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 February 12, 2026 in response to the Office Action of November 14, 2025 has been acknowledged and entered.
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 14: Claim limitation “a catheter strain relief feature formed around” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 sixth paragraph, because it uses a generic placeholder “feature” coupled with functional language “strain relief” without reciting sufficient structure to achieve the function.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claim 14: “a catheter strain relief feature” refers to the Specification as filed, Paragraph [0057], catheter strain relief feature 602 may be a rubberized or otherwise flexible material that is molded or otherwise secured around catheter 313 to reinforce the portion of catheter 313 immediately distal to catheter adapter 311.
See MPEP 2181.II.A. The disclosure of the structure (or material or acts) may be implicit or inherent in the specification if it would have been clear to those skilled in the art what structure (or material or acts) corresponds to the means- (or step-) plus-function claim limitation. See id. at 1380, 53 USPQ2d at 1229; In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir. 1997).
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.
For more information, see MPEP 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claims 1, 4-8, 10-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lew (WO 2022073987) (cited by Applicant).
Regarding claim 1, Lew illustrates a ported catheter (Fig. 1A, device 100) comprising: a catheter adapter (101) having a proximal opening (See Fig. 1A); a catheter (needle 110) extending distally from the catheter adapter (101);; and a bushing (50) having an inside surface that is configured to facilitate insertion of a tube (140) of a blood draw device or other vascular probe or instrument into the catheter. (See Fig. 7).
Lew illustrates wherein the inside surface of the bushing (50) includes a curved section (i.e., curved section formed at the distal end 57 and the conical or funnel shaped tapered seat 55), wherein the curved section (55) the curved section having a convex cross-sectional shape relative to a center longitudinal axis of the catheter adapter. (See Fig. 4, cylindrical bushing comprises a circular cross-sectional shape, which is convex).
In one embodiment Lew teaches a port (184) (See Fig. 8, showing an embodiment of the catheter assembly further comprising a side fluid port 184).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Lew to include “a port”. Doing so provides an additional lumen for fluid inflow.
Regarding claim 4, Lew illustrates (Fig. 4) wherein the inside surface of the bushing (50) also includes a proximal section (56) positioned at a proximal opening of the bushing (Paragraph [0099] opening of 56), the curved section (55) extending distally from the proximal section. (See Fig. 4).
Regarding claim 5, Lew teaches wherein the inside surface of the bushing (50) also includes a sloped section (57) that extends proximally from the curved section (55). (See Fig. 5).
Regarding claim 6, Lew illustrates (Fig. 8) wherein the port (184) is angled towards the bushing (50).
Regarding claim 7, Lew illustrates (Fig. 4) wherein the inside surface of the bushing (50) includes a sloped section (57) that extends between a distal end (68) of the bushing (50) and a proximal opening (Paragraph [0099] opening of 56) of the bushing (50).
Regarding claim 8, Lew illustrates (Fig. 4) wherein the sloped section (57) intersects with an outer surface of the bushing (50) at the proximal opening (Paragraph [0099] opening of 56). (See Fig. 4).
Regarding claim 10, Lew illustrates (Fig. 4) wherein the inside surface includes a proximal section (proximal end 56) positioned at a proximal opening (Paragraph [0099] opening of 56) of the bushing (50) and a sloped section (57) that extends between the proximal section and a distal end (68) of the bushing (50). (See Fig. 4).
Regarding claim 11, Lew illustrates (Fig. 4) wherein a proximal end of the proximal section is curved (i.e., curved section formed at the distal end 57 between the elongated distal seat 70 and the conical or funnel shaped tapered seat 55).
Regarding claim 12, Lew illustrates (Fig. 4) wherein the inside surface includes a proximal section (56) positioned at a proximal opening of the bushing (50), a rounded section within the proximal section (i.e., cross-section of conical or funnel shaped tapered seat is round), a curved section (i.e., curved section formed at the distal end 57 and the conical or funnel shaped tapered seat 55) that extends distally from the proximal section (56) (Fig. 4), and a sloped section (57) that extends between the curved section (55) and a distal end (68) of the bushing (50). (See Fig. 4)
Regarding claim 13, Lew teaches wherein the bushing is formed of plastic, metal, or rubber. (Paragraph [0098]).
Regarding claim 14, Lew teaches a catheter strain relief feature (nose section 118) disposed around the catheter distal to the catheter adapter. (See Fig. 3)
Regarding claim 15, Lew illustrates (Fig. 4) a bushing (50) for a ported catheter (Fig. 8, port 184) comprising: a distal end (68) that is configured to secure a catheter within a catheter adapter (101) of the ported catheter; a proximal opening (Paragraph [0099] opening of 56); and an inside surface including a curved section extending distally from the proximate opening that is configured to facilitate insertion of a tube (140) of a blood draw device or other vascular probe or instrument into the catheter, wherein a diameter of the curved section decreases distally from the proximal opening. (See Fig. 7).
and an inside surface including a curved section extending distally from the proximate opening (See annotated Fig. 4) that is configured to facilitate insertion of a tube of a blood draw device or other vascular probe or instrument into the catheter, wherein a diameter of the curved section decreases distally from the proximal opening. (See annotated Fig. 4).
Regarding claim 17, Lew illustrates (Fig. 4) wherein the inside surface also includes a sloped section (57) and a proximal section (56), and wherein the curved section (i.e., curved section formed at the distal end 57 and the conical or funnel shaped tapered seat 55) is positioned between the sloped section (57) and the proximal section (56).
Regarding claim 18, Lew illustrates wherein the curved section (i.e., curved section formed at the distal end 57 and the conical or funnel shaped tapered seat 55) extends between the proximal opening (Paragraph [0099] opening of 56) and the distal end (68). (See Fig. 4)
Regarding claim 19, Lew illustrates wherein the inside surface includes a slanted section (55). (See Fig. 4).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lew in view of Licata (ES 2242304) (previously cited).
Regarding claim 9, Lew teaches wherein the inside surface of the bushing (50) includes a curved section (55) that extends between a distal end (68) of the bushing (50) and a proximal opening (56) of the bushing (50); however, Lew does not teach “the curved section having a convex cross-sectional shape.”
Licata, in a related field of endeavor, illustrates (Fig. 2) a medical introduction device comprising a bushing (17) wherein the curved section (34) has a convex cross-sectional shape. (See Fig. 2; Page 6, lines 11-12 of Machine Translation).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Lew such that the curved section of the bushing has “a convex cross-sectional shape” as taught by Licata. Doing so may facilitate insertion of the catheter. (Page 6, lines 10-11).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lew in view of Chong (US 20210138200).
Regarding claim 20, Lew illustrates a system for collecting a blood sample (Fig. 1A) comprising: a ported catheter (device 100); and a blood draw device having a tube (140) that is configured to extend through the ported catheter (See Fig. 7); wherein the ported catheter includes a bushing (50) having an inside surface that is configured to facilitate inserting the tube (140) through the ported catheter (100).
However, Lew does not teach “wherein the ported catheter includes an inner surface defining a protrusion extending towards a center longitudinal axis of the ported catheter, a proximal end of the bushing spaced apart distally along a longitudinal axis of the ported catheter from the protrusion”.
Chong, in a related field of endeavor, illustrates (Fig. 3) wherein the ported catheter (100) includes an inner surface defining a protrusion (retainer 95) extending towards a center longitudinal axis of the ported catheter, a proximal end of the bushing (50) spaced apart distally along a longitudinal axis of the ported catheter from the protrusion. (Paragraphs [0230]-[0231]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Lew to teach “wherein the ported catheter includes an inner surface defining a protrusion extending towards a center longitudinal axis of the ported catheter, a proximal end of the bushing spaced apart distally along a longitudinal axis of the ported catheter from the protrusion” as taught by Chong. Doing so may prevent the tapered seat of the bushing from sliding proximally out after snapping into position. (Paragraph [0231]).
Response to Arguments
Applicant's arguments filed 2/12/2026 with respect to claims 1, 4-15 and 17-19 have been fully considered but they are not persuasive. As discussed above, while Lew does not specifically teach “the curved section having a convex cross-sectional shape relative to a center longitudinal axis of the catheter adapter”, the purported advantage of this feature is not sufficiently disclosed nor is the criticality of the purported advantage evident anywhere in the Specification. Hence, it would have been obvious to one or ordinary skill in the art to modify the inside of the bushing to have a curved section with a convex cross-sectional shape relative to a center longitudinal axis of the catheter adapter, in accordance with the design of the Applicant’s invention.
With respect to the rejection of claim 20, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Chong is relied upon for the amended feature.
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 Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OM PATEL/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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