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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 June 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 16 June 2025. As directed by the amendment: claims 1, 14, 20, and 25 have been amended. Thus claims 1-25 are presently pending in this application. Applicant’s amendments to the Claims have overcome each 35 U.S.C. 112(b) rejection previously set forth in the Final Office Action mailed 17 March 2025.
Response to Arguments
As discussed in the interview held on 11 April 2025 with respect to the rejection(s) of claim(s) 1 and as mentioned in REMARKS filed 16 June 2025, the amendments do overcome the rejection, therefore the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Vaucher et al. (US 2022/0379016 A1) as outlined below. Additionally, Hasted et al. (US 2009/0204077 A1) discloses some of the amended limitations and is included as pertinent art.
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: “at least one feature for increasing the rigidity” in claims 4, 7, and 16. The structure that corresponds to at least one feature for increasing the rigidity includes ribs, projections, and structures that extend along the axial length as described in paragraph [0038] of the specification.
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 § 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.
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) 1-4, 7, 9-13, and 20-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mejlhede et al. (US 7887737 B2) in view of Smith et al. (US 2017/0232191 A1) and Vaucher et al. (US 2022/0379016 A1).
Regarding claim 1, Mejlhede et al. discloses a cannula (Figs 1-3) comprising a tubular body (See the tubular shape of the cannula in Figs 1-3) having an axial length (see the dashed line in Fig 2) and through which a flow channel extends (See the flow channel along the longitudinal axis in Fig 2), the tubular body comprising: a first end (the bottom end in Fig 2) for insertion into a subject (Col 1 lines 35-37 “The tube-shaped flexible part is adapted for insertion into a patient), the first end being open (See open end in Fig 2) in flow communication with the flow channel (Col 1 lines 35-37 “and it facilitates the fluid transport to or from a body cavity.”); a second end (the top end in Fig 2) configured to be held within a base of a medical device (Col 1 lines 42-44 “The hub is the connecting means on the tube shaped part adapted for connecting the tube shaped part to either the drug delivery devise”), a first length portion (See 1st length portion in annotated Fig 2 below, “tube-shaped part” 4 Fig 1) extending along the axial length from the first end toward the second end, the first length portion having an outer dimension (see the outer diameter at 8 Fig 2), an inner dimension (ID) (see the inner dimension at 8 Fig 2) and at least one tubing wall thickness (see the tubing thickness at 8 Fig 2); a second length portion (See 2nd length portion in annotated Fig 2 below) extending along the axial length from the first length portion toward the second end, the second length portion having an outer dimension that flares outward to be larger than the outer dimension of the first length portion (See the flare in zone 6 fig 2, Col 6 lines 38-40 “the hub decreases its diameter in a zone (6) until it has the same diameter as the tube-shaped part which begins at (7).”), the second length portion having a tubing wall thickness (see the tubing thickness at the top of the flare in zone 6 Fig 2) that is greater than the at least one tubing wall thickness of the first length portion (See the thicknesses of 1st and 2nd length portions in Fig 2); a third length portion (rim 2 Fig 1, See 3rd length portion in annotated Fig 2 below) extending along the axial length from the second length portion to the second end of the tubular body, the third length portion having a flat and top-most end surface (the flat top-most end surface as shown in annotated Fig 2 below).
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However, Mejlhede et al. fails to disclose the flat and top-most end surface that fully surrounds an opening into the flow channel, the third length portion has a cross-section shape perpendicular to the axial length, wherein the cross-section shape has a non- round section that comprises a flat edge, wherein the non-round section is configured to inhibit rotation when the third length portion is arranged within a correspondingly shaped receptacle of the base and not inhibit movement of the third length portion along the axial length as the third length portion is arranged within the correspondingly shaped receptacle of the base.
Smith et al. teaches a top-most end surface that fully surrounds an opening into the flow channel (as shown in Fig 10B, the top-most end surface of cannula 541 fully surrounds the opening into the cannula). It would have been obvious to one of ordinary skill in the art at the time of effective filing to make the flat and top-most end surface of Mejlhede et al. fully surround the opening into the flow channel as taught by Smith et al. to allow a seal between a septum that will prevent fluid from flowing through the sides of the cannula when fluid is being introduced from above the cannula as shown in Smith et al. as opposed to through the sides of the cannula. This modification would result in the removal of the cut outs (1 Fig 1) of Mejlhede et al., making the flat end surface continuous to allow the formation of a seal against the septum. The configuration taught by Smith et al. allows a trocar to form a seal to prevent dispensing of medicament until proper activation by a user [0102].
Vaucher et al. teaches a third length portion (204 Fig 12A) has a cross-section shape (the cross section is best seen in Fig 12A) having a non- round section that comprises a flat edge (the flat edges on both sides of 204 that extend into wings 207 and include clips 206 Fig 12A), wherein the non-round section is configured to inhibit rotation when the third length portion is arranged within a correspondingly shaped receptacle (See Fig 10E, the flat edges are fit into the corresponding receptacle 106) of the base and not inhibit movement of the third length portion along the axial length as the third length portion is arranged within the correspondingly shaped receptacle of the base (the flat edges slide along the receptacle 106 during cannula insertion as shown in Figs 10A -10B). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the cross-section shape as taught by Vaucher et al. to align the cannula within the base radially “to ensure that cannula is inserted into the wearer's skin at a particular orientation, which may be helpful for aligning radially spaced apertures in the cannula within the wearer's skin” [0201] to target and precisely control the infusion location [0221].
Regarding claim 2, modified Mejlhede et al. teaches the cannula as recited in claim 1. Modified Mejlhede et al. further teaches wherein the first length portion has an outer dimension that is smaller at the first end and increases in size toward the second length portion (See Fig 3, the outer diameter at the end on the right is the smallest and increases to the left, Col 6 lines 46-47 “the cylindrical part is rounded (10)”).
Regarding claim 3, modified Mejlhede et al. teaches the cannula as recited in claim 1. Modified Mejlhede et al. further teaches wherein the ID of the first length portion (the inner diameter at the cylindrical part as shown in Fig 3) is constant along an axial length of the first length portion (the first length includes the end (5) as shown in Fig 2, this is described as a cylindrical part that has a constant inner diameter as shown in Fig 3).
Regarding claim 4, modified Mejlhede et al. teaches the cannula as recited in claim 1, wherein the first length portion has at least one feature for increasing the rigidity of at least a section of the first length portion (Col 3 lines 56-59 “Preferably soft needle catheters are composed of a material which are sufficiently flexible to bend, when the carrier moves and sufficiently rigid to avoid kinking closing off the drug supply.”- see the 112f interpretation above, the material selected for the first length portion is a feature for increasing rigidity and it is part of a structure that extends along the axial length in the form of the side wall of the tubing).
Regarding claim 7, modified Mejlhede et al. discloses the cannula as recited in claim 1. Modified Mejlhede et al. further teaches wherein a section of the flow channel in the first length portion has at least one feature for increasing the rigidity of a section of the first length portion located adjacent the second length portion (Col 3 lines 56-59 “Preferably soft needle catheters are composed of a material which are sufficiently flexible to bend, when the carrier moves and sufficiently rigid to avoid kinking closing off the drug supply.”- see the 112f interpretation above, the material selected for the section of the first length portion located adjacent the second length portion is a feature for increasing rigidity and it is part of a structure that extends along the axial length in the form of the side wall of the tubing).
Regarding claim 9, modified Mejlhede et al. teaches the cannula as recited in claim 1. Modified Mejlhede et al. further discloses wherein the second length portion has an outer surface (See the outer surface of hub 3 Fig 1) that is configured to engage a surface of a medical device (Col 1 lines 42-44 “The hub is the connecting means on the tube shaped part adapted for connecting the tube shaped part to either the drug delivery devise”) to provide a liquid seal (The hub is fully capable of providing a liquid tight seal), the outer surface being parallel to the axial dimension (See the outer surface of the hub 3 in Fig 2).
Regarding claim 10, modified Mejlhede et al. discloses the cannula as recited in claim 1. Modified Mejlhede et al. further discloses wherein the second length portion has an inner dimension (See the inner dimension at the top of the flare in zone 6 Fig 2) that is greater than the inner dimension of the first length portion (Col 6 lines 30-33 “the core. (9) has a cone-shaped part extending into the tube-shaped part (from the top to (8)) and a cylindrical part (from, (8) and the rest of the core))”, as shown in Fig 2, the cone shaped part narrows from the 2nd end towards the first end, thus the inner dimension of the first length portion is more narrow that the inner dimensions of the second length portion) and is configured to receive a needle guide (the interior of the second length portion is hollow and is fully capable of receiving a needle guide therewithin, Fig 2).
Regarding claim 11, modified Mejlhede et al. discloses the cannula as recited in claim 1. Modified Mejlhede et al. further discloses wherein the second length portion has a further section that extends from the flared section, substantially parallel to the axial length (See the outer surface of the 2nd length portion that is parallel to the axial length in Fig 2).
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Regarding claim 12, modified Mejlhede et al. teaches the cannula as recited in claim 1. Modified Mejlhede et al. further discloses the third length portion having an outer dimension that is greater than the outer dimension of the second length portion (See the outer diameter of the 3rd length portion at the second end being larger than the outer diameter of the hub 3 Fig 1 and 2), the third length portion configured to be received in the medical device (the third length portion is part of the hub which is configured to be received in the medical device, Col 1 lines 42-44 “The hub is the connecting means on the tube shaped part adapted for connecting the tube shaped part to either the drug delivery devise”).
Regarding claim 13, modified Mejlhede et al. further discloses the medical device comprising the cannula of claim 1 (Although the medical device is not described in detail or shown in the Figures, it is described as receiving the cannula, Col 1 lines 42-44 “The hub is the connecting means on the tube shaped part adapted for connecting the tube shaped part to either the drug delivery devise”).
Regarding claim 21, modified Mejlhede et al. teaches the medical device of claim 13 wherein the end surface of the third length portion defines the second end of the tubular body (the angled inner wall of the third length portion defines the second end of the cannula as no part of the cannula extends beyond it in the axial direction). However, modified Mejlhede et al. fails to teach further comprising a needle guide; and wherein the needle guide has a shaft section and a flange section, the shaft section extending into the second length portion of the tubular body, the flange section extending over the second end of the tubular body.
Smith et al. teaches a needle guide (642 Fig 11A,); and wherein the needle guide has a shaft section and a flange section (See the sections in annotated Fig 11A below), the shaft section extending into the second length portion of the tubular body, the flange section extending over the second end of the tubular body (See the assembly in Fig 11B, the flange rests on and extends over the end surface of the third length portion). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the medical device of modified Mejlhede et al. to include a needle guide with the limitations as taught by Smith et al. to “guides trocar 647 into place within cannula 641 during assembly and prevents the sharp end of the trocar from piercing the cannula.” [0103]
Regarding claim 22, modified Mejlhede et al. teaches the medical device of claim 21. Modified Mejlhede et al. further teaches wherein the flange section of the needle guide abuts the end surface of the third length portion (the flange taught by Smith et al. fits within the funnel shape of the third length portion, in the device of modified Mejlhede et al., the needle guide would fit within the funnel shaped opening which is formed by the end surface of the third length portion).
Regarding claim 23, modified Mejlhede et al. teaches the medical device of claim 21. Modified Mejlhede et al. further teaches wherein a cross-section shape of the flange section of the needle guide (a cross-section is shown in Fig 11A, taken parallel to the axial dimension) has a non-round section that inhibits rotation when the needle guide is received in the third length portion of the tubular body and the third length portion is arranged within a correspondingly shaped receptacle of the base (the cross section shown in Fig 11A is non-round, it has a funnel shape that corresponds to a funnel shape it is inserted into, the funnel shape would prevent rotation about an axis perpendicular to the axial dimension).
Regarding claim 20, Mejlhede et al. discloses a method of making cannula having a tubular body (Col 2 lines 52-54 “Another aspect of the invention relates to a method for one-piece injection moulding of a soft needle catheter comprising a hub and a tube-shaped flexible part”) with an axial length (see the dashed line in Fig 2) and through which a flow channel extends (See the flow channel along the longitudinal axis in Fig 2), the method comprising: providing a mold for forming a tubular body (Col 2 lines 47-51 “there is provided a mould comprising a hub cavity, a tube-shaped cavity and a core having a cone-shaped part and a cylindrical part being characterized in that the cone-shaped part of the core extends into the tube-shaped cavity.”) having (The moulding described forms the device shown in Figs 1-3): a first end (the bottom end in Fig 2) for insertion into a subject (Col 1 lines 35-37 “The tube-shaped flexible part is adapted for insertion into a patient), the first end being open (See open end in Fig 2) in flow communication with a flow channel (Col 1 lines 35-37 “and it facilitates the fluid transport to or from a body cavity.”); a second end (the top end in Fig 2) configured to be held within a base of a medical device (Col 1 lines 42-44 “The hub is the connecting means on the tube shaped part adapted for connecting the tube shaped part to either the drug delivery devise”), a first length portion (See 1st length portion in annotated Fig 2 below, “tube-shaped part” 4 Fig 1) extending along the axial length from the first end toward the second end, the first length portion having an outer dimension (see the outer dimension at 8 Fig 2) and at least one tubing wall thickness (see the tubing thickness at 8 Fig 2); a second length portion (See 2nd length portion in annotated Fig 2 below) extending along the axial length from the first length portion toward the second end, the second length portion having an outer dimension that flares outward to be larger than the outer dimension of the first length portion (See the flare in zone 6 Fig 2, Col 6 lines 38-40 “the hub decreases its diameter in a zone (6) until it has the same diameter as the tube-shaped part which begins at (7).”), the second length portion having a tubing wall thickness (see the tubing thickness at the top of the flare in zone 6 Fig 2) that is greater than the at least one tubing wall thickness of the first length portion (See the thicknesses of 1st and 2nd length portions in Fig 2); a third length portion (rim 2 Fig 1, See 3rd length portion in annotated Fig 2 below) extending along the axial length from the second length portion to the second end of the tubular body, the third length portion having a flat and top-most end surface (the flat and top-most end surface as shown in annotated Fig 2 below); and adding a moldable material to the mold to form the cannula in the mold (Col 3 lines 20-21 “molten polymer is fed into a mould”).
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However, Mejlhede et al. fails to disclose the flat and top-most end surface fully surrounds an opening into the flow channel, the third length portion has a cross-section shape perpendicular to the axial length, wherein the cross-section shape has a non-round section, wherein the non-round section is configured to inhibit rotation when the third length portion is arranged within a correspondingly shaped receptacle of the base.
Smith et al. teaches a top-most end surface that fully surrounds an opening into the flow channel (as shown in Fig 10B, the top-most end surface of cannula 541 fully surrounds the opening into the cannula). It would have been obvious to one of ordinary skill in the art at the time of effective filing to make the flat and top-most end surface of Mejlhede et al. fully surround the opening into the flow channel as taught by Smith et al. to allow a seal between a septum that will prevent fluid from flowing through the sides of the cannula when fluid is being introduced from above the cannula as shown in Smith et al. as opposed to through the sides of the cannula. This modification would result in the removal of the cut outs (1 Fig 1) of Mejlhede et al., making the flat end surface continuous to allow the formation of a seal against the septum. The configuration taught by Smith et al. allows a trocar to form a seal to prevention dispensing of medicament until proper activation by a user [0102].
Vaucher et al. teaches a third length portion (204 Fig 12A) has a cross-section shape (the cross section is best seen in Fig 12A) having a non- round section that comprises a flat edge (the flat edges on both sides of 204 that extend into wings 207 and include clips 206 Fig 12A), wherein the non-round section is configured to inhibit rotation when the third length portion is arranged within a correspondingly shaped receptacle (See Fig 10E, the flat edges are fit into the corresponding receptacle 106) of the base and not inhibit movement of the third length portion along the axial length as the third length portion is arranged within the correspondingly shaped receptacle of the base (the flat edges slide along the receptacle 106 during cannula insertion as shown in Figs 10A -10B). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the cross-section shape as taught by Vaucher et al. to align the cannula within the base radially “to ensure that cannula is inserted into the wearer's skin at a particular orientation, which may be helpful for aligning radially spaced apertures in the cannula within the wearer's skin” [0201] to target and precisely control the infusion location [0221].
Regarding claim 24, modified Smith et al. teaches the medical device of claim 14. Smith et al. further teaches wherein the flange section of the needle guide abuts the end surface of the third length portion (the flange section of the needle guide fits within the funnel shaped opening which is formed by the end surface of the third length portion as shown in the assembled Fig 11B).
Regarding claim 25, modified Smith et al. teaches the medical device of claim 14. Smith et al. further teaches wherein the end surface of the third length portion (the end surface includes the angled/curved inner wall of the third length portion) fully surrounds an opening into the flow channel (the curved inner wall of the third length portion fully surrounds the opening into the flow channel of the third length portion).
Claim(s) 5-6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mejlhede et al. (US 7887737 B2) in view of Smith et al. (US 2017/0232191 A1), Vaucher et al. (US 2022/0379016 A1), and Yavorsky et al. (US 2018/0207355 A1).
Regarding claim 5, modified Mejlhede et al. teaches the cannula as recited in claim 1. However, modified Mejlhede et al. fails to disclose wherein the first length portion has at least one axially extending rib on an inner surface of the flow channel in the first length portion for increasing the rigidity of at least a section of the first length portion.
Yavorsky et al. teaches a cannula wherein the first length portion has at least one axially extending rib (ribs 42 Fig 7A) on an inner surface of the flow channel in the first length portion ([0054] “The ribs can be added in localized areas of the cannula or along the entire length of the cannula.”, when the ribs are added along the entire length of the cannula this would include at least a section of the first length portion) for increasing the rigidity of at least a section of the first length portion [0054]. It would have been obvious to one of ordinary skill in the art at the time of effective filing for the cannula of Mejlhede et al. to include the at least one axially extending rib with the limitations as taught by Yavorsky et al. to “strengthen the internal surface 17 of the cannula wall 15” [0054]. Additionally ribbing “provides resistance to kinking, while overall having a more flexible and comfortable cannula and a greater flow area through the cannula. Ribbing such as a helical or straight ribbed version, where the rib is predominantly triangular in cross section may provide an additional benefit over uniform thickening. Ribbing can allow for a tighter fit along a longer length of the introducer needle without increasing friction between the cannula and the needle by as much as if the entire wall were in contact with the needle. Low friction is beneficial as it reduces the forces needed for insertion needle removal.” [0055]
Regarding claim 6, modified Mejlhede et al. teaches the cannula as recited in claim 5. Modified Mejlhede et al. further teaches wherein the at least one axially extending rib comprises a plurality of axially extending ribs (Yavorsky et al.- See the plurality of ribs 42 in Fig 7A).
Regarding claim 8, modified Mejlhede et al. teaches the cannula as recited in claim 1. However, modified Mejlhede et al. fails to disclose wherein a section of the flow channel in the first length portion adjacent the second length portion has at least one axially extending rib on an inner surface of the flow channel in the first length portion for increasing the rigidity of a section of the first length portion located adjacent the second length portion.
Yavorsky et al. teaches a cannula wherein a section of the flow channel (18 Fig 7A) has at least one axially extending rib (ribs 42 Fig 7A) on an inner surface of the flow channel in the first length portion for increasing the rigidity of a section of the first length portion located adjacent the second length portion ([0054] “The ribs can be added in localized areas of the cannula or along the entire length of the cannula.”, when the ribs are added along the entire length of the cannula this would include a section of the flow channel in the first length portion adjacent the second length portion and would increase the rigidity of the whole cannula including a section of the first length portion located adjacent the second length portion). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the cannula of Mejlhede et al. to include the feature for increasing the rigidity with the limitations as taught by Yavorsky et al. to “strengthen the internal surface 17 of the cannula wall 15” [0054]. Additionally ribbing “provides resistance to kinking, while overall having a more flexible and comfortable cannula and a greater flow area through the cannula. Ribbing such as a helical or straight ribbed version, where the rib is predominantly triangular in cross section may provide an additional benefit over uniform thickening. Ribbing can allow for a tighter fit along a longer length of the introducer needle without increasing friction between the cannula and the needle by as much as if the entire wall were in contact with the needle. Low friction is beneficial as it reduces the forces needed for insertion needle removal.” [0055]
Claim(s) 14-16 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2017/0232191 A1) in view of Vaucher et al. (US 2022/0379016 A1).
Regarding claim 14, Smith et al. discloses a medical device (100a Fig 9A) comprising: a base (638 Fig 11A) having a receptacle (See receptacle in annotated Fig 11A below) and an opening (See opening in annotated Fig 11A below); a needle guide (642 Fig 11A, [0103] “cannula insert 642 guides trocar 647 into place within cannula 641 during assembly and prevents the sharp end of the trocar from piercing the cannula.”); and a cannula (641 Fig 11A) comprising a tubular body (See tubular structure of 641 Fig 11A) extending through the opening in the base (See assembled extension in Fig 11C) and through which a flow channel extends (See flow channel in annotated Fig 11A below), the tubular body having an axial length (See dashed arrow in annotated Fig 11A below), the tubular body comprising: a first end for insertion into a subject (See 1st end in annotated Fig 11A below), the first end being open in flow communication with the flow channel (See the opening in Fig 11A); a second end configured to be held within the receptacle of the base of a medical device (See the assembled position of the 2nd end in Fig 11C); a first length portion extending along the axial length from the first end toward the second end (See 1st length portion in annotated Fig 11A below), the first length portion having an outer dimension and at least one tubing wall thickness (See the tapering outer dimension and the tapering thickness of the tubing wall at the first end of the 1st length portion Fig 11A); a second length portion (See 2nd length portion in annotated Fig 11A below) extending along the axial length from the first length portion toward the second end, the second length portion having an outer dimension that flares outward to be larger than the outer dimension of the first length portion (See the flare at the bottom of the 2nd length portion in annotated Fig 11A below), the second length portion having a tubing wall thickness that is greater than each of the at least one tubing wall thicknesses of the first length portion (the thickness of the 2nd length portion is thicker than the tapered 1st end of the first length portion Fig 11A), and a third length portion (See 3rd length portion in annotated Fig 11A below) extending along the axial length from the second length portion to the second end of the tubular body, the third length portion having an end surface that defines the second end of the tubular body (the end surface includes the angled/curved inner wall of the third length portion); wherein the first length portion extends along the axial length a greater distance than the combined second length portion and third length portion extends along the axial length (See the length of the first length portion extending a greater distance than both the second and third lengths combined in annotated Fig 11A below); and wherein the needle guide has a shaft section and a flange section (See the sections in annotated Fig 11A below), the shaft section extending into the second length portion of the tubular body, the flange section extending over the second end of the tubular body (See the assembly in Fig 11B, the flange rests on and extends over the end surface of the third length portion).
However, Smith et al. fails to disclose the third length portion has a cross-section shape having a non-round section that comprises a flat edge, wherein the non-round section is configured to inhibit rotation when the third length portion is arranged within a correspondingly shaped receptacle of the base and not inhibit movement of the third length portion along the axial length as the third length portion is arranged within the correspondingly shaped receptacle of the base.
Vaucher et al. teaches a third length portion (204 Fig 12A) has a cross-section shape (the cross section is best seen in Fig 12A) having a non- round section that comprises a flat edge (the flat edges on both sides of 204 that extend into wings 207 and include clips 206 Fig 12A), wherein the non-round section is configured to inhibit rotation when the third length portion is arranged within a correspondingly shaped receptacle (See Fig 10E, the flat edges are fit into the corresponding receptacle 106) of the base and not inhibit movement of the third length portion along the axial length as the third length portion is arranged within the correspondingly shaped receptacle of the base (the flat edges slide along the receptacle 106 during cannula insertion as shown in Figs 10A -10B). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the cross-section shape as taught by Vaucher et al. to align the cannula within the base radially “to ensure that cannula is inserted into the wearer's skin at a particular orientation, which may be helpful for aligning radially spaced apertures in the cannula within the wearer's skin” [0201] to target and precisely control the infusion location [0221].
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Regarding claim 15, modified Smith et al. discloses the medical device as recited in claim 14. Smith et al. further discloses wherein the first length portion has an outer dimension that is smaller at the first end and increases in size toward the second length portion (See the outer dimension of the tapered section at the 1st end increasing).
Regarding claim 16, modified Smith et al. discloses the medical device as recited in claim 14. Smith et al. further teaches wherein the first length portion has at least one feature for increasing the rigidity of at least a section of the first length portion ([01013] “Cannula 641 may be made of polytetrafluoroethylene (PTFE), such as TEFLON® PTFE, or other biocompatible polymeric material”- see the 112f interpretation above, the material selected for the cannula construction is a feature for increasing rigidity and it is part of a structure that extends along the axial length in the form of the side wall of the tubing).
Regarding claim 18, modified Smith et al. discloses the medical device as recited in claim 14. Smith et al. further teaches wherein the second length portion has an outer surface that is configured to engage a surface of the opening in the base to provide a liquid seal ([0103] “Cannula insert 642 holds cannula 641 in place and seals cannula 641 against reservoir outlet 638.”, the cannula insert 642 seals the second length portion as shown in assembled Fig 11C, this seal would be a fluid tight seal to prevent the fluid that would flow through the cannula from infiltrating into a space between the components), the outer surface being parallel to the axial length (See the outer surface in Figs 11A and 11C being parallel to the axial length).
Regarding claim 19, modified Smith et al. discloses the medical device as recited in claim 14. Smith et al. further discloses wherein the second length portion has an inner dimension that is greater than the inner dimension of the first length portion (See the inner diameter of the second portion above the flair being larger that the inner diameter of the first portion in annotated Fig 11A below), the needle guide being received in the inner dimension of the second length portion (See the position of the cannula insert 642 within the larger diameter of the second length in the assembled Fig 11C).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2017/0232191 A1) in view of Vaucher et al. (US 2022/0379016 A1) and Yavorsky et al. (US 2018/0207355 A1).
Regarding claim 17, modified Smith et al. discloses the medical device as recited in claim 14. However, modified Smith et al. fails to teach wherein first length portion has at least one axially extending rib on an inner surface of the flow channel in the first length portion for increasing the rigidity of at least a section of the first length portion.
Yavorsky et al. teaches a cannula wherein the first length portion has at least one axially extending rib (ribs 42 Fig 7A) on an inner surface of the flow channel om the first length portion for increasing the rigidity of at least a section of the first length portion ([0054] “The ribs can be added in localized areas of the cannula or along the entire length of the cannula.”, when the ribs are added along the entire length of the cannula this would include the first length portion). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the cannula of Smith et al. to include the feature for increasing the rigidity with the limitations as taught by Yavorsky et al. to “strengthen the internal surface 17 of the cannula wall 15” [0054]. Additionally ribbing “provides resistance to kinking, while overall having a more flexible and comfortable cannula and a greater flow area through the cannula. Ribbing such as a helical or straight ribbed version, where the rib is predominantly triangular in cross section may provide an additional benefit over uniform thickening. Ribbing can allow for a tighter fit along a longer length of the introducer needle without increasing friction between the cannula and the needle by as much as if the entire wall were in contact with the needle. Low friction is beneficial as it reduces the forces needed for insertion needle removal.” [0055]
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hasted et al. (US 2009/0204077 A1) discloses a cannula assembly that has a cross-section shape that has a non-round section that comprises a flat edge, and a top-most end surface that fully surrounds an opening into a flow channel.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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