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 .
Status of the Claims
This Office Action is responsive to the amendment filed April 20, 2026. As directed by the amendment: Claims 1 and 16 have been amended. Claims 20-24 were cancelled. Claims 1-19 are presently pending in this application.
Examiner’s Note
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.
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.
Claim(s) 1-6, 9, and 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prommersberger (US 2008/0308608) in view of Hodgkinson et al. (US 2021/0259684), herein referred to as Hodgkinson.
Regarding claim 1, Prommersberger discloses a surgical staple cartridge assembly (30) (figure 11), comprising a cartridge body (22), comprising a tissue-supporting deck (110), and staple cavities (elements 112) defined in the tissue-supporting deck (110) (figure 11), staples (178) removably stored in the staple cavities (elements 112) (¶76), wherein the staples (178) are deployable into tissue of a patient (element “T”, see figures 24-26), and an implantable layer (26) (¶47) configured to (i.e. capable of) be installed in the patient upon deployment of the staples (178) into tissue of the patient (element “T”, see figures 24-26), wherein the implantable layer (26) is comprised of a bioabsorbable polymer (¶47, ¶48) and is configured to (i.e. capable of) degrade at a layer degradation rate over an expected layer life in the patient.
Yet, Prommersberger lacks a detailed description on wherein the staples are comprised of a bioabsorbable metal alloy and are configured to degrade at a staple degradation rate over an expected staple life in the patient.
However, Hodgkinson teaches staples (44) (title and figure 2) are comprised of a bioabsorbable metal alloy (title and ¶25) and are configured to (i.e. capable of) degrade at a staple degradation rate over an expected staple life in the patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Prommersberger’s staples with wherein the staples are comprised of a bioabsorbable metal alloy as taught by Hodgkinson, since such materials increase the healing performance of tissue (¶25).
Thus, the modified Prommersberger’s surgical staple cartridge assembly has wherein the staple degradation rate and the layer degradation rate are selected such that the implantable layer (26 of Prommersberger) supports the staples (the modified Prommersberger’s staples) as the staples weaken and degrade within the patient's tissue (considered functional).
Regarding claim 2, the modified Prommersberger’s surgical staple cartridge assembly has wherein the implantable layer (26 of Prommersberger) is configured to (i.e. capable of) mechanically support a portion of the staple (the modified Prommersberger’s staple) during deployment of the staples into tissue of the patient.
Regarding claim 3, the modified Prommersberger’s surgical staple cartridge assembly has wherein the implantable layer (26 of Prommersberger) is configured to (i.e. capable of) mechanically support a portion of the staple during the expected staple life in the patient.
Regarding claim 4, the modified Prommersberger’s surgical staple cartridge assembly has wherein the implantable layer (26 of Prommersberger) is configured to (i.e. capable of) distribute a tissue load within the staples during the expected staple life in the patient.
Regarding claim 5, the modified Prommersberger’s surgical staple cartridge assembly has wherein each staple (the modified Prommersberger’s staple) comprises a crown (182 of Prommersberger) (figure 23 of Prommersberger), a first leg (184 of Prommersberger) extending from the crown (182 of Prommersberger) at a first transition (figure 23 of Prommersberger), and a second leg (186 of Prommersberger) extending from the crown (182 of Prommersberger) at a second transition (figure 23 of Prommersberger), wherein the implantable layer (26 of Prommersberger) is configured to (i.e. capable of) mechanically support the staple at the first transition and the second transition.
Regarding claim 6, the modified Prommersberger’s surgical staple cartridge assembly has wherein the first leg (184 of Prommersberger) and the second leg (186 of Prommersberger) are deformed from an initial configuration (figures 23 and 24 of Prommersberger) to a formed configuration (figures 23 and 24 of Prommersberger) during deployment (figures 23 and 24 of Prommersberger), and wherein the implantable layer (26 of Prommersberger) is configured to (i.e. capable of) resist deformation of the first leg (184 of Prommersberger) and the second leg (186 of Prommersberger) away from the formed configuration by tissue compressed within the staple (figure 24 of Prommersberger).
Regarding claim 9, the modified Prommersberger’s surgical staple cartridge assembly has wherein the implantable layer (26 of Prommersberger) is releasably secured to the tissue-supporting deck (¶69 and figures 11 and 12 of Prommersberger).
Regarding claim 11, the modified Prommersberger’s surgical staple cartridge assembly has wherein at least one of the staple degradation rate and the layer (26 of Prommersberger) degradation rate comprises a variable rate (due to their materialistic properties).
Regarding claim 12, the modified Prommersberger’s surgical staple cartridge assembly has wherein the expected staple life and the expected layer life are different (due to their materialistic properties).
Regarding claim 13, the modified Prommersberger’s surgical staple cartridge assembly has wherein the staple degradation rate (¶25 of Hodgkinson) is faster than the layer degradation rate (¶47, ¶48 of Prommersberger) (due to the size and their materialistic properties).
Regarding claim 14, the modified Prommersberger’s surgical staple cartridge assembly has wherein the bioabsorbable metal alloy is selected from a group consisting of a magnesium-based alloy (¶25 of Hodgkinson), a zinc-based alloy, and an iron-based alloy.
Regarding claim 15, the modified Prommersberger’s surgical staple cartridge assembly has wherein the bioabsorbable metal alloy further comprises lithium, zinc (¶25 of Hodgkinson), calcium, and manganese.
Regarding claim 16, Prommersberger discloses a surgical staple cartridge assembly (30) (figure 11), comprising a cartridge body (22), comprising a deck (110), and staple cavities (elements 112) defined in the deck (110) (figure 11), staples (178) removably stored in the staple cavities (elements 112) (¶76), wherein the staples (178) are deployable into tissue of a patient (element “T”, see figures 24-26), and a buttress (26) configured to (i.e. capable of) be installed in the patient along with the staples (178) (figures 23-26), wherein the buttress (26) is comprised of a bioabsorbable polymer (¶47, ¶48) and is configured to (i.e. capable of) degrade at a buttress degradation rate over an expected layer life in the patient, and wherein the buttress (26) is configured to (i.e. capable of) mechanically support a portion of the staple (178) at a predefined time (figure 26).
Yet, Prommersberger lacks a detailed description on wherein the staples are comprised of a bioabsorbable metal alloy and are configured to degrade at a staple degradation rate over an expected staple life in the patient.
However, Hodgkinson teaches staples (44) (title and figure 2) are comprised of a bioabsorbable metal alloy (title and ¶25) and are configured to (i.e. capable of) degrade at a staple degradation rate over an expected staple life in the patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Prommersberger’s staples with wherein the staples are comprised of a bioabsorbable metal alloy as taught by Hodgkinson, since such materials increase the healing performance of tissue (¶25).
Thus, the modified Prommersberger’s surgical staple cartridge assembly has wherein a buttress degradation rate and the staple degradation rate are selected such that the buttress (26 of Prommersberger) supports the staples (the modified Prommersberger’s staples) as the staples weaken and degrade within the patient's tissue (considered functional).
Regarding claim 17, the modified Prommersberger’s surgical staple cartridge assembly has wherein the predefined time comprises a portion of the expected staple life in the patient (figure 26 of Prommersberger).
Regarding claim 18, the modified Prommersberger’s surgical staple cartridge assembly has wherein each staple (the modified Prommersberger’s staple) comprises a crown (182 of Prommersberger) and legs (184+186 of Prommersberger) extending from the crown (182 of Prommersberger) at a transitional curve (figure 23 of Prommersberger), and wherein the portion of the staple comprises the transitional curve (figure 23 of Prommersberger).
Regarding claim 19, the modified Prommersberger’s surgical staple cartridge assembly has wherein the buttress degradation rate is slower than the staple degradation rate (due to the size and their materialistic properties).
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prommersberger and Hodgkinson as applied to claim 1 above, and further in view of Mandakolathur Vasudevan et al. (US 2016/0199063), herein referred to as Mandakolathur Vasudevan.
Regarding claim 7, the modified Prommersberger’s surgical staple cartridge assembly discloses all the features/elements as claimed including wherein the staples comprises legs (figure 23 of Prommersberger) but lacks wherein channels are defined in the implantable layer, and wherein the channels are aligned with the legs and structured to guide the legs during deployment of the staples into tissue of the patient.
However, Mandakolathur Vasudevan teaches channels (considered wherein elements 32 are situated in, see figure 1A) are defined in an implantable layer (38) (¶620), and wherein the channels (considered wherein elements 32 are situated in, see figure 1A) are aligned with the legs (figure 1A) and structured to guide the legs during deployment of the staples (32) into tissue of the patient.
Therefore, 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 modified Prommersberger’s surgical staple cartridge assembly with wherein channels are defined in the implantable layer, and wherein the channels are aligned with the legs and structured to guide the legs during deployment of the staples into tissue of the patient as taught by Mandakolathur Vasudevan, since such a modification would provide an alternative implantable layer.
Regarding claim 8, the modified Prommersberger’s surgical staple cartridge assembly discloses all the features/elements as claimed but lacks wherein channels are defined in the implantable layer, and wherein the channels are positioned and structured to support the staples during the expected staple life in the patient.
However, Mandakolathur Vasudevan teaches channels (considered wherein elements 32 are situated in, see figure 1A) are defined in an implantable layer (38) (¶620), and wherein the channels (considered wherein elements 32 are situated in, see figure 1A) are positioned and structured to support the staples (32) during the expected staple life in the patient.
Therefore, 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 modified Prommersberger’s surgical staple cartridge assembly with wherein channels are defined in the implantable layer, and wherein the channels are positioned and structured to support the staples during the expected staple life in the patient as taught by Mandakolathur Vasudevan, since such a modification would provide an alternative implantable layer.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prommersberger and Hodgkinson as applied to claim 1 above, and further in view of Harris et al. (US 2015/0297235), herein referred to as Harris.
Regarding claim 10, the modified Prommersberger’s surgical staple cartridge assembly discloses all the features/elements as claimed but lacks wherein the tissue-supporting deck comprises pocket extenders extending into the implantable layer, and wherein the pocket extenders at least partially surround a perimeter of the staple cavities.
However, Harris teaches wherein a tissue-supporting deck (5311) (figure 92) comprises pocket extenders (¶109 and figure 90) extending into an implantable layer (¶356), and wherein the pocket extenders (5351) at least partially surround a perimeter of the staple cavities (5350) (figure 92).
Therefore, 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 modified Prommersberger’s surgical staple cartridge assembly with wherein the tissue-supporting deck comprises pocket extenders extending into the implantable layer, and wherein the pocket extenders at least partially surround a perimeter of the staple cavities as taught by Harris, since such a modification would guide and maintain the staples position.
Response to Arguments
Applicant's arguments filed April 20, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 5-7, under 35 U.S.C. 103, of the Remarks are directed to the amended claims 1 and 16 and the combination of references (Prommersberger in view of Hodgkinson). Applicant argues “Applicant respectfully submits that neither Prommersberger nor Hodgkinson, alone or in combination, teaches or suggests the amended claim limitations requiring that the degradation rates be "selected such that" the implantable layer or buttress "supports the staples as the staples weaken and degrade within the patient's tissue." This claim limitation requires a purposeful selection of degradation rates to achieve a coordinated support function-not merely that different materials happen to have different degradation rates.” In response to applicant's argument that “are selected such that the implantable layer supports the staples as the staples weaken and degrade within the patient's tissue”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues on page 6 of the Remarks that “Hodgkinson's staples are intended to degrade and be absorbed by the body without any reliance on external support structures during the degradation process. There is no teaching or suggestion in Hodgkinson that the staples would require or benefit from support by a buttress or implantable layer as they weaken”. The Examiner notes that Prommersberger’s staples were modified to comprise a bioabsorbable metal alloy as taught by Hodgkinson, since such materials increase the healing performance of tissue (¶25).
Applicant further argues on page 6 that “Prommersberger's buttress is designed to work with conventional, non-degradable staples that maintain their structural integrity indefinitely”. However, the Examiner notes that the reference Prommersberger does not preclude such a material cannot be used.
Lastly, applicant argues that “Furthermore, the combination would require substantial redesign and reconfiguration that is not suggested by either reference.” Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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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/SI MING KU/Primary Examiner, Art Unit 3775
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