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 Office Action is in response to the applicant’s filing on 10/30/2025.
Applicant’s cancelation of claims 4-5, 11, 15-19, 22, 25, 27-30 and 35 is acknowledged and require no further examining. Claims 1-3, 6-10, 12-14, 20-21, 23-24, 26, and 31-34 are pending and examined below.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6-10, 12-14, 20-21, 23-24, 26, and 31-34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 1 line 6, the phrase “applying sufficient thermal energy” renders claim 1 vague and indefinite because the term is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 1 line 6, the phrase “to one or more surfaces of the component” renders claim 1 vague and indefinite because there is insufficient antecedent basis for this limitation. Prior to the quoted phrase, claim 1 disclose an end effector, a first jaw, and an anvil. Claim 1 does not disclose a component with one or more surfaces. For examining purposes, the phrase is interpreted as “to the surface of the anvil”. Claims 2 and 3 are interpreted in in the same way for the same reason.
Claims 2-3, 6-10, and 14 are dependent of claim 1 and include all the same limitations.
Regarding claim 12 line 3, the phrase “the method comprising” renders claim 12 vague and indefinite because there is insufficient antecedent basis for this limitation. Claim 12 is dependent of claim 1, and claim 1 discloses a surgical stapler instrument. Claim 1 does not disclose a method. For examining purposes, the phrase is interpreted as “wherein the thermal energy is applied to”. Claim 13 is interpreted in the same way for the same reason.
Claim 13 is dependent of claim 12 and includes all the limitations.
Regarding claim 20 line 5, the phrase “applying sufficient thermal energy” renders claim 20 vague and indefinite because the term is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 20 line 6, the phrase “to at least one of shape or increase the smoothness or hardness of the one or more surfaces” renders claim 20 vague and indefinite because it is unclear what is included in the list. The phrase “at least one” implies that different combination so items from a list of items are included. It is unclear what items are included in the “at least one” list. For examining purposes, the phrase is interpreted as “at least one of: form a shape; increase the smoothness of the anvil; or increase the hardness of the anvil”.
Regarding claim 21 line 3, the phrase “a factor of at least about 5% to about 200%” renders claim 21 vague and indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The phrase further renders claim 21 vague and indefinite because it is unclear what further limitation the phrase “at least” implies. Claiming a range implies the claimed value is within said range. It is unclear what other values are implied by the phrase “at least”. For examining purposes, the phrase is interpreted as “a factor of 5% to 200%.
Regarding claim 23 line 1, the phrase “further comprising emitting coherent light” renders claim 23 vague and indefinite because it is unclear if this is the same or different from the applying thermal energy step. Claim 23 is dependent of claim 20, and claim 20 discloses the step of applying thermal energy. It is unclear if the coherent light is the thermal energy or is a different element. For examining purposes, the phrase is interpreted as “wherein the thermal energy is applied by emitting coherent light”.
Claims 24-25 are dependent of claim 23 and include all the same limitations.
Regarding claim 31, the phrase “instrument comprising: an end effector … a staple cartridge … and an anvil … and one or more staple pockets” renders claim 31 vague and indefinite because it is unclear what is included in the list. When presenting a list, the last item in said list is preceded by the term “and” in order to signify the following item is the last item of said list. It is unclear if the staple pockets are part of the comprising list. For examining purposes, the phrase is interpreted as “instrument comprising: an end effector … a staple cartridge … an anvil … and one or more staple pockets”.
Claims 32-34 are dependent of claim 31 and include all the same limitations.
Claim Rejections - 35 USC § 103
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, 6-10, 12-14, 20-21, 23-24, 26, and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over reference Nalagatla et al. (11,291,450) in view of reference Whitman et al. (8,008,598).
Regarding claim 1, Nalagatla et al. disclose a surgical stapler instrument (10) comprising an end effector (300, 400) having a metallic first jaw (400), wherein the first jaw (400) is produced by a process comprising the steps of:
forming an anvil (412) on an inner surface of the first jaw (400) through:
an additive manufacturing process; or
a metal injection molding process; and
forming one or more pockets (414) into the anvil (412).
(Figure 1, 4 and Column 3 lines 64-67 through Column 4 lines 1-3, Column 4 lines 50-57)
However, Nalagatla et al. do not disclose applying thermal energy to the surface of the anvil to shape said surface.
Whitman et al. disclose a process of forming an anvil comprising the steps of using a laser beam (102) to form one or more pockets (110) in the anvil. (Figure 5 and Column 3 lines 10-15, Column 5 lines 27-37)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the anvil of Nalagatla et al. by incorporating the use of a laser beam to form the pockets in the anvil as taught by Whitman et al., since column 6 lines 59-62 of Whitman et al. states such a modification would allow for easy, quick, and/or inexpensive modify the shape of the pockets.
Regarding claim 2, Nalagatla et al. modified by Whitman et al. disclose the thermal energy increases a smoothness of the shaped surface of the anvil. (Whitman et al. – Column 6 lines 31-36)
Regarding claim 3, in column 3 lines 12-15 of Whitman et al., the pockets of the anvil are formed by using a laser beam. On page 6 paragraph 25 of the present Specification, the use of a laser beam is disclosed to increase hardness of the anvil. Therefore, Nalagatla et al. modified by Whitman et al. is interpreted to disclose the thermal energy increases a hardness of the anvil.
Regarding claim 6, Nalagatla et al. modified by Whitman et al. disclose the thermal energy is applied by emitting coherent light onto the surface of the anvil (Nalagatla et al. – 412) with a laser beam (Whitman et al. – 102). (Whitman et al. – Column 3 lines 12-15)
Regarding claim 7, in column 3 lines 17-24 of Whitman et al., the laser beam is moved relative to the anvil to form the pocket. Therefore, Nalagatla et al. modified by Whitman et al. is interpreted to disclose steering the laser beam (Whitman et al. – 102) along a plurality of trajectories along the surface of the anvil (Nalagatla et al. – 412).
Regarding claim 8, in Figure 5 of Whitman et al., the pockets (110) are shown to comprise a proximal recess (122) and a distal recess (124) that define a substantially hourglass shape. In column 3 lines 17-24 of Whitman et al., the laser beam is moved relative to the anvil to form the pocket. Therefore, Nalagatla et al. modified by Whitman et al. is interpreted to disclose the plurality of trajectories form a substantially hourglass shape on the surface of the anvil.
Regarding claim 9, in column 3 lines 56-61 of Whitman et al., the pockets (110) formed by the laser beam are disclosed to have a depth and a curvature. Therefore, Nalagatla et al. modified by Whitman et al. is interpreted to disclose forming a plurality of troughs (Whitman et al. – 122, 124) in the surface of the anvil (Whitman et al. – 412) with the laser beam (Whitman et al. – 102).
Regarding claim 10, Nalagatla et al. modified by Whitman et al. disclose a second jaw (Nalagatla et al. – 300) for receiving a staple cartridge (Nalagatla et al. – 320) with a plurality of staples. (Nalagatla et al. – Column 5 lines 62-55, Column 6 lines 60-67 through Column 7 lines 1-3)
Regarding claim 12, Nalagatla et al. modified by Whitman et al. disclose the inner surface of the anvil (Nalagatla et al. – 412) comprises a plurality of staple pockets (Whitman et al. – 110) each having a staple deforming surface facing towards the second jaw (Nalagatla et al. – 300), wherein the thermal energy is applied to the staple deforming surface to increase a smoothness of said staple deforming surface. (Nalagatla et al. – Column 6 lines 60-67 through Column 7 lines 1-3) (Whitman et al. – Column 6 lines 31-36)
Regarding claim 13, Nalagatla et al. modified by Whitman et al. disclose each of the plurality of staple pockets (Whitman et al. – 110) comprise a first (Whitman et al. – 122) and a second (Whitman et al. – 124) forming pockets configured to deform corresponding legs of a staple. (Whitman et al. – Column 5 lines 27-32)
In column 3 lines 17-24 of Whitman et al., the laser beam is moved relative to the anvil to form the pocket. Therefore, Nalagatla et al. modified by Whitman et al. is interpreted to disclose steering the laser beam (Whitman et al. – 102) along a plurality of trajectories from the first (Whitman et al. – 122) to the second (Whitman et al. – 124).
Regarding claim 14, in column 3 lines 17-24 of Whitman et al., the laser beam is moved relative to the anvil to form the pocket. Therefore, Whitman et al. is interpreted to disclose steering the laser beam (102) along a plurality of trajectories along the surface of the anvil.
However, Nalagatla et al. modified by Whitman et al. do not explicitly disclose the trajectories converges towards a longitudinal axis.
It would have been obvious to the person of ordinary skill in the art to have the trajectories converges towards a longitudinal axis, since it has been held that a change in shape is a matter of design choice absent of persuasive evidence that the particular change is significant. [MPEP 2144.04 (IV-B)] Therefore, it would have been prima facie obvious to modify Nalagatla et al. and Whitman et al. to obtain the invention as specified in claim 14 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art.
Regarding claim 20, Nalagatla et al. disclose of forming an anvil (412) of a surgical instrument (10), the method comprises the steps of:
forming the anvil (412) through:
an additive manufacturing process; or
a metal injection molding process; and
forming one or more pockets (414) into the anvil (412).
(Figure 1, 4 and Column 3 lines 64-67 through Column 4 lines 1-3, Column 4 lines 50-57)
However, Nalagatla et al. do not disclose applying thermal energy to the surface of the anvil to shape said surface.
Whitman et al. disclose a method of forming an anvil, the method comprising the step of using a laser beam (102) to form one or more pockets (110) in the anvil, wherein the use of the laser beam (102) at least: forms a shape; increases the smoothness of the anvil; or increases the hardness of the anvil”. (Figure 5 and Column 3 lines 10-15, Column 5 lines 27-37)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the anvil of Nalagatla et al. by incorporating the use of a laser beam to form the pockets in the anvil as taught by Whitman et al., since column 6 lines 59-62 of Whitman et al. states such a modification would allow for easy, quick, and/or inexpensive modify the shape of the pockets.
Regarding claim 21, in column 3 lines 12-15 of Whitman et al., the pockets of the anvil are formed by using a laser beam. On page 5 paragraph 22 of the present Specification, the use of a laser beam is disclosed to increase the smoothness and/or hardness by a factor of 5% to 200%. Therefore, Nalagatla et al. modified by Whitman et al. is interpreted to disclose the thermal energy increases the smoothness or hardness by a factor of 5% to 200%.
Regarding claim 23, Nalagatla et al. modified by Whitman et al. disclose the thermal energy is applied by emitting coherent light onto the surface of the anvil (Nalagatla et al. – 412) with a laser beam (Whitman et al. – 102). (Whitman et al. – Column 3 lines 12-15)
Regarding claim 24, in column 3 lines 17-24 of Whitman et al., the laser beam is moved relative to the anvil to form the pocket. Therefore, Nalagatla et al. modified by Whitman et al. is interpreted to disclose the step of steering the laser beam (Whitman et al. – 102) along a plurality of trajectories along the surface of the anvil (Nalagatla et al. – 412).
Regarding claim 26, in column 3 lines 56-61 of Whitman et al., the pockets (110) formed by the laser beam are disclosed to have a depth and a curvature. Therefore, Nalagatla et al. modified by Whitman et al. is interpreted to disclose the step of creating a plurality of troughs (Whitman et al. – 122, 124) in the surface of the anvil (Whitman et al. – 412) with the laser beam (Whitman et al. – 102).
Regarding claim 31, Nalagatla et al. disclose a surgical stapler instrument (10) comprising
an end effector (300, 400) comprising:
a first jaw (400); and
a second jaw (300) movable relative to the first jaw (400);
a staple cartridge (320) comprising a plurality of staples;
an anvil (412) configured to deform the staples,
wherein the anvil comprises a tissue engaging surface; and
one or more staple pockets (414) defined in the tissue engaging surface,
wherein the one or more staple pockets (414) are configured to deform the staples.
(Figure 1, 4 and Column 3 lines 64-67 through Column 4 lines 1-3, Column 4 lines 50-57, Column 5 lines 62-55, Column 6 lines 60-67 through Column 7 lines 1-3)
However, Nalagatla et al. do not disclose applying thermal energy to the surface of the one or more staple pockets to shape said surface.
Whitman et al. disclose a process of forming an anvil comprising the steps of using a laser beam (102) to form one or more pockets (110) in the anvil. (Figure 5 and Column 3 lines 10-15, Column 5 lines 27-37)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the anvil of Nalagatla et al. by incorporating the use of a laser beam to form the pockets in the anvil as taught by Whitman et al., since column 6 lines 59-62 of Whitman et al. states such a modification would allow for easy, quick, and/or inexpensive modify the shape of the pockets.
Regarding claim 32, Nalagatla et al. modified by Whitman et al. disclose each of the plurality of staple pockets (Whitman et al. – 110) comprise a first (Whitman et al. – 122) and a second (Whitman et al. – 124) forming pockets configured to deform corresponding legs of a staple. (Whitman et al. – Column 5 lines 27-32)
In column 3 lines 17-24 of Whitman et al., the laser beam is moved relative to the anvil to form the pocket. Therefore, Nalagatla et al. modified by Whitman et al. is interpreted to disclose steering the laser beam (Whitman et al. – 102) along a plurality of trajectories from the first (Whitman et al. – 122) to the second (Whitman et al. – 124).
Regarding claim 33, in column 3 lines 17-24 of Whitman et al., the laser beam is moved relative to the anvil to form the pocket. Therefore, Whitman et al. is interpreted to disclose steering the laser beam (102) along a plurality of trajectories along the surface of the anvil.
However, Nalagatla et al. modified by Whitman et al. do not explicitly disclose the trajectories converges towards a longitudinal axis.
It would have been obvious to the person of ordinary skill in the art to have the trajectories converges towards a longitudinal axis, since it has been held that a change in shape is a matter of design choice absent of persuasive evidence that the particular change is significant. [MPEP 2144.04 (IV-B)] Therefore, it would have been prima facie obvious to modify Nalagatla et al. and Whitman et al. to obtain the invention as specified in claim 33 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art.
Regarding claim 34, in column 3 lines 17-24 of Whitman et al., the laser beam is moved relative to the anvil to form the pocket. Therefore, Whitman et al. is interpreted to disclose steering the laser beam (102) along a plurality of trajectories along the surface of the anvil.
However, Nalagatla et al. modified by Whitman et al. do not explicitly disclose the trajectories are laterally spaced from each other relative to the longitudinal axes.
It would have been obvious to the person of ordinary skill in the art to have the trajectories converges towards a longitudinal axis, since it has been held that a change in shape is a matter of design choice absent of persuasive evidence that the particular change is significant. [MPEP 2144.04 (IV-B)] Therefore, it would have been prima facie obvious to modify Nalagatla et al. and Whitman et al. to obtain the invention as specified in claim 34 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art.
Conclusion
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/PATRICK B FRY/Examiner, Art Unit 3731 August 20, 2026
/SHELLEY M SELF/Supervisory Patent Examiner, Art Unit 3731
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