DETAILED ACTION
The following Office Action is in response to the Amendment filed on November 28, 2025. Claims 52, 57-66, and 68-73 are currently pending.
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 .
Response to Amendment
Concerning the “Section 112 Rejections” section on pages 9-10 of the Applicant’s Response filed on November 28, 2025, the amendment to claim 52 has obviated the necessity of the rejections of claims 52-55 and 57-69 under 35 U.S.C. §112(a) and 35 U.S.C. §112(b) and the rejection of claim 69 under 35 U.S.C. §112(d). Therefore, the rejections are withdrawn.
Response to Arguments
Concerning the “Section 112 Rejections” section on pages 9-10 of the Applicant’s Response filed on November 28, 2025, with regards to the rejection of claim 69 under 35 U.S.C. §112(b), the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Specification provides ample support of a standalone, universal sheath assembly. However, the examiner asserts that a standalone, universal sheath assembly is much different than a sheath assembly that is incapable of being connected to alternative casings, housings, bases, handles, hubs, connectors, or luer locks. There a variety of devices on the market that have varying structures that may be compatible with connecting to other sheath assemblies on the market, and the Specification does not provide any evidence that the sheath assembly of the instant application is incapable of connecting with any of these alternative devices. Furthermore, the term “connect” is defined as “to join together”, wherein simply placing the disclosed sheath assembly into a larger sheath would be connecting the two. Although the invention of the instant application may be a standalone device based on its intended use, this does not mean it is incapable of being placed into another sheath. If anything, the excerpts presented in the arguments suggest that the invention would be capable of connecting with other casings, housings, bases, handles, hubs, connectors, or luer locks given the invention’s intention of being compatible with other devices and its versatility. No structure has been presented that would suggest that the invention of the instant application is incapable of or prevents a connection with an alternative casing, housing, base, handle, hub, connector, or luer lock. Furthermore, it is noted that the claim recites that “the sheath assembly” is not capable of being connected to a casing, a housing, a base, a handle, a hub, a connector or a luer lock, while the Specification specifically teaches that “the connector” may not be capable of being connected to a casing, housing, base, handle, hub or luer lock. Therefore, the rejection of claim 69 under 35 U.S.C. §112(a) stands.
Concerning the “Section 103 Rejections” section on pages 10-14 of the Applicant’s Response filed on November 28, 2025, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
Claim Objections
Claims 70-72 are objected to because of the following informalities:
Concerning claim 52, line 17 of the claim recites “the second and third clamping member”, line 20 recites “the second and third clamping member”, lines 17-18 recite “the first, second and third clamping member”, lines 21-22 recite “the second and third clamping member”, and lines 26-27 recite “the second and third clamping member”, wherein, in each instance, the word “member” should be in the plural form “members”. The same issues are repeated in various instances in claims 71 and 72.
Concerning claim 70, lines 4-5 of the claim recites the phrase “first , second and third”, wherein the space between “first” and the comma should be deleted, and line 6 of the claim recites “the second and third clamping hole”, wherein the word “hole” should be in the plural form “holes”.
Concerning claim 72, line 19 of the claim recites the phrase “which ,”, wherein the space between “which” and the comma should be deleted.
Appropriate correction is required.
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.
Claims 69, 71, and 73 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 69 and 73 recite the limitation of “wherein the sheath assembly is not capable of being connected to a casing, a housing, a base, a handle, a hub, a connector or a luer lock”. However, Paragraph [125] of the Instant Application states that “The connector 18 may not be capable of being connected to a casing, housing, base, handle, hub or luer lock of a needle assembly or catheter assembly, which is part of the same set” [Emphasis Added]. This disclosure shows that the connector is not supposed to be connectable to a needle assembly or catheter assembly that is within the same set, not necessarily any casing, housing, base, handle, hub or luer lock in existence. Given the claims have not positively recited any needle assembly or catheter assembly as being part of the set of the claimed invention, the claims have not provided adequate written description for the limitation. The same applies to the limitation of new claim 71. Claim 71 recites “the connector is not capable of being [connected] to a casing, a housing, a base, a handle, a hub, a connector or a luer lock”. This limitation similarly does not include any positively recited needle assembly or catheter assembly as being part of the same set, therein failing to comply with the written description requirement. Furthermore, it is noted that claims 69 and 73 recite that “the sheath assembly” is not capable of being connected to a casing, a housing, a base, a handle, a hub, a connector or a luer lock, while the Specification specifically teaches that “the connector” may not be capable of being connected to a casing, housing, base, handle, hub or luer lock.
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.
Claims 52, 57-66, 68-70 and 72-73 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Concerning claims 52, line 19 of the claim recites the limitation of “the first clamping member is located between the second and second clamping member”, wherein it is indefinite as to what the limitation of “the second and second clamping member” is intended to refer to. For the purposes of compact prosecution, the limitation will be interpreted as “the first clamping member is located between the second and third clamping members”.
Concerning claim 72, lines 21-22 of the claim recites the limitation of “the first, second and third clamping members”. There is a lack of antecedent basis for this limitation in the claim. The claim recites “at least a first clamping member and a second clamping member”, but does not recite a third clamping member, making it indefinite as to whether the third clamping member is within the scope of the claims. For the purposes of compact prosecution, the limitation will be interpreted as “the at least first and second clamping members”.
Claims 57-66, 68-70, and 73 are further rejected for being dependent upon indefinite claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 52, 57, 61-66, 68, and 70-72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marsh et al. (US 2001/0021824, hereinafter Marsh) in view of Vidlund et al. (US 2013/0190809, hereinafter Vidlund) and Bacon et al. (US 2009/0024056, hereinafter Bacon).
Concerning claims 52 and 71, the Marsh et al. prior art reference teaches a sheath assembly (Figure 1; 16, 22) configured to be positioned over a needle of a needle assembly which may be interpreted as a catheter assembly, wherein the needle has a cannula wall (Figure 1; 14), the sheath assembly comprising an elongated tube (Figure 1; 16) with a defined bore (Figure 1; 12), wherein the sheath assembly further comprises a connector (Figure 1; 22) which is connected to the elongate tube and which is configured to be fixated to an outside of the cannula wall of the needle, thereby fixating the sheath assembly ([¶ 0029]), wherein the connector comprises a clamp configured to exert a clamping force on the outside of the cannula wall of the needle (Figure 1; 36), wherein the connector further comprises a proximal wall (Figure 3; proximal wall of 21) and an opposed distal wall (Figure 3; distal wall of 19), wherein a proximal portion of the elongated tube of the sheath assembly is securably affixed to a portion of the opposed distal wall (Figure 3; 16), and wherein the proximal wall comprises a hole (Figure 2; 24) configured to non-fixedly abut a hub of the needle assembly (Figure 2; hub 15 may non-affixedly nest into hole of proximal wall), wherein the connector is not capable of being connected to a casing, housing, base, handle, hub or lock of the needle assembly or catheter assembly, but it does not teach the specifically claimed structure of the connector nor does it teach the elongated tube comprising an echogenic structure, wherein the echogenic structure is part of the elongated tube and configured to be inserted into a body of a patient and to provide echogenicity inside the body.
However, the Vidlund reference teaches a sheath assembly (Figure 1; 2) configured to be positioned over a needle of a catheter assembly (Figure 1; 10), therein being in the same field of endeavor as the Marsh reference, wherein the sheath assembly further comprises a connector (Figure 1; 72) which is configured to be fixated to an outside of a cannula wall of the needle (Figure 1; 14), therein fixating the sheath assembly, wherein the connector comprises a clamp (Figure 1; 86) configured to exert a clamping force on the outside of the cannula wall of the needle (Figure 1; 14), wherein the clamp comprises a first clamping member, a second clamping member, and a third clamping member (See OA Figure 1 below), wherein the second and third clamping member are located at a distance from one another in an axial direction of the elongated tube and the first clamping member is located between the second and third clamping members (See OA Figure 1 below), wherein the first clamping member is movable relative to the second and third clamping members (Figure 6A; y), wherein the first, second, and third clamping members are configured to clamp the outside of the cannula wall of the needle (Figure 6B | [¶ 0060]), wherein the connector comprises a biasing member (Figure 61A; 194) configured for exerting a biasing force which pushes the first clamping member on the one hand and the second and third clamping members on the other hand toward one another when the needle is located between the first, second, and third clamping members, such that a biasing force automatically fixes the connector to the needle ([¶ 0059-0060]), wherein the connector further comprises at least one operating member (Figure 6A; 190) which, when operated by a user, moves the first clamping member on the one hand and the second and third clamping member on the other hand away from one another from a clamping position (Figure 6B) to a disengaged position (Figure 7A), allowing a user to slide the sheath assembly over the needle to a desired position relative to the needle ([¶ 0059]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the connector and clamp structure of the Marsh reference with the connector and clamp structure of the Vidlund reference as a simple substitution of one known connector and clamp structure for a sheath assembly (the biased securing assembly of the Vidlund reference) for another known connector and clamp structure for a sheath assembly (the V or U-shaped clamp of the Marsh reference), which would yield the expected result of simply providing an alternative fixing and clamping structure that would perform equally as well.
Furthermore, the Bacon reference teaches a sheath assembly similar to that of the Marsh reference, wherein the sheath assembly (Figure 2; 12) is configured to be positioned over a needle of a needle assembly (Figure 2; 14), the sheath assembly comprising an elongated tube (Figure 2; 18) with a defined bore (Figure 2; 20) and which comprises an echogenic structure ([¶ 0053]), wherein the echogenic structure is part of the elongated tube and configured to be inserted into a body of a patient and to provide echogenicity inside the body ([¶ 0048]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the elongated tube of the sheath assembly of the Marsh reference include the echogenic structure of the Bacon reference to allow the needle assembly to be positioned by using an imaging system by enhancing visibility using common imaging systems (Bacon; [¶ 0048]).
Concerning claim 57, the combination of the Marsh, Vidlund, and Bacon references as discussed above teaches the sheath assembly according to claim 52, wherein the Marsh reference further teaches the sheath assembly constructed and intended to be positioned over a needle of a needle assembly for epidural, which is a type of peripheral nerve block ([¶ 0010]).
Concerning claim 61, the combination of the Marsh, Vidlund, and Bacon references as discussed above teaches the sheath assembly according to claim 52, wherein the Bacon reference teaches that the echogenic structure has a surface which provides angles of reflectance of incoming sound waves, resulting in the sound waves being scattered in every direction (Column 4, Lines 39-50 of U.S. 5,820,554, which is incorporated by reference).
Concerning claim 62, the combination of the Marsh, Vidlund, and Bacon references as discussed above teaches the sheath assembly according to claim 52, wherein the Bacon reference further teaches the echogenic structure not being applied over the full length of the elongated tube, but only over a part of the length thereof, wherein the echogenic structure has a length which extends over at most 50 percent of the length of the elongated tube (Figure 10; markers spaced every 1 cm, but does not extend along the length, and the markers are smaller than the bands of the tube that does not include the markers).
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OA Figure 1
Concerning claim 63, the combination of the Marsh, Vidlund, and Bacon references as discussed above teaches the sheath assembly according to claim 62, wherein the Bacon reference teaches that the sheath may be enhanced in any of the methods disclosed by Davis et al. (US 5,820,554), wherein Davis discloses that the echogenic structure (Davis; Figure 7; 28) may be located at a distal end of an elongate tube structure and not at a proximal end of the elongate tube, wherein the distal end of the elongate tube is opposite to the end where the connector is located (Marsh; Figure 2).
Concerning claim 64, the combination of the Marsh, Vidlund, and Bacon references as discussed above teaches the sheath assembly according to claim 52, wherein the Bacon reference teaches that the sheath may be enhanced in any of the methods disclosed by Davis et al. (US 5,820,554), wherein Davis discloses that the echogenic structure may at least partially be manufactured from metal (Davis; Column 3, Lines 51-61), wherein the metal echogenic structure is not a coating, and wherein the metal echogenic structure may comprise a coil (Davis; Figure 7; 42).
Concerning claim 65, the combination of the Marsh, Vidlund, and Bacon references as discussed above teaches the sheath assembly according to claim 52, wherein the Bacon reference teaches that the sheath may be enhanced in any of the methods disclosed by Davis et al. (US 5,820,554), wherein Davis discloses that the echogenic structure may comprise particles (Davis; Column 5, line 34 – Column 6, Line 4).
Concerning claim 66, the combination of the Marsh, Vidlund, and Bacon references as discussed above teaches a combination of a sheath assembly according to claim 53 and a needle assembly, wherein the Marsh reference further teaches that a shape of the clamping member may correspond with a radius of the outside of the cannula wall of the needle assembly, the clamping member being concave according to a radius of curvature (Marsh; Figure 8; 37a-c).
Concerning claim 68, the combination of the Marsh, Vidlund, and Bacon references as discussed above teaches a method of making a sheath assembly according to claim 52, the method comprising: providing an elongate tube having an echogenic structure (Marsh; Figure 1; 16 | Bacon; Figure 11; 94), and connecting said elongated tube to a connector configured to be fixated to an outside of a cannula wall of a needle, thereby fixating the sheath assembly to the needle (Marsh; [¶ 0029]).
Concerning claim 70, the combination of the Marsh, Vidlund, and Bacon references as discussed above teaches a combination of a sheath assembly according to claim 52, wherein the connector comprises a first clamping hole having a first edge, a second clamping hole having a second edge and a third clamping hole having a third edge, wherein the first, second and third edges define the first, second and third clamping members (See OA Figure 1 above), wherein in the disengaged position the first, second and third clamping holes are aligned (Figure 6B) and wherein in the clamping position, the first clamping hole is not aligned with the second and third clamping holes (Figure 7B).
Concerning claim 72, the Marsh et al. prior art reference teaches a sheath assembly (Figure 1; 16, 22) configured to be positioned over a needle of a needle assembly which may be interpreted as a catheter assembly, wherein the needle has a cannula wall (Figure 1; 14), the sheath assembly comprising an elongated tube (Figure 1; 16) with a defined bore (Figure 1; 12), wherein the sheath assembly further comprises a connector (Figure 1; 22) which is connected to the elongate tube and which is configured to be fixated to an outside of the cannula wall of the needle, thereby fixating the sheath assembly ([¶ 0029]), wherein the connector comprises a clamp configured to exert a clamping force on the outside of the cannula wall of the needle (Figure 1; 36), wherein the connector further comprises a proximal wall (Figure 3; proximal wall of 21) and an opposed distal wall (Figure 3; distal wall of 19), wherein a proximal portion of the elongated tube of the sheath assembly is securably affixed to a portion of the opposed distal wall (Figure 3; 16), and wherein the proximal wall comprises a hole (Figure 2; 24) configured to non-fixedly abut a hub of the needle assembly (Figure 2; hub 15 may non-affixedly nest into hole of proximal wall), but it does not teach the specifically claimed structure of the connector nor does it teach the elongated tube comprising an echogenic structure, wherein the echogenic structure is part of the elongated tube and configured to be inserted into a body of a patient and to provide echogenicity inside the body.
However, the Vidlund reference teaches a sheath assembly (Figure 1; 2) configured to be positioned over a needle of a catheter assembly (Figure 1; 10), therein being in the same field of endeavor as the Marsh reference, wherein the sheath assembly further comprises a connector (Figure 1; 72) which is configured to be fixated to an outside of a cannula wall of the needle (Figure 1; 14), therein fixating the sheath assembly, wherein the connector comprises a clamp (Figure 1; 86) configured to exert a clamping force on the outside of the cannula wall of the needle (Figure 1; 14), wherein the clamp comprises a first clamping member (Figure 7A; 186) and a second clamping member (Figure 7A; 172), wherein the first clamping member is movable relative to the second member (Figure 6A; y), wherein the first and second clamping members are configured to clamp the outside of the cannula wall of the needle (Figure 6B | [¶ 0060]), wherein the connector comprises a biasing member (Figure 61A; 194) configured for exerting a biasing force which pushes the first clamping member on the one hand and the second member on the other hand toward one another when the needle is located between the first and second clamping members, such that a biasing force automatically fixes the connector to the needle ([¶ 0059-0060]), wherein the connector further comprises at least one operating member (Figure 6A; 190) which, when operated by a user, moves the first clamping member on the one hand and the second clamping member on the other hand away from one another from a clamping position (Figure 6B) to a disengaged position (Figure 7A) when the needle is located between the first and second clamping members, allowing a user to slide the sheath assembly over the needle to a desired position relative to the needle ([¶ 0059]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the connector and clamp structure of the Marsh reference with the connector and clamp structure of the Vidlund reference as a simple substitution of one known connector and clamp structure for a sheath assembly (the biased securing assembly of the Vidlund reference) for another known connector and clamp structure for a sheath assembly (the V or U-shaped clamp of the Marsh reference), which would yield the expected result of simply providing an alternative fixing and clamping structure that would perform equally as well.
Furthermore, the Bacon reference teaches a sheath assembly similar to that of the Marsh reference, wherein the sheath assembly (Figure 2; 12) is configured to be positioned over a needle of a needle assembly (Figure 2; 14), the sheath assembly comprising an elongated tube (Figure 2; 18) with a defined bore (Figure 2; 20) and which comprises an echogenic structure ([¶ 0053]), wherein the echogenic structure is part of the elongated tube and configured to be inserted into a body of a patient and to provide echogenicity inside the body ([¶ 0048]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the elongated tube of the sheath assembly of the Marsh reference include the echogenic structure of the Bacon reference to allow the needle assembly to be positioned by using an imaging system by enhancing visibility using common imaging systems (Bacon; [¶ 0048]).
Claim(s) 58-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marsh et al. (US 2001/0021824, hereinafter Marsh) in view of Vidlund et al. (US 2013/0190809, hereinafter Vidlund) and Bacon et al. (US 2009/0024056, hereinafter Bacon) as applied to claims 52, 57, 61-66, 68, and 70-72 above, and further in view of Fearnot et al. (US 2013/0267848, hereinafter Fearnot).
Concerning claims 58-60, the combination of the Marsh, Vidlund, and Bacon references as discussed above teaches the sheath assembly according to claim 58, but does not teach the echogenic structure being a coating.
However, the Fearnot reference teaches a sheath including an echogenic structure, therein being in the same field of endeavor as the Marsh and Bacon combination, wherein the Fearnot reference teaches that the echogenic structure may be a coating wherein the coating comprises small particles having a different acoustic impedance than the coating layer itself and tissues of the human body (Fearnot; [¶ 0030]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the echogenic structure of the Marsh, Vidlund, and Bacon reference be a coating comprising small particles as in the Fearnot reference given it has been disclosed as an alternative method of applying an echogenic structure to a sheath (Fearnot; [¶ 0030]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MARTIN T TON/Examiner, Art Unit 3771 2/25/2026