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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the winding mechanism and splitting mechanism must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 132.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: The parts objected to in the drawings above (see drawing objection above) fail to include reference characters in the written description as well. Each part in the drawings/specification, especially the modules, should include a reference character/number.
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: winding mechanism in claims 7, 8 and 17, and splitting mechanism in claims 8 and 17.
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 the first paragraph of 35 U.S.C. 112(a):
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.
Claims 7, 8 and 17 are 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 8 recites the limitation “the splitting mechanism.” There is insufficient antecedent basis for this limitation in the claim because claim 8 previously recites “a roll-sock splitting device”. Examiner interprets “a roll-sock splitting device” as “a splitting mechanism”.
Claim limitations “winding mechanism” and “splitting mechanism” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Neither the specification of the drawings provide any clearly linked structures to the functions of winding and splitting performed by the winding mechanism and splitting mechanism, respectively. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cully (US 20190247210) in view of Gunderson (US 20120101562).
Regarding claim 1, Cully discloses a coated medical balloon assembly comprising: a balloon catheter (Figs. 1A-B: elongate member 160 being a balloon catheter; paras. [0096] and [0034]) having a proximal end and a distal end (Fig. 1A: distal end at “160” label and proximal end at “135” label), and a medical balloon mounted to the balloon catheter at or proximate the catheter distal end (Figs. 1A-B: medical device 150 being a balloon; para. [0034]); a bioactive material coating on at least the medical balloon (para. [0034], the medical device balloon 150 being drug-coated); a roll-sock sheath disposed over the medical balloon and at least a part of the balloon catheter (Fig. 1A: roll-sock sheath 100 over 150 and over proximal portion of 160), the roll-sock sheath comprising a first, inner, roll-sock layer disposed adjacent the medical balloon (Fig. 1A: 104; para. [0042], sentences 1-2) and a second, outer, roll-sock layer disposed over the first roll-sock layer (Fig. 1A: 105; para. [0042], sentences 1-2), the roll-sock sheath including first and second roll-sock sheath ends (Fig. 1A: first end 107, second end 108 + 180; para. [0044], sentence 1) and a fold line (Fig. 1A: fold 106; para. [0044], sentence 2), the first and second roll-sock sheath ends being disposed at a proximal location relative to the fold line (Fig. 1A: 107 and 108 both proximal to fold 106), the fold line being disposed adjacent the distal end of the balloon catheter (Fig. 1A: 106 at distal end of 150), the first roll-sock sheath end being an end of the first roll-sock layer and the second roll-sock sheath end being an end of the second roll-sock layer (Figs. 1A-B: end of outer layer 105 being at 108 and the end of inner layer 104 being at 107); a roll-sock sheath retraction mechanism coupled to the second roll-sock end and configured to retract the second roll-sock layer towards the proximal end of the catheter (Figs. 1A and 1D: 180; para. [0061]), whereby the first roll-sock layer progressively wraps over itself outwardly to the second roll-sock layer, thereby rolling back the roll-sock sheath and exposing the coated medical balloon for deployment (Fig. 1C; Figs. 1A-B). However, Cully does not explicitly disclose that the outer surface of the second roll-sock layer and assembly is coated in a hydrophilic or lubricous layer.
Gunderson teaches an analogous expanding medical device with a roll-sock sheath (Figs. 1-2: device assembly 10), which comprises a coating of hydrophilic or lubricous material on an outer surface of the second roll-sock layer (Fig. 1: outer sheath layer 14) and forming an outer layer of the coated medical balloon assembly (para. [0054], the lubricious/hydrophilic coating covering assembly 10 when inserted, including outer layer 14). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Cully medical assembly by incorporating the outer coating of the lubricous/hydrophilic layer taught by Gunderson in order to more easily slide the device into the patient’s vasculature (Gunderson: para. [0054], sentences 2-3).
Regarding claim 2, Cully in view of Gunderson teaches an assembly according to claim 1, as described above, comprising a dilator tip at the distal end of the balloon catheter (Cully: Figs. 1A-B: expended dilator tip at distal end of 160), the roll-sock sheath fold line being disposed adjacent the dilator tip when the roll-sock sheath is in a balloon overlying configuration (Cully: Fig. 1A: 106 at end of dilator tip), the coating of hydrophilic or lubricous material being disposed over the second roll-sock layer and the dilator tip (Gunderson: para. [0054], the lubricious/hydrophilic coating covering assembly 10 when inserted, including dilator tip 22).
Regarding claim 3, Cully in view of Gunderson teaches an assembly according to claim 1, as described above, wherein the first roll-sock layer of the roll-sock sheath contacts the medical balloon when the roll-sock sheath is in a balloon overlying configuration (Cully: Fig. 1A: 104 in contact with 150).
Regarding claim 4, Cully in view of Gunderson teaches an assembly according to claim 1, as described above, wherein the first end of the roll sock sheath is disposed at or adjacent a proximal end of the coated balloon (Cully: Figs. 1A-B: 107 at proximal end of 150).
Regarding claim 5, Cully in view of Gunderson teaches an assembly according to claim 1, as described above, wherein the first end of the roll sock sheath is attached to the catheter at or adjacent the proximal end of the coated balloon (Cully: Figs. 1A-B: 107 attached to 160 at the proximal end of 150).
Regarding claim 6, Cully in view of Gunderson teaches an assembly according to claim 1, as described above, wherein the second end of the roll sock sheath is disposed at one of: (1) a location at or adjacent a proximal end of the catheter; and (2) an intermediate location of the catheter between its proximal and distal ends (Cully: Figs. 1A-B: 108 adjacent and proximal to 150).
Regarding claim 7, Cully in view of Gunderson teaches an assembly according to claim 1, as described above, comprising a roll-sock sheath winding mechanism operable to wind the second end of the roll-sock sheath during retraction thereof (Cully: Fig. 1D: winding mechanism 185; para. [0062]).
Regarding claim 8, Cully in view of Gunderson teaches an assembly according to claim 7, as described above, comprising a roll-sock splitting device configured to split the second end of the roll-sock sheath longitudinally prior to winding on the winding mechanism (Cully: Fig. 1D: splitter 181 which splits the end portion of 180 of the second end 108 of the roll-sock sheath; para. [0063]), wherein the splitting mechanism splits the roll-sock sheath only at or adjacent the proximal end of the balloon catheter (Cully: Fig. 1D: splitting at 181 at the proximal end of 160).
Regarding claim 9, Cully in view of Gunderson teaches an assembly according to claim 1, as described above, comprising a low friction material disposed between the first and second layers of the roll-sock sheath (Cully: Fig. 1B: material 120; para. [0041], sentences 3-5).
Regarding claim 10, Cully in view of Gunderson teaches an assembly according to claim 9, as described above, wherein the low friction material comprises one or more of: a material forming the roll-sock sheath, a layer of low friction compound between the first and second roll-sock layers of the roll-sock sheath, a liquid or gas disposed between the first and second roll-sock layers of the roll-sock sheath (Cully: para. [0041], sentences 3-5, 120 being a fluid between 104 and 105).
Regarding claim 11, Cully in view of Gunderson teaches an assembly according to claim 10, as described above, wherein the layer of low friction compound is a layer of hydrophilic material (Gunderson: para. [0054], sentences 1 and 5). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the low friction compound taught by Cully (120, which is not explicitly disclosed to be hydrophilic), by also incorporating the hydrophilic lubricious coating taught by Gunderson, such that the low friction compound taught by Cully in the Cully-Gunderson combination is also hydrophilic, in order to utilize the lubricating qualities of a hydrophilic polymer (Gunderson: para. [0054], sentence 5).
Regarding claim 12, Cully in view of Gunderson teaches an assembly according to claim 10, as described above, wherein the liquid or gas is disposed between the first and second roll-sock layers at the time of retraction of the roll-sock sheath, the apparatus comprising a device for locating such liquid or gas between the first and second roll-sock layers of roll-sock sheath at the time of retraction (Cully: para. [0041], the disposal of 120 causes the eversion, disposed at the time of retracting).
Regarding claim 13, Cully discloses a method of deploying a coated medical balloon in a patient comprising: providing a balloon catheter (Figs. 1A-B: elongate member 160 being a balloon catheter; paras. [0096] and [0034]) having a proximal end and a distal end (Fig. 1A: distal end at “160” label and proximal end at “135” label), and a medical balloon mounted to the balloon catheter at or proximate the catheter distal end (Figs. 1A-B: medical device 150 being a balloon; para. [0034]); a bioactive material coating on at least the medical balloon (para. [0034], the medical device balloon 150 being drug-coated); a roll-sock sheath disposed over the medical balloon and at least a part of the balloon catheter (Fig. 1A: roll-sock sheath 100 over 150 and over proximal portion of 160), the roll-sock sheath comprising a first, inner, roll-sock layer disposed adjacent the medical balloon (Fig. 1A: 104; para. [0042], sentences 1-2) and a second, outer, roll-sock layer disposed over the first roll-sock layer (Fig. 1A: 105; para. [0042], sentences 1-2), the roll-sock sheath including first and second roll-sock sheath ends (Fig. 1A: first end 107, second end 108; para. [0044], sentence 1) and a fold line (Fig. 1A: fold 106; para. [0044], sentence 2), the first and second roll-sock sheath ends being disposed at a proximal location relative to the fold line (Fig. 1A: 107 and 108 both proximal to fold 106), the fold line being disposed adjacent the distal end of the balloon catheter (Fig. 1A: 106 at distal end of 150), the first roll-sock sheath end being an end of the first roll-sock layer and the second roll-sock sheath end being an end of the second roll-sock layer (Figs. 1A-B: end of outer layer 105 being at 108 and the end of inner layer 104 being at 107); retracting the second roll-sock layer, whereby the first roll-sock layer progressively wraps over itself outwardly to the second roll-sock layer to roll back the roll-sock sheath and expose the medical balloon for deployment (Fig. 1C; Figs. 1A-B; para. [0041]). However, the method of Cully does not explicitly disclose that the outer surface of the second roll-sock layer and assembly is coated in a hydrophilic or lubricous layer.
Gunderson teaches an analogous method for deploying an expanding medical device with a roll-sock sheath (Figs. 1-2: device assembly 10), which comprises a coating of hydrophilic or lubricous material on an outer surface of the second roll-sock layer and forming an outer layer of the coated medical balloon assembly (para. [0054], the lubricious/hydrophilic coating covering assembly 10 when inserted, including outer layer 14); feeding the assembly endoluminally through the vasculature of a patient, whereby the hydrophilic or lubricous coating eases the passage of the assembly through the vasculature (para. [0054], sentences 2-3); and whereby the hydrophilic or lubricous layer overlying the second roll-sock layer is retracted with the second roll-sock layer and such that contact between the hydrophilic or lubricous layer on the roll-sock sheath and the bioactive material layer on the balloon is avoided or minimized (para. [0054], the lubricious/hydrophilic coating covering assembly 10 when inserted, being outer layer 14 and not the inner layer). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Cully medical assembly and method by incorporating the outer coating of the lubricous/hydrophilic layer taught by Gunderson in order to more easily slide the device into the patient’s vasculature (Gunderson: para. [0054], sentences 2-3).
Regarding claim 14, Cully in view of Gunderson teaches a method according to claim 13, as described above, wherein a dilator tip disposed at the distal end of the balloon (Cully: Figs. 1A-B: expended dilator tip at distal end of 160) is coated with the hydrophilic or lubricous material disposed over the second roll-sock layer, and wherein the step of feeding the assembly endoluminally through the vasculature of a patient is eased by the hydrophilic or lubricous coating over the roll-sock sheath and the dilator tip (Gunderson: para. [0054]).
Regarding claim 15, Cully in view of Gunderson teaches a method according to claim 13, as described above, wherein the first roll-sock layer of the roll-sock sheath contacts the medical balloon when the roll-sock sheath is in a balloon overlying configuration (Cully: Fig. 1A: 104 in contact with 150).
Regarding claim 16, Cully in view of Gunderson teaches a method according to claim 13, as described above, comprising winding the second end of the roll- sock sheath during retraction thereof (Cully: Fig. 1D: winding mechanism 185; para. [0062]).
Regarding claim 17, Cully in view of Gunderson teaches a method according to claim 16, as described above, comprising splitting the second end of the roll- sock sheath longitudinally prior to winding on the winding mechanism (Cully: Fig. 1D: splitter 181 which splits the end portion of 180 of the second end 108 of the roll-sock sheath; para. [0063]), wherein the splitting mechanism splits the roll-sock sheath only at or adjacent the proximal end of the balloon catheter (Cully: Fig. 1D: splitting at 181 at the proximal end of 160).
Regarding claim 18, Cully in view of Gunderson teaches a method according to claim 13, as described above, comprising disposing a low friction material between the first and second roll-sock layers of the roll-sock sheath (Cully: Fig. 1B: material 120; para. [0041], sentences 3-5).
Regarding claim 19, Cully in view of Gunderson teaches a method according to claim 18, as described above, the low friction material comprises one or more of: a material forming the roll-sock sheath, a layer of low friction compound between the first and second roll-sock layers of the roll-sock sheath, a liquid or gas disposed between the first and second roll-sock layers of the roll-sock sheath (Cully: para. [0041], sentences 3-5, 120 being a fluid between 104 and 105).
Regarding claim 20, Cully in view of Gunderson teaches a method according to claim 19, as described above, comprising the step of disposing the liquid or gas between the first and second roll-sock layers at the time of retraction of the roll- sock sheath (Cully: para. [0041], the disposal of 120 causes the eversion, disposed at the time of retracting).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL TSAI can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
Prosecution Insights