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 .
Status of the Application
This Office action is in response to the amendment of April 24, 2023 which amended claims 3-8, 12, 14-16, 20-24, 26 and 30.
Specification
The disclosure is objected to because of the following informalities: on page 12, line 5, “to the vessel wall.,” should be “to the vessel wall.”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: mechanism for controlling the maximum needle extension depth in claim 25.
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 § 102
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 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) 1-5, 7, 8, 16, 22, 24 and 30 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Wang (USPN 8,083,726).
With regards to claim 1, Wang discloses (see Figs.4-7) a drug delivery device (300) comprising:
an axially extending elongate member (312) having a proximal portion (313), a distal portion (314), a first lumen (328) and a second lumen (lumina housing needles (334), (336));
an inflatable balloon (320) coupled to the distal portion (314) of the axially extending elongate member (312), the inflatable balloon (320) having a proximal end (right end of Fig. 4) and a distal end (left end of Fig. 4) that are coupled together by a working portion (see Fig.4, the outer cylindrical surface of 320), the balloon (320) having an exterior surface and an interior surface that defines a balloon chamber (clearly shown inside 320 in Fig. 4), where the first lumen (328) of the axially extending elongate member (312) is in fluid communication with the balloon chamber;
two or more (see Col.5, line 58-67) guiding cannulas (330,332), each having a proximal portion (right end in Fig. 4) and a distal portion (left end in Fig.4), wherein the proximal portion of each guiding cannula is coupled to the axially extending elongate member (312),
two or more (see Col.5, line 58-67) needles (334, 336), each having a lumen and being housed within one of the two or more guiding cannulas (330, 332), such that each needle (334, 336) is reversibly extendable from the distal portion of the guiding cannula (330, 332) that houses it, and wherein the second lumen (lumina housing needles 334,336) of the axially extending elongate member (312) is fluidly connectable to the lumen of each needle (334,336),
wherein, when the inflatable balloon (320) is inflated, the distal portion of each of the two or more guiding cannulas (330,332) do not extend beyond an outermost diameter (see Col. 10, lines 4-8: "a distal end of each of delivery cannula 330 and delivery cannula 332 extend to a point equivalent to or less than a length of proximal taper wall 322 of balloon 320") of the exterior surface of the inflatable balloon (320).
With regards to claim 2 Wang discloses the drug delivery device of claim 1 as set forth above, wherein the inflatable balloon (320) being coupled to the distal end (314) of the axially extending elongate member (312).
With regards to claim 3 Wang discloses the drug delivery device of claim 2 as set forth above, further comprising a balloon support element (318 and the wall within 325 shown in Figs. 5-7) within the balloon (320).
With regards to claim 4 Wang discloses the drug delivery device of claim 1 as set forth above, wherein the elongate member (312) comprises a third lumen (316).
With regards to claim 5 Wang discloses the drug delivery device of claim 1 as set forth above, wherein the balloon (320) is disposed over the distal portion (314) of the elongate member (312), see Fig. 4.
With regards to claim 7 Wang discloses the drug delivery device of claim 1 as set forth above, wherein the guiding cannula (330, 332 shown holding needles 334, 336) are disposed around the circumference of the axially extending elongate member at substantially evenly spaced intervals (see Fig. 6).
With regards to claim 8 Wang discloses the drug delivery device of claim 1 as set forth above, wherein the distal portions of the guiding cannulas (330, 332) are configured to contact the exterior surface of the inflatable balloon (see col. 10 lines 4-13 setting forth that the distal ends of the cannulas 330, 332 are glued to the outer surface of the balloon 320 and would thus move with the balloon) and move with the exterior surface of the inflatable balloon as the inflatable balloon is inflated.
With regards to claim 16 Wang discloses the drug delivery device of claim 1 as set forth above, wherein the needles are retractable (see col. 9, lines 52-57), since the needles extend through separate guiding cannulas they are capable of being simultaneously reversibly extendable.
With regards to claim 22 Wang discloses the drug delivery device of claim 1 as set forth above, wherein the device is a rapid exchange or over the wire catheter (see col 8, lines 18-24).
With regards to claim 24 Wang discloses the drug delivery device of claim 1 as set forth above, further comprising a handle 340 disposed at the proximal end (the right end in Fig. 4) of the axially extending elongate member.
With regards to claim 30 Wang discloses the drug delivery device of claim 1 as set forth above, wherein the guiding cannulas (330, 332) comprise a curved portion at their distal end and each needle (334, 336) comprises a curved end portion, wherein the distal portions of the guiding cannulas (330, 332) contact the exterior surface of the inflatable balloon (320) and move with the balloon exterior as the balloon (320) is inflated and the guiding cannulas (330, 332) are able to revert back to their original shape after the balloon (320) is deflated.
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Minoletti et al (USPAP 2015/0297870).
As set forth above Wang discloses the invention substantially as claimed but does not disclose wherein each guiding cannula comprises slits cut into one side of the guiding cannula. Minoletti et al disclose a similar drug delivery device including a cannula (16) having such slits (153) in a similar balloon catheter arrangement (see Figs.1 and 5A-B).
Thus, it would have been obvious to one of ordinary skill in the art to use the common technique of cutting slits into the sides of the guiding cannulas in the device Wang as taught by Minoletti et al. Using the known technique of cutting slits in the cannula sides provides the desired feature of increasing the flexibility of the deformable guiding cannula. KSR Int’l Co. V. Teleflex Inc. 550 U.S. ___, 82 USPQ 2d 1385 (Supreme Court 2007) (KSR).
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Muni et al (USPAP 2009/0028923).
As set forth above Wang discloses the invention substantially as claimed but does not disclose the device further comprising a sheath disposed over the axially extending elongate member, wherein the sheath has an extended state and a retracted state, and wherein in the extended state the sheath covers the entirety of the two or more cannula and at least part of the inflatable balloon, and in the retracted state the sheath does not cover a part of the inflatable balloon. Muni et al discloses a similar drug delivery device including a sheath 30 disposed over the axially extending elongate member 12, wherein the sheath has an extended state and a retracted state, and wherein in the extended state (see Fig. 1F) the sheath covers the entirety of the two or more cannula and at least part of the inflatable balloon 14, and in the retracted state the sheath does not cover a part of the inflatable balloon (Fig. 1D).
At the time of the effective filing date of the instant application it would have been obvious to one of ordinary skill in the art to provide a sheath as taught by Muni et al to the device of Wang in order to allow for a mechanism to allow for the targeted positioning of the catheter bellows and then the delivery of the medication (see [0099]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Hofling (USPN 5,354,279).
As set forth above Wang disclose the drug delivery device substantially as claimed but does not disclose a support structure for positioning and securing the guiding cannulas to the elongate member. Hofling disclose a drug delivery device having an elongated member (the construction of Figs. 1 and 2) having a support structure 20 for positioning and securing the guiding cannulas 12 in place.
At the time of the instant application it would have been obvious to one of ordinary skill in the art to utilize support structure such as taught by Hofling within the cannulas of Wang in order to provide support to the cannulas while allowing the retractable needles to be accommodated therein (see the abstract of Hofling).
Claim(s) 21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang.
As set forth above Wang discloses the invention substantially as claimed but does not disclose that the distal end of the axially extending elongate member is coupled to a flexible tip (claim 21) or that there is at least one radiopaque element (claim 23). The Examiner gives official notice that drug delivery devices with a distal end coupled to a flexible tip (claim 21) and drug delivery devices having at least one radiopaque element (claim 23) are common and well-known.
At the time of the invention it would have been obvious to utilize a flexible tip in order to ensure atraumatic catheter insertion and to provide a radiopaque in order to allow tracking and correct positioning of the balloon at a treatment site.
Claim(s) 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Mandrusov et al (USPAP 2004/0002650).
As set forth above Wang disclose the invention substantially as claimed but does not disclose a mechanism for controlling the maximum needle extension depth (claim 25) or set forth that the handle comprises a means for reversibly extending the needles from the cannulas (claim 26).
Mandrusov et al a similar drug delivery device including a mechanism for controlling the maximum needle extension depth ( see the needle lock 355) or set forth that the handle comprises a means for reversibly extending the needles from the cannulas (see the adjustment knob 357 of Fig. 3).
At the time of the effective filing date of the instant application it would have been obvious to one of ordinary skill in the art to include a mechanism for controlling needle extension depth and a means for reversibly extending the needles, as taught by Mandrusov et al, in order to prevent and control over extension of the needles and thus preventing trauma to the patient and to provide a means for reversibly extending the needles in order to have a mechanism to precisely control the needle extended and retracted position.
Allowable Subject Matter
Claim 6 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art neither discloses nor makes obvious a drug delivery device as set forth in claim 1 wherein the distal portion of each guiding cannula is able to move freely with respect to the inflatable balloon, and/or wherein the distal portion of each guiding cannula is not affixed to the inflatable balloon, as noted above, the closest prior art to Wang teaches of adhesively attaching the guiding cannulas to the balloon 320.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Orth, Fischell (‘458) & (‘792), and Jacobsen disclose drug delivery devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES G FREAY whose telephone number is (571)272-4827. The examiner can normally be reached Mon - Fri: 8:00 - 5:00.
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/CHARLES G FREAY/ Primary Examiner, Art Unit 3746
CGF
November 20, 2025