Prosecution Insights
Last updated: April 19, 2026
Application No. 18/114,080

SINGLE CAVITY HEMOSTASIS VALVE HUB FOR INTRODUCER SHEATHS

Non-Final OA §103
Filed
Feb 24, 2023
Examiner
FARRELL, KATHLEEN PAIGE
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
BOSTON SCIENTIFIC CORPORATION
OA Round
1 (Non-Final)
54%
Grant Probability
Moderate
1-2
OA Rounds
3y 12m
To Grant
88%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allow Rate
36 granted / 66 resolved
-15.5% vs TC avg
Strong +34% interview lift
Without
With
+33.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 12m
Avg Prosecution
56 currently pending
Career history
122
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
53.6%
+13.6% vs TC avg
§102
20.0%
-20.0% vs TC avg
§112
21.3%
-18.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 66 resolved cases

Office Action

§103
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 without traverse of Invention I: claims 1-15 in the reply filed on 12/15/25 is acknowledged. Claims 16-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/15/25. Information Disclosure Statement The information disclosure statement (IDS) submitted on 02/12/24 and 08/11/25 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Claim Objections Claim 10 objected to because of the following informalities: Claim 10 lines 1-2 read “the seal assembly” but should likely read “the seal [[assembly]]” to provide proper antecedent basis for the seal structure (a seal assembly has not been recited in the claims) Appropriate correction is required. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: Claim 1 line 2: “a base having a securing mechanism for securing”. Therefore, claim 1 is interpreted under 112(f) according to the 3-prong test: Prong 1: means or generic placeholder is recited— “a securing mechanism” is considered a generic placeholder for “means” because “a securing mechanism” has no specific structural meaning Prong 2: functional language—for securing Prong 3: not modified by other structural language in the claims—no structure is recited for how the securing mechanism functions in order to achieve secure the hub. Only the desired outcome of securing is recited. According to Applicant’s disclosure under 112(f), the “securing mechanism for securing” is interpreted as a ferrule or equivalent (see FIG. 5 and [0059]). Claim 11 line 6: “a base having a securing mechanism for securing”. Therefore, claim 1 is interpreted under 112(f) according to the 3-prong test: Prong 1: means or generic placeholder is recited— “a securing mechanism” is considered a generic placeholder for “means” because “a securing mechanism” has no specific structural meaning Prong 2: functional language—for securing Prong 3: not modified by other structural language in the claims—no structure is recited for how the securing mechanism functions in order to achieve secure the hub. Only the desired outcome of securing is recited. According to Applicant’s disclosure under 112(f), the “securing mechanism for securing” is interpreted as a ferrule or equivalent (see FIG. 5 and [0059]). Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: The securing mechanism in claims 2 and 15 because further structure of a ferrule is recited, failing the test at prong C Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof. If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function. 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 1-7, 11-13, and 15 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 Carlyon et al. (U.S. PGPUB No. 2008/0082082), hereinafter Carlyon. 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) PNG media_image1.png 568 469 media_image1.png Greyscale having a securing mechanism for securing (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) 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); PNG media_image2.png 441 433 media_image2.png Greyscale 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 the securing mechanism being specifically a ferrule as interpreted under 112f above. However, Carlyon teaches a hemostasis valve hub (see FIG.1) for use with an introducer sheath (108), the hub comprising a base (106) having a securing mechanism (107, see [0045]: a ferrule 107 secure to hub 106) for securing the hub to the introducer sheath (108, see [0045]: ferrule 107 secured to sheath 108 at proximal end as seen in FIG. 1 and 107 secured to hub 106). 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 securing mechanism disclosed in Raj to include a ferrule as taught by Carlyon for the purpose of forming the mechanical coupling of the securing mechanism by preferred conventional means known in the art (see [0045]), thus achieving the securing mechanism being specifically a ferrule as interpreted under 112f. Regarding claim 2, the modified system of Raj teaches the hemostasis valve hub of claim 1, but Raj is silent to “wherein the securing mechanism is a ferrule positioned within the base for engaging with the introducer sheath and the hemostasis valve hub.” However, Carlyon teaches a hemostasis valve hub (see FIG.1) for use with an introducer sheath (108), the hub comprising a base (106) having a securing mechanism (107, see [0045]: a ferrule 107 secure to hub 106), wherein the securing mechanism (107) is a ferrule (see [0045]) positioned within the base (106, see FIG. 1 with ferrule 107 disposed within) for engaging with (see [0045]: ferrule 107 secured to sheath 108 at proximal end as seen in FIG. 1 and 107 secured within hub 106 as seen in FIG.1) the introducer sheath (108) and the hemostasis valve hub (FIG.1) . 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 securing mechanism disclosed in Raj to include a ferrule as taught by Carlyon for the purpose of forming the mechanical coupling of the securing mechanism by preferred conventional means known in the art (see [0045]), thus achieving “wherein the securing mechanism is a ferrule positioned within the base for engaging with the introducer sheath and the hemostasis valve hub.” 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 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 PNG media_image1.png 568 469 media_image1.png Greyscale 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) having a securing mechanism for securing (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) 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); PNG media_image2.png 441 433 media_image2.png Greyscale 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 the securing mechanism being specifically a ferrule as interpreted under 112f above. However, Carlyon teaches a delivery system for inserting a plurality of medical devices (108 &156, see FIG. 1) into a blood vessel, comprising an introducer sheath (108) and a hub base (106) having a securing mechanism (107, see [0045]: a ferrule 107 secure to hub 106) for securing the hub to the introducer sheath (108, see [0045]: ferrule 107 secured to sheath 108 at proximal end as seen in FIG. 1 and 107 secured to hub 106). 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 securing mechanism disclosed in Raj to include a ferrule as taught by Carlyon for the purpose of forming the mechanical coupling of the securing mechanism by preferred conventional means known in the art (see [0045]), thus achieving the securing mechanism being specifically a ferrule as interpreted under 112f. 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). Regarding claim 15, the modified system of Raj teaches the delivery system of claim 11, but Raj is silent to “wherein the securing mechanism is a ferrule positioned within the base of the hub for engaging the base and the introducer sheath.” However, Carlyon teaches a delivery system for inserting a plurality of medical devices (108 &156, see FIG. 1) into a blood vessel, comprising an introducer sheath (108) and a hub base (106) having a securing mechanism (107, see [0045]: a ferrule 107 secure to hub 106), wherein the securing mechanism (107) is a ferrule (see [0045]) positioned within the base (see [0045]: ferrule 107 secured to sheath 108 at proximal end as seen in FIG. 1 and 107 secured within hub 106 as seen in FIG.1) of the hub (106) for engaging the base (106) and the introducer sheath (108). 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 securing mechanism disclosed in Raj to include a ferrule as taught by Carlyon for the purpose of forming the mechanical coupling of the securing mechanism by preferred conventional means known in the art (see [0045]), thus achieving “wherein the securing mechanism is a ferrule positioned within the base of the hub for engaging the base and the introducer sheath.” Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Raj in view of Carlyon 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.” Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Raj in view of Carlyon as applied to claim 1 above, and further in view of Arnett et al. (U.S. PGPUB No. 2020/0147360), hereinafter Arnett. Regarding claim 9, the modified system of Raj teaches the hemostasis valve hub of claim 1, but Modified Raj is silent to “wherein the hub comprises a hub cap configured for engaging with the outer shell.” However, Arnett teaches a hemostasis valve hub (122, see FIG. 1D and [0073]: mating member 100 includes hub 122) for use with an introducer sheath (see [0073]: sheath 120), wherein the hub (122, see ‘Modified FIG. 5D(ii)’ below and [0076]: hub 122 includes 125 that couples to housing 124 and [0083]: housing 124 of 5D formed by 124b and 126) PNG media_image3.png 564 779 media_image3.png Greyscale comprises a hub cap (126) configured for engaging (see [0083]: 124b and 126 coupled by snap-fit arrangement) with an outer shell (124b). 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 hub having an outer shell securable to the base disclosed in Raj to include a hub cap configured for engagement with the outer shell (such as by snap-fit) as taught by Arnett for the purpose of retaining the internal components of the shell (see [0106]), thus achieving “wherein the hub comprises a hub cap configured for engaging with the outer shell”. Regarding claim 10, the modified system of Raj teaches the hemostasis valve hub of claim 9, and Raj further discloses the hub having a main branch (see [0073]: working channel with sheath 14) and a side arm access port (20, see FIG. 1), wherein the access port may be disposed to the side of the device or at another location (see [0075]) to transition the access point to a size matching the working channel (see [0076]). Raj is silent to “wherein the base, the outer shell, the seal assembly and the hub cap are aligned longitudinally to define a lumen.” However, Arnett teaches a hemostasis valve hub (122, see FIG. 1D and [0073]: mating member 100 includes hub 122) for use with an introducer sheath (see [0073]), wherein a base (125, see ‘Modified FIG. 5D(ii)’ above), an outer shell (124b), and an internal assembly (see ‘Modified FIG. 5D(ii)’ above and [0077-0078]: coupling member 1000 attached to housing) are aligned longitudinally (see longitudinal axis of dotted line in ‘Modified FIG. 5D(ii)’ above) to define a lumen of a working channel (see [0052-0054]). 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 dispose the access port (including the outer shell and seal assembly) forming the working channel disclosed in Raj longitudinally (such as along the main branch of Raj) as taught by Arnett for the purpose of forming the working channel longitudinally through the device to allow multiple devices to be delivered through the same lumen such that a distal position in fixed relative to the hub (see [0052-0054], specifically [0054]), thus achieving “wherein the base, the outer shell, the seal assembly are aligned longitudinally to define a lumen”. Next, 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 access port disposed longitudinally taught by Raj in view of Arnett to include a hub cap (such as by snap-fitting to the outer shell) as taught by Arnett for the purpose of retaining the internal components of the shell (See [0106]), thus achieving wherein the base, the outer shell, the seal assembly “and the hub cap” are aligned longitudinally to define a lumen. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Raj in view of Carlyon as applied to claim 11 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 11, 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. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Feb 24, 2023
Application Filed
Jan 05, 2026
Non-Final Rejection — §103 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12599404
DISPOSABLE MEDICAL DEVICE INTRODUCTION SYSTEM
2y 5m to grant Granted Apr 14, 2026
Patent 12594222
ENTERAL FEEDING ADAPTERS AND METHODS OF USING THE ENTERAL FEEDING ADAPTERS
2y 5m to grant Granted Apr 07, 2026
Patent 12564705
Splitable Needle and Dilator Catheter Placement Device and Associated Methods
2y 5m to grant Granted Mar 03, 2026
Patent 12544511
SYSTEMS AND METHODS FOR PRE-FILLED DUAL-CHAMBER MEDICAL AGENT DELIVERY
2y 5m to grant Granted Feb 10, 2026
Patent 12521530
INTRAVASCULAR DEVICES AND METHODS FOR DELIVERY OF FLUIDS AND THERAPEUTIC AGENTS INTO BLOOD VESSEL WALLS AND INTRAVASCULAR STRUCTURES
2y 5m to grant Granted Jan 13, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

1-2
Expected OA Rounds
54%
Grant Probability
88%
With Interview (+33.6%)
3y 12m
Median Time to Grant
Low
PTA Risk
Based on 66 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month