DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/23/26 has been entered.
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 71-73, 78, 106-107 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (WO 2019083896) (cited by Applicant) (previously cited) in view of Gasparyan (WO 2014029424) (previously cited) and Mark (EP 2398407).
Regarding claim 71, Kim teaches a tissue containment and removal system, (Fig. 67; Paragraph [0011]), comprising: a tissue container (Fig. 66, 850) and a bulk tissue reducer including: a tissue cutter (1016) comprising a hollow structure with an inner lumen extending a length thereof, (Paragraph [00328] tissue cutter 1016 may have a generally tubular configuration made from a high strength rigid material such as stainless steel) and a tissue cutting blade (408) disposed at a distal end of the tissue cutter (Paragraph [00331]).
However, Kim does not teach “a light energy source configured to emit light energy in a distal direction through the inner lumen and from the distal end of the tissue cutter to illuminate a tissue specimen disposed distal to the tissue cutting blade or within the inner lumen during tissue cutting and extraction operations through the inner lumen.”
Mark, in a related field of endeavor, teaches a tissue cutting device (Figs. 30, 32) comprising a light energy source configured to emit light energy (Paragraph [0080] transmitting light provided via fiber optic connector 304) in a distal direction through the inner lumen (shaft 312) and from the distal end of the tissue cutter (distal end 318 of trocar 307) to illuminate a tissue specimen disposed distal to the tissue cutting blade or within the inner lumen during tissue cutting and extraction operations through the inner lumen. (Paragraph [0080], shaft 306 includes a conduit (not separately shown) for transmitting light provided via fiber optic connector 304 to the surgical area.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “a light energy source configured to emit light energy in a distal direction through the inner lumen and from the distal end of the tissue cutter to illuminate a tissue specimen disposed distal to the tissue cutting blade or within the inner lumen during tissue cutting and extraction operations through the inner lumen” of Mark. Doing so enhances visualization capabilities during a procedure. (Paragraph [0094]).
Regarding claim 72, Kim teaches all of the elements of the claimed invention except “wherein the light energy source is disposed adjacent a proximal end of the inner lumen of the tissue cutter.”
Gasparyan teaches wherein the light energy source (312) is disposed adjacent a proximal end (205) of the inner lumen (202) of the tissue cutter (211). (See Figure 2B).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “wherein the light energy source is disposed adjacent a proximal end of the inner lumen of the tissue cutter” of Gasparyan. Doing so detects provides the ability to visually detect the moment of a successful venipuncture and enables fast and accurate intravascular catheter placement. (Page 12, lines 37-38; Page 13, lines 1-3).
Regarding claims 73, Kim teaches all of the elements of the claimed invention except “a light guide which is operatively coupled to the light energy source, which is disposed within the inner lumen of the tissue cutter and which is configured to transmit light energy from the light energy source in distal direction through the light guide to be emitted out of the distal end of the tissue cutter.”
Gasparyan teaches a light guide (210) which is operatively coupled to the light energy source (312) which is disposed within the inner lumen (202) of the tissue cutter and which is configured to transmit light energy from the light energy source in distal direction through the light guide to be emitted out of the distal end of the tissue cutter. (Page 12, lines 11-13).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “a light energy source configured to emit light energy in a distal direction through the inner lumen and from the distal end of the tissue cutter” of Gasparyan. Doing so provides the ability to visually detect the moment of a successful venipuncture and enables fast and accurate intravascular catheter placement. (Page 12, lines 37-38; Page 13, lines 1-3).
Regarding claim 78, Kim teaches wherein the tissue cutter (1016) is coupled to the housing (1014) so as to allow rotation of the tissue cutter (1016) about a longitudinal axis thereof with respect to the housing (1014). (Paragraph [0321]).
However, Kim does not teach “a housing that is secured in fixed relation with the light guide”.
Gasparyan teaches a housing (light guide unit 211) that is secured in fixed relation with the light guide (210). (Fig. 2B).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “a housing that is secured in fixed relation with the light guide” of Gasparyan. Doing so provides a hub for in the light guide structure during the procedure.
Regarding claim 106, Kim teaches wherein the tissue container (850) comprises a translucent wall structure. (Paragraph [00286] container embodiments 850 may include a wall or wall portions 852 that are transparent so as to allow visualization of an interior volume).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide wherein the tissue container comprises “a translucent wall structure” as it would serve a similar function as a transparent wall structure—to allow visualization of an interior volume.
Regarding claim 107, Kim teaches wherein the tissue container comprises a transparent wall structure. (Paragraph [00286] container embodiments 850 may include a wall or wall portions 852 that are transparent so as to allow visualization of an interior volume).
Claims 74 and 79 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Mark, further in view of Wood (WO 2016101056) (previously cited).
Regarding claim 74, Kim as modified teaches all of the elements of the claimed invention except “wherein the light guide comprises an elongate hollow configuration having an inner lumen extending a length thereof and a translucent polymer material that is configured to transmit the light energy from a proximal end of the light guide to a distal end of the light guide.”
Wood teaches an optical measurement system (Fig. 1) wherein the light guide (probe 603) comprises an elongate hollow configuration having an inner lumen extending a length thereof and a translucent polymer material that is configured to transmit the light energy from a proximal end of the light guide to a distal end of the light guide (Paragraph [0069] an optical probe 603 comprising: a tube 604 having a distal end 605, a proximal end 607 and one or more sidewalls 609 there between; Paragraph [0075] sidewalls 609 may be substantially transparent between distal end 605 and proximal end 607).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim as modified to provide “wherein the light guide comprises an elongate hollow configuration having an inner lumen extending a length thereof and a translucent polymer material that is configured to transmit the light energy from a proximal end of the light guide to a distal end of the light guide” of Wood. Doing so reflects light through sidewalls without encountering an optical interface. (Paragraph [0076]).
Regarding claim 79, Kim teaches all of the elements of the claimed invention except “wherein the light source emits light energy which is bright enough to be visible through the translucent wall structure of the tissue container.”
Wood teaches wherein the light source (601) emits light energy which is bright enough to be visible through the translucent wall structure of the tissue container. (Paragraphs [0069], [0075]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “wherein the light source emits light energy which is bright enough to be visible through the translucent wall structure of the tissue container” as taught by Wood. Doing so provides visibility through sidewalls without encountering an optical interface. (Paragraph [0076]).
Claims 75-76 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Mark and Wood, further in view of DiNardo (U.S. 20110015627) (cited by Applicant) (previously cited).
Regarding claims 75-76, Kim as modified teaches all of the elements of the claimed invention except “a plurality of light energy sources disposed at the proximal end of the inner lumen of the tissue cutter and operatively coupled to the light guide” (claim 75) and “wherein the plurality of light energy sources comprise light emitting diodes” (claim 76).
DiNardo teaches a plurality of light energy sources disposed at the proximal end of the inner lumen of the tissue cutter and operatively coupled to the light guide and wherein the plurality of light energy sources comprise light emitting diodes. (Fig. 1, output indicator 412 is contained in signal generator module 102 disposed at the proximal end of the inner lumen of the tissue cutter; Paragraph [0086] By way of example, and not limitation, visual feedback comprises any type of visual indication device including incandescent lamps or light emitting diodes (LEDs)).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim as modified to provide “a plurality of light energy sources disposed at the proximal end of the inner lumen of the tissue cutter” of DiNardo and “operatively coupled to the light guide” of Gasparyan and “wherein the plurality of light energy sources comprise light emitting diodes” as taught by DiNardo. Doing so provides visual feedback to the surgeon to indicate the status of a surgical procedure. (Paragraph [0086]).
Claim 77 is rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Mark, Wood and DiNardo, further in view of McGreevy (WO 02074339) (previously cited).
Regarding claims 77, Kim as modified teaches all of the elements of the claimed invention except “wherein the light emitting diodes comprise red light emitting diodes”.
DiNardo contemplates wherein the light emitting diodes comprise red light emitting diodes. (Paragraph [0086] visual feedback comprises any type of visual indication device including incandescent lamps or light emitting diodes (LEDs)). Incandescent lamps or light emitting diodes are well-known and may be commonly found in the color red. Moreover, the criticality of the red colored diode is not evident in the disclosure, and so, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “wherein the light emitting diodes comprise red light emitting diodes” as contemplated by DiNardo. Doing so provides illumination with red light, which is preferred because it penetrates the tissue well. (Page 4, lines 19-20 of McGreevy).
Claim 80 is rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Mark and Wood, further in view of Honeycutt (DE 19957856) (previously cited).
Regarding claim 80, Kim teaches all of the elements of the claimed invention except wherein the translucent wall structure of the tissue container comprises “a thin layer of polymer material including polyester, polyethylene, polyurethane, polypropylene, PET, PETG, aramid and para-aramids, poly-paraphenylene terepthalamide, and aliphatic or semi-aromatic polyamides.”
Honeycutt, in a related field of endeavor, teaches a medical device comprising a elongate tubular body extending between a rotatable cutter and a control, wherein the tubular body 12 may have any of a variety of constructions, such as, for example, polyethylene. (Page 20, lines 28-31).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide wherein the translucent wall structure of the tissue container comprises “a thin layer of polymer material including polyester, polyethylene, polyurethane, polypropylene, PET, PETG, aramid and para-aramids, poly-paraphenylene terepthalamide, and aliphatic or semi-aromatic polyamides” of Honeycutt. Doing so provides conventional, well-known medical device construction materials known to those skilled in the art. (Page 20, lines 28-31).
Claims 108-110, 115, 117-122 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (WO 2019083896) (cited by Applicant) in view of Yoon (9958044) (previously cited) and Mark.
Regarding claim 108, Kim teaches a bulk tissue reducer comprising: a tissue cutter (1016) including a hollow structure with an inner lumen extending a length thereof, (Paragraph [00328] tissue cutter 1016 may have a generally tubular configuration made from a high strength rigid material such as stainless steel) and a tissue cutting blade (408) disposed at a distal end of the tissue cutter, (Paragraph [00331]).
However, Kim does not teach “a light energy source configured to emit light energy in a distal direction through the inner lumen to illuminate a tissue specimen disposed distal to the tissue cutting blade or within the inner lumen during tissue cutting and extraction operations through the inner lumen.”
Mark, as previously discussed, teaches a tissue cutting device (Figs. 30, 32) comprising a light energy source configured to emit light energy (Paragraph [0080] transmitting light provided via fiber optic connector 304) in a distal direction through the inner lumen (shaft 312) to illuminate a tissue specimen disposed distal to the tissue cutting blade (distal end 318 of trocar 307) or within the inner lumen during tissue cutting and extraction operations through the inner lumen. (Paragraph [0080], shaft 306 includes a conduit (not separately shown) for transmitting light provided via fiber optic connector 304 to the surgical area.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “a light energy source configured to emit light energy in a distal direction through the inner lumen to illuminate a tissue specimen disposed distal to the tissue cutting blade or within the inner lumen during tissue cutting and extraction operations through the inner lumen” of Mark. Doing so enhances visualization capabilities during a procedure. (Paragraph [0094]).
Regarding claim 118, Kim teaches a bulk tissue reducer comprising: a housing (850); a tissue cutter (1016) operatively coupled to the housing (850), the tissue cutter (1016) having a hollow structure with an inner lumen extending a length thereof, (Paragraph [00328] tissue cutter 1016 may have a generally tubular configuration made from a high strength rigid material such as stainless steel) and a tissue cutting blade (408) disposed at a distal end of the tissue cutter. (Paragraph [00331]).
However, Kim does not teach “a light energy source configured to emit light energy in a distal direction through the inner lumen to illuminate a tissue specimen disposed distal of the tissue cutting blade or within the inner lumen during tissue cutting and extraction operations through the inner lumen..”
Mark, as previously discussed, teaches a tissue cutting device (Figs. 30, 32) comprising a light energy source (conduit) configured to emit light energy in a distal direction through the inner lumen (shaft 312) to illuminate a tissue specimen disposed distal to the tissue cutting blade (distal end 318 of trocar 307) or within the inner lumen during tissue cutting and extraction operations through the inner lumen. (Paragraph [0080], shaft 306 includes a conduit (not separately shown) for transmitting light provided via fiber optic connector 304 to the surgical area.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “a light energy source configured to emit light energy in a distal direction through the inner lumen to illuminate a tissue specimen disposed distal to the tissue cutting blade or within the inner lumen during tissue cutting and extraction operations through the inner lumen” of Mark. Doing so enhances visualization capabilities during a procedure. (Paragraph [0094]).
Regarding claims 115 and 120, Kim teaches wherein the tissue cutter (1016) is coupled to the housing (1014) so as to allow rotation of the tissue cutter (1016) about a longitudinal axis thereof with respect to the housing (1014). (Paragraph [0321]).
However, Kim does not teach “a housing that is secured in fixed relation with the light guide”.
Yoon teaches a housing (28) that is secured in fixed relation with the light guide (52). (Fig. 3).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “a housing that is secured in fixed relation with the light guide” as taught by Yoon. Doing so contains the light from the light source and transmits the light through light guide structure during the procedure.
Regarding claim 109, Kim teaches all of the elements of the claimed invention except “wherein the light energy source is disposed adjacent a proximal end of the inner lumen of the tissue cutter.”
Yoon illustrates wherein the light energy source (50) is disposed adjacent a proximal end (20) of the inner lumen (18) of the tissue cutter. (See Fig. 3)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “wherein the light energy source is disposed adjacent a proximal end of the inner lumen of the tissue cutter” as taught by Yoon. Doing so positions the light source near the light guide, enabling the light to be easily transmitted to the distal end.
Regarding claim 110, Kim teaches all of the elements of the claimed invention except “a light guide which is operatively coupled to the light energy source, which is disposed within the inner lumen of the tissue cutter and which is configured to transmit light energy from the light energy source in distal direction through the light guide to be emitted out of the distal end of the tissue cutter.”
Yoon teaches a light guide (52) which is operatively coupled to the light energy source (50) configured to emit light energy in a distal direction through the inner lumen (18), (See Fig. 3), and towards a tissue specimen (Fig. 9, tissue wall 260) to aid in visualization of the tissue specimen through the inner lumen of the tissue cutter (penetrating distal end 22).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “a light guide which is operatively coupled to the light energy source, which is disposed within the inner lumen of the tissue cutter and which is configured to transmit light energy from the light energy source in distal direction through the light guide to be emitted out of the distal end of the tissue cutter” as taught by Yoon. Doing so illuminates the field of view of the sealed optics package which renders everything at or beyond transparent tip in focus. (Page 8, lines 18-25).
Regarding claims 117 and 119, Kim teaches all of the elements of the claimed invention except “wherein the light energy source is positioned so as not to interfere with the extraction of a tissue specimen through the inner lumen.”
Yoon illustrates (Figure 3) wherein the light energy source (50) is positioned so as not to interfere with the extraction of a tissue specimen through the inner lumen (18).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “wherein the light energy source is positioned so as not to interfere with the extraction of a tissue specimen through the inner lumen” as taught by Yoon. Doing so provides a configuration that improves visibility during tissue removal.
Regarding claim 120, Kim teaches the tissue cutter (1016) is operatively coupled to the housing (1014) so as to allow rotation of the tissue cutter (1016) about a longitudinal axis thereof with respect to the housing. (Paragraph [00321]).
Regarding claim 121, Kim illustrates wherein the tissue cutter (1016) comprises an elongate tube having a circular transverse cross section. (see Figure 68).
Regarding claim 122, Kim illustrates a cannula (Figure 68, cannula 1024) which is secured to the housing (1014) and which has an elongate hollow configuration with an inner lumen (1026) disposed over the elongate tube of the tissue cutter (1016). (Paragraph [00321]).
Claim 111 is rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Mark, further in view of Wood.
Regarding claim 111, Kim as modified teaches all of the elements of the claimed invention except “wherein the light guide comprises an elongate hollow configuration having an inner lumen extending a length thereof and a translucent polymer material that is configured to transmit the light energy from a proximal end of the light guide to a distal end of the light guide.”
Wood teaches an optical measurement system (Fig. 1) wherein the light guide (probe 603) comprises an elongate hollow configuration having an inner lumen extending a length thereof and a translucent polymer material that is configured to transmit the light energy from a proximal end of the light guide to a distal end of the light guide (Paragraph [0069] an optical probe 603 comprising: a tube 604 having a distal end 605, a proximal end 607 and one or more sidewalls 609 there between; Paragraph [0075] sidewalls 609 may be substantially transparent between distal end 605 and proximal end 607).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim as modified to provide “wherein the light guide comprises an elongate hollow configuration having an inner lumen extending a length thereof and a translucent polymer material that is configured to transmit the light energy from a proximal end of the light guide to a distal end of the light guide” of Wood. Doing so reflects light through sidewalls without encountering an optical interface. (Paragraph [0076]).
Claims 112-113 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Mark and Wood, further in view of DiNardo.
Regarding claims 112-113, Kim as modified teaches all of the elements of the claimed invention except “a plurality of light energy sources disposed at the proximal end of the inner lumen of the tissue cutter and operatively coupled to the light guide” (claim 112) and “wherein the plurality of light energy sources comprise light emitting diodes” (claim 113).
DiNardo teaches a plurality of light energy sources disposed at the proximal end of the inner lumen of the tissue cutter and operatively coupled to the light guide and wherein the plurality of light energy sources comprise light emitting diodes. (Fig. 1, output indicator 412 is contained in signal generator module 102 disposed at the proximal end of the inner lumen of the tissue cutter; Paragraph [0086] By way of example, and not limitation, visual feedback comprises any type of visual indication device including incandescent lamps or light emitting diodes (LEDs)).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim as modified to provide “a plurality of light energy sources disposed at the proximal end of the inner lumen of the tissue cutter” of DiNardo and “operatively coupled to the light guide” of Yoon and “wherein the plurality of light energy sources comprise light emitting diodes” as taught by DiNardo. Doing so provides visual feedback to the surgeon to indicate the status of a surgical procedure. (Paragraph [0086]).
Claim 114 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Mark, Wood and DiNardo, further in view of McGreevy.
Regarding claim 114, DiNardo contemplates wherein the light emitting diodes comprise red light emitting diodes. (Paragraph [0086] visual feedback comprises any type of visual indication device including incandescent lamps or light emitting diodes (LEDs)). Incandescent lamps or light emitting diodes are well-known and may be commonly found in the color red. Moreover, the criticality of the red colored diode is not evident in the disclosure, and so, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide “wherein the light emitting diodes comprise red light emitting diodes” as contemplated by DiNardo. Doing so provides illumination with red light, which is preferred because it penetrates the tissue well. (Page 4, lines 19-20 of McGreevy).
Claim 116 is rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Mark, further in view of Lemperle (WO 0174418) (previously cited).
Regarding claim 116, Kim as modified teaches all of the elements of the claimed invention except wherein the translucent wall structure of the tissue container comprises “a light cone which is disposed adjacent the light energy source and which is configured to couple light energy into the inner lumen.”
Lemperle, in a related field of endeavor, teaches surgical device (Figure 3a) for viewing tissue comprising a light cone (tubular reflective structure 34) is disposed adjacent the light energy source (light guide 28) and which is configured to couple light energy into the inner lumen. (Page 5, lines 7-17, Page 8, lines 4-6, 14-17).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the tissue removal device of Kim to provide wherein the translucent wall structure of the tissue container comprises “a light cone which is disposed adjacent the light energy source and which is configured to couple light energy into the inner lumen” of Lemperle. Doing so routes light energy toward the distal end of the insertion probe, thus enabling visualization of the tissue structures located in front of the insertion probe. (Page 8, lines 16-17, 25-26).
Response to Arguments
Applicant’s arguments, see Remarks, filed 3/23/2026, with respect to the rejection(s) of claim(s) 71-80 and 106-122 under U.S.C. 103 have been fully considered and are persuasive. However, upon further consideration, a new ground of rejection is made in view of Mark.
Conclusion
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/OM PATEL/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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