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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 8 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Solish (US Pub No.: 2016/0007990).
Regarding claim 8, Solish teaches a thread insertion device (as per the abstract) comprising a moveable member (figure 32A part 42) extending along a longitudinal length of a thread part 42 extends along the longitudinal portion of thread part 40) and comprising laterally extending portions (being the walls of part 42 that the thread 40 resides in), wherein, in a first configuration, distal end portions of the laterally extending portions are positioned adjacent to each other and spaced apart by a first distance to surround at least a portion of a circumference of the thread (being shown in figure 32A, where part 42 forms an enclosure), and in a second configuration, the distal end portions of the laterally extending portions are spaced apart by a second distance (being the opening from the bottom to the top of figure 27A to which part 16 is depicted as passing through) to expose the thread shown from figure 28A-28C), wherein the second distance is larger than the first distance (shown in figure 32B, wherein the distance between the distal portion of the walls part 42 is greater than in 32A, wherein the distal end would be the portion closest to part 16. Here, the thread is no longer fully enclosed in part 42, meaning that the thread is exposed).
Regarding claim 15, Solish discloses the thread insertion device of Claim 8, wherein the moveable member is configured to shrink away from the thread when the moveable member transitions from the first configuration to the second configuration (shown from figure 32A to figure 32B, wherein the moveable member would move away from the thread when the moveable member 86 transitions from the first configuration in 32A to the second configuration in figure 32B).
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, 7, 12-14, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Solish (US Pub No.: 2016/0007990) in view of Fruci (US Pub No.: 2018/0071517).
Regarding claim 1, Solish (US Pub No.: 2016/0007990) teaches a thread insertion (an assembly for delivering dermal filler thread disclosed in the abstract) assembly comprising a moveable member that extends along a portion of a thread (the sheath part 42 in figures 28A-28C), wherein a portion of the moveable member comprises laterally extending portions that surrounds at least a portion of a circumference of the thread in a first configuration (in figure 27A, where walls of part 42 form an enclosure in figures 27A-27C that extend around thread 40).
However, Solish does not teach wherein said portion and circumferentially unfolds away from the thread in a second configuration.
Instead, Fruci (US Pub No.: 2018/0071517) teaches wherein said portion and circumferentially unfolds away from the thread in a second configuration (as per figures 8B to 8A, where the walls of part 86 are taken to unfold away from each other as the diameter of part 86 is shown to increase in 8A compared to 8B. the second configuration is shown in figures 8B to 8A with an unfolding disclosed of a protective sheath 86 in [0075]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the foldable sheath with a separate pulling means (disclosed in [0021]), being the moveable member of Fruci, into the device of Solish for the purpose of providing a protective sheath that can cover a thin member 16 but then be retracted to expose said member. This type of sheath could be used to protect the dermal filler thread of Solish before insertion into the body and then could be retracted during insertion of the thread. This sheath is seen to have an advantage over the sheath of Solish in figures 32A-32B as the sheath of Fruci could be manually operated via the tab part 50 (defined in [0061]) to cover and uncover part 16 whereas the cover of Solish in figures 32A and 32B is only folded when pressed into the patient’s skin.
Regarding claim 2, Solish in view of Fruci teach the thread insertion assembly of claim 1, wherein Solish discloses a distal portion of the moveable member extends along a distal portion of the thread (the distal portion of part 42 would extend along the distal portion of the thread 40 in figures 27A to 27C. The distal portion would be the leftmost part of part 42 which would be the farthest away from part 16).
Regarding claim 3, Solish in view of Fruci would teach the thread insertion assembly of claim 2, wherein Solish discloses wherein a longitudinal length of the moveable member, along the distal portion of the thread, remains constant in the first and second configurations (the longitudinal length of the movable member 42 of Solish would remain constant between the first configuration in figure 28A and the second configuration in 28C).
Regarding claim 4, Solish in view of Fruci teach the thread insertion assembly of claim 1, wherein Solish discloses a distal portion of the moveable member defines a cavity in the first configuration (the distal portion of part 42 defines a cavity to which part 40 will reside in in figure 28A).
Regarding claim 5, Solish in view of Fruci teach the thread insertion assembly of claim 4, wherein Solish teaches the cavity comprises a closed distal portion enclosing the cavity (the distal end of part 42 of Solish is depicted as being closed in figures 27A, 27B, and 27C).
Regarding claim 7, Solish in view of Fruci teach the thread insertion assembly of Claim 1, wherein Solish discloses, in the second configuration, the laterally extending portions are expanded relative to the first configuration (in the second configuration shown in figure 28C, the laterally extending portion at part 16 will be extended laterally with respect to part 42. This would be expanded with respect to the first configuration in figure 28A).
Regarding claim 12, Solish teaches the thread insertion device of claim 8. However, Solish does not teach an instance wherein the moveable member comprises a material that unfurls from the first configuration toward the second configuration.
Instead, Fruci (US Pub No.: 2018/0071517) does teach the moveable member comprises a material that unfurls from the first configuration toward the second configuration. (shown in figures 8B to 8A with an unfurling disclosed of a protective sheath 84 in [0075]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the foldable sheath, being the moveable member of Fruci, into the device of Solish for the purpose of providing a protective sheath that can cover a thin member 16 but then be retracted to expose said member. This type of sheath could be used to protect the dermal filler thread of Solish before insertion into the body and then could be retracted during insertion of the thread.
Regarding claim 13, Solish in view of Fruci teach the thread insertion device of claim 12. However, Solish does not teach wherein the moveable member is configured to unfurl after insertion into skin of a patient.
Instead, Fruci teaches wherein the moveable member is configured to unfurl after insertion into skin of a patient (in figures 8A and 8B of Fruci, the movable member 86 retracts from the distal end of the device toward the proximal end of the device. It stands to reason that the combination of Solish and Fruci would allow for the movable member of Fruci to retract on Solish out of the body).
Regarding claim 14, Solish in view of Fruci teach the thread insertion device of claim 12, wherein Solish teaches the moveable member comprises a material configured to shape upon actuation by a clinician (it is assumed that a clinician us operating the device of Solish as a clinician is mentioned in the operation of the device of Solish in [0064]).
Regarding claim 16, Solish teaches a method of inserting a thread (dermal thread insertion is disclosed in the abstract) comprising: inserting a distal portion of a moveable member into a patient (figure 28A part 16 is shown as being inserted into a patient’s skin part 50), in a first configuration (being figure 28A), wherein the moveable member extends along distal portion of a thread and surrounds a circumference of the thread (as shown in figures 28A-28C, part of the member 16 would surround part of the circumference of the thread 40);
However, Solish does not teach an unfolding the moveable member away from the thread in a second configuration to expose the thread.
Instead, Fruci (US Pub No.: 2018/0071517) does teach teach an unfolding the moveable member away from the thread in a second configuration (as per figures 8B to 8A, where the walls of part 86 are taken to unfold away from each other as the diameter of part 86 is shown to increase in 8A compared to 8B) to expose the thread (shown in figures 8B to 8A with an unfolding disclosed of a protective sheath 84 in [0075] with a thread part 16 being exposed along the length of the enclosure shown in figure 8A of Fruci). Here, the unfolding would be of the distal portions of Fruci as the sheath would be on the distal end of the laterally extending portion of Fruci. As the thickness of the sheath on the elongated member changes between figures 8A and 8B, it is also argued that the moveable member will unfold in a lateral direction as well as a longitudinal direction.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the foldable sheath, being the moveable member of Fruci, into the device of Solish for the purpose of providing a protective sheath that can cover a thin member 16 but then be retracted to expose said member. This type of sheath could be used to protect the dermal filler thread of Solish before insertion into the body and then could be retracted during insertion of the thread.
Regarding claim 17, Solish in view of Fruci teach the method of Claim 16. However, Solish does not teach an instance comprising retracting the distal portion of the moveable member from the patient.
Instead, Fruci teaches that retracting the distal portion of the moveable member from the patient (in figures 8A and 8B of Fruci, the movable member retracts from the distal end of the device toward the proximal end of the device. It stands to reason that the combination of Solish and Fruci would allow for the movable member of Fruci to retract on Solish out of the body). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the foldable sheath, being the moveable member of Fruci, into the device of Solish for the purpose of providing a protective sheath that can cover a thin member 16 but then be retracted to expose said member. This type of sheath could be used to protect the dermal filler thread of Solish before insertion into the body and then could be retracted during insertion of the thread.
Regarding claim 18, Solish in view of Fruci teach the method of claim 17. However, Solish does not teach retracting the moveable member in the first configuration.
Instead Fruci teaches an instance comprising retracting the moveable member in the first configuration (it stands to reason that the moveable member 84 of Fruci could be retracted in the first configuration of Solish). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the foldable sheath, being the moveable member of Fruci, into the device of Solish for the purpose of providing a protective sheath that can cover a thin member 16 but then be retracted to expose said member. This type of sheath could be used to protect the dermal filler thread of Solish before insertion into the body and then could be retracted during insertion of the thread.
Regarding claim 19, Solish in view of Fruci teaches the method of claim 17. However, Solish does not teach retracting the moveable member in the second configuration.
Instead, Fruci teaches an instance comprising retracting the moveable member in the second configuration (it stands to reason that the moveable member 84 of Fruci could be retracted in the second configuration of Solish). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the foldable sheath, being the moveable member of Fruci, into the device of Solish for the purpose of providing a protective sheath that can cover a thin member 16 but then be retracted to expose said member. This type of sheath could be used to protect the dermal filler thread of Solish before insertion into the body and then could be retracted during insertion of the thread.
Regarding claim 20, Solish in view of Fruci teach the method of Claim 16. However, Solish does not teach wherein unfolding the moveable member comprises exposing the moveable member to a temperature of between about 80 °F to about 96 °F.
Instead, Fruci would teach that unfolding the moveable member comprises exposing the moveable member to a temperature of between about 80ºF to about 96ºF (as the movable member of Fruci when combined with Solish is inserted into the skin and as the average skin temperature is about 91ºF, it is assumed that the movable member is exposed to a temperature between 80ºF to about 96ºF).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the foldable sheath, being the moveable member of Fruci, into the device of Solish for the purpose of providing a protective sheath that can cover a thin member 16 but then be retracted to expose said member. This type of sheath could be used to protect the dermal filler thread of Solish before insertion into the body and then could be retracted during insertion of the thread.
Claims 9 are rejected under 35 U.S.C. 103 as being unpatentable over Solish (US Pub No.: 2016/0007990) in view of Niu (US Pub No.: 2011/0282447).
Regarding claim 9, Solish teaches the thread insertion device of claim 8. However, Solish does not teach an instance wherein the moveable member transitions from the first configuration to the second configuration after exposure to a liquid.
Instead, Niu teaches a moveable member transitions from the first configuration to the second configuration after exposure to a liquid (being a construct body, disclosed in [0026], that would swell when exposed to liquid). This tube can be implemented in place of the movable member of Solish and to expand the member that holds the thread to allow easier removal of it from the device. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the construct body of Niu into the device of Solish to provide an alternative means to control the movement of the movable member with respect to the thread that would not require the user to induce said movement.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Solish (US Pub No.: 2016/0007990) in view of Weber (US Pub No.: 2018/0055506).
Regarding claim 10, Solish teaches the thread insertion device of claim 8. However, Solish does not teach wherein the moveable member transitions from the first configuration to the second configuration after exposure to electricity.
Instead, Weber discloses an instance wherein a moveable member transitions from a first configuration to the second configuration after exposure to electricity (Weber discloses an anchor that moves from a folded position to an unfolded position when exposed to an electric field as per [0095]. It stands to reason that this system could be implemented in Solish to control the member transitions of Solish).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the means for moving a movable member after exposure to electricity as presented in Weber into Solish for the purpose of providing a means to control the movement of the movable member in the body, as detailed in [0025]. The electric field to control a movement would allow for a movement to be induced within the body via an electric field generator that could be placed and controlled outside the body.
Regarding claim 11, Solish teaches the thread insertion device of claim 8. However, Solish does not teach wherein the moveable member transitions from the first configuration to the second configuration after exposure to heat.
Instead, Weber would teach an instance wherein the moveable member transitions from the first configuration to the second configuration after exposure to heat (as per [0095]-[0096] of Weber).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the means for moving a movable member after exposure to electricity as presented in Weber into Solish for the purpose of providing a means to control the movement of the movable member in the body, as detailed in [0096].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Solish (US Pub No.: 2016/0007990) in view of Fruci (US Pub No.: 2018/0071517) in further view of Feezor (US Pub No.: 2015/0250476).
Regarding claim 6, Solish in view of Fruci teaches the thread insertion assembly of claim 1. However, Solish in view of Fruci does not teach an instance comprising a base coupled to a proximal portion of the moveable member.
Solish in view of Fruci does not teach a base coupled to a proximal portion of the moveable member.
Instead, Feezor (US Pub No.: 2015/0250476) does disclose a base (the proximal handle 108 in [0089]) coupled to a proximal portion of the movable member (the rightmost part of part 42 of Solish could be coupled to the base 108 of Feezor). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the proximal handle of Feezor into the device of Solish for the purpose of providing a handle for the user of the device of Solish to manipulate during the use of Solish, as Solish does not appear to explicitly claim a handle member for the presented device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fires (US Pub No.: 2017/0181707) discloses a thread introducing means in [0025] and shown in the figures, Racz (US Pub No.: 2019/0110811) teaches a medical deployment device with threads disclosed in [0113]. Levine (US Pub No.: 2016/0038141) would teach a suture device with a laterally extending portion 19 with a thread part 20 in figure 10.
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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