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 September 12, 2025 has been entered. Claims 1-2, 4-8, 22-24, and 27-31 are pending. The rejection of claims 1-2,4-8,22-24 and 27-31 are overcome in light of Applicant’s amendments/arguments, which distinguishes the device’s elongated chambers from the prior art. As such, new grounds of rejection are required.
Claim Objections
Claim 29 objected to because of the following informalities: Claim 29 recites “housing have the” in line 2, but instead should recite --housing having the--. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The 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 1-2, 4-5, 7-8, and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Tingvatn (US 20220061650 A1- Previously cited) and further in view of Hellstrom et al. (US 20140107496 A1- Previously cited), hereinafter Hellstrom, and Lu (US 20080188769 A1- Previously cited).
Regarding claim 1, Tingvatn teaches a medical device for conducting a disease/condition test (see ABSTRACT and para. [0021]), comprising: an elongated protective guide having a first elongated chamber and a second elongated chamber, the first elongated chamber and the second elongated chamber extending from a proximal end of the elongated protected guide to a distal end of the elongated protective guide (see fig. 1, elongated chambers 102,104, extending from a proximal end to a distal end of guide 100 or towards the distal end),
a device positionable within the first elongated chamber of the elongated protective guide, the device having a camera and an assembly of one or more a light emitting device assembly (see para. [0018,0057] and fig. 2a, a camera 108 and light source is positioned in a first chamber 104 of the disposable protective guide 102),
wherein the first elongated chamber comprises a lip stopper, and wherein the device contacts the lip stopper to prevent the device from moving out of the first elongated chamber(see fig. 2a, lip stopper is the chamber 104 that prevents the device (108,110,112) to completely pass through), and wherein lip stopper comprises a hollow middle (see figs. 1-2a).
Tingvatn fails to explicitly teach wherein the second elongated chamber extends from a proximal to distal end of the elongated protective guide. However, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have rearranged the size of the second elongated chamber such that it is positioned at a distal location of the elongated protective guide as it would not have modified the operation of the device and is an obvious matter of design choice (see MPEP 2144.04 IV. A). Moreover, the configuration of extending two chambers distally on an elongated protective guide does not overcome the teachings of Gatto, cited below.
Tingvatn fails to teach wherein the hollow middle avoids creating a barrier in front of the camera and the light emitting device assembly of the device to provide better visualization of a targeted cervical area by the camera.
Hellstrom teaches an endoscope comprising a camera that is slight retracted behind the tip aperture, without a barrier, allowing for vision and LED as an illumination source (see ABSTRACT and para. [0008,0053,0094]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tingvatn, such that the there is no extra barrier in front of the light and lenses of the camera, as taught by Hellstrom, as it would merely be substituting of one known element (LED source) for another (light source) to obtain predictable results.
Tingvatn in view of Hellstrom fail to explicitly teach a cell extraction device slidably positioned within the second elongated chamber of the protective guide, the cell extraction device having a handle at a first end and one of a cell-extraction brush or a cell-extraction spatula at a second end, opposite the first end.
Tingvatn teaches wherein the chamber 102 allows for a cell/sample extraction/collection device that can be slidably positioned inward and/or outward around the user’s vagina/cervix (see para. [0004-8,0010]).
Lu teaches a foldable brush self-sampling device comprising a handle/stem and a brush for a user to collect a sample from the cervix for a PAP test by inserting the brush through a sheath, that’s been inserted into the vagina/cavity (see ABSTRACT, para. [0004-8,0030], and fig. 1A-1C,2A-2B). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tingvatn in view of Hellstrom, to include the cell extraction device comprising a handle (proximal) and a brush (distal) of Lu, because the device of Tingvatn is intended to be used with a cell extraction device.
It follows, Tingvatn in view of Hellstrom and Lu teach a computing device in communication with the device, the computing device having a processor and a memory having a software module executed by the processor (see para. [0017,0021] of Tingvatn, the camera/visualization device is in communication with a computing device comprising a processor and memory/storage with a software program); and
a display in communication with the computing device, the display adapted to display the targeted cervical area imaged by the camera of the device to assist the user in positioning the one of the cell-extraction brush (see para. [0017,0021] of Tingvatn, visualization device is used for imaging and therefore capable of assisting the user).
Regarding claim 2, Tingvatn teaches wherein the protective guide is a disposable protective guide (see fig. 1,2a, chamber 102,104; it is noted that anything is disposable).
Regarding claim 4, Tingvatnin view of Lu teach wherein the light emitting device assembly produces illumination of the targeted cervical area (see para. [0017,0037] of Tingvatn, “The visualization device may further comprise a light source to enable clearer visualization of the orifice to be obtained”).
Tingvatn in view of Lu fail to teach wherein the assembly is one or more light emitting diodes.
Hellstrom teaches an endoscope comprising a camera that is slight retracted behind the tip aperture, without a barrier, allowing for vision and LED as an illumination source (see ABSTRACT and para. [0008,0053,0094]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tingvatn in view of Hellstrom and Lu, such that the there is no extra barrier in front of the light and lenses of the camera, as taught by Hellstrom, as it would merely be substituting of one known element (LED source) for another (light source) to obtain predictable results.
Regarding claim 5, Tingvatn teaches wherein the computing device is in communication with the device via a universal serial bus (USB) cable (see para. [0021], wired or wireless communication, one skilled in the art understands that USB is a standard wired communication component used widely in medical devices).
Regarding claim 7, Tingvatn teaches wherein the computing device is a computer system configured to provide visual reference for the medical professional conducting the test (see para. [0017,0021], “doctor may view the image on a screen whilst a nurse performs the procedure”).
Regarding claim 8, Tingvatn teaches that the cells samples extracted by the device can be tested for anything including, detection of chlamydia, gonorrhea, human papillomavirus (HPV), and other sexually transmitted viruses or infections (see para. [0021] of Tingvatn).
Regarding claim 27, Tingvatn teaches wherein the lip stopper is located adjacent the distal end of the elongated protective guide (see figs. 1-2a, the lip stopper of 104 is located at the distal most part of the guide and therefore adjacent to the distal most part of the length of the guide).
Regarding claim 28, Tingvatn teaches wherein the lip stopper located adjacent the distal end of the elongated protective guide positions the camera of the device adjacent the distal end of the elongated protective guide (see fig. 2a, the camera is positioned near 114 via lip stopper at the distal end).
Regarding claim 29, Tingvatn teaches wherein the elongated protective guide comprises an elongated housing having the first chamber and the second elongated chamber (see fig. 2a, the outer surface of 102 houses both the first chamber and second chamber).
Regarding claim 30, Tingvatn teaches wherein sections of the first elongated chamber and the second elongated chamber are integrally formed with the elongated housing (see fig. 2a).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tingvatn in view of Hellstrom and Lu, as applied to claim 1, and further in view of Wolf et al. (US 20200237452 A1-Previously cited), hereinafter Wolf, Basch et al. (US 20030004755 A1-Previously cited), referred to as Basch hereinafter, and Liberty et al. (US 20140236635-Previously cited), referred to as Liberty hereinafter.
Regarding claim 6, Tingvatn in view of Hellstrom and Lu fail to teach wherein the processor is in communication with a database configured to store data related to at least one of testing documentation for patients, medical history forms and patient file database, training videos and guideline manuals, image and video file capture and storage, specimen label and laboratory requisition form printable templates, and Health Insurance Portability and Accountability Act (HIPAA) compliant integration options for Electronic Health Record (EMR) systems.
Wolf teaches a system and device for analyzing videos of a patient for medical procedures comprising a computing system (see ABSTRACT and para. [0002,0069,0310]). The computing system comprises computing devices with databases, accessible software packages (browser extensions), and processors in communication with a server via a network (see para. [0069,0078,0166-167,0310,0312-313,0324]). The database is in communication with the server and is configured to store data related to PAP test of the user (see para. [0180]).
Wolf further teaches wherein the database in communication with the server is configured to store data related to testing documentation for patients (see para. [0180] of Wolf, “characteristics of past medical test performed on the patient”), medical history forms and patient file database (see para. [0210] of Wolf, “a medical record may include any form of documentation of information relating to a patient's health, including diagnoses, treatment, and/or care”), training videos and guideline manuals (see para. [0168,0208,0485-486] of Wolf, “request surgical summary footage for review or training purposes” and “Accessing the stored data identifying a recommended sequence of events may include retrieving the stored data from a suitable storage location” indicating training videos, guideline manuals, image and video capture and storage), image and video file capture and storage.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tingvatn in view of Hellstrom and Lu, such that the database in communication with the server is configured to store data related to testing documentation for patients, medical history forms and patient file database, training videos and guideline manuals, image and video file capture and storage, as taught by Wolf, as it would merely be combining prior art elements (database, storage, files, videos) according to known devices (medical devices) to yield predictable results.
Tingvatn in view of Hellstrom, Lu, and Wolf fail to teach specimen label and laboratory requisition form printable templates, and Health Insurance Portability and Accountability Act (HIPAA) compliant integration options for Electronic Health Record (EMR) systems.
Basch teaches a system and method for producing and managing Custody and Control (CoC) Forms for laboratory testing including handling, controlling, storing, and delivering the donor/specimen information (see para. [0016-17,0024-25,0040]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tingvatn in view of Hellstrom, Lu, and Wolf, such that the database stores specimen label and laboratory requisition form printable templates, as taught by Basch, to aid in recording donor information and assuring specimens do not get separated from donor information (see para. [0003]). Also, it would merely be combining prior art elements (database content) to known devices (database) to obtain predictable results (storing pertinent paperwork in a database).
Liberty teaches a system for ensuring secure communication between the user and healthcare facilities (see para. [0003]). The communication data can be stored in a database based on HIPAA specified regulations for the user’s health record part of the EMR system (see para. [0055,0090-92,0102]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tingvatn in view of Hellstrom, Lu, Wolf, and Basch, such the database stores Health Insurance Portability and Accountability Act (HIPAA) compliant integration options for Electronic Health Record (EMR) systems, as taught by Liberty, to aid in ensuring secure communication between user and health care entities according to HIPAA regulations.
Claims 22-24 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Tingvatn in view of Hellstrom and Lu, as applied to claim 1, and further in view of Gatto (US 200301818230 Previously cited).
Regarding claim 22, Tingvatn in view of Hellstrom and Lu fail to teach wherein the elongated protective guide comprises a cylindrical guide having a constant external diameter from the proximal end to the distal end.
Gatto teaches an endoscope configured to be inserted in endoscope guide 14 which is configured to accept endoscope 14 which comprises a camera, and a scraping/cutting device (see para. [0036-39]). The endoscope guide 14 is formed having an outer diameter of 1.2mm (see para. [0036,0041] and fig. 4-6, “The tube portion 14 which has an outer diameter of approximately 1.2 mm has a working channel”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tingvatn in view of Hellstrom and Lu, such that the external diameter of the guide is constant from the proximal end to the distal end, as taught by Gatto, to aid in viewing the interior cavities of a subject, detecting abnormalities, and obtaining biological samples (see para. [0020] of Gatto). Additionally, the modification is merely substituting of one known arrangement (constant external guide diameter) for another (substantially constant external guide diameter).
Regarding claims 23-24, Tingvatn in view of Hellstrom, Lu, and Gatto teach wherein the constant external diameter does not exceed 1 or 0.5 centimeters (see para. [0036,0041] and fig. 4-6 of Gatto, “The tube portion 14 which has an outer diameter of approximately 1.2 mm has a working channel”).
Regarding claim 31, Tingvatn in view of Hellstrom, Lu fail to teach or suggest wherein the first elongated chamber and the second elongate chamber each comprise a uniform inside dimension from the proximal end of the elongated protective guide to a distal end of the elongated protective guide.
Gatto teaches an endoscope configured to be inserted in endoscope guide 14 which is configured to accept endoscope 14 which comprises a camera, and a scraping/cutting device (see para. [0036-39]). The endoscope guide 14 is formed of multiple elongated chambers that are of uniform diameters internally and externally (see para. [0036,0041] and fig. 4-6).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tingvatn in view of Hellstrom and Lu, such that the inner diameter of the elongated chambers are uniform from the proximal end to the distal end, as taught and/or suggested by Gatto, to aid in viewing the interior cavities of a subject, detecting abnormalities, and obtaining biological samples (see para. [0020] of Gatto). Additionally, the modification is merely substituting of one known arrangement (uniform inner chamber diameter) for another (substantially uniform inner chamber diameter).
Response to Arguments
Applicant's arguments filed 02/05/2025 have been fully considered but they are not persuasive.
Applicant contends that the expert opinion is far from being obvious in view of prior art combinations, on pages 6-7 of the Remarks. Applicant failed to provide which prior art combinations are nonobvious and how the expert opinion supports such arguments.
Applicant’s arguments with respect to amended limitations in claim 1 have been considered but are moot because amendments require new grounds of rejection.
Applicant contends that there is no teaching, suggestion, or motivation to modify Tingvatn in view of Lu or Wolf, on page 10 of the Remarks. The examiner disagrees. Applicant merely contends that the references cannot be combined, but fails to provide a reasoning as to why they cannot be combined. Tingvatn and Lu are both within the field of medical diagnostics, directed to obtaining biological samples, and comprise tubular elements for inserting into a cavity (see abstract of Tingvatn and Lu). Tingvatn and Wolf are both within the field of medical diagnostics and require medical imaging (see para. [0168,0180,0208,0485-486] of Wolf and para. [0021] and figs. 1-2 of Tingvatn).
Applicant contends that integrally formed dual chamber guides extending from a proximal end to a distal end are not evident in the prior art, on page 10 of the Remarks, but fails to provide a reasoning. Tingvatn teaches a dual chamber guide (see fig. 2) and Gatto teaches a multi chambered guide (see figs. 4-6).
Applicant contends that the cited references do not teach a lip stopper with a hollow middle, on page 10 of the Remarks. The examiner disagrees. Tingvatn teaches the lip stopper with a hollow middle (see para. [0018] and fig. 2a, lip stopper is the chamber 104 that prevents the device (108,110,112) to completely pass through) and Hellstrom teaches providing a camera that is slightly retracted behind the tip aperture, without a barrier in front (see abstract and para. [0008,0053,0094]). The combination of the two arrives at the claimed limitations. As such, the functions are not new nor make new improvements in view of the prior art.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, on pages 10-11 of the Remarks, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, each of the claimed elements are taught and/or suggested by the prior art of record.
Applicant contends that the prior art does not teach or suggest a computing device configured to communicate with a visualization device, processor, memory and display for positioning the sampling tool, on page 11 of the Remarks. The examiner disagrees. The following excerpts provided by Tingvatn teaches all of the elements above.
Preferably, the visualization device is connected (by a wired or wireless connection) to a processor and/or a storage device (e.g. a computer system). The processor may analyse data (e.g. images) obtained by the visualization device. A software program (e.g. running on the processor) may be capable of recognising symptoms of diseases and/or conditions from the data (e.g. images), and may be arranged to provide a suggested diagnosis. The program may include a machine learning algorithm, for example to associate data obtained with diseases and/or conditions.
Para. [0021].
Thus it will be seen by those skilled in the art that in accordance with at least embodiments of this invention, the observation channel allows a medical professional to perform a visual inspection via this channel, whilst the main body may be sealed or instruments may be inserted through the main body.
Para. [0010].
As such, the visualization device to view images, a processor, a storage device, software/machine learning, and a display for viewing within the subject for placement of instruments is taught and suggested in at least Tingvatn.
Applicant contends that the prior art does not address aspects of the invention, such as a computing interface configured to support HIPAA-compliant data integration, user guidance through training media, and optional configurations for collecting samples for detecting sexually transmitted infections including chlamydia, gonorrhea, and HPV, on page 11 of the Remarks. Applicant fails to provide reasonings as to why they are not taught by the prior art and fails to address which references lack such subject matter. As such, the argument is not persuasive and prior art cited teaches and/or suggest such subject matter. Moreover, Applicant contends that the features improve usability and unexpected advantages contribute to non-obviousness. It is unclear which features improve usability and what the improvement/ unexpected advantageous are in light of prior art that the Applicant is referring to.
Therefore, Applicants arguments are found unpersuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yates teaches a surgical system comprising various instruments including endoscopes. US 20190208641
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 MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARTIN NATHAN ORTEGA/ Examiner, Art Unit 3791
/JUSTIN XU/ Primary Examiner, Art Unit 3791