see [0063]) around the base portion of the inverted appendix (see Fig. 14); separating the inverted appendix from the cecum at the base portion of the inverted appendix adjacent to the one or more closure devices with the integrated cutting device (see [0063]); and removing the separated appendix from the subject (see Fig. 15 and [0063]).
Regarding claim 6, Bell discloses the method of claim 1, wherein the base of the inverted appendix is substantially aligned with an outer wall of the cecum (after inversion the appendix would be substantially aligned with an outer wall of the cecum, see Fig. 12).
Regarding claim 12, Bell discloses the method of claim 1, further comprising: prior to removing the inverted appendix from the subject, engaging the size reduction apparatus to reduce the size of the appendix to facilitate removal of the inverted appendix from the subject (prior to removal of the appendix, cautery snare 70 is tightened around the appendix which reduces the size of the appendix and then it is energized to transect the appendix which can also be considered a reduction in size, see [0063]).
Regarding claim 33, Bell discloses the method of claim 12, wherein size reduction is achieved by cutting, crushing, compression, or chemical degradation (in the method of Bell, size reduction is achieved by tightening a cautery snare around the appendix and then using it to transect tissue which can together be considered cutting, crushing and compression, see [0063]).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gasche et al. (US 2008/0262514).
Regarding claim 1, Gasche discloses a method for minimally-invasive appendectomy (see [0054] and Fig. 10 and 28-30) comprising: inserting an inverter apparatus (56) into an interior cavity of the appendix of a subject; engaging the inverter apparatus with an interior wall of the appendix (while [0053] of Gasche refers to the diverticulum, it is understood from [0054] that the method can be used in the appendix instead); inverting the appendix by pulling the inverter apparatus into the cecum until the appendix is substantially inverted (the diverticulum is inverted into the colon which translates to the appendix being inverted into the cecum, see [0061]); positioning one or more closure devices (ligating loop 34, see Fig. 29) around a base portion of the inverted appendix; closing the base portion of the inverted appendix with the one or more closure devices (cinch tube 100 closes the base of the inverted tissue, see Fig. 30 and [0061]); positioning a size reduction apparatus having an integrated cutting device (tissue heating device 102 including arms 104, 106 is considered a size reduction apparatus having an integrated cutting devices since the arms function to both reduce the size of the tissue and cut tissue, see [0063]) around the base portion of the inverted appendix (see Fig. 29); separating the inverted appendix from the cecum at the base portion of the inverted appendix adjacent to the one or more closure devices with the integrated cutting device (the tissue is cut by electrocautery [0064]); and removing the separated appendix from the subject (the tissue is removed from the body, see [0008]).
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.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Bell in view of Kappel et al. (US 2012/0172662).
Regarding claim 7, Bell discloses the method of claim 1, but fails to expressly teach wherein the integrated cutting device comprises a metal wire.
However, it is noted that the integrated cutting device of Bell is a cautery snare (70, see Fig. 14) and cautery snares comprised of metal wires are known in the art.
Kappel, in the same field of art, teaches a cautery snare (1, see Fig. 1) comprised of a metal wire (14, see [0032]).
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 integrated cutting device (i.e., cautery snare) of Bell so that it is comprised of a metal wire in view of the teaches of Kappel since the selection of a material based on its suitability for its intended use involves only routine skill to yield predictable results. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). See MPEP 2144.07.
Regarding claim 8, Bell discloses the method of claim 1, but fails to expressly teach wherein the integrated cutting device uses electromagnetic radiation at frequencies between 350-500 kHz.
However, it is noted that the integrated cutting device of Bell is a cautery snare (70, see Fig. 14) and cautery snares that use electromagnetic radiation frequencies are known in the art.
Kappel teaches a cautery snare (1, Fig. 1) that uses electromagnetic radiation at a frequency between 100kHz to 5MHz (see [0046]) for resecting tissue.
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 integrated cutting device of Bell to use electromagnetic radiation frequencies as taught by Kappel since doing so would make the device suitable for its intended purpose (i.e., tissue resection).
The combination of Bell and Kappel fails to expressly teach the frequency being between 350-500 kHz.
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 integrated cutting device of Bell and Kappel so that it uses electromagnetic radiation frequencies between 350-500 kHz as Applicant appears to have placed no criticality on the claimed range (see Specification pp. [0028] indicating the frequency “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 9, Bell discloses the method of claim 1, but fails to expressly teach wherein the integrated cutting device uses electromagnetic radiation at wavelengths between 800-1500 nm.
However, it is noted that the integrated cutting device of Bell is a cautery snare (70, see Fig. 14) and cautery snares that use electromagnetic radiation frequencies are known in the art.
Kappel teaches a cautery snare (50, Fig. 1) that uses electromagnetic radiation frequencies (see [0046]) for resecting tissue.
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 integrated cutting device of Bell to use electromagnetic radiation frequencies, as taught by Kappel, since doing so would make the device suitable for its intended purpose (i.e., tissue resection).
The combination of Bell and Kappel fails to expressly teach the wavelength being between 800-1500 nm.
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 separation apparatus of Bell and Kappel to have a wavelength between 800-1500 nm as a matter of obvious design choice since Applicant has not disclosed that using electromagnetic radiation at wavelengths between 800-1500 nm provides an advantage, is used for a particular purpose, or solves a stated problem (see specification [0028] indicating simply that the wavelength may be within this range). Further, since the integrated cutting device of Bell and Kappel is intended to work through a range of electromagnetic radiation frequencies, and therefore wavelengths, one of ordinary skill in the art would have expected the integrated cutting device of Bell and Kappel to work equally well with the claimed wavelengths.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gasche.
Regarding claim 10, Gasche discloses method of claim 1, but fails to expressly teach wherein the separated appendix remains engaged by the inverter apparatus.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to keep the inverter apparatus engaged with the appendix through the separation step and after as a matter of being obvious to try - 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, 1395-97 (2007)), to obtain the predictable result of separating the tissue and removing it from the body since the only two choices are 1) hold the tissue while it is cut, or 2) not to hold the tissue while it is cut. These are the only two options apparent to one of ordinary skill in the art, with there being no undue experimentation and there being a reasonable expectation of success at arriving at the tissue being separated and removed from the body.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bell.
Regarding claim 13, Bell discloses the method of claim 12, but fails to expressly teach wherein a cross-section of the inverted appendix is reduced to a width of 24 French or less.
It is noted that causing the size reduction apparatus to have a width of 24 French or less would cause the tissue to be reduced to this size. Bell is silent about the width of the cautery snare (i.e., size reduction apparatus).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Bell so that a the width of the size reduction apparatus is 24 French or less 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 method and device of Bell would not operate differently with the claimed width and would function appropriately having the claimed width. Further, applicant places no criticality on the range claimed, indicating simply that the width “may” be within the claimed range (specification pp. [0030]).
Claims 2, 15 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Bell in view of Gasche.
Regarding claim 2, Bell discloses the method of claim 1, but fails to teach wherein the inverter apparatus comprises a plurality of arms.
Gasche, in the same field of art, teaches a related method for tissue removal (see [0053]-[0054]) where a mechanical grasper (56, Fig. 10) having a plurality of arms is used inverting tissue. Gasche additionally teaches the inverter apparatus is inserted into a cavity to engage an interior wall of the cavity for inverting the tissue (see [0053] and Fig. 28-29).
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 of Bell by substituting the inverter apparatus of Bell with the inverter apparatus taught by Gasche since doing so would have yielded only predictable results, namely, the inverter apparatus of Gasche in the method of Bell would have inverted tissue of the appendix. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claims 15 and 34, Bell discloses the methods of claims 12 and 1, but fails to teach wherein the size reduction apparatus comprises articulating arms and wherein the integrated cutting device comprises ultrasonic vibration.
Gasche, in the same field of art teaches a related method for tissue removal (see see Fig. 28-30) where a tissue heating device 102 having comprising a pair of articulating arms 104 and 106 is used to reduce the size of inverted tissue by placing the arms around tissue to clamp the tissue and then energizing the arms to resect tissue (see [0063]-[0064]).
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 of Bell by substituting the size reduction apparatus of Bell with the size reduction apparatus taught by Gasche since doing so would have yielded only predictable results, namely, the size reduction apparatus of Gasche in the method of Bell would have the reduced the size of and cut tissue. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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