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
Claims 7-11 and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/20/2026.
Applicant’s election without traverse of species A (Figs 3-7) a hub assembly that prevents rotation in the reply filed on 04/20/2026 is acknowledged.
Claim 15 is additionally withdrawn as being drawn to a nonelected species, specifically to Species B (Figs. 8-13), as the locking member is directed to the embodiment shown in Figs. 8-13, particularly in Fig. 10.
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: “one or more features that are adapted to limit relative rotation between the delivery sheath assembly and the hub assembly” in claim 1.
The claim limitation “one or more features that are adapted to limit relative rotation between the delivery sheath assembly and the hub assembly” invokes U.S.C. 112(f) because the term “features” is a generic placeholder with not specific structural meaning further modified by the functional language “adapted to limit relative rotation” further modified by being between the delivery sheath assembly and the hub assembly, however this is not enough sufficient structure to perform the recited function. For the purpose of prior art examination this limitation will be interpreted as “a protrusion” see [0079] of applicant’s specification as the protrusion limit the relative rotation between the distal hub and the hub body.
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.
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.
Claim 20 is 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 20 is recites the limitation "the distal hub" in line 9. There is insufficient antecedent basis for this limitation in the claim. For the purpose of prior art interpretation this limitation will be interpreted as “the Luer fitting”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sutton et al (US 20030181942 A1), herein referenced to as “Sutton”
Claim 1
Sutton discloses: A delivery system 800a + 700 (see Figs. 2 and 6-7, [0072]) for an occlusive implant 700 (see Figs. 3c, 13A-13C, [072]) the delivery system 800a + 700 comprising: a delivery sheath assembly 800a (see Figs. 6-7, [0097[) comprising: a delivery sheath 220 + 230 (see Figs. 6-7, [0097]) extending from a proximal end proximal end of 220 attached to 812 (see Fig. 6) to a distal end distal end of 220 + 230 (see Figs. 3B and 7), the delivery sheath 220 defining a delivery lumen the lumen of 220 + 230 (see Figs. 3B and 7, [0097]-[0098]) extending therethrough, the delivery lumen the lumen of 220 + 230 adapted to accommodate an occlusive implant 700 (see Fig. 3B, [0098]) releasably secured to a core wire 410 (see Figs. 3b-3c, [0098]); and a proximal fitting 812 (see Figs. 6-7 and Figs. 17a-18b, [0100]) secured to the proximal end proximal end of 220 attached to 812 (see Fig. 6) of the delivery sheath 220 + 230; a hub assembly 810 (see Figs. 6-7, [0097]) adapted to be rotatably coupled with the delivery sheath assembly 220 + 230 (see Figs. 12a-12d, [0097]-[0098], [0102], and [0107], rotatably mounted like luer-type lock fittings), the hub assembly 810 comprising: a hub body the body of 810 (see Figs. 6-7 and 17a-17c); a distal hub 552 (see Figs. 17a-18b, [0107] and [0111]) secured relative to the hub body the body of 810 via 852 (see Figs. 17a-18b, [0107]) and adapted to engage the proximal fitting 812 (see [0111]) of the delivery sheath assembly 800a; a proximal hub proximal hub attached to 815 (see Figs. 17a-18b, [0111]) secured to the hub body 810, the proximal hub proximal hub attached to 815 adapted to accommodate the core wire 410 (see Figs. 17a-18b, [0111], core wire 410 extending through the proximal hub) extending through the proximal hub proximal hub attached to 815; and a side port 814 (see Figs. 17A-18b, [0097]) coupled to hub body 810 and adapted for flushing an interior (see [0097], flushing and contrast injection) of the delivery system 800a + 700, wherein the delivery system 800a + 700 includes one or more features tips of 852 (see Figs. 17a and 17c, [0107], meets 112f interpretation of a “protrusion”) that are adapted to limit relative rotation between the delivery sheath assembly and the hub assembly when the core wire is rotationally locked to the proximal hub.
The language, " that are adapted to limit relative rotation between the delivery sheath assembly and the hub assembly when the core wire is rotationally locked to the proximal hub," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Sutton meets the structural limitations of the claim, and is capable of the tips of 852 to limit rotation by securing to 514 while the tether 410 is held (see [0111]).
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-5, 12-13, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutton et al (US 20030181942 A1), herein referenced to as “Sutton” in view of Kriheli et al (US 20240009082 A1), herein referenced to as “Kriheli”.
Claim 2
Sutton discloses: The delivery system of claim 1, see 102 rejection above. Sutton does not explicitly disclose: wherein the proximal fitting comprises a Luer fitting.
However, Kriheli in a similar field of invention teaches a delivery system 1 (see Figs. 1-3I) with a proximal fitting 110A (see Figs. 1-3I) and a hub assembly 20 (see Fig. 3A) with a distal hub 110 (see Fig. 3A). Kriheli further teaches: wherein the proximal fitting 100A comprises a Luer fitting (see [0263], luer lock connection port).
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 proximal fitting of Sutton to incorporate the teachings of Kriheli and teach a delivery system with the proximal fitting comprises a Luer fitting. Motivation for such can be found in Kriheli as this ensures inadvertent transfer of hazardous fluids and ensuring proper disconnection and reduction of air pressure from building in the system (see [0003]-[0004] and [0020]).
Claim 3
The combination of Sutton and Kriheli teaches: The delivery system of claim 2, see 103 rejection above. Sutton further discloses: wherein the proximal fitting (will not be examined here due to being an optional claim limitation) and/or the distal hub 552 include one or more features tips of 852 (see Figs. 17a and 17c, [0107], meets 112f interpretation of a “protrusion”) that are adapted to limit relative rotation between the delivery sheath assembly and the hub assembly (see 102 rejection above, functional language).
Claim 4
The combination of Sutton and Kriheli teaches: The delivery system of claim 3, see 103 rejection above. Sutton does not explicitly teach: wherein the distal hub comprises a Luer adaptor.
However, Kriheli in a similar field of invention teaches a delivery system 1 (see Figs. 1-3I) with a proximal fitting 100A (see Figs. 1-3I) and a hub assembly 20 (see Fig. 3A) with a distal hub 110 (see Fig. 3A). Kriheli further teaches: wherein the distal hub 110 comprises a Luer adaptor 110 (see Fig. 3C, [0261], 100 is adapted to fit 230, hence is a luer adaptor).
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 distal hub of Sutton to incorporate the teachings of Kriheli and teach a delivery system with the distal hub comprises a Luer adaptor. Motivation for such can be found in Kriheli as this ensures inadvertent transfer of hazardous fluids and ensuring proper disconnection and reduction of air pressure from building in the system (see [0003]-[0004] and [0020]).
Claim 5
The combination of Sutton and Kriheli teaches: The delivery system of claim 4, see 103 rejection above. Sutton does not explicitly teach: wherein: the Luer adaptor includes a first protruding feature; and a distal region of the hub body includes a second protruding feature adapted to engage the first protruding feature as a result of relative rotation between the Luer adaptor and the hub body; where engagement between the first protruding feature and the second protruding feature limits relative rotation between the Luer adaptor and the hub body to less than 360 degrees.
However, Kriheli in a similar field of invention teaches a delivery system 1 (see Figs. 1-3I) with a proximal fitting 100 (see Figs. 1-3I) and a hub assembly 20 (see Fig. 3A) with a distal hub 110 (see Fig. 3A) with a hub body 210 (see Fig. 3A). Kriheli further teaches: wherein: the Luer adaptor 110 includes a first protruding feature 124 (see Figs. 3A-3C, [0259]) ; and a distal region 210A (see Figs. 3aA-3C, [0261]) of the hub body 210 includes a second protruding feature 232 (see Figs. 3A-3C, [0261]) adapted to engage the first protruding feature 124 as a result of relative rotation (see [0261], rotation between 110 and 210 causes 124 and 232 to come into contact and limits rotation in the clockwise direction when the two are coupled, see [0262]) between the Luer adaptor 110 and the hub body 210; where engagement between the first protruding feature 124 and the second protruding feature 232 limits relative rotation between the Luer adaptor 110 and the hub body 210 to less than 360 degrees (see [0262], restricts rotation in a clockwise direction during the coupling enabled state and furthermore, the angle of rotation between 232 and 124 when twisted to lock is determined by the widths of both, which are non-zero, hence rotation will be restricted at least below 360 degrees).
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 Sutton to incorporate the teachings of Kriheli and teach a delivery system with the Luer adaptor includes a first protruding feature; and a distal region of the hub body includes a second protruding feature adapted to engage the first protruding feature as a result of relative rotation between the Luer adaptor and the hub body; where engagement between the first protruding feature and the second protruding feature limits relative rotation between the Luer adaptor and the hub body to less than 360 degrees. Motivation for such can be found in Kriheli as this allows for selective rotation of the luer to the hub body (see [0262]).
Claim 12
Sutton discloses: A delivery system 800a + 700 (see Figs. 2 and 6-7, [0072]) for an occlusive implant 700 (see Figs. 3c, 13A-13C, [072]) the delivery system 800a + 700 comprising: a delivery sheath 220 + 230 (see Figs. 6-7, [0097]) defining a delivery lumen the lumen of 220 + 230 (see Figs. 3B and 7, [0097]-[0098]) extending therethrough, that is adapted to accommodate an occlusive implant 700 (see Fig. 3B, [0098]) releasably secured to a core wire 410 (see Figs. 3b-3c, [0098]); and a proximal fitting 812 (see Figs. 6-7 and Figs. 17a-18b, [0100]) secured to a proximal end proximal end of 220 attached to 812 (see Fig. 6) of the delivery sheath 220 + 230; a hub body the body of 810 (see Figs. 6-7 and 17a-17c); a distal hub 552 (see Figs. 17a-18b, [0107] and [0111]) secured relative to the hub body the body of 810 via 852 (see Figs. 17a-18b, [0107]) and adapted to engage the proximal fitting 812 (see [0111]); a proximal hub proximal hub attached to 815 (see Figs. 17a-18b, [0111]) secured to the hub body 810, the proximal hub proximal hub attached to 815 adapted to accommodate the core wire 410 (see Figs. 17a-18b, [0111], core wire 410 extending through the proximal hub) extending through the proximal hub proximal hub attached to 815; wherein the proximal fitting 812 and/or the distal hub includes one or more features tips of 852 (see Figs. 17a and 17c, [0107], meets 112f interpretation of a “protrusion”) that are adapted to limit relative rotation between the delivery sheath assembly and the hub assembly when the core wire is rotationally locked to the proximal hub.
The language, " that are adapted to limit relative rotation between the delivery sheath assembly and the hub assembly when the core wire is rotationally locked to the proximal hub," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Sutton meets the structural limitations of the claim, and is capable of the tips of 852 to limit rotation by securing to 514 while the tether 410 is held (see [0111]).
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Sutton does not explicitly teach: wherein the proximal fitting is a Luer fitting and the distal hub is a Luer adaptor.
However, Kriheli in a similar field of invention teaches a delivery system 1 (see Figs. 1-3I) with a proximal fitting 110A (see Figs. 1-3I) and a hub assembly 20 (see Fig. 3A) with a distal hub 110 (see Fig. 3A). Kriheli further teaches: wherein the proximal fitting 100A comprises a Luer fitting (see [0263], luer lock connection port) and wherein the distal hub 110 comprises a Luer adaptor 110 (see Fig. 3C, [0261], 100 is adapted to fit 230, hence is a luer adaptor).
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 proximal fitting of Sutton to incorporate the teachings of Kriheli and teach a delivery system with the proximal fitting comprises a Luer fitting and the distal hub is a Luer adaptor. Motivation for such can be found in Kriheli as this ensures inadvertent transfer of hazardous fluids and ensuring proper disconnection and reduction of air pressure from building in the system (see [0003]-[0004] and [0020]).
Claim 13
The combination of Sutton and Kriheli teaches: The delivery system of claim 12, see 103 rejection above. Kriheli further teaches: wherein: the Luer adaptor 110 includes a first protruding feature 124 (see Figs. 3A-3C, [0259]) ; and a distal region 210A (see Figs. 3aA-3C, [0261]) of the hub body 210 includes a second protruding feature 232 (see Figs. 3A-3C, [0261]) adapted to engage the first protruding feature 124 as a result of relative rotation (see [0261], rotation between 110 and 210 causes 124 and 232 to come into contact and limits rotation in the clockwise direction when the two are coupled, see [0262]) between the Luer adaptor 110 and the hub body 210; where engagement between the first protruding feature 124 and the second protruding feature 232 limits relative rotation between the Luer adaptor 110 and the hub body 210 to less than 360 degrees (see [0262], restricts rotation in a clockwise direction during the coupling enabled state and furthermore, the angle of rotation between 232 and 124 when twisted to lock is determined by the widths of both, which are non-zero, hence rotation will be restricted at least below 360 degrees).
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 Sutton to incorporate the teachings of Kriheli and teach a delivery system with the Luer adaptor includes a first protruding feature; and a distal region of the hub body includes a second protruding feature adapted to engage the first protruding feature as a result of relative rotation between the Luer adaptor and the hub body; where engagement between the first protruding feature and the second protruding feature limits relative rotation between the Luer adaptor and the hub body to less than 360 degrees. Motivation for such can be found in Kriheli as this allows for selective rotation of the luer to the hub body (see [0262]).
Claim 20
Sutton discloses: A delivery system 800a + 700 (see Figs. 2 and 6-7, [0072]) for an occlusive implant 700 (see Figs. 3c, 13A-13C, [072]) the delivery system 800a + 700 comprising: a delivery sheath assembly 800a (see Figs. 6-7, [0097[) comprising: a delivery sheath 220 + 230 (see Figs. 6-7, [0097]) defining a delivery lumen the lumen of 220 + 230 (see Figs. 3B and 7, [0097]-[0098]) extending therethrough, an occlusive implant 700 (see Fig. 3B, [0098]) releasably secured to a core wire 410 (see Figs. 3b-3c, [0098]), the occlusive implant 700 and the core wire disposed within the delivery lumen the lumen of 220 + 230 (see Figs. 3B-3C); a proximal fitting 812 (see Figs. 6-7 and Figs. 17a-18b, [0100]) secured to a proximal end proximal end of 220 attached to 812 (see Fig. 6) of the delivery sheath 220 + 230; a hub body the body of 810 (see Figs. 6-7 and 17a-17c); and a distal hub 552 (see Figs. 17a-18b, [0107] and [0111]) secured relative to the hub body the body of 810 via 852 (see Figs. 17a-18b, [0107]) and adapted to engage the proximal fitting 812 (see [0111]); wherein the proximal fitting 812 includes one or more features tips of 852 (see Figs. 17a and 17c, [0107], meets 112f interpretation of a “protrusion”) that are adapted to limit relative rotation between the proximal fitting and the distal hub.
The language, " that are adapted to limit relative rotation between the proximal fitting and the distal hub," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Sutton meets the structural limitations of the claim, and is capable of the tips of 852 to limit rotation by securing to 514 while the tether 410 is held (see [0111]).
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Sutton does not explicitly teach: wherein the proximal fitting is a Luer fitting, the distal hub is a Luer adaptor, and the Luer adaptor includes one or more features.
However, Kriheli in a similar field of invention teaches a delivery system 1 (see Figs. 1-3I) with a proximal fitting 110A (see Figs. 1-3I) and a hub assembly 20 (see Fig. 3A) with a distal hub 110 (see Fig. 3A). Kriheli further teaches: wherein the proximal fitting 100A comprises a Luer fitting (see [0263], luer lock connection port) and wherein the distal hub 110 comprises a Luer adaptor 110 (see Fig. 3C, [0261], 100 is adapted to fit 230, hence is a luer adaptor) and the Luer adaptor 110 includes one or more features 232 (see Figs. 3A-3C, [0261], see [0262], restricts rotation in a clockwise direction during the coupling enabled state and furthermore, the angle of rotation between 232 and 124 when twisted to lock is determined by the widths of both, which are non-zero, hence rotation will be restricted at least below 360 degrees).
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 proximal fitting of Sutton to incorporate the teachings of Kriheli and teach a delivery system with the proximal fitting comprises a Luer fitting and the distal hub is a Luer adaptor and the Luer adaptor includes one or more features. Motivation for such can be found in Kriheli as this ensures inadvertent transfer of hazardous fluids and ensuring proper disconnection and reduction of air pressure from building in the system (see [0003]-[0004] and [0020]) and this allows for selective rotation of the luer to the hub body (see [0262]).
Claim(s) 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutton in view of Kriheli as applied to claim 5 and 13 above, respectively, and further in view of Lashinski et al (US 20250143713 A1), herein referenced to as “Lashinski”.
Claim 6
The combination of Sutton and Kriheli teaches: The delivery system of claim 5, see 103 rejection above. Kriheli further teaches: where engagement between the first protruding feature 124 and the second protruding feature 232 limits relative rotation between the Luer adaptor 110 and the hub body 210 (see [0262], restricts rotation in a clockwise direction during the coupling enabled state and furthermore, the angle of rotation between 232 and 124 when twisted to lock is determined by the widths of both, which are non-zero, hence rotation will be restricted at least below 360 degrees).
The combination of Sutton and Kriheli does not explicitly teach: to about 330 degrees.
However, Lashinski in a similar field of invention teaches a delivery system 8000 (see Fig. 13C) for an occlusive device 6034 (see Fig. 13C) and limited rotation (see [0207], predetermined angle) between a hub body 8084 (see Figs. 9A-9 and 13C) and a distal hub 8011 (see Figs. 9A-9 and 13C). Lashinski further teaches: limits relative rotation to about 330 degrees (see [0207], to 330 degrees).
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 combined connection between the Luer adaptor and hub body of Sutton and Kriheli to incorporate the teachings of Lashinski and teach a delivery system for an occlusive implant with limited relative rotation to about 330 degrees between the Luer adaptor and the hub body. Motivation for such can be found in Lashinski as this can set a predetermined distance for implanting a left atrial appendage occluder to achieve tighter compression of tissue and reduced angle of the fold relative to the longitudinal axis of the device (see [0206]-[0207]).
Claim 14
The combination of Sutton and Kriheli teaches: The delivery system of claim 13, see 103 rejection above. Kriheli further teaches: where engagement between the first protruding feature 124 and the second protruding feature 232 limits relative rotation between the Luer adaptor 110 and the hub body 210 (see [0262], restricts rotation in a clockwise direction during the coupling enabled state and furthermore, the angle of rotation between 232 and 124 when twisted to lock is determined by the widths of both, which are non-zero, hence rotation will be restricted at least below 360 degrees).
The combination of Sutton and Kriheli does not explicitly teach: to about 330 degrees.
However, Lashinski in a similar field of invention teaches a delivery system 8000 (see Fig. 13C) for an occlusive device 6034 (see Fig. 13C) and limited rotation (see [0207], predetermined angle) between a hub body 8084 (see Figs. 9A-9 and 13C) and a distal hub 8011 (see Figs. 9A-9 and 13C). Lashinski further teaches: limits relative rotation to about 330 degrees (see [0207], to 330 degrees).
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 combined connection between the Luer adaptor and hub body of Sutton and Kriheli to incorporate the teachings of Lashinski and teach a delivery system for an occlusive implant with limited relative rotation to about 330 degrees between the Luer adaptor and the hub body. Motivation for such can be found in Lashinski as this can set a predetermined distance for implanting a left atrial appendage occluder to achieve tighter compression of tissue and reduced angle of the fold relative to the longitudinal axis of the device (see [0206]-[0207]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Agrawal et al (US 20180256871 A1) teaches valve device handle for a medical system with rotation limitation
Rothenberg et al (US 20210322749 A1) teaches a luer valve with rotation limitation
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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, Darwin Erezo can be reached at 571-272-4695. 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.
RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
Prosecution Insights