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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5-6, 8, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leong US 2019/0350440.
Regarding claim 1, Leong discloses an endoscope 102 (figs. 1-6C, [0028-0031]) comprising: a handle 108 [0029] including a housing 200,202 and a suction valve 114, the housing 200,202 comprising a first half-shell 200 and a second half-shell 202, the first half-shell 200 including an outer fixing portion A (see annotated figs. 2A and 2B, A is an outer fixation portion because it has an outer and inner rims exposed to the outside of the handle 108 at the opening included in the shaded oval in the annotation that allows the button of the suction valve 114 to move relative to it) and an inner fixing portion B, the second half-shell 202 including an outer fixing portion C (see annotated fig. 2c) and an inner fixing portion D (see annotated fig. 2C) having a different geometry than the inner fixing portion B of the first half-shell 200 (as seen in the annotated figs. 2A-2C, the shaded gray area indicated by B and D have different inner structures and geometries that are different, that is the area D in the second half-shell 202 in annotated fig. 2C is more hollow in the general area under the oval shaded area in the second half shell 202 as compared to the shaded gray area B in the first half-shell 200 as shown in annotated figs. 2A-2B) [0045-0053], the suction valve 114 being mounted between the first half-shell 200 and the second half-shell 202 and comprising a valve body 600 (figs. 6A-6C), a stem 604, a first portion 614 and an second portion 616, the valve body 600 having an inlet 626 and an outlet E (see annotated fig. 6B), and the stem 604 being movable axially in the valve body 600 to open and close the suction valve 114 to control a suction through the suction valve 114 [0052-0057], an insertion cord 110,124 (fig. 2A, [0029,0041-0045]) extending from the handle 108 and configured to be inserted into a patient, and a working channel 206 (figs. 3A-3C, [0033,0034]) extending through the insertion cord 110,124 and being connected to the inlet 626 via 224 (fig. 2A) of the suction valve 114 and configured to suction fluids from the patient, wherein the outer fixing portion A and the inner fixing portion B of the first half-shell 200 receive, respectively, the first portion 614 and the second portion 616 of the suction valve 114 via 204 (see annotated fig. 2B, where in the oval shaded area A the upper part 614 of the valve body 600 is received and seated while the bottom/lower portion 616 of the valve body 600 is received and seated in the rectangular shaded gray area indicted by B), wherein the outer fixing portion C and the inner fixing portion D of the second half-shell 202 receive, respectively, the first portion 614 and the second portion 616 of the suction valve 114 (the oval shaded area C and the rectangular shaded gray area D shown in annotated fig. 2C on second half-shell 202 receives and covers the first portion 614 and second portion 616 of the valve 114), and wherein the inner fixing portion B of the first half-shell 200 is configured to suppress at least one degree of freedom of the suction valve 114 (when assembled in the first half shell 200, the valve 114 will not move due to restrictions provided by the shape of the valve and the walls/structures/connections within the shaded gray area B of the first half shell 200 as seen in annotated fig. 2B) and the inner fixing portion D of the second half-shell 202 is configured to suppress a remaining degree or remaining degrees of freedom of the suction valve 114 (when half shells 200 and 202 are assembled such that half-shell 202 covers the exposed half of the valve 114, the area shaded gray area D of the half-shell 202 receives the valve 114 such that the valve 114 will be held completely in place and won’t be able to be removed or moved thus suppressing the rest of the valve 114) , the inner fixing portion B of the first half-shell 200 and the inner fixing portion D of the second half-shell 202 fixing a position and an orientation of the suction valve 114 in the housing (within the cavity formed within the housing 200,202 that is defined by the first half-shell
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200 and second half-shell 202, [0045]).
Regarding claim 2, Leong discloses the inner fixing portion B of the first half-shell 200 is configured to suppress more degrees of freedom via X,Y,Z (see annotated figs. 2A and 2B) of the suction valve 114 than the inner fixing portion D of the second half-shell 202 (see figs. 2A,2B and annotated figs 2A and 2B show that the suction valve 114 has more degrees of freedom suppresses via the connection of 224 that extends through obstructions Z and keeps the valve from moving as well as the valve’s proximity to obstruction Y, furthermore, the walls of 204 keep the valve 114 suppressed).
Regarding claim 5, Leong further discloses the inner fixing portion B of the first half-shell 200 suppresses translational movement of the suction valve 114 relative to the housing 200,202 of the handle 108 (within the cavity of half-shell 200, the valve body 600 is restricted and suppresses from having any movement including translational (moving up and down or right or left).
Regarding claim 6, Leong discloses the inner fixing portion B of the first half-shell 200 suppresses translational movement of the suction valve 114 relative to the housing 200,202 of the handle 108 along an axial direction of the stem 604, but allows a translational movement of the suction valve 114 in a direction toward the second half-shell 202, and wherein the inner fixing portion B of the second half-shell D is configured to suppress the translational movement in the direction toward the second half-shell 202 (as seen in annotated figs. 2A-2C, the fixing portion B does not allow the valve body 600 from moving up and down, that is the axial direction of the stem 604, since the fixing portion B creates an obstruction/suppression of 224 which is connected to the valve inlet 626, so the valve body 600 cannot move up or down in the axial direction of the stem 604, however, fixing portion B does allow the removal of the suction valve 114 in a direction toward the second half-shell 202, that is in a direction along an axis that is perpendicular to the axial direction of the movement of the stem 604, as such when the second half-shell 202 is assembled onto the first half-shell 200, the second-half shell 202 suppresses and keeps in place the suction valve 114 such that the suction valve 114 does not move toward the second half-shell 202).
Regarding claim 8, Leong disclose the suction valve 114 comprises a fixing projection F, and wherein the inner fixing portion B of the first half-shell 200 comprises a slot-shaped receptacle W holding the fixing projection F of the suction valve 114 (see annotated figs. 2A, 2B, 6A and 6B).
Regarding claim 20, Leong discloses a system 100 (fig. 1) comprising the endoscope 102 of claim 1 (see rejection of claim 1 being anticipated by Leong) and a video processing apparatus 104,106,128 [0031-0033].
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 8, 10-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Leong US 2019/0350440 in view of Closs WO 2022/152674.
Regarding claim 8, Leong discloses the invention as discussed above.
Leong does not disclose the suction valve comprises a fixing projection, and wherein the inner fixing portion of the first half-shell comprises a slot-shaped receptacle holding the fixing projection of the suction valve.
Closs teaches an analogous suction valve 32,54 comprises a fixing projection 84, and wherein an analogous inner fixing portion 88 of an analogous first half-shell 48 (pages 13-14) comprises a slot-shaped receptacle 88 (88 has a slot as seen in fig. 1, page 17, lines 16-27) holding the fixing projection 84 (alignment protrusion 84, page 17, lines 16-27) of the suction valve 32,54 (figs. 1, 3, 4, page 15, lines 6-12, 20-29, page 17, lines 1-27), for accurate insertion of the fixing projection into the slot-shaped receptacle in an aligned manner to facilitate easy assembly.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the suction valve and also modified the inner fixation portion of the first half-shell of Leong with fixing projection and the slot shaped receptacle, respectively, as taught by Closs in order to have provided an improved and easy to assemble endoscope that has an improved suction valve and first half-shell such that the suction valve is easily and accurately aligned and installed in the first half-shell during the manufacturing stage while also facilitating easy repair and cleaning after use of the endoscope, contributing to the cost effectiveness and longevity of the endoscope (Closs, page 17, lines 16-27).
Regarding claim 10, Leong discloses the invention as discussed above.
Leong does not disclose the inner fixing portion of the first half-shell comprises two U-shaped brackets and a split slot in between them, the U-shaped brackets and the split slot forming the slot-shaped receptacle.
Leong in view of Closs disclose the analogous inner fixing portion 88 of the analogous first half-shell 48 comprises two brackets 86,88 and a split slot (each of 86 and 88 in between them have a gap or slot, while each of 88 and 86 are L-shaped slots such that the vertical slot and the horizontal slot forming the L is considered a split slot as well), brackets 86,88 and the split slot forming the slot-shaped receptacle as taught by Closs (see fig. 1, page 17, lines 16-27 of Closs). Although Leong in view of Closs disclose the two brackets are L-shaped brackets, Leong in view of Closs does not disclose the two brackets are U-shaped brackets.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the shape of the L-shaped bracket to have been U-shaped brackets in order to facilitate easy manufacturing of the brackets and assembly by avoiding sharp edges, also, it has been held that In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed shape was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant). The applicant does not show any evidence of criticality or unexpected properties or results arising from the U-shape of the brackets (see paragraphs [0068, 0155, 0157, 0170, 0177, 0194]).
Regarding claim 11, Leong discloses the invention as discussed above.
Leong does not disclose the suction valve comprises a fixing projection, wherein the inner fixing portion of the second half-shell comprises a V-shaped receptacle configured to guide in the fixing projection of the suction valve during assembly.
Leong in view of Closs disclose the analogous inner fixing portion 88 of the analogous first half-shell 48 comprises two brackets 86,88 and a split slot (each of 86 and 88 in between them have a gap or slot, while each of 88 and 86 are L-shaped slots such that the vertical slot and the horizontal slot forming the L is considered a split slot as well), brackets 86,88 and the split slot forming the slot-shaped receptacle as taught by Closs (see fig. 1, page 17, lines 16-27 of Closs). Although Leong in view of Closs disclose the two brackets are L-shaped brackets, Leong in view of Closs does not disclose the two brackets are V-shaped brackets.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the shape of the L-shaped bracket to have been U-shaped brackets in order to facilitate easy manufacturing of the brackets and assembly by avoiding sharp edges, also, it has been held that In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed shape was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant). The applicant does not show any evidence of criticality or unexpected properties or results arising from the V-shape of the brackets (see paragraphs [0078-0085, 0089, 0107, 0114, 0163-0165, 0172, 0178, 0185-0186, 0195-0197]).
Regarding claim 16, Leong discloses the invention as discussed above.
Leong is silent on the valve body and the stem are each comprised in one piece of a thermoplastic material comprising at least 70% polypropylene.
Closs teaches an analogous valve body and stem that are each comprise in one piece of a thermoplastic material (injection molded or 3D printed/additive manufactured, see page 4, lines 23-30, page 5, lines 1-12, preferably made from a polymer/plastic material including thermoplastic polyurethane, silicone, etc., page 10, lines 7-23), which are known for their cost-effectiveness, sufficient rigidity and flexibility, and preferred tensile strength and modulus of elasticity (page 10, lines 7-16).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have manufactured each of the valve body and the stem of the suction valve of Leong to each comprised in one piece of a thermoplastic material as taught by Closs in order to have provided a cost effective and low priced endoscope having an improved suction valve that has cost effective valve body and stem which are cheap to manufacture while having the desired material properties of a thermoplastic polymer. Moreover, it would have also obvious to one of ordinary skill in the art to have used 70% polypropylene as the thermoplastic polymer material that is knows for its lightweight, durability, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle, also because it has been held that The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) also see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious). Furthermore, with regards to the 70% polypropylene, a skilled artisan would have recognized polypropylene as an interchangeable and known thermoplastic choice and would have tried known polypropylene blends to obtain acceptable mechanical and processing properties (such as being lightweight, durable, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle which is a predictable result). Selection of a specific polypropylene content is a predictable optimization—balancing mechanical and processing properties (see above)—such that choosing 70% polypropylene would have been an obvious design choice. Under Graham v. John Deere and KSR v. Teleflex, the limitation ‘70% polypropylene’ is an obvious variation of the prior art in view of the cited references and common general knowledge. The applicant does not show any evidence of criticality or unexpected properties arising from 70% polypropylene that would establish nonobviousness. (see applicant’s written specification [0038, 0104, 0105, 0106, 0149, 0158, 0202, 0203 which do not evidence any unpredictable results). See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) and In re Brana, 51 F.3d 1560 (Fed. Cir. 1995).
Regarding claim 12, Leong in view of Closs discloses the invention as discussed above.
Leong further discloses the suction valve 114 comprises a button 612 pushable to translate the stem 604 axially [0053-0057]. Leong in view of Closs in combination disclose wherein the V-shaped receptacle (88 modified to be V-shaped) comprises a flat force-taking surface portion (the straight plate like formations of the V) perpendicular to a direction in which the button 612 of the suction valve 114 is pushable to translate the stem 604 (the receptacle 88 is positioned in the vertical wall of the first half-shell 48 and protrude out from the inner surface of the wall 48 such that the flat V-shaped surfaces (as can be seen in the L-shaped surfaced in Closs, fig. 1) are flat force-taking surface portions are in a plane that are perpendicular to the translation (up/down) direction of the stem 604.
Regarding claim 13, Leong in view of Closs discloses the invention as discussed above.
Leong in view of Closs in combination disclose the flat force-taking surface portion supresses movement of the suction valve 32,54 relative to the housing 36,48, parallel to the axial direction of the stem 604 (the projection 84 when inserted into the receptacle 88 holds the suction valve 32,54 such that when the button is pressed and the stem moves down, the valve is not moved up/down in the direction of the stem, thus being suppressed) as taught by Closs.
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Leong US 2019/0350440 in view of Closs WO 2022/152674 further in view of Schroeder US 20180073676.
Regarding claim 7, Leong discloses the invention as discussed above.
Leong does not disclose the suction valve comprises a fixing projection, wherein the inner fixing portion of the first half-shell comprises a slot-shaped receptacle holding the fixing projection of the suction valve, and wherein the slot-shaped receptacle tapers and forms a press-fit with the fixing projection of the suction valve.
Closs teaches an analogous suction valve 32,54 comprises a fixing projection 84, and wherein an analogous inner fixing portion 88 of an analogous first half-shell 48 (pages 13-14) comprises a slot-shaped receptacle 88 (88 has a slot as seen in fig. 1, page 17, lines 16-27) holding the fixing projection 84 (alignment protrusion 84, page 17, lines 16-27) of the suction valve 32,54 (figs. 1, 3, 4, page 15, lines 6-12, 20-29, page 17, lines 1-27), for accurate insertion of the fixing projection into the slot-shaped receptacle in an aligned manner to facilitate easy assembly.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the suction valve and also modified the inner fixation portion of the first half-shell of Leong with fixing projection and the slot shaped receptacle, respectively, as taught by Closs in order to have provided an improved and easy to assemble endoscope that has an improved suction valve and first half-shell such that the suction valve is easily and accurately aligned and installed in the first half-shell during the manufacturing stage while also facilitating easy repair and cleaning after use of the endoscope, contributing to the cost effectiveness and longevity of the endoscope (Closs, page 17, lines 16-27).
Leong in view of Closs discloses the invention as discussed above.
Leong in view of Closs is silent on the slot-shaped receptacle tapers and forms a press-fit with the fixing projection of the suction valve.
Schroder teaches an analogous slot-shaped receptacle 17,18,20 the slot-shaped receptacle 17,18,20 tapers and forms a press-fit with an analogous fixing projection 137 [0058-0059], the downwardly tapering slot allowing centering of the fixing projection on the central axis as the fixing projection is transitioned from wider area of the tapering to the narrower part of the tapering for securing the fixation projection and mitigating removal from slot-shaped receptacle [0062].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the slot-shaped receptacle 88 of Leong in view of Closs to taper and form a press-fit with the fixation projection as taught by Schroeder in order to have provided an improved slot-shaped receptacle that allows for easy centering of the fixing projection on the central axis as the fixing projection is transitioned from wider area of the tapering to the narrower part of the tapering for better alignment and securing of the fixation projection of the suction valve and mitigating removal from the slot-shaped receptacle during assembly (Schroeder, [0062]).
Regarding claim 9, Leong in view of Closs discloses the invention as discussed above.
Leong in view of Closs is silent on the slot-shaped receptacle tapers and forms a press-fit with the fixing projection of the suction valve.
Schroder teaches an analogous slot-shaped receptacle 17,18,20 the slot-shaped receptacle 17,18,20 tapers and forms a press-fit with an analogous fixing projection 137 [0058-0059], the downwardly tapering slot allowing centering of the fixing projection on the central axis as the fixing projection is transitioned from wider area of the tapering to the narrower part of the tapering for securing the fixation projection and mitigating removal from slot-shaped receptacle [0062].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the slot-shaped receptacle 88 of Leong in view of Closs to taper and form a press-fit with the fixation projection as taught by Schroeder in order to have provided an improved slot-shaped receptacle that allows for easy centering of the fixing projection on the central axis as the fixing projection is transitioned from wider area of the tapering to the narrower part of the tapering for better alignment and securing of the fixation projection of the suction valve and mitigating removal from the slot-shaped receptacle during assembly (Schroeder, [0062]).
Claim 3 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Leong US 2019/0350440 in view of Christensen EP 3903661 further in view of Closs WO 2022/152674.
Regarding claim 3, Leong discloses the invention as discussed above. Leong does not disclose the handle, the valve body and the stem, are each comprised of at least 20% polypropylene material.
Christensen teaches an analogous endoscope 1 having a handle 2 having an analogous handle housing 116 (fig. 1, [0081] comprising of polypropylene material (PP) or copolymers including the PP [0017-0018], for the advantage of saving material costs, weight, and ease of manufacture [0012].
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was made to have manufactured the handle of Leong such that it comprised of 20% polypropylene in order to have provided a cost effective endoscope that has a lightweight handle that is cheap and easy to manufacture while providing the preferred rigidity, tensile strength, durability, and heat/chemical resistance [0012]. Furthermore, with regards to the 20% polypropylene, a skilled artisan would have recognized polypropylene as an interchangeable and known thermoplastic choice and would have tried known polypropylene blends to obtain acceptable mechanical and processing properties (such as being lightweight, durable, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle which is a predictable result). Selection of a specific polypropylene content is a predictable optimization—balancing mechanical and processing properties (see above)—such that choosing 20% polypropylene would have been an obvious design choice. Under Graham v. John Deere and KSR v. Teleflex, the limitation ‘20% polypropylene’ is an obvious variation of the prior art in view of the cited references and common general knowledge. The applicant does not show any evidence of criticality or unexpected properties arising from 20% polypropylene that would establish nonobviousness. (see applicant’s written specification [0038, 0104, 0105, 0106, 0149, 0158, 0202, 0203 which do not evidence any unpredictable results). See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) and In re Brana, 51 F.3d 1560 (Fed. Cir. 1995).
Leong in view of Christensen discloses the invention as discussed above. Leong in view of Christensen does not explicitly disclose the valve body and the stem, are each comprised of at least 20% polypropylene material.
Closs teaches an analogous valve body and stem that are each comprise in one piece of a thermoplastic material (injection molded or 3D printed/additive manufactured, see page 4, lines 23-30, page 5, lines 1-12, preferably made from a polymer/plastic material including thermoplastic polyurethane, silicone, etc., page 10, lines 7-23), which are known for their cost-effectiveness, sufficient rigidity and flexibility, and preferred tensile strength and modulus of elasticity (page 10, lines 7-16).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have manufactured each of the valve body and the stem of the suction valve of Leong to each comprised in one piece of a thermoplastic material as taught by Closs in order to have provided a cost effective and low priced endoscope having an improved suction valve that has cost effective valve body and stem which are cheap to manufacture while having the desired material properties of a thermoplastic polymer. Moreover, it would have also obvious to one of ordinary skill in the art to have used 20% polypropylene as the thermoplastic polymer material that is knows for its lightweight, durability, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle, also because it has been held that The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) also see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious). Furthermore, with regards to the 20% polypropylene, a skilled artisan would have recognized polypropylene as an interchangeable and known thermoplastic choice and would have tried known polypropylene blends to obtain acceptable mechanical and processing properties (such as being lightweight, durable, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle which is a predictable result). Selection of a specific polypropylene content is a predictable optimization—balancing mechanical and processing properties (see above)—such that choosing 20% polypropylene would have been an obvious design choice. Under Graham v. John Deere and KSR v. Teleflex, the limitation ‘20% polypropylene’ is an obvious variation of the prior art in view of the cited references and common general knowledge. The applicant does not show any evidence of criticality or unexpected properties arising from 20% polypropylene that would establish nonobviousness. (see applicant’s written specification [0038, 0104, 0105, 0106, 0149, 0158, 0202, 0203 which do not evidence any unpredictable results). See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) and In re Brana, 51 F.3d 1560 (Fed. Cir. 1995).
Regarding claim 17, Leong discloses the invention as discussed above.
Leong does not disclose the handle, the valve body and the stem, are each comprised of at least 70% polypropylene material.
Christensen teaches an analogous endoscope 1 having a handle 2 having an analogous handle housing 116 (fig. 1, [0081] comprising of polypropylene material (PP) or copolymers including the PP [0017-0018], for the advantage of saving material costs, weight, and ease of manufacture [0012].
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was made to have manufactured the handle of Leong such that it comprised of 20% polypropylene in order to have provided a cost-effective endoscope that has a lightweight handle that is cheap and easy to manufacture while providing the preferred rigidity, tensile strength, durability, and heat/chemical resistance [0012]. Furthermore, with regards to the 70% polypropylene, a skilled artisan would have recognized polypropylene as an interchangeable and known thermoplastic choice and would have tried known polypropylene blends to obtain acceptable mechanical and processing properties (such as being lightweight, durable, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle which is a predictable result). Selection of a specific polypropylene content is a predictable optimization—balancing mechanical and processing properties (see above)—such that choosing 70% polypropylene would have been an obvious design choice. Under Graham v. John Deere and KSR v. Teleflex, the limitation ‘20% polypropylene’ is an obvious variation of the prior art in view of the cited references and common general knowledge. The applicant does not show any evidence of criticality or unexpected properties arising from 70% polypropylene that would establish nonobviousness. (see applicant’s written specification [0038, 0104, 0105, 0106, 0149, 0158, 0202, 0203 which do not evidence any unpredictable results). See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) and In re Brana, 51 F.3d 1560 (Fed. Cir. 1995).
Leong in view of Christensen discloses the invention as discussed above. Leong in view of Christensen does not explicitly disclose the valve body and the stem, are each comprised of at least 70% polypropylene material.
Closs teaches an analogous valve body and stem that are each comprise in one piece of a thermoplastic material (injection molded or 3D printed/additive manufactured, see page 4, lines 23-30, page 5, lines 1-12, preferably made from a polymer/plastic material including thermoplastic polyurethane, silicone, etc., page 10, lines 7-23), which are known for their cost-effectiveness, sufficient rigidity and flexibility, and preferred tensile strength and modulus of elasticity (page 10, lines 7-16).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have manufactured each of the valve body and the stem of the suction valve of Leong to each comprised in one piece of a thermoplastic material as taught by Closs in order to have provided a cost effective and low priced endoscope having an improved suction valve that has cost effective valve body and stem which are cheap to manufacture while having the desired material properties of a thermoplastic polymer. Moreover, it would have also obvious to one of ordinary skill in the art to have used 70% polypropylene as the thermoplastic polymer material that is known for its lightweight, durability, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle, also because it has been held that The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) also see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious). Furthermore, with regards to the 70% polypropylene, a skilled artisan would have recognized polypropylene as an interchangeable and known thermoplastic choice and would have tried known polypropylene blends to obtain acceptable mechanical and processing properties (such as being lightweight, durable, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle which is a predictable result). Selection of a specific polypropylene content is a predictable optimization—balancing mechanical and processing properties (see above)—such that choosing 70% polypropylene would have been an obvious design choice. Under Graham v. John Deere and KSR v. Teleflex, the limitation ‘70% polypropylene’ is an obvious variation of the prior art in view of the cited references and common general knowledge. The applicant does not show any evidence of criticality or unexpected properties arising from 70% polypropylene that would establish nonobviousness. (see applicant’s written specification [0038, 0104, 0105, 0106, 0149, 0158, 0202, 0203 which do not evidence any unpredictable results). See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) and In re Brana, 51 F.3d 1560 (Fed. Cir. 1995).
Regarding claim 18, Leong in view of Christensen in view of Closs discloses the invention as discussed above.
Leong in view of Christensen in view of Closs does not explicitly disclose at least 20% of the polypropylene material is bio-polypropylene.
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was made to have manufactured the handle of Leong in view of Christensen in view of Closs such that it comprised of 20% bio-polypropylene in order to have provided a cost-effective endoscope that has a lightweight handle that is cheap and easy to manufacture while providing the preferred rigidity, tensile strength, durability, and heat/chemical resistance [0012]. Furthermore, with regards to the 20% bi0polypropylene, a skilled artisan would have recognized bio-polypropylene as an interchangeable and known thermoplastic polypropylene choice and would have tried known polypropylene blends from natural/recycled resources to obtain acceptable mechanical and processing properties (such as being lightweight, durable, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle which is a predictable result while maintaining environmental benefits such as sourcing from bioproducts rather than petrochemical sources). Selection of a specific polypropylene content is a predictable optimization—balancing mechanical and processing properties (see above)—such that choosing 20% bio-polypropylene would have been an obvious design choice. Under Graham v. John Deere and KSR v. Teleflex, the limitation ‘20% bio-polypropylene’ is an obvious variation of the prior art in view of the cited references and common general knowledge. The applicant does not show any evidence of criticality or unexpected properties arising from 20% bio-polypropylene that would establish nonobviousness. (see applicant’s written specification [0038, 0104, 0105, 0106, 0149, 0158, 0202, 0203 which do not evidence any unpredictable results). See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)).
Regarding claim 19, Leong in view of Christensen in view of Closs discloses the invention as discussed above.
Although Leong discloses the first half-shell 200 comprises a wall having an outer surface (exposed to the environment outside of the endoscope) and an inner surface (defining an opposite wall that faces internally of the endoscope handle 108 facing the second half-shell 202), wherein the wall inherently has a thickness, Leong does not explicitly disclose the wall having an average wall thickness of 2.5 mm or less.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the wall thickness of the first half-shell 200 of Leong in view of Christensen in view of Closs to have been 2.5 mm or less for the obvious purpose of making the handle 108 lighter, easier to manufacture, and cheaper, since it has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Also, the applicant does not show any evidence of criticality or unexpected properties arising from the wall thickness being 2.5 mm or less that would establish nonobviousness or an unpredictable result. (see applicant’s written specification [0145, 0158] which do not evidence any unpredictable results). See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Leong US 2019/0350440 in view of Christensen EP 3903661.
Regarding claim 4, Leong discloses the invention as discussed above.
Although Leong discloses the first half-shell 200 comprises a wall having an outer surface (exposed to the environment outside of the endoscope) and an inner surface (defining an opposite wall that faces internally of the endoscope handle 108 facing the second half-shell 202), wherein the wall inherently has a thickness, Leong does not explicitly disclose the wall having an average wall thickness of 2.5 mm or less, and wherein the handle comprises at least 20% bio-polypropylene material.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the wall thickness of the first half-shell 200 of Leong to have been 2.5 mm or less for the obvious purpose of making the handle 108 lighter, easier to manufacture, and cheaper, since it has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Also, the applicant does not show any evidence of criticality or unexpected properties arising from the wall thickness being 2.5 mm or less that would establish nonobviousness or an unpredictable result. (see applicant’s written specification [0145, 0158] which do not evidence any unpredictable results). See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)).
Leong discloses the invention as discussed above. Leong does not explicitly disclose wherein the handle comprises at least 20% bio-polypropylene material
Christensen teaches an analogous endoscope 1 having a handle 2 having an analogous handle housing 116,116a having an analogous first half-shell and second half-shell having an analogous wall thickness (fig. 1, [0081, 0091, 0092, 0095]) comprising of polypropylene material (PP) or copolymers including the PP [0017-0018], for the advantage of saving material costs, weight, and ease of manufacture [0012].
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was made to have manufactured the handle of Leong such that it comprised of 20% bio-polypropylene in order to have provided a cost-effective endoscope that has a lightweight handle that is cheap and easy to manufacture while providing the preferred rigidity, tensile strength, durability, and heat/chemical resistance [0012]. Furthermore, with regards to the 20% bi0polypropylene, a skilled artisan would have recognized bio-polypropylene as an interchangeable and known thermoplastic polypropylene choice and would have tried known polypropylene blends from natural/recycled resources to obtain acceptable mechanical and processing properties (such as being lightweight, durable, high chemical resistance, and high-heat tolerance which is ideal for endoscopes that are exposed to high-heat sterilization during the endoscope’s product lifecycle which is a predictable result while maintaining environmental benefits such as sourcing from bioproducts rather than petrochemical sources). Selection of a specific polypropylene content is a predictable optimization—balancing mechanical and processing properties (see above)—such that choosing 20% bio-polypropylene would have been an obvious design choice. Under Graham v. John Deere and KSR v. Teleflex, the limitation ‘20% bio-polypropylene’ is an obvious variation of the prior art in view of the cited references and common general knowledge. The applicant does not show any evidence of criticality or unexpected properties arising from 20% bio-polypropylene that would establish nonobviousness. (see applicant’s written specification [0038, 0104, 0105, 0106, 0149, 0158, 0202, 0203 which do not evidence any unpredictable results). See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)).
Allowable Subject Matter
Claims 14 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 14 and 15, the prior art of record (Leong, Christensen, Closs) either taken alone or in combination, do not disclose, teach, or render obvious “wherein the suction valve comprises a fixing projection, wherein the inner fixing portion of the second half-shell comprises a V-shaped receptacle configured to guide in the fixing projection of the suction valve during assembly, wherein the suction valve comprises a button pushable to translate the stem axially, wherein the V-shaped receptacle comprises a flat force-taking surface portion perpendicular to a direction in which the button of the suction valve is pushable to translate the stem, and wherein the flat force-taking surface portion supresses movement of the suction valve, relative to the housing, parallel to the axial direction of the stem.” Leong’s second half-shell 202 is generally open and free and has a different geometry to that of the first half-sell 202. Also, neither do Closs nor Christensen teach projections facing a second half-shell. In fact, neither Closs nor Christensen teach a visible second half-shell such that the second half-shell would have receptacles that would mate with projections on the suction valve. Closs teaches projections that mate to receptacles on an analogous first half-shell. So there is no motivation for one skilled in the art to introduce receptacles on the inner surface of the second half-shell nor projections on the side of the suction valve that face the second half-shell.
Conclusion
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