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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 – 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 of US Patent No. 12,070,195. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 – 30 of the instant application is anticipated by claims 1 – 20 of US 12,070,195.
Claim Objections
Claims 5, 6, 8, 12 – 14, 16 – 20, 23, 27, and 30 are objected to because of the following informalities:
Claim 5 depends on claim 5. In this office action, claim 5 is examined as depending on claim 4.
Claim 5 recites: “the pharyngoscope of the oral cavity retractor”. Applicant is advised to change this to “the pharyngoscope [[of]]or the oral cavity retractor”.
Claim 5 recites: “to provide structural reinforcement of said segments or components”. Applicant is advised to change this to “to provide structural reinforcement of said identified one or more segments or components”.
Claim 6 depends on claim 6. In this office action, claim 6 is examined as depending on claim 5.
Claim 6 recites: “composition of said segments or components such that said segments or components can withstand forces applied”. Applicant is advised to change this to “composition of said identified one or more segments or components such that said identified one or more segments or components can withstand forces applied”.
Claim 6 recites: “said laryngoscope, pharyngoscope, and the oral cavity retractor”. Applicant is advised to change this to “said laryngoscope, pharyngoscope, [[and]]or the oral cavity retractor”.
Claim 8 recites: “said laryngoscope, pharyngoscope, and the oral cavity retractor” in line 3 and 4. Applicant is advised to change these to “said laryngoscope, pharyngoscope, [[and]]or the oral cavity retractor”.
Claim 8 recites: “the aerodigestive tract”. Applicant is advised to change this to “ the upper aerodigestive tract”.
Claim 12 recites: “the aerodigestive tract”. Applicant is advised to change this to “ the upper aerodigestive tract”.
Claim 13 recites: “the anatomic soft tissues peripheral to the airway lumen”. Applicant is advised to change this to “anatomic soft tissues peripheral to the airway lumen”.
Claim 13 recites: “the airway lumen”. Applicant is advised to change this to “an airway lumen”.
Claim 14 recites: “producing the component of the laryngoscope”. Applicant is advised to change this to “producing the at least one component of the laryngoscope”.
Claim 16 recites: “the component of the laryngoscope”. Applicant is advised to change this to “the at least one component of the laryngoscope”.
Claim 17 recites: “the component”. Applicant is advised to change this to “the at least one component”.
Claim 18 recites: “the component”. Applicant is advised to change this to “the at least one component”.
Claim 18 recites: “a baseplate”. Applicant is advised to change this to “a base plate”.
Claim 19 recites: “the component” in line 2 and line 3. Applicant is advised to change these to “the at least one component”.
Claim 20 recites: “the parameter includes the length of any of the speculum and/or the base plate, the inner diameter of the lumen of the laryngoscope, the radius of curvature of the speculum, a tilt angle of a proximal portion of the base plate relative to the rest of the baseplate”. Applicant is advised to change these to ”the parameter includes [[the]]a length of any of [[the]]a speculum and/or [[the]]a base plate, [[the]]a inner diameter of [[the]]a lumen of the laryngoscope, [[the]]a radius of curvature of [[the]]a speculum, or a tilt angle of a proximal portion of [[the]]a base plate relative to the rest of the base plate”.
Claim 23 recites: “the parameter includes the length of any of the speculum and/or the base plate, the inner diameter of the lumen of the laryngoscope, the radius of curvature of the speculum, a tilt angle of a proximal portion of the base plate relative to the rest of the baseplate”. Applicant is advised to change these to ”the parameter includes [[the]]a length of any of [[the]]a speculum and/or [[the]]a base plate, [[the]]a inner diameter of [[the]]a lumen of the laryngoscope, [[the]]a radius of curvature of [[the]]a speculum, or a tilt angle of a proximal portion of [[the]]a base plate relative to the rest of the base plate”.
Claim 27 recites: “a baseplate”. Applicant is advised to change this to “a base plate”.
Claim 30 recites: “a laryngoscope, pharyngoscope, or oral-cavity retractor”. Applicant is advised to change these to “a laryngoscope, a pharyngoscope, or an oral-cavity retractor”.
Claim 30 recites: “baseplate” in line 2, line 6 and line 9. Applicant is advised to change these to “base plate”.
Appropriate correction is required.
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 – 20 and 29 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 "the upper aerodigestive tract ". There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the upper aerodigestive tract". There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation " the three-dimensional profile". There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation " the material". There is insufficient antecedent basis for this limitation in the claim.
Specification
The disclosure is objected to because of the following informalities:
“baseplate” in the specification should be “base-plate” for consistency.
“oral-cavity” should be “oral cavity” for consistency.
Appropriate correction is required.
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.
Claims 11, 12, 14 – 30 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Wu et al. US 10,582,836 (hereinafter Wu).
Regarding claim 11, Wu teaches: a method comprising:
generating an anatomical profile of the upper aerodigestive tract associated with a patient or a group of patients (Fig. 9, C14, L32- L34 - - an image is taken of anatomical structures of a patient); and
producing at least one component of a laryngoscope, pharyngoscope, or oral cavity retractor based on the anatomical profile (Fig. 9, C14, L44-46 - - a customized laryngoscope is printed).
Regarding claim 12, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: the step of generating the anatomical profile comprises utilizing image data of the aerodigestive tract (C14, L31-40 - - image data of anatomical structures of a patient; C2, L1-L10 - - upper aerodigestive tract).
Regarding claim 14, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: producing the component of the laryngoscope, pharyngoscope, or oral cavity retractor with a three-dimensional (3D) printer (Fig. 9, C14, L44-46 - - a customized laryngoscope is printed using a 3D printer).
Regarding claim 15, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: the component comprises a metal, plastic, or composite material (C14, L46-49 - - polymers, biocompatible material).
Regarding claim 16, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: determining a material of the component of the laryngoscope based on at least one of the anatomical profiles, structural requirements (C5, L53-65 - - lightweight, radiolucent), ease of maintenance and sterilization, and economy of production (C5, L10-13 - - reducing cost).
Regarding claim 17, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: the component is a top plate of a speculum (Fig. 1, #130).
Regarding claim 18, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: the component is a baseplate of a speculum (Fig. 1, #120).
Regarding claim 19, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: determining a parameter of the component based on the anatomical profile (Fig. 9, C14, L34-44 - - design a customized laryngoscope based on width of patient throat; thus a structural parameter is adjusted per width of patient throat), and
producing the component based on the determined parameter (Fig. 9, C14, L44-46 - - a customized laryngoscope is printed).
Regarding claim 20, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: the parameter includes the length of any of the speculum and/or the base plate, the inner diameter of the lumen of the laryngoscope, the radius of curvature of the speculum, a tilt angle of a proximal portion of the base plate relative to the rest of the baseplate (Fig. 2B, C14, L34-L44 - - the design of the laryngoscope is based on the depth of the patient’s throat, this influences the length of the speculum and base plate).
Regarding claim 21, Wu teaches: a system comprising:
a component producing system;
a computer-readable storage medium with computer readable program instructions; and
a processor in communication with the computer-readable storage
medium, wherein the processor is configured to execute computer readable program instructions stored in the computer-readable storage medium which causes the processor to:
determine an anatomical profile of a patient (Fig. 9, C14, L32- L34 - - an image is taken of anatomical structures of a patient); and
send a signal to produce the component to a component producing system based on the anatomical profile, wherein in response to receiving the signal, the component-producing system is configured to produce the component based on the anatomical profile (Fig. 9, C14, L44-46 - - a customized laryngoscope is printed).
Regarding claim 22, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: determine parameters of a component of a laryngoscope based on the anatomical profile and in response to receiving the signal, and the component producing system is further configured to produce the component based on the parameters (Fig. 9, C14, L34-44 - - design a customized laryngoscope based width of patient throat; thus a structural parameter is adjusted per width of patient throat; Fig. 9, C14, L44-46 - - a customized laryngoscope is printed).
Regarding claim 23, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: the parameter includes the length of any of the speculum and/or the base plate, the inner diameter of the lumen of the laryngoscope, the radius of curvature of the speculum, a tilt angle of a proximal portion of the base plate relative to the rest of the baseplate (C14, L34-L44 - - the design of the laryngoscope is based on the depth of the patient’s throat, this influences the length of the speculum and base plate).
Regarding claim 24, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: determine the parameter based on image data (C14, L31-40 - - image data of anatomical structures of a patient; customized design a customized laryngoscope based on image data).
Regarding claim 25, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: the component producing system is a 3D printer or other additive manufacturing equipment (Fig. 9, C14, L44-46 - - a customized laryngoscope is printed using a 3D printer).
Regarding claim 26, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: the component is a speculum (Fig. 1).
Regarding claim 27, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: the component is a baseplate (Fig. 1, #120).
Regarding claim 28, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: the material of the component is metal, plastic, or a composite (C14, L46-49 - - polymers, biocompatible material).
Regarding claim 29, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: determine the material based on the anatomical profile (C5, L53-65 - - using thicker material at the rib to withstand the forces imparted by patient; the anatomical profile influences the forces; C14, L46 - - using biocompatible material since the component will contact the anatomical profile).
Regarding claim 30, Wu teaches: a method of fabricating a laryngoscope, pharyngoscope, or oral-cavity retractor having a speculum releasably attached to a baseplate for use with an individual patient (Fig. 1 A), comprising:
obtaining anatomical data regarding an individual patient's larynx (Fig. 9, C14, L32- L34 - - an image is taken of anatomical structures of a patient; C1, L25 - - Larynx), obtaining one or more structural and/or compositional parameters of at least one of the speculum and the baseplate by adjusting the parameters so as to obtain a desired visual access to a site of interest when using the speculum to visualize that site in the patient (Fig. 9, C14, L34-44 - - design a customized laryngoscope based width of patient throat; thus a structural parameter is adjusted per width of patient throat; C7, L51-58 - - the laryngoscope provides an unobstructed path between the outside and the patient’s throat, thus the doctor can have a clear view of the larynx of patient), and
using the parameters to fabricate the speculum and the baseplate (Fig. 9, C14, L44-46 - - a customized laryngoscope is printed).
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 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.
Claims 1 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. US 10,582,836 (hereinafter Wu) in view of Cali et al. “Feature-Based Modelling of Laryngoscope Blades for Customized Applications” from “JCM 2020, LNME, pp. 206–211, 2021” (hereinafter Cali).
Regarding claim 1, Wu teaches: a method of redesigning a laryngoscope, a pharyngoscope, or an oral cavity retractor, comprising:
adjusting one or more parameters of a 3-D design of a laryngoscope, pharyngoscope, or oral cavity retractor that can provide a desired visual access to the upper aerodigestive tract of a patient or a group of patients (Fig. 9, C14, L34-44 - - design a customized laryngoscope based width of patient throat; thus a structural parameter is adjusted per width of patient throat; C7, L51-58 - - the laryngoscope provides an unobstructed path between the outside and the patient’s throat, thus the doctor can have a clear view of the larynx of patient; C2, L1-L15 - - accessing upper aerodigestive tract), fabricating a laryngoscope, pharyngoscope, or an oral cavity retractor based on said 3-D design using an additive manufacturing technique (Fig. 9, C14, L44-46 - - a customized laryngoscope is printed using a 3D printer).
But Wu does not explicitly teach:
generating a computerized 3-D model of a laryngoscope, pharyngoscope, or an oral cavity retractor;
However, Cali teaches:
generating a computerized 3-D model of a laryngoscope, pharyngoscope, or an oral cavity retractor (Page 207, section 2.1 - - Two different commercial blade shapes (one for adult and the other for pediatric use, Fig. 2) were digitized and generate 3D tessellated surfaces);
Wu and Cali are analogous art because they are from the same field of endeavor. They all relate to design and fabricate laryngoscope.
Therefore before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Wu, and incorporating generating a 3D model of a laryngoscope, as taught by Cali.
One of ordinary skill in the art would have been motivated to do this modification in order to provide a good view to doctors with minimal discomfort to patients, as suggested by Cali (Abstract).
Regarding claim 2, the combination of Wu and Cali teaches all the limitations of the base claims as outlined above.
Wu further teaches: additive manufacturing technique comprises 3-D printing (Fig. 9, C14, L44-46 - - a customized laryngoscope is printed using a 3D printer).
Regarding claim 3, the combination of Wu and Cali teaches all the limitations of the base claims as outlined above.
Wu further teaches: acquiring anatomical profile of a patient or a group of patients (Fig. 9, C14, L32- L34 - - an image is taken of anatomical structures of a patient);
Cali further teaches:
generating said computerized 3-D model based on an anatomical profile (page 208, section 2.3 - - “the customized blade was generated through patient-specific modelling”).
Wu and Cali are combinable for the same rationale as set forth.
Regarding claim 4, the combination of Wu and Cali teaches all the limitations of the base claims as outlined above.
Cali further teaches: utilizing a structural finite element analysis to identify one or more segments or components associated with said 3-D design that require structural reinforcement (page 208, section 2.3 - - meet the requirement of strength and stiffness; optimize the tongue thickness using the result of finite element simulations) .
Wu and Cali are combinable for the same rationale as set forth.
Regarding claim 5, the combination of Wu and Cali teaches all the limitations of the base claims as outlined above.
Cali further teaches: fabricating step the laryngoscope, the pharyngoscope of the oral cavity retractor comprises structurally configuring said identified one or more segments or components so as to provide structural reinforcement of said segments or components (page 208, section 2.3 - - meet the requirement of strength and stiffness; optimize the tongue thickness using the result of finite element simulations; page 209, section 2.4 - - Additive Manufacturing of a Laryngoscope Prototype).
Wu and Cali are combinable for the same rationale as set forth.
Regarding claim 6, the combination of Wu and Cali teaches all the limitations of the base claims as outlined above.
Cali further teaches: the step of structurally configuring said identified one or more segments or components comprises selecting any of a thickness, shape and composition of said segments or components such that said segments or components can withstand forces applied thereto during use of said laryngoscope, pharyngoscope, and the oral cavity retractor (page 208, section 2.3 - - meet the requirement of strength and stiffness; optimize the tongue thickness using the result of finite element simulations; page 209, section 2.4 - - Additive Manufacturing of a Laryngoscope Prototype).
Wu and Cali are combinable for the same rationale as set forth.
Regarding claim 7, the combination of Wu and Cali teaches all the limitations of the base claims as outlined above.
Cali further teaches: laryngoscope comprises a speculum having a top plate coupled to a base plate and said method includes adjusting a thickness, shape, and composition of at least a portion of said top plate (page 208, section 2.3 - - meet the requirement of strength and stiffness; optimize the tongue thickness using the result of finite element simulations; the blade is a top plate; Table 1, Fig. 3 - - different shape or parameters of the blade; Page 209, section 2.4 - - the selected material has better mechanical properties, improved superficial finish and antibacterial properties.).
Wu and Cali are combinable for the same rationale as set forth.
Regarding claim 8, the combination of Wu and Cali teaches all the limitations of the base claims as outlined above.
Wu further teaches: said desired visual access is characterized by a maximum tilt (Fig. 1A, tilt defined by 136 as it transitions from 140 toward 138 and opens into 130) of a surgical microscope optically coupled to any of said laryngoscope, pharyngoscope and the oral cavity retractor relative to a longitudinal axis (Fig. 1A, an axis defined along and through center of 136) of any of said laryngoscope, pharyngoscope and the oral cavity retractor that can be used for viewing a surgical site of interest in the aerodigestive tract of a patient or a group of patients (C7, L54-L61 - - provide an unobstructed path for viewing a larynx, voice box, glottis, etc. ).
Regarding claim 9, the combination of Wu and Cali teaches all the limitations of the base claims as outlined above.
Wu further teaches: said maximum tilt is about 30 degrees (Fig. 1A shows the angle is about 30 degrees).
Regarding claim 10, the combination of Wu and Cali teaches all the limitations of the base claims as outlined above.
Wu further teaches: said surgical site of interest comprises an anatomical structure of the upper aerodigestive tract (C7, L54-L61 - - larynx, voice box, glottis and other structures).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. US 10,582,836 (hereinafter Wu) in view of Diong et al. US 2008/0139956 (hereinafter Diong).
Regarding claim 13, Wu teaches all the limitations of the base claims as outlined above.
Wu further teaches: the anatomical profile includes the three- dimensional profile of jaw-opening capacity (C14, L30-44 - - throat depth), aerodigestive lumen (C14, L30-44 - - throat width),
But Wu does not explicitly teach:
anatomical soft-tissue structural conformation as well as a rheological assessment of the anatomic soft tissues peripheral to the airway lumen.
However, Diong teaches:
anatomical soft-tissue structural conformation as well as a rheological assessment of the anatomic soft tissues peripheral to the airway lumen ([0006] - - viscoelastic model of the airway);
Wu and Diong are analogous art because they are from the same field of endeavor. They all relate to medical process around airway.
Therefore before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Wu, and incorporating rheological assessment of airway, as taught by Diong.
One of ordinary skill in the art would have been motivated to do this modification in order to improve detection and diagnosis processes, as suggested by Diong ([0002]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUHUI R PAN whose telephone number is (571)272-9872. The examiner can normally be reached Monday-Friday 8AM-5PM EST.
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/YUHUI R PAN/Primary Examiner, Art Unit 2116