DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in response to the RCE filed on 01/02/2026. Claims 1, 3, 4, and 6-23 are pending. Claims 1 and 17 are independent. Claims 8-10, 13, and 18 are withdrawn. Claim 4 is canceled.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/02/2026 has been entered.
Drawings
The drawings are objected to because the depth “128” shown in Fig. 7C is the same as the thickness “120” shown in Fig. 7B (“128” is the same as “120” by flipping image 7C by 180 degrees). As described in the specification, the “depth” is the third dimension different from the length and the thickness of the staple. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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, 4, 6, 7, 11, 12, 14-17, and 19-23 is 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “a pair of legs extending a generally equal distance orthogonally from the crown and having a depth that ranges from 0.25 mm to 1.5 mm” which contains new matter. First, the specification describes the depth of the legs to be represented by numeral “128” as shown in Fig. 7C (specification, Para. [0056]). The specification is completely silent on the pair of legs having a depth that ranges from 0.25 mm to 1.5 mm. Secondly, the specification describes that the surgical staple is formed from a sheet of the biodegradable metal having a thickness (12, Para. [0041]) ranging from 0.25 mm to 1.5 mm using a laser cutting process. It should be noted that the thickness of the staple is represented by the numeral 12 which is different than the depth. Furthermore, the specification describes that the sheet of the metal has a thickness 12 ranging from 0.25 mm to 1.5 mm. It does not necessary means that the thickness of the staple has a thickness ranging from 0.25 mm to 1.5 mm because of the laser cutting process which removes some of the material from the sheet of metal to form the staple. Furthermore, the “depth” is the third dimension different from the length and the thickness of the staple as described in the specification. However, Fig 7C mistakenly shows the thickness “120” to represent the depth “128” (“128” is the same as “120” by flipping image 7C by 180 degrees). Although the specification describes that the thickness 12 is ranging from 0.25 mm to 1.5 mm (Para. [0048]) and the depth 128 may remain constant due to the use of a constant-thickness sheet (e.g., sheet 10, depicted in FIGS. 2B and 2C), however it does not describe that the depth 128 of the staple is the thickness 12 of the sheet or just another thickness of the sheet in a different dimension. Instead, the specification specifically describes that the depth 120 and the thickness 128 of the legs are different dimensions (Paras. [0055] and [0056] “a thickness 120 of the leg portion 102” and “the thickness of the legs 102 may be varied, the depth 128 may remain constant”).
Claim 17 recites the limitation “a pair of legs extending a generally equal distance orthogonally from the crown and having a depth that ranges from 0.25 mm to 1.5 mm” which contains new matter. First, the specification describes the depth of the legs to be represented by numeral “128” as shown in Fig. 7C (specification, Para. [0056]). The specification is completely silent on the pair of legs having a depth that ranges from 0.25 mm to 1.5 mm. Secondly, the specification describes that the surgical staple is formed from a sheet of the biodegradable metal having a thickness ranging from 0.25 mm to 1.5 mm using a laser cutting process. It should be noted that the thickness of the staple is represented by the numeral 12 which is different than the depth. Furthermore, the specification describes that the sheet of the metal has a thickness ranging from 0.25 mm to 1.5 mm. It does not necessary means that the thickness of the staple has a thickness ranging from 0.25 mm to 1.5 mm because of the laser cutting process which removes some of the material from the sheet of metal to form the staple. Furthermore, the “depth” is the third dimension different from the length and the thickness of the staple as described in the specification. However, Fig 7C mistakenly shows the thickness “120” to represent the depth “128” (“128” is the same as “120” by flipping image 7C by 180 degrees). Although the specification describes that the thickness 12 is ranging from 0.25 mm to 1.5 mm (Para. [0048]) and the depth 128 may remain constant due to the use of a constant-thickness sheet (e.g., sheet 10, depicted in FIGS. 2B and 2C), however it does not describe that the depth 128 of the staple is the thickness 12 of the sheet or just another thickness of the sheet in a different dimension. Instead, the specification specifically describes that the depth 120 and the thickness 128 of the legs are different dimensions (Paras. [0055] and [0056] “a thickness 120 of the leg portion 102” and “the thickness of the legs 102 may be varied, the depth 128 may remain constant”).
The art rejections below is/are made as best understood by the examiner because of the 35 U.S.C. 112(s) issues stated above.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 4, 12, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fishbein (US Pat. No.: 3,873,016) in view of Storace (US Pat. No.: 4,669,647), Becht et al. (US Pat. No.: 4,261,244), and Viola et al. (US Pub. No.: 2011/0087278).
Regarding claims 1, 3, and 4, Fishbein discloses a surgical staple (staple shown in Figs. 2 and 6) configured for external wound closure (see Abstract), comprising a crown comprising a center portion and a foldable portion (Fig. 2, crown of staple with a center portion and foldable portion), and a pair of legs (legs of the staple, Figs. 1 and 2) extending a generally equal distance orthogonally from the crown and configured to puncture tissue on opposing sides of an incision or wound (Figs. 2 and 6). However, Fishbein does not disclose that a length of the crown ranges from 10 mm to 20 mm; the pair of legs having a depth that ranges from 0.25 mm to 1.5 mm, wherein each leg of the pair of legs terminates in a sharpened end; wherein the crown and the pair of legs are fabricated from a biodegradable metal configured such that a first portion of the surgical staple is configured to be ejected from the tissue and a second portion of the surgical staple is configured to degrade and absorbed within the tissue; and wherein the biodegradable metal comprises magnesium alloyed with at least one alloying element.
Storace teaches, in the same field of endeavor (surgical staple), a length of a crown of a surgical staple (34, Fig. 6) ranges from 10 mm to 20 mm, such as about 14mm (Fig. 6, the length W1 if the crown is about 0.555” which is about 14.097 mm, Col. 7, lines 45-56); each leg of a pair of legs terminates in a sharpened end (Fig. 6), and wherein the sharpened ends of the pair of legs are configured to puncture skin and be driven into tissue on opposing sides of an incision or wound (Fig. 6 and Col. 1, lines 20-26).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the length of the crown of the surgical staple of Fishbein to range from 10 mm – 20 mm, such as about 14mm as taught by Storace, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05. Also, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify each leg of a pair of legs of Fishbein to terminate in a sharpened end, and wherein the sharpened ends of the pair of legs are configured to puncture skin and be driven into tissue on opposing sides of an incision or wound as taught by Storace in order to facilitate the staple to puncture through the skin and into the tissue (Storace, Col. 1, lines 20-26).
Becht teaches, in the same field of endeavor (surgical staple), a pair of legs of a staple having a depth that ranges from 0.25 mm to 1.5 mm, such as about 0.51 mm (Col. 9, line 53 – Col. 10, line 2; diameter/thickness of 0.02 inch is about 0.51 mm).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the depth of the legs to range from 0.25 mm to 1.5 mm, such as 0.51 mm as taught by Becht, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
Viola teaches, in the same field of endeavor (surgical staple), a staple (10, Para. [0021] and [0024]-[0025]) having a crown and pair of legs (Figs. 1 and 2); wherein the crown and the pair of legs are fabricated from a biodegradable metal (Paras. [0024]-[0025]) configured such that a first portion of the surgical staple is fully capable to be ejected from the tissue and a second portion of the surgical staple is fully capable to degrade and absorbed within the tissue (Para. [0021] and [0024]-[0025], a first portion of the surgical staple is fully capable to be ejected from the tissue and a second portion of the surgical staple is fully capable to degrade and absorbed within the tissue since the staple is formed a biodegradable material); and wherein the biodegradable metal comprises magnesium alloyed with at least one alloying element (Paras. [0024]-[0025], Mg—RE—Zn or Mg—RE—Zr); wherein the at least one alloying element is a rare earth element (Para. [0024], such as zirconium); and wherein the rare earth element comprises zirconium (Para. [0024]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the staple of Fishbein to include that the crown and the pair of legs are fabricated from a biodegradable metal configured such that a first portion of the surgical staple is fully capable to be ejected from the tissue and a second portion of the surgical staple is fully capable to degrade and absorbed within the tissue; and wherein the biodegradable metal comprises magnesium alloyed with at least one alloying element; wherein the at least one alloying element is a rare earth element; and wherein the rare earth element comprises zirconium as taught by Viola in order to obtain the advantage of allowing the staples to be automatically removed/disappeared from the body without any harmful effect on the patient (Viola, Paras. [0023] and [0025]).
Regarding claim 12, Storace further teaches that each leg of the pair of legs terminates in a plurality of faces converging to a pointed end (Fig. 6, each leg of the pair of legs terminates in a plurality of flat and round faces converging a pointed end).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the staple of Fishbein to include that each leg of the pair of legs terminates in a plurality of faces converging to a pointed end as taught by Storace in order to obtain the advantage of facilitating penetration of the staple into the tissue (Storace, Col. 1, lines 20-26).
Regarding claim 21, in the modified invention, the center portion of the crown is configured to be located supracutaneously to the tissue and the foldable portion of the crown is configured to be driven subcutaneously into the tissue (Fishbein, Figs. 5 and 6);
Regarding claim 22, in the modified invention, the first portion of the surgical staple comprises the center portion of the crown and the second portion of the surgical staple comprises at least a portion of each leg in the pair of legs (Fishbein, Figs. 2, 5, and 6).
Regarding claim 23, in the modified invention, the first portion of the surgical staple comprises at least a portion of the crown and the second portion of the surgical staple comprises at least a tip portion of each leg in the pair of legs (Fishbein, Figs. 2, 5, and 6)
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fishbein (US Pat. No.: 3,873,016) in view of Storace (US Pat. No.: 4,669,647), Becht et al. (US Pat. No.: 4,261,244), and Viola et al. (US Pub. No.: 2011/0087278) as applied to claim 1 above, and further in view of Furst et al.’869 (US Pub. No.: 2006/0198869).
Regarding claim 6, Fishbein in view of Storace, Becht, and Viola discloses substantially all the limitation of the claim as taught above but fails to disclose that the at least one alloying element comprises up to 35% of a total biodegradable metal weight.
Furst’869 teaches, in the same field of endeavor (staple, Para. [0007]), the at least one alloying element of the staple comprises up to 35% of a total biodegradable metal weight (Paras. [0007] and [0011] and Table shown between Paras. [0011] and [0012]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the at least one alloying element of the staple of Fishbein in view of Storace, Becht, and Viola to include up to 35% of a total biodegradable metal weight (such as 0.2-0.8% or 2%) as taught by Furst’869, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fishbein (US Pat. No.: 3,873,016) in view of Storace (US Pat. No.: 4,669,647), Becht et al. (US Pat. No.: 4,261,244), and Viola et al. (US Pub. No.: 2011/0087278) as applied to claim 1 above, and further in view of Coleman et al. (US Pub. No.: 2017/0202552).
Regarding claim 7, Fishbein in view of Storace, Becht, and Viola discloses substantially all the limitation of the claim as taught above but fails to disclose that the crown includes a minimum height region is located at the center portion that tapers outwardly to pair of maximum height regions located at the foldable portion proximate the pair of legs.
Coleman teaches, in the same field of endeavor (staple), a crown of a staple includes a minimum height region is located at a center portion (center portion at 160) that tapers outwardly to pair of maximum height regions located at the foldable portion proximate the pair of legs (Figs. 1 and 2, the center portion tapers outwardly to pair of maximum height regions located at the foldable portion proximate the pair of legs); wherein a thickness of the minimum height region is the same as a thickness of a pair of maximum height regions (Fig. 1 and also see Fig. 5).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the crown of the staple of Fishbein in view of Storace, Becht, and Viola to include a minimum height region is located at the center portion that tapers outwardly to pair of maximum height regions located at the foldable portion proximate the pair of legs; wherein a thickness of the minimum height region is the same as a thickness of a pair of maximum height regions as taught by Coleman in order to manipulate the stress distribution with the staple crown and the legs to achieve a desired performance (Coleman, Para. [0024]). In the modified invention, the first portion of the staple fully capable to be rejected from the tissue comprises the center portion of the crown when it is placed external to the body tissue.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fishbein (US Pat. No.: 3,873,016) in view of Storace (US Pat. No.: 4,669,647), Becht et al. (US Pat. No.: 4,261,244), and Viola et al. (US Pub. No.: 2011/0087278) as applied to claim 1 above, and further in view of Milo (US Pub. No.: 2011/0034953).
Regarding claim 11, Fishbein in view of Storace, Becht, and Viola discloses substantially all the limitation of the claim as taught above with the metal of the staple being biodegradable but fails to disclose that the surgical staple is formed from a sheet of the metal having a thickness ranging from 0.25 mm to 1.5 mm using a laser cutting process. The claimed phrase “wherein the surgical staple is formed from a sheet of the biodegradable metal having a thickness ranging from 0.25 mm to 1.5 mm using a laser cutting process” is being treated as a product by process limitation and means that the staple was made by laser cutting a sheet of the biodegradable metal having a thickness ranging from 0.25 mm to 1.5 mm.
Milo teaches, in the same field of endeavor (staple), a surgical staple formed a sheet of the metal having a thickness ranging from 0.25 mm to 1.5 mm using a laser cutting process (Para. [0044]).
Therefore, even if “laser cutting a sheet of the metal having a thickness ranging from 0.25 mm to 1.5 mm” results in different structural characteristics of the end product than other manufacturing methods, it still would have been prima facie obvious at the time the invention was made to use a material formed by “laser cutting a sheet of the metal having a thickness ranging from 0.25 mm to 1.5 mm” in Fishbein in view of Storace, Becht, and Viola as claimed since Milo teaches that laser cutting a sheet of the metal having a thickness ranging from 0.25 mm to 1.5 mm is recognized as a useful technique for forming a surgical staple.
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fishbein (US Pat. No.: 3,873,016) in view of Storace (US Pat. No.: 4,669,647), Becht et al. (US Pat. No.: 4,261,244), and Viola et al. (US Pub. No.: 2011/0087278) as applied to claim 1 above, and further in view of Furst’805 (US Pub. No.: 2007/0288085).
Regarding claim 14, Fishbein in view of Storace, Becht, and Viola discloses substantially all the limitation of the claim as taught above but fails to disclose that at least a portion of the surgical staple is coated with a biodegradable coating configured to provide a moisture and dielectric barrier, wherein the biodegradable coating has a thickness of at least 0.001 microns.
Furst’805 teaches, in the same field of endeavor (staple, Para. [0006]), at least a portion of a surgical staple (Para. [0006]) is coated with a biodegradable coating configured to provide a moisture and dielectric barrier (Para. [0060], such as polyvinyl alcohol or polyethylene glycol), wherein the biodegradable coating has a thickness of at least 0.001 microns (Para. [0060]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the surgical staple of Fishbein in view of Storace, Becht, and Viola to include at least a portion of the surgical staple is coated with a biodegradable coating configured to provide a moisture and dielectric barrier, wherein the biodegradable coating has a thickness of at least 0.001 microns as taught by Furst’805 in order to improve the durability or biocompatibility of the staples (Furst’805, Para. [0060]), and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
Regarding claim 15, Fishbein in view of Storace, Becht, and Viola discloses substantially all the limitation of the claim as taught above but fails to disclose that at least a portion of the surgical staple is coated with an oxide layer having a thickness between 5 and 8 microns.
Furst’805 teaches, in the same field of endeavor (staple, Para. [0006]), at least a portion of the surgical staple is coated with an oxide layer (Para. [0060], such as polyethylene oxide) having a thickness between 5 and 8 microns (Para. [0060]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the surgical staple of Fishbein in view of Storace, Becht, and Viola to include at least a portion of the surgical staple is coated with an oxide layer having a thickness between 5 and 8 microns as taught by Furst’805 in order to improve the durability or biocompatibility of the staples (Furst’805, Para. [0060]), and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
Regarding claim 16, Fishbein in view of Storace, Becht, and Viola discloses substantially all the limitation of the claim as taught above but fails to disclose that at least a portion of the surgical staple is coated with a plasticized biodegradable polymer.
Furst’805 teaches, in the same field of endeavor (staple, Para. [0006]), at least a portion of the surgical staple is coated with a plasticized biodegradable polymer (Para. [0060], such as polyvinyl alcohol).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the surgical staple of Fishbein in view of Storace, Becht, and Viola to include at least a portion of the surgical staple is coated with a plasticized biodegradable polymer as taught by Furst’805 in order to improve the durability or biocompatibility of the staples (Furst’805, Para. [0060]).
Claim(s) 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fishbein (US Pat. No.: 3,873,016) in view of Storace (US Pat. No.: 4,669,647), Becht et al. (US Pat. No.: 4,261,244), Viola et al. (US Pub. No.: 2011/0087278), and Curry (US Pat. No.: 5,620,289).
Regarding claims 17 and 19, Fishbein discloses [claim 17] a surgical staple system, comprising: a plurality of surgical staples (staples shown in Figs. 2 and 6) fully capable for external wound closure (see Abstract), each of the surgical staples comprising: a crown comprising a center portion and a foldable portion (Fig. 2); and a pair of legs extending a generally equal distance orthogonally from the crown and configured to puncture tissue on opposing sides of an incision or wound (Figs. 1 and 2); and [claim 19] a surgical staple carrier (10, Figs. 1-10), comprising: a support frame (20 with 50, Figs. 1, 2, and 10) configured to receive a subassembly of staples; a pusher (76, Fig. 2) coupled to a compression spring (the spring 76 exerting a force on 76, Col. 5, lines 30-52 and Fig. 2), the pusher and the compression spring configured to apply a force to the subassembly to slide the subassembly along the support frame (Col. 5, lines 30-52); and a crimping blade (32, Figs. 4-7) configured to be lowered onto the crowns to drive each of the plurality of surgical staples into the tissue. However, Fishbein does not disclose that a length of the crown ranges from 10 mm to 20 mm; the pair of legs having a depth that ranges from 0.25 mm to 1.5 mm, wherein each leg of the pair of legs terminates in a sharpened end; and wherein the crown and the pair of legs are fabricated from a biodegradable metal configured such that a first portion of the surgical staple is configured to be ejected from the tissue and a second portion of the surgical staple is configured to degrade and absorbed within the tissue; and wherein the biodegradable metal comprises magnesium alloyed with at least one alloying element; and a binder coating configured to secure the plurality of surgical staples to each other into a single subassembly, wherein the binder coating is selectively applied to a region of the crown.
Storace teaches, in the same field of endeavor (surgical staple), a length of a crown of a surgical staple (34, Fig. 6) ranges from 10 mm to 20 mm, such as about 14mm (Fig. 6, the length W1 if the crown is about 0.555” which is about 14.097 mm, Col. 7, lines 45-56); each leg of a pair of legs terminates in a sharpened end (Fig. 6), and wherein the sharpened ends of the pair of legs are configured to puncture skin and be driven into tissue on opposing sides of an incision or wound (Fig. 6 and Col. 1, lines 20-26).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the length of the crown of the surgical staple of Fishbein to range from 10 mm – 20 mm, such as about 14mm as taught by Storace, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05. Also, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify each leg of a pair of legs of Fishbein to terminate in a sharpened end, and wherein the sharpened ends of the pair of legs are configured to puncture skin and be driven into tissue on opposing sides of an incision or wound as taught by Storace in order to facilitate the staple to puncture through the skin and into the tissue (Storace, Col. 1, lines 20-26).
Becht teaches, in the same field of endeavor (surgical staple), a pair of legs of a staple having a depth that ranges from 0.25 mm to 1.5 mm, such as about 0.51 mm (Col. 9, line 53 – Col. 10, line 2; diameter/thickness of 0.02 inch is about 0.51 mm).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the depth of the legs to range from 0.25 mm to 1.5 mm, such as 0.51 mm as taught by Becht, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
Viola teaches, in the same field of endeavor (surgical staple), a staple (10, Para. [0021] and [0024]-[0025]) having a crown and pair of legs (Figs. 1 and 2); wherein the crown and the pair of legs are fabricated from a biodegradable metal (Paras. [0024]-[0025]) configured such that a first portion of the surgical staple is fully capable to be ejected from the tissue and a second portion of the surgical staple is fully capable to degrade and absorbed within the tissue (Para. [0021] and [0024]-[0025], a first portion of the surgical staple is fully capable to be ejected from the tissue and a second portion of the surgical staple is fully capable to degrade and absorbed within the tissue since the staple is formed a biodegradable material); and wherein the biodegradable metal comprises magnesium alloyed with at least one alloying element (Paras. [0024]-[0025], Mg—RE—Zn or Mg—RE—Zr).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the staple of Fishbein to include that the crown and the pair of legs are fabricated from a biodegradable metal configured such that a first portion of the surgical staple is fully capable to be ejected from the tissue and a second portion of the surgical staple is fully capable to degrade and absorbed within the tissue; and wherein the biodegradable metal comprises magnesium alloyed with at least one alloying element as taught by Viola in order to obtain the advantage of allowing the staples to be automatically removed/disappeared from the body without any harmful effect on the patient (Viola, Paras. [0023] and [0025]).
Curry discloses, in the same field of endeavor (staple), a binder coating (30 with 36/38, Figs 1-8) configured to secure the plurality of surgical staples to each other into a single subassembly, wherein the binder coating is selectively applied to a region of the crown of the staples (Figs. 1-8 and Col. 5, lines 19-29).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the surgical staple system of Fishbein to include that a binder coating configured to secure the plurality of surgical staples to each other into a single subassembly, wherein the binder coating is selectively applied to a region of the crown as taught by Curry in order to attached the staples together in a stack while separate the staples from one another as they are being deployed during operation of use (Col. 4, lines 23-31 and Col. 5, lines 6-29).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fishbein (US Pat. No.: 3,873,016) in view of Storace (US Pat. No.: 4,669,647), Becht et al. (US Pat. No.: 4,261,244), Viola et al. (US Pub. No.: 2011/0087278), and Curry (US Pat. No.: 5,620,289) as applied to claim 19 above, and further in view of Green et al. (US Pat. No.: 5,505,363) and Pinjala et al. (US Pub. No.: 2016/0256159).
Regarding claim 20, Fishbein in view of Storace, Becht, Viola, and Curry discloses substantially all the limitations of the claim but fails to disclose that at least one of the support frame and the crimping blade are at least one of: coated in a layer of dielectric paint having a thickness of at least 1 micron; and fabricated from a thermoplastic.
Green teaches, in the same field of endeavor (staple system), the support frame (anvil assembly 10 with member 30 and/or member 28 of the stapler) is coated in a layer of dielectric paint having a thickness of at least 1 micron (Col. 6, lines 16-32 and Col. 5, lines 1-8, PTFE is dielectric and painted on the support frame forming a coating).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the surgical staple system of Fishbein in view of Storace, Becht, Viola, and Curry to include that the support frame of the staple system to be coated in a layer of dielectric paint having a thickness of at least 1 micron as taught by Green in order to minimize the wear (Green, Col. 6, lines 16-32 and Col. 5, lines 1-8).
Pinjala teaches, in the same field of endeavor (staple system), the support frame (combination of 120 and 110) of a staple system is fabricated from a thermoplastic (Para. [0038]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify support frame of the surgical staple system of Fishbein in view of Storace, Becht, Viola, and Curry to fabricated from a thermoplastic as taught by Pinjala, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. See MPEP 2144.07
Response to Arguments
In response to the argument(s) on pages 7-8 of the remarks, claim 1 recites the limitation “a pair of legs extending a generally equal distance orthogonally from the crown and having a depth that ranges from 0.25 mm to 1.5 mm” which contains new matter. First, the specification describes the depth of the legs to be represented by numeral “128” as shown in Fig. 7C (specification, Para. [0056]). The specification is completely silent on the pair of legs having a depth that ranges from 0.25 mm to 1.5 mm. Secondly, the specification describes that the surgical staple is formed from a sheet of the biodegradable metal having a thickness (12, Para. [0041]) ranging from 0.25 mm to 1.5 mm using a laser cutting process. It should be noted that the thickness of the staple is represented by the numeral 12 which is different than the depth. Furthermore, the specification describes that the sheet of the metal has a thickness 12 ranging from 0.25 mm to 1.5 mm. It does not necessary means that the thickness of the staple has a thickness ranging from 0.25 mm to 1.5 mm because of the laser cutting process which removes some of the material from the sheet of metal to form the staple. Furthermore, the “depth” is the third dimension different from the length and the thickness of the staple as described in the specification. However, Fig 7C mistakenly shows the thickness “120” to represent the depth “128” (“128” is the same as “120” by flipping image 7C by 180 degrees). Although the specification describes that the thickness 12 is ranging from 0.25 mm to 1.5 mm (Para. [0048]) and the depth 128 may remain constant due to the use of a constant-thickness sheet (e.g., sheet 10, depicted in FIGS. 2B and 2C), however it does not describe that the depth 128 of the staple is the thickness 12 of the sheet or just another thickness of the sheet in a different dimension. Instead, the specification specifically describes that the depth 120 and the thickness 128 of the legs are different dimensions (Paras. [0055] and [0056] “a thickness 120 of the leg portion 102” and “the thickness of the legs 102 may be varied, the depth 128 may remain constant”).
Claim 17 recites the limitation “a pair of legs extending a generally equal distance orthogonally from the crown and having a depth that ranges from 0.25 mm to 1.5 mm” which contains new matter. First, the specification describes the depth of the legs to be represented by numeral “128” as shown in Fig. 7C (specification, Para. [0056]). The specification is completely silent on the pair of legs having a depth that ranges from 0.25 mm to 1.5 mm. Secondly, the specification describes that the surgical staple is formed from a sheet of the biodegradable metal having a thickness ranging from 0.25 mm to 1.5 mm using a laser cutting process. It should be noted that the thickness of the staple is represented by the numeral 12 which is different than the depth. Furthermore, the specification describes that the sheet of the metal has a thickness ranging from 0.25 mm to 1.5 mm. It does not necessary means that the thickness of the staple has a thickness ranging from 0.25 mm to 1.5 mm because of the laser cutting process which removes some of the material from the sheet of metal to form the staple. Furthermore, the “depth” is the third dimension different from the length and the thickness of the staple as described in the specification. However, Fig 7C mistakenly shows the thickness “120” to represent the depth “128” (“128” is the same as “120” by flipping image 7C by 180 degrees). Although the specification describes that the thickness 12 is ranging from 0.25 mm to 1.5 mm (Para. [0048]) and the depth 128 may remain constant due to the use of a constant-thickness sheet (e.g., sheet 10, depicted in FIGS. 2B and 2C), however it does not describe that the depth 128 of the staple is the thickness 12 of the sheet or just another thickness of the sheet in a different dimension. Instead, the specification specifically describes that the depth 120 and the thickness 128 of the legs are different dimensions (Paras. [0055] and [0056] “a thickness 120 of the leg portion 102” and “the thickness of the legs 102 may be varied, the depth 128 may remain constant”).
In response to the argument(s) on pages 8-11 of the remarks, the limitation “a first portion of the surgical staple is configured to be ejected from the tissue and a second portion of the surgical staple is configured to degrade and be absorbed within the tissue” is functional limitation or a recitation of intended use. 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. In the modified invention as stated above, the modified surgical staple is made from the same claimed material with the same claimed structure. Therefore, a first portion of the surgical staple is fully capable to be ejected from the tissue and a second portion of the surgical staple is fully capable to degrade and absorbed within the tissue since the staple is formed a biodegradable material.
Furthermore, applicant argued that “[a] person having ordinary skill in the art would recognize that such processing (cutting, shearing, or grinding the staple wire) is appropriate for a hard, high-yield, non-degrading material like stainless steel, which can hold a fine point formed in this way and still withstand the driving and bending forces encountered in external skin stapling” on page 10 of the remarks. However, applicant did not provide the evidence that person having ordinary skill in the art would recognize that such processing (cutting, shearing, or grinding the staple wire) is appropriate for a hard, high-yield, non-degrading material like stainless steel, which can hold a fine point formed in this way and still withstand the driving and bending forces encountered in external skin stapling, and not appropriate for magnesium alloy.
In addition, the motivation for the modification of Fishbein to include that the crown and the pair of legs are fabricated from a biodegradable metal configured such that a first portion of the surgical staple is fully capable to be ejected from the tissue and a second portion of the surgical staple is fully capable to degrade and absorbed within the tissue; and wherein the biodegradable metal comprises magnesium alloyed with at least one alloying element; wherein the at least one alloying element is a rare earth element; and wherein the rare earth element comprises zirconium as taught by Viola was to obtain the advantage of allowing the staples to be automatically removed/disappeared from the body without any harmful effect on the patient (Viola, Paras. [0023] and [0025]) instead of using simple substitution.
Applicant’s arguments with respect to claim(s) 7 on pages 11-12 of the remarks, have been considered but are moot in view of new ground(s) of rejection.
Conclusion
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/JING RUI OU/Primary Examiner, Art Unit 3771
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