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 .
Preliminary Note
In the Office Action dated 17 October 2025, the rejection heading fails to include Claim 17, despite being cited as rejected in the body of the rejection. Claim 17 should be included in the rejection heading, as below.
Response to Arguments
Applicant’s argument on Pages 14-15 regarding the objections to the drawings has been fully considered. While most of the objections were addressed, one outstanding objection remains. The reference character “660” is still used to designate both gel chamber and orifice. Therefore, the objection to the drawings is maintained.
Applicant’s argument on Page 15 regarding the objection to the specification has been fully considered. While most of the objections were addressed, in [0123]-[0126] “attaching assembly 640” should be amended to “attaching means 640.” Therefore, the objection to the specification is maintained.
Applicant’s argument on Pages 15-16 regarding the objections to Claims 3, 8, 10, 14, and 16-17 has been fully considered. While most of the objections were addressed, Claim 3 was not canceled, so the objection remains. Additionally, Claim 17 was not amended to overcome the objection. Therefore the objections to Claims 3 and 17 are maintained.
Applicant’s argument on Page 16 regarding the claim interpretation does not fully address the claim interpretation under 35 U.S.C. 112(f), nor have the claims been amended to avoid the interpretation. Therefore, the claim interpretation is maintained.
Applicant’s argument on Page 16 regarding the rejection of Claims 10-16 and 18 under 35 U.S.C. 112(a) has been fully considered. Applicant argues that a full explanation is in the specification and “these expressions are evocative of the components and their functions.” However, as cited below in the claim interpretation, some elements in Claims 10, 12, 15, and 17 have only been described with a generic placeholder with functional language. Therefore the rejection to Claims 10-18 under 35 U.S.C. 112(a) is maintained.
Applicant’s argument on Page 17 regarding the rejection of Claim 4 under 35 U.S.C. 112(b) has been fully considered. Applicant’s amended does not overcome issues under 35 U.S.C. 112(b). The limitation “similar to” was merely used in applying prior art, and the claim should be amended, without adding new matter, to ascertain the requisite degree to which the pivoting base and shape of the bottom portion of the ultrasound transducer are similar or substantially matching. Therefore, the rejection of Claim 4 under 35 U.S.C. 112(b) is maintained.
Applicant’s argument on Pages 17-18 regarding the rejection of Claim 1 under 35 U.S.C. 102 as being anticipated by Sonek has been fully considered but is not persuasive under new grounds of rejection as below.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Page 18 relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “660” has been used to designate both gel chamber and orifice. 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. 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.
Specification
The disclosure is objected to because of the following informalities: [0123]-[0126] should be amended to “[[attaching assembly]] attaching means 640 […].” Appropriate correction is required.
Claim Objections
Claim 2 is objected to because of the following informalities: grammatical error. The claim should be amended to “[…] the articulated arm is being used to […]” in order to make sense grammatically. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: grammatical error. The claim should be amended to “[…] wherein the mounting assembly [[comprising]] comprises a pivoting base […] a rotation mechanism for engaging rotation […]” in order to make sense grammatically. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: grammatical error. The claim should be amended to “[…] and away [[of]] from the mounting assembly […]” in order to make sense grammatically. Appropriate correction is required.
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.
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 limitations 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 limitations are: medical device in Claim 1, suspending mechanism in Claim 5, medical device attaching assembly in Claim 10, touchless cover removal mechanism in Claim 11, slidable member in Claims 12 and 17, and lateral force absorption member in Claim 15.
The medical device is interpreted as a needle, a catheter, or any other medical device requiring ultrasound guidance during a procedure or insertion, as disclosed in [0072]; the suspending mechanism is interpreted as a spring, an air suspension assembly, a magnetic suspension assembly, or any other suitable system for the storage of mechanical energy, as disclosed in [0104]; the disclosure cites the medical device attaching assembly is configured to attach the medical device to the elongated arm of the apparatus ([0083]); the touchless cover removal mechanism is interpreted as the medical device attaching assembly ([0123]) and slidable member ([0126]); the disclosure cites the slidable member is configured to generally allow the medical device to move toward or away the subject or transducer ([0092]) and push the cover away from the medical device ([0124]); and the disclosure cites the lateral force absorption member is along a longitudinal axis of the medical device ([0012]).
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 specification 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 § 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.
Regarding Claims 10-18, the claims recite “medical device attaching assembly” in Claim 10, “slidable member” in Claims 12 and 17, and “lateral force absorption member” in Claim 15, which are interpreted under 35 U.S.C. 112(f) according to analysis made of record. The “medical device attaching assembly,” “slidable member,” and “lateral force absorption member” are described exclusively in terms of the functions they perform, without naming an intended structure to be used, and therefore applicant has not demonstrated possession of that structure.
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The term “substantially” in Claim 4 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of applying prior art, “substantially” is interpreted as “similar to.”
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The claim states that the mounting assembly comprises a pivoting base for receiving the ultrasound transducer and a rotation mechanism engaging rotation of the pivoting base, which has already been established in Claim 1 (“a mounting assembly having a pivoting base configured for receiving an ultrasound transducer […] the mounting assembly further comprising a rotation mechanism rotatably mounted onto the pivoting base” Lines 3-5).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-5, 7-10, 14, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al. US 20190192119 in view of Kim (KR 20190121577).
Regarding Claim 1¸ Salcudean teaches an apparatus, (Abstract “system useful for performing ultrasound elastography of organs”), comprising:
a) a mounting assembly, (Fig. 5B) having a pivoting base, (Fig. 5B and [0076] “The parallelogram linkage can pivot about its joints 502 and 503, allowing transducer 101 to pivot about imaging array 101A.”), configured for receiving an ultrasound transducer having a scanning plane, (Fig. 5B, [0067] “A “transducer” or “ultrasound transducer” is a probe that contains an array of piezo-electric crystals which can transmit high frequency sound waves and receive echoes to provide spatial information that may be applied for image reconstruction and tissue displacement tracking” and [0071] “ultrasound transducer 101”), the pivoting base being configured for moving with the ultrasound transducer, ([0076] “The parallelogram linkage can pivot about its joints 502 and 503, allowing transducer 101 to pivot about imaging array 101A.”), the mounting assembly further including a rotation mechanism rotatably mounted onto the pivoting base, whereby the rotation mechanism is configured to be rotatable around the ultrasound transducer ([0076] “Stabilizer mechanism 401 can be built externally to move a transducer or miniaturized and built within the transducer housing to move a transducer array (e.g. 101A) relative to a transducer housing.”); and
b) wherein the rotation mechanism is configured to be handled by a first hand of a user while a second hand of the user rotates the ultrasound transducer, the articulated arm and the pivoting base relative to the rotation mechanism, ([0076] “The parallelogram linkage can pivot about its joints 502 and 503, allowing transducer 101 to pivot about imaging array 101A. Stabilizer mechanism 401 can be built externally to move a transducer or miniaturized and built within the transducer housing to move a transducer array (e.g. 101A) relative to a transducer housing. Stabilizer mechanism 401 may allow transducer 101 to rotate about an axis parallel to the ribs. In some embodiments the axis of rotation may be parallel to and in between two adjacent ribs. Transducer 101 may rotate about an axis that passes through the point of contact with the tissue of the patient or may rotate about an axis that passes through a point underneath the point of contact (for example 3 cm underneath the skin at the point of contact)” and Figs. 5A-5B, where a user handles the locking handles 403, 404, while moving the transducer 101 (probe) to the appropriate position).
However, Salcudean does not explicitly teach an articulated arm having a first end attachable to the pivoting base of the mounting assembly and a second end attachable to the medical device, the articulated arm moving along a single plane to hold a longitudinal axis of the medical device continuously within the scanning plane; wherein the rotation mechanism is configured to be handled by a first hand of a user while a second hand of the user rotates the ultrasound transducer, the articulated arm and the pivoting base relative to the rotation mechanism, while the articulated arm maintains the longitudinal axis of the medical device continuously within the scanning plane.
In an analogous injection device with an ultrasonic probe field of endeavor, Kim teaches an apparatus to guide movement of a medical device insertable in a physical body, (Abstract “an injection device using an ultrasonic probe”), the apparatus comprising:
a) an articulated arm, (Fig. 1 “control arm portion 330”), having a first end, (Fig. 1 “first arm 331”), attachable to the pivoting base of the mounting assembly (taught by Salcudean) and a second end attachable to the medical device, (Fig. 1 “second arm 335”), the articulated arm moving along a single plane to hold a longitudinal axis of the medical device continuously within the scanning plane (Fig. 2 and Page 4 of translation “A second adjusting bolt 332 and a nut are installed at the other end of the first arm 331 and one end of the second arm 335 to adjust the spread of the adjusting arm in the horizontal axis direction of the laser beam.”);
b) while the articulated arm maintains the longitudinal axis of the medical device continuously within the scanning plane (Page 4 “The ultrasound probe 100 is irradiated from the first beam irradiator 210 by placing the ultrasound probe 100 at an examination position of a patient based on an image result obtained when performing an intracorporeal tissue biopsy by the ultrasound probe 100” and Page 4 “a nut is set at an insertion angle of the injection needle from the target position to the lesion position.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Salcudean with the mounting assembly of Kim because injections are important in terms of angle and depth, and the modification allows for an operator to apply the needle as precisely as required to the region of interest, thereby improving the accuracy of the procedure.
Regarding Claim 2, the modified apparatus of Salcudean teaches all limitations of Claim 1, as discussed above. Furthermore, Kim teaches wherein the articulated arm being used [sic] to rotate the mounting assembly (Page 4 “The setting member 300, the rotary part 310 to be adjusted in the left, right direction from the upper end of the ultrasonic probe 100 is installed. The rotating part 310 is provided with a control arm portion 330 […]. The rotating part 310 of the setting member 300 is formed on the upper and lower inner surfaces of the control cap 311 and the control cap 311 is installed to be rotated in the left and right direction from the upper end of the ultrasonic probe 100”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Salcudean with the articulated arm of Kim because the modification allows for both the adjustment of the ultrasound probe containing the transducer as well as the needle for insertion, thereby improving accuracy of the procedure.
Regarding Claim 3, the modified apparatus of Salcudean teaches all limitations of Claim 1, as discussed above. Furthermore, Salcudean teaches wherein the mounting assembly comprising [sic] a pivoting base, (Fig. 5B and [0076] “The parallelogram linkage can pivot about its joints 502 and 503, allowing transducer 101 to pivot about imaging array 101A.”), for receiving the ultrasound transducer, (Fig. 5B, [0067] “A “transducer” or “ultrasound transducer” is a probe that contains an array of piezo-electric crystals which can transmit high frequency sound waves and receive echoes to provide spatial information that may be applied for image reconstruction and tissue displacement tracking” and [0071] “ultrasound transducer 101”), and a rotation mechanism engaging rotation of the pivoting base ([0076] “The parallelogram linkage can pivot about its joints 502 and 503, allowing transducer 101 to pivot about imaging array 101A.”).
Regarding Claim 4, the modified apparatus of Salcudean teaches all limitations of Claim 1, as discussed above. Furthermore, Salcudean teaches wherein the pivoting base having a shape similar to a shape of a bottom portion of the ultrasound transducer (Fig. 4B, where generally, the connection between the probe 101 and pivoting base (support 401) is the same shape as the transducer 101A (curved/arched/circular).
Regarding Claim 5, the modified apparatus of Salcudean teaches all limitations of Claim 1, as discussed above. Furthermore, Salcudean teaches wherein the pivoting base includes a suspending mechanism adapted to receive the bottom portion of the ultrasound transducer (Figs. 4A-4B).
Regarding Claim 7, the modified apparatus of Salcudean teaches all limitations of Claim 1, as discussed above. Furthermore, Salcudean teaches wherein the pivoting base has a shape configured to lock with a bottom portion of the ultrasound transducer(Figs. 4A-4B and 5A-5B, where the locking handle and connection point between the pivoting base and probe in 4A and 4B are unlabeled, and [0076] “a stabilizer mechanism 401, which can be locked in place through a locking handle 403 or handles 403 and 404.”).
Regarding Claim 8, the modified apparatus of Salcudean teaches all limitations of Claim 1, as discussed above. Furthermore, Salcudean teaches wherein the pivoting base includes a brake to maintain the pivoting base to a specific angle (Figs. 4A-4B and 5A-5B, where the locking handle in 4A and 4B is unlabeled, [0076] “a stabilizer mechanism 401, which can be locked in place through a locking handle 403 or handles 403 and 404,” and [0077] “Stabilizer mechanism 401 may allow transducer 101 to rotate through a small angle, for example through angles in the range of 5° to 10° in each direction or a total angle of 10 to 20 degrees.”).
Regarding Claim 9, the modified apparatus of Salcudean teaches all limitations of Claim 1, as discussed above. Furthermore, Kim teaches wherein the second end of the articulated arm is detachably connected to the medical device (Pages 6-7 “After the needle reaches the lesion tissue, the knob 435 at the lock position of the knob hole 415 of the slide tube 410 is moved to the unlock position to release the locked state of the slider 430 [sic, should be 420] in the locked state.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Salcudean with the teachings of Kim because the modification allows for the syringe to be removed to be refilled with the injectable, in the case of Kim, or to exchange the needle between patients.
Regarding Claim 10, the modified apparatus of Salcudean teaches all limitations of Claim 1, as discussed above. Furthermore, Kim teaches wherein the second end of the articulated arm includes a medical device attaching assembly for mounting the medical device, (Figs. 1-2), the medical device attaching assembly is a slidable chariot (Claims “a control member interlocked with the setting member and configured to insert and control the needle of the syringe into the lesion position” and Page 5 “The control member 400 formed on the outer surface of the clip body 351, that is, the position corresponding to the position of the tub tail 356, protrudes from the outer surface of the clip body 351, A slide tube 410 is formed in a longitudinal direction, and a slider 420 mounted in a guide hole 411 formed in the slide tube 410 is provided.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Salcudean with the teachings of Kim because the modification allows for controlled insertion of the needle and drug into the patient accurately.
Regarding Claim 14, the modified apparatus of Salcudean teaches all limitations of Claim 1, as discussed above. Furthermore, Kim teaches including the medical device, the medical device having a needle (Abstract “an injection needle” and Figs. 1-2).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Salcudean with the needle of Kim because the modification allows for controlled insertion of the needle and drug into the patient accurately.
Regarding Claim 17, the modified apparatus of Salcudean teaches all limitations of Claim 1, as discussed above. Furthermore, Kim teaches wherein the second end of the articulated arm includes a slidable member to move the medical device toward and away the mounting assembly (Fig. 2, where based on the movement of the needle depicted and slider 420, the medical device will move towards and away the mounting assembly on the probe, taught by Salcudean.
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Salcudean with the slidable member of Kim because the modification allows for controlled insertion of the needle and drug into the patient accurately under ultrasound guidance.
Regarding Claim 18, the modified apparatus of Salcudean teaches all limitations of Claim 10, as discussed above. Furthermore, Kim teaches wherein the medical device attaching assembly has a shape conforming with an external surface of the medical device (Page 5 “the clip body 351, the insertion hole 352 to the syringe is formed in a cylindrical shape” and Figs. 1-2).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Salcudean with the teachings of Kim because the modification allows for controlled insertion of the needle and drug into the patient accurately under ultrasound guidance.
Regarding Claim 32, the modified apparatus of Salcudean teaches all limitations of Claim 1, as discussed above. Furthermore, Salcudean teaches including the ultrasound transducer ([0071] “ultrasound transducer 101”).
Regarding Claim 33, the modified apparatus of Salcudean teaches all limitations of Claim 32, as discussed above. Furthermore, Kim teaches including the medical device, the medical device having a needle (Abstract “an injection needle” and Figs. 1-2).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Salcudean with the needle of Kim because the modification allows for controlled insertion of the needle and drug into the patient accurately.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al. US 20190192119 in view of Kim (KR 20190121577), as applied to Claim 1, further in view of Masaki et al. (US 20170209119).
Regarding Claim 6, the modified apparatus of Salcudean teaches all limitations of Claim 1, as discussed above. However, the modified apparatus of Salcudean does not explicitly teach wherein the pivoting base includes a liquid fillable sealed chamber below a bottom portion of the ultrasound transducer.
In an analogous photoacoustic ultrasonic imaging field of endeavor, Masaki teaches an apparatus, ([0029] “photoacoustic ultrasonic imaging apparatus 100”), wherein the pivoting base, (Fig. 1 and [0037] “the light emitting portion 101c is provided at an intersection point of the rotation center axis of the bowl-shaped supporting member 10”), includes a liquid fillable sealed chamber below a bottom portion of the ultrasound transducer (Fig. 1 and [0032] “The acoustic matching liquid 41 is stored in a vessel 42 such that the acoustic matching liquid 41 is acoustically in contact with the transducers 20 or 21 and the subject 40 between the transducers 20 or 21 and the subject 40.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the pivoting base of Masaki because the modification ensures there is efficient transfer of energy between the apparatus and the physical body, resulting in accurate imaging results.
Claims 11-12 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al. US 20190192119 in view of Kim (KR 20190121577), as applied to Claim 10, further in view of Shuart et al. (US 20180325500).
Regarding Claim 11, the modified apparatus of Salcudean teaches all limitations of Claim 10, as discussed above. However, the modified apparatus of Salcudean does not explicitly teach the medical device attaching assembly includes a touchless cover removal mechanism to remove a cover of the medical device.
In an analogous biopsy field of endeavor, Shuart teaches an apparatus to guide movement of a medical device insertable in a physical body, (Abstract “biopsy device”), the medical device attaching assembly includes a touchless cover removal mechanism, ([0083] “resilient latches (438) and locking tabs (439) are generally configured to engage at least a portion of mount (420) to selectively secure probe protector (430) to mount (420). Resilient latches (438) and locking tabs (439) protrude outward from elongate shaft (432) and are configured to releasably attach probe protector (430) to mount (420). Although resilient latches (438) and locking tabs (439) of the present example are shown as being integral to the exterior surface of elongate shaft (432), it should be understood that in other examples resilient latches (438) and locking tabs (439) are configured as separate components. In addition, or in the alternative, it should be understood that resilient latches (438) and locking tabs (439) may include numerous alternative geometric configurations in other examples. Alternatively, other suitable alternative configurations for resilient latches (438) and locking tabs (439) will be apparent to those of ordinary skill in the art in view of the teachings herein.”), to remove a cover of the medical device ([0082] “probe protector (430) is generally configured to cover needle (110) of biopsy device (10)”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the touchless cover removal mechanism of Shuart because the modification prevents inadvertent contact with the piercing tip of the needle, as taught by Shuart in [0082].
Regarding Claim 12, the modified apparatus of Salcudean teaches all limitations of Claim 11, as discussed above. Furthermore, Shuart teaches the touchless cover removal mechanism comprising a slidable member to move the cover of the medical device away from the medical device ([0082] “Open proximal end (434) is sized and shaped to slidably receive and securely hold biopsy device (10) within elongate shaft (432).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Shuart for the same reasons as Claim 11 as above.
Regarding Claim 15, the modified apparatus of Salcudean teaches all limitations of Claim 10, as discussed above. Furthermore, Shuart teaches the medical device includes a lateral force absorption member ([0086] “resilient latches (438) are configured to bend inwardly into elongate shaft (432) when a lateral force is exerted upon the protrusions of resilient latches (438), such as the lateral force created by chamfered edge (425) when resilient latches (438) are pressed against chamfered edge (425) as probe protector (430) is slidably inserted into mount (420).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the lateral force absorption member of Shuart because the modification allows the design of the apparatus to have some give and not break upon removal (or insertion) of components of the device or guiding the medical device into the physical body.
Regarding Claim 16, the modified apparatus of Salcudean teaches all limitations of Claim 15, as discussed above. Furthermore, Shuart teaches the lateral force absorption member being resilient along a longitudinal axis of the medical device ([0086] “resilient latches (438) are configured to bend inwardly into elongate shaft (432) when a lateral force is exerted upon the protrusions of resilient latches (438), such as the lateral force created by chamfered edge (425) when resilient latches (438) are pressed against chamfered edge (425) as probe protector (430) is slidably inserted into mount (420).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the lateral force absorption member of Shuart for the same reasons as Claim 15 above.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Salcudean et al. US 20190192119 in view of Kim (KR 20190121577), as applied to Claim 33, further in view of Schlitt et al. (US 20100041990).
Regarding Claim 34, the modified apparatus of Salcudean teaches all limitations of Claim 33, as discussed above. However, the modified apparatus of Salcudean does not explicitly teach wherein the medical device is a catheter.
In an analogous needle guide for catheter delivery field of endeavor, Schlitt teaches an apparatus to guide movement of a medical device insertable in a physical body, (Abstract “Provided are needle locks and methods of using the same for ultrasound guided catheter insertion.”), wherein the medical device is a catheter ([0043] “a catheter 126 has been inserted through the needle 122 and is disposed in the area of interest.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the catheter of Schlitt because the modification allows for proper placement of the catheter for a procedure, as taught by Schlitt in [0006], [0008], and [0012].
Conclusion
THIS ACTION IS MADE FINAL. 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 MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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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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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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