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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show first and second handles as described in the specification [Par. 0052]. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
Election/Restrictions
Newly submitted claims 2(as amended) and 23-26 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The location of the optical emitter is different. The original embodiment cited an optical emitter arranged on the first jaw. Claims 2 and 23 recite an optical emitter arranged on a handle.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 2 and 23-26 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
For the sake of compact prosecution, the examiner notes that Claims 2 and 23-26 would, if examined, be 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.
Claims 2 and 23 recite “the optical emitter is arranged on a first portion of the handle,” and “the optical detector is arranged on a second portion of the handle.” However, the specification refers to the emitter (140) and detector (145) as being located on the respective jaws, not on the handle. Although Par. 0052 recites “the optical emitter…arranged on the first handle” and the optical detector being “arranged on the second handle,” these first and second handles are not shown in the drawings and it is not clear to what they refer. Regardless, the specification and drawings fail to provide support for the emitter and detector being located on the same handle as claimed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hazelton et al. [US 20200315735 A1, hereinafter “Hazelton”] in view of Timm et al. [US 20240000500 A1, hereinafter “Timm”], and further in view of Holm [US 2008/0285813 A1, newly cited].
Re. claim 1, Hazelton discloses a system [“animal identification” relates to the intended use of the device, not given further patentable weight beyond what is claimed] comprising:
an applicator [100, Figs. 1, with shaft shown in Fig. 2, and jaws in Fig. 4A]. comprising:
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a set of jaws [400, Fig. 4A] comprising: a first jaw [440]; and a second jaw [410]: opposing the first jaw [Fig. 4A, Par. 0060]; and capable of cooperating with the first jaw to close over and to flatten a portion of an ear of an animal [this functional language relates to the intended use of the device. The system of Hazelton is capable of such use, and it is disclosed as used in medical settings, including veterinary settings (Par. 0028) to grasp (see title) tissue, applying force to the tissue (Par. 0032)];
an optical emitter [460, “one of first imaging module 460 and second imaging module 460 may correspond to a radiation emitter,” Par. 0063, so in this instance 470 is selected as the emitter]: configured to emit light to illuminate the portion of the ear (note: the ear is not a positively recited part of the invention and not given further patentable weight) inserted between the first jaw and the second jaw [“capable of imaging at and/or around end effector 400, including the area and/or space between first jaw surface 450 and second jaw surface 420,” Par. 0066];
an optical detector [470, Par. 0063] configured to receive light emitted by the optical emitter and transmitted through the portion of the ear [Fig. 4A, with related description of field of vision in Par. 0053. “the portion of the ear” is the object worked upon, not given further patentable weight];
a sensor [260, Fig. 2]: coupled to the set of jaws; and configured to output a signal representing closure of the set of jaws over the portion of the ear [signal, Par. 0064. Par. 0069 describes the system determining the closure of the set of jaws over a portion of an anatomical object]; and
a controller [140, Fig. 1] configured to trigger the optical detector to capture an image of the portion of the ear, illuminated by the optical emitter [Par. 0066].
The invention of Hazelton differs from the claimed invention in that Hazelton is silent regarding the controller triggering the optical detector to capture an image based on the signal, and fails to teach detecting the first and second set of features to generate an earprint.
Regarding the signal, Timm teaches, in a medical device with a pair of jaws and an optical detector and controller: a sensor [“a first sensor to detect tissue disposed between the first jaw and the second jaw, a second sensor to detect that the end effector is in a closed configuration” Par. 0010] coupled to the set of jaws; and configured to output a signal representing closure of the set of jaws over the portion of the ear [Par. 0010], and wherein the controller is configured to configured to trigger the optical detector to capture an image of the portion of the ear, illuminated by the optical emitter [Par. 0066], based on the signal [“The control circuit determines if the end effector is in a closed configuration 1804. If the end effector is in a closed configuration, then the control circuit proceeds to determine if the jaws are clamped on tissue 1806. If the jaw is clamped on tissue, then the control circuit proceeds to calculate the distal tip location in the video data 1808. If the end effector was not in a closed configuration or the jaws were not clamped on tissue, then the control circuit would start the process 1800 over again by receiving the next batch of video data from the camera 1802,” Par. 0120]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Hazelton by configuring the controller to trigger the optical detector to capture an image of the portion of the ear, illuminated by the optical emitter [Par. 0066], based on the signal, as taught by Timm, because this “allows the control circuit to only perform the video analysis when the surgical device is clamped on tissue” which “reduces the computational burden” [Timm Par. 0120].
Regarding the features and ear prints:
Holm teaches a controller configured to: trigger the optical detector to capture a first image of a portion of the first ear of a first animal[“a first print of an ear 10…is taken,” Par. 0034];
detect a first set of ear features in the first image [“Assignments are made…for reference point…at the bottom edge of the lobulo…the calnal ingertraguiano…many more points may be assigned…” Par. 0034]: based on the first set of ear features, generate a first earprint uniquely identifying the first animal [“A first print of an ear is…stored,” Par. 0034]; populate an electronic profile, associated with the first animal, with the first earprint [“a first print…is stored for later verification,” Par. 0034];
trigger the optical detector to capture a second image of a portion of a second ear of a second animal [“a second print of the user’s ear is taken,” Par 0035];
detect a second set of ear features in the second image of the portion of the ear [“The above steps are repeated for the second print…assign reference points…and measuring distances between reference points,” Par. 0035];
based on the second set of ear features, generate a second earprint [“a second print of the user’s ear is taken,” Par. 0035]
retrieve the first earprint from the electronic profile [“stored distances,” Par. 0035];
characterize a difference between presence and spatial distribution of the first set of ear features represented in the first earprint and the second set of ear features represented in the second earprint [Par. 0035; Step 178, Fig. 5] and
in response to the difference falling below a threshold difference:
match the second earprint to the first earprint and-identify the second animal as the first animal [step 179, Fig. 5; “a determination is made whether the values are within a threshold. If the values are within a threshold, the identity…is verified 179,” Par. 0035].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of the modified Hazelton so that the controller is configured to operate as set forth above regarding the first and second earprints and the identification process, to generate and access an image to detect a set of ear features and generate a unique earprint and populate a data profile as taught by Holm in order to allow a person/animal being operated on to be uniquely identified.
Regarding the first instance of the signal triggering the capture of the first image, and the second instance of the signal capturing a second instance of the image, given the above teachings (the signal of Timm and obtaining the first and second ear print images as in Holm), one of ordinary skill would reasonably be apprised of the benefits of the above as claimed (the two ear prints are for two ears, taken at different times, and thus would reasonably correspond to two different signals).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hazelton in view of Timm and Holm, as applied to claim 1 above, and further in view of Baily [US 20050021026 A1].
Re. claim 3, the modified Hazelton discloses the device set forth above but fails to teach the handle or the stop.
Regarding the handle, Timm teaches a handle [1205, Fig 6] configured to close the set of jaws along a jaw articulation path [Par. 0099]; It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Hazelton to add aa handle as taught by Timm in order to allow a user to actuate the jaws to close when desired.
Regarding the stop, Baily teaches, in a device with a pair of jaws, a stop [150 a, b, c] interposed between the first jaw and the second jaw [Fig. 3C]; and configured to prevent the set of jaws from impinging the portion of the ear [Pars. 0016,0017]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hazelton to add stops to at least one of the jaws, between the first and second jaws, in order to regulate the distance between the jaw members [Par. 0015] which avoid over-pressing the tissue.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hazelton in view of Timm and Holm, as applied to claim 1 above, and further in view of Arya et al. [US 20160089198 A1, hereinafter “Arya”].
Re. claim 4, the modified Hazelton discloses the device set forth above including the jaw articulation path being vertical in Figs. 1, 4A, etc., and wherein the optical emitter is arranged on the first jaw and configured to emit light toward the second jaw perpendicular to the articulation path [Fig. 4A]; wherein the optical detector is arranged on the second jaw [Fig. 4A] and defines a focus axis perpendicular to the articulation path [Fig. 4A], and a light pipe [Par. 0076] configured to direct light, emitted by the optical emitter perpendicular to the articulation path, along the articulation path toward the portion of the ear
but fails to teach a handle, the light pipe being arranged adjacent the optical emitter, and the mirror.
Regarding the handle, Timm teaches a handle [1205, Fig 6] configured to close the set of jaws along a jaw articulation path [Par. 0099]; It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Hazelton to add aa handle as taught by Timm in order to allow a user to actuate the jaws to close when desired.
Regarding the light pipe being adjacent the optical emitter: Hazelton discloses both. Configuring them to be adjacent amounts to a simple rearrangement of parts which does not impact the operation of the device and thus is an obvious modification. See MPEP 2144.04.VI.
Regarding the mirror, Arya teaches a mirror configured to redirect light, directed along the articulation path, toward the optical detector [Par. 0107, Figs. 4A-C]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hazelton to add a mirror as taught by Arya in order to direct light to the desired area. Regarding the mirror being arranged adjacent the optical detector; and configured to redirect light, directed along the articulation path and through the ear by the light pipe, toward the optical detector, this amounts to a simple rearrangement of parts and would have been obvious in order to ensure that the emitted light reaches its desired location.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hazelton in view of Timm and Holm, as applied to claim 1 above, and further in view of Destoumieux et al. [US 20130204159 A1, hereinafter “Destoumieux”].
Re. claim 7, the modified Hazelton discloses the device set forth above, but fails to teach a tissue sample collection system. However, Destoumieux teaches, in a device [Figs. 4-5] with first and second jaws [412 and 411, respectively], a tissue sample collection system [as set forth below] comprising: a die [23] arranged on the first jaw; and a punch [21] arranged on the second jaw opposite the die; and configured to cooperate with the die to resect a tissue sample from the ear during closure of the set of jaws onto the portion of the ear [Pars. 0106-0107]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hazelton by adding a tissue sample collection system as taught by Destoumieux in order to preserve cells for disease identification [Destoumieux Par. 0002].
Re. claim 8, the requirement that the tissue sample collection system is configured to transiently install on the set of jaws is a requirement that the sample system be separable. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hazelton such that the tissue sample collection system is configured to transiently install on the set of jaws because this allows the sample collection system to be removed when a tissue sample is not needed. See MPEP 2144.4.V.C.
Re. claim 9, the modified Hazelton discloses the device set forth above. Destoumieux further teaches a vial holder arranged on the second jaw behind the die [tube 31 is held in the second jaw behind the die, Fig. 5A-B]; and a replaceable vial [31] transiently coupled to the vial holder; arranged below the die; and configured to receive the tissue sample resected from the ear [Par. 0116]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hazelton to add the vial holder and couple it to the vial, as taught by Destoumieux, in order to allow a sample to be transmitted to a laboratory [Destoumieux, Par. 0116].
Re. claim 10, the modified Hazelton discloses the device set forth above. Destoumieux further teaches the tissue sample collection system further comprises an actuator [42] affixed to one of the punch and the die; and wherein the system is configured to trigger the actuator to drive the punch toward the die to resect the tissue sample from the ear during closure of the set of jaws onto the portion of the ear [Par. 0161]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hazelton to include the actuator and to trigger the actuator as claimed in order to allow a sample to be taken. Regarding the controller causing the actuator to actuate, Destoumieux teaches a manual actuator. However, configuring the controller to perform the actuation amounts to automating a manual activity. This does not provide a difference in operation and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the actuator to be actuated by the controller as claimed. See MPEP 2144.04.III.
Response to Arguments
Applicant's arguments filed 8/13/26 have been fully considered but they are not persuasive. Regarding claim 1, due to the amendments altering the scope of this claim, a new reference, Holm, has been introduced to teach limitations regarding the method of identifying a match.
Allowable Subject Matter
Claims 27-32 are allowed. The prior art of record fails to teach or suggest, in combination with the other claimed elements, the controller configured to calculate a predicted difference in spatial distribution of ear features represented in two earprints of a single ear captured over a time interval between the first and second time periods, and, based on this predicted difference, calculate a threshold difference for the first earprint.
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 ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-Th 9 am to 3 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACKIE HO can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
