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 .
Response to Amendment
The amendment filed 04/10/26 has been entered. Claims 1, 10-11, and 14 have been amended. Claims 3-8 and 12-13 are in the original/ previously presented form. Claims 2, 9, and 15-20 are cancelled. Claims 21-24 are newly presented. Thus, claims 1, 3-8, 10-14, and 21-24 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 01/14/26, hereinafter NFOA. Further, the amendments to the claims no longer require interpretation under 112f as previously set forth in the NFOA (pages 2-7).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the base “defining a cavity” as recited in at least new claim 21 must be shown or the feature(s) canceled from the claim(s). There does not appear to be a numeral in any of the figures to indicate the cavity of the base wherein the outer shell is disposed. Applicant could amend the specification and a figure, such as FIG. 5, to include a numeral (shown as ‘#’ in the examples below) for the structure and overcome this drawing objection (see examples provided below).
Specification [0059] can be amended to read “The hub base 226 additionally comprises a cavity # housing an outer shell 236 enclosing an interior region 238 that includes a seal assembly 237.”
FIG 5 could be amended to include the cavity numeral. The examiner has assumed the location of the cavity based on where the outer shell is housed, but Applicant should correct the examiner location in the amended drawings if the assumed placement is incorrect.
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No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 21-24 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.
Regarding claim 21, line 7 reads “an outer shell disposed within the cavity of the base” and lines 16-17 read “a hub cap engaged with a proximal end of the base, wherein the outer shell is positioned between the base and the hub cap within the cavity of the base”. It is unclear to the examiner how the outer shell is disposed “within” the base and also “between” the base and the hub cap. According to Applicant disclosure (see FIG. 5 and [0059]), the outer shell (236) is within the base cavity (see FIG. 5), confining the outer shell within the cavity such that the outer shell (236) is disposed between a distal end (224) of the base (226) and the hub cap (248).
Therefore, for purposes of examination, the examiner interprets lines 16-17 to read “a hub cap engaged with a proximal end of the base, wherein the outer shell is positioned between [[the]] a distal end of the base and the hub cap [[within the cavity of the base]]” to align with Applicant disclosure regarding the positional arrangement of the outer shell.
Due to claim dependency, claims 22-24 are subsequently rejected under 112b.
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.
Claims 1, 3-7, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Rajarathnam et al. (U.S. PGPUB No. 2019/0046016), hereinafter Raj, in view of Haslam et al. (U.S. PGPUB No. 2022/0184367), hereinafter Haslam.
Regarding claim 1, Raj discloses a hemostasis valve hub (12, see FIG. 1) for use with an introducer sheath (14), comprising:
a base (see ‘Modified FIG. 1’ below or FIG. 2)
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Securable (see [0073-0074]: 14 extends distally from 12 and is controllable via 12 and therefore there must be some securing mechanism/ coupling the components together) to the introducer sheath (14);
an outer shell (casing of cap 40, see Modified FIG. 1’ above and [0078]: cap 40 replaces cap 30 as shown in FIG.1 and casing of cap 40 forms outer shell as seen in FIG. 4) securable to the base (see [0075]: cap 30 coupled to base by coupling 28 and therefore cap 40 which replaces 30, see [0078] functions similarly) and defining an interior volume (see ‘Modified FIG. 4’ below or numeral 56 in FIG. 6B);
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a shutter helix section (44) disposed within the interior volume (see ‘Modified FIG. 4’ above) and including a plurality of fins (100a,b,c as seen in FIG. 10B and [0090]) arranged in a helical fashion (see ‘Modified FIG. 4 above and [0004]: fins arranged in helical fashion);
a brush section (46) disposed within the interior volume (see ‘Modified FIG. 4’ above) adjacent (see [0078]: 46 above 44) the shutter helix section (44), the brush section (46) including a plurality of brushes (80, see FIG. 9D) arranged in a helical fashion (see [0004] & [0083]: brushes arranged in helical fashion); and
a seal (48) positioned within the base (seal 48 contained in outer shell, aligning with applicant disclosure in [0059], and outer shell is secured with base and thus the seal is within the base) and adjacent (see [0078]: 48 above 46) the brush section (46), the seal (48) having a partial cross slit arrangement (58a,b, see FIG. 7A and [0080]).
Raj is silent to “wherein the hemostasis valve hub includes a hub cap engaged with the outer shell, wherein the outer shell is positioned between the base and the hub cap.”
However, Haslam teaches a hemostasis valve hub for use with an introducer sheath (102, see FIG. 8A and [0047]: hemostasis hub device coupled to catheter 102) comprising a base (110); an outer shell (120) securable to (see [0033]: 120 coupled to base 110) the base (110); wherein the hemostasis valve hub includes a hub cap (180) engaged with the outer shell (120), wherein the outer shell (120) is positioned between (see ‘Modified FIG. 8A’ below and [0046]) the base (110) and the hub cap (180).
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Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hemostasis valve hub device comprising an outer shell disclosed in Raj to include a hub cap engaged with the outer shell as taught by Haslam for the purpose of distinguishing between hemostasis valve hub devices (see [0046]), thus achieving “wherein the hemostasis valve hub includes a hub cap engaged with the outer shell, wherein the outer shell is positioned between the base and the hub cap.”
Regarding claim 3, the modified system of Raj teaches the hemostasis valve hub of claim 1, and Raj further discloses wherein the outer shell (casing of cap 40, see FIG. 5) comprises a top cap (50) and a bottom cap (42) coupled with (see [0078]: 50 connectable to 42) the top cap (50).
Regarding claim 4, the modified system of Raj teaches the hemostasis valve hub of claim 3, and Raj further discloses wherein the seal (48, see FIG. 5) is positioned adjacent (see [0078]) the top cap (50) and the brush section (46).
Regarding claim 5, the modified system of Raj teaches the hemostasis valve hub of claim 1, and Raj further discloses wherein the seal (48, see FIG. 4 and [0080]: seal formed of deformable foam and is configured to accommodate medical device) is configured to (configured to is functional language. Therefore the seal only need be capable of achieving the claimed limitation) have a diameter of at least 8.0 mm (see [0075-0077]: seal needs to seal the port and therefore the seal is dependent on the medical device and the size of the port and see [0117]: size of components of the device may be changed. Thus, the seal is “configured to” have a diameter of at least 8mm).
Regarding claim 6, the modified system of Raj teaches the hemostasis valve hub of claim 5, and Raj further discloses wherein the seal (48, see FIG.4) is composed of silicone (see [0111-0112]: components of cap—seal is of cap 40 as seen in FIG. 4-- can be formed of commonly known medical device materials such as polymers that include silicone).
Regarding claim 7, the modified system of Raj teaches the hemostasis valve hub of claim 1, and Raj further discloses wherein the shutter helix section (44, see FIG. 10B) comprises a plurality of fins (100a,b,c) extending radially inward (see [0090]: “the fins 100a, 100b, 100c extend inwardly from an annular ring 102 and terminate proximate a center point 104.”) from an outer ring (102).
Regarding claim 10, the modified system of Raj teaches the hemostasis valve hub of claim 1, and Raj further discloses wherein the base (base includes port 20 as shown in FIG. 2 that longitudinally aligns with outer shell 40—replacing shell 30 as shown in FIG.2), the outer shell (40—see exploded view in FIG. 5), the shutter helix section (44), the brush section (46), and the seal (48) are aligned longitudinally (longitudinal axis as shown by exploded view line in FIG. 2) to define a lumen (see [0075-0076] & [0078]: elongate devices inserted through channel of cap 40 & port 20).
Raj is silent to the components including “the hub cap” are aligned longitudinally to define a lumen.
However, Haslam teaches a hemostasis valve hub for use with an introducer sheath (102, see FIG. 8A and [0047]: hemostasis hub device coupled to catheter 102) comprising a base (110); an outer shell (120) securable to (see [0033]: 120 coupled to base 110) the base (110); wherein the hemostasis valve hub includes a hub cap (180) engaged with the outer shell (120), wherein the outer shell (120) is positioned between (see ‘Modified FIG. 8A’ in rejection of claim 1 above and [0046]) the base (110) and the hub cap (180), wherein the base (110), the outer shell (120), and the hub cap (180) are aligned longitudinally (as shown in FIG. 8A) to define a lumen (see [0046]: medical appliances inserted through lumen of device, including through lumen of hub cap).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hemostasis valve hub device comprising an outer shell disclosed in Raj to include a hub cap engaged with the outer shell as taught by Haslam for the purpose of distinguishing between hemostasis valve hub devices (see [0046]), thus achieving the components including “the hub cap” are aligned longitudinally to define a lumen.
Regarding claim 11, Raj discloses a delivery system for inserting a plurality of medical devices into a blood vessel (see FIG. 1 and [0073]), comprising:
an introducer sheath (14) having a proximal end (see ‘Modified FIG. 1’ below and [0073]) and a distal end (18); and
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a hemostasis valve hub (12) configured for engaging the proximal end of the introducer sheath (see ‘Modified FIG. 1’ above and [0073]: sheath 14 terminates at port 20 at therefore the hub 12 is configured for engaging the proximal end of the sheath), the hemostasis valve hub (12) comprising:
a base (see ‘Modified FIG. 1’ above or FIG. 2) securable to the proximal end (see [0073-0074]: 14 extends distally from 12 and is controllable via 12 and therefore there must be some securing mechanism/ coupling the components) of the introducer sheath (14);
an outer shell (casing of cap 40, see Modified FIG. 1’ above and [0078]: cap 40 replaces cap 30 as shown in FIG.1 and casing of cap 40 forms outer shell as seen in FIG. 4) securable to the base (see [0075]: cap 30 coupled to base by coupling 28 and therefore cap 40 which replaces 30, see [0078] functions similarly) and defining an interior volume (see ‘Modified FIG. 4’ below or numeral 56 in FIG. 6B);
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a shutter helix section (44) disposed within the interior volume (see ‘Modified FIG. 4’ above) and including a plurality of fins (100a,b,c as seen in FIG. 10B and [0090]) arranged in a helical fashion (see ‘Modified FIG. 4 above and [0004]: fins arranged in helical fashion);
a brush section (46) disposed within the interior volume (see ‘Modified FIG. 4’ above) adjacent (see [0078]: 46 above 44) the shutter helix section (44), the brush section (46) including a plurality of brushes (80, see FIG. 9D) arranged in a helical fashion (see [0004] & [0083]: brushes arranged in helical fashion); and
a seal (48) positioned within the base (seal 48 contained in outer shell, aligning with applicant disclosure in [0059], and outer shell is secured with base and thus the seal is within the base) and adjacent (see [0078]: 48 above 46) the brush section (46), the seal (48) having a partial cross slit arrangement (58a,b, see FIG. 7A and [0080]).
Raj is silent to “wherein the hemostasis valve hub includes a hub cap engaged with the outer shell, wherein the outer shell is positioned between the base and the hub cap.”
However, Haslam teaches a hemostasis valve hub for use with an introducer sheath (102, see FIG. 8A and [0047]: hemostasis hub device coupled to catheter 102) comprising a base (110); an outer shell (120) securable to (see [0033]: 120 coupled to base 110) the base (110); wherein the hemostasis valve hub includes a hub cap (180) engaged with the outer shell (120), wherein the outer shell (120) is positioned between (see ‘Modified FIG. 8A’ below and [0046]) the base (110) and the hub cap (180).
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Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hemostasis valve hub device comprising an outer shell disclosed in Raj to include a hub cap engaged with the outer shell as taught by Haslam for the purpose of distinguishing between hemostasis valve hub devices (see [0046]), thus achieving “wherein the hemostasis valve hub includes a hub cap engaged with the outer shell, wherein the outer shell is positioned between the base and the hub cap.”
Regarding claim 12, the modified system of Raj teaches the delivery system of claim 11, and Raj further discloses wherein the outer shell (casing of cap 40, see FIG. 5) comprises a top cap (50) coupled to (see [0078]: 50 connectable to 42) a bottom cap (42).
Regarding claim 13, the modified system of Raj teaches the delivery system of claim 12, and Raj further discloses wherein the seal (48, see FIG. 5) is positioned adjacent (see [0078]) the top cap (50) and the brush section (46).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Raj in view of Haslam as applied to claim 1 above, and further in view of Knapp (U.S. PGPUB No. 2004/0204629).
Regarding claim 8, the modified system of Raj teaches the hemostasis valve hub of claim 1, but Modified Raj is silent to “wherein the base comprises a plurality of suture rings for securing the position of the device.”
However, Knapp teaches a hemostasis valve hub (18, see FIG. 1) for use with an introducer sheath (12), wherein the base (18) comprises a plurality of suture rings (38,40, see FIG.2 and [0064]: suture rings 38/40) for securing the position of the device (see [0064]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hemostasis valve hub disclosed by Raj to include a plurality of suturing rings as taught by Knapp for the purpose of providing a means by which sutures can be attached to the device for securing (see [0064]), thus achieving “wherein the base comprises a plurality of suture rings for securing the position of the device.”
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Raj in view of Haslam as applied to claim 12 above, and further in view of Magno et al. (U.S. PGPUB No. 2019/0191985), hereinafter Magno.
Regarding claim 14, the modified system of Raj teaches the delivery system of claim 12, and Raj further discloses wherein the bottom cap (42, see FIG. 5) is for forming a seal (see [0081]: portions of 42 formed of silicone materials and frictionally engage with base such as port 20 and thus form some degree of a seal due to frictional engagement) between the bottom cap (42) and the base (see ‘Modified FIG. 1’ above or FIG. 2). Raj further discloses the bottom cap (42, see FIG. 8B) includes a groove (64) that assists in securing the cap to the hub base (see [0081]).
Modified Raj is silent to wherein the bottom cap “comprises an O- ring seal” for forming a seal between the bottom cap and the base.
However, Magno teaches a delivery system for inserting medical devices into a body lumen (46, see FIG. 7D and [0018]) comprising a sheath (42), and a cap (66) securable to the sheath (42), wherein the cap (66) comprises an O-ring (72) disposed in a groove (70, see FIG. 7B) for forming a seal between (see [0035]) the cap (66) and sheath (42).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the groove of the bottom cap forming a seal with the base disclosed by Raj to include an O-ring as taught by Magno for the purpose of forming an additional seal point between the coupled elements or for sealing a sheath extending within the lumen of the cap (see [0035]), which would be advantageous to Raj that receives medical devices/ sheath elements through the port 20 comprising the bottom cap coupled to the base (see Raj [0075-0077]), thus achieving wherein the bottom cap “comprises an O- ring seal” for forming a seal between the bottom cap and the base.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Raj (U.S. PGPUB No. 2019/0046016) in view of Dinino et al. (U.S. PGPUB No. 2021/0030437), hereinafter Dinino.
Regarding claim 21, Raj discloses a delivery system for inserting a medical device into a blood vessel (see FIG. 1 and [0073]), comprising:
an introducer sheath (14) having a proximal end (see ‘Modified FIG. 1’ below and [0073]) and a distal end (18); and
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a hemostasis valve hub (12) secured to the proximal end of the introducer sheath (14, see [0073-0074]: 14 extends distally from 12 and is controllable via 12 and therefore there must be some securing mechanism/ coupling the components), the hemostasis valve hub (12) comprising:
a base (see ‘Modified FIG. 1’ above or FIG. 2) secured to (see [0073-0074]: 14 extends distally from 12 and is controllable via 12 and therefore there must be some securing mechanism/ coupling the components) the proximal end (see ‘Modified FIG. 1’ above) of the introducer sheath (14),
an outer shell (casing of cap 40, see Modified FIG. 1’ above and [0078]: cap 40 replaces cap 30 as shown in FIG.1 and casing of cap 40 forms outer shell as seen in FIG. 4), the outer shell (40) defining an interior volume (see ‘Modified FIG. 4’ below or numeral 56 in FIG. 6B);
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a shutter helix section (44) disposed within the interior volume (see ‘Modified FIG. 4’ above) of the outer shell (40) and including a plurality of fins (100a,b,c as seen in FIG. 10B and [0090]) arranged in a helical fashion (see ‘Modified FIG. 4 above and [0004]: fins arranged in helical fashion);
a brush section (46) disposed within the interior volume (see ‘Modified FIG. 4’ above) of the outer shell (40) adjacent (see [0078]: 46 above 44) the shutter helix section (44), the brush section (46) including a plurality of brushes (80, see FIG. 9D) arranged in a helical fashion (see [0004] & [0083]: brushes arranged in helical fashion);
a seal (48) positioned within the interior volume (see ‘Modified FIG. 4’ above) of the outer shell (40) adjacent (see [0078]: 48 above 46) the brush section (46), the seal (48) having a partial cross slit arrangement (58a,b, see FIG. 7A and [0080]).
Raj is silent to the hemostasis valve hub comprising: “the base defining a cavity therein; an outer shell disposed within the cavity of the base” and “a hub cap engaged with a proximal end of the base, wherein the outer shell is positioned between [[the]] a distal end of the base and the hub cap [[within the cavity of the base]].”
However, Dinino teaches a delivery system for inserting a medical device into a blood vessel (see FIG. 2 and [0047]), comprising: an introducer sheath (102) having a proximal end (104) and a distal end (see [0045]: sheath has proximal end and see FIG. 1 for distal end); and a hemostasis valve hub (110) secured to (as in FIG. 2) the proximal end (104) of the introducer sheath (102), the hemostasis valve hub (110) comprising: a base (114/116, see [0045]) secured to (see [0045]) the proximal end (104) of the introducer sheath (102), the base (114/116) defining a cavity (see ‘Modified FIG. 2’ below) therein;
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An outer shell (assembly 120 from structure 192 to structure 194 as seen best in FIG. 3) disposed within the cavity (see ‘Modified FIG. 2’ above and [0045] & [0048] describing 120 housed in base) of the base (114/116), the outer shell (assembly 120, see FIG. 3) housing sealing components therein (see [0048]: seal assembly 160 retained in valve assembly/ outer shell 120 and [0054] & [0058]); and a hub cap (112) engaged with (see FIG. 2) a proximal end (114) of the base (114/116), wherein the outer shell (assembly 120, see FIG. 3) is positioned between [[the]] a distal end (116) of the base (114/116) and the hub cap (112) [[within the cavity of the base]].
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer shell disclosed in Raj to be disposed within a cavity of the base as taught by Dinino for the purpose of supporting the valve assembly within a housing (see [0047]), thus providing enhanced protection of the outer shell and seal assembly and achieving “the base defining a cavity therein; an outer shell disposed within the cavity of the base”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end of the base with a cavity taught by Raj in view of Dinino to include a hub cap engaged with the proximal end of the base as taught by Dinino for the purpose of selectively attaching the housing to the base which retains the outer shell and seal assembly (see [0045]), thus achieving “a hub cap engaged with a proximal end of the base, wherein the outer shell is positioned between [[the]] a distal end of the base and the hub cap [[within the cavity of the base]].”
Regarding claim 22, the modified system of Raj teaches the delivery system of claim 21, and Raj further discloses wherein the outer shell (casing of cap 40, see FIG. 5) comprises a top cap (50) coupled with (see [0078]: 50 connectable to 42) a bottom cap (42).
Regarding claim 23, the modified system of Raj teaches the delivery system of claim 22, and Raj further discloses wherein the seal (48, see FIG. 5) is positioned adjacent (see [0078]) the top cap (50) and the brush section (46).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Raj in view of Dinino as applied to claim 22 above, and further in view of Magno (U.S. PGPUB No. 2019/0191985).
Regarding claim 24, the modified system of Raj teaches the delivery system of claim 22, and Raj further discloses wherein the bottom cap (42, see FIG. 5) is for forming a seal (see [0081]: portions of 42 formed of silicone materials and frictionally engage with base such as port 20 and thus form some degree of a seal due to frictional engagement) between the bottom cap (42) and the base (see ‘Modified FIG. 1’ above or FIG. 2). Raj further discloses the bottom cap (42, see FIG. 8B) includes a groove (64) that assists in securing the cap to the hub base (see [0081]).
Modified Raj is silent to wherein the bottom cap “comprises an O- ring seal” for forming a seal between the bottom cap and the base.
However, Magno teaches a delivery system for inserting medical devices into a body lumen (46, see FIG. 7D and [0018]) comprising a sheath (42), and a cap (66) securable to the sheath (42), wherein the cap (66) comprises an O-ring (72) disposed in a groove (70, see FIG. 7B) for forming a seal between (see [0035]) the cap (66) and sheath (42).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the groove of the bottom cap forming a seal with the base disclosed by Raj to include an O-ring as taught by Magno for the purpose of forming an additional seal point between the coupled elements or for sealing a sheath extending within the lumen of the cap (see [0035]), which would be advantageous to Raj that receives medical devices/ sheath elements through the port 20 comprising the bottom cap coupled to the base (see Raj [0075-0077]), thus achieving wherein the bottom cap “comprises an O- ring seal” for forming a seal between the bottom cap and the base.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 11, and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Pages 7-9 of Applicant arguments only argue combinations of Raj in view of Carlyon and/or Arnett, which are combinations no longer used in this rejection due to the amendment. New 35 U.S.C. § 103 claim rejections under Raj in view of Haslam and Raj in view of Dinino are presented herein.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights