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 amendment received on July 31st and the remarks received on August 20, 2026.
Response to Arguments
Applicant's arguments filed July 31, 2026 with respect to the 35 USC 103 rejection of unpatentability over REITZE and GOODSTEIN have been fully considered but they are not persuasive.
Applicant has first argued that the primary reference, REITZE, is drawn to a staple used to fasten sheets of paper whereas the claimed invention and the disclosure of GOODSTEIN is drawn to a staple configured for use in a surgical procedure. Although the claims do not explicitly claim staples formed from a specific material, Applicant has argued that the preamble phrasing of the claimed invention being drawn to a surgical staple inherently invokes a staple formed from a biocompatible material.
It is well known in the art of staples, particularly those that are intended for the use in fastening papers, to form the staple from a stainless steel. While the primary reference of REITZE merely references the staples as being formed from wire (column 2 lines 58-59), REITZE is silent to the material from which the staple is formed. However, HUJISHIMA et al. (US 6,086,304) supports the knowledge in the art to form staples, intended for the use of fastening paper (column 1 lines 6-10), from stainless steel (column 4 lines 5-7). Applicant acknowledges on page 2 of the remarks filed on August 20, 2026, that it is well known in the art of forming staples intended for a surgical procedure from stainless steel. Thus, Examiner has found that a staple intended for use in fastening paper can be structurally capable of fastening tissue.
Examiner has also found that staples utilized in a process of fastening paper are analogous to staples utilized in a surgical procedure. This position is supported by JARRETT et al. (US 5,324,307), which discloses stainless steel as a commonly used material in forming a staple intended for use in a surgical procedure; additionally, column 7 lines 34-37 of JARRETT et al. references the similar shaping of a surgical staple and that of a staple intended for use in fastening sheets of paper. JARRETT et al. also acknowledges that surgical staples are not limited to metal materials; rather, polymers are also a known material suitable for use in forming staples intended for surgical procedures. In essence, the term “surgical” is not found to invoke any particular structural limitation to the claimed invention. Furthermore, 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 as a matter of obvious design choice.1
As a final point regarding the material significance of the term “surgical” being a structural limitation of the claimed staple, Examiner has found the term “surgical” to merely reference an intended use of the staple. For example, should one be found in a medical emergency in a non-ideal nor sanitary environment (e.g. substantial wound in an office environment), one could reasonably use a staple intended for fastening paper to also fasten tissue. Neither Applicant’s specification nor the claim language is found to reference a significance of the staple material nor definitive structural recitation of the material from which Applicant’s staple is formed. Nonetheless, it would have been obvious to one having ordinary skill in the art at the time the invention was made to form a staple from a stainless steel, which is well known in both the field of paper fastening and tissue fastening, 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 as a matter of obvious design choice.2
Applicant has also argued that neither REITZE nor GOODSTEIN disclose a recess “spaced from the backspan and is located entirely in the curved section of the first bend” of the staple.
PNG
media_image1.png
265
308
media_image1.png
Greyscale
Diagram A
Despite Applicant’s figures 26-28 of the claimed surgical staple embodiment distinguishing the backspan, legs and bends of the surgical staple with distinct lines, such distinctions are not found to be limited by the claim language.
Claim 1 lines 13-14 state:
“a first recess at the first bend and a second recess at the second bend”
while lines 17-18 of claim 1 state:
“wherein the first recess is spaced from the backspan and is located entirely in the curved section of the first bend”.
The term “at” with respect to the recess position relative to the bend is found to indicate the recess can merely be near the bend3. The subsequent limitations of lines 17-18 are drawn to a curved section, which found to be disclosed by the portion of the staple detailed in Figure 6 of REITZE as as detailed in Diagram A above. Even so, when considering the subsequent limitation of the recess being entirely in the curved section of the bend, Applicant appears to base the pending arguments on limitations which are not provided in the claimed invention (i.e. 90° bend, 45° axis of symmetry, and perpendicular to straight segment of the leg/backspan).
PNG
media_image2.png
192
495
media_image2.png
Greyscale
Diagram B
Lastly, page 4 of the August 20, 2026 remarks state “Goodstein also does not disclose or suggest the above features (i.e. recess formed in a curvilinear side of the bend) and is not being relied upon for the disclosure of such a feature. On the contrary, the previous rejection (and pending rejection below) clearly state “REITZE discloses each recess positioned at a curved section/bend of the staple rather than included within the curved section/bend. GOODSTEIN teaches … each bend includes a curved section in which each recess 15 is positioned entirely within each curved section of the bends. “; wherein, GOODSTEIN is the secondary teaching reference to the primary disclosure of REITZE as it pertains to the location of a recess relative to a bend. Examiner maintains that REITZE discloses a recess in at and/or in a curved section of a bend; whereas, figure 6 of GOODSTEIN definitively discloses a recess entirely within a curvilinear bend of a staple (see Diagram B above).
Applicant’s arguments with respect to claim 7 have been fully considered and are persuasive. However, upon further consideration, a new grounds of rejection is made in view of REITZE (US 4,718,803), GOODSTEIN (US 1,910,688) and REYNOLDS, Jr. (US 6,015,417)
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 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.
Claims 1-6 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over REITZE (US 4,718,803) in view of GOODSTEIN (US 1,910,688).
In reference to claim 1, REITZE discloses a staple 30 comprising: a backspan 31 extending between a first leg and a second leg 32; a first bend (see Diagram I below) between the first leg and the backspan; a second bend (see Diagram I below) between the second leg and the backspan; a first recess 33 (see Diagram I below) at the first bend; a second recess 33 (see Diagram I below) at the second bend; wherein figure 4 illustrates the surgical staple in a pre-deployed configuration where both recesses and both legs are closer to an (inner) first side of the backspan than an opposing second side of the backspan; wherein figures 1 and 2 illustrates the surgical staple in a deployed configuration in which both recesses and both legs are closer to an (inner) first side of the backspan than an opposing second side of the backspan; the first side of the backspan 31 configured to abut a substrate 20, 21 in the deployed configuration (figures 1 and 2).
PNG
media_image3.png
369
406
media_image3.png
Greyscale
Diagram I
REITZE discloses each recess positioned at a curved section/bend of the staple rather than included within the curved section/bend. GOODSTEIN teaches a staple (figure 6) having a backspan 9 extending between a first staple leg 10 and a second staple leg 10; a first bend between the first staple leg and the backspan; a second bend between the second staple leg and the backspan; wherein each bend includes a curved section in which each recess 15 is positioned entirely within each curved section of the bends. It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the position of each recess in the staple of REITZE to be within the curved section since page 3 lines 21-29 of GOODSTEIN suggests such a modification facilitates movement/formation of the staple legs relative to the backspan.
Regarding claim 2, column 2 lines 12-15 of REITZE further discloses the first recess 33 at the first bend as a configuration configured to reduce the force required to move the first leg (i.e. weaken) at the first bend (figure 2).
With respect to claim 3, figure 2 of REITZE further discloses a gap between the first and second staple legs 22 and the backspan 31 in the deployed configuration in which the substrate is supported.
In reference to claim 4 and 5, figure 2 of REITZE discloses a gap between the first and second staple legs 22 and the backspan 31 in the deployed configuration in which the substrate is supported, but does not disclose the specific dimensions of the gap. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to form the gap of less than or greater to 0.3048 millimeters since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.4 Furthermore, it is well known in the art of stapling that the gap formed between the backspan and the legs of the staple in the deployed configuration are contingent upon the thickness of the substrate to which the staple is secured.
In reference to claim 6, figure 1 of REITZE discloses the backspan 31 having a rectilinear configuration (column 2 lines 58-65)
Regarding claims 9, 10 and 12, In reference to claim 7, In reference to claim 1, REITZE discloses a staple 30 comprising: a backspan 31 extending between a first leg and a second leg 32; a first bend (see Diagram I above) between the first leg and the backspan; a second bend (see Diagram I above) between the second leg and the backspan; a first recess 33 (see Diagram I above) at the first bend; a second recess 33 (see Diagram I above) at the second bend; wherein figure 4 illustrates the surgical staple in a pre-deployed configuration where both recesses and both legs are closer to an (inner) first side of the backspan than an opposing second side of the backspan; wherein figures 1 and 2 illustrates the surgical staple in a deployed configuration in which both recesses and both legs are closer to an (inner) first side of the backspan than an opposing second side of the backspan; the first side of the backspan 31 configured to abut a substrate 20, 21 in the deployed configuration (figures 1 and 2).
REITZE disclosees each recess positioned at a curved section/bend of the staple rather than included within the curved section/bend. GOODSTEIN teaches a staple (figure 6) having a backspan 9 extending between a first staple leg 10 and a second staple leg 10; a first bend between the first staple leg and the backspan; a second bend between the second staple leg and the backspan; wherein each bend includes a curved section in which each recess 15 is positioned entirely within each curved section of the bends. It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the position of each recess in the staple of REITZE to be within the curved section since page 3 lines 21-29 of GOODSTEIN suggests such a modification facilitates movement/formation of the staple legs relative to the backspan. Figure 4 of REITZE discloses the first recess formed in a curvilinear inner side of the first bend, the first bend further having an outer curvinlinear side formed from a deformation of a wire defining the staple (column 2 lines 58-61).
With respect to claim 11, figure 11 of REITZE discloses the first and second legs 32 having a rectilinear configuration (column 2 lines 58-65).
In reference to claim 13, column 3 lines 3-7 of REITZE discloses a stapler comprising a cartridge (e.g. carriage) configured to house the staple 30.
Regarding claim 14, column 3 lines 3-10 of REITZE further discloses the stapler to comprise and anvil 40 that opposes the cartridge (e.g. carriage).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over REITZE (US 4,718,803) in view of GOODSTEIN (US 1,910,688) and REYNOLDS, Jr. (US 6,015,417).
In reference to claim 7, In reference to claim 1, REITZE discloses a staple 30 comprising: a backspan 31 extending between a first leg and a second leg 32; a first bend (see Diagram I above) between the first leg and the backspan; a second bend (see Diagram I above) between the second leg and the backspan; a first recess 33 (see Diagram I above) at the first bend; a second recess 33 (see Diagram I above) at the second bend; wherein figure 4 illustrates the surgical staple in a pre-deployed configuration where both recesses and both legs are closer to an (inner) first side of the backspan than an opposing second side of the backspan; wherein figures 1 and 2 illustrates the surgical staple in a deployed configuration in which both recesses and both legs are closer to an (inner) first side of the backspan than an opposing second side of the backspan; the first side of the backspan 31 configured to abut a substrate 20, 21 in the deployed configuration (figures 1 and 2).
REITZE disclosees each recess positioned at a curved section/bend of the staple rather than included within the curved section/bend. GOODSTEIN teaches a staple (figure 6) having a backspan 9 extending between a first staple leg 10 and a second staple leg 10; a first bend between the first staple leg and the backspan; a second bend between the second staple leg and the backspan; wherein each bend includes a curved section in which each recess 15 is positioned entirely within each curved section of the bends. It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the position of each recess in the staple of REITZE to be within the curved section since page 3 lines 21-29 of GOODSTEIN suggests such a modification facilitates movement/formation of the staple legs relative to the backspan.
Neither REITZE nor GOODSTEIN disclose a staple having a textured surface. Figures 2-6 of REYNOLDS, Jr disclose surgical fasteners having a textured surface. It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have further modified the staple of REITZE in view of GOODSTEING to include a textured surface since column 2 lines 3-5 and 16-23 of REYNOLDS, Jr states such a modification enhances gripping capabilities of the surgical fastener for the purpose of resisting displacement of the surgical staple once secured to a substrate (e.g. tissue).
Claims 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over HUANG et al. (US 2016/0100837) in view of REITZE (US 4,718,803) and GOODSTEIN (US 1,910,688).
PNG
media_image4.png
442
839
media_image4.png
Greyscale
Diagram II
With respect to claim 13-15, HUANG et al. discloses a stapler (figure 1) comprising: a cartridge 140, 240 housing a plurality of staples 285 formed from a wire (paragraph [0047]); an anvil 130 opposing the cartridge; and a cutting mechanism (figure 2) having an elongated member 160 supporting a cutting surface 163 at a distal end of the elongated member 160, and an elongated slot (figure 5) extending a portion of the length of the elongated member at the distal end (figure 2; See Diagram II above of Figure 5). Although figure 8 of HUANG et al. discloses the wire staples 285 to have a backspan extending between a first and second bend in a pre-deployed configuration, HUANG et al. does not disclose the wire staples 285 having a recess at the bends as claimed.
REITZE teaches a staple 30 comprising: a backspan 31 extending between a first leg and a second leg 32; a first bend (see Diagram I below) between the first leg and the backspan; a second bend (see Diagram I below) between the second leg and the backspan; a first recess 33 (see Diagram I below) at the first bend; a second recess 33 (see Diagram I below) at the second bend; wherein figure 4 illustrates the surgical staple in a pre-deployed configuration where both recesses and both legs are closer to an (inner) first side of the backspan than an opposing second side of the backspan; wherein figures 1 and 2 illustrates the surgical staple in a deployed configuration in which both recesses and both legs are closer to an (inner) first side of the backspan than an opposing second side of the backspan; the first side of the backspan 31 configured to abut a substrate 20, 21 in the deployed configuration (figures 1 and 2). REITZE discloses each recess positioned at a curved section/bend of the staple rather than included within the curved section/bend. GOODSTEIN teaches a staple (figure 6) having a backspan 9 extending between a first staple leg 10 and a second staple leg 10; a first bend between the first staple leg and the backspan; a second bend between the second staple leg and the backspan; wherein each bend is includes a curved section in which each recess 15 is positioned entirely within each curved section of the bends. It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the position of each recess in the staple of REITZE to be within the curved section since page 3 lines 21-29 of GOODSTEIN suggests such a modification facilitates movement/formation of the staple legs relative to the backspan.
It would have been further obvious to one having ordinary skill in the art at the time of filing the invention to provide the stapler of HUANG et al. with staples formed with a a first and second recess in the curved section/bends of the wire staples as modified by REITZE in view of GOODSTEIN since column 2 lines 12-15 of REITZE states such a modification weakens the wire for the purpose of forming the wire staple into the pre-deployed configuration.
In reference to claim 16, HUANG et al. further discloses the elongated slot of the elongated member 160 to have a proximal slot portion, an intermediate slot portion and a distal slot portion (figure 5); wherein the distal slot portion extends higher than the proximal slot portion (see Diagram II of figure 5 above).
Regarding claim 17, HUANG et al. discloses the stapler further comprising a clamping member 114 detachably engaged (paragraph [0028]) by the distal portion 164 of the elongated member 160.
With respect to claim 18, figure 5 of HUANG et al. discloses the stapler further comprising a staple pusher 170 detachably engaged by a distal portion 162 of the elongated member 160.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Refer to previously attached PTO-892’s and the currently attached PTO-892 for a notice of references cited and recommended for consideration based on their disclosure of limitations related to the claimed invention. In particular, figure 2 of CARHART et al. (US 3,515,194) and figure 2 of CRAINICH (US 4,607,638) disclose staples having a recess in the bend of the staple between a backspan and the legs of the staple. Likewise, figure 20 of HARRIS et al. teaches the knowledge in the art to coat a surgical staple
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GLORIA R WEEKS whose telephone number is (571)272-4473. The examiner can normally be reached M-F 8am-2pm & 5pm-7pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelley Self can be reached on 571-272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Other helpful telephone numbers are listed for applicant's benefit:
Allowed Files & Publication (888) 786-0101
Assignment Branch (800) 972-6382
Certificates of Correction (703) 305-8309
Fee Questions (571) 272-6400
Inventor Assistance Center (800) PTO-9199
Petitions/special Programs (571) 272-3282
Information Help line 1-800-786-9199
/GLORIA R WEEKS/Primary Examiner, Art Unit 3731
October 3, 2026
1 In re Leshin, 125 USPQ 416.
2 In re Leshin, 125 USPQ 416.
3 AT Definition & Meaning - Merriam-Webster : a function word to indicate presence or occurrence in, on or near
4 In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 198C).
