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 .
Response to Amendment
The amendment filed on 3/19/2026 has been entered. Claims 1-10, 12-16, and 18 remain pending in the application. With the exception of the rejection under 35 USC § 112(b) of claim 1, Applicant’s amendments to the Specification and Claims have overcome each and every objection and 112 rejection previously set forth in the Non-Final Office Action mailed 12/19/2025.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 3/19/2026, with respect to rejection under 35 USC § 112(b) of claim 1, have been fully considered and are not persuasive in light of Applicant’s amendments.
The applicant argues that the specification provides clear guidance as to what constitutes a high-level disinfection. Examiner respectfully disagrees. Applicant highlights para. [0066] of Applicant’s specification which states a “high level disinfection” refers to any treatment of medical devices and instruments that inhibits most viable microorganisms. The Applicant’s specification further provides a list of some harsh chemicals that could potentially be used in high level disinfection. This definition of “high level disinfection” fails to provide objective boundaries for determining the scope of the claim. Specifically, it is unclear what constitutes “any treatment”, as there is no criteria provided for identifying which treatments qualify as high-level disinfection and which do not. Additionally, the phrase “most viable microorganisms” is indefinite because the specification does not establish a threshold, percentage, or other objective standard for determining when “most” viable microorganism have been inhibited. Further, the disclosure that the treatment “may” utilize certain chemicals does not provide a definite boundary because the listed chemicals are merely exemplary and do not define the full scope of qualifying treatments. Accordingly, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the term “high level disinfection.”
Accordingly, the rejection under 35 USC § 112(b) of claim 1 as set forth in the Non-Final Office Action mailed 12/19/2025 stands. Please see section Claim Rejections - 35 USC § 112 below for further explanation.
Applicant’s arguments, see pages 7-9, filed 3/19/2026, with respect to rejection under 35 USC § 102 of claim 1 over Rutgers, have been fully considered and are not persuasive in light of Applicant’s amendments.
Applicant’s arguments are on the grounds that Rutgers does not disclose a device capable of withstanding high level disinfection. Specifically, applicant argues that Rutgers does not disclose that the device may be sterilized with glutaraldehyde, hydrogen, peroxide, peracetic acid or ortho-phthalaldehyde. Examiner agrees that Rutgers does not explicitly disclose the use of the listed chemicals in the sterilization solution; however, the broadest reasonable interpretation of the limitation “high level disinfection” can include a sterilization solution without the above list of chemicals. Applicant does not place any criticality on the above chemicals as para. [0066] of the Applicant’s specification states that glutaraldehyde, hydrogen, peroxide, peracetic acid and ortho-phthalaldehyde “may” be used.
Additionally, Applicant argues that Rutgers does not disclose the flexible portion and the controller portion are integrally formed. Examiner respectfully disagrees. The Merriam-Webstar dictionary defined integral as “formed as a unit with another part” or “composed of constituent parts.” Therefore, the broadest reasonable interpretation of “integrally formed” can include any essential device components that together create a unit. Rutgers discloses a flexible portion and a controller portion that are integrally formed to form an endoscope (Fig. 1, paragraph 0061). Examiner suggests the use of the limitation “monolithically formed” if applicant intends for the scope of the claim to be limited to a device formed or composed of a material constituting a single unit or without joints or seams.
Furthermore, Applicant argues that Rutgers does not disclose wherein the flexible portion and the controller portion form a single reusable waterproof article. The Applicant’s arguments are on the grounds that the shaft and outer casing do not form a single reusable waterproof article since an additional article is provided to help form the hermetic seal. Examiner respectfully disagrees. The claim does not exclude the presence of additional components associated with the endoscope, nor does it require that the handle and the flexible component be the only components present. Under the broadest reasonable interpretation, the limitation “the flexible portion and the controller portion form a single reusable waterproof article” does not require that the waterproofness be provided solely by the flexible portion and the controller portion without any additional components. The presence of the additional article merely represents an additional structure associated with the endoscope and does not negate that the flexible portion and the controller portion form a single reusable waterproof article.
Accordingly, the rejections under 35 USC § 102 of claim 1 as set forth in the Non-Final Office Action mailed 12/19/2025 stand. Please see section Claim Rejections - 35 USC § 102 below for further explanation.
Applicant’s arguments, see pages 9-10, filed 3/19/2026, with respect to rejection under 35 USC § 103 of claims 2, 3, and 15 over Rutgers in view of Sun, have been fully considered and are not persuasive in light of Applicant’s amendments.
Applicant’s arguments are on the grounds that the bending section structure of Rutgers is not equivalent to the bending section structure of Sun. The Applicant argues that the devices of Rutgers and Sun serve entirely different medical purposes and operate in different anatomical environments with different structural requirements. Examiner respectfully disagrees. Rutgers and Sun are analogous art as they are both directed to the field of endoscopes. Additionally, the bending sections of Rutgers and Sun are equivalent as they both are directed to mechanisms for steering the insertion portion of an endoscope.
Accordingly, the rejections under 35 USC § 103 of claims 2, 3, and 15 over Rutgers in view of Sun as set forth in the Non-Final Office Action mailed 12/19/2025 stand. Please see section Claim Rejections - 35 USC § 103 below for further explanation.
Applicant’s arguments, see page 10, filed 3/19/2026, with respect to rejection under 35 USC § 103 of claims 4-5 over Rutgers in view of Nakatate, have been fully considered and are not persuasive in light of Applicant’s amendments.
Applicant’s arguments are on the grounds that Nakatate does not disclose an art-recognized suitability for the indended purpose of the claimed tip. Examiner respectfully disagrees. Rutgers discloses benefits of constructing the shaft of a malleable material. As evidenced by Kido, SUS304 can be very malleable and as taught by Nakatate, SUS304 can be used to construct the distal tip of an endoscope shaft.
Additionally, Stainless steel SUS304 is widely known in the endoscope field as the industry standard for medical materials because of its corrosion resistance in sterile environments, biocompatibility, and its durable, cost-efficient performance. Therefore, stainless steel does have an art-recognized suitability for use in endoscopes.
Accordingly, the rejections under 35 USC § 103 of claims 4-5 over Rutgers in view of Nakatate as set forth in the Non-Final Office Action mailed 12/19/2025 stand. Please see section Claim Rejections - 35 USC § 103 below for further explanation.
Applicant’s arguments, see page 10, filed 3/19/2026, with respect to rejection under 35 USC § 103 of claims 7-8 over Rutgers in view of Gardeski, have been fully considered and are not persuasive in light of Applicant’s amendments.
Applicant’s arguments are the grounds that Gardeski does not disclose art-recognized suitability for the bending section of a medical endoscope and that one of ordinary skill in the art would have no reason to apply materials from a cardiac lead stylet to an endotracheal intubation device. Applicant respectfully disagrees. It would have been obvious to one of ordinary skill in the art to utilize precipitation hardening stainless steel for the bending section because precipitation hardening stainless steel was a known material for use in steerable flexible medical devices. Although Gardeski is directed to a guidewire rather than an endoscope, both devices are elongated, flexible medical instruments that are designed to navigate tortuous anatomical pathways while transmitting steering or bending forces. Therefore, one of ordinary skill in the art would have reasonably looked to the teachings of Gardeski when selecting suitable materials for a flexible bending component. Additionally, Gardeski teaches that precipitation hardening stainless steel, in its annealed condition, is readily weldable and may be shaped by precision stamping and coiling, thereby facilitating fabrication of a structure that provides a smooth and even bend (col. 2, paragraph 1). Accordingly, it would have been obvious to employ precipitation hardening stainless steel in the flexible bending section of the endoscope to obtain these recognized manufacturing and bending characteristics, yielding predictable results.
Accordingly, the rejections under 35 USC § 103 of claims 7-8 over Rutgers in view of Gardeski as set forth in the Non-Final Office Action mailed 12/19/2025 stand. Please see section Claim Rejections - 35 USC § 103 below for further explanation.
Applicant’s arguments, see page 11, filed 3/19/2026, with respect to rejection under 35 USC § 103 of claims 9-10 over Rutgers in view of Nakai, have been fully considered and are not persuasive in light of Applicant’s amendments.
In response to applicant's argument that Rutgers is designed for use in airway navigation and Nakai is designed for digestive tract and esophagus navigation, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The motivation to combine Rutgers and Nakai is to provide a bending section that is less likely to be broken regardless of repeated operation and is excellent in sterilization resistance. This advantage remains beneficial if the device is used in either the digestive tract or the airway.
Accordingly, the rejections under 35 USC § 103 claims 9-10 over Rutgers in view of Nakai as set forth in the Non-Final Office Action mailed 12/19/2025 stand. Please see section Claim Rejections - 35 USC § 103 below for further explanation.
Applicant’s arguments, see page 11, filed 3/19/2026, with respect to rejection under 35 USC § 103 of claim 12 over Rutgers in view of Suzuki, have been fully considered and are not persuasive in light of Applicant’s amendments.
The Applicant argues that Suzuki fails to explicitly disclose a pressure valve for measuring an internal pressure of the controller portion. The Applicant’s arguments are on the grounds that Suzuki discloses a passive pressure relief valve, not a measurement device. Examiner respectfully disagrees. The broadest reasonable interpretation of “for measuring an internal pressure of the controller portion” is not limited to an active measurement device, rather it can include any valve that measures internal pressure of the controller portion. The valve of Suzuki measures the internal pressure of the controller portion when it exceeds the atmospheric pressure (paragraph 0041).
Accordingly, the rejections under 35 USC § 103 of claim 12 over Rutgers in view of Suzuki as set forth in the Non-Final Office Action mailed 12/19/2025 stand. Please see section Claim Rejections - 35 USC § 103 below for further explanation.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation is:
“the angulation mechanism controls movement of the tip” in claim 1 as described in Para. [0053] and [0069-0070] of Applicant’s specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10, 12-16, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “wherein the flexible portion and the controller portion are capable of withstanding high level disinfection conditions” in l. 12-13 of claim 1. The claim is indefinite as it is unknown what constitutes as a high-level disinfection condition. The Applicant’s specification provides details on “high level disinfection” in para. [0066], however, the specification does not provide clear guidance as to what constitutes as “high level disinfection.” For the purposes of examination, “wherein the flexible portion and the controller portion are capable of withstanding high level disinfection conditions” is being interpreted as any structure which is capable of being disinfected.
Claims 2-10, 12-16, and 18 are rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Appl. Publ. No. 2019/0104931 A1 to Rutgers (“Rutgers”).
Regarding claim 1, Rutgers discloses a portable medical endoscope (endoscope 10; Fig. 1, paragraph 0062) comprising:
a flexible portion having a proximal end (proximal end of flexible or malleable shaft 18 is coupled to the outer casing 12; Fig. 1) and a distal end (distal end 16 of a flexible or malleable shaft 18; Fig. 1, paragraph 0061), wherein the flexible portion comprises a bending section and a tip at the distal end (a steering control mechanism 14 can be manually manipulated to steer the distal end 16 of a flexible or malleable shaft 18 to a number of different angular positions … just a few of the numerous angular positions that can be attained by the distal end 16 are represented by dotted lines appearing in Fig. 1; Fig. 1, paragraph 0061), and wherein the tip comprises an image-capturing device (a wide angle lens 28 extends from the distal end 16 of the bendable shaft 18; Fig. 1, paragraph 0062);
a controller portion disposed at the proximal end of the flexible portion (outer casing 12 is disposed at the proximal end of the flexible or malleable shaft 18; Fig. 1), wherein the controller portion comprises:
an angulation mechanism coupled to the bending section and the tip, wherein the angulation mechanism controls movement of the tip (an outer casing 12 which houses a steering control mechanism 14 can be manually manipulated to steer the distal end 16 of a flexible or malleable shaft 18 to a number of different angular positions; Fig. 1, paragraph 0061); and
a handle in a pistol grip configuration (the endoscope includes a handle 24 which enable the medical practitioner to firmly grasp the instrument during the medical procedure; Fig. 1, paragraph 0062); and
a detachable monitor configured to releasably engage the controller portion (both the video screen 16 and battery pack can be easily removed from the outer casing 12; Fig. 1, paragraph 0062);
wherein the flexible portion and the controller portion are integrally formed (the shaft 18 and the outer casing 12 together form the hermetically-sealed endoscope 10; Fig. 1) to form a single reusable waterproof capable of withstanding high level disinfection conditions while maintaining structural and functional integrity (both the video screen 26 and battery pack can be easily removed from the outer casing 12 to allow the unit to be immersed in a sterilizing solution without compromising the steering control mechanism 14 or other visualization components housed within the shaft 18 and outer casing 12. As will be described below in greater detail, the endoscope 10 can be hermetically sealed to protect the internal components from the sterilization solution; Fig. 1, paragraph 0062).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 3, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rutgers in view of WO 2014/019321 A1 to Sun et al. (“Sun”).
Regarding claim 2, Rutgers discloses the portable medical endoscope according to claim 1. However, Rutgers does not explicitly disclose wherein the bending section comprises a plurality of vertebrae.
Sun teaches wherein the bending section comprises a plurality of vertebrae (a soft bending portion 8 is formed by the snake bone structure; Fig. 2, paragraph 0032).
Sun is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a bending section and a detachable monitor mounted on the handle. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have substituted the bending section structure of Rutgers with the vertebrae of Sun, because the substitution of art recognized equivalents as shown by Sun is within the level of ordinary skill in the art. In addition, the substitution of one bending section structure for another is likely to be obvious when it does no more than yield predictable results.
Regarding claim 3, Rutgers, as previously modified by Sun, discloses the portable medical endoscope according to claims 1 and 2. Sun further teaches wherein the plurality of vertebrae are coupled together by hinges (a soft bending portion 8 is formed by the snake bone structure; Fig. 2, paragraph 0032).
Regarding claim 15, Rutgers discloses the portable medical endoscope according to claim 1. However, Rutgers does not explicitly disclose wherein the angulation mechanism comprises:
a lever configured to control the angulation of the tip;
a crank shaft coupled to the lever and to a pair of angulation wires, wherein the pair of angulation wires extend from the controller portion to the tip;
wherein a displacement of the lever operates the crank shaft to cause movement of the pair of angulation wires, thereby angulating the tip.
Sun teaches wherein the angulation mechanism comprises:
a lever configured to control the angulation of the tip (the operating lever 13 is fixed to the body 4; Fig. 2, paragraph 0032);
a crank shaft coupled to the lever and to a pair of angulation wires (the outer shaft 11 is connected to lever 13, and … traction rope 14; Fig. 2, paragraph 0032), wherein the pair of angulation wires extend from the controller portion to the tip (the tow rope 14 through the lever 13 and the mirror tube end a soft curved portion 8 is connected to the curved portion 8 using the soft snake bone structure; Fig. 2, paragraph 0032);
wherein a displacement of the lever operates the crank shaft to cause movement of the pair of angulation wires, thereby angulating the tip (Fig. 1, paragraph 0032).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have substituted the angulation mechanism of Rutgers with the angulation mechanism of Sun, because the substitution of art recognized equivalents as shown by Sun is within the level of ordinary skill in the art. In addition, the substitution of one angulation mechanism for another is likely to be obvious when it does no more than yield predictable results.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Rutgers in view of U.S. Patent Appl. Publ. No. 2016/0038006 A1 to Nakatate et al. (“Nakatate”) as evidenced by U.S. Patent Appl. Publ. No. 2002/0100160 A1 to Kido et al. (“Kido”).
Regarding claim 4, Rutgers discloses the portable medical endoscope according to claim 1. Rutgers discloses wherein the tip of the shaft is made of a malleable material (paragraph 0085). However, Rutgers does not explicitly disclose wherein the tip is made of stainless steel.
Nakatate teaches wherein the tip is made of stainless steel (the tip section 3 is made of, for example, stainless steel (e.g. SUS304); Fig. 1, paragraph 0040).
Nakatate is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a distal tip. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscope of Rutgers to incorporate the teachings of Nakatate by constructing the tip of stainless steel. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07. SUS304 is known to malleable (very malleable SUS304; see Kido, paragraph 0055).
Regarding claim 5, Rutgers, as previously modified by Nakatate, discloses the portable medical endoscope according to claims 1 and 4. Nakatate further teaches wherein the stainless steel is SUS304 (the tip section 3 is made of, for example, stainless steel (e.g. SUS304); Fig. 1, paragraph 0040).
Claims 6, 13-14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Rutgers in view of U.S. Patent Appl. Publ. No. 2011/0009694 A1 to Schultz et al. (“Schultz”).
Regarding claim 6, Rutgers discloses the portable medical endoscope according to claim 1. However, Rutgers does not explicitly disclose wherein the image-capturing device comprises a complementary metal-oxide- semiconductor (CMOS) sensor.
Schultz teaches wherein the image-capturing device comprises a complementary metal-oxide- semiconductor (CMOS) sensor (within the distal tip 120 of the probe piece, as shown in Figs. 1D and 1E, is a … CMOS visualization sensor (referred to herein as a camera) 124; Fig. 1D-E, paragraph 0120).
Schultz is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a pistol grip handle with a detachable monitor. As the reference is not limited to any specific examples of an image capturing device and as a complementary metal-oxide- semiconductor (CMOS) sensor is well known in the art at the time the invention was made, as evidenced by Schultz, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use a complementary metal-oxide- semiconductor (CMOS) sensor in the device of Rutgers. Said combination would amount to use of a known element for its intended use in a known environment to accomplish entirely expected result.
Regarding claim 13, Rutgers discloses the portable medical endoscope according to claim 1. However, Rutgers does not explicitly disclose wherein the detachable monitor is an LCD monitor.
Schultz teaches wherein the detachable monitor is an LCD monitor (by monitor is meant a visual display unit, which includes a screen that displays visual data in the form of images and/or text to a user. The screen may vary, where a screen type of interest is an LCD screen; #30, Fig. 1A, paragraph 0080).
As the reference is not limited to any specific examples of detachable monitor and as an LCD monitor is well known in the art at the time the invention was made, as evidenced by Schultz, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use an LCD monitor in the device of Rutgers. Said combination would amount to use of a known element for its intended use in a known environment to accomplish entirely expected result.
Regarding claim 14, Rutgers discloses the portable medical endoscope according to claim 1. However, Rutgers does not explicitly disclose wherein the detachable monitor comprises a rechargeable battery.
Schultz teaches wherein the detachable monitor comprises a rechargeable battery (the device additionally contains a battery 195 that may be rechargeable; Fig. 1D, paragraph 0119).
As the reference is not limited to any specific examples of removable battery and as a rechargeable battery is well known in the art at the time the invention was made, as evidenced by Schultz, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use a rechargeable battery in the device of Rutgers. Said combination would amount to use of a known element for its intended use in a known environment to accomplish entirely expected result.
Regarding claim 18, Rutgers discloses the portable medical endoscope according to claim 1. However, Rutgers does not explicitly disclose comprising one or more buttons disposed on the controller portion for activating a function of the image-capturing device.
Schultz teaches comprising one or more buttons disposed on the controller portion for activating a function of the image-capturing device (one example of what a switch 145 may control is image capture from the camera; Fig. 1C, paragraph 0128). As seen in Fig. 1C, the switch is a button.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention of have incorporated one or more buttons disposed on the controller portion of Rutgers, as taught by Schultz, to increase the functionality of the endoscope system of Rutgers by enabling the user to activate a function of the image-capturing device with the same hand that holds the controller.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Rutgers in view of U.S. Patent Publ. No. 6,146,338 to Gardeski et al. (“Gardeski”).
Regarding claim 4, Rutgers discloses the portable medical endoscope according to claim 1. However, Rutgers does not explicitly disclose wherein the bending section is made of a precipitation hardening stainless steel.
Gardeski teaches wherein the bending section is made of a precipitation hardening stainless steel (the coil and backbone are preferably formed of a wrought stainless steel, more preferably a precipitation hardened stainless steel such as PH15-7 Mo or 17-7PH; Fig. 4a, Col. 2, lines 9-13). Gardeski teaches that the particular construction of the bending section with a precipitation hardening stainless steel helps to provide a smooth and even bend (Col. 2, lines 16-18).
Gardeski is considered to be analogous to the claimed invention because it is in the same field of diagnostic medical devices with a flexible tube. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscope of Rutgers to incorporate the teachings of Gardeski by constructing the bending section of precipitation hardening stainless steel. Doing so would help to provide a smooth and even bend, as recognized by Gardeski. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
Regarding claim 8, Rutgers, as previously modified by Gardeski, discloses the portable medical endoscope according to claims 1 and 7. Gardeski further teaches wherein the precipitation hardening stainless steel is SUS631 (the coil and backbone are preferably formed of a wrought stainless steel, more preferably a precipitation hardened stainless steel such as PH15-7 Mo or 17-7PH; Fig. 4a, Col. 2, lines 9-13).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Rutgers in view of U.S. Patent Appl. Publ. No. 2022/0025152 A1 to Nakai et al. (“Nakai”).
Regarding claim 9, Rutgers discloses the portable medical endoscope according to claim 1. However, Rutgers does not explicitly disclose wherein the bending section is covered by a bending rubber.
Nakai teaches wherein the bending section is covered by a bending rubber (the present invention provides a crosslinked material appropriate for a constituting material of an endoscopic tube (outer cover) that has sufficient flexibility as a constituting member of an endoscope; Fig. 1, paragraph 0010 and 0031). Nakai teaches the use of a bending rubber to cover the bending section is advantageous as it is less likely to be broken regardless of repeated bending operation and is excellent in sterilization resistance (paragraph 0027).
Nakai is considered to be analogous to the claimed invention because it is in the same field of flexible endoscopes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscope of Rutgers to incorporate the teachings of Nakai by covering the bending section with a bending rubber. Doing so helps the endoscope become less likely to be broken regardless of repeated bending operation and is excellent in sterilization resistance, as recognized by Nakai.
Regarding claim 10, Rutgers, as previously modified by Nakai, discloses the portable medical endoscope according to claims 1 and 9. Nakai further teaches wherein the bending rubber is made of a high-performance fluoroelastomer (the crosslinked material for an endoscope of the present invention includes a fluorinated elastomer and fibrous carbon nanostructures, and is a crosslinked material in which crosslinked structures are introduced to at least a part of the fluorinated elastomer; Fig. 1, paragraph 0031).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Rutgers in view of U.S. Patent Appl. Publ. No. 2021/0169307 A1 to Suzuki (“Suzuki”).
Regarding claim 12, Rutgers discloses the portable medical endoscope according to claim 1. However, Rutgers does not explicitly disclose wherein the controller portion further comprises a pressure valve for measuring an internal pressure of the controller portion.
Suzuki teaches wherein the controller portion further comprises a pressure valve for measuring an internal pressure of the controller portion (a first cap denoted as reference numeral 10 and includes a check valve that opens when the pressure in the operation portion 5 is greater than the outer pressure; Fig. 1, paragraph 0041).
Suzuki is considered to be analogous to the claimed invention because it is in the same field of flexible endoscopes with a monitor mounted on the controller portion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention of have incorporated a pressure valve disposed on the controller portion of Rutgers, as taught by Suzuki, to increase the functionality of the endoscope system of Rutgers by enabling controlled pressure regulation and protecting the controller during reprocessing and cleaning.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Rutgers in view of U.S. Patent Appl. Publ. No. 2022/0079418 A1 to Ouyang et al. (“Ouyang”).
Regarding claim 16, Rutgers discloses the portable medical endoscope according to claim 1. However, Rutgers does not explicitly disclose wherein the angulation mechanism allows the tip to be angulated up to 150 degrees in two directions on a single plane, with a total angulation of 300 degrees. Rutgers does not disclose an exact range of angulation, rather shows some potential bending angles in the figures (Fig. 1).
Ouyang teaches wherein the angulation mechanism allows the tip to be angulated up to 150 degrees in two directions on a single plane, with a total angulation of 300 degrees (according to some embodiments, the amount of bending angulation upwards and downwards is in the range of 130 degrees and 210 degrees. According to some embodiments, the amount of bending is not equal, such as bending upwards of 210 degrees and downwards of 130 degrees; Fig. 10A, paragraph 0086).
Ouyang is considered to be analogous to the claimed invention because it is in the same field of flexible endoscopes with a monitor mounted on the controller portion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscope of Rutgers to incorporate the teachings of Ouyang by designing the angulation mechanism to allow the tip to be angulated up to 150 degrees in two directions on a single plane, with a total angulation of 300 degrees. In a case where the angulation angles of an endoscope tip are not disclosed, it would be obvious to one of ordinary skill in the art to use any suitable conventional angle range.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2020/0315444 A1 to Ramanujan et al. teaches a waterproof endoscope that is capable of withstanding high-level disinfection between patients as described in the abstract and following descriptive text.
THIS ACTION IS MADE FINAL. 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.
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/OLIVIA GRACE STARKEY/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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