DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This office action is in response to Applicant’s filing on 2 December 2025.
Claims 1 – 10 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following feature(s) must be shown or the feature(s) canceled from the claims. No new matter should be entered.
“a gap” – claims 1 and 10
The drawings are objected for the following reasons:
37 CFR 1.84(a) states black and white drawings must use India ink, or its equivalent that secures solid black lines. Additionally, 37 CFR 1.84(l) states all drawings must be made by a process which will give them satisfactory reproduction characteristics such that every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. In the instant case, the lines and numbers of the figures seem to be made using a dot-matrix type machine and are not shown with solid, well-defined black lines as required and do not have satisfactory reproduction characteristics.
37 CFR 1.84(p) states numbers, letters, and reference characters must measure at least .32 cm. (1/8 inch) in height. Please ensure all numbers, letters, and reference characters, specifically figures 7 and 8, comply.
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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1 – 10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claims 1 and 10, the limitation, “the restored elastic member”, is indefinite because the limitation lacks antecedent basis. Furthermore, the limitation is ambiguous whether the limitation refers a previously recited limitation, “an elastic member”, or the limitation refers to a new elastic member. For the purpose of compact prosecution, the examiner interprets the limitation, “the restored elastic member”, to mean “the elastic member”. Please note, since claims 2 – 9 depend upon claim 1, claims 2 – 9 are likewise rejected under 35 USC §112(b) for indefiniteness.
Regarding claims 1 and 10, the limitation, “the gap between the elastic member and either the first inner surface or the second inner surface”, is indefinite because the limitation is given in the alternative having a first alternative (the gap between the elastic member and the first inner surface) and a second alternative (the gap between the elastic member and the second inner surface) wherein the second alternative, the term, “the gap”, lacks antecedent basis. That nis, a prior limitation reciting, “a gap is provided between the elastic member and the first inner surface”, provides antecedent basis for the first alternative; however, no prior limitation is given for a gap provided between the elastic member and the second inner surface. For the purpose of compact prosecution, the examiner interprets the limitation to mean either the gap between the elastic member and the first inner surface or a gap between the elastic member and the second inner surface. Please note, since claims 2 – 9 depend upon claim 1, claims 2 – 9 are likewise rejected under 35 USC §112(b) for indefiniteness.
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 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 – 3 and 9 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sun (US 2023/0138441 A1), in view of Hufnagel (US 9,936,951 B2), in further view of Demmy (US 9,936,952 B2).
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[AltContent: textbox (B)][AltContent: textbox (E)][AltContent: textbox (Sun (US 2023/0138441 A1)
Annotated fig. 29)][AltContent: textbox (Sun (US 2023/0138441 A1)
Annotated fig. 24)][AltContent: textbox (Sun (US 2023/0138441 A1)
Annotated fig. 6)]
Regarding claim 1, Sun discloses a surgical stapling instrument comprising:
a fixed cartridge assembly (28, fig. 1);
an anvil assembly (30, fig. 1) rotatably hinged to the cartridge assembly; and
an end component (200f, fig. 29) detachably mounted on the anvil assembly and comprising a curved portion (curved portion A, annotated fig. 29) bent toward the cartridge assembly;
wherein the end component comprises a lumen (portion of an accommodation cavity 297f inside a working/curved portion A of a separation member 200f, fig. 29) opened toward a proximal end;
a distal portion of the anvil assembly comprises a ramp surface (sidewall of a first excavated portion 51/ramp B, annotated figs. 6 and 27. Annotated figures 6 and 27 shows two sidewalls of the first excavated portion 51/ramp B within a clipping port 60 facing a proximal end of an anvil assembly 30/30f) facing the proximal end;
the end component comprises an elastic member (240f, fig. 29) extending outward from the lumen and the ramp surface is configured to be engageable with the elastic member (As shown in figure 27);
the lumen comprises a first inner surface (a top surface of the portion of an accommodation cavity 297f inside the working/curved portion A of the separation member 200f as shown in fig. 29) located near the cartridge assembly;
a gap (a gap between portion C of a clipping portion 240f and the top surface of the portion of an accommodation cavity 297f inside the working/curved portion of the separation member 200f as shown in fig. 29) is provided between the elastic member and the first inner surface, which is configured to allow the distal portion to be inserted or withdrawn (When portion D of the clipping portion 240f is inserted into an insertion channel 50, as shown in figure 6, the clipping portion 240f is deflected along portion C of the clipping portion 240f in order to move inside the first excavated portion 51 causing the gap between portion C of the clipping portion 240f and the top surface of the portion of the accommodation cavity 297f inside the working/curved portion of the separation member 200f to increase due to this deflection);
the lumen comprises a second inner surface located away from the cartridge assembly (the bottom surface of the portion of an accommodation cavity 297f inside the working/curved portion of the separation member 200f, as shown in fig. 29), and
the elastic member is configured to be deformable (specifically portion C of the clipping portion 240f) between the first inner surface and the second inner surface, which is configured to change the gap between the elastic member and either the first inner surface or the second inner surface (see above).
Sun does not disclose a fixed anvil assembly and a cartridge assembly rotatably hinged to the anvil assembly.
However, Hufnagel, in the same field of endeavor, teaches a fixed anvil assembly (13, fig. 2 ) and a cartridge assembly (11, fig. 2) rotatably hinged to the anvil assembly.
Please note, both the fixed cartridge assembly and the anvil assembly rotatably hinged to the cartridge assembly of Sun and the fixed anvil assembly and the cartridge assembly rotatably hinged to the anvil assembly of Hufnagel describes methods to pivotably connect the anvil assembly and the cartridge assembly. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the cartridge assembly of Sun for the fixed anvil assembly and the cartridge assembly rotatably hinged to the anvil assembly of Hufnagel to achieve the predicable result of pivotably connecting the anvil assembly and the cartridge assembly. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) - Simple substitution of one known element for another to obtain predictable results.
The modified Sun does not explicitly disclose the anvil assembly comprises a distal portion configured to be insertable into the lumen.
However, Demmy, in the same field of endeavor, teaches the anvil assembly (24, fig. 4a) comprises a distal portion (24A, fig. 4A) configured to be insertable into the lumen (173, fig. 4A) (With the incorporation of the teachings of Demmy and the invention of Sun, the lumen of Sun would be further dimensioned about the perimeter E of the end component to facilitate the distal portion of the anvil assembly of Sun to be insertable into the lumen, as taught and shown in Demmy. With this modification, as the distal portion of the anvil assembly is initially pressed into the modified lumen, the portion D of the clipping portion 240f is inserted into the insertion channel 50, as shown in figure 6. Afterwards, the clipping portion 240f is deformed along portion C of the clipping portion 240f as portion D of the clipping portion 240f moves into and through the first excavated portion 51 of the distal portion of the anvil assembly as the distal portion of the anvil assembly is partially inserted into the modified lumen When distal portion of the anvil assembly is fully inserted into the modified lumen, the portion D of the clipping portion 240f engages sidewall of a first excavated portion 51/ramp B of the distal portion of the anvil assembly – as shown in figure 24. Lastly, when the distal portion of the anvil assembly is fully withdrawn from the modified lumen, the portion D of the clipping portion 240f is removed and disengaged from the insertion channel 50 of the distal portion of the anvil assembly).
Demmy is evidence that having the anvil assembly comprises a distal portion configured to be insertable into the lumen was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the end component and the anvil assembly of the modified Sun such that the anvil assembly comprises a distal portion configured to be insertable into the lumen, as taught and shown by Demmy. Moreover, the one having ordinary skill in the art would have been motivated to modify the end component and the anvil assembly of the modified Sun such that the anvil assembly comprises a distal portion configured to be insertable into the lumen, as taught and shown by Demmy, so that the lumen may stretch, or otherwise conform, to the shape of different anvils of different sizes and shapes (Col. 6, ll. 29 – 37).
Regarding claim 2, Sun, as modified by Hufnagel, as further modified by Demmy, discloses the invention as recited in claim 1.
The modified Sun discloses a shape of the lumen (Demmy – 173, fig. 4A) is adapted to a shape of the distal portion (Demmy – 24A, fig. 4A), and the distal portion is configured to be fitted with the lumen (Demmy – Col. 6, ll. 29 – 37).
Regarding claim 3, Sun, as modified by Hufnagel, as further modified by Demmy, discloses the invention as recited in claim 1.
Sun discloses a proximal portion (portion D, annotated fig. 29) of the elastic member (240f, fig. 29) extends outward from the lumen (portion of an accommodation cavity 297f inside a working/curved portion A of a separation member 200f, fig. 29) and is inclined toward the cartridge assembly (Annotated figure 29 shows portion D of the clipping portion 240f having an incline directed towards the cartridge assembly).
Regarding claim 9, Sun, as modified by Hufnagel, as further modified by Demmy, discloses the invention as recited in claim 1.
Sun discloses the anvil assembly comprises a channel (50, 60, fig. 6) adjacent to the distal portion, and the channel is configured to accommodate a proximal portion (portion D, annotated fig. 29) of the elastic member (240f, fig. 29).
Regarding claim 10, Sun discloses an attachment and detachment method of a surgical stapling instrument, wherein the surgical stapling instrument comprises a fixed cartridge assembly (28, fig. 1); an anvil assembly (30, fig. 1) rotatably hinged to the cartridge assembly; and an end component (200f, fig. 29) detachably mounted on the anvil assembly and comprising a curved portion (curved portion A, annotated fig. 29) bent toward the cartridge assembly; wherein the end component comprises a lumen (portion of an accommodation cavity 297f inside a working/curved portion A of a separation member 200f, fig. 29) opened toward a proximal end; a distal portion of the anvil assembly comprises a ramp surface (sidewall of a first excavated portion 51/ramp B, annotated figs. 6 and 27. Annotated figures 6 and 27 shows two sidewalls of the first excavated portion 51/ramp B within a clipping port 60 facing a proximal end of an anvil assembly 30/30f) facing the proximal end; the end component comprises an elastic member (240f, fig. 29) extending outward from the lumen, and the ramp surface is configured to be engageable with the elastic member (As shown in figure 27); the lumen comprises a first inner surface (a top surface of the portion of an accommodation cavity 297f inside the working/curved portion A of the separation member 200f as shown in fig. 29) located near the cartridge assembly; a gap (a gap between portion C of a clipping portion 240f and the top surface of the portion of an accommodation cavity 297f inside the working/curved portion of the separation member 200f as shown in fig. 29) is provided between the elastic member and the first inner surface, which is configured to allow the distal portion to be inserted or withdrawn (When portion D of the clipping portion 240f is inserted into an insertion channel 50, as shown in figure 6, the clipping portion 240f is deflected along portion C of the clipping portion 240f in order to move inside the first excavated portion 51 causing the gap between portion C of the clipping portion 240f and the top surface of the portion of the accommodation cavity 297f inside the working/curved portion of the separation member 200f to increase due to this deflection); the lumen comprises a second inner surface located away from the cartridge assembly (the bottom surface of the portion of an accommodation cavity 297f inside the working/curved portion of the separation member 200f, as shown in fig. 29), and the elastic member is configured to be deformable (specifically portion C of the clipping portion 240f) between the first inner surface and the second inner surface, which is configured to change the gap between the elastic member and either the first inner surface or the second inner surface (see above).
Sun does not disclose a fixed anvil assembly and a cartridge assembly rotatably hinged to the anvil assembly.
However, Hufnagel, in the same field of endeavor, teaches a fixed anvil assembly (13, fig. 2 ) and a cartridge assembly (11, fig. 2) rotatably hinged to the anvil assembly.
Please note, both the fixed cartridge assembly and the anvil assembly rotatably hinged to the cartridge assembly of Sun and the fixed anvil assembly and the cartridge assembly rotatably hinged to the anvil assembly of Hufnagel describes methods to pivotably connect the anvil assembly and the cartridge assembly. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the cartridge assembly of Sun for the fixed anvil assembly and the cartridge assembly rotatably hinged to the anvil assembly of Hufnagel to achieve the predicable result of pivotably connecting the anvil assembly and the cartridge assembly. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) - Simple substitution of one known element for another to obtain predictable results.
The modified Sun does not explicitly disclose the anvil assembly comprises a distal portion configured to be insertable into the lumen.
However, Demmy, in the same field of endeavor, teaches the anvil assembly (24, fig. 4a) comprises a distal portion (24A, fig. 4A) configured to be insertable into the lumen (173, fig. 4A).
Demmy is evidence that having the anvil assembly comprises a distal portion configured to be insertable into the lumen was known and within the skill of one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the end component and the anvil assembly of the modified Sun such that the anvil assembly comprises a distal portion configured to be insertable into the lumen, as taught and shown by Demmy. Moreover, the one having ordinary skill in the art would have been motivated to modify the end component and the anvil assembly of the modified Sun such that the anvil assembly comprises a distal portion configured to be insertable into the lumen, as taught and shown by Demmy, so that the lumen may stretch, or otherwise conform, to the shape of different anvils of different sizes and shapes (Col. 6, ll. 29 – 37).
This modified Sun discloses the attachment and detachment method comprises:
causing the distal portion to press the elastic member to deform, and to be partially inserted into the lumen (As the distal portion of the anvil assembly is initially pressed into the modified lumen, the portion D of the clipping portion 240f is inserted into the insertion channel 50, as shown in figure 6. Afterwards, the clipping portion 240f is deformed along portion C of the clipping portion 240f as portion D of the clipping portion 240f moves into and through the first excavated portion 51 of the distal portion of the anvil assembly as the distal portion of the anvil assembly is partially inserted into the modified lumen);
causing the distal portion to be fully inserted into the lumen and to engage with the elastic member (When distal portion of the anvil assembly is fully inserted into the modified lumen, the portion D of the clipping portion 240f engages sidewall of a first excavated portion 51/ramp B of the distal portion of the anvil assembly – as shown in figure 24);
causing the distal portion to press the elastic member to deform, and to be partially withdrawn from the lumen (When the portion D of the clipping portion 240f is initially pushed into a clipping port 60 from its position in figure 4, the clipping portion 240f is deformed along portion C of the clipping portion 240f as portion D of the clipping portion 240f moves into and through the first excavated portion 51 of the distal portion of the anvil assembly as the distal portion of the anvil assembly is partially withdrawn from the modified lumen);
causing the distal portion to be fully withdrawn from the lumen and to disengage from the elastic member (When the distal portion of the anvil assembly is fully withdrawn from the modified lumen, the portion D of the clipping portion 240f is removed and disengaged from the insertion channel 50 of the distal portion of the anvil assembly).
Allowable Subject Matter
Claims 4 – 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID G SHUTTY whose telephone number is 571-272-3626. The examiner can normally be reached 7:30 am - 5:30 pm, Monday - Friday.
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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.
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/DAVID G SHUTTY/Examiner, Art Unit 3731
3 June 2026
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