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 .
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 12-13, 15-23, 28, 31-32, drawn to a balloon catheter, classified in A61M 25/10.
II. Claims 24, 26-27, 33 and 34, drawn to a method of making a balloon for a balloon catheter, classified in A61M 25/1029.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the product as claimed can be made by another and materially different process such as preparing the wrap made using single fiber and then sliding the balloon inside the single fiber wrap. Additionally, the process as claimed can be made using another and materially different product such as designing a balloon having a central section with first and second end located away from ends of the balloon and then wrapping the single fiber thereby leaving portions of the balloons on either or both ends exposed without any wraps from the single fiber.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) The inventions require a different field of search (for example, searching
different classes/subclasses or electronic resources, or employing different search queries);
(b) The prior art applicable to one invention would not likely be applicable to another invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Damon Boyd on 12/5/2025 a provisional election was made without traverse to prosecute the invention of invention I, claims 12-13, 15-23, 28, 31-32. Affirmation of this election must be made by applicant in replying to this Office action. Claims 24, 26-27, 33 and 34 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Specification
The disclosure is objected to because of the following informalities:
The reference character “30” has been used to refer to “fiber wrap” on page 7, line 5 and “fiber layer” on page 5, line 6.
Appropriate correction is required.
Claim Objections
Claims 17 and 21 are objected to because of the following informalities:
Regarding claim 17, line 3, line 3, the recitation “balloon body” appears to be amended to recite “a balloon body” in order to refer to “a balloon body” in claim 12, line 3.
Regarding claim 21, lines 1-2, the recitation “an encapsulating polymer layer” appears to be amended to recite “the encapsulating polymer layer” to refer to “an encapsulating polymer layer” recited in claim 20.
Appropriate correction is required.
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.
Claims 12, 13, 15-23 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 12 recites the limitation “the longitudinal axis” in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. Examiner acknowledges the recitation of “a longitudinal axis” in line 4 however, “a longitudinal axis” in line 4 refers to an axis of a balloon whereas “the longitudinal axis” in lines 9-10 refers to an axis of the balloon catheter. Therefore, claim is unclear if “the longitudinal axis” of the balloon catheter and “a longitudinal axis” of a balloon are same or not. For examination purposes, examiner construes that longitudinal axis of “a balloon” and the balloon catheter are same.
Claims 13 and 15-23 being dependent on claim 12 are also rejected.
Regarding claim 13, the recitation of “a figure-8 pattern” in line 2 renders the claim indefinite because the claim is unclear if “a figure-8 pattern” in claim 13 refers to “a figure-8 wrap” recited in line 9 or additional. For examination purposes, examiner construes that “a figure-8 pattern” refers to “a figure-8 wrap” recited in claim 12.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 recites the same limitation as recited in claim 20. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 12, 13, 15-17, 19, 20, 21, 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US 2008/0033477 A1) in view of Tilson et al. (US 2016/0121076 A1) and further in view of Lysgaard et al. (US 2017/0072172 A1).
Regarding claim 12, Campbell discloses a balloon catheter 20 (figure 1 with balloon 48 shown in figures 4A-5B, 7), comprising:
a shaft 24 having a distal end (end of element 24 where element 48 would be connected) and a proximal end (end of element 24 comprising element 22); and
a balloon 48 provided at the distal end (end of element 48 closest to the patient when getting inserted into the patient), the balloon 48 having a balloon body (body of element 48) having opposing first and second ends (both ends of body of element 48), a longitudinal axis 50, and a reinforcement fiber layer (layer formed by elements 52, 54) wrapped on the balloon body (body of element 48), the reinforcement fiber layer including a single fiber 54 wrapped radially on a surface (surface of element 48) of the balloon 48 in rows, and wrapped fiber 52 in an axial direction along the longitudinal to continuously traverse from the first end to the second end (see figures 4A-5B, 7), and the second end back to the first end in a longitudinal figure-8 wrap (see figures 4A-5B, 7) such that the fiber is non-parallel to the longitudinal axis 50 of the balloon catheter.
Campbell does disclose the use of single continuous fiber for longitudinal layers (paragraph 0039, lines 15-17) but is silent regarding the use of single continuous fiber for both radially and axial direction wrap.
However, Tilson teaches a design of a balloon (figure 10) wherein a single continuous fiber is used for wrapping in both radial and axial direction (paragraph 0011, lines 7-11) for the purpose of using a well-known alternative to make a fiber-reinforced composite balloon (paragraph 0019, lines 1-6).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the number of fibers used in Campbell to include the use of a single continuous fiber for wrapping in both radial and axial direction as taught by Tilson for the purpose of using a well-known alternative to make a fiber-reinforced composite balloon (paragraph 0019, lines 1-6).
Campbell is silent regarding a fiber first wrapped radially on a surface of the balloon and then wrapped over the radially wrapped fiber.
However, Lysgaard teaches a design of a high strength balloon (figures 3, 4) comprising a fiber first wrapped radially on a surface of the balloon and then wrapped over the radially wrapped fiber (paragraph 0037, lines 7-10) for the purpose of using a well-known alternative configuration to design a high strength balloon (paragraph 0008, lines 1-3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to reverse the fiber wrapping of Campbell to incorporate a fiber first wrapped radially on a surface of the balloon and then wrapped over the radially wrapped fiber as taught by Lysgaard for the purpose of using a well-known alternative configuration to design a high strength balloon (paragraph 0008, lines 1-3).
Regarding claim 13, Campbell discloses wherein the fiber layer further comprises a figure-8 pattern (see figures 4A-5B, 7).
Regarding claim 15, Campbell discloses further comprising a Y-connector 22 at the proximal end.
Regarding claim 16, Campbell discloses wherein the radially wrapped fiber comprises non-continuous rows 54 (gap exists between two adjacent elements 54).
Regarding claim 17, Campbell discloses wherein the balloon has an outer surface (outer surface of element 48) and a base coating of tacky material (paragraph 0038) is applied to the outer surface of balloon body.
Regarding claim 19, Campbell discloses wherein the reinforcement fiber layer (layer formed by elements 52, 54) is wrapped over the balloon body (body of element 48) and the base coating (paragraph 0039).
Regarding claims 20 and 21, Campbell discloses wherein an encapsulating polymer layer (paragraph 0059) is applied over the reinforcement fiber layer (layer formed by elements 52, 54).
Regarding claim 22, Campbell discloses wherein the balloon 48 has a cylindrical central section 60 having opposite ends (ends of element 60), and a tapered neck 58 provided at each of the opposite ends but is silent regarding wherein the radial wrap does not cover at least one of the tapered necks.
However, Lysgaard teaches wherein the radial wrap 52 does not cover at least one of the tapered necks 34 (figure 3) for the purpose of regulating the level of strength that can be imparted to the balloon only in the desired area as needed (paragraph 0036).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the balloon of Campbell to incorporate wherein the radial wrap does not cover at least one of the tapered necks as taught by Lysgaard for the purpose of regulating the level of strength that can be imparted to the balloon only in the desired area as needed (paragraph 0036).
Regarding claim 23, Campbell discloses wherein the balloon 48 has a cylindrical central section 60 having opposite ends (ends of element 60), and a tapered neck 58 provided at each of the opposite ends and wherein the figure-8 wrap extends across the cylindrical central section 60 and the tapered necks 58 (see figures 4A-5B, 7).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US 2008/0033477 A1) in view of Tilson et al. (US 2016/0121076 A1) in view of Lysgaard et al. (US 2017/0072172 A1) and further in view of Bierman et al. (US 7,628,154 B2).
Regarding claim 18, Campbell/Tilson/Lysgaard (hereinafter referred as “modified Campbell”) discloses the claimed invention substantially as claimed, as set forth above in claims 12 and 17.
Modified Campbell is silent regarding wherein the base coating of tacky material is Kraton.
However, Bierman teaches a design of an endo-tracheal tube securement system (figure 2) wherein base coating of tacky material is Kraton (column 22, lines 42-49) for the purpose of using a well-known biocompatible material for providing traction between two components (column 22, lines 42-49).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the base coating of tacky material of modified Campbell to incorporate Kraton as taught by Bierman for the purpose of using a well-known biocompatible material for providing traction between two components (column 22, lines 42-49).
Claim(s) 28, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US 2008/0033477 A1) in view of Tilson et al. (US 2016/0121076 A1) in view of Lysgaard et al. (US 2017/0072172 A1) and further in view of Krivoruchko (US 2008/0255512 A1).
Regarding claim 28, Campbell discloses a balloon catheter 20 (figure 1 with balloon 48 shown in figures 4A-5B, 7), comprising:
a shaft 24 having a distal end (end of element 24 where element 48 would be connected) and a proximal end (end of element 24 comprising element 22); and
a balloon 48 provided at the distal end (end of element 48 closest to the patient when getting inserted into the patient), the balloon 48 having a balloon body (body of element 48) having opposing first and second ends (both ends of body of element 48), a longitudinal axis 50, and a reinforcement fiber 52, 54 wrapped radially on a surface (surface of element 48) of the balloon body (body of element 48), the fiber includes a continuous fiber 52, 54 that continuously traverse from the first end to the second end (see figures 4A-5B, 7), and wrapping the fiber to traverse in an axial direction along the longitudinal axis from the first end to the second end, and the second end back to the first end in a longitudinal figure-8 wrap (see figures 4A-5B, 7) such that the fiber is non-parallel to the longitudinal axis 50 of the balloon catheter.
Campbell does disclose the use of single continuous fiber for longitudinal layers (paragraph 0039, lines 15-17) but is silent regarding the use of single continuous fiber for both radially and axial direction wrap.
However, Tilson teaches a design of a balloon (figure 10) wherein a single continuous fiber is used for wrapping in both radial and axial direction (paragraph 0011, lines 7-11) for the purpose of using a well-known alternative to make a fiber-reinforced composite balloon (paragraph 0019, lines 1-6).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the number of fibers used in Campbell to include the use of a single continuous fiber for wrapping in both radial and axial direction as taught by Tilson for the purpose of using a well-known alternative to make a fiber-reinforced composite balloon (paragraph 0019, lines 1-6).
Campbell is silent regarding a fiber first wrapped radially on a surface of the balloon and then wrapped over the radially wrapped fiber.
However, Lysgaard teaches a design of a high strength balloon (figures 3, 4) comprising a fiber first wrapped radially on a surface of the balloon and then wrapped over the radially wrapped fiber (paragraph 0037, lines 7-10) for the purpose of using a well-known alternative configuration to design a high strength balloon (paragraph 0008, lines 1-3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to reverse the fiber wrapping of Campbell to incorporate a fiber first wrapped radially on a surface of the balloon and then wrapped over the radially wrapped fiber as taught by Lysgaard for the purpose of using a well-known alternative configuration to design a high strength balloon (paragraph 0008, lines 1-3).
Campbell is silent regarding wrapping the fiber that continuously traverses the second end back to the first end.
However, Krivoruchko teaches a design of a balloon (figure 5) with improved strength that teaches wrapping the fiber that continuously traverses the second end back to the first end (see figure 5) for the purpose of designing a balloon with balanced properties necessary to perform medical procedures (paragraph 0013).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify the transverse wrapping of fiber of Campbell to incorporate wrapping the fiber that continuously traverses the second end back to the first end as taught by Krivoruchko for the purpose of designing a balloon with balanced properties necessary to perform medical procedures (paragraph 0013).
Campbell modified in view of Tilson already teaches the use of single fiber for performing different wrapping patterns therefore, Campbell in view of Tilson and Krivoruchko will result in having the fiber including a single fiber that continuously traverses from the first end to the second end, and the second end back to the first end.
Regarding claim 31, Campbell discloses wherein the single continuous fiber 52, 54 is further radially wrapped around the balloon in rows (rows formed by element 54).
Regarding claim 32, Campbell discloses wherein the balloon body rows are non-continuous (gaps exist between two adjacent elements 54).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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, CHELSEA STINSON can be reached at 571-270-1744. 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.
/NILAY J SHAH/Primary Examiner, Art Unit 3783