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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/13/2025 has been entered.
Response to Amendment
Claims 1-6, 24-25, 28-30 are pending. Claims 1-6, 24-25, 28-30 as amended overcome the rejection. New grounds of rejection in light of amendments are set forth.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “lip stopper” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 24-25 and 28-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein the lip stopper is 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” in lines 10-12. However, the specification lacks details that support or suggest that the lip stopper is in the specified position. Further clarification required.
Claims not listed are rejected by virtue of claim dependency.
Claim Objections
Claim 30 is objected to because of the following informalities: Claim 30 recites “protected” in line 3, but instead should be --protective--. 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, 5-6, 24, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Tingvatn (US 20220061650 A1- Previously cited) and further in view of Gatto (US 20030181823 A1- Previously cited), Lu (US 20080188769 A1- Previously cited) and Wolf et al. (US 20200237452 A1-Previously cited), referred to as Wolf hereinafter.
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 extends from a proximal end of the elongated protected guide to a distal end of the elongated protective guide (see fig. 1, elongated chamber 102 extends from a proximal end to a distal end of guide 100 or towards the distal end).
Tingvatn fails to teach wherein the elongated protective guide comprises a cylindrical guide having a constant external diameter that does not exceed 0.5 centimeters.
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 from 0.5mm to 1.2mm (see para. [0036] and fig. 4-6).
It would have been obvious to one of ordinary skill in the art such at the time the invention was effectively filed to have modified the device of Tingvatn, such that the guide has a constant external diameter that does not exceed 0.5 centimeters, as taught by Gatto, to aid in the detection, sample collection and/or treatment of abnormal tissue (see para. [0018] of Gatto). Furthermore, the modification is merely using a known technique (endoscope guide formed with external diameter less than 1 cm) to improve similar devices (endoscope assembly) in the same way.
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 (see fig. 1 and 6, the dual chambers extend from the proximal and distal end of the guide). As such, 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-Gatto, such that the second elongated chamber extends from a proximal to distal end of the elongated protective guide, as taught by Gatto, as it would merely be combining prior art elements (dual chambered guides) according to known devices (the dual chambers extend from a proximal to a distal end of the guide) to yield predictable results.
It follows, Tingvatn-Gatto teach a device positionable within the first elongated chamber of the elongated protective guide, the device having a camera and 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);
and 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), 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 as modified by Tingvatn and Gatto. Here, Gatto teaches the two chamber being positioned at the distal end, wherein camera and sample extraction components are located. Para. [0039,0043]).
Tingvatn fails 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-Gatto, 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-Gatto-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 a 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).
Tingvatn fails to teach wherein the processor is in communication with a server via a network, and a database in communication with the server configured to store data related to the PAP test for the user, wherein the data related to the PAP test comprises at least one of training videos and guideline manuals, image and video files, specimen label.
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]).
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-Gatto-Lu, wherein the processor is in communication with a server via a network, and a database in communication with the server configured to store data related PAP test for the user, as taught by Wolf, as it would merely be combining prior art elements (software module, server, network, and database) according to known devices (medical devices) to yield predictable results.
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-Gatto-Lu-Wolf, such that the data is related to store at least training videos and guideline manuals, and 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.
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 5, Tingvatn teaches wherein the computing device is a computer system (see para. [0017,0021], “doctor may view the image on a screen whilst a nurse performs the procedure”).
Regarding claim 6, Tingvatn-Lu-Wolf teach that the samples extracted by the device can be used in the process for testing diseases including, detection of chlamydia, gonorrhea, human papillomavirus (HPV), and other sexually transmitted viruses or infections (see para. [0004-5,0021] of Tingvatn, the device is capable of being used for such testing ).
Regarding claim 24, Tingvatn teaches wherein lip stopper comprises a hollow middle (see figs. 1-2a).
Regarding claim 28, Tingvatn teaches wherein the elongated protective guide comprises an elongated housing 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 29, Tingvatn teaches wherein sections of the first elongated chamber and the second elongated chamber are integrally formed with the elongated housing (see fig. 2a).
Regarding claim 30, Tingvatn-Lu-Wolf fail to teach 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 teach the endoscope guide 14 is formed of multiple elongate chambers that are of uniform diameters internally and externally (see para. [90036,0041] 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-Gatto-Lu-Wolf, 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).
Claims 3 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Tingvatn in view of Gatto, Lu and Wolf, as applied to claims 1 and 24, in view of Hellstrom et al. (US 20140107496 A1-Previously cited), hereinafter Hellstrom.
Regarding claim 3, Tingvatn-Lu-Wolf 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-Lu-Wolf 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-Lu-Wolf, 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 25, 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).
Hellstrom teaches an endoscope comprising a camera that is slight retracted behind the tip aperture, without a barrier, allowing for vision (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-Gatto-Lu-Wolf, 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 (endoscope with no barrier in front of the camera) for another (endoscope with barrier in front of the camera) to obtain predictable results.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tingvatn in view of Gatto, Lu, and Wolf, as applied to claim 1, further in view of Basch et al. (US 20030004755 A1-Previously cited), referred to as Basch hereinafter, and Liberty et al. (US 20140236635 A1- Previously cited), referred to as Liberty hereinafter.
Regarding claim 4, Tingvatn-Gatto-Lu-Wolf fail to teach wherein the data related to the PAP test at least one of testing documentation for patients, medical history forms and patient file 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-Gatto-Lu-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 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-Gatto-Lu-Wolf-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.
Response to Arguments
Applicant's arguments filed 10/13/2025 have been fully considered but they are not persuasive.
Applicant contends that there is no articulated rationale for combining the cited references in a manner to produce the claimed dual-chamber device with the specific structural features, on page 8 of the Remarks. The Examiner disagrees. Applicant fails to specify which references lack a rationale for combination. Applicant is required to support their arguments by pointing out specific deficiencies in the articulated rationales.
Applicant contends that there is an insufficient factual basis showing how the individual teachings of the cited references are combined to arrive at the claimed invention, on page 9 of the Remarks. The Examiner disagrees. Applicant fails to argue which specific references lack a sufficient factual basis for their combined teachings. Applicant is required to support their arguments by identifying the insufficient factual basis for each prior art reference relied upon.
Applicant contends that the combination of Tingvatn, Lu, and Wolf results from improper hindsight, on page 9 of the Remarks. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, 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).
Applicant contends that no reference discloses the claimed lip stopper, on page 9 of the Remarks. The Examiner disagrees. Tingvatn discloses the lip stopper as claimed because it prevents the camera and its connected contents from moving forward by forming the lip stopper such that they cannot move forward (see figs. 1-2, chamber 104 comprises the lip stopper at the proximal end). Moreover, the claimed lip stopper lacks specific structural details to overcome the rejection. As currently claimed, the lip stopper is merely a component that prevents a device from moving out of a chamber, which can be accomplished by a plurality of structures.
Applicant contends that the cited references fail to teach a slidably positioned extraction tool within the second chamber, on page 10 of the Remarks. The Examiner disagrees. It is clear that Tingvatn teaches extracting samples using an extraction device in combination with the invention (see para. [0004], “a device for visual inspection of a body orifice that allows for simultaneous visual examination of the orifice and sample collection or inspection using medical equipment”).
Applicant contends that training and diagnostic aids,- including video content, guidelines, and labels, are not addressed by the cited prior art, on page 10 of the Remarks. The Examiner disagrees. Tingvatn explicitly teaches using video content for analyzing data and diagnosing diseases (see para. [0021], “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.”) Wolf is relied upon to teach using training videos that provide alternative outcomes/guidelines (see para. [0126] of Wolf). Lastly, Basch is relied upon for labeling specimens (see para. [0016-17,0024-25,0040]). While the Applicant argues each individual component of the limitation, it is noted that the limitation only require at least one of the components, not all.
Applicant contends that the references do not disclose the specific diseases the device will be used to diagnose, nor a diameter constraint of less than 0.5 cm, on page 10 of the Remarks. The Examiner disagrees in part. Applicant appears to be arguing against the rationale for Claim 6. However, the limitation is directed towards how the invention is used, not what the device itself performs. As such, there is no patentable weight because the limitation is not positively recited and the device itself cannot perform such diagnostics. Additionally, the diameter constraint of the chambers is taught by Gatto (see para. [0036] and fig. 4-6, the diameter is constrained to 0.5 mm to 1.2 mm).
Applicant contends that the positioning of a camera adjacent to the distal end via the lip stopper is not disclosed or suggested, on page 10 of the Remarks. The Examiner disagrees. Tingvatn discloses the camera and lip stopper, but fails to teach that the camera is at the distal most part of the guide. Gatto is relied upon to teach the dual chambers of a guide extending from a proximal end to the distal most end (see figs. 2-6). Additionally, Gatto teaches a camera that extends the length of a chamber that extends the length of the chamber(see para. [0041]). The combination teaches the limitation and is obvious because they are both guides comprising dual chambers, cameras and sample extraction. Thus, the claimed subject matter is taught by the references.
Applicant contends that none of the references disclose real time, on device AI/ML analysis for diagnostic purposes, on page 11 of the Remarks. However, such subject matter is not claimed and therefore is not required to be taught. For completeness, Tingvatn teaches “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.” (see para. [0021])
Therefore, Applicants arguments are found unpersuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dreyfuss teaches a surgical sheath system having a sheath with a hollow shaft; and a head coupled to and in fluid communication with the hollow shaft. US 20250049303
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791