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 .
This action is in response to applicant amendment received on 10/07/2025;
Amendments of Claims 1, 4, 5, 7, 8 and 11 are acknowledged.
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 to 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.
Regarding Claim 1:
The Claim reads “wherein said distal anvil tip of said anvil is supported at a first location on said cartridge jaw when said end effector is in said clamped configuration and said first staple cartridge is positioned in said cartridge jaw, wherein said distal anvil tip of said anvil is supported at a second location on said cartridge jaw when said end effector is in said clamped configuration and said second staple cartridge is positioned in said cartridge jaw”. The Claim is unclear since on Figures 85, 86 and 102 to 106 the distal anvil tip is never directly supported at a location on the cartridge jaw. Figures 102 to 106 show the distal anvil tip of several unfired surgical staplers, in a closed configuration but not clamping any tissue, being supported by a first seal door 27052 of a floating seal assembly 27050 that is part of a trocar seal system 27040 that is not mentioned in the claim.
For prosecution it will be considered that the anvil seal tip is indirectly supported by the cartridge jaw.
Also, the Claim reads “a first proximal end, wherein said first proximal end is aligned with the proximal end of said cartridge jaw” and “a second proximal end, wherein said second proximal end is aligned with said proximal end of said cartridge jaw”. This is confusing since that limitation does not seem to be supported in the specification or Figures, in particular Figure 15 shows the proximal end of the cartridge 1700 distanced from the distal end proximal end portion 1610 of the elongate channel 1602.
For prosecution it will be considered that the first and second proximal ends are placed at the proximal end of the corresponding cartridge jaw.
Regarding Claim 8:
The claim is dependent of Claim 7 and reads “said second vertical distance is shorter than said first vertical distance”; that contradicts claim 7 that reads “said second vertical distance is taller than said first vertical distance”. For prosecution it will be considered that it actually dependent of Claims 1 or Claim 2.
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 1 to 10 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid US 20130075448).
Regarding Claims 1 to 4, 7 and 9:
Schmid discloses a staple cartridge system, comprising: an end effector configurable in an unclamped configuration and a clamped configuration, comprising: an anvil jaw including a distal anvil tip; and a cartridge jaw configured to receive staple cartridges of differing lengths, wherein said cartridge jaw comprises a proximal end, a distal end, and a bottom surface spanning between the proximal end and the distal end and configured to support the staple cartridge (Paragraph 0691, Figures 271, 272 shows the end effector of a staple applying assembly, comprising anvil jaw 10760 including a distal anvil tip not numbered, rotatably coupled to channel 10770, considered the cartridge jaw receiving a cartridge 10700 on a not numbered bottom surface spanning between the proximal end and the distal end, not numbered, cartridge 10700 has a support portion 10710 also supports a nose sock 10703 that has a cavity 10706 to receive at least a portion of the support portion 10710 and includes a tissue thickness compensator 10720 over the deck of support portion 10710, cartridge 10700 including nose sock 10703 and tissue thickness compensator 10720 will be considered the first staple cartridge), the first staple cartridge comprising:
a first deck configured to support the tissue of a patient; first staple cavities defined in said first deck; first staples removably stored in said first staple cavities (Paragraph 650, Figures 204 to 210 describe a typical staple cartridge 9020 with cavities 9024 on the not numbered deck for staples 9023); a first proximal end, wherein said first proximal end is aligned with the proximal end of said cartridge jaw when said first staple cartridge is positioned in said cartridge jaw; and a first distal end, wherein a first cartridge length is defined between said first proximal end and said first distal end (Figure 271 shows the first staple cartridge having a proximal end where cartridge 10700 is inserted at the proximal end of channel 10770 and a distal end 10702, the first cartridge length will comprise the length of cartridge 10700 plus the added length of the nose 10703);
the distal anvil tip of said anvil is supported at a first location on said cartridge jaw when said end effector is in said clamped configuration and said first staple cartridge is positioned in said cartridge jaw, wherein said first location is a first vertical distance away from said bottom surface of said cartridge jaw when said first staple cartridge is positioned in said cartridge jaw (Figure 271, the clamped configuration will be considered the anvil placed over tissue compensator 1720, the first vertical distance would be the thickness of the cartridge plus the thickness of the tissue compensator and tissue).
Schmid also discloses embodiments where similar staple cartridges are received without the use of the nose sock 10703 and tissue thickness compensator 10720 that are placed on similar end effectors, such as the one described on Paragraph 650, Figures 204 to 210; on that embodiment cartridge length will comprise just the length of cartridge, that will be considered the second cartridge length, while the vertical distance would be basically the thickness of the cartridge and tissue, and will be considered a second vertical distance.
Therefore, it would be obvious to combine both embodiments and place the staple cartridge 10700 of the embodiment of Figures 271 and 272 on channel 10770 considered a first staple cartridge with a first cartridge length and a first vertical distance and also the same staple cartridge 10700 without the nose sock 10703 and tissue thickness compensator 10720, that will be considered a second stapler cartridge with a second cartridge length and a second vertical distance; lacking the additional length of the nose, the second cartridge length would be shorter than the first; and, for the same tissue thickness and lacking the tissue thickness compensator, the second vertical distance would be also shorter than the first, and having the tip of the anvil supported at different first and second locations in reference to the bottom surface of the cartridge jaw from where the vertical distances are being measured, making also the distance from the second location closer from the distal end of the cartridge jaw, since the use of cartridges without nose sock and thickness compensators is a very common practice in the art.
Regarding Claims 5, 6, 8 and 10:
Alternatively, if the rejection of Claim 1, is made considering that the cartridge of the embodiment Figures 271, 272 is the second cartridge and the cartridges of the embodiment on Figures 204 to 210 is the first cartridge will result on the second vertical distance being taller than said first vertical distance; the second cartridge length being longer than said first cartridge length and the distance from the second location being further from the distal end of the cartridge jaw.
Claims 11 to 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid US 20130075448) as applied to claim 2 above, in view of Scirica (US 2005/0216055).
Regarding Claim 11:
As discussed for Claim 2 above, Schmid discloses the invention as claimed.
Schmid does not disclose that the anvil jaw comprises a distal anvil tip, wherein said first cartridge length is set such that said distal anvil tip extends beyond said first distal end, and wherein said second cartridge length is set such that said distal anvil tip does not extend beyond said second distal end.
Scirica teaches using a dissecting tip, attached to the end of the anvil jaw for accessing and/or separating tissue before the stapling operation instead of using a separate tool. The tip can be made to extends beyond said first distal end (Figure 7 and 7a, tip 214) or for the tip not to extend beyond the distal end (Figures 8 and 8a, tip 314). Note that if the cartridge of Huang is used on the embodiment of Figure 8 or 9 of Scirica the tip would most likely extend beyond the distal end of the cartridge, also (paragraph 0086) Distal tip 314d of dissecting tip 314 is preferably positioned proximally of the distal end of cartridge assembly 36. Alternately, distal tip 314d may be positioned adjacent to or distally of the distal end of cartridge assembly 36.
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the Schmid the teachings of Scirica and add a dissecting tip as claimed at the distal end of the anvil and select the length of the cartridge and position of the tip to have the tip extending beyond or not from the distal end of the cartridge.
Regarding Claim 12:
Schmid does not specifically disclose wherein said anvil jaw experiences a first deflection when said end effector is in said clamped configuration and said first staple cartridge is positioned in said cartridge jaw, wherein said anvil jaw experiences a second deflection when said end effector is in said clamped configuration and said second staple cartridge is positioned in said cartridge jaw, and wherein said second deflection is larger than said first deflection. The anvil of the embodiments of Figures 271 and 273 are meant to be identical; but, as discussed above for claim 1 and on the 112(b) rejection, the amount of deflection of the anvil jaw is a result of the tissue being treated, the material and thickness of the tissue thickness compensator, the size of the staples and even the pressure applied.
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to have different anvil jaw deflections, some larger or shorter, if using the cartridge to treat different tissue or tissue of different thickness or hardness, have different material or thickness of the tissue thickness compensator, different size of the staples or even the pressure applied to close the jaws.
Regarding Claims 13, 14 and 15:
Schmid discloses that the first and second cartridges can have staples of a different unformed staple length to be appropriate for a given application, and even staples of different sizes on the same cartridge (Figures 296 to 298, staples 15130a to 15130c); the height of the staple is related to the thickness of the tissue thickness compensator and the formed height required to catch the tissue and the tissue thickness compensator).
Regarding Claim 16:
As discussed for Claim 12 above, the modified invention of Schmid discloses the invention as claimed.
The modified invention of Schmid does not disclose that the anvil jaw comprises a distal anvil tip, wherein said first cartridge length is set such that said distal anvil tip extends beyond said first distal end, and wherein said second cartridge length is set such that said distal anvil tip is shorter than said second distal end.
Scirica teaches using a dissecting tip, attached to the end of the anvil jaw for accessing and/or separating tissue before the stapling operation instead of using a separate tool. The tip can be made to extends beyond said first distal end (Figure 7 and 7a, tip 214) or for the tip not to extend beyond the distal end (Figures 8 and 8a, tip 314). Note that if the cartridge of Huang is used on the embodiment of Figure 8 or 9 of Scirica the tip would most likely extend beyond the distal end of the cartridge, also (paragraph 0086) Distal tip 314d of dissecting tip 314 is preferably positioned proximally of the distal end of cartridge assembly 36. Alternately, distal tip 314d may be positioned adjacent to or distally of the distal end of cartridge assembly 36.
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the modified invention of Schmid the teachings of Scirica and add a dissecting tip as claimed at the distal end of the anvil and select the length of the cartridge and position of the tip to have the tip extending beyond or not from the distal end of the cartridge.
Regarding Claim 17 and 18:
Schmid discloses that the anvil is rotatable relative to the cartridge (Figures 271 and 273) but also on Figure 385, Paragraph 0710 indicates that as an alternative, the staple cartridge channel can rotate relative to the anvil so staple cartridge channel can be rotated toward the tissue to clamp the tissue against the anvil.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid US 20130075448) in view of Scirica (US 2005/0216055) as applied to claim 11 above, and further in view of Huang (US 2016/0100837).
Regarding Claims 19 and 20:
As discussed for Claim 11 above, Schmid discloses the invention as claimed.
Schmid does not specifically disclose if the second cartridge nose is blunter than said first cartridge nose or if the second cartridge nose is shorter than said first cartridge nose.
Huang teaches a cartridge that is fitted on a very similar cartridge jaw that has a very short nose and the nose being particularly blunt (Figure 2, distal end 149) as part of a tissue stop to inhibit tissue from flowing out of the distal end of the stapling instrument as the tissue is being stapled.
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the modified invention of Schmid the teachings of Huang and modify the cartridge of Figure 273 making the nose short and blunt, similar to the one of Huang, if a tissue stop is required to inhibit tissue from flowing out of the distal end of the stapling instrument as the tissue is being stapled.
Alternatively, claims 1 to 10 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2017/0296173).
Regarding Claims 1, 4, 5, 7 and 8:
Shelton discloses a staple cartridge system, comprising: an end effector configurable in an unclamped configuration and a clamped configuration, comprising: an anvil jaw including an anvil tip; and a cartridge jaw (Figure 9, end effector 300, anvil jaw 306 with a not numbered tip, carrier 316 will be considered the cartridge jaw) configured to receive staple cartridges of differing lengths (Paragraph 0693, a stapling assembly, an example of one can be seen on Figure 80 as stapling assembly or loading unit 21030, can be configured for use with staple cartridges having different lengths and/or different quantities of staples stored therein, For example, the stapling assembly can be usable with a first staple cartridge configured to apply an approximately 45 mm staple line and a second staple cartridge configured to apply an approximately 60 mm staple line Paragraph 0694, wherein said cartridge jaw comprises a proximal end, a distal end, and a bottom surface spanning between the proximal end and the distal end and configured to support the staple cartridge; Paragraph 0695, such an arrangement would allow the controller to stop the staple firing system at the appropriate moment regardless of the length of the staple cartridge attached to the stapling assembly),
both first the first and the second staple cartridge, comprising: a first or a second deck configured to support the tissue of a patient; first or a second staple cavities defined in said first or second deck; first or second staples removably stored in said staple cavities (Paragraph 0691, Figure 140 shows a deck not numbered with openings 26232 where staples are to be ejected); a first or a second proximal end, wherein said first or second proximal end is aligned with the proximal end of said cartridge jaw when said first staple cartridge is positioned in said cartridge jaw (Figures 103, 104 and 105, paragraph 0609, 0610 show the proper way the proximal end of a cartridge is aligned with the proximal end of said cartridge jaw); and a first or a second distal end, wherein a first or cartridge length is defined between said first proximal end and said first distal end (Figure 140A show the distal end of the cartridge corresponding to 45 mm staple line and the difference with the cartridge of 60 mm staple line and the difference on length of the firing stroke); and
wherein said anvil is supported at a first location on said cartridge jaw when said end effector is in said clamped configuration and said first staple cartridge is positioned in said cartridge jaw, wherein said anvil is supported at a second location on said cartridge jaw when said end effector is in said clamped configuration and said second staple cartridge is positioned in said cartridge jaw (Surely since the cartridges are different the position would be over the 45 mm cartridge and over the 600 mm cartridge).
Shelton does not specifically disclose the locations being a first or a second vertical distances away from said bottom surface of the cartridge jaw, the distances being different or wherein said anvil jaw deflects differently in response to whether said first staple cartridge or said second staple cartridge is positioned in said cartridge jaw.
The mentioned vertical distances and deflection of the anvil jaw can a result of the tissue being treated and the thickness of the tissue, if a buttress or tissue thickness compensator is used, the size of the staples and even the pressure applied, also relevant is that even cartridges can also come on different deck heights, making the distance from the bottom to the anvil smaller or larger and that the “tissue gap” between anvil and the deck in many cases is adjustable.
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to have different orthogonal distances, larger or smaller, or anvil jaw deflections if using the cartridge to treat different tissue, the use of a buttress or tissue thickness compensator, different cartridge deck height or simply adjustment on the gap between anvil and the deck.
Regarding Claims 2, 3 and 6.
As discussed above for Claim 1, the cartridge of 60 mm would be longer that the cartridge of the cartridge of 45 mm, considering one them first or the second would result on the first or the second being the longer or the shorter.
Regarding Claims 9 and 10:
Shelton discloses that the center of the second location would be closer to the second distal end than the center of the first location to the first distal end when the second cartridge is the shorter cartridge, in this case the 45 mm; the opposite will be true if the first cartridge is selected as the shorter cartridge.
Regarding Claims 11 to 20, similar rejections could have been made as the one made above for Schmid US 20130075448).
Response to Arguments
Applicant's arguments filed 10/07/2025 have been fully considered but they are not persuasive.
The Amendment of Claim 1 overcame the rejection under 112(b), but new rejections were made. Regarding the support of the distal tip the Examiner wonders if the Applicant wants to claim the embodiments of Figures 102 to 106, but no trocar is being claimed.
Regarding the arguments about the reference Schmid (US 2013/0075448), the Applicant indicates that independent Claim 1 requires a cartridge jaw "configured to receive staple cartridges of differing lengths wherein said cartridge jaw comprises a proximal end, a distal end, and a bottom surface spanning between the proximal end and the distal end and configured to support the staple cartridge”. And also, that:
Figures 271 and 273, respectively, let alone those lengths being different. In fact, based on the figures, it appears the staple cartridges may be the same lengths, the difference being that Figure 271 includes a tissue thickness compensator 10720 including a nose sock 10703 that is fit over the end of the staple cartridge 10700. Second, there is nothing in Schmid connecting the staple channel 9018 of Figure 203 to either the staple channel 10770 of Figure 271 or the staple channel 11070 of Figure 273. Thus, even if the distances of the respective staple cartridges were different, Schmid does not disclose that the respective staple channels are the same and thus configured to receive staple cartridges of different lengths, as claimed.
The Examiner in general can agree with the arguments up to a point; the cartridge staple cartridge 10700 of Figures 271 is apparently identical to the staple cartridge 11000 of Figure 273. Figures 273 and 203 were used for the disclosure of components of cartridge 10700 of Figure 271 that are common on stapler cartridges but are not specifically shown. The embodiment of Figure 271 is used for the disclosure of adding the “nose sock 1073” on the distal end of a regular cartridge and the “first cartridge” being formed by the cartridge 10700 plus the nose sock and the buttress material, resulting on a first cartridge longer and thicker than a regular cartridge as shown in the embodiments of Figure 203, 204, 208 and 210, having the same size as cartridge 10700, but with no nose sock or buttress, considered the “second cartridge”.
The Examiner notes that no arguments were presented in reference to the rejection over the reference Shelton (US 2017/0296173).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. In particular Yates (US 2010/0076474) teaches the possibility of using cartridges of different lengths on an end effector; Huang (US 2016/0100837) teaches the cartridge with a blunt short end in combination with a reference that disclose a cartridge with a regular nose could be used for a rejection of the independent claim and also Baber (US 2016/0066915) teaches that second jaw member 3604 is configured to receive a plurality of staple cartridge types, the height of the staple cartridge deck may vary based on the type of staple cartridge coupled to the second jaw member and the jaws accepting cartridges of different lengths, the end effector having a sensor to detect the parameters of the cartridge such as the length of the staple cartridge, the height of the cartridge deck, the thickness of tissue useable/optimal for the staple cartridge, and/or the pattern of the staples in the staple cartridge.
THIS ACTION IS MADE FINAL. 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 EDUARDO R FERRERO whose telephone number is (571)272-9946. The examiner can normally be reached M-F 9:30-7:00.
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, SHELLEY SELF can be reached at 571-272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EDUARDO R FERRERO/Examiner, Art Unit 3731
/STEPHEN F. GERRITY/Primary Examiner, Art Unit 3731 16 December 2025