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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/03/2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 8-10, filed 05/22/2025, with respect to the rejection(s) of claim(s) 1 and 24 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in further view of Puchy (US 4,887,756) to teach the newly recited limitations.
Claim Rejections - 35 USC § 103
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 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, 3, 4, 6, 7, 9-12, 14, 15, 17, 24, and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (US 2008/0082126) in view of Parihar et al. (US 2014/0305989), further in view of Ransick et al. (US 2006/0052825), further in view of Puchy (US 4,887,756).
Regarding claims 1 and 24, Murray et al. discloses a method of selecting a staple cartridge for a surgical procedure that treats the tissue of a patient (Abstract), comprising: manufacturing ([0125] and FIGs 85, 100 show a process of manufacturing by forming staples from elongate wires. [0184] further discloses a process of separately manufacturing crowns and assembling them to the base of the staples) a first staple cartridge (64, FIG 3, and 318, [0199, FIGs 67-70) having first staples (120, FIG 5-6 and 302, FIGs 58-70; various other staple embodiments are shown throughout the disclosure as well) stored therein, wherein the first staple cartridge is useable with a surgical stapling instrument (The cartridges are usable with an instrument such as 30, FIG 2, [0177]) wherein the first staples degrade in the patient after being implanted in the patient ([0187] discloses degradation or absorption of the material of the staples after implantation in the tissue), wherein the first staples transition from a functional state to a degraded non-functional and fully dissolved state in a first time frame ([0187] discloses the characteristics of the material determines the degradation rate. A “fully dissolved state” is interpreted to also meet the limitations of a “degraded non functional state”); manufacturing ([0125] and FIGs 85, 100 show a process of manufacturing by forming staples from elongate wires. [0184] further discloses a process of separately manufacturing crowns and assembling them to the base of the staples) a second staple cartridge (64, FIG 3, and 318, [0199, FIGs 67-70; it is understood that the disclosure supports the creation of at least a second staple cartridge) having second staples (120, FIG 5-6 and 302, FIGs 58-70; various other staple embodiments are shown throughout the disclosure as well) stored therein, wherein the second staple cartridge is useable with the surgical stapling instrument (The cartridges are usable with an instrument such as 30, FIG 2, [0177]), wherein the second staples degrade in the patient after being implanted in the patient ([0187] discloses degradation or absorption of the material of the staples after implantation in the tissue), wherein the second staples transition from a functional state to a degraded non-functional and fully dissolved state in a second time frame ([0187] discloses the characteristics of the material determines the degradation rate. A “fully dissolved state” is interpreted to also meet the limitations of a “degraded non functional state”) which is longer than the first time frame ([0187] discloses use of a material such as titanium or steel has a longer degradation rate. [0187] further discloses staples within the same cartridge can dissolve at different rates. Therefore, there are staples in one cartridge which dissolve faster than in another cartridge). Murray et al. further discloses the material of the staple components can be “selected” such that they dissolve at the desired rates ([0187]), which is understood to be the same as selecting the staples to match the first time frame or the second time frame with a healing window of the patient tissue). Murray further discloses the healing window is defined by a healing window of an incision in the patient tissue ([0024, 0179, 0224] discloses use of the staples to heal an incision).
Murray et al. is silent regarding the step of offering the first staple cartridge and the second staple cartridge such that a clinician can select between the first staple cartridge and the second staple cartridge to match the first time frame or the second time frame with a healing window of the patient tissue.
Parihar discloses the use of a surgical stapling instrument end effector (1000, [0456]) along with a replaceable cartridge (1060) which houses staples ([0456]) and wherein, as a part of the method of use, a clinician can select between at least a first and second staple cartridge ([0456] discloses a user can select a staple cartridge for use in the end effector based on a particular treatment tissue and that a first staple cartridge of the surgical instrument system can include a first type of staple and a second staple cartridge can include a second type of staple).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method to include offering the first staple cartridge and the second staple cartridge such that a clinician can select between the first staple cartridge and the second staple cartridge to match the first time frame or the second time frame with a healing window of the patient tissue, for the purpose of optimizing the procedure by selecting the most compatible staples for use with a particular tissue.
The method as modified is silent regarding matching the first time frame or the second time frame with the healing window of the patient tissue comprises selecting one of the first time frame or the second time frame such that the selected one of the first time frame or the selected second time frame exceeds the healing window but exceeds the healing window by the least amount of time relative to the other of the first time frame or the second time frame.
However, Ransick et al. discloses biodegradable surgical staples (10, FIGs 1-3, abstract, [0020]) wherein the material selected to form the implant is based on a desired time frame (healing window) in which the implant should remain structurally operative within the patient before degrading ([0021-0022]). Ransick teaches wherein the time frame should be selected “so that the patient does not carry an implant after the implant is no longer needed” ([0022]). In other words, the material composition should be selected such that the implant remains functional long enough for healing of the tissue but not longer than needed i.e. exceeds the healing window by the minimal amount of time.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method such that matching the first time frame or the second time frame with the healing window of the patient tissue comprises selecting one of the first time frame or the second time frame such that the selected one of the first time frame or the selected second time frame exceeds the healing window but exceeds the healing window by the least amount of time relative to the other of the first time frame or the second time frame, as taught by Ransick et al., for the purpose of selecting the implant that will remain structurally active long enough for a desired healing of the tissue to occur while exceeding this time window by the minimal amount in order to reduce the time which the patient is carrying the implant after the implant is no longer needed.
The method as modified is further silent regarding manufacturing a first packaging comprising a first indica indicative of the first time frame; positioning the first staple cartridge in the first packaging; manufacturing a second packaging comprising a second indica indicative of the second time frame; and positioning the second staple cartridge in the second packaging.
However, Puchy teaches that it is common practice in the art to provide staples within a packaging and to provide a variety of staple types within said packaging, such that the surgeon can select the type most appropriate for the particular procedure (Col 6 lines 9-15). Puchy also teaches that the packaging would contain an indica indicative of the staple type (In the example provided: `normal`, `wide` and `extra wide’). Puchy teaches that the surgeon would be offered a variety of staple types within a variety of packaging, each labeled with in indicator of what staple is contained therein, and would then select the staple type best suited for the procedure “to satisfy different wound situations” (Col 6 lines 9-15).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method such that the first and second staple cartridges are positioned within a first and second packaging, and that said first and second packaging is provided with an indicia indicative of the first and second time frames, for the purpose of labeling the packages to denote the different staple type contained therewithin and do so in a manner which is easily offered to the clinician such that they can readily determine what is contained within each package and select the one most suitable for a particular procedure.
Regarding claim 3, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. The method as modified further discloses providing the staple cartridge selected by the clinician (Because a staple cartridge has been selected, it is interpreted as also being “provided” to the user).
Regarding claim 4, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first staples are comprised of magnesium and the second staples are comprised of stainless steel ([0187] discloses forming the staples from magnesium or stainless steel depending on the desired degradation rate).
Regarding claim 6, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first staples are comprised of iron and the second staples are comprised of stainless steel ([0187] discloses forming the staples from iron or stainless steel depending on the desired degradation rate).
Regarding claim 7, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first staples are comprised of magnesium and the second staples are comprised of titanium ([0187] discloses forming the staples from magnesium or titanium depending on the desired degradation rate).
Regarding claim 9, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first staples are comprised of iron and the second staples are comprised of titanium ([0187] discloses forming the staples from iron or titanium depending on the desired degradation rate).
Regarding claims 10-12, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1.
Murray et al. is silent regarding wherein the first staples are comprised of a first magnesium, zinc, or iron alloy and the second staples are comprised of a second magnesium, zinc, or iron alloy, wherein the first alloy and the second alloy are different.
Ransick et al. teaches a surgical staple (10, FIG 2, [0024]) wherein the staple can be formed of a magnesium alloy ([0028]), a zinc alloy ([0028] discloses the alloy can comprise zinc, therefore making it a zinc alloy as well), or an iron alloy ([0028] discloses the alloy can comprise iron, therefore making it a iron alloy as well).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the staples of the cartridge to comprise a magnesium, zinc, and/or iron alloy, as taught by Ransick et al., for the purpose of selecting a material commonly known in the art for forming biocompatible surgical staples having the desired structural and degradation properties ([0003]).
The device as modified is further silent regarding the respective first alloy and the second alloy being different.
However, it would have been obvious to one of ordinary skill in the art at the time of filing to provide the cartridges such that the first and second magnesium alloy are different, the first and second zinc alloy are different, and the first and second iron alloy are different, in order to obtain staples having different degradation rates and therefore offering a different first and second staple cartridge to closest match to the healing window of the patient tissue.
Regarding claim 14, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first staples are comprised of magnesium and the second staples are comprised of iron ([0187] discloses forming the staples from magnesium or iron depending on the desired degradation rate).
Regarding claim 15, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first staples are not coated with a coating and the second staples are at least partially coated with a coating ([0185 and 0195-0197] disclose the use of partial coating 274 “in some embodiments”. Therefore, it is understood that other embodiments are not coated).
Regarding claim 17, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. The method as modified further discloses matching the first time frame or the second time frame with the healing window of the patient tissue comprises selecting the one of the first time frame and the second time frame that exceeds the healing window by the least amount of time (exceeding by the least amount of time also includes being closest to the healing window as recited in claim 17 and 26) (Selecting the appropriate cartridge in the method as modified is based on which cartridge comprises staple material which will allow the staple to dissolve in the desired time. It is understood that selecting the optimal staple for a procedure includes one that degrades closest to the time frame of the healing window and must exceed the healing window such that the staples do not dissolve before the incision is fully healed, as supported by the teachings of Ransick).
Regarding claims 27 and 28, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1 and 24. The method as modified further discloses the healing window (i) comprises an amount of time needed before the incised tissue achieves a predicted desirable stability or strength (Ransick teaches “absorbed by the body after a period of time so that the patient does not carry an implant after the implant is no longer needed”. It is understood that tissue achieving a predicted desirable stability or strength is used to determine how long an implant is needed) and (ii) depends on an organ type of the patient tissue and the surgical procedure performed (It is commonly known that tissue of different organs will heal under different time windows).
Regarding claims 29 and 30, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1 and 24. The method as modified further discloses first indicia comprises at least one of a number, letter, word, symbol, or color corresponding to the first time frame and the second indicia comprises at least one of a number, letter, word, symbol, or color corresponding to the second time frame (Puchy teaches using words as the indica to indicate the staple type contained within the respective packaging).
Claim(s) 5, 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (US 2008/0082126) in view of Parihar et al. (US 2014/0305989), further in view of Ransick et al. (US 2006/0052825), further in view of Puchy (US 4,887,756), further in view of Eckert et al. (US 2017/0056007).
Regarding claims 5, 8, and 13, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first or second staples comprised of stainless steel (claim 5), titanium (claim 8), and magnesium (claim 13) ([0187] discloses forming the staples from stainless steel, titanium, or magnesium depending on the desired degradation rate).
Murray et al. is silent regarding the other of the staples comprising zinc.
However, Eckert et al. teaches forming staples of a variety of materials such as stainless steel, titanium, magnesium, or zinc ([0248]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the other of the first or second staples of Murray to comprise zinc, as taught by Eckert et al., for the purpose of selecting a commonly known material in the art for forming staple and having desired biocompatibility properties, and because Eckert et al. further states that zinc increases the healing performance of tissue ([0248]).
Claim(s) 1, 3, 4, 6, 7, 9-12, 14, 15, 17, 24, and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (US 2008/0082126) in view of Shelton (US 2018/0168633), further in view of Ransick et al. (US 2006/0052825), further in view of Puchy (US 4,887,756).
Regarding claims 1 and 24, Murray et al. discloses a method of selecting a staple cartridge for a surgical procedure that treats the tissue of a patient (Abstract), comprising: manufacturing ([0125] and FIGs 85, 100 show a process of manufacturing by forming staples from elongate wires. [0184] further discloses a process of separately manufacturing crowns and assembling them to the base of the staples) a first staple cartridge (64, FIG 3, and 318, [0199, FIGs 67-70) having first staples (120, FIG 5-6 and 302, FIGs 58-70; various other staple embodiments are shown throughout the disclosure as well) stored therein, wherein the first staple cartridge is useable with a surgical stapling instrument (The cartridges are usable with an instrument such as 30, FIG 2, [0177]) wherein the first staples degrade in the patient after being implanted in the patient ([0187] discloses degradation or absorption of the material of the staples after implantation in the tissue), wherein the first staples transition from a functional state to a degraded non-functional and fully dissolved state in a first time frame ([0187] discloses the characteristics of the material determines the degradation rate. A “fully dissolved state” is interpreted to also meet the limitations of a “degraded non functional state”); manufacturing ([0125] and FIGs 85, 100 show a process of manufacturing by forming staples from elongate wires. [0184] further discloses a process of separately manufacturing crowns and assembling them to the base of the staples) a second staple cartridge (64, FIG 3, and 318, [0199, FIGs 67-70; it is understood that the disclosure supports the creation of at least a second staple cartridge) having second staples (120, FIG 5-6 and 302, FIGs 58-70; various other staple embodiments are shown throughout the disclosure as well) stored therein, wherein the second staple cartridge is useable with the surgical stapling instrument (The cartridges are usable with an instrument such as 30, FIG 2, [0177]), wherein the second staples degrade in the patient after being implanted in the patient ([0187] discloses degradation or absorption of the material of the staples after implantation in the tissue), wherein the second staples transition from a functional state to a degraded non-functional and fully dissolved state in a second time frame ([0187] discloses the characteristics of the material determines the degradation rate. A “fully dissolved state” is interpreted to also meet the limitations of a “degraded non functional state”) which is longer than the first time frame ([0187] discloses use of a material such as titanium or steel has a longer degradation rate. [0187] further discloses staples within the same cartridge can dissolve at different rates. Therefore, there are staples in one cartridge which dissolve faster than in another cartridge). Murray et al. further discloses the material of the staple components can be “selected” such that they dissolve at the desired rates ([0187]), which is understood to be the same as selecting the staples to match the first time frame or the second time frame with a healing window of the patient tissue). Murray further discloses the healing window is defined by a healing window of an incision in the patient tissue ([0024, 0179, 0224] discloses use of the staples to heal an incision).
Murray et al. is silent regarding the step of offering the first staple cartridge and the second staple cartridge such that a clinician can select between the first staple cartridge and the second staple cartridge to match the first time frame or the second time frame with a healing window of the patient tissue.
Shelton discloses the use of a surgical stapling instrument end effector (1100, [0350]) along with a replaceable cartridge (1110, FIG 1) which houses staples ([00352-0354]) and wherein, as a part of the method of use, a clinician can select between at least a first and second staple cartridge ([0355] discloses a surgeon may select a staple cartridge having a particular arrangement of staple cavities based on the surgical procedure to be performed and/or the properties of the tissue to be treated during the surgical procedure, for example).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method to include offering the first staple cartridge and the second staple cartridge such that a clinician can select between the first staple cartridge and the second staple cartridge to match the first time frame or the second time frame with a healing window of the patient tissue, for the purpose of optimizing the procedure by selecting the most compatible staples for use with a particular tissue.
The device as modified is silent regarding matching the first time frame or the second time frame with the healing window of the patient tissue comprises selecting one of the first time frame or the second time frame such that the selected one of the first time frame or the selected second time frame exceeds the healing window but exceeds the healing window by the least amount of time relative to the other of the first time frame or the second time frame.
However, Ransick et al. discloses biodegradable surgical staples (10, FIGs 1-3, abstract, [0020]) wherein the material selected to form the implant is based on a desired time frame (healing window) in which the implant should remain structurally operative within the patient before degrading ([0021-0022]). Ransick teaches wherein the time frame should be selected “so that the patient does not carry an implant after the implant is no longer needed” ([0022]). In other words, the material composition should be selected such that the implant remains functional long enough for healing of the tissue but not longer than needed i.e. exceeds the healing window by the minimal amount of time.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method such that matching the first time frame or the second time frame with the healing window of the patient tissue comprises selecting one of the first time frame or the second time frame such that the selected one of the first time frame or the selected second time frame exceeds the healing window but exceeds the healing window by the least amount of time relative to the other of the first time frame or the second time frame, as taught by Ransick et al., for the purpose of selecting the implant that will remain structurally active long enough for a desired healing of the tissue to occur while exceeding this time window by the minimal amount in order to reduce the time which the patient is carrying the implant after the implant is no longer needed.
The method as modified is further silent regarding manufacturing a first packaging comprising a first indica indicative of the first time frame; positioning the first staple cartridge in the first packaging; manufacturing a second packaging comprising a second indica indicative of the second time frame; and positioning the second staple cartridge in the second packaging.
However, Puchy teaches that it is common practice in the art to provide staples within a packaging and to provide a variety of staple types within said packaging, such that the surgeon can select the type most appropriate for the particular procedure (Col 6 lines 9-15). Puchy also teaches that the packaging would contain an indica indicative of the staple type (In the example provided: `normal`, `wide` and `extra wide’). Puchy teaches that the surgeon would be offered a variety of staple types within a variety of packaging, each labeled with in indicator of what staple is contained therein, and would then select the staple type best suited for the procedure “to satisfy different wound situations” (Col 6 lines 9-15).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method such that the first and second staple cartridges are positioned within a first and second packaging, and that said first and second packaging is provided with an indicia indicative of the first and second time frames, for the purpose of labeling the packages to denote the different staple type contained therewithin and do so in a manner which is easily offered to the clinician such that they can readily determine what is contained within each package and select the one most suitable for a particular procedure.
Regarding claim 3, Murray et al/ Shelton/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. The method as modified further discloses providing the staple cartridge selected by the clinician (Because a staple cartridge has been selected, it is interpreted as also being “provided” to the user).
Regarding claim 4, Murray et al/ Shelton/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first staples are comprised of magnesium and the second staples are comprised of stainless steel ([0187] discloses forming the staples from magnesium or stainless steel depending on the desired degradation rate).
Regarding claim 6, Murray et al/ Shelton/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first staples are comprised of iron and the second staples are comprised of stainless steel ([0187] discloses forming the staples from iron or stainless steel depending on the desired degradation rate).
Regarding claim 7, Murray et al/ Shelton/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first staples are comprised of magnesium and the second staples are comprised of titanium ([0187] discloses forming the staples from magnesium or titanium depending on the desired degradation rate).
Regarding claim 9, Murray et al/ Shelton/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first staples are comprised of iron and the second staples are comprised of titanium ([0187] discloses forming the staples from iron or titanium depending on the desired degradation rate).
Regarding claims 10-12, Murray et al/ Shelton/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1.
Murray et al. is silent regarding wherein the first staples are comprised of a first magnesium, zinc, or iron alloy and the second staples are comprised of a second magnesium, zinc, or iron alloy, wherein the first alloy and the second alloy are different.
Ransick et al. teaches a surgical staple (10, FIG 2, [0024]) wherein the staple can be formed of a magnesium alloy ([0028]), a zinc alloy ([0028] discloses the alloy can comprise zinc, therefore making it a zinc alloy as well), or an iron alloy ([0028] discloses the alloy can comprise iron, therefore making it a iron alloy as well).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the staples of the cartridge to comprise a magnesium, zinc, and/or iron alloy, as taught by Ransick et al., for the purpose of selecting a material commonly known in the art for forming biocompatible surgical staples having the desired structural and degradation properties ([0003]).
The device as modified is further silent regarding the respective first alloy and the second alloy being different.
However, it would have been obvious to one of ordinary skill in the art at the time of filing to provide the cartridges such that the first and second magnesium alloy are different, the first and second zinc alloy are different, and the first and second iron alloy are different, in order to obtain staples having different degradation rates and therefore offering a different first and second staple cartridge to closest match to the healing window of the patient tissue.
Regarding claim 14, Murray et al/ Shelton/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first staples are comprised of magnesium and the second staples are comprised of iron ([0187] discloses forming the staples from magnesium or iron depending on the desired degradation rate).
Regarding claim 15, Murray et al/ Shelton/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first staples are not coated with a coating and the second staples are at least partially coated with a coating ([0185 and 0195-0197] disclose the use of partial coating 274 “in some embodiments”. Therefore, it is understood that other embodiments are not coated).
Regarding claim 17, Murray et al/ Shelton/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. The method as modified further discloses matching the first time frame or the second time frame with the healing window of the patient tissue comprises selecting the one of the first time frame and the second time frame that exceeds the healing window by the least amount of time (exceeding by the least amount of time also includes being closest to the healing window as recited in claim 17 and 26) (Selecting the appropriate cartridge in the method as modified is based on which cartridge comprises staple material which will allow the staple to dissolve in the desired time. It is understood that selecting the optimal staple for a procedure includes one that degrades closest to the time frame of the healing window and must exceed the healing window such that the staples do not dissolve before the incision is fully healed, as supported by the teachings of Ransick).
Regarding claims 27 and 28, Murray et al/ Shelton/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1 and 24. The method as modified further discloses the healing window (i) comprises an amount of time needed before the incised tissue achieves a predicted desirable stability or strength (Ransick teaches “absorbed by the body after a period of time so that the patient does not carry an implant after the implant is no longer needed”. It is understood that tissue achieving a predicted desirable stability or strength is used to determine how long an implant is needed) and (ii) depends on an organ type of the patient tissue and the surgical procedure performed (It is commonly known that tissue of different organs will heal under different time windows).
Regarding claims 29 and 30, Murray et al/Parihar/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1 and 24. The method as modified further discloses first indicia comprises at least one of a number, letter, word, symbol, or color corresponding to the first time frame and the second indicia comprises at least one of a number, letter, word, symbol, or color corresponding to the second time frame (Puchy teaches using words as the indica to indicate the staple type contained within the respective packaging).
Claim(s) 5, 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (US 2008/0082126) in view of Shelton (US 2018/0168633), further in view of Ransick et al. (US 2006/0052825), further in view of Puchy (US 4,887,756), further in view of Eckert et al. (US 2017/0056007).
Regarding claims 5, 8, and 13, Murray et al/ Shelton/Ransick/Puchy discloses the invention substantially as claimed, as set forth above for claim 1. Murray et al. further discloses the first or second staples comprised of stainless steel (claim 5), titanium (claim 8), and magnesium (claim 13) ([0187] discloses forming the staples from stainless steel, titanium, or magnesium depending on the desired degradation rate).
Murray et al. is silent regarding the other of the staples comprising zinc.
However, Eckert et al. teaches forming staples of a variety of materials such as stainless steel, titanium, magnesium, or zinc ([0248]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the other of the first or second staples of Murray to comprise zinc, as taught by Eckert et al., for the purpose of selecting a commonly known material in the art for forming staple and having desired biocompatibility properties, and because Eckert et al. further states that zinc increases the healing performance of tissue ([0248]).
Conclusion
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771