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 amendments to claim 1 in the response filed on 07/29/2025 are acknowledged.
Claims 1 and 5-16 remain pending in the application
Claims 2-4 are cancelled.
Claims 1 and 5-16 are examined
Response to Arguments
The applicant’s arguments have been considered but are moot in view of the new grounds of rejection necessitated by the applicant’s amendments to the claims. The applicant has modified claim 1 to require a coupler releasably coupled to the smart phone by hook and loop fasteners with one strip of the hook and loop fastener affixed to the smart phone, wherein the coupler is positioned on a rear surface of the smart phone and is located between the smart phone and the orifice inspection device, below a lens of the image capture device, limitations heretofore not presented for examination in this application. As such, the scope of the claims was substantially changed and new grounds for rejection are presented.
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(s) is/are: “data interface” in claim 10.
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 Applicant’s specification [0035] as “a data communications network, Bluetooth, WiFi…modem”, 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 § 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.
Claim(s) 1, 5-6, and 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0303857 to Perkins et al. (hereinafter “Perkins”) in view of U.S. Publication No. 2013/0158358 to Holland and in view of U.S. Publication No. 2014/0072189 to Jena et al. (hereinafter “Jena”).
Regarding claim 1, Perkins discloses an orifice inspection system, including:
an orifice inspection device for illuminating a patient's orifice (200, Figs. 4a-4f; [0095]), the orifice inspection device including a handle (200, Fig. 4a, [0095]) with a light source (Fig. 9b, [0105]) a power source (Fig. 9b, [0105]),
a smart phone including a screen and an image capture device for capturing a photograph of the patient's orifice as illuminated by the orifice inspection device (220, Fig. 4a, [0097]); and
a coupler releasably coupled to the smart phone by fasteners with one strip of the fastener affixed to the smart phone so as to releasably couple the handle body of the orifice inspection device to the smart phone (208, Fig. 4e, [0097]), thereby positioning the disposable light transmissive structure relative to the image capture device (217, Fig. 4d, [0097]), wherein the coupler is positioned on a rear surface of the smart phone (208, Fig. 4e, [0097])and is located between the smart phone and the orifice inspection device below a lens of the image capture device (208, Fig. 4e, [0097]), and the handle body includes a substantially flat rear surface with a slot arranged to slidably receive the coupler (207, Fig. 4d, [0097]);
wherein the orifice inspection device is operable in a first condition disconnected from the smart phone in which a user may clasp the handle body to illuminate the patient's orifice (200, Figs. 4a-4d, [0095]), and a second condition in which the handle body is coupled to the smart phone by sliding the coupler into the slot with the substantially flat rear surface of the handle body and the rear surface of the smart phone fitted immediately adjacent one another so as to position the disposable light transmissive structure laterally spaced apart from the image capture device so that the image capture device is unobstructed thereby allowing the user to capture the photograph of the patient's orifice surrounding the disposable light transmissive structure whilst holding the smart phone (200, Figs. 4a-4d, [0095]).
Perkins fails to expressly teach and a disposable light transmissive structure formed of a light transmissive material releasably connectable to the handle, the handle including a handle body and a coupling portion extending therefrom, the light source being located within the coupling portion of the handle and the coupling portion including a switch in communication with the light source and the power source, and the disposable light transmissive structure includes a cavity to receive the coupling portion of the handle and activate the switch such that the light source is directed there along;
and hook and loop fasteners.
However, Holland teaches of an orifice inspection device for illuminating a patient's orifice (Fig. 2A - tongue depressor 1), the orifice inspection device including a handle (Fig. 2A - handle 4) with a light source (Fig. 2A - light source 14), and a disposable light transmissive structure formed of a light transmissive material (Fig. 2A - blade 2; [0161]- the blade 2 may be made of any suitable materials which are capable of transmitting light) releasably connectable to the handle ([0192]- The handle 4 may also include one or more releasing members to release the blade from the handle), the handle including a handle body (Fig. 2A - handle 4) and a coupling portion extending therefrom (Fig. 2A - portion of the handle 42), the light source being located within the coupling portion of the handle (Fig. 2A) and the coupling portion including a switch in communication with the light source and the power source (Fig. 2A – switch 6; [0183]- a multi-positionable switch 6 to open or close the circuit between the power supply and the light source 14), and the disposable light transmissive structure includes a cavity to receive the coupling portion of the handle (Fig. 2A - cavity 40) and activate the switch such that the light source is directed there along ([0147]- projection 36 is located within the cavity 40… the projection 36 engages the switch 6 and activates the light source 14).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Perkins to utilize the orifice inspection device, in the manner as taught by Holland. It would have been advantageous to make the combination for the purpose of making it easier for an operator to identify certain features within the oral cavity ([0007] of Holland).
Perkins, in view of Holland, fails to expressly teach hook and loop fasteners.
However, Jena teaches of an analogous device (Jena: Fig. 21, 22) including hook and loop fasteners (Jena: [0110]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Perkins, in view of Holland, to utilize hook and loop fasteners in the manner as taught by Jena. It would have been advantageous to make the combination for the purpose of fixing the components together ([0110] of Jena).
Regarding claim 5, Perkins, in view of Holland and Jena, teaches the orifice inspection system according to claim 1.
Perkins, in view of Holland and Jena, fails to expressly teach including a light guide structure, wherein the coupler and the handle body are arranged such that the light guide structure is positioned non-obstructively adjacent to and extending in a direction away from a lens of the image capture device.
However, Jena further teaches (Fig. 26) teaches including a light guide structure (64, Fig. 26, [0112]), wherein the coupler (242, Fig. 26, [0112]) and the handle body are (30, Fig. 26, [0110]) arranged such that the light guide structure is positioned non-obstructively (72, Fig. 4, [0073]) adjacent to and extending in a direction away from a lens of the image capture device (Fig. 26).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Perkins, in view of Holland and Jena, to utilize a light guide structure, as taught by Jena. It would have been advantageous to make the combination for the purpose of providing light ([0111]-[0114] of Jena).
Regarding claim 6 Perkins, in view of Holland and Jena, teaches the orifice inspection system according to claim 1.
Perkins, in view of Holland and Jena, fails to expressly teach wherein the disposable light transmissive structure is removable from the handle irrespective of whether or not the handle is coupled to the coupler.
However, Holland further teaches wherein the disposable light transmissive structure is removable from the handle irrespective of whether or not the handle is coupled to the coupler (Holland: [0025]- the blade is removably coupled to the handle).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Raz, in view of Holland and Jena, so that the disposable light transmissive structure is removable from the handle irrespective of whether or not the handle is coupled to the coupler, as taught by Holland. It would have been advantageous to make the combination so that when the blade is coupled to the handle light from the light sources is transmitted by the blade into the oral cavity (Holland: [0025]).
Regarding claim 12, Raz, in view of Holland and Jena, teaches the orifice inspection system according to claim 1, and Raz further discloses wherein the coupler is planer (Raz: Fig. 2- The removable jacket 200).
Regarding claim 13, Raz, in view of Holland and Jena, teaches the orifice inspection system according to claim 1.
Raz, in view of Holland and Jena, fails to expressly teach wherein the light source extends laterally across the coupling portion of the handle.
However, Holland further teaches wherein the light source extends laterally across the coupling portion of the handle (Holland: Fig. 2A - light source 14).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Perkins, in view of Holland and Jena, so that the light source extends laterally across the coupling portion of the handle, as taught by Holland. It would have been advantageous to make the combination for the purpose of making it easier for an operator to identify certain features within the oral cavity ([0007] of Holland).
Regarding claim 14, Perkins, in view of Holland and Jena, teaches the orifice inspection system according to claim 13.
Perkins, in view of Holland and Jena, fails to expressly teach wherein the light source includes a plurality of LED lights extending across the coupling portion of the handle.
However, Holland teaches of an analogous medical system wherein the light source includes a plurality of LED lights extending across the coupling portion of the handle (Holland: [0166]- typically the light source or plurality of light sources 14 in the handle 4 are light-emitting diodes (LEDs), such as surface mount LEDs).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Perkins, in view of Holland and Jena to utilize a plurality of LED lights extending across the coupling portion of the handle, as taught by Holland. It would have been advantageous to make the combination in order to maximize battery life and prevent the handle from overheating ([0166] of Holland).
Regarding claim 15, Perkins, in view of Holland and Jena, teaches the orifice inspection system according to claim 1, and Perkins further discloses wherein in the second condition an elongate axis of the handle body is parallel to an elongate axis of the smart phone (Fig. 4a-4f).
Regarding claim 16, Perkins, in view of Holland and Jena, teaches the orifice inspection system according to claim 1, and Perkins further discloses wherein the handle body is elongate and extends perpendicularly to the disposable light transmissive structure (Fig. 4a-4f).
Claim(s) 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perkins, in view of Holland and Jena, and further in view of U.S. Publication No. 2015/0065803 to Douglas et al. (hereinafter “Douglas”) and CN 101046597 A to Zheng.
Regarding claim 7, Perkins, in view of Holland and Jena, teaches the orifice inspection system according to claim 1.
Perkins, in view of Holland and Jena, fails to expressly teach wherein the orifice inspection system is configured to detect the presence of the orifice inspection device, and to automatically adjust the image magnification of the image capture device based on the location of the orifice inspection device.
However Douglas teaches of an analogous orifice inspection device wherein the orifice inspection system is configured to detect the presence of the orifice inspection device (Douglas: see [0077] - A method of detecting if an otoscope lens device is attached to a mobile telecommunications device), and to adjust the image magnification of the image capture device based on the location of the orifice inspection device (Douglas: see [0043]- The magnification level may be chosen according to the desired application).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Perkins, in view of Holland and Jena, to include an orifice inspection system configured to detect the presence of the orifice inspection device and to adjust the image magnification of the image capture device based on the location of the orifice inspection device, as seen above of the teachings of Douglas. It would have been advantageous to make the combination to enable dynamic configuration of the magnification or focus ([0043] of Douglas).
Perkins, in view of Holland and Jena, fails to expressly teach to automatically adjust the image magnification of the image capture device based on the location of the orifice inspection device.
However, Zheng teaches of a mobile device and method including automatically adjusting the image magnification (Zheng: [0021]- Another aspect of the present invention is an electronic zoom method for a camera. A lever is actuated by a current signal or a voltage signal to move the lever from a first focal position (ie, a first side position) to a The second focal length position (that is, the second side position), thereby realizing the automatic zoom function).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporate the teachings of Zheng that teach automatically adjusting the image magnification into the teachings Perkins, in view of Holland, Jena, and Douglas, that teaches automatically adjusting the image magnification. It would have been advantageous to make the combination for mobile phone cameras to meet the special needs of mobile phone products ([0007] of Zheng).
Regarding claim 8, Perkins, in view of Holland and Jena, and Douglas and Zheng, teaches the orifice inspection device according to claim 7.
Perkins, in view of Holland and Jena, and Douglas and Zheng, fails to expressly teach wherein the orifice inspection system is configured to detect the presence of the orifice inspection device based on user input.
However, Douglas further teaches wherein the orifice inspection system is configured to detect the presence of the orifice inspection device based on user input (Douglas: see [0077] - A method of detecting if an otoscope lens device is attached to a mobile telecommunications device having a digital camera).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Perkins, in view of Holland and Jena, Douglas and Zheng, to include the orifice inspection system is configured to detect the presence of the orifice inspection device based on user input, as seen above in the teachings of Douglas. It would have been advantageous to make the combination in order to indicate to the user in real time that it has been detected ([0326] of Douglas).
Regarding claim 9, Perkins, in view of Holland and Jena, and Douglas and Zheng, teaches the orifice inspection device according to claim 7.
55. Perkins, in view of Holland and Jena, and Douglas and Zheng, fails to expressly teach wherein the system further includes a graphical user interface presented on a screen of the smart phone including an orifice positioning guide for positioning a patient's orifice in the photograph captured by the image capturing device.
However, Douglas further teaches wherein the system further includes a graphical user interface (Douglas: Fig. 32, Fig. 57, Fig. 46) presented on a screen of the smart phone (Douglas: Fig. 57, [0417]) including an orifice positioning guide for positioning a patient's orifice in the photograph (Douglas: Fig. 27A, [0320]) captured by the image capturing device (Douglas: Fig. 57, [0417]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Perkins, in view of Holland and Jena, and Douglas and Zheng, to include a graphical user interface presented on a screen of the smart phone including an orifice positioning guide, as seen above in the teachings of Douglas. It would have been advantageous to make the combination so that the subject may move the otoscope device to adjust the view being taken ([0039] of Douglas).
Regarding claim 10, Perkins, in view of Holland and Jena and Douglas and Zheng, teaches the orifice inspection device system according to claim 7, and Perkins further discloses wherein the orifice inspection system further includes a data interface for transmitting the photograph to the patient's medical service provider (Perkins: [0080]; note the claim interpretation section above; the examiner interprets data interface as the Wifi or Bluetooth connection as explain in [0034]).
Regarding claim 11, Perkins, in view of Holland and Jena and Douglas and Zheng, teaches the orifice inspection device according to claim 7.
Perkins, in view of Holland and Jena and Douglas and Zheng, fails to expressly teach wherein the orifice inspection system further includes a graphical user interface configured to display the captured photograph and at least one photograph of an orifice having a known condition for comparison, to assist in identifying a condition affecting the patient's orifice.
However, Douglas teaches of an analogous orifice inspection device wherein the orifice inspection system further includes a graphical user interface configured to display the captured photograph and at least one photograph of an orifice having a known condition for comparison (Douglas: Fig. 33; [0121] - FIG. 33 illustrates one example of an access comparison screen for comparing an image of a patient's tympanic membrane to other (library) images), to assist in identifying a condition affecting the patient's orifice ([0350]- By visually comparing different intervention… They can use this information... in order to decide on the most appropriate intervention).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Perkins, in view of Holland and Jena and Douglas and Zheng, to include a graphical user interface, as seen above in the teachings of Douglas. It would have been advantageous to make the combination for the purpose of educating users about the meanings of different image features and to decide on the most appropriate intervention (([0342] and [0350] of Douglas).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTEN A. SHARPLESS whose telephone number is (571)272-2387. The examiner can normally be reached Monday-Tuesday 6:00 AM - 2:00 PM, and Friday 6:00 AM - 10:00 AM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.A.S./Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795