DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
NOTE REGARDING CLAIM RENUMBERING
2. The original claims filed 03/12/2024 include two claims consecutively numbered as "claim 24." Accordingly, for purposes of examination, the second "claim 24" through claim 45 have been renumbered as claims 25-46 [see the annotated (renumbered) claim set attached to this Office Action].
3. Applicant should likewise renumber the claims accordingly in any future submissions.
Election/Restriction
4. Applicant’s election without traverse of Group I (claims 1-38) in the reply filed on 05/05/2026 is acknowledged. Claims 39-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
5. Claims 1-38 have been examined on the merits.
Claim Objections
6. Claims 1, 2, 4, 7, 11, 23-25, 34, & 38 are objected to because of the following informalities:
a. In claim 1, line 1, the recitation of “Apparatus” should instead recite --An apparatus--.
b. In claim 1, line 21, the recitation of “during period of application” should instead recite --during a period of application--.
c. In claim 1, line 22, the recitation of “a cutting and pursing cable” should instead recite --a cutting and pursing cable (33)-- since the reference character “(33)” is used in subsequent claims when referring to the cutting and pursing cable (see, e.g., claim 5).
d. In claim 1, line 53, the recitation of “is less that a predetermined minimum rate” should instead recite --is less than a predetermined minimum rate--.
e. In claim 1, line 108, the recitation of “tissue cutting and capture (394)” should instead recite --tissue cutting and capture assembly position (394)-- to be consistent with the prior recitation in lines 87-88 of the claim.
f. In claim 2, lines 5-6, the recitation of “an initial position (401) of cable mounting hub to position (402) of cable mounting hub” should instead recite --an initial position (401) of the cable mounting hub to position (402) of the cable mounting hub--.
g. In claim 2, line 9, the recitation of “cable mounting hub” should instead recite --the cable mounting hub--.
h. In claim 4, lines 1-2, the recitation of “the forward end (27)” should instead recite --the forward region (27)-- to be consistent with the prior recitation in independent claim 1 (at line 54) from which claim 4 depends.
i. In claim 4, line 4, the recitation of “a targeted tissue volume (354)” should instead recite --the targeted tissue volume (354)--.
j. In claim 7, line 3, the recitation of “the forward end (27)” should instead recite --the forward region (27)--.
k. In claim 7, lines 3-4, the recitation of “a single-use support housing (100)” should instead recite --the single-use support housing (100)--.
l. In claim 7, lines 6-7, the recitation of “a first pivotable drive finger (185a)” should instead recite --the first pivotable drive finger (185a)--.
m. In claim 7, lines 8-9, the recitation of “a first motor-actuated drive tube drive member translation assembly (180a)” should instead recite --the first motor-actuated drive tube drive member translation assembly (180a)--.
n. In claim 11, line 8, the recitation of “the forward end (27)” should instead recite --the forward region (27)--.
o. In claim 11, lines 16-17, the recitation of “a targeted tissue volume (354)” should instead recite --the targeted tissue volume (354)--.
p. In claim 23, lines 1-2, the recitation of “wherein the biocompatible, electrically insulative coating is capable of operating at temperature of up to 400° C” should instead recite --wherein the biocompatible, electrically insulative coating is configured to operate at a temperature of up to 400° C--.
q. In claim 24, lines 1-2, the recitation of “wherein programmed first microcomputer and programmed second microcomputer are replaced by a single programmed microcomputer” should instead recite --wherein the programmed first microcomputer and the programmed second microcomputer comprise a single programmed microcomputer--.
r. In claim 25, line 7, the recitation of “the diameter” should instead recite --a diameter--.
s. In claim 25, line 8, the recitation of “display of selected capture size (485)” should instead recite --and a display of selected capture size (485)--.
t. In claim 25, line 10, the recitation of “in handpiece assembly” should instead recite --in the handpiece assembly--.
u. In claim 25, lines 12-13, the recitation of “controlling activation of audible tone from speaker (200) during period of applying constant current” should instead recite
--controlling activation of an audible tone from speaker (200) during a period of applying constant current--.
v. In claim 25, lines 13 & 14, the recitation of “to resistively heated portions of cutting and pursing cable” should instead recite --to resistively heated portions of a cutting and pursing cable (33)-- since the reference character “(33)” is used in subsequent claims when referring to the cutting and pursing cable (see, e.g., claim 36).
w. In claim 25, line 21, the recitation of “in handpiece assembly” should instead recite --in the handpiece assembly--.
x. In claim 25, line 23, the recitation of “for period” should instead recite --for a period--.
y. In claim 25, lines 23-24, the recitation of “if measured increase” should instead recite --if a measured increase--.
z. In claim 25, lines 33-34, the recitation of “corresponding to initial ramp” should instead recite --corresponding to an initial ramp--.
aa. In claim 25, lines 34-35, the recitation of “within tissue capture basket (326)” should instead recite --within a tissue capture basket (326)--.
ab. In claim 25, lines 36-37, the recitation of “supplied to first motor (170a) if rate, Rrate is less that a predetermined minimum rate” should instead recite --supplied to a first motor (170a) if rate, Rrate is less than a predetermined minimum rate--.
ac. In claim 25, line 39, the recitation of “in handpiece assembly” should instead recite --in the handpiece assembly--.
ad. In claim 25, lines 41-42, the recitation of “for retrieving targeted tissue volume” should instead recite --for retrieving a targeted tissue volume--.
ae. In claim 25, line 44, the recitation of “within handpiece assembly” should instead recite --within the handpiece assembly--.
af. In claim 25, line 45, the recitation of “a single-use support housing (100)” should instead recite --the single-use support housing (100)--.
ag. In claim 25, lines 45-46, the recitation of “for driving cable mounting hub rearwardly” should instead recite --for driving the cable mounting hub rearwardly--.
ah. In claim 25, line 50, the recitation of “forming tissue capture basket (326)” should instead recite --forming the tissue capture basket (326)--.
ai. In claim 25, lines 51-52, the recitation of “within handpiece assembly for inserting single-use tissue incision and retrieval assembly (12)” should instead recite -- within the handpiece assembly for inserting a single-use tissue incision and retrieval assembly (12)--.
aj. In claim 25, line 53, the recitation of “inserting a single-use tissue incision and retrieval assembly” should instead recite --inserting the single-use tissue incision and retrieval assembly--.
ak. In claim 25, line 58, the recitation of “with a targeted tissue volume (354)” should instead recite --with the targeted tissue volume (354)--.
al. In claim 25, lines 59-60, the recitation of “for excision of a target tissue volume (354)” should instead recite -- for excision of the target tissue volume (354)--.
am. In claim 25, line 64, the recitation of “with scalpel” should instead recite --with a scalpel--.
an. In claim 25, line 65, the recitation of “at the forward end of the cannula (27)” should instead recite --at the forward end (27) of the cannula (22)--.
ao. In claim 25, lines 66-67, the recitation of “an imagining apparatus” should instead recite --an imaging apparatus--.
ap. In claim 25, line 74, the recitation of “that are electrical communicating” should instead recite --that are electrically communicating--.
aq. In claim 25, lines 80-81, the recitation of “supplied by a constant current source (247) incorporated in circuit board assembly (184)” should instead recite --supplied by the constant current source (247) incorporated in the circuit board assembly (184)--.
ar. In claim 25, lines 88-89, the recitation of “a second motor-actuated cable mounting hub translation assembly (180b)” should instead recite --the second motor-actuated cable mounting hub translation assembly (180b)--.
as. In claim 25, lines 89-91, the recitation of “driven engagement with a cable mounting hub (296) within a single-use support housing (100)” should instead recite --driven engagement with the cable mounting hub (296) within the single-use support housing (100)--.
at. In claim 25, line 95, the recitation of “a tissue capture basket (326)” should instead recite --the tissue capture basket (326)--.
au. In claim 34, lines 1-2, the recitation of “wherein the biocompatible, electrically insulative coating is capable of operating at temperature of up to 400° C” should instead recite --wherein the biocompatible, electrically insulative coating is configured to operate at a temperature of up to 400° C--.
av. In claim 38, lines 1-2, the recitation of “wherein the functions performed in the first programmed microcomputer and the second programmed microcomputer are performed within a single programmed microcomputer” should instead recite --wherein the programmed first microcomputer and the second programmed microcomputer comprise a single programmed microcomputer--.
Appropriate correction is required.
7. NOTE: an effort has been made to document any identified inconsistencies in the use of terminology and corresponding reference characters throughout the claims. However, given the widespread use of reference characters in the claims, Applicant’s cooperation is respectfully requested in correcting any issues of which Applicant may become aware while reviewing the claims.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 1-38 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
10. Claim 1 recites the limitation “the cutting and pursing cable circuit” in line 24. There is insufficient antecedent basis for this recitation in the claim.
11. Claim 1 recites the limitation “the resistively heated portions (89-94)” in line 24. There is insufficient antecedent basis for this recitation in the claim.
12. Claim 1 recites the limitation “the multi-lumen flexible polymeric extrusion assembly (427)” in line 29. There is insufficient antecedent basis for this recitation in the claim.
13. Claim 1 recites the limitation “the measured increase” in line 35. There is insufficient antecedent basis for this recitation in the claim.
14. Claim 1 recites the limitation “the predetermined time interval” in line 37. There is insufficient antecedent basis for this recitation in the claim.
15. Claim 1 recites the limitation “the maximum acceptable increase” in lines 37-38. There is insufficient antecedent basis for this recitation in the claim.
16. Claim 1 recites the limitation “the first second electrically and thermally conductive eyelet (446)” in line 41. In addition to including a grammatical error (“first second”), there is insufficient antecedent basis for this recitation in the claim.
17. Claim 1 recites the limitation “the second electrically and thermally conductive eyelet (450)” in lines 41-42. There is insufficient antecedent basis for this recitation in the claim.
18. In claim 1, the relationship, if any, between “the first and second electrically and thermally conductive eyelets (446 and 450)” recited in lines 42-43, and the “first and second electrically and thermally conductive eyelets (533a, 533b)” previously recited in line 28 is not clear. See also the recitation of “first and second eyelets (533a, 533b)” in lines 99-100.
19. Claim 1 recites the limitation “the rate of increase” in line 44. There is insufficient antecedent basis for this recitation in the claim.
20. Claim 1 recites the limitation “the tissue capture basket (326)” in line 49. There is insufficient antecedent basis for this recitation in the claim.
21. Claim 1 recites the limitation “the forward portion” in line 69. There is insufficient antecedent basis for this recitation in the claim.
22. Claim 1 recites the limitation “the eyelet containing tip (330)” in line 99. There is insufficient antecedent basis for this recitation in the claim.
23. Claim 1 recites the limitation “leaf members (82-86)” in lines 103-104. This recitation renders the claim indefinite, as the relationship, if any, between leaf members (348) as previously recited in line 89 of the claim and leaf members (82-86) is not clear. Clarification is required.
24. Claim 1 recites the limitation “the tissue capture assembly (392)” in lines 105-106. There is insufficient antecedent basis for this recitation in the claim.
25. Claims 2-24 are rejected as ultimately depending from a claim (claim 1) rejected under 35 U.S.C. 112(b).
26. Claim 2 recites the limitation “the proximal ends” in line 1. There is insufficient antecedent basis for this recitation in the claim.
27. Claim 2 recites the limitation “the second movement direction (405)” in line 12. There is insufficient antecedent basis for this recitation in the claim.
28. Claim 8 is rejected as ultimately depending from a claim (claim 2) rejected under 35 U.S.C. 112(b).
29. Claim 9 recites the limitation “wherein functions of first and second microcomputers (202a, 202b) may be combined into a single microcomputer (202)” in lines 1-2. The recitation of “may be” renders the claim indefinite, because it is susceptible to more than one plausible construction. It is unclear, for example, whether the limitation refers to a capability that is required to be present in the claimed device, or whether it refers to a device capability that is a mere possibility that is not required. Accordingly, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
30. Claim 11 recites the limitations “a plurality of leaf members (82-86)” in line 3, “a multi-lumen flexible polymeric extrusion assembly (427)” in lines 3-4, “an eyelet containing tip (330)” in lines 4-5, and “eyelets (533a, 533b)” in line 6. These recitations render the claim indefinite, as each of the foregoing elements are already positively recited in independent claim 1 (from which claim 11 depends). As such, it is not clear whether these elements are intended to comprise the previously-recited elements, or whether they are intended to comprise separate elements provided in addition to those previously recited in independent claim 1. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
31. Claims 12-14 are rejected as ultimately depending from a claim (claim 11) rejected under 35 U.S.C. 112(b).
32. Claim 15 recites the limitation “the material” in line 1. There is insufficient antecedent basis for this recitation in the claim.
33. Claim 18 recites the limitation “the material” in line 1. There is insufficient antecedent basis for this recitation in the claim.
34. Claim 19 recites the limitation “the material” in line 1. There is insufficient antecedent basis for this recitation in the claim.
35. Claim 19 recites the limitation “the multi-lumen flexible polymeric extrusion (420 or 508)” in lines 1-22. There is insufficient antecedent basis for this recitation in the claim.
36. Claim 20 recites the limitation “the height” in line 1. There is insufficient antecedent basis for this recitation in the claim.
37. Claim 20 recites the limitation “the multi-lumen flexible polymeric extrusion (420 or 508)” in lines 1-22. There is insufficient antecedent basis for this recitation in the claim.
38. Claim 21 recites the limitation “the width” in line 1. There is insufficient antecedent basis for this recitation in the claim.
39. Claim 21 recites the limitation “the multi-lumen flexible polymeric extrusion (420 or 508)” in lines 1-22. There is insufficient antecedent basis for this recitation in the claim.
40. Claim 22 recites the limitation “the leaf member” in line 1. This recitation renders the claim indefinite, because it is not clear which leaf member of the “plurality of leaf members” of independent claim 1 (from which claim 22 depends) is being referred to by this recitation. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
41. Claim 23 is rejected as ultimately depending from a claim (claim 22) rejected under 35 U.S.C. 112(b).
42. Claim 25 recites the limitation “the electrical impedance” in lines 16-17. There is insufficient antecedent basis for this recitation in the claim.
43. Claim 25 recites the limitation “the resistively heated cutting and pursing cable circuit” in line 17. There is insufficient antecedent basis for this recitation in the claim.
44. Claim 25 recites the limitation “within a circuit board assembly” in lines 20-21. This recitation renders the claim indefinite, as it is not clear whether the recited “a circuit board assembly” is intended to be the same “circuit board assembly” previously recited in the claim, or a separate/additional circuit board assembly. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
45. Claim 25 recites the limitation “the multi-lumen flexible polymeric extrusion and leaf members” in line 23. There is insufficient antecedent basis for this recitation in the claim.
46. Claim 25 recites the limitation “the maximum acceptable increase” in lines 25-26. There is insufficient antecedent basis for this recitation in the claim.
47. Claim 25 recites the limitation “the first and/or sixth segments” in line 27. There is insufficient antecedent basis for this recitation in the claim.
48. Claim 25 recites the limitation “the first and/or second electrically and thermally conductive eyelets (533a and/or 533b)” in lines 28-29. There is insufficient antecedent basis for this recitation in the claim.
49. Claim 25 recites the limitation “the rate of increase” in line 31. There is insufficient antecedent basis for this recitation in the claim.
50. Claim 25 recites the limitation “the initial period of deployment” in line 33. There is insufficient antecedent basis for this recitation in the claim.
51. Claim 25 recites the limitation “the first and second tensioning portions” in lines 46-47. There is insufficient antecedent basis for this recitation in the claim.
52. Claim 25 recites the limitation “the cutting and pursing cables” in line 47. There is insufficient antecedent basis for this recitation in the claim.
53. Claim 25 recites the limitation “the pursing down” in line 48. There is insufficient antecedent basis for this recitation in the claim.
54. Claim 25 recites the limitation “the leaf members (82-86) and multi-lumen flexible polymeric extrusion assembly (427)” in lines 48-49. There is insufficient antecedent basis for this recitation in the claim.
55. Claim 25 recites the limitation “blade (31)” in line 65. There is insufficient antecedent basis for this recitation in the claim. This recitation renders the claim indefinite, as it is not clear whether the recited blade is intended to be the “scalpel” previously recited in line 64, or a separate/additional component. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
56. Claim 25 recites the limitation “the hemispherical shape” in lines 85-86. There is insufficient antecedent basis for this recitation in the claim.
57. Claim 25 recites the limitation “the proximal end” in line 86. There is insufficient antecedent basis for this recitation in the claim.
58. Claim 25 recites the limitation “the captured target tissue volume (354)” in line 96. There is insufficient antecedent basis for this recitation in the claim.
59. Claims 26-38 are rejected as ultimately depending from a claim (claim 25) rejected under 35 U.S.C. 112(b).
60. Claim 26 recites the limitation “the material” in line 1. There is insufficient antecedent basis for this recitation in the claim.
61. Claim 27 recites the limitation “the width” in line 1. There is insufficient antecedent basis for this recitation in the claim.
62. Claim 28 recites the limitation “the thickness” in line 1. There is insufficient antecedent basis for this recitation in the claim.
63. Claim 29 recites the limitation “the material” in line 1. There is insufficient antecedent basis for this recitation in the claim.
64. Claim 30 recites the limitation “the material” in line 1. There is insufficient antecedent basis for this recitation in the claim.
65. Claim 30 recites the limitation “the multi-lumen flexible polymeric extrusion (420 or 508)” in lines 1-2. There is insufficient antecedent basis for this recitation in the claim.
66. Claim 30 recites the limitation “including polyamides (e.g., Nylon 6, Nylon 11 and Nylon 12)” in lines 2-3. The phrase "(e.g., Nylon 6, Nylon 11 and Nylon 12)" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase (e.g.) are part of the claimed invention. See MPEP § 2173.05(d).
67. Claim 31 recites the limitation “the height” in line 1. There is insufficient antecedent basis for this recitation in the claim.
68. Claim 31 recites the limitation “the multi-lumen flexible polymeric extrusion (420 or 508)” in lines 1-2. There is insufficient antecedent basis for this recitation in the claim.
69. Claim 32 recites the limitation “the width” in line 1. There is insufficient antecedent basis for this recitation in the claim.
70. Claim 32 recites the limitation “the multi-lumen flexible polymeric extrusion (420 or 508)” in lines 1-2. There is insufficient antecedent basis for this recitation in the claim.
71. Claim 33 recites the limitation “the leaf member” in line 1. This recitation renders the claim indefinite, because it is not clear which leaf member of the “leaf members” of independent claim 25 (from which claim 33 depends) is being referred to by this recitation. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
72. Claim 34 is rejected as ultimately depending from a claim (claim 33) rejected under 35 U.S.C. 112(b).
73. Claim 35 recites the limitation “the rate of advancement” in line 1. There is insufficient antecedent basis for this recitation in the claim.
74. Claim 37 recites the limitation “the material” in line 1. There is insufficient antecedent basis for this recitation in the claim.
75. NOTE: While claims 1-38 are not currently subject to a rejection under either 35 U.S.C.
§§ 102 or 103, the claim objections and the rejections under § 112(b) above have precluded a
determination of allowability at this time. Upon correction of the issues underlying the § 112(b)
rejections, the allowability of claims 1-38 will be reconsidered by the Examiner.
Conclusion
76. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M. Rodden can be reached on 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
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