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 .
Election/Restrictions
Applicant's election with traverse of Species 1 in the reply filed on 06/29/2026 is acknowledged. The traversal is on the ground(s) that:
(1) Examiner has not specified which different classes and subclasses would need to be searched if all purported species were examined, and believes that a manageable number of classes and subclasses would be required if all purported species were considered, and
(2) Examiner has failed to demonstrate the independence and distinctness required.
This is not found persuasive because:
(1) the examination burden is not limited exclusively to a prior art search but also includes that effort required to apply the art by making and discussing all appropriate grounds of rejection. Multiple inventions, such as those in the present application, normally require additional reference material and further discussion for each additional invention examined. Concurrent examination of multiple inventions would thus typically involve a significant burden even if all searches were coextensive.
(2) MPEP 803 explicitly states “Under the statute, the claims of an application may properly be required to be restricted to one of two or more claimed inventions only if they are able to support separate patents and they are either independent (MPEP § 802.01, § 806.06, and § 808.01) or distinct (MPEP § 806.05 - § 806.05(j)).” However, the restriction requirement properly demonstrates both independence and distinctness by stating “independent and distinct structural features such as the valve assembly, the sections, attachments between sections, etc.. that yield independent and distinct functional relationships” as the identified species are unrelated in design, operation, and effect and are used in practice as independent hub assemblies, and are not connected in at least design, operation or effect as claimed.
Examiner notes Species 1, hub assembly is intended to incorporate Fig. 7A-7B when stating Fig. 1-7. Examiner further notes that Fig. 19D is generic with reference to the species as it only illustrates the buttons 19A and 19B in combination with a medical device and is not specific for use with a hub assembly.
Claims 5 and 14-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species 2 and 5, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/29/2026
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 1, 6, 11, 18, and 20 are objected to because of the following informalities:
Regarding claim 1, examiner notes the indenting is not consistent with independent claims 11 and 20 and the spec., and examiner suggests amending the indentations as follows for consistency:
1. (Original) An introducer assembly, comprising:
a sheath comprising a proximal end, a distal end, and at least one lumen disposed therethrough; and
a hub assembly interconnected with the proximal end of the sheath, the hub assembly comprising:
a body defining an interior passageway in fluid communication with the lumen of the sheath, the body having a proximal end and a distal end;
a valve assembly positioned within the interior passageway of the body, the valve assembly comprising a valve member, the valve member being at least partially movable from a first position to a second position; and
a vacuum chamber positioned distal to the valve assembly and in fluid communication with the interior passageway of the body and the lumen of the sheath, the vacuum chamber including a vacuum port.
Regarding claim 1, the phrase “the lumen of the sheath” in line 7 should read “the at least one lumen of the sheath” for proper antecedent basis,
Regarding claim 1, the phrase “the lumen of the sheath” in lines 12-13 should read “the at least one lumen of the sheath” for proper antecedent basis,
Regarding claim 6, the phrase “of interior chamber of the body” in line 2 should read “of the interior passageway of the body” for proper antecedent basis,
Regarding claim 11, the phrase “the valve assembly comprising,” in lines 4-5 should read “the valve assembly comprising:” to replace the comma with a colon for proper grammar,
Regarding claim 11, the phrase “and defining an interior passageway” in line 7 should read “and defining a second interior passageway” to clearly differentiate from the interior passageway of the body,
Regarding claim 11, the phrase “the interior chamber of the body” in line 12 should read “the interior passageway of the body” for proper antecedent basis,
Regarding claim 18, the phrase “of interior chamber of the body” in line 2 should read “of the interior passageway of the body” for proper antecedent basis,
Regarding claim 20, the phrase “the lumen of the multi-layer sheath” in line 8 should read “the at least one lumen of the multi-layer sheath” for proper antecedent basis,
Regarding claim 20, the phrase “the valve assembly comprising,” in lines 10-11 should read “the valve assembly comprising:” to replace the comma with a colon for proper grammar,
Regarding claim 20, the phrase “the lumen of the sheath” in line 19 should read “the at least one lumen of the sheath” for proper antecedent basis,
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 11-13 and 18-19 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.
Claim 11 recites the limitation "the distal end of the valve collar" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 12-13 and 18-19, these claims are rejected due to their dependency upon a rejected base claim.
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) 1, 3-4, 6, 11, 13, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Merritt et al. (U.S Patent Pub. No. 20190070401 A1, “Merritt”).
Regarding claim 1, Merritt discloses (Claim 1) an introducer assembly (100 in Fig. 1-4), comprising:
a sheath (102 in Fig. 1) comprising a proximal end (108 in Fig. 1), a distal end (110 in Fig. 1), and at least one lumen (112 in Fig. 1) disposed therethrough (see Fig. 1 and para. 0035); and
a hub assembly (104 in Fig. 1-2) interconnected with the proximal end (108) of the sheath (102, see Fig. 1-2 and para. 0035-0038 – hub assembly is interpreted as the valve 104 comprising the outer shell 114 as the body which comprises a distal cap 120 and a proximal cap 116), the hub assembly (104) comprising:
a body (114 in Fig. 1-2) defining an interior passageway in fluid communication with the lumen (112) of the sheath (102, see para. 0037 and 0039 – interior passageway of body 114 is interpreted as the combination of the proximal channel 124, interior channel 130, and distal channel 126, and interior portion of the housing 128 where the buttons 144 translate), the body (114) having a proximal end (118 in Fig . 2) and a distal end (122 in Fig. 2, see para. 0037);
a valve assembly (141 in Fig. 2) positioned within the interior passageway of the body (114, see para. 0042-0044 – constricting mechanism 141 comprises components such as the filament 150 that is positioned within the interior channel 130 and the buttons 144 are positioned within the interior portion of housing 128), the valve assembly (141) comprising a valve member (144-A, 144-B in Fig. 2), the valve member (144-A, 144-B) being at least partially movable from a first position to a second position (see Fig. 2-3 and para. 0044-0045 – the first button 144-A and second button 144-B function as valve members for constricting the fluid flow through the interior passageway that are movable between a first position in Fig. 2 and a second position in Fig. 3); and
a vacuum chamber (316 in Fig. 3) positioned distal to the valve assembly (141) and in fluid communication with the interior passageway of the body (114) and the lumen (112) of the sheath (102, see Fig. 2 and para. 0053-0054), the vacuum chamber (316) including a vacuum port (314 in Fig. 2, see para. 0053-0054).
Regarding claim 3, Merritt discloses (Claim 3) the introducer assembly (100) of claim 1, wherein the valve member (144-A, 144-B in Fig. 2) comprises a first button (144-A) and a second button (144-B, see para. 0044).
Regarding claim 4, Merritt discloses (Claim 4) the introducer assembly (100) of claim 1, wherein the valve member (144-A, 144-B) is laterally moveable with respect to a longitudinal axis (154 in Fig. 2) of the hub assembly (104, see Fig. 2-3 and para. 0048-0049).
Regarding claim 6, Merritt discloses (Claim 6) the introducer assembly (100) of claim 1, wherein the valve member (144-A, 144-B) has a radius of curvature that engages an interior surface of interior chamber of the body (114, see Fig. 1-3 and para. 0044 – the housing 128 of body 144 has retention features 140 wherein the buttons 144-A and 144-B have a radius of curvature best seen in Fig. 1 for engaging an interior surface of the retention features 140 which form part of the interior chamber of the body 114).
Regarding claim 11, Merritt discloses (Claim 11) a hub assembly (104 in Fig. 1-3) for an introducer assembly (100 in Fig. 1-4, see para. 0035-0038), comprising:
a body (114 in Fig. 1-2) defining an interior passageway (see para. 0037 and 0039 – interior passageway of body 114 is interpreted as the combination of the proximal channel 124, interior channel 130, and distal channel 126, and interior portion of the housing 128 where the buttons 144 translate), the body (114) having a proximal end (118 in Fig. 2) and a distal end (122 in Fig. 2, see para. 0037);
a valve assembly (141 in Fig. 2) positioned within the interior passageway of the body (114, see para. 0042-0044 – constricting mechanism 141 comprises components such as the filament 150 that is positioned within the interior channel 130 and the buttons 144 are positioned within the interior portion of housing 128), the valve assembly (141) comprising,
a valve collar (132 in Fig. 1-2) positioned within the interior passageway of the body (114) and defining an interior passageway (138 in Fig. 1-2, see para. 0039-0040 – elongate member 132 is a tubular member, septum, or tubular septum that extends within the housing 128 to connect the proximal cap 116 and the distal cap 120 and thus forms a tubular structure that encircles the interior surface of housing 128); and
a valve member (144-A, 144-B in Fig. 2) connected to the valve collar (132, see Fig. 2-3 and para. 0043 and 0048), the valve member (144-A, 144-B) being at least partially movable from a first position to a second position with respect to the valve collar (132, see Fig. 2-3 and para. 0044-0045 and 0048 – the first button 144-A and second button 144-B function as valve members for constricting the fluid flow through the interior passageway that are movable between a first position in Fig. 2 and a second position in Fig. 3 relative to the elongate member 132); and
a vacuum chamber (316 in Fig. 3) interconnected with the distal end of the valve collar (132) and in fluid communication with the interior chamber of the body (114, see Fig. 2-3 and para. 0053-0054 – vacuum chamber 316 is interconnected with the distal end of valve collar 132 through the distal cap 120), the vacuum chamber (316) including a vacuum port (314 in Fig. 2, see para. 0053-0054).
Regarding claim 13, Merritt discloses (Claim 13) the hub assembly (104) of claim 11, wherein the valve member (144-A, 144-B) comprises a first button (144-A) having a first surface and a second surface and a second button (144-B) having a first surface and a second surface (see Fig. 2-3 – each button 144-A, 144-B have an outer surface for actuation and an inner surface contacting by the springs 148-A, 148-B).
Regarding claim 18, Merritt discloses (Claim 18) the introducer assembly (100) of claim 11, wherein the valve member (144-A, 144-B) has a radius of curvature that engages an interior surface of interior chamber of the body (114, see Fig. 1-3 and para. 0044 – the housing 128 of body 144 has retention features 140 wherein the buttons 144-A and 144-B have a radius of curvature best seen in Fig. 1 for engaging an interior surface of the retention features 140 which form part of the interior chamber of the body 114).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2, 7, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Merritt in view of Lazic (U.S Patent Pub. No. 20190328942 A1).
Regarding claim 2, Merritt discloses the introducer assembly of claim 1, as discussed above.
However, Merritt fails to disclose (Claim 2) wherein the valve member of the valve assembly is flexible.
Lazic discloses a housing (1 in Fig. 1a-1b) comprising a valve assembly (6, 8 in Fig. 1a-1b) for controlling fluid flow from aspirating channel (3 in Fig. 1a) and flushing channel (4 in Fig. 1a, see para. 0021), wherein the valve assembly (6, 8) comprises a valve member in the form of a push button (8 in Fig. 1a-1b, see para. 0021). Lazic teaches (Claim 2) wherein the valve member (8) of the valve assembly (6, 8) is flexible (see para. 0007 and 0022 – push button 8 is formed as an elastic rubber material such as silicone indicating it is flexible).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve push buttons of Merritt to be formed of an elastic rubber material such that they are flexible as taught by Lazic. Lazic teaches that the valve push button is formed from an elastic rubber material to assist with forming a sealing section for sealing the housing (1) to prevent leakage of the fluid therein (see para. 0007).
Regarding claim 7, Merritt discloses the introducer assembly of claim 1, as discussed above.
However, Merritt fails to disclose (Claim 7) wherein the valve assembly comprises silicone.
Lazic discloses a housing (1 in Fig. 1a-1b) comprising a valve assembly (6, 8 in Fig. 1a-1b) for controlling fluid flow from aspirating channel (3 in Fig. 1a) and flushing channel (4 in Fig. 1a, see para. 0021), wherein the valve assembly (6, 8) comprises a valve member in the form of a push button (8 in Fig. 1a-1b, see para. 0021). Lazic teaches (Claim 7) wherein the valve assembly (6, 8) comprises silicone (see para. 0007 and 0022 – push button 8 is formed as an elastic rubber material such as silicone).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve push buttons of Merritt to be formed of an elastic rubber material such as silicone as taught by Lazic. Lazic teaches that the valve push button is formed from an elastic rubber material such as silicone to assist with forming a sealing section for sealing the housing (1) to prevent leakage of the fluid therein (see para. 0007).
Regarding claim 12, Merritt discloses the hub assembly of claim 11, as discussed above.
However, Merritt fails to disclose (Claim 12) wherein the valve member of the valve assembly is flexible.
Lazic discloses a housing (1 in Fig. 1a-1b) comprising a valve assembly (6, 8 in Fig. 1a-1b) for controlling fluid flow from aspirating channel (3 in Fig. 1a) and flushing channel (4 in Fig. 1a, see para. 0021), wherein the valve assembly (6, 8) comprises a valve member in the form of a push button (8 in Fig. 1a-1b, see para. 0021). Lazic teaches (Claim 12) wherein the valve member (8) of the valve assembly (6, 8) is flexible (see para. 0007 and 0022 – push button 8 is formed as an elastic rubber material such as silicone indicating it is flexible).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve push buttons of Merritt to be formed of an elastic rubber material such that they are flexible as taught by Lazic. Lazic teaches that the valve push button is formed from an elastic rubber material to assist with forming a sealing section for sealing the housing (1) to prevent leakage of the fluid therein (see para. 0007).
Regarding claim 19, Merritt discloses the hub assembly of claim 11, as discussed above.
However, Merritt fails to disclose (Claim 19) wherein the valve assembly comprises silicone.
Lazic discloses a housing (1 in Fig. 1a-1b) comprising a valve assembly (6, 8 in Fig. 1a-1b) for controlling fluid flow from aspirating channel (3 in Fig. 1a) and flushing channel (4 in Fig. 1a, see para. 0021), wherein the valve assembly (6, 8) comprises a valve member in the form of a push button (8 in Fig. 1a-1b, see para. 0021). Lazic teaches (Claim 19) wherein the valve assembly (6, 8) comprises silicone (see para. 0007 and 0022 – push button 8 is formed as an elastic rubber material such as silicone).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve push buttons of Merritt to be formed of an elastic rubber material such as silicone as taught by Lazic. Lazic teaches that the valve push button is formed from an elastic rubber material such as silicone to assist with forming a sealing section for sealing the housing (1) to prevent leakage of the fluid therein (see para. 0007).
Claim(s) 8-10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Merritt in view of Dittman et al. (U.S Patent Pub. No. 20100163159 A1, “Dittman”).
Regarding claim 8, Merritt discloses the introducer assembly of claim 1, as discussed above.
However, Merritt fails to disclose (Claim 8) wherein the sheath comprises two or more layers.
Dittman discloses a vascular delivery sheath (30 in Fig. 2, see Abstract and para. 0016), wherein Dittman teaches (Claim 8) wherein the sheath (30) comprises two or more layers (31, 32, see Fig. 2 and para. 0016 – sheath 30 comprises an inner tube 32 forming a first layer and an outer tube 31 forming a second layer with a coil 33 positioned therebetween).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vascular delivery sheath of Merritt to have one or more layers such as an inner layer, outer layer, and coil positioned therebetween as taught by the vascular delivery sheath of Dittman. Dittman discloses a multi-layer delivery sheath having an inner layer and an outer layer with a coil positioned therebetween to provide flexibility and kink-resistance (see para. 0009, 0021, and 0025).
Regarding claim 9, modified Merritt discloses the introducer assembly of claim 8, as discussed above. In modified Merritt, Dittman discloses (Claim 9) wherein the sheath (30) comprises an inner layer (32 in Fig. 2) having an inner diameter and an outer layer (31 in Fig. 2) having an outer diameter (see Fig. 2 and para. 0016), the outer diameter of the outer layer (31) being greater than the inner diameter of the inner layer (32, see Fig. 2).
Regarding claim 10, modified Merritt discloses the introducer assembly of claim 9, as discussed above. In modified Merritt, Dittman discloses (Claim 10) wherein at least one coil (33 in Fig. 2) is embedded between the inner layer (32) and the outer layer (31, see Fig. 2 and para. 0031-0032).
Regarding claim 20, Merritt discloses the limitations of (Claim 20) an introducer assembly (100 in Fig. 1-4), comprising:
a sheath (102 in Fig. 1) comprising a proximal end (108 in Fig. 1), a distal end (110 in Fig. 1), and at least one lumen (112 in Fig. 1) disposed therethrough (see Fig. 1 and para. 0035); and
a hub assembly (104 in Fig. 1-2) interconnected with the proximal end (108) of the sheath (102) and having a proximal end (118 in Fig. 2), a distal end (122 in Fig. 2), and a body (114 in Fig. 1-2) defining an interior chamber in fluid communication with the lumen (112) of the sheath (102, see Fig. 1-2 and para. 0035-0038 – hub assembly is interpreted as the valve 104 comprising the outer shell 114 as the body which comprises a distal cap 120 and a proximal cap 116, see para. 0037 and 0039 – interior chamber of body 114 is interpreted as the combination of the proximal channel 124, interior channel 130, and distal channel 126, and interior portion of the housing 128 where the buttons 144 translate), the body (112) having a proximal end (118 in Fig. 2), a distal end (122 in Fig. 2);
a valve assembly (141 in Fig. 2) positioned within the interior chamber of the body (114, see para. 0042-0044 – constricting mechanism 141 comprises components such as the filament 150 that is positioned within the interior channel 130 and the buttons 144 are positioned within the interior portion of housing 128), the valve assembly (141) comprising,
a valve collar (132 in Fig. 1-2) positioned within the interior chamber of the body (114) and defining an interior passageway (138 in Fig. 1-2, see para. 0039-0040 – elongate member 132 is a tubular member, septum, or tubular septum that extends within the housing 128 to connect the proximal cap 116 and the distal cap 120 and thus forms a tubular structure that encircles the interior surface of housing 128); the interior passageway (138) being in fluid communication with the at least one lumen (112) of the sheath (102, see Fig. 1 and para. 0040 and 0072-0073);
a valve member (144-A, 144-B in Fig. 2) connected to the valve collar (132, see Fig. 2-3 and para. 0043 and 0048), the valve member (144-A, 144-B) being at least partially movable from a first position to a second position with respect to the valve collar (132, see Fig. 2-3 and para. 0044-0045 and 0048 – the first button 144-A and second button 144-B function as valve members for constricting the fluid flow through the interior passageway that are movable between a first position in Fig. 2 and a second position in Fig. 3 relative to the elongate member 132); and
a vacuum chamber (316 in Fig. 3) positioned distal to the valve assembly (141) and in fluid communication with the interior passageway of the body (114) and the lumen (112) of the sheath (102, see Fig. 2 and para. 0053-0054), the vacuum chamber (316) including a vacuum port (314 in Fig. 2, see para. 0053-0054).
However, Merritt fails to disclose the limitations of (Claim 20) a multi-layer sheath, the multi-layer sheath having an inner layer having an outer diameter, an outer layer having an outer diameter, and at least one coil embedded between the inner layer and the outer layer.
Dittman discloses a vascular delivery sheath (30 in Fig. 2, see Abstract and para. 0016), wherein Dittman teaches (Claim 20) a multi-layer sheath (30 in Fig. 2, see para. 0016), the multi-layer sheath (30) having an inner layer (32 in Fig. 2) having an outer diameter (see Fig. 2 and para. 0016), an outer layer (31 in Fig. 2) having an outer diameter (see Fig. 2 and para. 0016), and at least one coil (33 in Fig. 2) embedded between the inner layer (32) and the outer layer (31, see Fig. 2 and para. 0031-0032).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vascular delivery sheath of Merritt to be a multi-layer sheath having an inner layer, outer layer, and coil embedded therebetween as taught by the vascular delivery sheath of Dittman. Dittman discloses a multi-layer delivery sheath having an inner layer and an outer layer with a coil embedded therebetween to provide flexibility and kink-resistance (see para. 0009, 0021, and 0025).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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