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
Receipt is acknowledged of an amendment, filed 02 July 2025, which has been placed of record and entered in the file.
Status of the claims:
Claims 21-30 and 33-40 are pending.
Claims 21, 35-36, and 38 are amended.
Claims 1-20 and 31-32 are canceled.
Specification and Drawings:
Amendments to the specification and drawings have been submitted in the amendment filed 02 July 2025.
Claim Status Identifier
Claims 38 and 39 have an incorrect status identifier. Claim 38 has an identifier of “Previously Presented”, and includes additions and deletions to the text of the claim. Claim 39 has an identifier of “Currently Amended”, and does not include additions or deletions to the text of the claim.
Appropriate correction should be made in any amendment filed in response to the Office action.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton et al. (US Patent Publ. No. 2017/0056010) in view of Robb et al. (US Patent Publ. No. 2006/0249875).
With respect to claim 21, Shelton et al. disclose a compressible adjunct for use with a staple cartridge (fig. 1), the compressible adjunct comprising: an adjunct material formed of at least one fused bioabsorbable polymer (adjunct may be formed of a bioabsorbable polymer, [0116], medicant may be encapsulated in a bioabsorbable vessel, [0160]) and configured to be releasably retained on a staple cartridge and configured to be delivered to tissue by deployment of staples in the cartridge (adjunct 316 is releasably coupled to a stapler for release to tissue, [0241]), the adjunct material comprising a lattice macrostructure being formed of a plurality of unit cells (the adjunct 316 is formed of lattice sections/cells 318a-e, fig. 48, [0237]), the plurality of unit cells comprises first unit cells having a first compression profile (lattice section 318d has a first compression profile shown by the expansion in figs. 49, 50), the first unit cells being positioned proximate to an intended cut line of the adjunct that extends along a central longitudinal axis extending from a first end to a second end of the adjunct material (lattice section 318d is along the cut edge of the adjunct, fig. 49, Annotated Figure 48), wherein each first unit cell contains a first dosage of drug (tissue healing medicant 320, fig. 49), the drug being configured to promote tissue healing (hemostatic agent, [0239]), and second unit cells having a second compression profile that is different than the first compression profile (lattice sections 318b have a compression profile different from lattice section 318d shown by expansion in figs. 49, 50, [0243]), the second unit cells being positioned a distance away from the intended cut line of the adjunct (lattice sections 318b, 318c positioned opposite the cut line, fig. 49), wherein each second unit cell contains a second dosage of the drug (lattice sections 318b contain a medicant to encourage tissue growth, [0238]), the second dosage being different than the first dosage (dosage of medicant is different since the size of the lattice sections 318b is different from size of lattice section 318d, and the lattice sections may include different or the same drugs, [0238]), wherein the second unit cells are positioned along opposed longitudinal edges of the adjunct (lattice sections 318b, 318c positioned along opposed longitudinal edges, Annotated Figure 48), wherein the first unit cells and the second unit cells extend an entire thickness of the adjunct (318c, 318d, 318b, together, extend an entire thickness of the adjunct, Annotated Figure 48).
Shelton et al. fail to disclose a non-fibrous adjunct material wherein the first unit cells and the second unit cells are triply periodic minimal surface structures.
Robb et al. disclose a similar surgical device comprising a tissue support structure, such as a tissue scaffold ([0002]), that is used in surgical procedures to promote tissue growth in damaged tissue, the scaffold formed of a non-fibrous material of repeating unit cells that are triply periodic minimal surface structures ([0010], figs. 8a-d, a monolithic material formed by 3D printing, [0039]), for improving tissue growth, increase blood flow, and provide mechanical support ([0025]).
It 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 to modify the adjunct of Shelton et al., to replace the adjunct material with the non-fibrous material of repeating unit cells that are triply periodic minimal surface structures as taught by Robb et al., to improve tissue growth, increase blood flow, and provide mechanical support, and as the substitution of an art-recognized equivalent material suitable for the intended purpose of providing mechanical support and promoting tissue growth. MPEP 2144.07
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With respect to claim 22, Shelton et al. disclose that the first unit cells are configured to exert a first compressive pressure to tissue stapled to the adjunct (lattice section 318d, figs. 49, 50), and wherein the second unit cells are configured to exert a second compressive pressure to tissue stapled to the adjunct (lattice sections 318b expand a greater amount than lattice section 318d, and thus exert a greater pressure, figs. 49, 50).
Shelton et al. fail to disclose that the second compressive pressure is lower than the first compressive pressure.
It 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 to modify the Shelton et al. device to replace the adjunct material with the second compressive pressure being lower than the first compressive pressure, for the first compressive pressure being lower than the second compressive pressure, for a surgical purpose such as to adapt to the anatomy of a certain organ, since reversing the positions of the lattice sections would provide no particular mechanical advantage, and would involve only a repositioning of the elements of the device. MPEP 2144.04 VI. C.
With respect to claim 23, Shelton et al. fail to disclose each of the first unit cells is a Schwarz-P structure.
Robb et al. disclose a similar surgical device comprising a tissue support structure, such as a tissue scaffold ([0002]), that is used in surgical procedures to promote tissue growth in damaged tissue, the scaffold formed of a non-fibrous material of repeating unit cells that are Schwarz-P structures ([0010], figs. 5A, 8a-d, a monolithic material formed by 3D printing, [0039]), for improving tissue growth, increase blood flow, and provide mechanical support ([0025]).
It 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 to modify the adjunct of Shelton et al., to replace the adjunct material with the non-fibrous material of repeating unit cells that are Schwarz-P structures as taught by Robb et al., to improve tissue growth, increase blood flow, and provide mechanical support, and as the substitution of an art-recognized equivalent material suitable for the intended purpose of providing mechanical support and promoting tissue growth. MPEP 2144.07
With respect to claim 24, Shelton et al. fail to disclose each of the second unit cells is a Schwarz-P structure.
Robb et al. disclose a similar surgical device comprising a tissue support structure, such as a tissue scaffold ([0002]), that is used in surgical procedures to promote tissue growth in damaged tissue, the scaffold formed of a non-fibrous material of repeating unit cells that are Schwarz-P structures ([0010], figs. 5A, 8a-d, a monolithic material formed by 3D printing, [0039]), for improving tissue growth, increase blood flow, and provide mechanical support ([0025]).
It 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 to modify the adjunct of Shelton et al., to replace the adjunct material with the non-fibrous material of repeating unit cells that are Schwarz-P structures as taught by Robb et al., to improve tissue growth, increase blood flow, and provide mechanical support, and as the substitution of an art-recognized equivalent material suitable for the intended purpose of providing mechanical support and promoting tissue growth. MPEP 2144.07
With respect to claim 25, Shelton et al. fail to disclose triply periodic minimal surface structures that are Schwarz-P structures.
Robb et al. disclose a similar surgical device comprising a tissue support structure, such as a tissue scaffold ([0002]), that is used in surgical procedures to promote tissue growth in damaged tissue, the scaffold formed of a non-fibrous material of repeating unit cells that are triply periodic minimal surface Schwarz-P structures ([0010], figs. 5A, 8a-d, a monolithic material formed by 3D printing, [0039]), for improving tissue growth, increase blood flow, and provide mechanical support ([0025]).
It 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 to modify the adjunct of Shelton et al., to replace the adjunct material with the non-fibrous material of repeating unit cells that are triply periodic minimal surface Schwarz-P structures as taught by Robb et al., to improve tissue growth, increase blood flow, and provide mechanical support, and as the substitution of an art-recognized equivalent material suitable for the intended purpose of providing mechanical support and promoting tissue growth. MPEP 2144.07
With respect to claim 26, Shelton et al. fail to disclose that the second dosage of the drug is less than the first dosage of the drug.
It 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 to modify the device of Shelton et al. to provide the second dosage of the drug is less than the first dosage of the drug, as a matter of a change in proportion, since there does not appear to be any disclosed advantage to the structure of the adjunct having a second drug dosage that is less than the first drug dosage. The particular dosage and/or relative dosages of the drug does not patentably distinguish Applicant’s claimed device from the prior art where the only difference between the prior art and the claims is a recitation of relative drug dosages, and a device having the claimed drug dosages would not perform differently than the prior art device, especially since Shelton et al. disclose that the particular drug dosages may be modified in various implementations of the adjunct ([0214]). MPEP 2144.04 IV. A.
With respect to claim 27, Shelton et al. disclose that the first unit cells are configured to release drug therefrom upon activation (medicant 320 is released when the unit cells 318d are activated by cutting, fig. 49, [0242]) and the second unit cells are configured to release drug therefrom upon degradation of at least one of the at least one fused bioabsorbable polymer (unit cells 318b degrade by unwinding, fig. 50, [0243]).
With respect to claim 28, Shelton et al. disclose the drug comprises a tissue healing agent (the tissue growth encouraging agent and the tissue growth discouraging agent promote healing by directing tissue healing, promoting tissue growth, and preventing adhesion, [0237], [0240]).
With respect to claim 29, Shelton et al. disclose that the first unit cells each have a first size and the second unit cells each have a second size that is different than the first size (size of lattice section 318 is different from size of lattice sections 318a both before and after staple deployment, figs. 48, 49, 50).
With respect to claim 30, Shelton et al. fail to disclose the lattice macrostructure comprises a plurality of connecting structures that extend between and connect adjacent unit cells of the plurality of unit cells to each other.
Robb et al. disclose a similar surgical device comprising a tissue support structure, such as a tissue scaffold ([0002]), that is used in surgical procedures to promote tissue growth in damaged tissue, the scaffold comprising a plurality of connecting structures that extend between and connect adjacent unit cells (triply periodic minimal surface structures having connecting structures, [0010], figs. 5A, 8a-d), for improving tissue growth, increase blood flow, and provide mechanical support ([0025]).
It 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 to modify the adjunct of Shelton et al., to replace the adjunct material with the triply periodic minimal surface structures having connecting structures, as taught by Robb et al., to improve tissue growth, increase blood flow, and provide mechanical support, and as the substitution of an art-recognized equivalent material suitable for the intended purpose of providing mechanical support and promoting tissue growth. MPEP 2144.07
Response to Arguments
With respect to the objection to the specification and the objection to the drawings, the amendments and applicant’s arguments have been fully considered and are persuasive. The objections are hereby withdrawn.
With respect to the rejection of claim 21 under 35 U.S.C. 103 over Shelton et al. (US Patent Publ. No. 2017/0056010) in view of Robb et al. (US Patent Publ. No. 2006/0249875), applicant’s arguments have been fully considered but are not persuasive.
Applicant argues that Shelton et al. fail to teach “cells that extend an entire thickness of the adjunct”.
In response, Shelton et al. disclose an adjunct 316 (fig. 48) comprising a plurality of unit cells including first unit cells that are positioned proximate an intended cut line (lattice section 318d is proximate the central longitudinal axis/intended cut line, Annotated Figure 48, fig. 49), the intended cut line extending extends along the central longitudinal axis extending from a first end to a second end of the adjunct material (the intended cut line and the central longitudinal axis are the same and extend from a first end to a second end, Annotated Figure 48, fig. 49), wherein the second unit cells are positioned along opposed longitudinal edges of the adjunct (lattice sections 318b, 318c positioned along opposed longitudinal edges, Annotated Figure 48), and wherein the first unit cells and the second unit cells extend an entire thickness of the adjunct (318c, 318d, 318b, together, extend an entire thickness of the adjunct, Annotated Figure 48). As shown in Annotated Figure 48, the first unit cells and the second unit cells, together, extend an entire thickness of the adjunct. Annotated Figure 48 labels the thickness of the adjunct. Applicant has not explained in the remarks which dimension of the adjunct is the “thickness”. There is no disclosure in the written description to indicate which dimension of the adjunct is the “thickness”. There is nothing in the claim language to prevent this reading of “thickness” of the adjunct.
Further, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In view of all of the above, the rejection of claim 21 under 35 U.S.C. 103 over Shelton et al. in view of Robb et al. is still deemed proper.
Applicant has provided no arguments pointing out errors with respect to the rejections of dependent claims 22-30, and these rejections are still deemed proper.
Allowable Subject Matter
Claims 33-40 are allowed.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance:
Regarding independent claim 33: the subject matter of claim 33 is allowable over the prior art because of the combination of structural limitations and their functional relationship to one another. Claim 33 includes the following limitations which in combination with the other limitations of the claim are not taught or suggested by the prior art:
“the lattice macrostructure being formed of first Schwarz-P structures and second Schwarz-P structures, the first Schwarz-P structures being configured to exhibit different mechanical behavior relative to the second Schwarz-P structures when the adjunct is in a tissue deployed state, wherein the first Schwarz-P structures are positioned proximate to an intended cut line of the adjunct, the first Schwarz-P structures having a first dosage of the tissue healing agent disposed therein, and wherein the second Schwarz-P structures positioned adjacent to the first Schwarz-P structures and a distance away from the intended cut line of the adjunct, the second Schwarz-P structures having a second dosage of the tissue healing agent disposed therein”.
Shelton et al. (US Patent Publ. No. 2017/0056010) and Robb et al. (US Patent Publ. No. 2006/0249875) are considered to be the closest prior art.
Shelton et al. disclose a compressible adjunct for use with a staple cartridge, the compressible adjunct comprising: an adjunct material 316 formed of at least one fused bioabsorbable polymer ([0116], [0160]) and configured to be releasably retained on a staple cartridge and configured to be delivered to tissue by deployment of staples in the cartridge, the adjunct material comprising a lattice macrostructure being formed of a plurality of unit cells (the adjunct 316 is formed of lattice sections/cells 318a-e containing medicants, fig. 48, [0237]). Shelton et al. disclose first unit cells having a first mechanical behavior (lattice section 318d has a first compression profile shown by the expansion in figs. 49, 50) and being positioned proximate to an intended cut line of the adjunct (lattice section 318d is along the cut edge of the adjunct, fig. 49)), and second unit cells having a second mechanical behavior that is different than the first mechanical behavior (lattice sections 318b including a medicant and having a compression profile different from lattice section 318d shown by expansion in figs. 49, 50, [0243]), the second unit cells being positioned a distance away from the intended cut line of the adjunct (lattice sections 318b positioned opposite the cut line, fig. 49).
Shelton et al. fail to disclose a non-fibrous adjunct material wherein the first unit cells and the second unit cells are triply periodic minimal surface structures.
Robb et al. disclose a tissue support structure, such as a tissue scaffold ([0002]), that is used in surgical procedures to promote tissue growth in damaged tissue, the scaffold formed of a non-fibrous material of repeating unit cells that are Schwarz-P structures ([0010], figs. 8a-d, a monolithic material formed by 3D printing, [0039]), for improving tissue growth, increase blood flow, and provide mechanical support ([0025]).
Shelton et al. and Robb et al. fail to disclose first Schwarz-P structures and second Schwarz-P structures, the first Schwarz-P structures being configured to exhibit different mechanical behavior relative to the second Schwarz-P structures when the adjunct is in a tissue deployed state.
The difference between the claimed subject matter and Shelton et al., or a combination of Shelton et al. and Robb et al., is that Shelton et al., or a combination of Shelton et al. and Robb et al., do not disclose or teach “the lattice macrostructure being formed of first Schwarz-P structures and second Schwarz-P structures, the first Schwarz-P structures being configured to exhibit different mechanical behavior relative to the second Schwarz-P structures when the adjunct is in a tissue deployed state, wherein the first Schwarz-P structures are positioned proximate to an intended cut line of the adjunct, the first Schwarz-P structures having a first dosage of the tissue healing agent disposed therein, and wherein the second Schwarz-P structures positioned adjacent to the first Schwarz-P structures and a distance away from the intended cut line of the adjunct, the second Schwarz-P structures having a second dosage of the tissue healing agent disposed therein”.
The difference between the claimed subject matter and Shelton et al., or a combination of Shelton et al. and Robb et al., would not have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, since such modifications to the Shelton et al. structure would have gone beyond mere substitution or incorporation of a known structure capable of achieving predictable results. Any modification to the Shelton et al. structure to arrive at the claimed subject matter would have required a reworking of the structure and the principle of operation in a manner which would not have been apparent to a person having ordinary skill in the relevant art, and would have required the improper benefit of the teachings of Applicant’s disclosure.
Claims 34-40 depend from claim 33 and are likewise allowable.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linda J. Hodge whose telephone number is (571)272-0571. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/LINDA J. HODGE/Examiner, Art Unit 3731
/ANNA K KINSAUL/Supervisory Patent Examiner, Art Unit 3731