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 Objections
Claim 15 is objected to because of the following informalities: line 1 includes the phrase “the endoscope further comprising and a suction valve”. Examiner believes that this contains a typographical error, and should read “the endoscope further comprising [[and]] a suction valve”. Appropriate correction by Applicant is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1, 3-4, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Christensen et al. (EP 3903661 A1 – “Christensen”) and Closs et al. (WO 2022152674 A1 – “Closs”).
Regarding Claim 1, Leong discloses:
An endoscope (Leong FIG. 1, endoscope 102)
wire pipes (Leong FIG. 3A, pull wire lumens 304);
steering wires (Leong FIG. 2B and Leong FIG. 3A, pull wires 208/210) arranged in the wire pipes;
an insertion cord (Leong FIG. 1, shaft 110) including a bending section (Leong FIG. 1, flexible tip 124) which is bendable by manipulation of the steering wires (Leong paragraph [0058], “To control the articulation of flexible tip 124, pull wires 208 extend through shaft 120 proximal and intermediate portions 122/120 of shaft 110 and couple to control wheel assembly 204”);
a working channel tube (Leong FIG. 3A, tube that forms internal working channel 206) forming at least part of a working channel (Leong FIGs. 2A-3C, working channel 206); and
a handle (Leong FIG. 1, handle 108) comprising:
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housing shells including a first housing shell (Leong FIG. 2B, right shell 200) and a second housing shell (Leong FIG. 2C, left shell 202), each of the first and the second housing shells comprising integral fasteners, the fasteners securing the first housing shell to the second housing shell to form an inner compartment, the fasteners and the housing shells comprising the same material and comprising snap-fit fasteners or press-fit fasteners (Examiner-annotated Leong FIG. 2A shown above; Leong paragraph [0029], ”handle 108 may be formed of two similarly sized halves, referred to as a right shell 200 (interior features of which are shown in FIG. 2B) and a left shell 202 (interior features of which are shown in FIG. 2C), which snap or otherwise connect together along a longitudinal center line of handle 108, as shown in FIG. 2A; see also Leong paragraph [0047], “shells 200 and 202 may be secured together via a plurality of clips spaced about periphery portions 218/220”; see also Examiner-annotated Leong FIGs. 2B and 2C in the rejection of Claim 9 below);
a roller (Leong FIG. 2B, control wheel assembly 204) for bending the bending section by pulling the steering wires (Leong paragraph [0058], “To control the articulation of flexible tip 124, pull wires 208 extend through shaft 120 proximal and intermediate portions 122/120 of shaft 110 and couple to control wheel assembly 204”);
a suction valve (Leong FIG. 1 and FIGs. 2A/2B, suction valve assembly 114) configured to control suction through the working channel (Leong paragraph [0052], “suction valve assembly 114 is also configured for insertion between right shell 200 and left shell 202 during assembly and operatively couples an external source of suction to working channel 206 via suction connector 224 and tube fitting 502”), the suction valve comprising a body (Leong FIG. 6A, cylindrical housing 600) and a stem (Leong FIG. 6A, plunger 604) translatable in the body to open or close the suction valve (Leong FIG. 6B and Leong FIG. 6B; Leong paragraph [0052], “FIGS. 6B and 6C are cross-sectional detailed views of suction valve assembly 114 in closed and open states, respectively”);
interfaces configured to secure the roller (Leong FIG. 2C, control lever opening 236; see also Leong FIG. 2A, wheel boss 226) and the suction valve to at least one of the housing shells inside the inner compartment (Leong FIG. 2B, portion of right shell 200 that surrounds/supports suction valve assembly 114; Leong paragraph [0052], “As shown in FIGS. 2A and 2B, suction valve assembly 114 is also configured for insertion between right shell 200 and left shell 202 during assembly”), at least one of the interfaces being integral with the housing shells and comprising the same material as one or the other of the housing shells (see Leong 2A, showing wheel boss 226, which Leong paragraph [0065] describes as being integrally formed with right shell 200).
Leong does not explicitly disclose wherein at least 70% of the material of the housing shells comprises polypropylene material.
Christensen teaches an analogous endoscope (Christensen FIG. 1, endoscope 1) having a handle (Christensen FIG. 1, endoscope handle 2 ) that comprises an analogous handle housing shell (Christensen FIG. 1, handle housing 116) that comprises polypropylene material (PP) or copolymers including the PP (see Christensen paragraph [0017], for the advantage of saving material costs, weight, and ease of manufacture; see also Christensen paragraph [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 is comprised of 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 (see Christensen paragraph [0012]). Furthermore, with regards to the 70% polypropylene feature of the housing shells, 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. That is, while applicant’s written specification teaches that the housing shell may comprise at least 70% polypropylene (paragraph [0013]), there is no evidence in the specification that these percentages are critical to the operation of the invention or that they would result in 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 does not explicitly teach wherein the body of the suction valve is comprised of at least 70% polypropylene material.
Closs teaches an analogous body for a suction valve (Closs FIG. 1, valve insert 46) that is comprised of polymer material (Closs page 4, line 29 – page 5, line 2, “it is possible to easily manufacture the valve insert using a polymer material. E.g. the valve insert can be easily produced by injection molding or 3D printing/ additive manufacturing.” Closs thus provides advantages with respect to manufacture, assembly and costs (see also Closs 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 the valve body of Leong in the endoscope taught by Leong in view of Christensen using the thermoplastic material as taught by Closs (see Closs page 10, lines 15-19) in order to have provided a cost effective and low priced endoscope having an improved suction valve that has a cost effective valve body that is 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 in the construction of the suction valve body 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. 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). Under Graham v. John Deere and KSR v. Teleflex, the limitation ‘70% polypropylene’ for constructing the suction valve body 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 paragraph [0106] of Applicant’s written specification, which teaches that components may comprise more than 70% of polypropylene, but does not evidence any criticality of this percentage or any unpredictable result from the use thereof. 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 3, Leong in view of Christensen and Closs teaches the features of Claim 1, as described above.
Leong further discloses wherein the roller (Leong FIG. 2A, control wheel assembly 204) is rotatably connected to a roller interface (Leong FIG. 2A, wheel boss 226) forming an axle for the roller (Leong paragraph [0065], “Main control wheel boss 226 is a tubular body that projects inwardly from right shell 200 and receives a corresponding central shaft 808 of first control wheel 800 therein, such that first control wheel 800, when assembled, rotates within main control wheel boss 226”), the roller interface being integral and comprising the same material as one of the housing shells (Leong paragraph [0065], “As shown in FIG. 2A, main control wheel boss 226 may be formed integrally with right shell 200.”).
Regarding Claim 4, Leong in view of Christensen and Closs teaches the features of Claim 3, as described above.
Leong further discloses wherein the roller interface comprises ribs provided to enforce a connection between the roller interface and the one of the housing shells (Examiner-annotated Leong FIG. 2A shown above, roller interface ribs connected to control wheel boss 226 and right shell 200).
Regarding Claim 15, Leong in view of Christensen teaches the features of Claim 5, as described below.
Leong further discloses the suction valve configured to control suction through the working channel (Leong paragraph [0052], “suction valve assembly 114 is also configured for insertion between right shell 200 and left shell 202 during assembly and operatively couples an external source of suction to working channel 206 via suction connector 224 and tube fitting 502”), wherein the suction valve is secured to at least one of the housing shells inside the inner compartment with the interfaces (Leong FIG. 2B, portion of right shell 200 that surrounds/supports suction valve assembly 114; Leong paragraph [0052], “As shown in FIGS. 2A and 2B, suction valve assembly 114 is also configured for insertion between right shell 200 and left shell 202 during assembly”).
Leong in view of Christensen does not explicitly teach the endoscope further comprising a suction valve comprised of the at least 70% polypropylene material.
Closs teaches an analogous body the suction valve (Closs FIG. 1, valve insert 46) is comprised of polymer material (Closs page 4, line 29 – page 5, line 2, “it is possible to easily manufacture the valve insert using a polymer material. E.g. the valve insert can be easily produced by injection molding or 3D printing/ additive manufacturing.” Closs thus provides advantages with respect to manufacture, assembly and costs (see also Closs 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 the valve body of Leong in the endoscope taught by Leong in view of Christensen using the thermoplastic material as taught by Closs (see Closs page 10, lines 15-19) in order to have provided a cost effective and low priced endoscope having an improved suction valve that has cost effective valve body that is 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, in constructing the suction valve, 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. 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 composition of the suction valve, 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 paragraph [0013] of Applicant’s written specification, which teaches that components may comprise more than 70% of polypropylene, but does not evidence any criticality of this percentage or any unpredictable result from the use thereof. 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).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Christensen et al. (EP 3903661 A1 – “Christensen”), Closs et al. (WO 2022152674 A1 – “Closs”), and Kulshrestha et al. (AU 2016201295 A1 – “Kulshrestha”).
Regarding Claim 2, Leong in view of Christensen and Closs teaches the features of Claim 1, as described above.
Leong in view of Christensen and Closs does not explicitly teach wherein the polypropylene material comprises at least 20% bio-polypropylene.
Kulshrestha teaches wherein the polypropylene material comprises at least 20% bio-polypropylene.
Kulshrestha teaches that polypropylene polymers (i.e., those formed from virgin resin components such as fossil fuels) and bio-propylene (i.e., those formed from biological sources or renewable agricultural sources) are commonly used when fabricating medical articles (see Kulshrestha paragraphs [0035] – [0055]). The present patent application states in paragraph [0013] that a components of the housing shells can be made of polypropylene, with at least 20% of which is bio-based polypropylene. The present specification does not describe why using at least 20% bio-polypropylene is critical or would show an unexpected result. As such, using at least 20% bio-polypropylene is merely a design choice, which is not described as critical in the specification.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize polypropylene that includes at least 20% bio-polypropylene in the construction of an endoscope. A person having ordinary skill in the art would be motivated to use bio-polypropylene based on its availability, desire to protect Earth’s environment, etc.
Claims 5, 8-14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Christensen et al. (EP 3903661 A1 – “Christensen”).
Regarding Claim 5, Leong discloses:
An endoscope (Leong FIG. 1, endoscope 102) comprising:
steering wires (Leong FIG. 2B and FIG. 3A, pull wires 208/210) arranged in wire pipes (Leong FIG. 3A, pull wire lumens 304);
an insertion cord (Leong FIG. 1, shaft 110) including a bending section (Leong FIG. 1, flexible tip 124) which is bendable by manipulation of the steering wires (Leong paragraph [0058], “To control the articulation of flexible tip 124, pull wires 208 extend through shaft 120 proximal and intermediate portions 122/120 of shaft 110 and couple to control wheel assembly 204”); and
a handle (Leong FIG. 1, handle 108) comprising:
housing shells including a first housing shell (Leong FIG. 2B, right shell 200) and a second housing shell (Leong FIG. 2C, left shell 202), each of the first and the second housing shells comprising integral fasteners (see snap-fit clips in Examiner-annotated Leong FIGs. 2B and 2C below):
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the fasteners securing the first housing shell to the second housing shell to form an inner compartment (Examiner-annotated Leong FIG. 2A shown above in the rejection of Claim 1; Leong paragraph [0029], ”handle 108 may be formed of two similarly sized halves, referred to as a right shell 200 (interior features of which are shown in FIG. 2B) and a left shell 202 ((interior features of which are shown in FIG. 2C), which snap or otherwise connect together along a longitudinal center line of handle 108, as shown in FIG. 2A; see also Leong paragraph [0047], “shells 200 and 202 may be secured together via a plurality of clips spaced about periphery portions 218/220”), the fasteners and the housing shells comprising the same material (Leong FIGs. 2B and 2C, showing snap-fit clips integral components of the shells; see also Leong paragraph [0046], which teaches that shells 200/202 may be formed using injection molding, which would result in all features shown in Leong FIGs. 2B and 2C to be the same material);
at least one component selected from a group comprising: a roller (Leong FIG. 2B, control wheel assembly 204) for bending the bending section by pulling the steering wires (Leong paragraph [0058], “To control the articulation of flexible tip 124, pull wires 208 extend through shaft 120 proximal and intermediate portions 122/120 of shaft 110 and couple to control wheel assembly 204”), a wire pipe fastener (Leong FIG. 2B, routing vanes 232 connected to right shell 200) connecting the wire pipes to one of the housing shell, and/or an encasement for a circuit board; and
interfaces (Leong FIG. 2A, wheel boss 226) configured to secure the at least one component to at least one of the housing shells inside the inner compartment (Leong paragraph [0065], “Main control wheel boss 226 is a tubular body that projects inwardly from right shell 200 and receives a corresponding central shaft 808 of first control wheel 800 therein, such that first control wheel 800, when assembled, rotates within main control wheel boss 226”), at least one of the interfaces being integral with and comprising the same material as one or the other of the housing shells (Leong paragraph [0065], “As shown in FIG. 2A, main control wheel boss 226 may be formed integrally with right shell 200.”), the interfaces extending into the inner compartment (Leong FIG. 2A, showing main control wheel boss 226 extending into the interior of right shell 200).
Leong does not explicitly disclose that each of the first and second housing shells are comprising at least 70% polypropylene material.
Christensen teaches an analogous endoscope (Christensen FIG. 1, endoscope 1) having a handle (Christensen FIG. 1, endoscope handle 2 ) that comprises an analogous handle housing shell (Christensen FIG. 1, handle housing 116) that comprises polypropylene material (PP) or copolymers including the PP [see Christensen paragraph [0017], for the advantage of saving material costs, weight, and ease of manufacture (see Christensen paragraph [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 is comprised of 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 (see Christensen paragraph [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 ‘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. That is, while applicant’s written specification teaches that the housing shell may comprise at least 70% polypropylene (paragraph [0013]), there is no evidence in the specification that these percentages are critical to the operation of the invention or that they would result in 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 8, Leong in view of Christensen teaches the features of Claim 5, as described above.
Leong further discloses wherein the fasteners comprise snap-fit fasteners or press-fit fasteners (Examiner-annotated Leong FIG. 2A shown above; Leong paragraph [0029], ”handle 108 may be formed of two similarly sized halves, referred to as a right shell 200 (interior features of which are shown in FIG. 2B) and a left shell 202 ((interior features of which are shown in FIG. 2C), which snap or otherwise connect together along a longitudinal center line of handle 108, as shown in FIG. 2A; see also Leong paragraph [0047], “shells 200 and 202 may be secured together via a plurality of clips spaced about periphery portions 218/220”; see also Examiner-annotated Leong FIGs. 2B and 2C shown above in the rejection of Claim 5).
Regarding Claim 9, Leong in view of Christensen teaches the features of Claim 8, as described above.
Leong further discloses wherein 6 – 12 snap-fits fasteners are used to attach the first housing shell to the second housing shell (see Examiner-annotated Leong FIG. 2B above in the rejection of Claim 5, showing 9 female snap-fit clips on right shell 200, and Examiner-annotated Leong FIG. 2C shown above in the rejection of Claim 5, showing 9 corresponding male snap-fit clips on left shell 202).
Regarding Claim 10, Leong in view of Christensen teaches the features of Claim 9, as described above.
Leong further discloses wherein the housing shells further comprise integral guiding means (Leong FIG. 2B, routing posts 230 for guiding pull wires 208/210).
Regarding Claim 11, Leong in view of Christensen teaches the features of Claim 5, as described above.
Leong further discloses wherein the handle comprises the roller (Leong FIG. 2B, control wheel assembly 204) and the wire pipe fastener (Leong FIG. 2B, routing vanes in the inner compartment of right shell 200) in the inner compartment.
Regarding Claim 12, Leong in view of Christensen teaches the features of Claim 11, as described above.
Leong further discloses wherein the roller (Leong FIG. 2A, control wheel assembly 204) is rotatably connected to a roller interface (Leong FIG. 2A, wheel boss 226) forming an axle for the roller (Leong paragraph [0065], “Main control wheel boss 226 is a tubular body that projects inwardly from right shell 200 and receives a corresponding central shaft 808 of first control wheel 800 therein, such that first control wheel 800, when assembled, rotates within main control wheel boss 226”), the roller interface being integral and comprising the same material as one of the housing shells (Leong paragraph [0065], “As shown in FIG. 2A, main control wheel boss 226 may be formed integrally with right shell 200.”).
Regarding Claim 13, Leong in view of Christensen teaches the features of Claim 12, as described above.
Leong further discloses wherein the roller interface comprises ribs provided to enforce a connection between the roller interface and the one of the housing shells (Examiner-annotated Leong FIG. 2A shown above, roller interface ribs connected to control wheel boss 226 and right shell 200).
Regarding Claim 14, Leong in view of Christensen teaches the features of Claim 5, as described above.
Leong further discloses:
a working channel tube (Leong FIG. 3A, tube that forms internal working channel 206) forming at least part of a working channel (Leong FIGs. 2A-3C, working channel 206,
the handle further comprising a working channel port (Leong FIG. 1, access port assembly 116) enabling insertion of tools into and through the working channel (Leong paragraph [0051], “enables connecting a syringe into the access port assembly 116 so that fluids can be administered into the working channel 206”), and/or a suction valve (Leong FIG. 1 and FIGs. 2A/2B, suction valve assembly 114) to control suction through the working channel,
wherein the working channel port and/or the suction valve are secured to at least one of the housing shells inside the inner compartment with the interfaces (Leong FIG. 2B, showing access port assembly 116 and/or suction valve assembly 114 secured to right shell 200).
Regarding Claim 20, Leong in view of Christensen teaches the features of the endoscope described in Claim 5, as described above.
Leong further discloses a monitor (Leong FIG. 1, video monitor 106) and a control unit (Leong FIG. 1, control pad 130).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Christensen et al. (EP 3903661 A1 – “Christensen”) and Kulshrestha et al. (AU 2016201295 A1 – “Kulshrestha”).
Regarding Claim 6, Leong in view of Christensen teaches the features of Claim 5, as described above.
Leong in view of Christensen does not explicitly teach wherein the polypropylene material comprises at least 20% bio-polypropylene.
Kulshrestha teaches wherein the polypropylene material comprises bio-polypropylene.
Kulshrestha teaches that polypropylene polymers (i.e., those formed from virgin resin components such as fossil fuels) and bio-propylene (i.e., those formed from biological sources or renewable agricultural sources) are commonly used when fabricating medical articles (see Kulshrestha paragraphs [0035] – [0055]). The present patent application states in paragraph [0013] that a components of the housing shells can be made of polypropylene, with at least 20% of which is bio-based polypropylene. The present specification does not describe why using at least 20% bio-polypropylene is critical or would show an unexpected result. As such, using at least 20% bio-polypropylene is merely a design choice, which is not described as critical in the specification.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize polypropylene that includes at least 20% bio-polypropylene in the construction of an endoscope. A person having ordinary skill in the art would be motivated to use bio-polypropylene based on its availability, desire to protect Earth’s environment, etc. (See Kulshrestha paragraphs [0006] and [0008])
Regarding Claim 7, Leong in view of Christensen and Kulshrestha teaches the features of Claim 6, as described above.
Kulshrestha further teaches wherein the polypropylene material comprises at least 40% bio-polypropylene.
As described above, Kulshrestha teaches that polypropylene polymers (i.e., those formed from virgin resin components such as fossil fuels) and bio-propylene (i.e., those formed from biological sources or renewable agricultural sources) are commonly used when fabricating medical articles (see Kulshrestha paragraphs [0035] – [0055]). The present patent application states in paragraph [0013] that a components of the housing shells can be made of polypropylene, with at least 40% of which is bio-based polypropylene. The present specification does not describe why using at least 40% bio-polypropylene is critical or would show an unexpected result. As such, using at least 40% bio-polypropylene is merely a design choice, which is not described as critical in the specification.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize polypropylene that includes at least 40% bio-polypropylene in the construction of an endoscope. A person having ordinary skill in the art would be motivated to use bio-polypropylene based on its availability, desire to protect Earth’s environment, etc. (See Kulshrestha paragraphs [0006] and [0008])
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Christensen et al. (EP 3903661 A1 – “Christensen”), Closs et al. (WO 2022152674 A1 – “Closs”), and Leiner et al. (US Patent 5,554,100 – “Leiner”).
Regarding Claim 16, Leong in view of Christensen and Closs teaches the features of Claim 15, as described above.
Leong in view of Christensen and Closs does not explicitly teach wherein the suction valve is connected to the at least one of the housing shells without any non-polypropylene material adding strength or stability to the connection.
Leiner teaches analogous art of two half sections (Leiner FIGs 9) that form a housing portion of an arthroscope (Leiner FIGs. 1 and 9, housing portion 200 of arthroscope 100) and wherein the suction valve is connected to the at least one of the housing shells without any non-polypropylene material that is not integral with the at least one of the housing shells (Leiner col. 7 lines 38-47, “Referring now to FIG. 9, in conjunction with FIG. 1, housing portion 200 of arthroscope 100 includes two housing half sections 210. Half sections 210 are preferably formed of a suitable plastic material such as…polyethylene…and are attached along a seam by suitable attachment techniques, including…ultrasonic welding”. Examiner notes that the plastic materials listed in Leiner col. 7 lines 38-47 are mutually exclusive, in that there is nothing to suggest that the materials are combined with one another or any other non-polypropylene material).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Leiner’s ultrasonic welding of polypropylene components in order to secure Leong’s suction valve therebetween, in the endoscope taught by Leong in view of Christensen and Closs. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope that is assembled using the well-known technique of ultrasonic welding of polypropylene. (Examiner notes that a search of prior art patents/publications using the search terms of polypropylene and ultra-sonic welding in the same sentence resulted in the identification of 3,847 prior art patents/publications).
Regarding Claim 17, Leong in view of Christensen and Closs teaches the features of Claim 15, as described above.
Leong in view of Christensen and Closs does not explicitly teach wherein the suction valve is connected to the at least one of the housing shells without any non-polypropylene material that is not integral with the at least one of the housing shells.
Leiner teaches analogous art of two half sections (Leiner FIGs 9) that form a housing portion of an arthroscope (Leiner FIGs. 1 and 9, housing portion 200 of arthroscope 100) and wherein the suction valve is connected to the at least one of the housing shells without any non-polypropylene material that is not integral with the at least one of the housing shells (Leiner col. 7 lines 38-47, “Referring now to FIG. 9, in conjunction with FIG. 1, housing portion 200 of arthroscope 100 includes two housing half sections 210. Half sections 210 are preferably formed of a suitable plastic material such as…polyethylene…and are attached along a seam by suitable attachment techniques, including…ultrasonic welding”. Examiner notes that the plastic materials listed in Leiner col. 7 lines 38-47 are mutually exclusive, in that there is nothing to suggest that the materials are combined with one another or any other non-polypropylene material).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Leiner’s ultrasonic welding of polypropylene components in order to secure Leong’s suction valve therebetween, in the endoscope taught by Leong in view of Christensen and Closs. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope that is assembled using the well-known technique of ultrasonic welding of polypropylene. (Examiner notes that a search of prior art patents/publications using the search terms of polypropylene and ultra-sonic welding in the same sentence resulted in the identification of 3,847 prior art patents/publications).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Christensen et al. (EP 3903661 A1 – “Christensen”) and Guest (US Patent 4,946,213 – “Guest”).
Regarding Claim 18, Leong in view of Christensen teaches the features of Claim 5, as described above.
Leong in view of Christensen does not explicitly teach wherein at least one of the interfaces is configured for heat staking or ultrasonic welding.
Guest teaches in the analogous art of tube couplings in which a coupling body and inserts made of polypropylene are secured together by ultrasonic welding (Guest FIG. 1, coupling body and 11 and inserts 14; Guest col. 2 lines 44-47, “coupling body 11 and inserts 14 are formed from a plastics material such as polypropylene and the inserts are secured in the ends of the coupling body by ultrasonic welding”. Examiner interprets this as analogous art for securing two polypropylene elements together using ultrasonic welding.)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Guest’s ultrasonic welding of polypropylene components with the interfaces disclosed by Leong in the endoscope taught by Leong in view of Christensen. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope whose components are able to be ultrasonic welded to another component. (Examiner notes that a search of prior art patents/publications using the search terms of polypropylene and ultra-sonic welding in the same sentence resulted in the identification of 3,847 prior art patents/publications).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US PGPUB 2019/0350440 – “Leong”) in view of Christensen et al. (EP 3903661 A1 – “Christensen”) and Leiner et al. (US Patent 5,554,100 – “Leiner”).
Regarding Claim 19, Leong in view of Christensen teaches the features of Claim 5, as described above.
As described above, Examiner-annotated Leong FIGs. 2B-2C teaches the first housing shell secured to the second housing shell.
Leong in view of Christensen does not explicitly teach wherein the first housing shell is secured to the second housing shell without any non-polypropylene material that is not integral with the at least one of the housing shells.
Leiner teaches analogous art of two half sections (Leiner FIGs 9) that form a housing portion of an arthroscope (Leiner FIGs. 1 and 9, housing portion 200 of arthroscope 100) and wherein the suction valve is connected to the at least one of the housing shells without any non-polypropylene material that is not integral with the at least one of the housing shells (Leiner col. 7 lines 38-47, “Referring now to FIG. 9, in conjunction with FIG. 1, housing portion 200 of arthroscope 100 includes two housing half sections 210. Half sections 210 are preferably formed of a suitable plastic material such as…polyethylene…and are attached along a seam by suitable attachment techniques, including…ultrasonic welding”. Examiner notes that the plastic materials listed in Leiner col. 7 lines 38-47 are mutually exclusive, in that there is nothing to suggest that the materials are combined with one another or any other non-polypropylene material).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Leiner’s ultrasonic welding of polypropylene components in order to secure Leong’s suction valve therebetween, in the endoscope taught by Leong in view of Christensen and Closs. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope that is assembled using the well-known technique of ultrasonic welding of polypropylene. (Examiner notes that a search of prior art patents/publications using the search terms of polypropylene and ultra-sonic welding in the same sentence resulted in the identification of 3,847 prior art patents/publications).
Conclusion
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
3/8/26