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 Office Action is in response to the applicant’s amendment filing on 01/23/2025.
Applicant’s cancelation of claim 4 is acknowledged and require no further examining. Claims 1-3 and 5-8 are pending and examined below.
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 1-3 and 5-8 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the phrase “each staple cavity free of any portion of the attachment features” renders claim 1 to be non-complying with the written description requirement because the feature appears to be new matter. On page 36 paragraph 126 of the Specification, the first and second extension features are disclosed to be formed at opposed sides of the pocket along a longitudinal axis. The Specification as originally filed does not disclose the staple cavity is free of any portion of the attachment features. Therefore, the feature is considered new matter.
Claims 2-3 and 5-8 are dependent of claim 1 and include all the same limitations.
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 1-3 and 5-8 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, the phrase “the attachment features being spaced away from the opposed sides” renders claim 1 vague and indefinite because it is unclear what are the metes and bounds of the position of the attachment features to be considered “spaced away” from the opposed sides. It is unclear how far away the attachment features must be situated to be considered “spaced away” from the opposed sides. For examining purposes, prior art that discloses an attachment feature that does not directly contact the oppose sides is interpreted to be spaced away from the oppose sides.
Regarding claim 1, the phrase “each staple cavity free of any portion of the attachment features” also renders claim 1 vague and indefinite because it is unclear how the staple cavity is considered free of any portion of the attachment features. The term “cavity” is understood as an opening in an element, or in other words an area void of said element. It is unclear how a cavity is free of any portion of the attachment features when the cavity is already void of any portion of the cartridge. For examining purposes, prior art that discloses a cavity in the cartridge and disclose an attachment feature extending from the cartridge, the cavity is interpreted as free of any portion of the attachment feature.
Claims 2-3 and 5-8 are dependent of claim 1 and include all the same limitations.
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 1-3 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over reference Harris et al. (2015/0297235) in view of reference Schmid et al. (9,050,084).
Regarding claim 1, Harris et al. disclose an end effector (16) for a surgical instrument (10), said end effector (16) comprising:
a first jaw (22) having a cartridge (8000) with staple cavities (2050) configured to seat staples therein,
wherein the staple cavities (2050) each having an opening defined by a first terminal end (see figure 54A below), a second terminal end (see figure 54A below), and opposed sides (see figure 54A below) extending between the first terminal end (see figure 54A below) and the second terminal end (see figure 54A below), and
wherein each staple cavities (2050) formed on a tissue-facing surface (8016) of the cartridge (8000);
a second jaw (20) opposing the first jaw (22) and having an anvil with staple forming cavities (89) formed on a tissue-facing surface thereof,
wherein the first and second jaws (20, 22) are configured to clamp tissue therebetween;
attachment features (8017, 8019) formed on the tissue-facing surface (8016) and adjacent to the staple cavities (2050),
wherein the attachment features (8017, 8019) are positioned at the first terminal end (see figure 54A below) and the second terminal end (see figure 54A below), and
wherein each of the staple cavities (2050) are free of any portion of the attachment features (8017, 8019); and
an adjunct material (8020) configured to be releasably retained on the first jaw (22) and having mating features (8027, 8029),
wherein all the mating features of the adjunct material (8020) are each configured to mate with only one respective attachment feature (8017, 8019) of the cartridge (8000).
(Figures 99-102 and Page 9 paragraph 283, Page 10 paragraph 286, Page 14 paragraph 305, Page 44 paragraph 445, 446, Page 45 paragraph 448)
[AltContent: textbox (Side)][AltContent: arrow][AltContent: textbox (Second Terminal End)][AltContent: arrow][AltContent: textbox (First Terminal End)][AltContent: arrow][AltContent: textbox (Harris et al.)]
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However, Harris et al. do not disclose the attachment features are positioned only at the first terminal end and the second terminal end with the opposed sides of each staple cavity being free of any portion of the attachment features.
Schmid et al. disclose a first jaw having a cartridge (10000) with staple cavities (10012) configured to seat staples therein,
wherein the staple cavities (10012) each having an opening defined by a first terminal end (see figure 220 below), a second terminal end (see figure 220 below), and opposed sides (see figure 220 below) extending between the first terminal end (see figure 220 below) and the second terminal end (see figure 220 below),
wherein each staple cavities (10012) formed on a tissue-facing surface (10011) of the cartridge (10012),
wherein the tissue-facing surface (10011) has attachment features (10013),
wherein the attachment features (10013) are positioned only at the first terminal end (see figure 220 below) and the second terminal end (see figure 220 below),
wherein the attachment features (10013) being spaced away from the opposed sides (see figure 220 below) of each staple cavity (10012) such that each staple cavity (10012) is free of any portion of the attachment features (10013), and
wherein the attachment features (10013) have a spike shape.
(Figure 220 and Column 125 lines 21-27, Column 127 lines 10-24)
[AltContent: textbox (Side)][AltContent: arrow][AltContent: textbox (First Terminal End)][AltContent: arrow][AltContent: textbox (Second Terminal End)][AltContent: arrow][AltContent: textbox (Schmid et al.)]
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It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified attachment features of Harris et al. by incorporating the position of the attachment features only at the terminal ends as taught by Schmid et al., since column 127 lines 24-30 states such a modification would allow the attachment feature have a spike shape and help ensure the attachment extends into thickness of the adjunct material.
Regarding claim 2, Harris et al. modified by Schmid et al. disclose the adjunct material (Harris et al. – 8020) is at least partially formed of a stretchable material. (Harris et al. – Page 28 paragraph 362)
Regarding claim 3, Harris et al. disclose the mating features (8027, 8029) of the adjunct material (8020) are configured to stretch to accommodate the respective attachment features (8017, 8019). (Page 45 paragraph 449)
Therefore, Harris et al. modified by Schmid et al. are interpreted to disclose, prior to mating the mating features with the attachment features, the mating features are positioned at a first distance relative to each other, and after mating the mating features with the attachment features, at least a portion of the mating features are positioned at a second distance relative to each other, the second distance being greater than the first distance.
Regarding claim 5, Harris et al. modified by Schmid et al. disclose the second terminal end (Harris et al. – see figure 54A above) is opposite the first terminal end (Harris et al. – see figure 54A above). (Harris et al. – Figure 54A)
Regarding claim 6, Harris et al. modified by Schmid et al. disclose the attachment features (Harris et al. – 8017, 8019) have curved configuration. (Schmid et al. – Column 127 lines 24-30)
Regarding claim 7, Harris et al. disclose, when the mating features (8027, 8029) are mated with the respective attachment features (8017, 8019), the mating features (8027, 8029) are situated around the respective attachment features (8017, 8019). (Figure 100, 102 and Page 45 paragraph 448)
Therefore, Harris et al. modified by Schmid et al. are interpreted to disclose the attachment features are positioned at a first distance relative to each other and the mating features are positioned at a second distance relative to each other, wherein the first and second distances are equal.
Regarding claim 8, Harris et al. modified by Schmid et al. disclose the cartridge (Harris et al. – 8000) is configured to be removable from the first jaw (Harris et al. – 22) and to be replaceable. (Harris et al. – Page 14 paragraph 305)
Response to Arguments
The Amendments filed on 01/23/2025 have been entered. Applicant’s cancelation of claim 4 is acknowledged and require no further examining. Claims 1-3 and 5-8 are pending in the application.
In response to the arguments of the rejections under 35 U.S.C. 103 with reference Harris et al. (2015/0297235) modified by reference Schmid et al. (9,050,084), Examiner finds the arguments not persuasive.
Applicant states:
The Examiner’s modification of Schmid FIG. 235 (reproduced above, highlighting added) shows attachment features (guides 10013) that are not spaced away from the opposed sides of the staple cavity (staple cavity 10012).
In column 127 lines 13-16 of Schmid et al., the guides are disclosed to be “positioned adjacent to the staple cavity openings in the deck surface 10011 such that the staple legs can be at least partially supported by the guides”. The guides are not disclosed to wrap around the cavity openings or extend along the sides of the cavity openings. In column 127 lines 24-27 of Schmid et al., the guides are disclosed to comprise “a groove or slot, such as groove 10016, for example, within which a staple leg 10032 can be slidably received”.
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The groove is not disclosed to wrap around the cavity opening or extend along the sides of the cavity openings. Since the neither the guides nor the grooves wrap around the cavity opening or extend along the sides of the cavity openings, the guides and the grooves are considered to not contact the opposing sides. Therefore, Schmid et al. do disclose an attachment feature positioned only at the terminal end along a longitudinal axis of the staple cavity, with the attachment features spaced away from the opposed sides of the staple cavity.
Applicant states:
The guide 10013 (which represented by the concentric circles on the right of the Examiner’s drawing) contains a groove 10016 (which represented by the highlighted portion) that extends into the staple cavity 10012 (represented by the shape on the left of the Examiner’s drawing). Thus, the groove 10016 (attachment feature is not “spaced away from the opposed sides of each staple cavity such that each staple cavity is free of any portion of the attachment features,” as required by amended claim 1.
In column 127 lines 10-30 of Schmid et al., the guide (10013) is disclosed to extend from the deck surface (10011). The guide is disclosed to have a groove (10016) that allows the guide to at least partially support the staple leg. The groove is not disclosed as extending into the staple cavity opening. The groove also does not define the guide. Therefore, it is unclear how the guide having a groove renders the guide itself to extend or interfere with the staple cavity opening.
If any intermediate feature that contacts the attachment feature and the staple cavity opening is interpreted as the attachment feature interfering with the staple cavity opening, then the Applicant’s attachment features is considered to interfere with the staple cavity opening. In Figure 19B of the present application, the attachment feature (706a) extends from the cartridge (704), and the staple cavity (706) is defined by the cartridge (704). Therefore, the staple cavity of the present application is not free of any portion of the attachment feature.
Conclusion
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.
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/PATRICK B FRY/Examiner, Art Unit 3731 April 24, 2025
/THANH K TRUONG/Supervisory Patent Examiner, Art Unit 3731