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 amendments dated June 5, 2026.
Claims 1-4, 7-8, and 14-27 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the written description does not disclose at least 70% of the material used in the interfaces and the alignment means comprising polypropylene material. Paragraph [0013] and original Claim 5 of the present patent application disclose the housing shells being at least 70% polypropylene. Similarly, Original Claims 1 and 15 disclose the housing shells and the suction valve being at least 70% polypropylene. However, Examiner is unable to identify any passage in the present specification that discloses the interfaces and the alignment means being at least 70% polypropylene.
For purposes of examination, Examiner will interpret the feature claimed in lines 25-26 of Claim 1 of “wherein at least 70% of the material of the housing shells, the interfaces and the alignment means comprises polypropylene material” as “wherein at least 70% of the material of the housing shells comprises polypropylene material”.
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, 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”) and Bowe et al. (US PGPUB 2002/0165484 – “Bowe”).
Regarding Claim 1, Leong discloses:
An endoscope (Leong FIG. 1, endoscope 102) comprising:
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”); and
a handle (Leong FIG. 1, handle 108) comprising:
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housing shells consisting of 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 a shell wall (Leong FIG. 2B and 2C, interior walls of right shell 200 and left shell 202) and 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 the fasteners comprising snap-fit fasteners or press-fit fasteners, the shell wall having an inner surface and an outer surface (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”);
interfaces, one of the interfaces being a roller interface configured to secure the roller to the housing shell inside the inner compartment (Leong FIG. 2A, wheel boss 226, which is inside of right shell 200 and secures control wheel 204) the interfaces being integral with the housing shells and comprising the same material as 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 is analogous art in the field of endoscopy that teaches an 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).
Although Leong FIGs. 2A-2C appear to show internal slots and protrusions from the interiors of the right shell 200 and left shell 202 for aligning the two shells together when mated, Leong does not explicitly disclose alignment means, the first alignment means being integral with and extending from the inner surface of one of the housing shells toward the other of the housing shells to align the shell walls during assembly of the handle.
Bowe is analogous art in the field of endoscope construction that teaches alignment means (Examiner-annotated Bowe FIG. 4 shown below, attachment point), the first alignment means being integral with and extending from the inner surface of one of the housing shells (Bowe FIG. 4, housing shell 42 of handle 10 shown in Bowe FIG. 1) toward the other of the housing shells (Bowe FIG. 4, housing shell 40) to align the shell walls during assembly of the handle (Bowe paragraph [0030], “disk housing shell 40 and the spacer housing shell 42 are also joined at least one other attachment point with a screw 77”).
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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 Bowe’s attachment point and screw with the endoscope handle 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 having a handle made up of two half-shells that are securely and reversibly connected to one another by a screw.
As such, and with regard to the claimed feature of wherein the interfaces, the fasteners, and the alignment means collectively define a three-dimensional structural support network extending withing the inner compartment and configured to compensate for reduced rigidity of the polypropylene material without adhesive bonding, Leong FIG. 2A, wheel boss 226 teaches the claimed roller interface, Leong paragraph [0029] teaches the fasteners, and Examiner-annotated Bowe FIG. 4 teaches the alignment means, which define a three-dimensional structural support network when combined. The feature of these three components being configured to compensate for reduced rigidity of the polypropylene material without adhesive bonding is provides no structural features/limitations, and thus provides no additional patentable weight.
Regarding Claim 8, Leong in view of Christensen and Bowe teaches the features of Claim 1, as described above.
Leong further discloses wherein the fasteners comprise 6-12 snap-fit fasteners configured to attach the first housing shell to the second housing shell (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 14, Leong in view of Christensen and Bowe teaches the features of Claim 1, 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, and
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”),
wherein the interfaces comprise working channel port interfaces configured to secure the working channel port to at least one of the housing shells inside the inner compartment (Leong FIG. 2B, showing access port assembly 116 secured to right shell 200).
Regarding Claim 20, Leong in view of Christensen and Bowe teaches the features of the endoscope described in Claim 1, 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 2 and 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”), Bowe et al. (US PGPUB 2002/0165484 – “Bowe”), and Kulshrestha et al. (AU 2016201295 A1 – “Kulshrestha”).
Regarding Claim 2, Leong in view of Christensen and Bowe teaches the features of Claim 1, as described above.
Leong in view of Christensen and Bowe does not explicitly teach wherein the polypropylene material comprises at least 20% bio-polypropylene.
Kulshrestha is analogous art in the field of materials used in device construction that teaches wherein the polypropylene material comprises at least 20% bio-polypropylene. Specifically, 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.
Regarding Claim 7, Leong in view of Christensen and Bowe teaches the features of Claim 1, as described above.
Leong in view of Christensen and Bowe does not explicitly teach wherein the polypropylene material comprises at least 40% bio-polypropylene.
Kulshrestha is analogous art in the field of instrument construction that 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])
Claim 15 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”), Bowe et al. (US PGPUB 2002/0165484 – “Bowe”), and Closs et al. (WO 2022152674 A1 – “Closs”).
Regarding Claim 15, Leong in view of Christensen and Bowe teaches the features of Claim 14, as described herein.
Leong further discloses a 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 interfaces comprise suction valve interfaces (Leong FIG. 2B, portion of right shell 200 that surrounds/supports suction valve assembly 114), and wherein the suction valve is secured to at least one of the housing shells inside the inner compartment with the suction valve 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 and Bowe does not explicitly teach the endoscope further comprising a suction valve comprised of at least 70% polypropylene material.
Closs is analogous art in the field of instrument construction that teaches an analogous 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 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 non-obviousness. 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).
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”), Bowe et al. (US PGPUB 2002/0165484 – “Bowe”), 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, Bowe, and Closs teaches the features of Claim 15, as described above.
Leong in view of Christensen, Bowe, 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 is analogous art in the field of endoscope construction that teaches 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, Bowe, 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, Bowe, and Closs teaches the features of Claim 15, as described above.
Leong in view of Christensen, Bowe, 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 is analogous art in the field of endoscope construction that teaches 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, Bowe, 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”), Bowe et al. (US PGPUB 2002/0165484 – “Bowe”), and Guest (US Patent 4,946,213 – “Guest”).
Regarding Claim 18, Leong in view of Christensen and Bowe teaches the features of Claim 1, as described above.
Leong in view of Christensen and Bowe does not explicitly teach wherein at least one of the interfaces is configured for heat staking or ultrasonic welding.
Guest is analogous art in the field of tube couplings that teaches 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 and Bowe. 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”), Bowe et al. (US PGPUB 2002/0165484 – “Bowe”), and Leiner et al. (US Patent 5,554,100 – “Leiner”).
Regarding Claim 19, Leong in view of Christensen and Bowe teaches the features of Claim 1, 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 and Bowe 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 is analogous art in the field of endoscope construction that teaches 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 Bowe. 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).
Claims 21-24 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”), Bowe et al. (US PGPUB 2002/0165484 – “Bowe”), and Fasano et al. (US PGPUB 2015/0141914 – “Fasano”).
Regarding Claim 21, Leong in view of Christensen and Bowe teaches the features of Claim 1, as described above.
Leong further discloses wherein the alignment means comprise two alignment parts integral with, respectively, the first housing shell and the second housing shell such that the outer surfaces of the housing shells are brought into a flush relationship at a joint therebetween (Leong FIG. 1, handle 108; 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”).
However, Leong does not explicitly disclose that the snap connectors function as alignment parts, such that one of the alignment parts including a slanted surface configured to cam the other of the alignment parts during assembly of the housing.
Fasano is analogous art in the field of instrument construction that teaches snap connectors (Fasano FIG. 1, snap closing means 5 including slanted hooked portion 5a and corresponding slot 5b, control handle 1) function as alignment parts, such that one of the alignment parts including a slanted surface configured to cam the other of the alignment parts during assembly of the housing (Fasano paragraph [0050], “control handle 1 comprises closing means 5 acting between the two half-shells 2a, 2b to keep the two half-shells stable in the configuration in which they are moved near each other. Preferably, said closing means 5 are of the snap type. In a possible embodiment, the closing means 5 comprise at least one hooked portion 5a fixed onto the first half-shell 2a while the second half-shell 2b has at least one corresponding slot 5b adapted for engagement with the aforementioned hooked portion 5a. In the embodiment illustrated in FIGS. 1A-3, the closing means 5 comprise two hooked portions 5a and two corresponding slots 5b defining two reciprocal anchoring points between the half-shells 2a, 2b.).
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 Fasano’s cam/slanted alignment system with the endoscope taught by Leong in view of Christensen and Bowe. 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 having a two-shell handle whose shells are securely fastened together for use.
Regarding Claim 22, Leong in view of Christensen and Bowe teaches the features of Claim 1, as described above.
Leong further discloses wherein the alignment means such that the outer surfaces of the housing shells are brought into a flush relationship at a joint therebetween (Leong FIG. 1, handle 108; 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”).
However, Leong does not explicitly disclose that the snap connectors function as alignment parts, such that the alignment means comprise a first alignment part having an inclined surface configured to cam the other of the housing shells during assembly relative to the one of the housing shells comprising the first alignment part.
Fasano is analogous art in the field of instrument construction that teaches that the alignment means (Fasano FIG. 1, snap closing means 5, control handle 1) comprise a first alignment part (Fasano FIG. 1, slanted hooked portion 5a) having an inclined surface configured to cam the other of the housing shells during assembly relative to the one of the housing shells comprising the first alignment part (Fasano FIG. 1, corresponding slot 5b; Fasano paragraph [0050], “control handle 1 comprises closing means 5 acting between the two half-shells 2a, 2b to keep the two half-shells stable in the configuration in which they are moved near each other. Preferably, said closing means 5 are of the snap type. In a possible embodiment, the closing means 5 comprise at least one hooked portion 5a fixed onto the first half-shell 2a while the second half-shell 2b has at least one corresponding slot 5b adapted for engagement with the aforementioned hooked portion 5a. In the embodiment illustrated in FIGS. 1A-3, the closing means 5 comprise two hooked portions 5a and two corresponding slots 5b defining two reciprocal anchoring points between the half-shells 2a, 2b.).
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 Fasano’s cam/slanted alignment system with the endoscope taught by Leong in view of Christensen and Bowe. 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 having a two-shell handle whose shells are securely fastened together for use.
Regarding Claim 23, Leong in view of Christensen, Bowe, and Fasano teaches the features of Claim 22, as described above.
Fasano further teaches wherein the walls of the housing shells comprise overlapping lips at the joint (Fasano FIG. 1B., showing hooked portions 5a forming overlapping lips at the joint that is made up of the two walls of the shells 2a and 2b).
Regarding Claim 24, Leong in view of Christensen, Bowe, and Fasano teaches the features of Claim 23, as described above.
Fasano further teaches wherein the overlapping lips (Fasano FIG. 1B, hooked portions 5a) define an outer split line (Fasano FIG. 1B, exterior face of hooked portions 5a) and an inner split line (Fasano FIG. 1B, interface line between shell 2a and shell 2b), and wherein the first alignment part extends from the one of the housing shells toward the other of the housing shells traversing the inner split line (Fasano FIG. 1B, showing hooked portions 5a passing across the interface line between shell 2a and shell 2b).
Claim 26 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”), Bowe et al. (US PGPUB 2002/0165484 – “Bowe”), and Clark et al. (US PGPUB 2010/0249773 – “Clark”).
Regarding Claim 26, Leong in view of Christensen and Bowe teaches the features of Claim 1, as described above.
Leong in view of Christensen and Bowe does not explicitly teach wherein the handle further comprises an encasement, a circuit board, and a wire pipe fastener connecting the wire pipes to one of the handle shells, the encasement comprising a support platform, the encasement and the wire pipe fastener comprising a one-piece part attached to the one of the handle shells by some of the interfaces, wherein the encasement encloses the circuit board.
Clark is analogous art in the field of handle/instrument construction that teaches wherein the handle (Clark FIG. 3B, handle assembly 200) further comprises an encasement (Clark FIG. 2A, interior surface of housing assembly 240), a circuit board (Clark FIG. 3B, circuit board 290), and a wire pipe fastener (Clark FIG. 3B, carrier 280, control wire 40; Clark paragraph [0050], “control wire 40 is proximally coupled to the carrier 280”) connecting the wire pipes (Clark FIG. 3B, arcuate segment 289 of carrier 280 that guides control wire 40) to one of the handle shells, the encasement comprising a support platform (Clark FIG. 3B, housing posts 282a/b supporting carrier 280), the encasement and the wire pipe fastener comprising a one-piece part attached to the one of the handle shells by some of the interfaces, wherein the encasement encloses the circuit board (Clark FIG. 3B, showing handle assembly 200 formed by mating upper and lower housings 242/244 to create an interior surface that encloses the circuit board 290 and the carrier 280).
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 Clark’s circuit board and wire pipe carrier with the handle of the endoscope taught by Leong in view of Christensen and Bowe. 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 handle that encases an on-board circuit board for self-sufficient processing, which eliminates the need for remote processing.
Response to Arguments
Applicant’s arguments, see page 7, filed June 5, 2026, with respect to the objection to a typographical error in Claim 15 have been fully considered and are persuasive in view of the present amendments to Claim 15. The objection to Claim 15 has been withdrawn.
Applicant's arguments, see pages 7-8, filed June 5, 2026, with respect to the rejection(s) of currently-amended Claims 1, 3-4, and 15 under 35 U.S.C. 103 have been fully considered and are not persuasive. Specifically, Applicant argues that the newly-claimed feature of wherein the interfaces, the fasteners, and the alignment means collectively define a three-dimensional structural support network extending withing the inner compartment and configured to compensate for reduced rigidity of the polypropylene material without adhesive bonding is not described in the cited prior art. However, cited art Leong FIG. 2A, wheel boss 226 teaches the claimed roller interface, Leong paragraph [0029] teaches the fasteners, and Examiner-annotated Bowe FIG. 4 teaches the alignment means, which define a three-dimensional structural support network when combined. The feature of these three components being configured to compensate for reduced rigidity of the polypropylene material without adhesive bonding is provides no structural features/limitations, and thus provides no additional patentable weight.
As such, the rejection of Claims 1 and 15 under 35 U.S.C. 103 are maintained. Due to the amendments to Claim 3, Claims 3-4 are deemed allowable, as described below.
Allowable Subject Matter
Dependent Claim 3 is 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, and if the rejection to base/independent Claim 1 under 35 U.S.C. 112(a) is overcome. The following is a statement of reasons for the indication of allowable subject matter: No combination of the identified prior art teaches or suggests “wherein the roller is rotatably connected to the roller interface, the roller interface forming an axle for the roller and comprising: a tubular body having an outer surface, outer ribs extending radially outward from the outer surface, and support walls extending along the inner surface of the first housing shell and radially outwardly from the support surface further than the outer ribs to enforce a connection between the roller interface and the first housing shell, the outer ribs and the support walls comprising rotation surfaces rotatably supporting the roller”. That is, while Leong FIG. 2A’s wheel boss 226 discloses a roller interface having an axel (shaft 808), neither Leong nor any combination of the identified prior art teaches or suggests a roller interface that has outer ribs, support walls that extend along the inner surface of the first housing shell and radially outwardly from the support surface further than the outer ribs, and the first housing shell, the outer ribs and the support walls comprising rotation surfaces rotatably supporting the roller. Furthermore, there is no reason or suggestion provided in the prior art to modify the identified prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Claim 4 is deemed allowable for depending on Claim 3, and is subject to the same conditions for allowability presented for Claim 3.
Dependent Claim 25 is 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, and if the rejection to base/independent Claim 1 under 35 U.S.C. 112(a) is overcome. The following is a statement of reasons for the indication of allowable subject matter: no combination of the identified prior art teaches or suggests wherein the handle further comprises a support platform, a circuit board, and a wire pipe fastener connecting the wire pipes to one of the handle shells, the support platform and the wire pipe fastener comprising a one-piece part attached to the one of the handle shells by some of the interfaces, wherein the support platform comprises a planar surface from which the wire pipe fastener extends, the planar surface being larger than a surface of the wire pipe fastener that is parallel and adjacent to the planar surface, providing a strong and stable connection between the wire pipes and the one of the handle shells, and wherein the circuit board is positioned intermediate the inner surface of the one of the handle shells and the planar surface of the support platform. That is, while Clark FIG. 3B teaches a circuit board 290, and Clark FIG. 3B, carrier 280, control wire 40; Clark paragraph [0050], “control wire 40 is proximally coupled to the carrier 280” teach a wire pipe fastener, a combination of the cited prior art does not teach or suggest the additional structural features of the support platform and the wire pipe fastener comprising a one-piece part attached to the one of the handle shells by some of the interfaces, wherein the support platform comprises a planar surface from which the wire pipe fastener extends, the planar surface being larger than a surface of the wire pipe fastener that is parallel and adjacent to the planar surface, providing a strong and stable connection between the wire pipes and the one of the handle shells, and wherein the circuit board is positioned intermediate the inner surface of the one of the handle shells and the planar surface of the support platform. Furthermore, there is no reason or suggestion provided in the prior art to modify the identified prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Dependent Claim 27 is 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, and if the rejection to base/independent Claim 1 under 35 U.S.C. 112(a) is overcome. The following is a statement of reasons for the indication of allowable subject matter: no combination of the identified prior art teaches or suggests wherein the encasement comprises a planar surface from which the wire pipe fastener extends, the planar surface being larger than a surface of the wire pipe fastener that is parallel and adjacent to the planar surface, providing a strong and stable connection between the wire pipes and the one of the handle shells, and wherein the circuit board is positioned intermediate the inner surface of the one of the handle shells and the planar surface of the support platform. That is, while Clark FIG. 2A, interior surface of housing assembly 240 teaches an encasement, and Clark FIG. 3B teaches a circuit board 290, neither Clark nor any combination of the identified prior art teaches or suggests comprises a planar surface from which the wire pipe fastener extends, the planar surface being larger than a surface of the wire pipe fastener that is parallel and adjacent to the planar surface, providing a strong and stable connection between the wire pipes and the one of the handle shells, and wherein the circuit board is positioned intermediate the inner surface of the one of the handle shells and the planar surface of the support platform. Furthermore, there is no reason or suggestion provided in the prior art to modify the identified prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
7/28/26
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